H. R. 2430 
One Hundred Fifteenth Congress 
of the 
United States of America 
AT THE FIRST SESSION 
Begun and held at the City of Washington on Tuesday, 
the third day of January, two thousand and seventeen 
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 biological products, and for other purposes. 
Be it enacted by the Senate and House of Representatives 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. 
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.
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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 con-
taining single enantiomers. 
Sec. 602. Reauthorization of the critical path public-private partnerships. 
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 appli-
cations. 
Sec. 808. Incentivizing competitive generic drug development. 
Sec. 809. GAO study of issues regarding first cycle approvals of generic medicines. 
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’’. 
(b) FINDING.—The Congress finds that the fees authorized by 
the amendments made in this title will be dedicated toward expe-
diting the drug development process and the process for the review 
of human drug applications, including 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
H. R. 2430—3 
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 Rep-
resentatives, as set forth in the Congressional Record. 
SEC. 102. AUTHORITY TO ASSESS AND USE DRUG FEES. 
(a) TYPES OF FEES.— 
(1) IN GENERAL.—Section 736(a) of the Federal 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’’; 
(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 sub-
section (c)(5) for a human drug application for which 
clinical data (other than bioavailability or bioequiva-
lence 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 INDICATION’’; 
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); 
(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 before 
the Secretary a human drug application or supplement, 
shall pay the annual prescription drug program fee estab-
lished 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 paragraph (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 inserting ‘‘A prescription 
drug program fee shall not be assessed for a prescrip-
tion drug product’’; and
H. R. 2430—4 
(L) by adding at the end of such paragraph (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 fiscal year for prescription drug products identi-
fied in such approved human drug application.’’. 
(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 section 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, 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 inflation adjust-
ment for the fiscal year (as determined under subsection 
(c)(1)); 
‘‘(C) the dollar amount equal to the capacity planning 
adjustment for the fiscal year (as determined under sub-
section (c)(2)); 
‘‘(D) the dollar amount equal to the operating reserve 
adjustment for the fiscal year, if applicable (as determined 
under subsection (c)(3)); 
‘‘(E) the dollar amount equal to the additional 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. 
‘‘(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 deter-
mined for a fiscal year under paragraph (1)— 
‘‘(A) 20 percent shall be derived from human drug 
application fees under subsection (a)(1); and 
‘‘(B) 80 percent shall be derived from prescription 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 previous fiscal year, not including 
any adjustments made under subsection (c)(3) or (c)(4).’’.
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(c) ADJUSTMENTS; ANNUAL FEE SETTING.—Subsection (c) of sec-
tion 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h) is amended to read as follows: 
‘‘(c) ADJUSTMENTS; ANNUAL FEE SETTING.— 
‘‘(1) INFLATION ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For purposes of subsection (b)(1)(B), 
the dollar amount of the inflation adjustment to the annual 
base revenue for each fiscal year shall be equal to the 
product of— 
‘‘(i) such annual base revenue for the fiscal year 
under subsection (b)(1)(A); and 
‘‘(ii) the inflation adjustment percentage under 
subparagraph (B). 
‘‘(B) INFLATION ADJUSTMENT PERCENTAGE.—The infla-
tion 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 
Administration, of all personnel compensation and 
benefits paid with respect to such positions for the 
first 3 years of the preceding 4 fiscal years, multiplied 
by the proportion of personnel compensation and bene-
fits costs to total costs of the process for the review 
of human drug applications (as defined in section 
735(6)) for the first 3 years of the preceding 4 fiscal 
years; and 
‘‘(ii) the average annual percent change that 
occurred in the Consumer Price Index for urban con-
sumers (Washington-Baltimore, DC–MD–VA–WV; Not 
Seasonally Adjusted; All items; Annual Index) for the 
first 3 years of the preceding 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. 
‘‘(B) INTERIM METHODOLOGY.— 
‘‘(i) IN
GENERAL.—Until the capacity planning 
methodology described in subparagraph (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
H. R. 2430—6 
most recent year for which data are available, over 
the 3-year average ending in the previous year, for— 
‘‘(I) the total number of human drug applica-
tions, efficacy supplements, and manufacturing 
supplements submitted to the Secretary; 
‘‘(II) the total number of active commercial 
investigational new drug applications; and 
‘‘(III) the total number of formal meetings 
scheduled by the Secretary, and written responses 
issued by the Secretary in lieu of such formal 
meetings, 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 METHODOLOGY.— 
‘‘(i) DEVELOPMENT; EVALUATION AND REPORT.—The 
Secretary shall obtain, through a contract with an 
independent accounting or consulting firm, a report 
evaluating 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 plan-
ning methodological options and recommendations pre-
sented in such report shall utilize and be informed 
by personnel time reporting data as an input. The 
report shall be published for public comment no later 
than the end of fiscal year 2020. 
‘‘(ii) ESTABLISHMENT AND IMPLEMENTATION.—After 
review of the report described in clause (i) and any 
public comments thereon, the Secretary shall establish 
a capacity planning methodology for purposes of this 
paragraph, which shall— 
‘‘(I) replace the interim methodology under 
subparagraph (B); 
‘‘(II) 
incorporate 
such 
approaches 
and 
attributes as the Secretary determines appro-
priate; and 
‘‘(III) be effective beginning with the first fiscal 
year for which fees are set after such capacity 
planning methodology is established. 
‘‘(D) LIMITATION.—Under no circumstances 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 fiscal year). 
‘‘(E) PUBLICATION
IN
FEDERAL
REGISTER.—The Sec-
retary shall publish in the Federal Register notice under 
paragraph (5) of the fee revenue and fees resulting from 
the adjustment 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 rev-
enue and fees if such an adjustment is necessary to provide
H. R. 2430—7 
for not more than 14 weeks of operating reserves of carry-
over user fees for the process for the review of human 
drug applications. 
‘‘(B) DECREASE.—If the Secretary has carryover bal-
ances for such process in excess of 14 weeks of such oper-
ating reserves, the Secretary shall decrease such fee rev-
enue and fees to provide for not more than 14 weeks 
of such operating reserves. 
‘‘(C) NOTICE OF RATIONALE.—If an adjustment under 
subparagraph (A) or (B) is made, the rationale for the 
amount of the increase or decrease (as applicable) in fee 
revenue and fees shall be contained in the annual Federal 
Register notice under paragraph (5) establishing fee rev-
enue and fees for the fiscal year involved. 
‘‘(4) ADDITIONAL DIRECT COST ADJUSTMENT.— 
‘‘(A) IN GENERAL.—The Secretary shall, in addition to 
adjustments under paragraphs (1), (2), and (3), further 
increase the fee revenue and fees— 
‘‘(i) for fiscal year 2018, by $8,730,000; and 
‘‘(ii) for fiscal year 2019 and subsequent fiscal 
years, by the amount determined 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 con-
sumers (Washington-Baltimore, DC–MD–VA–WV; Not 
Seasonally Adjusted; 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— 
‘‘(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 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 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 review 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 subparagraph (B); 
(B) by striking subparagraph (C); and 
(C) by redesignating subparagraph (D) as subpara-
graph (C); 
(2) by striking paragraph (3) (relating to use of standard 
costs); 
(3) by redesignating paragraph (4) as paragraph (3); and 
(4) in paragraph (3), as so redesignated— 
(A) in subparagraphs (A) and (B), by striking ‘‘para-
graph (1)(D)’’ and inserting ‘‘paragraph (1)(C)’’; and
H. R. 2430—8 
(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 inserting ‘‘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 establishments, and prescription 
drug products’’ and inserting ‘‘prescription drug program fees’’. 
(g) CREDITING AND AVAILABILITY OF FEES.—Section 736(g) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)) 
is amended— 
(1) in paragraph (3)— 
(A) by striking ‘‘2013 through 2017’’ and inserting 
‘‘2018 through 2022’’; and 
(B) by striking ‘‘and paragraph (4) of this subsection’’; 
and 
(2) by striking paragraph (4). 
(h) ORPHAN DRUGS.—Section 736(k) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379h(k)) is amended by striking 
‘‘product and establishment fees’’ each place it appears and inserting 
‘‘prescription drug program fees’’. 
SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 736B of the Federal Food, Drug, and Cosmetic 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 ‘‘Prescription 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’’. 
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 October 1, 2017, 
subsections (a) and (b) of section 105 of the Food and Drug Adminis-
tration 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
H. R. 2430—9 
for all human drug applications received on or after October 1, 
2017, regardless 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 enact-
ment of this title, shall continue to be in effect with respect to 
human drug applications and supplements (as defined in such part 
as of such day) that on or after October 1, 2012, but before October 
1, 2017, were accepted by the Food and Drug Administration for 
filing with respect to assessing and collecting any fee required 
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 authorized 
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 effectiveness 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 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 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— 
(1) by redesignating paragraphs (8) through (13) as para-
graphs (9) through (14), respectively; 
(2) by inserting after paragraph (7) the following new para-
graph: 
‘‘(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 paragraph (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 inserting ‘‘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)— 
(A) in subparagraph (A)—
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(i) in the matter preceding clause (i), by striking 
‘‘October 1, 2012’’ and inserting ‘‘October 1, 2017’’; 
(ii) in clause (viii), by striking ‘‘2’’ and inserting 
‘‘3.4’’; and 
(iii) by adding at the end the following new clause: 
‘‘(xi) For a de novo classification request, 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 inserting ‘‘premarket notifica-
tion 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 derived from the base fee amounts 
specified in paragraph (2), to generate the total revenue 
amounts specified in paragraph (3). 
‘‘(2) BASE FEE AMOUNTS SPECIFIED.—For purposes of para-
graph (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 Registra-
tion ................................
$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 inserting the 
following new subparagraph: 
‘‘(B) 
APPLICABLE
INFLATION
ADJUSTMENT.—The 
applicable inflation adjustment for fiscal year 2018 and 
each subsequent fiscal year is the product of— 
‘‘(i) the base inflation adjustment under subpara-
graph (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 fiscal year, beginning with fiscal year 
2016.’’;
H. R. 2430—11 
(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 specified in sub-
section (b)(2) for such fiscal year by multiplying such 
amounts by the applicable inflation adjustment under 
subparagraph (B) for such year; and 
‘‘(ii) if the Secretary determines necessary, increase 
(in addition to the adjustment under clause (i)) such 
base fee amounts, on a uniform proportionate basis, 
to generate the total revenue amounts under sub-
section (b)(3), as adjusted for inflation under subpara-
graph (A).’’; and 
(3) in paragraph (3)— 
(A) by striking ‘‘2014 through 2017’’ and inserting 
‘‘2018 through 2022’’; and 
(B) by striking ‘‘further adjusted’’ and inserting 
‘‘increased’’. 
(d) SMALL BUSINESSES; FEE WAIVER
AND FEE REDUCTION 
REGARDING PREMARKET APPROVAL FEES.—Section 738(d) of the Fed-
eral 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 ‘‘speci-
fied in clauses (i) through (vii) and clauses (ix), (x), and (xi)’’; 
and 
(2) in paragraph (2)(C)— 
(A) by striking ‘‘supplement, or’’ and inserting ‘‘supple-
ment,’’; and 
(B) by inserting ‘‘, or a de novo classification request’’ 
after ‘‘class III device’’. 
(e) SMALL BUSINESSES; FEE REDUCTION REGARDING PREMARKET 
NOTIFICATION SUBMISSIONS.—Section 738(e)(2)(C) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(e)(2)(C)) is amended 
by striking ‘‘50’’ and inserting ‘‘25’’. 
(f) FEE WAIVER OR REDUCTION.— 
(1) REPEAL.—Section 738 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j) is amended 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 Cos-
metic Act (21 U.S.C. 379j), as amended by paragraph (1), 
is further amended— 
(i) by redesignating subsections (g) through (l) as 
subsections (f) through (k); 
(ii) in subsection (a)(2)(A), by striking ‘‘(d), (e), 
and (f)’’ and inserting ‘‘(d) and (e)’’; and 
(iii) in subsection (a)(3)(A), by striking ‘‘and sub-
section (f)’’. 
(g) EFFECT OF FAILURE TO PAY FEES.—Subsection (f)(1), as 
so redesignated, of section 738 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j) is amended—
H. R. 2430—12 
(1) by striking ‘‘or periodic reporting concerning a class 
III device’’ and inserting ‘‘periodic reporting concerning a class 
III device, or de novo classification request’’; and 
(2) by striking ‘‘all fees’’ and inserting ‘‘all such fees’’. 
(h) CONDITIONS.—Subsection (g)(1)(A), as so redesignated, of 
section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j) is amended by striking ‘‘$280,587,000’’ and inserting 
‘‘$320,825,000’’. 
(i) CREDITING AND AVAILABILITY OF FEES.—Subsection (h), as 
so redesignated, of section 738 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j) is amended— 
(1) in paragraph (3)— 
(A) by striking ‘‘2013 through 2017’’ and inserting 
‘‘2018 through 2022’’; and 
(B) by striking ‘‘subsection (c)’’ and all that follows 
through the period at the end and inserting ‘‘subsection 
(c).’’; and 
(2) by striking paragraph (4). 
SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS. 
(a) PERFORMANCE REPORTS.—Section 738A(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(a)) is amended— 
(1) in paragraph (1)— 
(A) in subparagraph (A)— 
(i) by striking ‘‘2013’’ and inserting ‘‘2018’’; and 
(ii) by striking ‘‘the Medical Device User Fee 
Amendments of 2012’’ and inserting ‘‘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’’. 
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 CONFORMITY ASSESS-
MENT.— 
‘‘(1) IN
GENERAL.—The Secretary shall establish a pilot 
program under which— 
‘‘(A) testing laboratories may be accredited, by accredi-
tation bodies meeting criteria specified by the Secretary, 
to assess the conformance of a device with certain stand-
ards recognized under this section; and 
‘‘(B) subject to paragraph (2), determinations by testing 
laboratories so accredited that a device conforms with such 
standard or standards shall be accepted by the Secretary 
for purposes of demonstrating such conformity under this 
section unless the Secretary finds that a particular such 
determination shall not be so accepted.
H. R. 2430—13 
‘‘(2) SECRETARIAL
REVIEW
OF
ACCREDITED
LABORATORY 
DETERMINATIONS.—The Secretary may— 
‘‘(A) review determinations by testing laboratories 
accredited pursuant to this subsection, including by con-
ducting periodic audits of such determinations or processes 
of accredited bodies or testing laboratories and, following 
such review, taking additional measures under this Act, 
such as suspension or withdrawal of accreditation of such 
testing laboratory under paragraph (1)(A) or requesting 
additional information with respect to such device, as the 
Secretary determines appropriate; and 
‘‘(B) if the Secretary becomes aware of information 
materially bearing on safety or effectiveness of a device 
assessed for conformity by a testing laboratory so accred-
ited, take such additional measures under this Act as the 
Secretary determines appropriate, such as suspension or 
withdrawal of accreditation of such testing laboratory 
under paragraph (1)(A), or requesting additional informa-
tion 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 September 30, 2018, to discuss and 
obtain input and recommendations from stakeholders 
regarding 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 program 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 Sep-
tember 30, 2020, the Secretary shall initiate the pilot pro-
gram under this subsection. 
‘‘(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 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 determination 
described in subparagraph (B)(ii), the Secretary shall not 
continue to recognize the accreditation of testing labora-
tories accredited under paragraph (1)(A); and 
‘‘(D) the Secretary may take actions in accordance with 
paragraph (2) with respect to the determinations made
H. R. 2430—14 
prior to such date and recognition of the accreditation 
of testing laboratories 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: 
‘‘(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 determined by the Secretary in accordance 
with subparagraph (B)(i)(II) and listed as eligible for 
review under subparagraph (B)(iii); or 
‘‘(iv) a device that is of a type, or subset of a 
type, listed as not eligible for review under subpara-
graph (B)(iii).’’; 
(B) by striking subparagraph (B) and inserting the 
following: 
‘‘(B) DESIGNATION FOR REVIEW.—The Secretary shall— 
‘‘(i) issue draft guidance on the factors the Sec-
retary 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, 
including— 
‘‘(I) the risk of the device type, or subset of 
such device type; and 
‘‘(II) whether the device type, or subset of such 
device type, is permanently implantable, life sus-
taining, 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 guidance; and 
‘‘(iii) beginning on the date such guidance is final-
ized, designate and post on the internet website of 
the Food and Drug Administration, an updated list 
of class I and class II device types, or subsets of such 
device types, and the Secretary’s determination with 
respect to whether each such device type, or subset 
of a device type, is eligible or not eligible for review 
by an accredited person under this section based on 
the factors described in clause (i).’’; and 
(C) by adding at the end the following: 
‘‘(C) INTERIM
RULE.—Until the date on which the 
updated list is designated and posted in accordance with 
subparagraph (B)(iii), the list in effect on the date of enact-
ment the Medical Device User Fee Amendments of 2017 
shall be in effect.’’; 
(2) in subsection (b)— 
(A) in paragraph (2)— 
(i) by striking subparagraph (D); and
H. R. 2430—15 
(ii) by redesignating subparagraph (E) as subpara-
graph (D); and 
(B) in paragraph (3)— 
(i) by redesignating subparagraph (E) as subpara-
graph (F); 
(ii) in subparagraph (F) (as so redesignated), by 
striking ‘‘The operations of’’ and all that follows 
through ‘‘it will—’’ and inserting ‘‘Such person shall 
agree, at a minimum, to include in its request for 
accreditation a commitment to, at the time of accredita-
tion, and at any time it is performing any review 
pursuant to this section—’’; and 
(iii) by inserting after subparagraph (D) the fol-
lowing new subparagraph: 
‘‘(E) The operations of such person shall be in accord-
ance with generally accepted professional and ethical busi-
ness 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 Cosmetic Act 
(21 U.S.C. 379k–1(b)) is amended by adding at the end the following 
new paragraph: 
‘‘(3) PRESUBMISSIONS AND SUBMISSIONS SOLELY IN ELEC-
TRONIC FORMAT.— 
‘‘(A) IN GENERAL.—Beginning on such date as the Sec-
retary specifies in final guidance issued under subpara-
graph (C), presubmissions and submissions for devices 
described in paragraph (1) (and any appeals of action taken 
by the Secretary with respect to such presubmissions or 
submissions) shall be submitted solely in such electronic 
format as specified by the Secretary in such guidance. 
‘‘(B) DRAFT GUIDANCE.—The Secretary shall, not later 
than October 1, 2019, issue draft guidance providing for— 
‘‘(i) any further standards for the submission by 
electronic format required under subparagraph (A); 
‘‘(ii) a timetable for the establishment by the Sec-
retary of such further standards; and 
‘‘(iii) criteria for waivers of and exemptions 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 guidance 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 submissions listed in section 
738(a)(2)(A) of such Act (as defined in such part as of such day) 
that on or after October 1, 2012, but before October 1, 2017, were 
accepted by the Food and Drug Administration for filing with 
respect to assessing and collecting any fee required by such part 
for a fiscal year prior to fiscal year 2018.
H. R. 2430—16 
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 listed 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 reauthor-
ization and reporting requirements) shall cease to be effective 
January 31, 2023. 
(c) PREVIOUS SUNSET PROVISION.—Effective October 1, 2017, 
section 207(a) of the Food and Drug Administration Safety and 
Innovation Act (Public Law 112–144) is repealed. 
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 authorized by 
the amendments made in this title will be dedicated to human 
generic drug activities, as set forth in the goals identified for pur-
poses 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 Congressional Record. 
SEC. 302. DEFINITIONS. 
Section 744A of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j–41) is amended— 
(1) in paragraph (1)(B), by striking ‘‘application for a 
positron emission tomography drug.’’ and inserting ‘‘applica-
tion— 
‘‘(i) for a positron emission tomography drug; or 
‘‘(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 para-
graphs (6) through (13), respectively; and 
(3) by inserting after paragraph (4) the following: 
‘‘(5) The term ‘contract manufacturing organization facility’ 
means a manufacturing facility of a finished dosage form of 
a drug approved pursuant to an abbreviated new drug applica-
tion, where such manufacturing facility is not identified in 
an approved abbreviated new drug application held by the 
owner of such facility or an affiliate of such owner or facility.’’.
H. R. 2430—17 
SEC. 303. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG 
FEES. 
(a) TYPES OF FEES.—Section 744B(a) of the Federal 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’’; 
(2) in paragraph (1), by adding at the end the following: 
‘‘(E) SUNSET.—This paragraph shall cease to be effec-
tive October 1, 2022.’’; 
(3) in paragraph (2)— 
(A) by amending subparagraph (C) to read as follows: 
‘‘(C) NOTICE.—Not later than 60 days before the start 
of each of fiscal years 2018 through 2022, the Secretary 
shall publish in the Federal Register the amount of the 
drug master 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: 
‘‘(II) the date on which the drug master file 
holder requests the initial completeness assess-
ment.’’; and 
(ii) in clause (ii), by striking ‘‘notice provided for 
in clause (i) or (ii) of subparagraph (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 applica-
tion’’; 
(C) by amending subparagraphs (B) and (C) to read 
as follows: 
‘‘(B) NOTICE.—Not later than 60 days before 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 subpara-
graphs (A) and (F) shall be due no later than the date 
of submission of the abbreviated new drug application or 
prior approval supplement for which such fee applies.’’; 
(D) in subparagraph (D)— 
(i) in the heading, by inserting ‘‘, IS WITHDRAWN 
PRIOR TO BEING RECEIVED, OR IS NO LONGER RECEIVED’’ 
after ‘‘RECEIVED’’; 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
APPLICATIONS
WITHDRAWN
PRIOR
TO 
BEING RECEIVED.—The Secretary shall refund 75 per-
cent of the fee paid under subparagraph (A) for any 
abbreviated new drug application that the Secretary
H. R. 2430—18 
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 withdrawn prior to being 
received within the meaning of section 505(j)(5)(A). 
‘‘(ii) APPLICATIONS NO LONGER RECEIVED.—The Sec-
retary shall refund 100 percent of the fee paid under 
subparagraph (A) for any abbreviated new drug 
application if the Secretary initially receives the 
application under section 505(j)(5)(A) and subsequently 
determines that an exclusivity period for a listed drug 
should have prevented the Secretary from receiving 
such application, such that the abbreviated new drug 
application is no longer received within 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 intended to be identified, in 
at least one generic drug submission that is pending 
or’’ and inserting ‘‘in at least one generic drug submis-
sion that is’’; 
(ii) in clause (i), by striking ‘‘or intended to be 
identified in at least one generic drug submission that 
is pending or’’ and inserting ‘‘in at least one generic 
drug submission that is’’; 
(iii) in clause (ii), by striking ‘‘produces,’’ and all 
that follows through ‘‘such a’’ and inserting ‘‘is identi-
fied 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 manufacture of the finished dosage forms’’; and 
(B) by amending subparagraphs (C) and (D) to read 
as follows: 
‘‘(C) NOTICE.—Within the timeframe specified in sub-
section (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 subparagraph (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 providing for the collection 
and obligation of fees for such year under this section 
for such year.’’;
H. R. 2430—19 
(6) by redesignating paragraph (5) as paragraph (6); and 
(7) by inserting after paragraph (4) the following: 
‘‘(5) GENERIC DRUG APPLICANT PROGRAM FEE.— 
‘‘(A) IN GENERAL.—A generic drug applicant program 
fee shall be assessed annually as described in subsection 
(b)(2)(E). 
‘‘(B) AMOUNT.—The amount of fees established under 
subparagraph (A) shall be established under subsection 
(d). 
‘‘(C) NOTICE.—Within the timeframe specified in sub-
section (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 subparagraph (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 enact-
ment of an appropriations Act providing for the collec-
tion and obligation of fees for such fiscal year under 
this section 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 
(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 inserting ‘‘through 
(5)’’; 
(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).
H. R. 2430—20 
‘‘(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 facility shall be equal to one-third the amount 
of the fee for a facility that is not a contract manufacturing 
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 
(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 purposes of this subparagraph, if a 
person has affiliates, a single program fee shall be assessed 
with respect to that person, including its affiliates, and 
may be paid by that person or any one of its affiliates. 
The Secretary shall determine the fees as follows: 
‘‘(I) If a person (including its affiliates) owns at 
least one but not more than 5 approved abbreviated 
new drug applications on the due date for the fee 
under this subsection, the person (including its affili-
ates) shall be assessed a small business generic drug 
applicant program fee equal to one-tenth of the large 
size operation generic drug applicant program fee. 
‘‘(II) If a person (including its affiliates) owns at 
least 6 but not more than 19 approved abbreviated 
new drug applications on the due date for the fee 
under this subsection, the person (including its affili-
ates) shall be assessed a medium size operation generic 
drug applicant program fee equal to two-fifths of the 
large size operation generic drug applicant program 
fee. 
‘‘(III) If a person (including its affiliates) owns 
20 or more approved abbreviated new drug applications 
on the due date for the fee under this subsection, 
the person (including its affiliates) shall be assessed 
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 with-
drawal 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’’;
H. R. 2430—21 
(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 appears and 
inserting ‘‘2022’’; 
(B) by striking ‘‘the first 3 months of fiscal 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 inserting 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 para-
graphs (2) through (5) of subsection (a), based on the revenue 
amounts established under subsection (b) and the adjustments 
provided under subsection (c).’’; 
(2) by redesignating paragraph (3) as paragraph (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 Fed-
eral 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 para-
graphs (1) through (3), respectively; 
(3) in paragraph (1) (as so redesignated)— 
(A) by striking ‘‘paragraph (4)’’ and inserting ‘‘para-
graph (3)’’; and 
(B) by striking ‘‘Such information shall’’ and all that 
follows through the end of subparagraph (B) and inserting 
‘‘Such information shall, for each fiscal year, be submitted, 
updated, or reconfirmed on or before June 1 of the previous 
fiscal year.’’; and 
(4) in paragraph (2), as so redesignated— 
(A) in the heading, by striking ‘‘CONTENTS OF NOTICE’’ 
and inserting ‘‘INFORMATION REQUIRED 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—
H. R. 2430—22 
(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: 
‘‘(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 subpara-
graph (D) of such subsection, shall be subject to the fol-
lowing: 
‘‘(i) The Secretary shall place the person on a pub-
licly available arrears list. 
‘‘(ii) Any abbreviated new drug application sub-
mitted by the generic drug applicant or an affiliate 
of such applicant shall not be received, within the 
meaning of section 505(j)(5)(A). 
‘‘(iii) All drugs marketed pursuant to any abbre-
viated new drug application held by such applicant 
or an affiliate of such applicant shall be deemed mis-
branded 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 Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j–42(h)(2)) is amended by striking 
‘‘for Type II active pharmaceutical ingredient drug master files, 
abbreviated new drug applications and prior approval supplements, 
and generic drug facilities and active pharmaceutical ingredient 
facilities’’. 
(h) CREDITING AND AVAILABILITY OF FEES.—Section 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 ‘‘subparagraphs 
(C) and (D)’’ and inserting ‘‘subparagraph (C)’’; 
(B) by striking subparagraph (C) (relating to fee collec-
tion 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 subpara-
graph (C); and 
(2) in paragraph (3), by striking ‘‘fiscal years 2013 through 
2017’’ and inserting ‘‘fiscal years 2018 through 2022’’. 
(i) INFORMATION
ON ABBREVIATED NEW DRUG APPLICATIONS 
OWNED BY APPLICANTS AND THEIR AFFILIATES.—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 AFFILIATES.— 
‘‘(1) IN GENERAL.—By April 1 of each year, each person 
that owns an abbreviated new drug application, or a designated 
affiliate of such person, shall submit, on behalf of the person 
and the affiliates of such person, to the Secretary a list of—
H. R. 2430—23 
‘‘(A) all approved abbreviated new drug applications 
owned by such person; and 
‘‘(B) if any affiliate of such person also owns an abbre-
viated 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.’’. 
SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 744C of the Federal Food, Drug, and Cosmetic 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 Amend-
ments 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. 
(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 enact-
ment of this title, shall continue to be in effect with respect to 
abbreviated new drug applications (as defined in such part as 
of such day) that were received by the Food and Drug Administra-
tion within the meaning of section 505(j)(5)(A) of such Act (21
H. R. 2430—24 
U.S.C. 355(j)(5)(A)), prior approval supplements that were sub-
mitted, and drug master files for Type II active pharmaceutical 
ingredients that were first referenced on or after 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 authorized by 
the amendments made in this title will be dedicated to expediting 
the process for the review of biosimilar biological product applica-
tions, including postmarket safety activities, as set forth in the 
goals identified for purposes of part 8 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 
Congressional Record. 
SEC. 402. DEFINITIONS. 
(a) ADJUSTMENT FACTOR.—Section 744G(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–51(1)) is amended to read 
as follows: 
‘‘(1) The term ‘adjustment factor’ applicable to a fiscal 
year is the Consumer Price Index for urban consumers (Wash-
ington-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 Federal 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 ‘‘BIO-
SIMILAR’’ and inserting ‘‘BIOSIMILAR BIOLOGICAL PRODUCT’’; 
(3) in paragraph (1)(A)(i), by striking ‘‘(b)(1)(A)’’ and 
inserting ‘‘(c)(5)’’; 
(4) in paragraph (1)(B)(i), by striking ‘‘(b)(1)(B) for bio-
similar biological product development’’ and inserting ‘‘(c)(5) 
for the biosimilar biological 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’’;
H. R. 2430—25 
(6) in paragraph (1)(B)(iii), by striking ‘‘annual biosimilar 
development program fee’’ and inserting ‘‘annual biosimilar 
biological product development 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 biological 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 person for the product for such fiscal year. 
To qualify for consideration for a refund under this 
clause, a person shall submit to the Secretary a written 
request for such refund not later than 180 days after 
the marketing application is accepted for filing.’’; 
(8) in paragraph (1)(C), by striking ‘‘for a product effective 
October 1 of a fiscal year by,’’ and inserting ‘‘for a product, 
effective October 1 of a fiscal 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 participa-
tion in such program,’’ before ‘‘pay a fee’’; 
(B) in clause (i)(I), by inserting after ‘‘grants a request’’ 
the following: ‘‘by such person’’; and 
(C) in clause (i)(II), by inserting after ‘‘discontinued)’’ 
the following: ‘‘by such person’’; 
(10) in the heading of paragraph (1)(E), by striking ‘‘BIO-
SIMILAR DEVELOPMENT PROGRAM’’; 
(11) in paragraph (1)(F)— 
(A) in the subparagraph heading, by striking ‘‘BIO-
SIMILAR DEVELOPMENT PROGRAM’’; and 
(B) by amending clause (i) to read as follows: 
‘‘(i) REFUNDS.—Except as provided in subpara-
graph (B)(iv), the Secretary shall not refund any initial 
or annual biosimilar biological product development 
fee paid under subparagraph (A) or (B), or any reactiva-
tion fee paid under subparagraph (D).’’; 
(12) in paragraph (2)— 
(A) in the paragraph heading, by striking ‘‘AND SUPPLE-
MENT’’; 
(B) by amending subparagraphs (A) and (B) to read 
as follows: 
‘‘(A) IN GENERAL.—Each person that submits, on or 
after October 1, 2017, a biosimilar biological product 
application shall be subject to the following fees: 
‘‘(i) A fee established under subsection (c)(5) for 
a biosimilar biological product application for which 
clinical data (other than comparative bioavailability 
studies) with respect to safety or effectiveness are 
required for approval. 
‘‘(ii) A fee established under subsection (c)(5) for 
a biosimilar biological product application for which 
clinical data (other than comparative bioavailability 
studies) with respect to safety or effectiveness are not 
required for approval. Such fee shall be equal to half 
of the amount of the fee described in clause (i).
H. R. 2430—26 
‘‘(B) RULE OF APPLICABILITY; TREATMENT 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 biosimilar biological 
product application for that product after such date, shall— 
‘‘(i) be subject to any biosimilar biological product 
application fees that may be assessed at the time when 
such biosimilar biological product application is sub-
mitted; and 
‘‘(ii) be entitled to no reduction of such application 
fees based on the amount of fees paid for that product 
before October 1, 2017, under such subparagraph (A), 
(B), or (D).’’; 
(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 follows: 
‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT PROGRAM FEE.— 
‘‘(A) IN GENERAL.—Each person who is named as the 
applicant in a biosimilar biological product application shall 
pay the annual biosimilar biological product program fee 
established 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 discontinued biosimilar biological prod-
ucts. 
‘‘(B) DUE DATE.—The biosimilar biological product pro-
gram 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 providing 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 biological product application shall 
not be assessed more than 5 biosimilar biological product 
program fees for a fiscal year for biosimilar biological prod-
ucts identified in such biosimilar biological product applica-
tion.’’. 
(b) FEE REVENUE AMOUNTS.—Subsection (b) of section 744H 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
52) is amended to read as follows: 
‘‘(b) FEE REVENUE AMOUNTS.— 
‘‘(1) FISCAL YEAR 2018.—For fiscal year 2018, fees under 
subsection (a) shall be established to generate a total revenue 
amount equal to the sum of— 
‘‘(A) $45,000,000; and
H. R. 2430—27 
‘‘(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 subsection (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 inflation adjust-
ment for the fiscal year (as determined under subsection 
(c)(1)); 
‘‘(C) the dollar amount equal to the capacity planning 
adjustment for the fiscal year (as determined under sub-
section (c)(2)); and 
‘‘(D) the dollar amount equal to the operating reserve 
adjustment for the fiscal year, if applicable (as determined 
under subsection (c)(3)). 
‘‘(3) ALLOCATION OF REVENUE AMOUNT AMONG FEES; LIMITA-
TIONS ON FEE AMOUNTS.— 
‘‘(A) ALLOCATION.—The Secretary shall determine the 
percentage of the total revenue amount for a fiscal year 
to be derived from, respectively— 
‘‘(i) initial and annual biosimilar biological product 
development fees and reactivation fees under sub-
section (a)(1); 
‘‘(ii) biosimilar biological product application fees 
under subsection (a)(2); and 
‘‘(iii) biosimilar biological product program 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 subsection (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 biological product develop-
ment fee under subsection (a)(1)(A) for a fiscal year shall 
be equal to the annual biosimilar biological product 
development fee under subsection (a)(1)(B) for that fiscal 
year. 
‘‘(D) REACTIVATION FEE.—The reactivation fee under 
subsection (a)(1)(D) for a fiscal year shall be equal to twice 
the amount of the annual biosimilar biological product 
development 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 
revenue 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 sub-
sections (d) through (i), respectively;
H. R. 2430—28 
(2) in subsections (a)(2)(F) and (h) (as redesignated by 
paragraph (1)), by striking ‘‘subsection (c)’’ and inserting ‘‘sub-
section (d)’’; 
(3) in subsection (a)(4)(A), by striking ‘‘subsection (b)(1)(F)’’ 
and inserting ‘‘subsection (c)(5)’’; and 
(4) by inserting after subsection (b) the following: 
‘‘(c) ADJUSTMENTS; ANNUAL FEE SETTING.— 
‘‘(1) INFLATION ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For purposes of subsection (b)(2)(B), 
the dollar amount of the inflation adjustment to the annual 
base revenue for each fiscal year shall be equal to the 
product of— 
‘‘(i) such annual base revenue for the fiscal year 
under subsection (b); and 
‘‘(ii) the inflation adjustment percentage under 
subparagraph (B). 
‘‘(B) INFLATION ADJUSTMENT PERCENTAGE.—The infla-
tion 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 
Administration, of all personnel compensation and 
benefits paid with respect to such positions for the 
first 3 years of the preceding 4 fiscal years, multiplied 
by the proportion of personnel compensation and bene-
fits 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 pre-
ceding 4 fiscal years; and 
‘‘(ii) the average annual percent change that 
occurred in the Consumer Price Index for urban con-
sumers (Washington-Baltimore, DC–MD–VA–WV; Not 
Seasonally Adjusted; All items; Annual Index) for the 
first 3 years of the preceding 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 
increase the fee revenue and fees under this section 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 METHODOLOGY.— 
‘‘(i) DEVELOPMENT; EVALUATION AND REPORT.—The 
Secretary shall obtain, through a contract with an 
independent accounting or consulting firm, a report 
evaluating 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
H. R. 2430—29 
capacity planning methodological options and rec-
ommendations presented in such report shall utilize 
and be informed by personnel time reporting data as 
an input. The report shall be published for public com-
ment not later than September 30, 2020. 
‘‘(ii) ESTABLISHMENT AND IMPLEMENTATION.—After 
review of the report described in clause (i) and receipt 
and review of public comments thereon, the Secretary 
shall establish a capacity planning methodology for 
purposes of this paragraph, which shall— 
‘‘(I) 
incorporate 
such 
approaches 
and 
attributes as the Secretary determines appro-
priate; and 
‘‘(II) be effective beginning with the first fiscal 
year for which fees are set after such capacity 
planning methodology is established. 
‘‘(C) LIMITATION.—Under no circumstances 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 fiscal year). 
‘‘(D) PUBLICATION
IN
FEDERAL
REGISTER.—The Sec-
retary shall publish in the Federal Register notice under 
paragraph (5) the fee revenue and fees resulting from the 
adjustment and the methodologies under this paragraph. 
‘‘(3) OPERATING RESERVE ADJUSTMENT.— 
‘‘(A) INTERIM APPLICATION; FEE REDUCTION.—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 appropriate for long- 
term financial planning purposes. 
‘‘(B) GENERAL
APPLICATION
AND
METHODOLOGY.— 
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 para-
graphs (1) and (2)— 
‘‘(i) reduce the fee revenue and fees under this 
section as the Secretary determines appropriate for 
long-term financial planning purposes; or 
‘‘(ii) increase the fee revenue and fees under this 
section if such an adjustment is necessary to provide 
for not more than 21 weeks of operating reserves of 
carryover user fees for the process for the review of 
biosimilar biological product applications. 
‘‘(C) FEDERAL
REGISTER
NOTICE.—If an adjustment 
under subparagraph (A) or (B) is made, the rationale for 
the amount of the increase or decrease (as applicable) 
in fee revenue and fees shall be contained in the annual 
Federal Register notice under paragraph (5)(B) establishing 
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
H. R. 2430—30 
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 revenue and fees for fiscal year 2018. 
‘‘(C) LIMITATION.—No adjustment under this paragraph 
shall result in an increase in fee revenue and fees under 
this section in excess of $9,000,000. 
‘‘(5) ANNUAL FEE SETTING.—For fiscal year 2018 and each 
subsequent fiscal year, the Secretary shall, not later than 60 
days before the start of each such fiscal year— 
‘‘(A) establish, for the fiscal year, initial and annual 
biosimilar biological product development fees and reactiva-
tion fees under subsection (a)(1), biosimilar biological 
product application 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 BUSINESS.—Subsection 
(d)(1) of section 744H of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–52), as redesignated by subsection (c)(1), is 
amended— 
(1) by striking subparagraph (B); 
(2) by striking ‘‘; and’’ at the end of subparagraph (A) 
and inserting a period; and 
(3) by striking ‘‘shall pay—’’ and all that follows 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 Cosmetic Act (21 U.S.C. 
379j–52), as redesignated by subsection (c)(1), is amended by 
striking ‘‘all fees’’ and inserting ‘‘all such fees’’. 
(f) CREDITING AND AVAILABILITY OF FEES.—Subsection (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 collec-
tion during first program year) and inserting the following: 
‘‘(C) COMPLIANCE.—The Secretary shall be considered 
to have met the requirements of subparagraph (B) in any 
fiscal year if the costs described in such subparagraph 
are not more than 15 percent below the level specified 
in such subparagraph.’’; and 
(B) in subparagraph (D)— 
(i) in the heading, by striking ‘‘IN
SUBSEQUENT 
YEARS’’; and 
(ii) by striking ‘‘(after fiscal year 2013)’’; and 
(2) in paragraph (3), by striking ‘‘2013 through 2017’’ and 
inserting ‘‘2018 through 2022’’.
H. R. 2430—31 
SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 744I of the Federal Food, Drug, and Cosmetic 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 subsection (d); and 
(5) in subsection (d), as so redesignated, by striking ‘‘2017’’ 
each place it appears and inserting ‘‘2022’’. 
SEC. 405. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 744G and 744H of the Federal 
Food, Drug, and Cosmetic Act 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 biological product applications received on or after 
October 1, 2017, regardless of the date of the enactment of this 
Act. 
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 enact-
ment 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 
collecting any fee required by such part for a fiscal year prior 
to fiscal year 2018.
H. R. 2430—32 
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 identifica-
tion 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 fol-
lows: 
‘‘(B) AVAILABILITY OF REPORTS.— 
‘‘(i) IN
GENERAL.—Each report submitted under 
subparagraph (A) shall be considered to be in the public 
domain (subject 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 protection of— 
‘‘(aa) 
human 
research 
participants, 
including with respect to privacy, security, 
informed 
consent, 
and 
protected 
health 
information; and 
‘‘(bb) proprietary interests, confidential 
commercial information, and intellectual prop-
erty rights; and 
‘‘(II) assigned a docket number by the Commis-
sioner of Food and Drugs and made available for 
the submission of public comments. 
‘‘(ii) SUBMISSION
OF
COMMENTS.—An interested 
person may submit written comments 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 response to the reports submitted under subpara-
graph (A), and shall begin such action upon receipt 
of the report under subparagraph (A), in accordance 
with paragraph (7).’’; and 
(B) in paragraph (7)— 
(i) in the matter preceding subparagraph (A), by 
striking ‘‘During’’ and inserting ‘‘Within’’; 
(ii) in subparagraph (C)(i), by striking ‘‘place’’ and 
all that follows through ‘‘and of’’ and inserting ‘‘include 
in the public docket file a reference to the location 
of the report on the internet website of the National 
Institutes of Health and a copy of’’; and
H. R. 2430—33 
(iii) in clause (ii), by striking ‘‘in the Federal Reg-
ister and’’; 
(3) by striking subsection (d); 
(4) by redesignating subsection (e) as subsection (d); and 
(5) in paragraph (1) of subsection (d), as so redesignated, 
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 Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360e–1(a)(3)) is 
amended— 
(1) by redesignating subparagraphs (B) through (D) as sub-
paragraphs (D) through (F), respectively; 
(2) by inserting after subparagraph (A) the following: 
‘‘(B) any information, based on a review of data avail-
able to the Secretary, regarding devices used in pediatric 
patients but not labeled for such use for which the Sec-
retary determines 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 deter-
mination of a reasonable assurance of safety and effective-
ness in pediatric patients; and 
‘‘(H) the number of devices for which the Secretary 
relied on data from one pediatric subpopulation to support 
a determination of a reasonable assurance of safety and 
effectiveness in another pediatric subpopulation. 
For the items described in this paragraph, such report shall 
disaggregate the number of devices by pediatric subpopula-
tion.’’. 
(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 appro-
priate local committee’’ after ‘‘review committee’’ each place 
such term appears; and 
(B) in the matter following subparagraph (B), by 
inserting ‘‘or an appropriate local committee’’ 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 PEDIATRIC AVAIL-
ABILITY.—Section 305 of the Pediatric Medical 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;
H. R. 2430—34 
(B) in paragraph (5), by striking the period and 
inserting ‘‘; and’’; and 
(C) by adding at the end the following: 
‘‘(6) providing regulatory consultation to device sponsors 
in support of the submission of an application 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 DEVELOPMENT.— 
(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 Secretary shall invite to such meeting representatives from 
the medical device industry, academia, recipients 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 paragraph (1) shall 
include consideration of ways to— 
(A) improve research infrastructure and research net-
works to facilitate the conduct of clinical studies of devices 
for pediatric populations that would result in the approval 
or clearance, and labeling, of medical devices for such popu-
lations; 
(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 reg-
istries and data to increase pediatric medical device 
labeling; 
(D) increase Food and Drug Administration 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 develop-
ment and incentives to address such barriers. 
(3) 
REPORT.—The 
report 
submitted 
under 
section 
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. 
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 follows: 
‘‘(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 serious or life-threatening disease or 
condition, to discuss preparation of the initial pedi-
atric 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,
H. R. 2430—35 
or successor regulations) or within 30 calendar 
days of receipt of such request, whichever is later; 
‘‘(II) to discuss the initial pediatric study plan 
as soon as practicable, but not later than 90 cal-
endar 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 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), respectively, and adjusting the 
margins accordingly; 
(ii) by striking ‘‘A person’’ and inserting the fol-
lowing: 
‘‘(A) GENERAL REQUIREMENTS.—Except with respect to 
an application for which subparagraph (B) applies, a per-
son’’; 
(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 des-
ignated by clause (ii), the following: 
‘‘(B) CERTAIN MOLECULARLY TARGETED CANCER INDICA-
TIONS.—A person that submits, on or after the date that 
is 3 years after the date of enactment of the FDA Reauthor-
ization 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 para-
graph (3) if the drug or biological product that is the 
subject of the application is— 
‘‘(i) intended for the treatment of an adult cancer; 
and 
‘‘(ii) directed at a molecular target that the Sec-
retary determines to be substantially relevant to the 
growth or progression of a pediatric cancer.’’; 
(B) in paragraph (2)(A), by striking ‘‘paragraph (1)’’ 
and inserting ‘‘paragraph (1)(A)’’;
H. R. 2430—36 
(C) by redesignating paragraphs (3) and (4) as para-
graphs (4) and (5), respectively; 
(D) by inserting after paragraph (2) the following: 
‘‘(3) MOLECULARLY TARGETED PEDIATRIC CANCER INVESTIGA-
TION.— 
‘‘(A) IN GENERAL.—With respect to a drug or biological 
product described in paragraph (1)(B), the investigation 
described in this paragraph is a molecularly targeted pedi-
atric 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 
efficacy to inform potential pediatric labeling. 
‘‘(B) EXTRAPOLATION OF DATA.—Paragraph (2)(B) shall 
apply to investigations described 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.—Deferrals 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 paragraph (2)(B).’’; 
(E) in paragraph (4), as so redesignated— 
(i) by striking ‘‘assessments required under para-
graph (1)’’ each place it appears and inserting ‘‘assess-
ments required under paragraph (1)(A) or reports on 
the investigation required under paragraph (1)(B)’’; 
(ii) in subparagraph (A)(ii)(I), by inserting ‘‘or 
reports on the investigation’’ after ‘‘assessments’’; 
(iii) in subparagraph (B)(ii), by striking ‘‘assess-
ment under paragraph (1)’’ and inserting ‘‘assessment 
under paragraph (1)(A) or reports on the investigation 
under paragraph (1)(B)’’; and 
(iv) in subparagraph (C)(ii)(II), by inserting ‘‘or 
investigation’’ after ‘‘assessment’’; 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 ASSESSMENTS’’ in the heading; and 
(C) by inserting ‘‘or the investigation described in sub-
section (a)(3)’’ after ‘‘assessment described in subsection 
(a)(2)’’ each place it appears; 
(3) in subsection (e)— 
(A) in paragraph (1), by inserting ‘‘or the investigation 
described in subsection (a)(3)’’ after ‘‘under subsection 
(a)(2)’’; and 
(B) in paragraph (2)(A)(i), by inserting ‘‘or the inves-
tigation described in subsection (a)(3)’’ after ‘‘under sub-
section (a)(2)’’; and 
(4) by adding at the end the following: 
‘‘(m) LIST OF PRIMARY MOLECULAR TARGETS.—
H. R. 2430—37 
‘‘(1) IN GENERAL.—Within one year of the date of enactment 
of the FDA Reauthorization Act of 2017, the Secretary shall 
establish and update regularly, and shall publish on the inter-
net 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 development for which pediatric 
cancer study requirements under this section will be auto-
matically waived. 
‘‘(2) CONSULTATION.—In establishing the lists described in 
paragraph (1), the Secretary shall consult the National Cancer 
Institute, members of the internal committee under section 
505C, and the Pediatric Oncology Subcommittee of the Onco-
logic Drugs Advisory Committee, and shall take into account 
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 molecular target on 
the list published under such paragraph as a condition 
for triggering the requirements under subsection (a)(1)(B) 
with respect to a drug or biological product directed at 
such molecular target; or 
‘‘(B) to authorize the disclosure of confidential commer-
cial 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 Federal 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 INDICATIONS.— 
Unless the Secretary requires otherwise by regulation and 
except as provided in paragraph (2), this section does not apply 
to any drug or biological product for an indication for which 
orphan designation has been granted under section 526. 
‘‘(2) APPLICABILITY DESPITE ORPHAN DESIGNATION OF CER-
TAIN INDICATIONS.—This section shall apply with respect to 
a drug or biological product 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 Serv-
ices (referred to in this subsection as the ‘‘Secretary’’), acting 
through the Commissioner of Food and Drugs and in collabora-
tion with the Director of the National Cancer Institute, shall 
convene 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 dis-
ease specialists), patients, and other stakeholders to provide 
input on development 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—
H. R. 2430—38 
(A) the data necessary to determine that there is sci-
entific evidence that a drug or biological 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 sci-
entific evidence that a molecular target is considered to 
be substantially relevant to the growth or progression of 
a pediatric cancer; 
(C) the data needed to meet the requirement of con-
ducting an investigation described in section 505B(a)(3) 
of the Federal Food, Drug, and Cosmetic Act, as amended 
by subsection (a); 
(D) considerations when developing the list under sec-
tion 505B(m) of the Federal Food, Drug, and Cosmetic 
Act that contains molecular targets shared between dif-
ferent 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 updates shall occur; 
(F) how to overcome the challenges related to pediatric 
cancer drug and biological product development, including 
issues related to the ethical, practical, and other barriers 
to conducting clinical trials in pediatric cancer with small 
patient populations; 
(G) scientific or operational challenges associated with 
performing 
an 
investigation 
described 
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 pediatric cancer patients; 
(I) the ways in which the Secretary can improve the 
current process outlined under sections 505A and 505B 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355a, 355c) to encourage additional research and develop-
ment of pediatric cancer treatments; 
(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 feasible due to the ethical, practical, or other bar-
riers to conducting clinical trials in pediatric cancer popu-
lations; 
(K) how the Secretary will facilitate collaboration 
among pediatric networks, academic centers and experts 
in pediatric cancer to conduct an investigation described 
in such section 505B(a)(3); 
(L) how the Secretary may facilitate collaboration 
among sponsors of same-in-class drugs and biological prod-
ucts that would be subject to the requirements for an 
investigation under such section 505B based on shared 
molecular targets; and
H. R. 2430—39 
(M) the ways in which the Secretary will help to miti-
gate the risks, if any, of discouraging the research and 
development of orphan drugs when implementing such sec-
tion 505B as amended. 
(2) GUIDANCE.—Not later than 2 years after the date of 
enactment of this Act, the Secretary, acting 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 relevant to the growth or progression of 
a pediatric 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 investiga-
tion 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 inves-
tigation described in subsection (a)(3) of such section 505B, 
including adverse impacts on current pediatric studies 
underway in a pediatric patient population, studies 
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 networks, academic centers, 
and experts in pediatric cancer to conduct an investigation 
described 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 developments 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 amend-
ment 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 pediatric cancer populations; 
(G) the process for submission of an initial pediatric 
study plan for the investigation described 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 
investigation.
H. R. 2430—40 
(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 research and labeling of drugs and biological 
products and pediatric labeling of molecularly targeted drugs 
and biological products for the treatment of cancer; 
‘‘(12) an assessment of the efforts of the Secretary to imple-
ment the plan developed under section 505C–1 of the Federal 
Food, Drug, and Cosmetic 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 Cosmetic Act (21 U.S.C. 355(b)(1)) or sec-
tion 351(a) of the Public Health Service Act (42 U.S.C. 
262(a)) before studies conducted pursuant to such section 
505A, 505B, or section 351(m) are completed, submitted, 
and incorporated into labeling; 
‘‘(B) the average length of time after the receipt of 
a proposed pediatric study request before the Secretary 
responds to such request; 
‘‘(C) the average length of time after the submission 
of a proposed pediatric study request before the Secretary 
issues a written request for such studies; 
‘‘(D) the number of written requests issued for each 
investigational new drug or biological product prior to the 
submission of an application 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 amend-
ments to written requests; 
‘‘(13) a list of sponsors of applications or holders 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 sub-
mitted; 
‘‘(14) a list of assessments and investigations required 
under such section 505B; 
‘‘(15) how many requests under such section 505A for molec-
ular targeted cancer drugs, as defined by subsection (a)(1)(B) 
of such section 505B, approved prior to 3 years after the date 
of enactment of the FDA Reauthorization Act of 2017, have 
been issued by the Food and Drug Administration, 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 Reauthoriza-
tion Act of 2017 on the conduct and effectiveness of pediatric
H. R. 2430—41 
cancer research and the orphan drug program, as well any 
subsequent recommendations.’’. 
(e) RULE OF CONSTRUCTION.—Nothing in this section, 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 Cos-
metic 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 assessments 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 pediatric cancer indications. The 
Comptroller General shall examine— 
(A) the indications and associated molecular targets 
studied in assessments and investigations required for 
drugs or biological products intended for the treatment 
of an adult cancer; 
(B) the indication for which the study was requested 
as compared to the indication requested under the new 
drug application filed by the sponsor; 
(C) the number of pediatric cancer indications 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 investigations required under 
such section and the number of such deferral and waiver 
requests granted and denied; 
(E) the number of orphan-designated indications for 
drugs and biological products for which assessments and 
investigations were required under such section; 
(F) the number of drugs and biological products 
approved for the treatment of cancer in the pediatric popu-
lation for which the supportive 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 sub-
section (a)(1)(B) of such section 505B; and 
(H) any additional considerations by the Secretary 
regarding the effectiveness of requiring pediatric assess-
ments described in such section 505B in the development 
of drugs and biological products for pediatric cancer indica-
tions. 
(2) REVIEW.—The study under paragraph (1) shall include 
a review of the Food and Drug Administration’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 para-
graph (1), the Comptroller General of the United States shall 
consult with appropriate stakeholders that may be required
H. R. 2430—42 
to conduct the trials 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 Adminis-
tration. 
(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 submit a report containing the results 
of the study under paragraph (1) to the Secretary of Health 
and Human Services, the Committee on Health, Education, 
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 PEDIATRIC 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 COMMITTEE.—The Sec-
retary shall provide to the committee referred to in paragraph 
(1) any response issued to an applicant or holder with respect 
to a proposed pediatric study request.’’. 
(b) ACTION ON SUBMISSIONS.— 
(1) IN
GENERAL.—Section 505A(d) of the Federal 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), respectively; 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 pediatric studies within 120 calendar days of the 
submission.’’. 
(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 amended by paragraph (1), is further 
amended by striking subsection ‘‘(d)(3)’’ each place it 
appears and inserting ‘‘(d)(4)’’. 
(B) PUBLIC HEALTH SERVICE ACT.—Paragraphs (2), (3), 
and (4) of section 351(m) of the Public Health Service 
Act (42 U.S.C. 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 established 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 appro-
priate, 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, discus-
sion 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);
H. R. 2430—43 
(2) earlier issuance of written requests for a pediatric 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 
(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 period beginning on the date of enactment 
of this subsection, at’’ and inserting ‘‘At’’. 
(2) DRAFT GUIDANCE.—Not later than 2 years after the 
date of enactment of this Act, the Secretary shall issue draft 
guidance on clinical pharmacology 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.— 
(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 Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Representa-
tives, and make publicly available, including through posting 
on the internet website of the Food and Drug Administration, 
a report on the lack of information in the labeling of drugs 
for indications that have received 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 paragraph (1) shall 
include— 
(A) a list of drugs for which— 
(i) an indication was granted an orphan designa-
tion 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-
mitted to the Secretary of Health and Human Services 
on or after April 1, 1999; and 
(iii) the labeling for such indication lacks impor-
tant pediatric information, including information 
related to safety, dosing, 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 improve the 
labeling of drugs for indications that have received an
H. R. 2430—44 
orphan designation under such section 526 with respect 
to the use of such drugs pediatric populations.’’ 
TITLE VI—REAUTHORIZATIONS AND 
IMPROVEMENTS RELATED TO DRUGS 
SEC. 601. REAUTHORIZATION OF PROVISION RELATING TO EXCLU-
SIVITY 
OF 
CERTAIN 
DRUGS 
CONTAINING 
SINGLE 
ENANTIOMERS. 
Section 505(u)(4) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(u)(4)) is amended by striking ‘‘2017’’ and 
inserting ‘‘2022’’. 
SEC. 602. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE 
PARTNERSHIPS. 
Section 566(f) of the Federal Food, Drug, and Cosmetic 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 PROGRAM. 
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 inserting ‘‘(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 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 following: 
‘‘(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 dis-
ease or condition, or a related therapy or clinical investigation’’.
H. R. 2430—45 
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 
(3) by adding at the end the following: 
‘‘(D) disseminating information to health care providers 
about drug formulations or properties, including informa-
tion about the limitations or patient care implications of 
such formulations or properties, and how such formulations 
or properties may be related to serious adverse 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 disease 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 follows through ‘‘such license 
if’’ and inserting ‘‘During the 7-year period described in 
subsection (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 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 inserting ‘‘of exclusive 
approval or licensure notice and opportunity for the submis-
sion 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 provides’’; 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 approval or exclusive licensure described 
in subsection (a) for the same rare disease or condition as 
the already approved drug, the Secretary shall require such 
sponsor, as a condition of such exclusive approval or licensure, 
to demonstrate that such drug is clinically superior to any 
already approved or licensed 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 approved 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). Beginning on the date 
of enactment of the FDA Reauthorization Act of 2017, until such
H. R. 2430—46 
time as the Secretary promulgates regulations in accordance with 
this subsection, the Secretary may apply any definitions set forth 
in regulations 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 sponsor and relied upon by the Sec-
retary that the drug is clinically superior to a previously 
approved drug; and 
‘‘(2) upon granting exclusive approval or licensure under 
subsection (a) on the basis of a demonstration of clinical superi-
ority as described in subsection (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 determination 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 Reauthorization Act of 2017. 
SEC. 608. PEDIATRIC INFORMATION ADDED TO LABELING. 
Section 505A(o) of the Federal Food, Drug, and Cosmetic 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 section 505’’; and 
(B) by striking ‘‘or by exclusivity under clause (iii) 
or (iv) of section 505(j)(5)(F)’’ and inserting ‘‘, or by exclu-
sivity 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 section 505(j)’’ 
and inserting ‘‘drug approved pursuant to an application 
submitted under subsection (b)(2) or (j) of section 505’’; 
and 
(4) by amending paragraph (3) to read as follows: 
‘‘(3) PRESERVATION OF PEDIATRIC EXCLUSIVITY AND EXTEN-
SIONS.—This subsection does not affect— 
‘‘(A) the availability or scope of exclusivity under— 
‘‘(i) this section; 
‘‘(ii) section 505 for pediatric formulations; or 
‘‘(iii) section 527; 
‘‘(B) the availability or scope of an extension to any 
such exclusivity, including an extension under this section 
or section 505E;
H. R. 2430—47 
‘‘(C) the question of the eligibility for approval under 
section 505 of any application described in subsection (b)(2) 
or (j) of such section that omits any other aspect of labeling 
protected 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 paragraphs (1) 
and (2), the operation of section 505 or section 527.’’. 
SEC. 609. SENSE OF CONGRESS ON LOWERING THE COST OF PRESCRIP-
TION 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— 
(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 innovation 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 
coordination with the Director of the National Institutes 
of Health, and in consultation with patients, health care 
providers, drug sponsors, bioethicists, and other stake-
holders, shall, not later than 270 days after the date of 
enactment of this Act, convene a public meeting to discuss 
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 public 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 subparagraph (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 criteria; 
(ii) how appropriate patient populations can ben-
efit from the results of trials that employ alternative 
designs; 
(iii) barriers to participation in clinical trials, 
including— 
(I) information regarding any potential risks 
and benefits of participation; 
(II) 
regulatory, 
geographical, 
and 
socio-
economic barriers; and
H. R. 2430—48 
(III) the impact of exclusion criteria on the 
enrollment in clinical trials of particular popu-
lations, including infants and children, pregnant 
and lactating women, seniors, individuals with 
advanced disease, and individuals with co-morbid 
conditions; 
(iv) clinical trial designs and methods, including 
expanded access trials, that increase enrollment of 
more diverse patient populations, when appropriate, 
while facilitating the collection of data to establish 
safe use and support substantial evidence of effective-
ness, including data obtained from expanded access 
trials; and 
(v) how changes to clinical trial inclusion and 
exclusion criteria may impact the complexity and 
length of clinical trials, the data necessary to dem-
onstrate 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 Gen-
eral of the United States shall report to the Committee on 
Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Rep-
resentatives on individual access to investigational 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 report shall include— 
(A) a description of actions taken by manufacturers 
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 ‘‘Expanded Access to Investiga-
tional Drugs for Treatment Use—Questions and Answers’’ 
and ‘‘Individual Patient Expanded Access Applications: 
Form FDA 3926’’, issued by the Food and Drug Administra-
tion in June 2016, have reduced application burden with 
respect to individuals and physicians seeking access to 
investigational 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; 
(C) consideration of whether the guidance or regula-
tions 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 investigational 
drugs, and what barriers to such access remain; 
(D) an assessment of methods patients and health 
care providers use to engage with the Food and Drug 
Administration or drug sponsors on expanded access; and 
(E) an analysis of the Secretary’s report under para-
graph (1)(B). 
(3) GUIDANCE.— 
(A) IN
GENERAL.—Not later than 1 year after the 
publication of the report under paragraph (1)(B), the Sec-
retary, acting through the Commissioner of Food and 
Drugs, shall issue one or more draft guidances regarding
H. R. 2430—49 
eligibility criteria for clinical trials. Not later than 1 year 
after the public comment period on each such draft guid-
ance ends, the Secretary shall issue a revised draft guid-
ance or final guidance. 
(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 clinical trials and 
expanded access trials, especially with respect to drugs 
for the treatment 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 accurately reflects the patients most 
likely to receive the drug, as applicable and as appro-
priate, 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 appropriate for drugs intended 
for the treatment of rare diseases or conditions. 
(b) IMPROVING
INSTITUTIONAL
REVIEW
BOARD
REVIEW
OF 
SINGLE PATIENT EXPANDED ACCESS PROTOCOL.—Not later than 1 
year after the date of enactment of this Act, the Secretary, acting 
through the Commissioner of Food and Drugs, shall issue guidance 
or regulations, or revise existing guidance or regulations, to stream-
line the institutional review board review of individual patient 
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 protocols, 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 
designated member of the institutional review board) review a 
single patient expanded access protocol submitted under such sec-
tion 561(b) for a drug. The Secretary shall update any relevant 
forms associated with individual patient expanded access requests 
under such section 561(b) as necessary. 
(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); 
(3) by redesignating paragraph (2) as paragraph (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 receives a designa-
tion as a breakthrough therapy, fast track product, or regenera-
tive advanced therapy under subsection (a), (b), or (g), respec-
tively, of section 506.’’.