II 
Calendar No. 174 
115TH CONGRESS 
1ST SESSION H. R. 2430 
IN THE SENATE OF THE UNITED STATES 
JULY 13, 2017 
Received; read the first time 
JULY 17, 2017 
Read the second time and placed on the calendar 
AN ACT 
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 bio-
logical products, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘FDA Reauthorization 
Act of 2017’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents for this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
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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; finding. 
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 dates. 
TITLE III—FEES RELATING TO GENERIC DRUGS 
Sec. 301. Short title; finding. 
Sec. 302. Definitions. 
Sec. 303. Authority to assess and use human generic drug fees. 
Sec. 304. Reauthorization; reporting requirements. 
Sec. 305. Sunset dates. 
Sec. 306. Effective date. 
Sec. 307. Savings clause. 
TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL 
PRODUCTS 
Sec. 401. Short title; finding. 
Sec. 402. Definitions. 
Sec. 403. Authority to assess and use biosimilar fees. 
Sec. 404. Reauthorization; reporting requirements. 
Sec. 405. Sunset dates. 
Sec. 406. Effective date. 
Sec. 407. Savings clause. 
TITLE V—PEDIATRIC DRUGS AND DEVICES 
Sec. 501. Best pharmaceuticals for children. 
Sec. 502. Pediatric devices. 
Sec. 503. Early meeting on pediatric study plan. 
Sec. 504. Development of drugs and biological products for pediatric cancers. 
Sec. 505. Additional provisions on development of drugs and biological products 
for pediatric use. 
TITLE VI—REAUTHORIZATIONS AND IMPROVEMENTS RELATED 
TO DRUGS 
Sec. 601. Reauthorization of provision relating to exclusivity of certain drugs 
containing single enantiomers. 
Sec. 602. Reauthorization of the critical path public-private partnerships. 
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Sec. 603. Reauthorization of orphan grants program. 
Sec. 604. Protecting and strengthening the drug supply chain. 
Sec. 605. Patient experience data. 
Sec. 606. Communication plans. 
Sec. 607. Orphan drugs. 
Sec. 608. Pediatric information added to labeling. 
Sec. 609. Sense of Congress on lowering the cost of prescription drugs. 
Sec. 610. Expanded access. 
Sec. 611. Tropical disease product application. 
TITLE VII—DEVICE INSPECTION AND REGULATORY 
IMPROVEMENTS 
Sec. 701. Risk-based inspections for devices. 
Sec. 702. Improvements to inspections process for device establishments. 
Sec. 703. Reauthorization of inspection program. 
Sec. 704. Certificates to foreign governments for devices. 
Sec. 705. Facilitating international harmonization. 
Sec. 706. Fostering innovation in medical imaging. 
Sec. 707. Risk-based classification of accessories. 
Sec. 708. Device pilot projects. 
Sec. 709. Regulation of over-the-counter hearing aids. 
Sec. 710. Report on servicing of devices. 
TITLE VIII—IMPROVING GENERIC DRUG ACCESS 
Sec. 801. Priority review of generic drugs. 
Sec. 802. Enhancing regulatory transparency to enhance generic competition. 
Sec. 803. Competitive generic therapies. 
Sec. 804. Accurate information about drugs with limited competition. 
Sec. 805. Suitability petitions. 
Sec. 806. Inspections. 
Sec. 807. Reporting on pending generic drug applications and priority review 
applications. 
Sec. 808. Incentivizing competitive generic drug development. 
Sec. 809. GAO study of issues regarding first cycle approvals of generic medi-
cines. 
TITLE IX—ADDITIONAL PROVISIONS 
Sec. 901. Technical corrections. 
Sec. 902. Annual report on inspections. 
Sec. 903. Streamlining and improving consistency in performance reporting. 
Sec. 904. Analysis of use of funds. 
Sec. 905. Facilities management. 
TITLE I—FEES RELATING TO 
DRUGS 
SEC. 101. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Prescription Drug User Fee Amendments of 2017’’. 
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(b) FINDING.—The Congress finds that the fees au-
thorized by the amendments made in this title will be dedi-
cated toward expediting the drug development process and 
the process for the review of human drug applications, in-
cluding postmarket drug safety activities, as set forth in 
the goals identified for purposes of part 2 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. 102. AUTHORITY TO ASSESS AND USE DRUG FEES. 
(a) TYPES OF FEES.— 
(1) IN GENERAL.—Section 736(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
379h(a)) is amended— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘fiscal year 2013’’ and inserting 
‘‘fiscal year 2018’’; 
(B) in the heading of paragraph (1), by 
striking ‘‘AND SUPPLEMENT’’; 
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(C) in paragraph (1), by striking ‘‘or a 
supplement’’ and ‘‘or supplement’’ each place 
either appears; 
(D) in paragraph (1)(A)— 
(i) in clause (i), by striking ‘‘(c)(4)’’ 
and inserting ‘‘(c)(5)’’; and 
(ii) in clause (ii), by striking ‘‘A fee 
established’’ and all that follows through 
‘‘are required.’’ and inserting the following: 
‘‘A fee established under subsection (c)(5) 
for a human drug application for which 
clinical data (other than bioavailability or 
bioequivalence studies) with respect to 
safety or effectiveness are not required for 
approval.’’; 
(E) in the heading of paragraph (1)(C), by 
striking ‘‘OR SUPPLEMENT’’; 
(F) in paragraph (1)(F)— 
(i) in the heading, by striking ‘‘OR IN-
DICATION’’; and 
(ii) by striking the second sentence; 
(G) by striking paragraph (2) (relating to 
a prescription drug establishment fee); 
(H) by redesignating paragraph (3) as 
paragraph (2); 
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(I) in the heading of paragraph (2), as so 
redesignated, by striking ‘‘PRESCRIPTION DRUG 
PRODUCT FEE’’ and inserting ‘‘PRESCRIPTION 
DRUG PROGRAM FEE’’; 
(J) in subparagraph (A) of such paragraph 
(2), by amending the first sentence to read as 
follows: ‘‘Except as provided in subparagraphs 
(B) and (C), each person who is named as the 
applicant in a human drug application, and 
who, after September 1, 1992, had pending be-
fore the Secretary a human drug application or 
supplement, shall pay the annual prescription 
drug program fee established for a fiscal year 
under subsection (c)(5) for each prescription 
drug product that is identified in such a human 
drug application approved as of October 1 of 
such fiscal year.’’; 
(K) in subparagraph (B) of such para-
graph (2)— 
(i) in the heading of subparagraph 
(B), by inserting after ‘‘EXCEPTION’’ the 
following: ‘‘FOR
CERTAIN
PRESCRIPTION 
DRUG PRODUCTS’’; and 
(ii) by striking ‘‘A prescription drug 
product shall not be assessed a fee’’ and 
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inserting ‘‘A prescription drug program fee 
shall not be assessed for a prescription 
drug product’’; and 
(L) by adding at the end of such para-
graph (2) the following: 
‘‘(C) 
LIMITATION.—A 
person 
who 
is 
named as the applicant in an approved human 
drug application shall not be assessed more 
than 5 prescription drug program fees for a fis-
cal year for prescription drug products identi-
fied in such approved human drug applica-
tion.’’. 
(2) CONFORMING AMENDMENT.—Subparagraph 
(C) of section 740(a)(3) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j–12(a)(3)) is 
amended to read as follows: 
‘‘(C) LIMITATION.—An establishment shall 
be assessed only one fee per fiscal year under 
this section.’’. 
(b) FEE REVENUE AMOUNTS.—Subsection (b) of sec-
tion 736 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379h) is amended to read as follows: 
‘‘(b) FEE REVENUE AMOUNTS.— 
‘‘(1) IN GENERAL.—For each of the fiscal years 
2018 through 2022, fees under subsection (a) shall, 
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except as provided in subsections (c), (d), (f), and 
(g), be established to generate a total revenue 
amount under such subsection that is equal to the 
sum of— 
‘‘(A) the annual base revenue for the fiscal 
year (as determined under paragraph (3)); 
‘‘(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)); 
‘‘(D) the dollar amount equal to the oper-
ating reserve adjustment for the fiscal year, if 
applicable (as determined under subsection 
(c)(3)); 
‘‘(E) the dollar amount equal to the addi-
tional direct cost adjustment for the fiscal year 
(as determined under subsection (c)(4)); and 
‘‘(F) additional dollar amounts for each 
fiscal year as follows: 
‘‘(i) $20,077,793 for fiscal year 2018. 
‘‘(ii) $21,317,472 for fiscal year 2019. 
‘‘(iii) $16,953,329 for fiscal year 
2020. 
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‘‘(iv) $5,426,896 for fiscal year 2021. 
‘‘(v) $2,769,609 for fiscal year 2022. 
‘‘(2) TYPES
OF
FEES.—Of the total revenue 
amount determined for a fiscal year under para-
graph (1)— 
‘‘(A) 20 percent shall be derived from 
human drug application fees under subsection 
(a)(1); and 
‘‘(B) 80 percent shall be derived from pre-
scription drug program fees under subsection 
(a)(2). 
‘‘(3) ANNUAL BASE REVENUE.—For purposes 
of paragraph (1), the dollar amount of the annual 
base revenue for a fiscal year shall be— 
‘‘(A) for fiscal year 2018, $878,590,000; 
and 
‘‘(B) for fiscal years 2019 through 2022, 
the dollar amount of the total revenue amount 
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: 
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‘‘(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-
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 
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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 
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. 
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‘‘(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— 
‘‘(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 
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‘‘(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 
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. 
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‘‘(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 
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-
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eral Register notice under paragraph (5) of the 
fee revenue and fees resulting from the adjust-
ment and the methodologies under this para-
graph. 
‘‘(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. 
‘‘(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-
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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 Ad-
justed; All Items; Annual Index) for the 
most recent 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— 
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‘‘(A) establish, for each such 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); 
(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); 
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(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-
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— 
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(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’’ 
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’’. 
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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. 
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 
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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; FINDING. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Medical Device User Fee Amendments of 2017’’. 
(b) FINDING.—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 
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. 
(a) IN GENERAL.—Section 737 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379i) is amended— 
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(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’’. 
(b) CONFORMING AMENDMENT.—Section 714(b)(1) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379d–3(b)(1)) is amended by striking ‘‘737(8)’’ and in-
serting ‘‘737(9)’’. 
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— 
(1) in paragraph (1), by striking ‘‘fiscal year 
2013’’ and inserting ‘‘fiscal year 2018’’; and 
(2) in paragraph (2)— 
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(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-
rived from the base fee amounts specified in para-
graph (2), to generate the total revenue amounts 
specified in paragraph (3). 
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‘‘(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’’; 
(B) by striking subparagraph (B) and in-
serting the following new subparagraph: 
‘‘(B) APPLICABLE
INFLATION
ADJUST-
MENT.—The applicable inflation adjustment for 
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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 
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 
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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 
(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 
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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 AMENDMENTS.— 
(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 
(iii) in subsection (a)(3)(A), by strik-
ing ‘‘and subsection (f)’’. 
(g) EFFECT OF FAILURE TO PAY FEES.—Subsection 
(f)(1), as so redesignated, of section 738 of the Federal 
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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 ‘‘the Medical Device User Fee 
Amendments of 2017’’; and 
(B) in subparagraph (B), by striking ‘‘the 
Medical Device User Fee Amendments Act of 
2012’’ and inserting ‘‘the 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— 
(1) in paragraph (1), by striking ‘‘2017’’ and 
inserting ‘‘2022’’; and 
(2) in paragraph (5), by striking ‘‘2017’’ and 
inserting ‘‘2022’’. 
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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. 
‘‘(2) SECRETARIAL
REVIEW
OF
ACCREDITED 
LABORATORY
DETERMINATIONS.—The 
Secretary 
may— 
‘‘(A) review determinations by testing lab-
oratories accredited pursuant to this subsection, 
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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.— 
‘‘(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-
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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 internet website of the Food 
and Drug Administration an annual report on 
the progress of the pilot program under this 
subsection. 
‘‘(4) SUNSET.—As of October 1, 2022— 
‘‘(A) the authority for accreditation bodies 
to accredit testing laboratories pursuant to 
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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.’’. 
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: 
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‘‘(ii) a device classified under section 
513(f)(2) or designated under section 
515C(d); 
‘‘(iii) a device that is intended to be 
permanently implantable, life sustaining, 
or life supporting, unless otherwise deter-
mined by the Secretary in accordance with 
subparagraph (B)(i)(II) and listed as eligi-
ble for review under subparagraph (B)(iii); 
or 
‘‘(iv) a device that is of a type, or sub-
set of a type, listed as not eligible for re-
view 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 
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‘‘(II) whether the device type, or 
subset of such device type, is perma-
nently implantable, life sustaining, or 
life supporting, and whether there is a 
detailed public health justification for 
permitting the review by an accredited 
person of such device type or subset; 
‘‘(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 
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‘‘(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’’. 
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— 
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‘‘(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 
‘‘(iii) criteria for waivers of and ex-
emptions from the requirements of this 
subsection. 
‘‘(C) FINAL
GUIDANCE.—The Secretary 
shall, not later than 1 year after the close of 
the public comment period on the draft guid-
ance issued under subparagraph (B), issue final 
guidance.’’. 
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 
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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 
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 DATES. 
(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.—Effective Octo-
ber 1, 2017, section 207(a) of the Food and Drug Admin-
istration Safety and Innovation Act (Public Law 112–144) 
is repealed. 
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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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application under section 505(j)(5)(A) and 
subsequently determines that an exclusivity 
period for a listed drug should have pre-
vented the Secretary from receiving such 
application, such that the abbreviated new 
drug application is no longer received with-
in the meaning of section 505(j)(5)(A).’’; 
(E) in subparagraph (E), by striking ‘‘or 
prior approval supplement’’; and 
(F) in the matter preceding clause (i) of 
subparagraph (F)— 
(i) by striking ‘‘2012’’ and inserting 
‘‘2017’’; and 
(ii) by striking ‘‘subsection (d)(3)’’ 
and inserting ‘‘subsection (d)(2)’’; 
(5) in paragraph (4)— 
(A) in subparagraph (A)— 
(i) in the matter preceding clause (i) 
and in clause (iii), by striking ‘‘, or in-
tended to be identified, in at least one ge-
neric drug submission that is pending or’’ 
and inserting ‘‘in at least one generic drug 
submission that is’’; 
(ii) in clause (i), by striking ‘‘or in-
tended to be identified in at least one ge-
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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-
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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’’; 
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(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 
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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— 
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(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. 379j–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: 
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‘‘(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. 379j– 
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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. 379j–42(i)) is amended— 
(1) in paragraph (2)— 
(A) in subparagraph (A), by striking ‘‘sub-
paragraphs (C) and (D)’’ and inserting ‘‘sub-
paragraph (C)’’; 
(B) by striking subparagraph (C) (relating 
to fee collection during first program year); 
(C) in subparagraph (D)— 
(i) in the heading, by striking ‘‘IN 
SUBSEQUENT YEARS’’; and 
(ii) by striking ‘‘(after fiscal year 
2013)’’; and 
(D) 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’’. 
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(i) INFORMATION ON ABBREVIATED NEW DRUG AP-
PLICATIONS OWNED BY APPLICANTS AND THEIR AFFILI-
ATES.—Section 744B of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j–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 a designated affiliate of such person, 
shall submit, on behalf of the person and the affili-
ates of such person, 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 application 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.’’. 
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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)— 
(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.— 
(1) IN GENERAL.—Effective October 1, 2017, 
section 304 of the Food and Drug Administration 
Safety and Innovation Act (Public Law 112–144) is 
repealed. 
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(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 304. 
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 
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 were 
received by the Food and Drug Administration within the 
meaning of section 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 on or after 
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October 1, 2012, but before October 1, 2017, 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’’. 
(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: 
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‘‘(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) 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 
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)’’; 
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(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-
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 biological 
product development fee paid by the per-
son for the product for such fiscal year. To 
qualify for consideration for a refund 
under this clause, a person shall submit to 
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the Secretary a written request for such 
refund not later than 180 days after the 
marketing application is accepted for fil-
ing.’’; 
(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 
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 paragraph (1)(F)— 
(A) in the subparagraph heading, by strik-
ing ‘‘BIOSIMILAR
DEVELOPMENT
PROGRAM’’; 
and 
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(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 
any reactivation fee paid under subpara-
graph (D).’’; 
(12) in paragraph (2)— 
(A) in the paragraph heading, 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. 
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‘‘(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). 
‘‘(B) RULE
OF
APPLICABILITY; TREAT-
MENT OF CERTAIN PREVIOUSLY PAID FEES.— 
Any person who pays a fee under subparagraph 
(A), (B), or (D) of paragraph (1) for a product 
before October 1, 2017, but submits a bio-
similar biological product application for that 
product after such date, shall— 
‘‘(i) be subject to any biosimilar bio-
logical product application fees that may 
be assessed at the time when such bio-
similar biological product application is 
submitted; and 
‘‘(ii) be entitled to no reduction of 
such application fees based on the amount 
of fees paid for that product before Octo-
ber 1, 2017, under such subparagraph (A), 
(B), or (D).’’; 
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(C) in the heading of subparagraph (D), 
by striking ‘‘OR SUPPLEMENT’’; 
(D) in subparagraphs (C) through (F), by 
striking ‘‘or supplement’’ each place it appears; 
and 
(E) in subparagraph (D), by striking ‘‘or 
a supplement’’; 
(13) 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. 
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‘‘(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-
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.— 
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‘‘(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)). 
‘‘(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)). 
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‘‘(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— 
‘‘(i) initial and annual biosimilar bio-
logical product development fees and reac-
tivation 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-
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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-
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 (h) (as redesig-
nated by paragraph (1)), 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 
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(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 
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 
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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 
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-
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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.— 
‘‘(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-
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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 
‘‘(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.— 
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‘‘(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-
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. 
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‘‘(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)(B) es-
tablishing 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)(B) 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. 
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‘‘(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-
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— 
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(1) by striking subparagraph (B); 
(2) by striking ‘‘; and’’ at the end of subpara-
graph (A) and inserting a period; and 
(3) by striking ‘‘shall pay—’’ and all that fol-
lows through ‘‘application fees’’ and inserting ‘‘shall 
pay application fees’’. 
(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 
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(B) in subparagraph (D)— 
(i) in the heading, by striking ‘‘IN 
SUBSEQUENT YEARS’’; and 
(ii) by striking ‘‘(after fiscal year 
2013)’’; and 
(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’’. 
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SEC. 405. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 744G and 744H of 
the Federal Food, Drug, and Cosmetic Act shall cease to 
be effective October 1, 2022. 
(b) REPORTING REQUIREMENTS.—Section 744I of 
the Federal Food, Drug, and Cosmetic Act shall cease to 
be effective January 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. 
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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—PEDIATRIC DRUGS 
AND DEVICES 
SEC. 501. BEST PHARMACEUTICALS FOR CHILDREN. 
Section 409I of the Public Health Service Act (42 
U.S.C. 284m) is amended— 
(1) in subsection (a)(2)(A)(ii), by inserting 
‘‘and identification of biomarkers for such diseases, 
disorders, or conditions,’’ after ‘‘biologics,’’; 
(2) in subsection (c)— 
(A) in paragraph (6)— 
(i) by amending subparagraph (B) to 
read as follows: 
‘‘(B) AVAILABILITY OF REPORTS.— 
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‘‘(i) IN GENERAL.—Each report sub-
mitted under subparagraph (A) shall be 
considered to be in the public domain (sub-
ject to section 505A(d)(4) of the Federal 
Food, Drug, and Cosmetic Act) and not 
later than 90 days after submission of 
such report, shall be— 
‘‘(I) 
posted 
on 
the 
internet 
website of the National Institutes of 
Health in a manner that is accessible 
and consistent with all applicable Fed-
eral laws and regulations, including 
such laws and regulations for the pro-
tection of— 
‘‘(aa) human research par-
ticipants, including with respect 
to privacy, security, informed 
consent, and protected health in-
formation; and 
‘‘(bb) proprietary interests, 
confidential commercial informa-
tion, and intellectual property 
rights; and 
‘‘(II) assigned a docket number 
by the Commissioner of Food and 
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Drugs and made available for the sub-
mission of public comments. 
‘‘(ii) SUBMISSION OF COMMENTS.—An 
interested person may submit written com-
ments concerning such pediatric studies to 
the Commissioner of Food and Drugs, and 
the submitted comments shall become part 
of the docket file with respect to each of 
the drugs.’’; and 
(ii) in subparagraph (C), by striking 
‘‘appropriate action’’ and all that follows 
through the period and inserting ‘‘action in 
a timely and appropriate manner in re-
sponse to the reports submitted under sub-
paragraph (A), and shall begin such action 
upon receipt of the report under subpara-
graph (A), in accordance with paragraph 
(7).’’; and 
(B) in paragraph (7)— 
(i) in the matter preceding subpara-
graph (A), by striking ‘‘During’’ and in-
serting ‘‘Within’’; 
(ii) in subparagraph (C)(i), by strik-
ing ‘‘place’’ and all that follows through 
‘‘and of’’ and inserting ‘‘include in the 
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public docket file a reference to the loca-
tion of the report on the internet website 
of the National Institutes of Health and a 
copy of’’; and 
(iii) in clause (ii), by striking ‘‘in the 
Federal Register and’’; 
(3) by striking subsection (d); 
(4) by redesignating subsection (e) as sub-
section (d); and 
(5) in paragraph (1) of subsection (d), as so re-
designated, by striking ‘‘2013 through 2017’’ and 
inserting ‘‘2018 through 2022’’. 
SEC. 502. PEDIATRIC DEVICES. 
(a) 
PEDIATRIC
USE
OF
DEVICES.—Section 
515A(a)(3) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360e–1(a)(3)) is amended— 
(1) 
by 
redesignating 
subparagraphs 
(B) 
through (D) as subparagraphs (D) through (F), re-
spectively; 
(2) by inserting after subparagraph (A) the fol-
lowing: 
‘‘(B) any information, based on a review of 
data available to the Secretary, regarding de-
vices used in pediatric patients but not labeled 
for such use for which the Secretary determines 
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that approved pediatric labeling could confer a 
benefit to pediatric patients; 
‘‘(C) the number of pediatric devices that 
receive a humanitarian use exemption under 
section 520(m);’’; 
(3) in subparagraph (E), as so redesignated, by 
striking ‘‘; and’’ and inserting ‘‘;’’; 
(4) in subparagraph (F) (as so redesignated), 
by striking ‘‘(B), and (C).’’ and inserting ‘‘(C), (D), 
and (E);’’; and 
(5) by adding at the end the following: 
‘‘(G) the number of devices for which the 
Secretary relied on data with respect to adults 
to support a determination of a reasonable as-
surance of safety and effectiveness in pediatric 
patients; and 
‘‘(H) the number of devices for which the 
Secretary relied on data from one pediatric sub-
population to support a determination of a rea-
sonable assurance of safety and effectiveness in 
another pediatric subpopulation. 
For the items described in this paragraph, such re-
port shall disaggregate the number of devices by pe-
diatric subpopulation.’’. 
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(b) HUMANITARIAN DEVICE EXEMPTION.—Section 
520(m) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360j(m)) is amended— 
(1) in paragraph (4)— 
(A) in subparagraph (B), by inserting ‘‘or 
an appropriate local committee’’ after ‘‘review 
committee’’ each place such term appears; and 
(B) in the matter following subparagraph 
(B), by inserting ‘‘or an appropriate local com-
mittee’’ after ‘‘review committee’’ each place 
such term appears; and 
(2) in paragraph (6)(A)(iv), by striking ‘‘2017’’ 
and inserting ‘‘2022’’. 
(c) DEMONSTRATION GRANTS FOR IMPROVING PEDI-
ATRIC AVAILABILITY.—Section 305 of the Pediatric Med-
ical Device Safety and Improvement Act of 2007 (Public 
Law 110–85; 42 U.S.C. 282 note)) is amended— 
(1) in subsection (c)— 
(A) in paragraph (4), by striking ‘‘and’’ at 
the end; 
(B) in paragraph (5), by striking the pe-
riod and inserting ‘‘; and’’; and 
(C) by adding at the end the following: 
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‘‘(6) providing regulatory consultation to device 
sponsors in support of the submission of an applica-
tion for a pediatric device, where appropriate.’’; and 
(2) in subsection (e), by striking ‘‘2013 through 
2017’’ and inserting ‘‘2018 through 2022’’. 
(d) MEETING
ON PEDIATRIC DEVICE DEVELOP-
MENT.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this Act, the Secretary of 
Health and Human Services shall convene a public 
meeting on the development, approval or clearance, 
and labeling of pediatric medical devices. The Sec-
retary shall invite to such meeting representatives 
from the medical device industry, academia, recipi-
ents of funding under section 305 of the Pediatric 
Medical Device Safety and Improvement Act of 2007 
(Public Law 110–85; 42 U.S.C. 282 note), medical 
provider 
organizations, 
and 
organizations 
rep-
resenting patients and consumers. 
(2) TOPICS.—The meeting described in para-
graph (1) shall include consideration of ways to— 
(A) improve research infrastructure and 
research networks to facilitate the conduct of 
clinical studies of devices for pediatric popu-
lations that would result in the approval or 
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clearance, and labeling, of medical devices for 
such populations; 
(B) appropriately use extrapolation under 
section 515A(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360e–1(b)); 
(C) enhance the appropriate use of 
postmarket registries and data to increase pedi-
atric medical device labeling; 
(D) increase Food and Drug Administra-
tion assistance to medical device manufacturers 
in developing devices for pediatric populations 
that are approved or cleared, and labeled, for 
their use; and 
(E) identify current barriers to pediatric 
device development and incentives to address 
such barriers. 
(3) REPORT.—The report submitted under sec-
tion 515A(a)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360e–1(a)(3)) with respect 
to the calendar year in which the meeting described 
in paragraph (1) is held shall include a summary of, 
and responses to, recommendations raised in such 
meeting. 
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SEC. 503. EARLY MEETING ON PEDIATRIC STUDY PLAN. 
(a) 
IN
GENERAL.—Clause 
(i) 
of 
section 
505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355c(e)(2)(C)) is amended to read as fol-
lows: 
‘‘(i) shall meet with the applicant— 
‘‘(I) if requested by the applicant 
with respect to a drug or biological 
product that is intended to treat a se-
rious or life-threatening disease or 
condition, to discuss preparation of 
the initial pediatric study plan, not 
later than the end-of-Phase 1 meeting 
(as such term is used in section 
312.82(b) of title 21, Code of Federal 
Regulations, or successor regulations) 
or within 30 calendar days of receipt 
of such request, whichever is later; 
‘‘(II) to discuss the initial pedi-
atric study plan as soon as prac-
ticable, but not later than 90 calendar 
days after the receipt of such plan 
under subparagraph (A); and 
‘‘(III) to discuss the bases for the 
deferral under subsection (a)(4) or a 
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full or partial waiver under subsection 
(a)(5);’’. 
(b) CONFORMING CHANGES.—Section 505B(e) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355c(e)) is amended— 
(1) in the heading of paragraph (2), by striking 
‘‘MEETING’’ and inserting ‘‘MEETINGS’’; 
(2) in the heading of paragraph (2)(C), by 
striking ‘‘MEETING’’ and inserting ‘‘MEETINGS’’; 
(3) in clauses (ii) and (iii) of paragraph (2)(C), 
by striking ‘‘no meeting’’ each place it appears and 
inserting ‘‘no meeting under clause (i)(II)’’; and 
(4) in paragraph (3) by striking ‘‘meeting 
under paragraph (2)(C)(i)’’ and inserting ‘‘meeting 
under paragraph (2)(C)(i)(II)’’. 
SEC. 504. DEVELOPMENT OF DRUGS AND BIOLOGICAL 
PRODUCTS FOR PEDIATRIC CANCERS. 
(a) MOLECULAR
TARGETS
REGARDING
CANCER 
DRUGS AND BIOLOGICAL PRODUCTS.—Section 505B of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355c) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1)— 
(i) by redesignating subparagraphs 
(A) and (B) as clauses (i) and (ii), respec-
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tively, and adjusting the margins accord-
ingly; 
(ii) by striking ‘‘A person’’ and insert-
ing the following: 
‘‘(A) GENERAL
REQUIREMENTS.—Except 
with respect to an application for which sub-
paragraph (B) applies, a person’’; 
(iii) in clause (i), as so redesignated, 
by striking ‘‘, or’’ at the end and inserting 
‘‘; or’’; and 
(iv) by adding after subparagraph 
(A), as so designated by clause (ii), the fol-
lowing: 
‘‘(B) CERTAIN
MOLECULARLY
TARGETED 
CANCER INDICATIONS.—A person that submits, 
on or after the date that is 3 years after the 
date of enactment of the FDA Reauthorization 
Act of 2017, an original application for a new 
active ingredient under section 505 of this Act 
or section 351 of the Public Health Service Act, 
shall submit with the application reports on the 
investigation described in paragraph (3) if the 
drug or biological product that is the subject of 
the application is— 
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‘‘(i) intended for the treatment of an 
adult cancer; and 
‘‘(ii) directed at a molecular target 
that the Secretary determines to be sub-
stantially relevant to the growth or pro-
gression of a pediatric cancer.’’; 
(B) in paragraph (2)(A), by striking 
‘‘paragraph (1)’’ and inserting ‘‘paragraph 
(1)(A)’’; 
(C) by redesignating paragraphs (3) and 
(4) as paragraphs (4) and (5), respectively; 
(D) by inserting after paragraph (2) the 
following: 
‘‘(3) 
MOLECULARLY
TARGETED
PEDIATRIC 
CANCER INVESTIGATION.— 
‘‘(A) IN
GENERAL.—With respect to a 
drug or biological product described in para-
graph (1)(B), the investigation described in this 
paragraph is a molecularly targeted pediatric 
cancer investigation, which shall be designed to 
yield clinically meaningful pediatric study data, 
gathered using appropriate formulations for 
each age group for which the study is required, 
regarding dosing, safety, and preliminary effi-
cacy to inform potential pediatric labeling. 
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‘‘(B) EXTRAPOLATION
OF
DATA.—Para-
graph (2)(B) shall apply to investigations de-
scribed in this paragraph to the same extent 
and in the same manner as paragraph (2)(B) 
applies with respect to the assessments required 
under paragraph (1)(A). 
‘‘(C) DEFERRALS
AND
WAIVERS.—Defer-
rals and waivers under paragraphs (4) and (5) 
shall apply to investigations described in this 
paragraph to the same extent and in the same 
manner as such deferrals and waivers apply 
with respect to the assessments under para-
graph (2)(B).’’; 
(E) in paragraph (4), as so redesignated— 
(i) by striking ‘‘assessments required 
under paragraph (1)’’ each place it ap-
pears and inserting ‘‘assessments required 
under paragraph (1)(A) or reports on the 
investigation required under paragraph 
(1)(B)’’; 
(ii) in subparagraph (A)(ii)(I), by in-
serting ‘‘or reports on the investigation’’ 
after ‘‘assessments’’; 
(iii) in subparagraph (B)(ii), by strik-
ing ‘‘assessment under paragraph (1)’’ and 
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inserting ‘‘assessment under paragraph 
(1)(A) or reports on the investigation 
under paragraph (1)(B)’’; and 
(iv) in subparagraph (C)(ii)(II), by in-
serting ‘‘or investigation’’ after ‘‘assess-
ment’’; and 
(F) in paragraph (5), as so redesignated, 
by inserting ‘‘or reports on the investigation’’ 
after ‘‘assessments’’ each place it appears; 
(2) in subsection (d)— 
(A) by striking ‘‘subsection (a)(3)’’ each 
place it appears and inserting ‘‘subsection 
(a)(4)’’; 
(B) by inserting ‘‘AND REPORTS ON THE 
INVESTIGATION’’ after ‘‘SUBMISSION
OF AS-
SESSMENTS’’ in the heading; and 
(C) by inserting ‘‘or the investigation de-
scribed in subsection (a)(3)’’ after ‘‘assessment 
described in subsection (a)(2)’’ each place it ap-
pears; 
(3) in subsection (e)— 
(A) in paragraph (1), by inserting ‘‘or the 
investigation described in subsection (a)(3)’’ 
after ‘‘under subsection (a)(2)’’; and 
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(B) in paragraph (2)(A)(i), by inserting 
‘‘or the investigation described in subsection 
(a)(3)’’ after ‘‘under subsection (a)(2)’’; and 
(4) by adding at the end the following: 
‘‘(m) LIST OF PRIMARY MOLECULAR TARGETS.— 
‘‘(1) IN GENERAL.—Within one year of the date 
of enactment of the FDA Reauthorization Act of 
2017, the Secretary shall establish and update regu-
larly, and shall publish on the internet website of the 
Food and Drug Administration— 
‘‘(A) a list of molecular targets considered, 
on the basis of data the Secretary determines to 
be adequate, to be substantially relevant to the 
growth and progression of a pediatric cancer, 
and that may trigger the requirements under 
this section; and 
‘‘(B) a list of molecular targets of new 
cancer drugs and biological products in develop-
ment for which pediatric cancer study require-
ments under this section will be automatically 
waived. 
‘‘(2) CONSULTATION.—In establishing the lists 
described in paragraph (1), the Secretary shall con-
sult the National Cancer Institute, members of the 
internal committee under section 505C, and the Pe-
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diatric Oncology Subcommittee of the Oncologic 
Drugs Advisory Committee, and shall take into ac-
count comments from the meeting under subsection 
(c). 
‘‘(3) RULE
OF
CONSTRUCTION.—Nothing in 
paragraph (1) shall be construed— 
‘‘(A) to require the inclusion of a molec-
ular target on the list published under such 
paragraph as a condition for triggering the re-
quirements under subsection (a)(1)(B) with re-
spect to a drug or biological product directed at 
such molecular target; or 
‘‘(B) to authorize the disclosure of con-
fidential commercial information, as prohibited 
under section 301(j) of this Act or section 1905 
of title 18, United States Code.’’. 
(b) ORPHAN DRUGS.—Section 505B(k) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355c(k)) 
is amended to read as follows: 
‘‘(k) RELATION TO ORPHAN DRUGS.— 
‘‘(1) IN GENERAL; EXEMPTION FOR ORPHAN IN-
DICATIONS.—Unless the Secretary requires other-
wise by regulation and except as provided in para-
graph (2), this section does not apply to any drug 
or biological product for an indication for which or-
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phan designation has been granted under section 
526. 
‘‘(2) APPLICABILITY
DESPITE
ORPHAN
DES-
IGNATION OF CERTAIN INDICATIONS.—This section 
shall apply with respect to a drug or biological prod-
uct for which an indication has been granted orphan 
designation under 526 if the investigation described 
in subsection (a)(3) applies to the drug or biological 
product as described in subsection (a)(1)(B).’’. 
(c) MEETING, CONSULTATION, AND GUIDANCE.— 
(1) MEETING.—The Secretary of Health and 
Human Services (referred to in this subsection as 
the ‘‘Secretary’’), acting through the Commissioner 
of Food and Drugs and in collaboration with the Di-
rector of the National Cancer Institute, shall con-
vene a public meeting not later than 1 year after the 
date of enactment of this Act to solicit feedback 
from physicians and researchers (including pediatric 
oncologists and rare disease specialists), patients, 
and other stakeholders to provide input on develop-
ment of the guidance under paragraph (2) and the 
list under subsection (m) of section 505B of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355c), as added by subsection (a). The Secretary 
shall seek input at such meeting on— 
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(A) the data necessary to determine that 
there is scientific evidence that a drug or bio-
logical product is directed at a molecular target 
that is considered to be substantially relevant to 
the growth or progression of a pediatric cancer; 
(B) the data necessary to determine that 
there is scientific evidence that a molecular tar-
get is considered to be substantially relevant to 
the growth or progression of a pediatric cancer; 
(C) the data needed to meet the require-
ment of conducting an investigation described 
in section 505B(a)(3) of the Federal Food, 
Drug, and Cosmetic Act, as amended by sub-
section (a); 
(D) considerations when developing the list 
under section 505B(m) of the Federal Food, 
Drug, and Cosmetic Act that contains molec-
ular targets shared between different tumor 
types; 
(E) the process the Secretary shall utilize 
to update regularly a list of molecular targets 
that may trigger a pediatric study under section 
505B of the Federal Food, Drug, and Cosmetic 
Act, as so amended, and how often such up-
dates shall occur; 
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(F) how to overcome the challenges related 
to pediatric cancer drug and biological product 
development, including issues related to the eth-
ical, practical, and other barriers to conducting 
clinical trials in pediatric cancer with small pa-
tient populations; 
(G) scientific or operational challenges as-
sociated with performing an investigation de-
scribed in section 505B(a)(1)(B) of the Federal 
Food, Drug, and Cosmetic Act, including the 
effect on pediatric studies currently underway 
in a pediatric patient population, treatment of 
a pediatric patient population, and the ability to 
complete adult clinical trials; 
(H) the advantages and disadvantages of 
innovative clinical trial designs in addressing 
the development of cancer drugs or biological 
products directed at molecular targets in pedi-
atric cancer patients; 
(I) the ways in which the Secretary can 
improve the current process outlined under sec-
tions 505A and 505B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355a, 
355c) to encourage additional research and de-
velopment of pediatric cancer treatments; 
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(J) the ways in which the Secretary might 
streamline and improve the written request 
process, including when studies contained in a 
request under such section 505A are not fea-
sible due to the ethical, practical, or other bar-
riers to conducting clinical trials in pediatric 
cancer populations; 
(K) how the Secretary will facilitate col-
laboration among pediatric networks, academic 
centers and experts in pediatric cancer to con-
duct an investigation described in such section 
505B(a)(3); 
(L) how the Secretary may facilitate col-
laboration among sponsors of same-in-class 
drugs and biological products that would be 
subject to the requirements for an investigation 
under such section 505B based on shared mo-
lecular targets; and 
(M) the ways in which the Secretary will 
help to mitigate the risks, if any, of discour-
aging the research and development of orphan 
drugs when implementing such section 505B as 
amended. 
(2) GUIDANCE.—Not later than 2 years after 
the date of enactment of this Act, the Secretary, act-
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ing through the Commissioner of Food and Drugs, 
shall issue final guidance on implementation of the 
amendments to section 505B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355c) regarding 
molecularly targeted cancer drugs made by this sec-
tion, including— 
(A) the scientific criteria, types of data, 
and regulatory considerations for determining 
whether a molecular target is substantially rel-
evant to the growth or progression of a pedi-
atric cancer and would trigger an investigation 
under section 505B of the Federal Food, Drug, 
and Cosmetic Act, as amended; 
(B) the process by which the Secretary will 
engage with sponsors to discuss determinations, 
investigation requirements, deferrals, waivers, 
and any other issues that need to be resolved 
to ensure that any required investigation based 
on a molecular target can be reasonably con-
ducted; 
(C) the scientific or operational challenges 
for which the Secretary may issue deferrals or 
waivers for an investigation described in sub-
section (a)(3) of such section 505B, including 
adverse impacts on current pediatric studies un-
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derway in a pediatric patient population, stud-
ies involving drugs designated as orphan drugs, 
treatment of a pediatric patient population, or 
the ability to complete adult clinical trials; 
(D) how the Secretary and sponsors will 
facilitate collaboration among pediatric net-
works, academic centers, and experts in pedi-
atric cancer to conduct an investigation de-
scribed in subsection (a)(3) of such section 
505B; 
(E) scientific and regulatory considerations 
for study designs, including the applicability of 
innovative clinical trial designs for pediatric 
cancer drug and biological product develop-
ments under sections 505A and 505B of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355a, 355c); 
(F) approaches to streamline and improve 
the amendment process, including when studies 
contained in a request under such section 505A 
are not feasible due to the ethical, practical, or 
other barriers to conducting clinical trials in pe-
diatric cancer populations; 
(G) the process for submission of an initial 
pediatric study plan for the investigation de-
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scribed in section 505B(a)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
355c(a)(3)), including the process for a sponsor 
to meet and reach agreement with the Secretary 
on the initial pediatric study plan; and 
(H) considerations for implementation of 
such section 505B, as so amended, and waivers 
of the requirements of such section 505B with 
regard to molecular targets for which several 
drugs or biological products may be under in-
vestigation. 
(d) REPORT TO CONGRESS.—Section 508(b) of the 
Food and Drug Administration Safety and Innovation Act 
(21 U.S.C. 355c–1(b)) is amended— 
(1) in paragraph (10), by striking ‘‘; and’’ and 
inserting ‘‘;’’; and 
(2) by striking paragraph (11) and inserting 
the following: 
‘‘(11) an assessment of the impact of the 
amendments to such section 505B made by the 
FDA Reauthorization Act of 2017 on pediatric re-
search and labeling of drugs and biological products 
and pediatric labeling of molecularly targeted drugs 
and biological products for the treatment of cancer; 
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‘‘(12) an assessment of the efforts of the Sec-
retary to implement the plan developed under sec-
tion 505C–1 of the Federal Food, Drug, and Cos-
metic Act, regarding earlier submission of pediatric 
studies under sections 505A and 505B of such Act 
and section 351(m) of the Public Health Service 
Act, including— 
‘‘(A) the average length of time after the 
approval of an application under section 
505(b)(1) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(b)(1)) or section 
351(a) of the Public Health Service Act (42 
U.S.C. 262(a)) before studies conducted pursu-
ant to such section 505A, 505B, or section 
351(m) are completed, submitted, and incor-
porated into labeling; 
‘‘(B) the average length of time after the 
receipt of a proposed pediatric study request be-
fore the Secretary responds to such request; 
‘‘(C) the average length of time after the 
submission of a proposed pediatric study re-
quest before the Secretary issues a written re-
quest for such studies; 
‘‘(D) the number of written requests issued 
for each investigational new drug or biological 
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product prior to the submission of an applica-
tion under section 505(b)(1) of the Federal 
Food, Drug, and Cosmetic Act or section 
351(a) of the Public Health Service Act; and 
‘‘(E) the average number, and range of 
numbers, of amendments to written requests 
issued, and the time the Secretary requires to 
review and act on proposed amendments to 
written requests; 
‘‘(13) a list of sponsors of applications or hold-
ers of approved applications who received exclusivity 
under such section 505A or such section 351(m) 
after receiving a letter issued under such section 
505B(d)(1) for any drug or biological product before 
the studies referred to in such letter were completed 
and submitted; 
‘‘(14) a list of assessments and investigations 
required under such section 505B; 
‘‘(15) how many requests under such section 
505A for molecular targeted cancer drugs, as de-
fined by subsection (a)(1)(B) of such section 505B, 
approved prior to 3 years after the date of enact-
ment of the FDA Reauthorization Act of 2017, have 
been issued by the Food and Drug Administration, 
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and how many such requests have been completed; 
and 
‘‘(16) the Secretary’s assessment of the overall 
impact of the amendments made by section 504 of 
the FDA Reauthorization Act of 2017 on the con-
duct and effectiveness of pediatric cancer research 
and the orphan drug program, as well any subse-
quent recommendations.’’. 
(e) RULE OF CONSTRUCTION.—Nothing in this sec-
tion, including the amendments made by this section, shall 
limit the authority of the Secretary of Health and Human 
Services to issue written requests under section 505A of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355a) or section 351(m) of the Public Health Service Act 
(42 U.S.C. 262(m)), or to negotiate or implement amend-
ments to such requests proposed by the an applicant. 
(f) GAO REPORT.— 
(1) IN GENERAL.—Beginning on the date that 
is 5 years after the date of enactment of this Act, 
the Comptroller General of the United States shall 
conduct a study of the effectiveness of requiring as-
sessments and investigations described in section 
505B of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355c), as amended by this section, in the 
development of drugs and biological products for pe-
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diatric cancer indications. The Comptroller General 
shall examine— 
(A) the indications and associated molec-
ular targets studied in assessments and inves-
tigations required for drugs or biological prod-
ucts intended for the treatment of an adult can-
cer; 
(B) the indication for which the study was 
requested as compared to the indication re-
quested under the new drug application filed by 
the sponsor; 
(C) the number of pediatric cancer indica-
tions for which assessments and investigations 
have been required under such section 505B; 
(D) the number of requests for deferral 
and waiver of pediatric assessments and inves-
tigations required under such section and the 
number of such deferral and waiver requests 
granted and denied; 
(E) the number of orphan-designated indi-
cations for drugs and biological products for 
which assessments and investigations were re-
quired under such section; 
(F) the number of drugs and biological 
products approved for the treatment of cancer 
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in the pediatric population for which the sup-
portive studies were required to be conducted 
under such section; 
(G) the number of written requests made 
under section 505A of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355a) relating to 
investigations 
required 
under 
subsection 
(a)(1)(B) of such section 505B; and 
(H) any additional considerations by the 
Secretary regarding the effectiveness of requir-
ing pediatric assessments described in such sec-
tion 505B in the development of drugs and bio-
logical products for pediatric cancer indications. 
(2) REVIEW.—The study under paragraph (1) 
shall include a review of the Food and Drug Admin-
istration’s use of the authority under section 505B 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355c), as amended by this section, including 
the amendments to the deferral and waiver criteria 
under such section and how such criteria have been 
applied. 
(3) CONSULTATION.—In conducting the study 
under paragraph (1), the Comptroller General of the 
United States shall consult with appropriate stake-
holders that may be required to conduct the trials 
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under section 505B of the Federal Food, Drug, and 
Cosmetic Act, and the ability of such stakeholders to 
adhere to the requests issued by the Food and Drug 
Administration. 
(4) REPORT.—Not later than the date that is 
6 years after the date of enactment of this Act, the 
Comptroller General of the United States shall sub-
mit a report containing the results of the study 
under paragraph (1) to the Secretary of Health and 
Human Services, the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate, and the 
Committee on Energy and Commerce of the House 
of Representatives. 
SEC. 505. ADDITIONAL PROVISIONS ON DEVELOPMENT OF 
DRUGS AND BIOLOGICAL PRODUCTS FOR PE-
DIATRIC USE. 
(a) INFORMING INTERNAL REVIEW COMMITTEE.— 
Section 505A(f) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355a(f)) is amended by adding at the end 
the following: 
‘‘(7) INFORMING
INTERNAL
REVIEW
COM-
MITTEE.—The Secretary shall provide to the com-
mittee referred to in paragraph (1) any response 
issued to an applicant or holder with respect to a 
proposed pediatric study request.’’. 
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(b) ACTION ON SUBMISSIONS.— 
(1) IN GENERAL.—Section 505A(d) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
355a(d)) is amended— 
(A) 
by 
redesignating 
paragraphs 
(3) 
through (5) as paragraphs (4) through (6), re-
spectively; and 
(B) by inserting after paragraph (2) the 
following: 
‘‘(3) ACTION ON SUBMISSIONS.—The Secretary 
shall review and act upon a submission by a sponsor 
or holder of a proposed pediatric study request or a 
proposed amendment to a written request for pedi-
atric studies within 120 calendar days of the sub-
mission.’’. 
(2) CONFORMING AMENDMENTS.— 
(A) FEDERAL FOOD, DRUG, AND COSMETIC 
ACT.—Section 505A of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355a), as amend-
ed by paragraph (1), is further amended by 
striking subsection ‘‘(d)(3)’’ each place it ap-
pears and inserting ‘‘(d)(4)’’. 
(B) PUBLIC HEALTH SERVICE ACT.—Para-
graphs (2), (3), and (4) of section 351(m) of 
the Public Health Service Act (42 U.S.C. 
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262(m)) are amended by striking ‘‘section 
505A(d)(3)’’ each place it appears and inserting 
‘‘section 505A(d)(4)’’. 
(c) PLAN.—The Secretary of Health and Human 
Services, acting through the internal review committee es-
tablished under section 505C of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355d) shall, not later than 
one year after the date of enactment of this Act, develop 
and implement a plan to achieve, when appropriate, earlier 
submission of pediatric studies under section 505A of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) 
or section 351(m) of the Public Health Service Act (42 
U.S.C. 262(m)). Such plan shall include recommendations 
to achieve— 
(1) earlier discussion of proposed pediatric 
study requests and written requests with sponsors, 
and if appropriate, discussion of such requests at the 
meeting required under section 505B(e)(2)(C) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355c(e)(2)(C)), as amended by section 503(a); 
(2) earlier issuance of written requests for a pe-
diatric study under such section 505A, including for 
investigational new drugs prior to the submission of 
an application under section 505(b)(1) of such Act 
(21 U.S.C. 355(b)(1)); and 
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(3) shorter timelines, when appropriate, for the 
completion of studies pursuant to a written request 
under such section 505A or such section 351(m). 
(d) NEONATOLOGY EXPERTISE.— 
(1) IN
GENERAL.—Section 6(d) of the Best 
Pharmaceuticals for Children Act (21 U.S.C. 
393a(d)) is amended by striking ‘‘For the 5-year pe-
riod beginning on the date of enactment of this sub-
section, at’’ and inserting ‘‘At’’. 
(2) DRAFT GUIDANCE.—Not later than 2 years 
after the date of enactment of this Act, the Sec-
retary shall issue draft guidance on clinical pharma-
cology considerations for neonatal studies for drugs 
and biological products. 
(e) 
SUBMISSION
OF
ASSESSMENTS.—Section 
505B(d)(1) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355c(d)(1)) is amended by adding at the end 
the following: ‘‘The Secretary shall inform the Pediatric 
Advisory Committee of letters issued under this paragraph 
and responses to such letters.’’. 
(f) INTERNAL COMMITTEE.—Section 505C of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355d) 
is amended by inserting ‘‘or pediatric rare diseases’’ after 
‘‘psychiatry’’. 
(g) REPORT ON LABELING OF ORPHAN DRUGS.— 
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(1) IN GENERAL.—Not later than 2 years after 
the date of the enactment of this Act, the Secretary 
of Health and Human Services shall submit to the 
Committee on Health, Education, Labor and Pen-
sions of the Senate and the Committee on Energy 
and Commerce of the House of Representatives, and 
make publicly available, including through posting 
on the internet website of the Food and Drug Ad-
ministration, a report on the lack of information in 
the labeling of drugs for indications that have re-
ceived an orphan designation under section 526 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb) with respect to the use of such 
drugs pediatric populations. 
(2) CONTENTS.—The report described in para-
graph (1) shall include— 
(A) a list of drugs for which— 
(i) an indication was granted an or-
phan designation under section 526 of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb); 
(ii) an application described under 
section 505B(a)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 
355c(a)(1)) for such indication was sub-
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mitted to the Secretary of Health and 
Human Services on or after April 1, 1999; 
and 
(iii) the labeling for such indication 
lacks important pediatric information, in-
cluding information related to safety, dos-
ing, and effectiveness; 
(B) a description of the lack of information 
referred to in subparagraph (A)(iii) for each 
drug for an indication on such list; and 
(C) Federal policy recommendations to im-
prove the labeling of drugs for indications that 
have received an orphan designation under such 
section 526 with respect to the use of such 
drugs pediatric populations.’’ 
TITLE 
VI—REAUTHORIZATIONS 
AND 
IMPROVEMENTS 
RE-
LATED TO DRUGS 
SEC. 601. 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’’. 
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SEC. 602. 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. 603. 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. 604. PROTECTING AND STRENGTHENING THE DRUG 
SUPPLY CHAIN. 
(a) DIVERTED DRUGS.—Paragraph (1) of section 
801(d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 381(d)) is amended— 
(1) by striking ‘‘(d)(1) Except as’’ and insert-
ing ‘‘(d)(1)(A) Except as’’; and 
(2) by adding at the end the following: 
‘‘(B) Except as authorized by the Secretary in the 
case of a drug that appears on the drug shortage list 
under section 506E or in the case of importation pursuant 
to section 804, no drug that is subject to section 503(b)(1) 
may be imported into the United States for commercial 
use if such drug is manufactured outside the United 
States, unless the manufacturer has authorized the drug 
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to be marketed in the United States and has caused the 
drug to be labeled to be marketed in the United States.’’. 
(b) COUNTERFEIT DRUGS.—Subsection (b) of section 
303 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 333) is amended by adding at the end the fol-
lowing: 
‘‘(8) Notwithstanding subsection (a), any person who 
violates section 301(i)(3) by knowingly making, selling or 
dispensing, or holding for sale or dispensing, a counterfeit 
drug shall be imprisoned for not more than 10 years or 
fined in accordance with title 18, United States Code, or 
both.’’. 
SEC. 605. PATIENT EXPERIENCE DATA. 
Section 569C(c)(2)(A) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bbb–8c(c)(2)(A)) is 
amended by striking ‘‘impact of such disease or condition, 
or a related therapy,’’ and inserting ‘‘impact (including 
physical and psychosocial impacts) of such disease or con-
dition, or a related therapy or clinical investigation’’. 
SEC. 606. COMMUNICATION PLANS. 
Section 505–1(e)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355–1(e)(3)) is amended— 
(1) in subparagraph (B), by striking ‘‘; or’’; 
(2) in subparagraph (C), by striking the period 
and inserting ‘‘; or’’; and 
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(3) by adding at the end the following: 
‘‘(D) disseminating information to health 
care providers about drug formulations or prop-
erties, including information about the limita-
tions or patient care implications of such for-
mulations or properties, and how such formula-
tions or properties may be related to serious ad-
verse drug events associated with use of the 
drug.’’. 
SEC. 607. ORPHAN DRUGS. 
(a) IN GENERAL.—Section 527 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended— 
(1) in subsection (a), in the matter following 
paragraph (2), by striking ‘‘such drug for such dis-
ease or condition’’ and inserting ‘‘the same drug for 
the same disease or condition’’; 
(2) in subsection (b)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘If an application’’ and all that fol-
lows through ‘‘such license if’’ and inserting 
‘‘During the 7-year period described in sub-
section (a) for an approved application under 
section 505 or license under section 351 of the 
Public Health Service Act, the Secretary may 
approve an application or issue a license for a 
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drug that is otherwise the same, as determined 
by the Secretary, as the already approved drug 
for the same rare disease or condition if’’; 
(B) in paragraph (1), by striking ‘‘notice’’ 
and all that follows through ‘‘assure’’ and in-
serting ‘‘of exclusive approval or licensure no-
tice and opportunity for the submission of 
views, that during such period the holder of the 
exclusive approval or licensure cannot ensure’’; 
and 
(C) in paragraph (2), by striking ‘‘such 
holder provides’’ and inserting ‘‘the holder pro-
vides’’; and 
(3) by adding at the end the following: 
‘‘(c) CONDITION OF CLINICAL SUPERIORITY.— 
‘‘(1) IN GENERAL.—If a sponsor of a drug that 
is designated under section 526 and is otherwise the 
same, as determined by the Secretary, as an already 
approved or licensed drug is seeking exclusive ap-
proval or exclusive licensure described in subsection 
(a) for the same rare disease or condition as the al-
ready approved drug, the Secretary shall require 
such sponsor, as a condition of such exclusive ap-
proval or licensure, to demonstrate that such drug is 
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clinically superior to any already approved or li-
censed drug that is the same drug. 
‘‘(2) DEFINITION.—For purposes of paragraph 
(1), the term ‘clinically superior’ with respect to a 
drug means that the drug provides a significant 
therapeutic advantage over and above an already ap-
proved or licensed drug in terms of greater efficacy, 
greater safety, or by providing a major contribution 
to patient care. 
‘‘(d) REGULATIONS.—The Secretary may promulgate 
regulations for the implementation of subsection (c). Be-
ginning on the date of enactment of the FDA Reauthor-
ization Act of 2017, until such time as the Secretary pro-
mulgates regulations in accordance with this subsection, 
the Secretary may apply any definitions set forth in regu-
lations that were promulgated prior to such date of enact-
ment, to the extent such definitions are not inconsistent 
with the terms of this section, as amended by such Act. 
‘‘(e) DEMONSTRATION
OF CLINICAL SUPERIORITY 
STANDARD.—To assist sponsors in demonstrating clinical 
superiority as described in subsection (c), the Secretary— 
‘‘(1) upon the designation of any drug under 
section 526, shall notify the sponsor of such drug in 
writing of the basis for the designation, including, as 
applicable, any plausible hypothesis offered by the 
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sponsor and relied upon by the Secretary that the 
drug is clinically superior to a previously approved 
drug; and 
‘‘(2) upon granting exclusive approval or licen-
sure under subsection (a) on the basis of a dem-
onstration of clinical superiority as described in sub-
section (c), shall publish a summary of the clinical 
superiority findings.’’. 
(b) RULE
OF
CONSTRUCTION.—Nothing in the 
amendments made by subsection (a) shall affect any deter-
mination under sections 526 and 527 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bb, 360cc) made 
prior to the date of enactment of the FDA Reauthoriza-
tion Act of 2017. 
SEC. 608. PEDIATRIC INFORMATION ADDED TO LABELING. 
Section 505A(o) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355a(o)) is amended— 
(1) in the subsection heading, by striking 
‘‘UNDER SECTION 505(j)’’; 
(2) in paragraph (1)— 
(A) by striking ‘‘under section 505(j)’’ and 
inserting ‘‘under subsection (b)(2) or (j) of sec-
tion 505’’; and 
(B) by striking ‘‘or by exclusivity under 
clause (iii) or (iv) of section 505(j)(5)(F)’’ and 
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inserting ‘‘, or by exclusivity under clause (iii) 
or (iv) of section 505(j)(5)(F), clause (iii) or 
(iv) of section 505(c)(3)(E), or section 527(a), 
or by an extension of such exclusivity under this 
section or section 505E’’; 
(3) in paragraph (2), in the matter preceding 
subparagraph (A)— 
(A) by inserting ‘‘clauses (iii) and (iv) of 
section 505(c)(3)(E), or section 527,’’ after 
‘‘section 505(j)(5)(F),’’; and 
(B) by striking ‘‘drug approved under sec-
tion 505(j)’’ and inserting ‘‘drug approved pur-
suant to an application submitted under sub-
section (b)(2) or (j) of section 505’’; and 
(4) by amending paragraph (3) to read as fol-
lows: 
‘‘(3) PRESERVATION
OF
PEDIATRIC
EXCLU-
SIVITY AND EXTENSIONS.—This subsection does not 
affect— 
‘‘(A) the availability or scope of exclusivity 
under— 
‘‘(i) this section; 
‘‘(ii) section 505 for pediatric formu-
lations; or 
‘‘(iii) section 527; 
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‘‘(B) the availability or scope of an exten-
sion to any such exclusivity, including an exten-
sion under this section or section 505E; 
‘‘(C) the question of the eligibility for ap-
proval under section 505 of any application de-
scribed in subsection (b)(2) or (j) of such sec-
tion that omits any other aspect of labeling pro-
tected by exclusivity under— 
‘‘(i) clause (iii) or (iv) of section 
505(j)(5)(F); 
‘‘(ii) clause (iii) or (iv) of section 
505(c)(3)(E); or 
‘‘(iii) section 527(a); or 
‘‘(D) except as expressly provided in para-
graphs (1) and (2), the operation of section 505 
or section 527.’’. 
SEC. 609. SENSE OF CONGRESS ON LOWERING THE COST 
OF PRESCRIPTION DRUGS. 
It is the sense of the Congress that the Secretary of 
Health and Human Services should commit to engaging 
with the House of Representatives and the Senate to take 
administrative actions and enact legislative changes 
that— 
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(1) will lower the cost of prescription drugs for 
consumers and reduce the burden of such cost on 
taxpayers; and 
(2) in lowering such cost, will— 
(A) balance the need to encourage innova-
tion with the need to improve affordability; and 
(B) strive to increase competition in the 
pharmaceutical market, prevent anticompetitive 
behavior, and promote the timely availability of 
affordable, high-quality generic drugs and 
biosimilars. 
SEC. 610. EXPANDED ACCESS. 
(a) 
PATIENT
ACCESS
TO
INVESTIGATIONAL 
DRUGS.— 
(1) PUBLIC MEETING.— 
(A) 
IN
GENERAL.—The 
Secretary 
of 
Health and Human Services (referred to in this 
section as the ‘‘Secretary’’), acting through the 
Commissioner of Food and Drugs, in coordina-
tion with the Director of the National Institutes 
of Health, and in consultation with patients, 
health 
care 
providers, 
drug 
sponsors, 
bioethicists, and other stakeholders, shall, not 
later than 270 days after the date of enactment 
of this Act, convene a public meeting to discuss 
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clinical trial inclusion and exclusion criteria to 
inform the guidance under paragraph (3). The 
Secretary shall inform the Comptroller General 
of the United States of the date when the pub-
lic meeting will take place. 
(B) TOPICS.—The Secretary shall make 
available on the internet website of the Food 
and Drug Administration a report on the topics 
discussed at the meeting described in subpara-
graph (A) within 90 days of such meeting. Such 
topics shall include discussion of— 
(i) the rationale for, and potential 
barriers for patients created by, research 
clinical trial inclusion and exclusion cri-
teria; 
(ii) how appropriate patient popu-
lations can benefit from the results of 
trials that employ alternative designs; 
(iii) barriers to participation in clin-
ical trials, including— 
(I) information regarding any po-
tential risks and benefits of participa-
tion; 
(II) regulatory, geographical, and 
socioeconomic barriers; and 
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(III) the impact of exclusion cri-
teria on the enrollment in clinical 
trials of particular populations, in-
cluding infants and children, pregnant 
and lactating women, seniors, individ-
uals with advanced disease, and indi-
viduals with co-morbid conditions; 
(iv) clinical trial designs and methods, 
including expanded access trials, that in-
crease enrollment of more diverse patient 
populations, when appropriate, while facili-
tating the collection of data to establish 
safe use and support substantial evidence 
of effectiveness, including data obtained 
from expanded access trials; and 
(v) how changes to clinical trial inclu-
sion and exclusion criteria may impact the 
complexity and length of clinical trials, the 
data necessary to demonstrate safety and 
effectiveness, and potential approaches to 
mitigating those impacts. 
(2) REPORT.—Not later than 1 year after the 
Secretary issues the report under paragraph (1)(B), 
the Comptroller General of the United States shall 
report to the Committee on Health, Education, 
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Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of 
Representatives on individual access to investiga-
tional drugs through the expanded access program 
under section 561(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bbb(b)). The re-
port shall include— 
(A) a description of actions taken by man-
ufacturers and distributors under section 561A 
of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bbb–0); 
(B) consideration of whether Form FDA 
3926 and the guidance documents titled ‘‘Ex-
panded Access to Investigational Drugs for 
Treatment Use—Questions and Answers’’ and 
‘‘Individual Patient Expanded Access Applica-
tions: Form FDA 3926’’, issued by the Food 
and Drug Administration in June 2016, have 
reduced application burden with respect to indi-
viduals and physicians seeking access to inves-
tigational new drugs pursuant to section 561(b) 
of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bbb) and improved clarity for 
patients, physicians, and drug manufacturers 
about such process; 
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(C) consideration of whether the guidance 
or regulations issued to implement section 561 
of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bbb) have improved access for 
individual patients to investigational drugs who 
do not qualify for clinical trials of such inves-
tigational drugs, and what barriers to such ac-
cess remain; 
(D) an assessment of methods patients and 
health care providers use to engage with the 
Food and Drug Administration or drug spon-
sors on expanded access; and 
(E) an analysis of the Secretary’s report 
under paragraph (1)(B). 
(3) GUIDANCE.— 
(A) IN GENERAL.—Not later than 1 year 
after the publication of the report under para-
graph (1)(B), the Secretary, acting through the 
Commissioner of Food and Drugs, shall issue 
one or more draft guidances regarding eligi-
bility criteria for clinical trials. Not later than 
1 year after the public comment period on each 
such draft guidance ends, the Secretary shall 
issue a revised draft guidance or final guidance. 
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(B) CONTENTS.—The guidance documents 
described in subparagraph (A) shall address 
methodological approaches that a manufacturer 
or sponsor of an investigation of a new drug 
may take to— 
(i) broaden eligibility criteria for clin-
ical trials and expanded access trials, espe-
cially with respect to drugs for the treat-
ment of serious and life-threatening condi-
tions or diseases for which there is an 
unmet medical need; 
(ii) develop eligibility criteria for, and 
increase trial recruitment to, clinical trials 
so that enrollment in such trials more ac-
curately reflects the patients most likely to 
receive the drug, as applicable and as ap-
propriate, while establishing safe use and 
supporting findings of substantial evidence 
of effectiveness; and 
(iii) use the criteria described in 
clauses (i) and (ii) in a manner that is ap-
propriate for drugs intended for the treat-
ment of rare diseases or conditions. 
(b) IMPROVING INSTITUTIONAL REVIEW BOARD RE-
VIEW
OF SINGLE PATIENT EXPANDED ACCESS PRO-
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TOCOL.—Not later than 1 year after the date of enactment 
of this Act, the Secretary, acting through the Commis-
sioner of Food and Drugs, shall issue guidance or regula-
tions, or revise existing guidance or regulations, to stream-
line the institutional review board review of individual pa-
tient expanded access protocols submitted under 561(b) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb(b)). To facilitate the use of expanded access proto-
cols, any guidance or regulations so issued or revised may 
include a description of the process for any person acting 
through a physician licensed in accordance with State law 
to request that an institutional review board chair (or des-
ignated member of the institutional review board) review 
a single patient expanded access protocol submitted under 
such section 561(b) for a drug. The Secretary shall update 
any relevant forms associated with individual patient ex-
panded access requests under such section 561(b) as nec-
essary. 
(c) EXPANDED ACCESS POLICY TRANSPARENCY.— 
Section 561A(f) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb–0(f)) is amended— 
(1) in the matter preceding paragraph (1), by 
striking ‘‘later’’ and inserting ‘‘earlier’’; 
(2) by striking paragraph (1); 
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(3) by redesignating paragraph (2) as para-
graph (1); 
(4) in paragraph (1) as so redesignated, by 
striking the period at the end and inserting ‘‘; or’’; 
and 
(5) by adding at the end the following: 
‘‘(2) as applicable, 15 days after the drug re-
ceives a designation as a breakthrough therapy, fast 
track product, or regenerative advanced therapy 
under subsection (a), (b), or (g), respectively, of sec-
tion 506.’’. 
SEC. 611. TROPICAL DISEASE PRODUCT APPLICATION. 
(a) IN GENERAL.—Subparagraph (A) of section 
524(a)(4) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360n(a)(4)) is amended— 
(1) in clause (i), by striking ‘‘and’’ at the end; 
and 
(2) by adding at the end the following: 
‘‘(iii) that contains reports of one or 
more new clinical investigations (other 
than bioavailability studies) that are essen-
tial to the approval of the application and 
conducted or sponsored by the sponsor of 
such application; and 
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‘‘(iv) that contains an attestation 
from the sponsor of the application that 
such reports were not submitted as part of 
an application for marketing approval or li-
censure by a regulatory authority in India, 
Brazil, Thailand, or any country that is a 
member of the Pharmaceutical Inspection 
Convention or the Pharmaceutical Inspec-
tion Cooperation Scheme prior to Sep-
tember 27, 2007.’’. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply to human drug applications sub-
mitted after September 30, 2017. 
TITLE VII—DEVICE INSPECTION 
AND REGULATORY IMPROVE-
MENTS 
SEC. 701. RISK-BASED INSPECTIONS FOR DEVICES. 
(a) IN GENERAL.—Section 510(h) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)) is 
amended— 
(1) by striking paragraph (2) and inserting the 
following: 
‘‘(2) RISK-BASED SCHEDULE FOR DEVICES.— 
‘‘(A) IN GENERAL.—The Secretary, acting 
through one or more officers or employees duly 
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designated by the Secretary, shall inspect estab-
lishments described in paragraph (1) that are 
engaged in the manufacture, propagation, 
compounding, or processing of a device or de-
vices (referred to in this subsection as ‘device 
establishments’) in accordance with a risk-based 
schedule established by the Secretary. 
‘‘(B) FACTORS AND CONSIDERATIONS.—In 
establishing the risk-based schedule under sub-
paragraph (A), the Secretary shall— 
‘‘(i) apply, to the extent applicable for 
device establishments, the factors identified 
in paragraph (4); and 
‘‘(ii) consider the participation of the 
device establishment, as applicable, in 
international device audit programs in 
which the United States participates or the 
United States recognizes for purposes of 
inspecting device establishments.’’; and 
(2) in paragraph (4)— 
(A) in the matter preceding subparagraph 
(A), by striking ‘‘paragraph (3)’’ and inserting 
‘‘paragraph (2) or (3)’’; and 
(B) in subparagraph (C), by inserting ‘‘or 
device’’ after ‘‘drug’’. 
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(b) FOREIGN INSPECTIONS.—Section 809(a)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
384e(a)(1)) is amended by striking ‘‘section 510(h)(3)’’ 
and inserting ‘‘paragraph (2) or (3) of section 510(h)’’. 
SEC. 702. IMPROVEMENTS TO INSPECTIONS PROCESS FOR 
DEVICE ESTABLISHMENTS. 
(a) IN GENERAL.—Section 704 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374) is amended by 
adding at the end the following: 
‘‘(h)(1) In the case of inspections other than for- 
cause inspections, the Secretary shall review processes and 
standards applicable to inspections of domestic and for-
eign device establishments in effect as of the date of the 
enactment of this subsection, and update such processes 
and standards through the adoption of uniform processes 
and standards applicable to such inspections. Such uni-
form processes and standards shall provide for— 
‘‘(A) exceptions to such processes and stand-
ards, as appropriate; 
‘‘(B) announcing the inspection of the establish-
ment within a reasonable time before such inspection 
occurs, including by providing to the owner, oper-
ator, or agent in charge of the establishment a noti-
fication regarding the type and nature of the inspec-
tion; 
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‘‘(C) a reasonable estimate of the timeframe for 
the inspection, an opportunity for advance commu-
nications between the officers or employees carrying 
out the inspection under subsection (a)(1) and the 
owner, operator, or agent in charge of the establish-
ment concerning appropriate working hours during 
the inspection, and, to the extent feasible, advance 
notice of some records that will be requested; and 
‘‘(D) regular communications during the inspec-
tion with the owner, operator, or agent in charge of 
the establishment regarding inspection status, which 
may be recorded by either party with advance notice 
and mutual consent. 
‘‘(2)(A) The Secretary shall, with respect to a request 
described in subparagraph (B), provide nonbinding feed-
back with respect to such request not later than 45 days 
after the Secretary receives such request. 
‘‘(B) A request described in this subparagraph is a 
request for feedback— 
‘‘(i) that is made by the owner, operator, or 
agent in charge of such establishment in a timely 
manner; and 
‘‘(ii) with respect to actions proposed to be 
taken by a device establishment in a response to a 
report received by such establishment pursuant to 
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subsection (b) that involve a public health priority, 
that implicate systemic or major actions, or relate to 
emerging safety issues (as determined by the Sec-
retary). 
‘‘(3) Nothing in this subsection affects the authority 
of the Secretary to conduct inspections otherwise per-
mitted under this Act in order to ensure compliance with 
this Act.’’. 
(b) GUIDANCE.— 
(1) DRAFT
GUIDANCE.—Not later than 18 
months after the date of enactment of this Act, the 
Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall 
issue draft guidance that— 
(A) specifies how the Food and Drug Ad-
ministration will implement the processes and 
standards described in paragraph (1) of sub-
section (h) of section 704 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374), as 
added by subsection (a), and the requirements 
described in paragraph (2) of such subsection 
(h); 
(B) provides for standardized methods for 
communications described in such paragraphs; 
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(C) establishes, with respect to inspections 
of both domestic and foreign device establish-
ments (as referred to in section 510(h)(2) of 
the Federal Food, Drug, and Cosmetic Act, as 
amended by subsection (a)), a standard time-
frame for such inspections— 
(i) that occurs over consecutive days; 
and 
(ii) to which each investigator con-
ducting such an inspection shall adhere un-
less the investigator identifies to the estab-
lishment involved a reason that more time 
is needed to conduct such investigation; 
and 
(D) identifies practices for investigators 
and device establishments to facilitate the con-
tinuity of inspections of such establishments. 
(2) FINAL GUIDANCE.—Not later than 1 year 
after providing notice and opportunity for public 
comment on the draft guidance issued under para-
graph (1), the Secretary of Health and Human 
Services shall issue final guidance to implement sub-
section (h) of section 704 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374), as added 
by subsection (a). 
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(c) ADULTERATED DEVICES.—Subsection (j) of sec-
tion 501 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 351) is amended by inserting ‘‘or device’’ after 
‘‘drug’’. 
SEC. 703. 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. 704. CERTIFICATES TO FOREIGN GOVERNMENTS FOR 
DEVICES. 
Subsection (e)(4) of section 801 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(e)(4)) is amend-
ed— 
(1) by adding at the end the following: 
‘‘(E)(i)(I) If the Secretary denies a request for certifi-
cation under subparagraph (A)(ii) with respect to a device 
manufactured in an establishment (foreign or domestic) 
registered under section 510, the Secretary shall provide 
in writing to the person seeking such certification the 
basis for such denial, and specifically identify the finding 
upon which such denial is based. 
‘‘(II) If the denial of a request as described in sub-
clause (I) is based on grounds other than an injunction 
proceeding pursuant to section 302, seizure action pursu-
ant to section 304, or a recall designated Class I or Class 
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II pursuant to part 7, title 21, Code of Federal Regula-
tions, and is based on the facility being out of compliance 
with part 820 of title 21, Code of Federal Regulations, 
the Secretary shall provide a substantive summary of the 
specific grounds for noncompliance identified by the Sec-
retary. 
‘‘(III) With respect to a device manufactured in an 
establishment that has received a report under section 
704(b), the Secretary shall not deny a request for certifi-
cation as described in subclause (I) with respect to a de-
vice based solely on the issuance of that report if the 
owner, operator, or agent in charge of such establishment 
has agreed to a plan of correction in response to such re-
port. 
‘‘(ii)(I) The Secretary shall provide a process for a 
person who is denied a certification as described in clause 
(i)(I) to request a review that conforms to the standards 
of section 517A(b). 
‘‘(II) Notwithstanding any previous review conducted 
pursuant to subclause (I), a person who has been denied 
a certification as described in clause (i)(I) may at any time 
request a review in order to present new information relat-
ing to actions taken by such person to address the reasons 
identified by the Secretary for the denial of certification, 
including evidence that corrective actions are being or 
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have been implemented to address grounds for noncompli-
ance identified by the Secretary. 
‘‘(III) Not later than 1 year after the date of enact-
ment of the FDA Reauthorization Act of 2017, the Sec-
retary shall issue guidance providing for a process to carry 
out this subparagraph. Not later than 1 year after the 
close of the comment period for such guidance, the Sec-
retary shall issue final guidance. 
‘‘(iii)(I) Subject to subclause (II), this subparagraph 
applies to requests for certification on behalf of any device 
establishment registered under section 510, whether the 
establishment is located inside or outside of the United 
States, and regardless of whether such devices are to be 
exported from the United States. 
‘‘(II) If an establishment described in subclause (I) 
is not located within the United States and does not dem-
onstrate that the devices manufactured, prepared, propa-
gated, compounded, or processed at such establishment 
are to be exported from the United States, this subpara-
graph shall apply only if— 
‘‘(aa) the establishment has been inspected by 
the Secretary within 3 years of the date of the re-
quest; or 
‘‘(bb) the establishment participates in an audit 
program in which the United States participates or 
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the United States recognizes, an audit under such 
program has been conducted, and the findings of 
such audit are provided to the Secretary within 3 
years of the date of the request.’’; and 
(2) by moving the margins of subparagraphs 
(C) and (D) 4 ems to the left. 
SEC. 705. FACILITATING INTERNATIONAL HARMONIZATION. 
Section 704(g) of the Federal Food, Drug and Cos-
metic Act (21 U.S.C. 374) is amended by adding at the 
end the following: 
‘‘(15)(A) Notwithstanding any other provision of this 
subsection, the Secretary may recognize auditing organi-
zations that are recognized by organizations established 
by governments to facilitate international harmonization 
for purposes of conducting inspections of— 
‘‘(i) establishments that manufacture, prepare, 
propagate, compound, or process devices (other than 
types of devices licensed under section 351 of the 
Public Health Service Act), as required under sec-
tion 510(h); or 
‘‘(ii) establishments required to register pursu-
ant to section 510(i). 
‘‘(B) Nothing in this paragraph affects— 
‘‘(i) the authority of the Secretary to inspect 
any device establishment pursuant to this Act; or 
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‘‘(ii) the authority of the Secretary to determine 
the official classification of an inspection.’’. 
SEC. 706. FOSTERING INNOVATION IN MEDICAL IMAGING. 
(a) APPROVAL OF APPLICATIONS FOR CERTAIN DI-
AGNOSTIC MEDICAL IMAGING DEVICES.—Section 520 of 
the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 
360j) is amended by adding at the end the following: 
‘‘(p) DIAGNOSTIC IMAGING DEVICES INTENDED FOR 
USE WITH CONTRAST AGENTS.— 
‘‘(1) IN GENERAL.—The Secretary may, subject 
to the succeeding provisions of this subsection, ap-
prove an application (or a supplement to such an ap-
plication) submitted under section 515 with respect 
to an applicable medical imaging device, or, in the 
case of an applicable medical imaging device for 
which a notification is submitted under section 
510(k), may make a substantial equivalence deter-
mination with respect to an applicable medical imag-
ing device, or may grant a request submitted under 
section 513(f)(2) for an applicable medical imaging 
device, if such application, notification, or request 
involves the use of a contrast agent that is not— 
‘‘(A) in a concentration, rate of adminis-
tration, or route of administration that is dif-
ferent from those described in the approved la-
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beling of the contrast agent, except that the 
Secretary may approve such application, make 
such substantial equivalence determination, or 
grant such request if the Secretary determines 
that such differences in concentration, rate of 
administration, or route of administration exist 
but do not adversely affect the safety and effec-
tiveness of the contrast agent when used with 
the device; 
‘‘(B) in a region, organ, or system of the 
body that is different from those described in 
the approved labeling of the contrast agent, ex-
cept that the Secretary may approve such appli-
cation, make such substantial equivalence deter-
mination, or grant such request if the Secretary 
determines that such differences in region, 
organ, or system of the body exist but do not 
adversely affect the safety and effectiveness of 
the contrast agent when used with the device; 
‘‘(C) in a patient population that is dif-
ferent from those described in the approved la-
beling of the contrast agent, except that the 
Secretary may approve such application, make 
such substantial equivalence determination, or 
grant such request if the Secretary determines 
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such differences in patient population exist but 
do not adversely affect the safety and effective-
ness of the contrast agent when used with the 
device; or 
‘‘(D) in an imaging modality that is dif-
ferent from those described in the approved la-
beling of the contrast agent. 
‘‘(2) PREMARKET REVIEW.—The agency center 
charged with premarket review of devices shall have 
primary jurisdiction with respect to the review of an 
application, notification, or request described in 
paragraph (1). In conducting such review, such 
agency center may— 
‘‘(A) consult with the agency center 
charged with the premarket review of drugs or 
biological products; and 
‘‘(B) review information and data provided 
to the Secretary by the sponsor of a contrast 
agent in an application submitted under section 
505 of this Act or section 351 of the Public 
Health Service Act, so long as the sponsor of 
such contrast agent has provided to the sponsor 
of the applicable medical imaging device that is 
the subject of such review a right of reference 
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and the application is submitted in accordance 
with this subsection. 
‘‘(3) APPLICABLE REQUIREMENTS.—An appli-
cation submitted under section 515, a notification 
submitted under section 510(k), or a request sub-
mitted under section 513(f)(2), as described in para-
graph (1), with respect to an applicable medical im-
aging device shall be subject to the requirements of 
such respective section. Such application, notifica-
tion, or request shall only be subject to the require-
ments of this Act applicable to devices. 
‘‘(4) DEFINITIONS.—For purposes of this sub-
section— 
‘‘(A) the term ‘applicable medical imaging 
device’ means a device intended to be used in 
conjunction with a contrast agent (or class of 
contrast agents) for an imaging use that is not 
described in the approved labeling of such con-
trast agent (or the approved labeling of any 
contrast agent in the same class as such con-
trast agent); and 
‘‘(B) the term ‘contrast agent’ means a 
drug that is approved under section 505 or li-
censed under section 351 of the Public Health 
Service Act, is intended for use in conjunction 
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with an applicable medical imaging device, 
and— 
‘‘(i) is a diagnostic radiopharma-
ceutical, as defined in section 315.2 and 
601.31 of title 21, Code of Federal Regula-
tions (or any successor regulations); or 
‘‘(ii) is a diagnostic agent that im-
proves the visualization of structure or 
function within the body by increasing the 
relative difference in signal intensity within 
the target tissue, structure, or fluid.’’. 
(b) APPLICATIONS
FOR APPROVAL
OF CONTRAST 
AGENTS INTENDED
FOR USE WITH CERTAIN DIAG-
NOSTIC MEDICAL IMAGING DEVICES.—Section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
is amended by adding at the end the following: 
‘‘(y) CONTRAST AGENTS INTENDED FOR USE WITH 
APPLICABLE MEDICAL IMAGING DEVICES.— 
‘‘(1) IN GENERAL.—The sponsor of a contrast 
agent for which an application has been approved 
under this section may submit a supplement to the 
application seeking approval for a new use following 
the authorization of a premarket submission for an 
applicable medical imaging device for that use with 
the contrast agent pursuant to section 520(p)(1). 
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‘‘(2) REVIEW OF SUPPLEMENT.—In reviewing a 
supplement submitted under this subsection, the 
agency center charged with the premarket review of 
drugs may— 
‘‘(A) consult with the center charged with 
the premarket review of devices; and 
‘‘(B) review information and data sub-
mitted to the Secretary by the sponsor of an 
applicable medical imaging device pursuant to 
section 515, 510(k), or 513(f)(2) so long as the 
sponsor of such applicable medical imaging de-
vice has provided to the sponsor of the contrast 
agent a right of reference. 
‘‘(3) DEFINITIONS.—For purposes of this sub-
section— 
‘‘(A) the term ‘new use’ means a use of a 
contrast agent that is described in the approved 
labeling of an applicable medical imaging device 
described in section 520(p), but that is not de-
scribed in the approved labeling of the contrast 
agent; and 
‘‘(B) the terms ‘applicable medical imaging 
device’ and ‘contrast agent’ have the meanings 
given such terms in section 520(p).’’. 
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SEC. 707. RISK-BASED CLASSIFICATION OF ACCESSORIES. 
(a) IN GENERAL.—Subsection (f) of section 513 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360c) is amended by adding at the end the following new 
paragraph: 
‘‘(6)(A) Subject to the succeeding subparagraphs of 
this paragraph, the Secretary shall, by written order, clas-
sify an accessory under this section based on the risks of 
the accessory when used as intended and the level of regu-
latory controls necessary to provide a reasonable assur-
ance of safety and effectiveness of the accessory, notwith-
standing the classification of any other device with which 
such accessory is intended to be used. 
‘‘(B) The classification of any accessory distinct from 
another device by regulation or written order issued prior 
to December 13, 2016, shall continue to apply unless and 
until the accessory is reclassified by the Secretary, not-
withstanding the classification of any other device with 
which such accessory is intended to be used. Nothing in 
this paragraph shall preclude the Secretary’s authority to 
initiate the classification of an accessory through regula-
tion or written order, as appropriate. 
‘‘(C)(i) In the case of a device intended to be used 
with an accessory, where the accessory has been included 
in an application for premarket approval of such device 
under section 515 or a report under section 510(k) for 
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clearance of such device and the Secretary has not classi-
fied such accessory distinctly from another device in ac-
cordance with subparagraph (A), the person filing the ap-
plication or report (as applicable) at the time such applica-
tion or report is filed— 
‘‘(I) may include a written request for the prop-
er classification of the accessory pursuant to sub-
paragraph (A); 
‘‘(II) shall include in any such request such in-
formation as may be necessary for the Secretary to 
evaluate, based on the least burdensome approach, 
the appropriate class for the accessory under sub-
section (a); and 
‘‘(III) shall, if the request under subclause (I) 
is requesting classification of the accessory in class 
II, include in the application an initial draft proposal 
for special controls, if special controls would be re-
quired pursuant to subsection (a)(1)(B). 
‘‘(ii) The Secretary’s response under section 515(d) 
or section 510(n) (as applicable) to an application or re-
port described in clause (i) shall also contain the Sec-
retary’s granting or denial of the request for classification 
of the accessory involved. 
‘‘(iii) The Secretary’s evaluation of an accessory 
under clause (i) shall constitute an order establishing a 
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new classification for such accessory for the specified in-
tended use or uses of such accessory and for any accessory 
with the same intended use or uses as such accessory. 
‘‘(D) For accessories that have been granted mar-
keting authorization as part of a submission for another 
device with which the accessory involved is intended to be 
used, through an application for such other device under 
section 515(c), a report under section 510(k), or a request 
for classification under paragraph (2) of this subsection, 
the following shall apply: 
‘‘(i) Not later than the date that is one year 
after the date of enactment of the FDA Reauthor-
ization Act of 2017 and at least once every 5 years 
thereafter, and as the Secretary otherwise deter-
mines appropriate, pursuant to this paragraph, the 
Secretary shall publish in the Federal Register a no-
tice proposing a list of such accessories that the Sec-
retary determines may be suitable for a distinct clas-
sification in class I and the proposed regulations for 
such classifications. In developing such list, the Sec-
retary shall consider recommendations from spon-
sors of device submissions and other stakeholders for 
accessories to be included on such list. The notices 
shall provide for a period of not less than 60 cal-
endar days for public comment. Within 180 days 
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after the end of the comment period, the Secretary 
shall publish in the Federal Register a final action 
classifying such suitable accessories into class I. 
‘‘(ii) A manufacturer or importer of an acces-
sory that has been granted such marketing author-
ization may submit to the Secretary a written re-
quest for the appropriate classification of the acces-
sory based on the risks and appropriate level of reg-
ulatory controls as described in subparagraph (A), 
and shall, if the request is requesting classification 
of the accessory in class II, include in the submis-
sion an initial draft proposal for special controls, if 
special controls would be required pursuant to sub-
section (a)(1)(B). Such request shall include such 
information as may be necessary for the Secretary to 
evaluate, based on the least burdensome approach, 
the appropriate class for the accessory under sub-
section (a). The Secretary shall provide an oppor-
tunity for a manufacturer or importer to meet with 
appropriate personnel of the Food and Drug Admin-
istration to discuss the appropriate classification of 
such accessory prior to submitting a written request 
under this clause for classification of the accessory. 
‘‘(iii) The Secretary shall respond to a request 
made under clause (ii) not later than 85 calendar 
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days after receiving such request by issuing a writ-
ten order classifying the accessory or denying the re-
quest. If the Secretary does not agree with the rec-
ommendation for classification submitted by the 
manufacturer or importer, the response shall include 
a detailed description and justification for such de-
termination. Within 30 calendar days after granting 
such a request, the Secretary shall publish a notice 
in the Federal Register announcing such response. 
‘‘(E) Nothing in this paragraph may be construed as 
precluding a manufacturer of an accessory of a new type 
from using the classification process described in sub-
section (f)(2) to obtain classification of such accessory in 
accordance with the criteria and requirements set forth 
in that subsection.’’. 
(b) CONFORMING CHANGE.—Section 513(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360c(b)) is amended by striking paragraph (9) (relating 
to classification of an accessory). 
(c) EFFECTIVE DATE.—The amendments made by 
subsections (a) and (b) shall take effect on the date that 
is 60 days after the date of enactment of this Act. 
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SEC. 708. DEVICE PILOT PROJECTS. 
(a) POSTMARKET PILOT.—Section 519 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is 
amended by adding at the end the following: 
‘‘(i) POSTMARKET PILOT.— 
‘‘(1) IN GENERAL.—In order to provide timely 
and reliable information on the safety and effective-
ness of devices approved under section 515, cleared 
under section 510(k), or classified under section 
513(f)(2), including responses to adverse events and 
malfunctions, and to advance the objectives of part 
803 of title 21, Code of Federal Regulations (or suc-
cessor regulations), and advance the objectives of, 
and evaluate innovative new methods of compliance 
with, this section and section 522, the Secretary 
shall, within one year of the date of enactment of 
the FDA Reauthorization Act of 2017, initiate one 
or more pilot projects for voluntary participation by 
a manufacturer or manufacturers of a device or de-
vice type, or continue existing projects, in accord-
ance with paragraph (3), that— 
‘‘(A) are designed to efficiently generate 
reliable and timely safety and active surveil-
lance data for use by the Secretary or manufac-
turers of the devices that are involved in the 
pilot project; 
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‘‘(B) inform the development of methods, 
systems, data criteria, and programs that could 
be used to support safety and active surveil-
lance activities for devices included or not in-
cluded in such project; 
‘‘(C) may be designed and conducted in co-
ordination with a comprehensive system for 
evaluating medical device technology that oper-
ates under a governing board with appropriate 
representation of stakeholders, including patient 
groups and device manufacturers; 
‘‘(D) use electronic health data including 
claims data, patient survey data, or any other 
data, as the Secretary determines appropriate; 
and 
‘‘(E) prioritize devices and device types 
that meet one or more of the following criteria: 
‘‘(i) Devices and device types for 
which the collection and analysis of real 
world evidence regarding a device’s safety 
and effectiveness is likely to advance public 
health. 
‘‘(ii) Devices and device types that are 
widely used. 
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‘‘(iii) Devices and device types, the 
failure of which has significant health con-
sequences. 
‘‘(iv) Devices and device types for 
which the Secretary— 
‘‘(I) has received public rec-
ommendations in accordance with 
paragraph (2)(B); and 
‘‘(II) has determined to meet one 
or more of the criteria under clause 
(i), (ii), or (iii) and is appropriate for 
such a pilot project. 
‘‘(2) PARTICIPATION.—The Secretary shall es-
tablish the conditions and processes— 
‘‘(A) under which a manufacturer of a de-
vice may voluntarily participate in a pilot 
project described in paragraph (1); and 
‘‘(B) for facilitating public recommenda-
tions for devices to be prioritized under such a 
pilot project, including requirements for the 
data necessary to support such a recommenda-
tion. 
‘‘(3) CONTINUATION OF ONGOING PROJECTS.— 
The Secretary may continue or expand projects, with 
respect to providing timely and reliable information 
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on the safety and effectiveness of devices approved 
under section 515, cleared under section 510(k), or 
classified under section 513(f)(2), that are being 
carried out as of the date of the enactment of the 
FDA Reauthorization Act of 2017. The Secretary 
shall, beginning on such date of enactment, take 
such steps as may be necessary— 
‘‘(A) to ensure such projects meet the re-
quirements of subparagraphs (A) through (E) 
of paragraph (1); and 
‘‘(B) to increase the voluntary participa-
tion in such projects of manufacturers of de-
vices and facilitate public recommendations for 
any devices prioritized under such a project. 
‘‘(4) IMPLEMENTATION.— 
‘‘(A) 
CONTRACTING
AUTHORITY.—The 
Secretary may carry out a pilot project meeting 
the criteria specified in subparagraphs (A) 
through (E) of paragraph (1) or a project con-
tinued or expanded under paragraph (3) by en-
tering into contracts, cooperative agreements, 
grants, or other appropriate agreements with 
public or private entities that have a significant 
presence in the United States and meet the fol-
lowing conditions: 
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‘‘(i) If such an entity is a component 
of another organization, the entity and the 
organization have established an agree-
ment under which appropriate security 
measures are implemented to maintain the 
confidentiality and privacy of the data de-
scribed in paragraph (1)(D) and such 
agreement ensures that the entity will not 
make an unauthorized disclosure of such 
data to the other components of the orga-
nization in breach of requirements with re-
spect to confidentiality and privacy of such 
data established under such security meas-
ures. 
‘‘(ii) In the case of the termination or 
nonrenewal of such a contract, cooperative 
agreement, grant, or other appropriate 
agreement, the entity or entities involved 
shall comply with each of the following: 
‘‘(I) The entity or entities shall 
continue to comply with the require-
ments with respect to confidentiality 
and privacy referred to in clause (i) 
with respect to all data disclosed to 
the entity under such an agreement. 
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‘‘(II) The entity or entities shall 
return any data disclosed to such enti-
ty pursuant to this subsection and to 
which it would not otherwise have ac-
cess or, if returning such data is not 
practicable, destroy the data. 
‘‘(iii) The entity or entities shall have 
one or more qualifications with respect 
to— 
‘‘(I) research, statistical, epi-
demiologic, or clinical capability and 
expertise to conduct and complete the 
activities under this subsection, in-
cluding the capability and expertise to 
provide the Secretary access to de- 
identified data consistent with the re-
quirements of this subsection; 
‘‘(II) an information technology 
infrastructure to support electronic 
data and operational standards to 
provide security for such data, as ap-
propriate; 
‘‘(III) experience with, and exper-
tise on, the development of research 
on, and surveillance of, device safety 
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and 
effectiveness 
using 
electronic 
health data; or 
‘‘(IV) such other expertise which 
the Secretary determines necessary to 
carry out such a project. 
‘‘(B) REVIEW
OF
CONTRACT
IN
THE 
EVENT OF A MERGER OR ACQUISITION.—The 
Secretary shall review any contract, cooperative 
agreement, grant, or other appropriate agree-
ment entered into under this paragraph with an 
entity meeting the conditions specified in sub-
paragraph (A) in the event of a merger or ac-
quisition of the entity in order to ensure that 
the requirements specified in this subsection 
will continue to be met. 
‘‘(5) COMPLIANCE
WITH
REQUIREMENTS
FOR 
RECORDS OR REPORTS ON DEVICES.—The participa-
tion of a manufacturer in pilot projects under this 
subsection or a project continued or expanded under 
paragraph (3) shall not affect the eligibility of such 
manufacturer to participate in any quarterly report-
ing program with respect to devices carried out 
under this section 519 or section 522. The Secretary 
may determine that, for a specified time period to be 
determined by the Secretary, a manufacturer’s par-
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ticipation in a pilot project under this subsection or 
a project continued or expanded under paragraph 
(3) may meet the applicable requirements of this 
section or section 522, if— 
‘‘(A) the project has demonstrated success 
in capturing relevant adverse event information; 
and 
‘‘(B) the Secretary has established proce-
dures for making adverse event and safety in-
formation collected from such project public, to 
the extent possible. 
‘‘(6) PRIVACY
REQUIREMENTS.—With respect 
to the disclosure of any health information collected 
through a project conducted under this subsection— 
‘‘(A) individually identifiable health infor-
mation so collected shall not be disclosed when 
presenting any information from such project; 
and 
‘‘(B) any such disclosure shall be made in 
compliance with regulations issued pursuant to 
section 264(c) of the Health Insurance Port-
ability and Accountability Act of 1996 (42 
U.S.C. 1320d–2 note) and sections 552 and 
552a of title 5, United States Code. 
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‘‘(7) LIMITATIONS.—No pilot project under this 
subsection, or in coordination with the comprehen-
sive system described in paragraph (1)(C), may 
allow for an entity participating in such project, 
other than the Secretary, to make determinations of 
safety or effectiveness, or substantial equivalence, 
for purposes of this Act. 
‘‘(8) OTHER
PROJECTS
REQUIRED
TO
COM-
PLY.—Paragraphs (1)(B), (4)(A)(i), (4)(A)(ii), (5), 
(6), and (7) shall apply with respect to any pilot 
project undertaken in coordination with the com-
prehensive system described in paragraph (1)(C) 
that relates to the use of real world evidence for de-
vices in the same manner and to the same extent as 
such paragraphs apply with respect to pilot projects 
conducted under this subsection. 
‘‘(9) REPORT TO CONGRESS.—Not later than 
18 months after the date of enactment of this Act, 
and annually thereafter, the Secretary shall submit 
to the Committee on Energy and Commerce of the 
House of Representatives and the Committee on 
Health, Education, Labor and Pensions of the Sen-
ate a report containing a description of the pilot 
projects being conducted under this subsection and 
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projects continued or expanded pursuant to para-
graph (3), including for each such project— 
‘‘(A) how the project is being implemented 
in accordance with paragraph (4), including 
how such project is being implemented through 
a contract, cooperative agreement, grant, or 
other appropriate agreement, if applicable; 
‘‘(B) the number of manufacturers that 
have agreed to participate in such project; 
‘‘(C) the data sources used to conduct such 
project; 
‘‘(D) the devices or device categories in-
volved in such project; 
‘‘(E) the number of patients involved in 
such project; and 
‘‘(F) the findings of the project in relation 
to device safety, including adverse events, mal-
functions, and other safety information. 
‘‘(10) SUNSET.—The Secretary may not carry 
out a pilot project initiated by the Secretary under 
this subsection after October 1, 2022.’’. 
(b) REPORT.—Not later than January 31, 2021, the 
Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, shall conduct a re-
view through an independent third party to evaluate the 
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strengths, limitations, and appropriate use of evidence col-
lected pursuant to real world evidence pilot projects de-
scribed in the letters described in section 201(b) of the 
Medical Device User Fee Amendments of 2017 and sub-
section (i) of section 519 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360i), as amended by subsection 
(a), for informing premarket and postmarket decision-
making for multiple device types, and to determine wheth-
er the methods, systems, and programs in such pilot 
projects efficiently generate reliable and timely evidence 
about the effectiveness or safety surveillance of devices. 
SEC. 709. REGULATION OF OVER-THE-COUNTER HEARING 
AIDS. 
(a) IN GENERAL.—Section 520 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360j), as amended 
by section 708, is further amended by adding at the end 
the following: 
‘‘(q) REGULATION OF OVER-THE-COUNTER HEARING 
AIDS.— 
‘‘(1) DEFINITION.— 
‘‘(A) IN GENERAL.—In this subsection, the 
term ‘over-the-counter hearing aid’ means a de-
vice that— 
‘‘(i) uses the same fundamental sci-
entific technology as air conduction hear-
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ing aids (as defined in section 874.3300 of 
title 21, Code of Federal Regulations) (or 
any successor regulation) or wireless air 
conduction hearing aids (as defined in sec-
tion 874.3305 of title 21, Code of Federal 
Regulations) (or any successor regulation); 
‘‘(ii) is intended to be used by adults 
age 18 and older to compensate for per-
ceived mild to moderate hearing impair-
ment; 
‘‘(iii) through tools, tests, or software, 
allows the user to control the over-the- 
counter hearing aid and customize it to the 
user’s hearing needs; 
‘‘(iv) may— 
‘‘(I) use wireless technology; or 
‘‘(II) include tests for self-assess-
ment of hearing loss; and 
‘‘(v) 
is 
available 
over-the-counter, 
without the supervision, prescription, or 
other order, involvement, or intervention of 
a licensed person, to consumers through 
in-person transactions, by mail, or online. 
‘‘(B) EXCEPTION.—Such term does not in-
clude a personal sound amplification product in-
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tended to amplify sound for nonhearing im-
paired consumers in situations including hunt-
ing and bird-watching. 
‘‘(2) REGULATION.—An over-the-counter hear-
ing aid shall be subject to the regulations promul-
gated in accordance with section 709(b) of the FDA 
Reauthorization Act of 2017 and shall be exempt 
from sections 801.420 and 801.421 of title 21, Code 
of Federal Regulations (or any successor regula-
tions).’’. 
(b) REGULATIONS TO ESTABLISH CATEGORY.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the 
‘‘Secretary’’), not later than 3 years after the date 
of enactment of this Act, shall promulgate proposed 
regulations to establish a category of over-the- 
counter hearing aids, as defined in subsection (q) of 
section 520 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360j) as amended by sub-
section (a), and, not later than 180 days after the 
date on which the public comment period on the pro-
posed regulations closes, shall issue such final regu-
lations. 
(2) REQUIREMENTS.—In promulgating the reg-
ulations under paragraph (1), the Secretary shall— 
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