Subpart B - Applications

PUBLIC LAW 115–52—AUG. 18, 2017

131 STAT. 1005

Public Law 115–52
115th Congress
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’’.

Aug. 18, 2017
[H.R. 2430]

FDA
Reauthorization
Act of 2017.
21 USC 301 note.

SEC. 2. TABLE OF CONTENTS.

The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.

101.
102.
103.
104.
105.
106.

TITLE I—FEES RELATING TO DRUGS
Short title; finding.
Authority to assess and use drug fees.
Reauthorization; reporting requirements.
Sunset dates.
Effective date.
Savings clause.

Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.

201.
202.
203.
204.
205.
206.
207.
208.
209.
210.

TITLE II—FEES RELATING TO DEVICES
Short title; finding.
Definitions.
Authority to assess and use device fees.
Reauthorization; reporting requirements.
Conformity assessment pilot program.
Reauthorization of review.
Electronic format for submissions.
Savings clause.
Effective date.
Sunset dates.

Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.

301.
302.
303.
304.
305.
306.
307.

TITLE III—FEES RELATING TO GENERIC DRUGS
Short title; finding.
Definitions.
Authority to assess and use human generic drug fees.
Reauthorization; reporting requirements.
Sunset dates.
Effective date.
Savings clause.

Sec.
Sec.
Sec.
Sec.
Sec.
Sec.

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TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
401. Short title; finding.
402. Definitions.
403. Authority to assess and use biosimilar fees.
404. Reauthorization; reporting requirements.
405. Sunset dates.
406. Effective date.

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131 STAT. 1006

PUBLIC LAW 115–52—AUG. 18, 2017

Sec. 407. Savings clause.
Sec.
Sec.
Sec.
Sec.
Sec.

501.
502.
503.
504.
505.

TITLE V—PEDIATRIC DRUGS AND DEVICES
Best pharmaceuticals for children.
Pediatric devices.
Early meeting on pediatric study plan.
Development of drugs and biological products for pediatric cancers.
Additional provisions on development of drugs and biological products for
pediatric use.

TITLE VI—REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS
Sec. 601. Reauthorization of provision relating to exclusivity of certain drugs containing single enantiomers.
Sec. 602. Reauthorization of the critical path public-private partnerships.
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
Priority review of generic drugs.
Enhancing regulatory transparency to enhance generic competition.
Competitive generic therapies.
Accurate information about drugs with limited competition.
Suitability petitions.
Inspections.
Reporting on pending generic drug applications and priority review applications.
Sec. 808. Incentivizing competitive generic drug development.
Sec. 809. GAO study of issues regarding first cycle approvals of generic medicines.

Prescription
Drug User Fee
Amendments
of 2017.
21 USC 301 note.
21 USC 379g
note.

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Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.

801.
802.
803.
804.
805.
806.
807.

Sec.
Sec.
Sec.
Sec.
Sec.

901.
902.
903.
904.
905.

TITLE IX—ADDITIONAL PROVISIONS
Technical corrections.
Annual report on inspections.
Streamlining and improving consistency in performance reporting.
Analysis of use of funds.
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 expediting 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

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PUBLIC LAW 115–52—AUG. 18, 2017

131 STAT. 1007

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. 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 subsection (c)(5) for a human drug application for which
clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness
are not required for approval.’’;
(E) in the heading of paragraph (1)(C), by striking
‘‘OR SUPPLEMENT’’;
(F) in paragraph (1)(F)—
(i) in the heading, by striking ‘‘OR 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 established for a fiscal year under subsection (c)(5) for each
prescription drug product that is identified in such a human
drug application approved as of October 1 of such fiscal
year.’’;
(K) in subparagraph (B) of such 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 prescription drug product’’; and

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131 STAT. 1008

PUBLIC LAW 115–52—AUG. 18, 2017

(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 identified 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 adjustment 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 subsection (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 determined 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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PUBLIC LAW 115–52—AUG. 18, 2017

131 STAT. 1009

(c) ADJUSTMENTS; ANNUAL FEE SETTING.—Subsection (c) of section 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 inflation adjustment percentage under this subparagraph for
a fiscal year is equal to the sum of—
‘‘(i) the average annual percent change in the cost,
per full-time equivalent position of the Food and Drug
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 benefits costs to total costs of the process for the review
of human drug applications (as defined in section
735(6)) for the first 3 years of the preceding 4 fiscal
years; and
‘‘(ii) the average annual percent change that
occurred in the Consumer Price Index for urban consumers (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

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Time period.

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131 STAT. 1010

Contracts.
Recommendations.

Publication.
Public
information.
Deadline.

Effective date.

Time period.

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PUBLIC LAW 115–52—AUG. 18, 2017
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 applications, 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 planning methodological options and recommendations presented 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 appropriate; 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 Secretary 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 paragraph.
‘‘(3) OPERATING RESERVE ADJUSTMENT.—
‘‘(A) INCREASE.—For fiscal year 2018 and subsequent
fiscal years, the Secretary may, in addition to adjustments
under paragraphs (1) and (2), further increase the fee revenue and fees if such an adjustment is necessary to provide

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131 STAT. 1011

for not more than 14 weeks of operating reserves of carryover user fees for the process for the review of human
drug applications.
‘‘(B) DECREASE.—If the Secretary has carryover balances for such process in excess of 14 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 14 weeks
of such operating reserves.
‘‘(C) NOTICE OF RATIONALE.—If an 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 revenue 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 consumers (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 subparagraph (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 ‘‘paragraph (1)(D)’’ and inserting ‘‘paragraph (1)(C)’’; and

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Deadline.
Time period.

Federal Register,
publication.

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131 STAT. 1012

PUBLIC LAW 115–52—AUG. 18, 2017

(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.
21 USC 379g
note.
21 USC 379h–2
note.
Effective date.
Repeal.
21 USC 379g
note, 379h–2
note.
21 USC 379g
note.

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(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 Administration Safety and Innovation Act (Public Law 112–144) are
repealed.
SEC. 105. EFFECTIVE DATE.

The amendments made by this title shall take effect on October
1, 2017, or the date of the enactment of this Act, whichever is
later, except that fees under part 2 of subchapter C of chapter
VII of the Federal Food, Drug, and Cosmetic Act shall be assessed

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131 STAT. 1013

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 enactment of this title, shall continue to be in effect with respect to
human drug applications and supplements (as defined in such part
as of such day) that on or after October 1, 2012, but before October
1, 2017, were accepted by the Food and Drug Administration for
filing with respect to assessing and collecting any fee 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.

21 USC 379g
note.
Continuation.
Time period.

Medical Device
User Fee
Amendments
of 2017.
21 USC 301 note.
21 USC 379i
note.

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 paragraphs (9) through (14), respectively;
(2) by inserting after paragraph (7) the following new paragraph:
‘‘(8) The term ‘de novo classification request’ means a
request made under section 513(f)(2)(A) with respect to the
classification of a device.’’;
(3) in subparagraph (D) of paragraph (10) (as redesignated
by paragraph (1)), by striking ‘‘and submissions’’ and inserting
‘‘submissions, and de novo classification requests’’; and
(4) in paragraph (11) (as redesignated by 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 notification submission, or de novo classification request’’.
(b) FEE AMOUNTS.—Section 738(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j(b)) is amended to read as follows:
‘‘(b) FEE AMOUNTS.—
‘‘(1) IN GENERAL.—Subject to subsections (c), (d), (e), and
(h), for each of fiscal years 2018 through 2022, fees under
subsection (a) shall be 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 paragraph (1), the base fee amounts specified in this paragraph
are as follows:
‘‘Fee Type
Premarket Application ....
Establishment Registration ................................

Fiscal
Year
2018

Fiscal
Year
2019

Fiscal
Year
2020

Fiscal
Year
2021

Fiscal
Year
2022

$294,000

$300,000

$310,000

$328,000

$329,000

$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 subparagraph (C) for such fiscal year; and
‘‘(ii) the product of the base inflation adjustment
under subparagraph (C) for each of the fiscal years
preceding such fiscal year, beginning with fiscal year
2016.’’;

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131 STAT. 1015

(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 subsection (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 subsection (b)(3), as adjusted for inflation under subparagraph (A).’’; and
(3) in paragraph (3)—
(A) by striking ‘‘2014 through 2017’’ and inserting
‘‘2018 through 2022’’; and
(B) by striking ‘‘further adjusted’’ and inserting
‘‘increased’’.
(d) SMALL BUSINESSES; FEE WAIVER AND FEE REDUCTION
REGARDING PREMARKET APPROVAL FEES.—Section 738(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(d)) is amended—
(1) in paragraph (1), by striking ‘‘specified in clauses (i)
through (v) and clauses (vii), (ix), and (x)’’ and inserting ‘‘specified in clauses (i) through (vii) and clauses (ix), (x), and (xi)’’;
and
(2) in paragraph (2)(C)—
(A) by striking ‘‘supplement, or’’ and inserting ‘‘supplement,’’; 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 Cosmetic 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 subsection (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—

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(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 ASSESSMENT.—
‘‘(1) IN GENERAL.—The Secretary shall establish a pilot
program under which—
‘‘(A) testing laboratories may be accredited, by accreditation bodies meeting criteria specified by the Secretary,
to assess the conformance of a device with certain standards 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.

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PUBLIC LAW 115–52—AUG. 18, 2017
‘‘(2) SECRETARIAL REVIEW OF ACCREDITED
DETERMINATIONS.—The Secretary may—

131 STAT. 1017
LABORATORY

‘‘(A) review determinations by testing laboratories
accredited pursuant to this subsection, including by conducting 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 accredited, 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 information with regard to such device.
‘‘(3) IMPLEMENTATION AND REPORTING.—
‘‘(A) PUBLIC MEETING.—The Secretary shall publish in
the Federal Register a notice of a public meeting to be
held no later than 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 September 30, 2020, the Secretary shall initiate the pilot program 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 laboratories accredited under paragraph (1)(A); and
‘‘(D) the Secretary may take actions in accordance with
paragraph (2) with respect to the determinations made

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Audits.

Deadlines.
Federal Register,
publication.
Notice.

Web posting.

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PUBLIC LAW 115–52—AUG. 18, 2017
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.

Guidance.

Deadline.

Effective date.
Web posting.
Lists.
Determination.

Lists.

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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 subparagraph (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 Secretary will use in determining whether a class I or
class II device type, or subset of such device types,
is eligible for review by an accredited person,
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 sustaining, or life supporting, and whether there is
a detailed public health justification for permitting
the review by an accredited person of such device
type or subset;
‘‘(ii) not later than 24 months after the date on
which the Secretary issues such draft guidance, finalize
such guidance; and
‘‘(iii) beginning on the date such guidance is finalized, 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 enactment 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

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131 STAT. 1019

(ii) by redesignating subparagraph (E) as subparagraph (D); and
(B) in paragraph (3)—
(i) by redesignating subparagraph (E) as subparagraph (F);
(ii) in subparagraph (F) (as so 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 accreditation, and at any time it is performing any review
pursuant to this section—’’; and
(iii) by inserting after subparagraph (D) the following new subparagraph:
‘‘(E) The operations of such person shall be in accordance with generally accepted professional and ethical business practices.’’; and
(3) in subsection (c), by striking ‘‘2017’’ and inserting
‘‘2022’’.
SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS.

Section 745A(b) of the Federal Food, Drug, and 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 ELECTRONIC FORMAT.—
‘‘(A) IN GENERAL.—Beginning on such date as the Secretary specifies in final guidance issued under subparagraph (C), presubmissions and submissions for devices
described in 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 Secretary 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.

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Deadline.
Effective date.

Criteria.

21 USC 379i
note.
Continuation.
Time period.

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131 STAT. 1020

PUBLIC LAW 115–52—AUG. 18, 2017

21 USC 379i
note.

SEC. 209. EFFECTIVE DATE.

21 USC 378i
note.

SEC. 210. SUNSET DATES.

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.

21 USC 379j–1
note.

Effective date.
Repeal.
21 USC 379i
note.

(a) AUTHORIZATION.—Sections 737 and 738 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be
effective October 1, 2022.
(b) REPORTING REQUIREMENTS.—Section 738A (21 U.S.C. 739j–
1) of the Federal Food, Drug, and Cosmetic Act (regarding reauthorization and reporting 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

Generic Drug
User Fee
Amendments
of 2017.

SEC. 301. SHORT TITLE; FINDING.
21 USC 301 note.
21 USC 379j–41
note.

(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 purposes of part 7 of subchapter C of chapter VII of the Federal
Food, Drug, and Cosmetic Act, in the letters from the Secretary
of Health and Human Services to the Chairman of the Committee
on Health, Education, Labor, and Pensions of the Senate and the
Chairman of the Committee on Energy and Commerce of the House
of Representatives, as set forth in the 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 ‘‘application—
‘‘(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 paragraphs (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 application, 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.’’.

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131 STAT. 1021

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 effective 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 assessment.’’; 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 application’’;
(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 subparagraphs (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

Deadline.
Time period.
Federal Register,
publication.

Deadline.
Time period.
Federal Register,
publication.
Deadline.
Applicability.

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

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131 STAT. 1022

Refunds.

Federal Register,
publication.

Time period.
Deadlines.

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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 Secretary 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 submission 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 identified in at least one generic drug submission in which
the facility is approved to produce one or more active
pharmaceutical ingredients or in a Type II active
pharmaceutical ingredient drug master file referenced
in at least one such’’; and
(iv) in clause (iii), by striking ‘‘to fees under both
such clauses’’ and inserting ‘‘only to the fee attributable
to the 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 subsection (d)(1), the Secretary shall publish in the Federal
Register the amount of the fees under subparagraph (A)
for such fiscal year.
‘‘(D) FEE DUE DATE.—For each of fiscal years 2018
through 2022, the fees under 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.’’;

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(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 subsection (d)(1), the Secretary shall publish in the Federal
Register the amount of the fees under subparagraph (A)
for such fiscal year.
‘‘(D) FEE DUE DATE.—For each of fiscal years 2018
through 2022, the fees under 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 enactment of an appropriations Act providing for the collection 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).

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‘‘(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 affiliates) 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 affiliates) 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 withdrawal of approval of such abbreviated new drug application by April 1 of the previous fiscal year.’’.
(c) ADJUSTMENTS.—Section 744B(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j–42(c)) is amended—
(1) in paragraph (1)—
(A) by striking ‘‘2014’’ and inserting ‘‘2019’’;

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(B) by inserting ‘‘to equal the product of the total
revenues established in such notice for the prior fiscal
year multiplied’’ after ‘‘a fiscal year,’’; and
(C) by striking the flush text following subparagraph
(C); and
(2) in paragraph (2)—
(A) by striking ‘‘2017’’ each place it 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 paragraphs (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 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(f)) is
amended—
(1) by striking paragraph (1);
(2) by redesignating paragraphs (2) through (4) as paragraphs (1) through (3), respectively;
(3) in paragraph (1) (as so redesignated)—
(A) by striking ‘‘paragraph (4)’’ and inserting ‘‘paragraph (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—

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date.

Deadline.
Time period.

Public
information.
Lists.

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(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 subparagraph (D) of such subsection, shall be subject to the following:
‘‘(i) The Secretary shall place the person on a publicly available arrears list.
‘‘(ii) Any abbreviated new drug application submitted 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 abbreviated new drug application held by such applicant
or an affiliate of such applicant shall be deemed misbranded under section 502(aa).
‘‘(B) APPLICATION OF PENALTIES.—The penalties under
subparagraph (A) shall apply until the fee required under
subsection (a)(5) is paid.’’.
(g) LIMITATIONS.—Section 744B(h)(2) of the 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 collection during first program year);
(C) in subparagraph (D)—
(i) in the heading, by striking ‘‘IN SUBSEQUENT
YEARS’’; and
(ii) by striking ‘‘(after fiscal year 2013)’’; and
(D) by redesignating subparagraph (D) as subparagraph (C); and
(2) in paragraph (3), by striking ‘‘fiscal years 2013 through
2017’’ and inserting ‘‘fiscal years 2018 through 2022’’.
(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—

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‘‘(A) all approved abbreviated new drug applications
owned by such person; and
‘‘(B) if any affiliate of such person also owns an abbreviated new drug application, all affiliates that own any
such abbreviated new drug application and all approved
abbreviated new drug applications owned by any such affiliate.
‘‘(2) FORMAT AND METHOD.—The Secretary shall specify
in guidance the format and method for submission of lists
under this subsection.’’.

Guidance.

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 Amendments of 2017’’;
(2) in subsection (b), by striking ‘‘2013’’ and inserting
‘‘2018’’; and
(3) in subsection (d), by striking ‘‘2017’’ each place it
appears and inserting ‘‘2022’’.
SEC. 305. SUNSET DATES.

(a) AUTHORIZATION.—Sections 744A and 744B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41; 379j–42) shall
cease to be effective October 1, 2022.
(b) REPORTING REQUIREMENTS.—Section 744C of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43) shall cease to
be effective January 31, 2023.
(c) PREVIOUS SUNSET PROVISION.—
(1) IN GENERAL.—Effective October 1, 2017, section 304
of the Food and Drug Administration Safety and Innovation
Act (Public Law 112–144) is repealed.
(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.

21 USC 379j–41
note.

SEC. 306. EFFECTIVE DATE.

21 USC 379j–41
note.

The amendments made by this title shall take effect on October
1, 2017, or the date of the enactment of this Act, whichever is
later, except that fees under part 7 of subchapter C of chapter
VII of the Federal Food, Drug, and Cosmetic Act shall be assessed
for all abbreviated new drug applications received on or after
October 1, 2017, regardless of the date of the enactment of this
Act.
SEC. 307. SAVINGS CLAUSE.

Notwithstanding the amendments made by this title, part 7
of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act, as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to
abbreviated new drug applications (as defined in such part as
of such day) that were received by the Food and Drug Administration within the meaning of section 505(j)(5)(A) of such Act (21

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21 USC 379j–43
note.

Effective date.
Repeal.
21 USC 379j–41
note, 379j–43
note.

21 USC 379j–41
note.

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U.S.C. 355(j)(5)(A)), prior approval supplements that were submitted, 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

Biosimilar User
Fee Amendments
of 2017.

SEC. 401. SHORT TITLE; FINDING.
21 USC 301 note.
21 USC 379j–51
note.

(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 applications, 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 (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted;
All items) for October of the preceding fiscal year divided by
such Index for October 2011.’’.
(b) BIOSIMILAR BIOLOGICAL PRODUCT.—Section 744G(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51(3)) is
amended by striking ‘‘means a product’’ and inserting ‘‘means a
specific strength of a biological product in final dosage form’’.
SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.

(a) TYPES OF FEES.—Section 744H(a) of the 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 ‘‘BIOSIMILAR’’ 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 biosimilar 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’’;

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(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 participation 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 ‘‘BIOSIMILAR DEVELOPMENT PROGRAM’’;
(11) in paragraph (1)(F)—
(A) in the subparagraph heading, by striking ‘‘BIOSIMILAR DEVELOPMENT PROGRAM’’; and
(B) by amending clause (i) to read as follows:
‘‘(i) REFUNDS.—Except as provided in subparagraph (B)(iv), the Secretary shall not refund any initial
or annual biosimilar biological product development
fee paid under subparagraph (A) or (B), or any reactivation fee paid under subparagraph (D).’’;
(12) in paragraph (2)—
(A) in the paragraph heading, by striking ‘‘AND SUPPLEMENT’’;
(B) by amending subparagraphs (A) and (B) to read
as follows:
‘‘(A) IN GENERAL.—Each person that 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).

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‘‘(B) RULE OF APPLICABILITY; TREATMENT OF CERTAIN
PREVIOUSLY PAID FEES.—Any person who pays a fee under

Deadlines.

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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 submitted; 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 products.
‘‘(B) DUE DATE.—The biosimilar biological product program fee for a fiscal year shall be due on the later of—
‘‘(i) the first business day on or after October 1
of each such year; or
‘‘(ii) the first business day after the enactment
of an appropriations Act 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 products identified in such biosimilar biological product application.’’.
(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

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‘‘(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 adjustment 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 subsection (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; LIMITATIONS ON FEE AMOUNTS.—
‘‘(A) ALLOCATION.—The Secretary shall determine the
percentage of the total revenue amount for a fiscal year
to be derived from, respectively—
‘‘(i) initial and annual biosimilar biological product
development fees and reactivation fees under subsection (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 development 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 subsections (d) through (i), respectively;

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Time periods.

Effective date.

Contracts.

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(2) in subsections (a)(2)(F) and (h) (as redesignated by
paragraph (1)), by striking ‘‘subsection (c)’’ and inserting ‘‘subsection (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 inflation adjustment percentage under this subparagraph for
a fiscal year is equal to the sum of—
‘‘(i) the average annual percent change in the cost,
per full-time equivalent position of the Food and Drug
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 benefits costs to total costs of the process for the review
of biosimilar biological product applications (as defined
in section 744G(13)) for the first 3 years of the preceding 4 fiscal years; and
‘‘(ii) the average annual percent change that
occurred in the Consumer Price Index for urban consumers (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

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capacity planning methodological options and recommendations presented in such report shall utilize
and be informed by personnel time reporting data as
an input. The report shall be published for public comment 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 appropriate; 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 Secretary 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 longterm 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 paragraphs (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

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Publication.
Public
information.
Deadline.

Effective date.

Notice.

Effective date.

Time period.

Assessment.

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Federal Register,
publication.
Notice.

Time period.
Deadline.

Federal Register,
publication.

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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 reactivation fees under subsection (a)(1), biosimilar biological
product application fees under subsection (a)(2), and biosimilar 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 collection during first program year) and inserting the following:
‘‘(C) COMPLIANCE.—The Secretary shall be considered
to have met the requirements of subparagraph (B) in any
fiscal year if the costs described in such subparagraph
are not more than 15 percent below the level specified
in such subparagraph.’’; and
(B) in subparagraph (D)—
(i) in the heading, by striking ‘‘IN SUBSEQUENT
YEARS’’; and
(ii) by striking ‘‘(after fiscal year 2013)’’; and
(2) in paragraph (3), by striking ‘‘2013 through 2017’’ and
inserting ‘‘2018 through 2022’’.

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131 STAT. 1035

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.

21 USC 379j–51
note.

SEC. 406. EFFECTIVE DATE.

21 USC 379j–51
note.

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 enactment of this title, shall continue to be in effect with respect to
biosimilar biological product applications and supplements (as
defined in such part as of such day) that were accepted by the
Food and Drug Administration for filing on or after October 1,
2012, but before October 1, 2017, with respect to assessing and
collecting any fee required by such part for a fiscal year prior
to fiscal year 2018.

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21 USC 379j–53
note.

Effective date.
Repeal.
21 USC 379j–51
note, 379j–53
note.

21 USC 379j–51
note.
Continuation.
Time period.

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131 STAT. 1036

PUBLIC LAW 115–52—AUG. 18, 2017

TITLE V—PEDIATRIC DRUGS AND
DEVICES
SEC. 501. BEST PHARMACEUTICALS FOR CHILDREN.

Web posting.

Public
information.

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Section 409I of the Public Health Service Act (42 U.S.C. 284m)
is amended—
(1) in subsection (a)(2)(A)(ii), by inserting ‘‘and identification of biomarkers for such diseases, disorders, or conditions,’’
after ‘‘biologics,’’;
(2) in subsection (c)—
(A) in paragraph (6)—
(i) by amending subparagraph (B) to read as follows:
‘‘(B) AVAILABILITY OF REPORTS.—
‘‘(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 Federal 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 property rights; and
‘‘(II) assigned a docket number by the Commissioner 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 subparagraph (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

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(iii) in clause (ii), by striking ‘‘in the Federal Register 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 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e–1(a)(3)) is
amended—
(1) by redesignating subparagraphs (B) through (D) as subparagraphs (D) through (F), respectively;
(2) by inserting after subparagraph (A) the following:
‘‘(B) any information, based on a review of data available to the Secretary, regarding devices used in pediatric
patients but not labeled for such use for which the Secretary 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 determination of a reasonable assurance of safety and effectiveness 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 subpopulation.’’.
(b) HUMANITARIAN DEVICE EXEMPTION.—Section 520(m) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is
amended—
(1) in paragraph (4)—
(A) in subparagraph (B), by inserting ‘‘or an appropriate local committee’’ after ‘‘review committee’’ each place
such term appears; and
(B) in the matter following subparagraph (B), by
inserting ‘‘or an appropriate local 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 AVAILABILITY.—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;

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131 STAT. 1038

PUBLIC LAW 115–52—AUG. 18, 2017
(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 representing patients and consumers.
(2) TOPICS.—The meeting described in paragraph (1) shall
include consideration of ways to—
(A) improve research infrastructure and research networks to facilitate the conduct of clinical studies of devices
for pediatric populations that would result in the approval
or clearance, and labeling, of medical devices for such populations;
(B) appropriately use extrapolation under section
515A(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360e–1(b));
(C) enhance the appropriate use of postmarket registries and data to increase 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 development 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.

Consultation.

Deadline.
Public
information.

SEC. 503. EARLY MEETING ON PEDIATRIC STUDY PLAN.

Deadlines.

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(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 pediatric study plan, not later than the end-of-Phase
1 meeting (as such term is used in section
312.82(b) of title 21, Code of Federal Regulations,

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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 calendar days after the receipt of such plan under
subparagraph (A); and
‘‘(III) to discuss the bases for the deferral
under subsection (a)(4) or a 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 following:
‘‘(A) GENERAL REQUIREMENTS.—Except with respect to
an application for which subparagraph (B) applies, a person’’;
(iii) in clause (i), as so redesignated, by striking
‘‘, or’’ at the end and inserting ‘‘; or’’; and
(iv) by adding after subparagraph (A), as so designated by clause (ii), the following:
‘‘(B) CERTAIN MOLECULARLY TARGETED CANCER INDICATIONS.—A person that submits, on or after the date that
is 3 years after the date of enactment of the FDA Reauthorization Act of 2017, an original application for a new active
ingredient under section 505 of this Act or section 351
of the Public Health Service Act, shall submit with the
application reports on the investigation described in paragraph (3) if the drug or biological product that is the
subject of the application is—
‘‘(i) intended for the treatment of an adult cancer;
and
‘‘(ii) directed at a molecular target that the Secretary 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)’’;

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Reports.

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131 STAT. 1040

(C) by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively;
(D) by inserting after paragraph (2) the following:
‘‘(3) MOLECULARLY TARGETED PEDIATRIC CANCER INVESTIGATION.—
‘‘(A) IN GENERAL.—With respect to a drug or biological
product described in paragraph (1)(B), the investigation
described in this paragraph is a molecularly targeted pediatric cancer investigation, which shall be designed to yield
clinically meaningful pediatric study data, gathered using
appropriate formulations for each age group for which the
study is required, regarding dosing, safety, and preliminary
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 paragraph (1)’’ each place it appears and inserting ‘‘assessments required under paragraph (1)(A) or reports on
the investigation required under paragraph (1)(B)’’;
(ii) in subparagraph (A)(ii)(I), by inserting ‘‘or
reports on the investigation’’ after ‘‘assessments’’;
(iii) in subparagraph (B)(ii), by striking ‘‘assessment 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 subsection (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 investigation described in subsection (a)(3)’’ after ‘‘under subsection (a)(2)’’; and
(4) by adding at the end the following:
‘‘(m) LIST OF PRIMARY MOLECULAR TARGETS.—

Applicability.

Applicability.

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‘‘(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 internet website of the Food and Drug Administration—
‘‘(A) a list of molecular targets considered, on the basis
of data the Secretary determines to be adequate, to be
substantially relevant to the growth and progression of
a pediatric cancer, and that may trigger the requirements
under this section; and
‘‘(B) a list of molecular targets of new cancer drugs
and biological products in development for which pediatric
cancer study requirements under this section will be automatically 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 Oncologic 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 commercial information, as prohibited under section 301(j) of this
Act or section 1905 of title 18, United States Code.’’.
(b) ORPHAN DRUGS.—Section 505B(k) of the 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 CERTAIN 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 Services (referred to in this subsection as the ‘‘Secretary’’), acting
through the Commissioner of Food and Drugs and in collaboration 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 disease 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—

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(A) the data necessary to determine that there is scientific 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 scientific 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 conducting 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 section 505B(m) of the Federal Food, Drug, and Cosmetic
Act that contains molecular targets shared between different tumor types;
(E) the process the Secretary shall utilize to update
regularly a list of molecular targets that may trigger a
pediatric study under section 505B of the Federal Food,
Drug, and Cosmetic Act, as so amended, and how often
such 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 development 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 barriers to conducting clinical trials in pediatric cancer populations;
(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 products that would be subject to the requirements for an
investigation under such section 505B based on shared
molecular targets; and

Lists.

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(M) the ways in which the Secretary will help to mitigate the risks, if any, of discouraging the research and
development of orphan drugs when implementing such section 505B as amended.
(2) GUIDANCE.—Not later than 2 years after the date of
enactment of this Act, the Secretary, 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 section, 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 investigation based on a molecular target can be reasonably conducted;
(C) the scientific or operational challenges for which
the Secretary may issue deferrals or waivers for an investigation 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 amendment process, including when studies contained in a
request under such section 505A are not feasible due to
the ethical, practical, or other barriers to conducting clinical
trials in 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.

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Criteria.

Plan.

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Assessment.

Lists.

Lists.

Assessment.

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(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 implement 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 section 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 amendments 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 submitted;
‘‘(14) a list of assessments and investigations required
under such section 505B;
‘‘(15) how many requests under such section 505A for molecular targeted cancer drugs, as 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 Reauthorization Act of 2017 on the conduct and effectiveness of pediatric

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131 STAT. 1045

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 Cosmetic Act (21 U.S.C. 355a) or section 351(m) of the Public Health
Service Act (42 U.S.C. 262(m)), or to negotiate or implement amendments 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 population 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 subsection (a)(1)(B) of such section 505B; and
(H) any additional considerations by the Secretary
regarding the effectiveness of requiring pediatric assessments described in such section 505B in the development
of drugs and biological products for pediatric cancer indications.
(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 paragraph (1), the Comptroller General of the United States shall
consult with appropriate stakeholders that may be required

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note.

Effective date.
Time period.
Study.

Examination.

Criteria.

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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 Administration.
(4) REPORT.—Not later than the date that is 6 years after
the date of enactment of this Act, the Comptroller General
of the United States shall 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.

Deadline.

Deadline.
21 USC 355a
note.

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(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 Secretary 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 appropriate, earlier submission of pediatric studies under section 505A
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a)
or section 351(m) of the Public Health Service Act (42 U.S.C.
262(m)). Such plan shall include recommendations to achieve—
(1) earlier discussion of proposed pediatric study requests
and written requests with sponsors, and if appropriate, discussion of such requests at the meeting required under section
505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355c(e)(2)(C)), as amended by section 503(a);

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(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 Committee on Energy and Commerce of the House of Representatives, and make publicly available, including through posting
on the internet website of the Food and Drug 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 designation under section 526 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb);
(ii) an application described under section
505B(a)(1) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355c(a)(1)) for such indication was submitted to the Secretary of Health and Human Services
on or after April 1, 1999; and
(iii) the labeling for such indication lacks important pediatric information, 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

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21 USC 355a
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Public
information.
Web posting.

Lists.

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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 EXCLUSIVITY 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 disease or condition, or a related therapy or clinical investigation’’.

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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 information 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 submission of views, that during such period the holder of the
exclusive approval or licensure cannot ensure’’; and
(C) in paragraph (2), by striking ‘‘such holder provides’’
and inserting ‘‘the holder 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

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Determination.

Applicability.

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Publication.
Summary.

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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 enactment, 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 Secretary 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 superiority 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 exclusivity under clause (iii) or (iv) of section 505(j)(5)(F), clause
(iii) or (iv) of section 505(c)(3)(E), or section 527(a), or
by an extension of such exclusivity under this section or
section 505E’’;
(3) in paragraph (2), in the matter preceding subparagraph
(A)—
(A) by inserting ‘‘clauses (iii) and (iv) of section
505(c)(3)(E), or section 527,’’ after ‘‘section 505(j)(5)(F),’’;
and
(B) by striking ‘‘drug approved under 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 EXTENSIONS.—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;

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‘‘(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 PRESCRIPTION DRUGS.

It is the sense of the Congress that the Secretary of Health
and Human Services should commit to engaging with the House
of Representatives and the Senate to take administrative actions
and enact legislative changes that—
(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 stakeholders, 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 benefit 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 socioeconomic barriers; and

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note.
Coordination.
Consultation.
Deadline.

Web posting.
Reports.
Deadline.

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(III) the impact of exclusion criteria on the
enrollment in clinical trials of particular populations, 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 effectiveness, 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 demonstrate safety and effectiveness, and potential
approaches to mitigating those impacts.
(2) REPORT.—Not later than 1 year after the Secretary
issues the report under paragraph (1)(B), the Comptroller General of the United States shall report to the Committee on
Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives 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 Investigational Drugs for Treatment Use—Questions and Answers’’
and ‘‘Individual Patient Expanded Access Applications:
Form FDA 3926’’, issued by the Food and Drug Administration 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 regulations issued to implement section 561 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360bbb) have improved
access for individual patients to investigational drugs who
do not qualify for clinical trials of such 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 paragraph (1)(B).
(3) GUIDANCE.—
(A) IN GENERAL.—Not later than 1 year after the
publication of the report under paragraph (1)(B), the Secretary, acting through the Commissioner of Food and
Drugs, shall issue one or more draft guidances regarding

Assessment.

Analysis.

Deadlines.

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eligibility criteria for clinical trials. Not later than 1 year
after the public comment period on each such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.
(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 conditions 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 appropriate, 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 streamline 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 section 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 designation as a breakthrough therapy, fast track product, or regenerative advanced therapy under subsection (a), (b), or (g), respectively, of section 506.’’.

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Deadline.
Guidance.
21 USC 360bbb
note.

Update.

Time period.

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SEC. 611. TROPICAL DISEASE PRODUCT APPLICATION.

21 USC 360n
note.

(a) IN GENERAL.—Subparagraph (A) of section 524(a)(4) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(4)) is
amended—
(1) in clause (i), by striking ‘‘and’’ at the end; and
(2) by adding at the end the following:
‘‘(iii) that contains reports of one or more new
clinical investigations (other than bioavailability
studies) that are essential to the approval of the
application and conducted or sponsored by the sponsor
of such application; and
‘‘(iv) that contains an attestation from the sponsor
of the application that such reports were not submitted
as part of an application for marketing approval or
licensure by a regulatory authority in India, Brazil,
Thailand, or any country that is a member of the
Pharmaceutical Inspection Convention or the Pharmaceutical Inspection Cooperation Scheme prior to September 27, 2007.’’.
(b) EFFECTIVE DATE.—The amendments made by subsection
(a) shall apply to human drug applications submitted after September 30, 2017.

TITLE VII—DEVICE INSPECTION AND
REGULATORY IMPROVEMENTS
SEC. 701. RISK-BASED INSPECTIONS FOR DEVICES.

Applicability.

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(a) IN GENERAL.—Section 510(h) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360(h)) is amended—
(1) by striking paragraph (2) and inserting the following:
‘‘(2) RISK-BASED SCHEDULE FOR DEVICES.—
‘‘(A) IN GENERAL.—The Secretary, acting through one
or more officers or employees duly designated by the Secretary, shall inspect establishments described in paragraph
(1) that are engaged in the manufacture, propagation,
compounding, or processing of a device or devices (referred
to in this subsection as ‘device establishments’) in accordance with a risk-based schedule established by the Secretary.
‘‘(B) FACTORS AND CONSIDERATIONS.—In establishing
the risk-based schedule under subparagraph (A), the Secretary shall—
‘‘(i) apply, to the extent applicable for device
establishments, the factors identified in paragraph (4);
and
‘‘(ii) consider the participation of the device
establishment, as applicable, in international device
audit programs in which the United States participates
or the United States recognizes for purposes of
inspecting device establishments.’’; and
(2) in paragraph (4)—
(A) in the matter preceding subparagraph (A), by
striking ‘‘paragraph (3)’’ and inserting ‘‘paragraph (2) or
(3)’’; and

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131 STAT. 1055

(B) in subparagraph (C), by inserting ‘‘or device’’ after
‘‘drug’’.
(b) FOREIGN INSPECTIONS.—Section 809(a)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 384e(a)(1)) is amended
by striking ‘‘section 510(h)(3)’’ and inserting ‘‘paragraph (2) or (3)
of section 510(h)’’.
SEC. 702. IMPROVEMENTS TO INSPECTIONS PROCESS FOR DEVICE
ESTABLISHMENTS.

(a) IN GENERAL.—Section 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374) is amended by adding at the end
the following:
‘‘(h)(1) In the case of inspections other than for-cause inspections, the Secretary shall review processes and standards applicable
to inspections of domestic and foreign device establishments in
effect as of the date of the enactment of this subsection, and
update such processes and standards through the adoption of uniform processes and standards applicable to such inspections. Such
uniform processes and standards shall provide for—
‘‘(A) exceptions to such processes and standards, as appropriate;
‘‘(B) announcing the inspection of the establishment within
a reasonable time before such inspection occurs, including by
providing to the owner, operator, or agent in charge of the
establishment a notification regarding the type and nature
of the inspection;
‘‘(C) a reasonable estimate of the timeframe for the inspection, an opportunity for advance communications between the
officers or employees carrying out the inspection under subsection (a)(1) and the owner, operator, or agent in charge of
the establishment concerning appropriate working hours during
the inspection, and, to the extent feasible, advance notice of
some records that will be requested; and
‘‘(D) regular communications during the inspection with
the owner, operator, or agent in charge of the establishment
regarding inspection status, which may be recorded by either
party with advance notice and mutual consent.
‘‘(2)(A) The Secretary shall, with respect to a request described
in subparagraph (B), provide nonbinding feedback with respect
to such request not later than 45 days after the Secretary receives
such request.
‘‘(B) A request described in this subparagraph is a request
for feedback—
‘‘(i) that is made by the owner, operator, or agent in charge
of such establishment in a timely manner; and
‘‘(ii) with respect to actions proposed to be taken by a
device establishment in a response to a report received by
such establishment pursuant to subsection (b) that involve a
public health priority, that implicate systemic or major actions,
or relate to emerging safety issues (as determined by the Secretary).
‘‘(3) Nothing in this subsection affects the authority of the
Secretary to conduct inspections otherwise permitted under this
Act in order to ensure compliance with this Act.’’.
(b) GUIDANCE.—
(1) DRAFT GUIDANCE.—Not later than 18 months after the
date of enactment of this Act, the Secretary of Health and

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Review.

Deadline.

21 USC 374 note.
Deadline.

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131 STAT. 1056

Deadline.
Notice.
Public
information.

PUBLIC LAW 115–52—AUG. 18, 2017

Human Services, acting through the Commissioner of Food
and Drugs, shall issue draft guidance that—
(A) specifies how the Food and Drug Administration
will implement the processes and standards described in
paragraph (1) of subsection (h) of section 704 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 374), as added
by subsection (a), and the requirements described in paragraph (2) of such subsection (h);
(B) provides for standardized methods for communications described in such paragraphs;
(C) establishes, with respect to inspections of both
domestic and foreign device establishments (as referred
to in section 510(h)(2) of the Federal Food, Drug, and
Cosmetic Act, as amended by subsection (a)), a standard
timeframe for such inspections—
(i) that occurs over consecutive days; and
(ii) to which each investigator conducting such an
inspection shall adhere unless the investigator identifies to the establishment involved a reason that more
time is needed to conduct such investigation; and
(D) identifies practices for investigators and device
establishments to facilitate the continuity of inspections
of such establishments.
(2) FINAL GUIDANCE.—Not later than 1 year after providing
notice and opportunity for public comment on the draft guidance
issued under paragraph (1), the Secretary of Health and Human
Services shall issue final guidance to implement subsection
(h) of section 704 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 374), as added by subsection (a).
(c) ADULTERATED DEVICES.—Subsection (j) of section 501 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is
amended by inserting ‘‘or device’’ after ‘‘drug’’.
SEC. 703. REAUTHORIZATION OF INSPECTION PROGRAM.

Section 704(g)(11) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 374(g)(11)) is amended by striking ‘‘October 1, 2017’’
and inserting ‘‘October 1, 2022’’.
SEC. 704. CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES.

Summary.

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Subsection (e)(4) of section 801 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381(e)(4)) is amended—
(1) by adding at the end the following:
‘‘(E)(i)(I) If the Secretary denies a request for certification under
subparagraph (A)(ii) with respect to a device manufactured in an
establishment (foreign or domestic) registered under section 510,
the Secretary shall provide in writing to the person seeking such
certification the basis for such denial, and specifically identify the
finding upon which such denial is based.
‘‘(II) If the denial of a request as described in subclause (I)
is based on grounds other than an injunction proceeding pursuant
to section 302, seizure action pursuant to section 304, or a recall
designated Class I or Class II pursuant to part 7, title 21, Code
of Federal Regulations, and is based on the facility being out of
compliance with part 820 of title 21, Code of Federal Regulations,
the Secretary shall provide a substantive summary of the specific
grounds for noncompliance identified by the Secretary.
‘‘(III) With respect to a device manufactured in an establishment that has received a report under section 704(b), the Secretary

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shall not deny a request for certification as described in subclause
(I) with respect to a device based solely on the issuance of that
report if the owner, operator, or agent in charge of such establishment has agreed to a plan of correction in response to such report.
‘‘(ii)(I) The Secretary shall provide a process for a person who
is denied a certification as described in clause (i)(I) to request
a review that conforms to the standards of section 517A(b).
‘‘(II) Notwithstanding any previous review conducted pursuant
to subclause (I), a person who has been denied a certification
as described in clause (i)(I) may at any time request a review
in order to present new information relating to actions taken by
such person to address the reasons identified by the Secretary
for the denial of certification, including evidence that corrective
actions are being or have been implemented to address grounds
for noncompliance identified by the Secretary.
‘‘(III) Not later than 1 year after the date of enactment of
the FDA Reauthorization Act of 2017, the Secretary shall issue
guidance providing for a process to carry out this subparagraph.
Not later than 1 year after the close of the comment period for
such guidance, the Secretary shall issue final guidance.
‘‘(iii)(I) Subject to subclause (II), this subparagraph applies
to requests for certification on behalf of any device establishment
registered under section 510, whether the establishment is located
inside or outside of the United States, and regardless of whether
such devices are to be exported from the United States.
‘‘(II) If an establishment described in subclause (I) is not located
within the United States and does not demonstrate that the devices
manufactured, prepared, propagated, compounded, or processed at
such establishment are to be exported from the United States,
this subparagraph shall apply only if—
‘‘(aa) the establishment has been inspected by the Secretary
within 3 years of the date of the request; or
‘‘(bb) the establishment participates in an audit program
in which the United States participates or the United States
recognizes, an audit under such program has been conducted,
and the findings of such audit are provided to the Secretary
within 3 years of the date of the request.’’; and
(2) by moving the margins of subparagraphs (C) and (D)
4 ems to the left.

Review.

Deadlines.
Guidance.

Applicability.

Applicability.
Deadlines.

Audits.

SEC. 705. FACILITATING INTERNATIONAL HARMONIZATION.

Section 704(g) of the Federal Food, Drug and Cosmetic Act
(21 U.S.C. 374) is amended by adding at the end the following:
‘‘(15)(A) Notwithstanding any other provision of this subsection,
the Secretary may recognize auditing organizations that are recognized by organizations established by governments to facilitate
international harmonization for purposes of conducting inspections
of—
‘‘(i) establishments that manufacture, prepare, propagate,
compound, or process devices (other than types of devices
licensed under section 351 of the Public Health Service Act),
as required under section 510(h); or
‘‘(ii) establishments required to register pursuant to section
510(i).
‘‘(B) Nothing in this paragraph affects—
‘‘(i) the authority of the Secretary to inspect any device
establishment pursuant to this Act; or

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‘‘(ii) the authority of the Secretary to determine the official
classification of an inspection.’’.

SEC. 706. FOSTERING INNOVATION IN MEDICAL IMAGING.

(a) APPROVAL OF APPLICATIONS FOR CERTAIN DIAGNOSTIC MEDIMAGING DEVICES.—Section 520 of the Federal Food, Drug,
and Cosmetic Act (42 U.S.C. 360j) is amended by adding at the
end the following:
‘‘(p) DIAGNOSTIC IMAGING DEVICES INTENDED FOR USE WITH
CONTRAST AGENTS.—
‘‘(1) IN GENERAL.—The Secretary may, subject to the succeeding provisions of this subsection, approve an application
(or a supplement to such an application) submitted under section 515 with respect to an applicable medical imaging device,
or, in the case of an applicable medical imaging device for
which a notification is submitted under section 510(k), may
make a substantial equivalence determination with respect to
an applicable medical imaging device, or may grant a request
submitted under section 513(f)(2) for an applicable medical
imaging device, if such application, notification, or request
involves the use of a contrast agent that is not—
‘‘(A) in a concentration, rate of administration, or route
of administration that is different from those described
in the approved labeling of the contrast agent, except that
the Secretary may approve such application, make such
substantial equivalence determination, or grant such
request if the Secretary determines that such differences
in concentration, rate of administration, or route of
administration exist but do not adversely affect the safety
and effectiveness of the contrast agent when used with
the device;
‘‘(B) in a region, organ, or system of the body that
is different from those described in the approved labeling
of the contrast agent, except that the Secretary may
approve such application, make such substantial equivalence determination, or grant such request if the Secretary
determines that such differences in region, organ, or system
of the body exist but do not adversely affect the safety
and effectiveness of the contrast agent when used with
the device;
‘‘(C) in a patient population that is different from those
described in the approved labeling of the contrast agent,
except that the Secretary may approve such application,
make such substantial equivalence determination, or grant
such request if the Secretary determines such differences
in patient population exist but do not adversely affect the
safety and effectiveness of the contrast agent when used
with the device; or
‘‘(D) in an imaging modality that is different from
those described in the approved labeling of the contrast
agent.
‘‘(2) PREMARKET REVIEW.—The agency center charged with
premarket review of devices shall have primary jurisdiction
with respect to the review of an application, notification, or
request described in paragraph (1). In conducting such review,
such agency center may—
ICAL

Determinations.

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‘‘(A) consult with the agency center charged with the
premarket review of drugs or biological products; and
‘‘(B) review information and data provided to the Secretary by the sponsor of a contrast agent in an application
submitted under section 505 of this Act or section 351
of the Public Health Service Act, so long as the sponsor
of such contrast agent has provided to the sponsor of the
applicable medical imaging device that is the subject of
such review a right of reference and the application is
submitted in accordance with this subsection.
‘‘(3) APPLICABLE REQUIREMENTS.—An application submitted
under section 515, a notification submitted under section 510(k),
or a request submitted under section 513(f)(2), as described
in paragraph (1), with respect to an applicable medical imaging
device shall be subject to the requirements of such respective
section. Such application, notification, or request shall only
be subject to the requirements of this Act applicable to devices.
‘‘(4) DEFINITIONS.—For purposes of this subsection—
‘‘(A) the term ‘applicable medical imaging device’ means
a device intended to be used in conjunction with a contrast
agent (or class of contrast agents) for an imaging use
that is not described in the approved labeling of such
contrast agent (or the approved labeling of any contrast
agent in the same class as such contrast agent); and
‘‘(B) the term ‘contrast agent’ means a drug that is
approved under section 505 or licensed under section 351
of the Public Health Service Act, is intended for use in
conjunction with an applicable medical imaging device,
and—
‘‘(i) is a diagnostic radiopharmaceutical, as defined
in section 315.2 and 601.31 of title 21, Code of Federal
Regulations (or any successor regulations); or
‘‘(ii) is a diagnostic agent that improves the visualization of structure or function within the body by
increasing the relative difference in signal intensity
within the target tissue, structure, or fluid.’’.
(b) APPLICATIONS FOR APPROVAL OF CONTRAST AGENTS
INTENDED FOR USE WITH CERTAIN DIAGNOSTIC MEDICAL IMAGING
DEVICES.—Section 505 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355) is amended by adding at the end the following:
‘‘(y) CONTRAST AGENTS INTENDED FOR USE WITH APPLICABLE
MEDICAL IMAGING DEVICES.—
‘‘(1) IN GENERAL.—The sponsor of a contrast agent for which
an application has been approved under this section may submit
a supplement to the application seeking approval for a new
use following the authorization of a premarket submission for
an applicable medical imaging device for that use with the
contrast agent pursuant to section 520(p)(1).
‘‘(2) REVIEW OF SUPPLEMENT.—In reviewing a supplement
submitted under this subsection, the agency center charged
with the premarket review of drugs may—
‘‘(A) consult with the center charged with the premarket review of devices; and
‘‘(B) review information and data submitted to the
Secretary by the sponsor of an applicable medical imaging
device pursuant to section 515, 510(k), or 513(f)(2) so long
as the sponsor of such applicable medical imaging device

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has provided to the sponsor of the contrast agent a right
of reference.
‘‘(3) DEFINITIONS.—For purposes of this subsection—
‘‘(A) the term ‘new use’ means a use of a contrast
agent that is described in the approved labeling of an
applicable medical imaging device described in section
520(p), but that is not described in the approved labeling
of the contrast agent; and
‘‘(B) the terms ‘applicable medical imaging device’ and
‘contrast agent’ have the meanings given such terms in
section 520(p).’’.

SEC. 707. RISK-BASED CLASSIFICATION OF ACCESSORIES.

Applicability.

Evaluation.

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(a) IN GENERAL.—Subsection (f) of section 513 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by
adding at the end the following new paragraph:
‘‘(6)(A) Subject to the succeeding subparagraphs of this paragraph, the Secretary shall, by written order, classify an accessory
under this section based on the risks of the accessory when used
as intended and the level of regulatory controls necessary to provide
a reasonable assurance of safety and effectiveness of the accessory,
notwithstanding the classification of any other device with which
such accessory is intended to be used.
‘‘(B) The classification of any accessory distinct from another
device by regulation or written order issued prior to December
13, 2016, shall continue to apply unless and until the accessory
is reclassified by the Secretary, notwithstanding the classification
of any other device with which such accessory is intended to be
used. Nothing in this paragraph shall preclude the Secretary’s
authority to initiate the classification of an accessory through regulation or written order, as appropriate.
‘‘(C)(i) In the case of a device intended to be used with an
accessory, where the accessory has been included in an application
for premarket approval of such device under section 515 or a report
under section 510(k) for clearance of such device and the Secretary
has not classified such accessory distinctly from another device
in accordance with subparagraph (A), the person filing the application or report (as applicable) at the time such application or report
is filed—
‘‘(I) may include a written request for the proper classification of the accessory pursuant to subparagraph (A);
‘‘(II) shall include in any such request such information
as may be necessary for the Secretary to evaluate, based on
the least burdensome approach, the appropriate class for the
accessory under subsection (a); and
‘‘(III) shall, if the request under subclause (I) is requesting
classification of the accessory in class II, include in the application an initial draft proposal for special controls, if special
controls would be required pursuant to subsection (a)(1)(B).
‘‘(ii) The Secretary’s response under section 515(d) or section
510(n) (as applicable) to an application or report described in clause
(i) shall also contain the Secretary’s granting or denial of the
request for classification of the accessory involved.
‘‘(iii) The Secretary’s evaluation of an accessory under clause
(i) shall constitute an order establishing a new classification for

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such accessory for the specified intended use or uses of such accessory and for any accessory with the same intended use or uses
as such accessory.
‘‘(D) For accessories that have been granted marketing
authorization as part of a submission for another device with which
the accessory involved is intended to be used, through an application
for such other device under section 515(c), a report under section
510(k), or a request for classification under paragraph (2) of this
subsection, the following shall apply:
‘‘(i) Not later than the date that is one year after the
date of enactment of the FDA Reauthorization Act of 2017
and at least once every 5 years thereafter, and as the Secretary
otherwise determines appropriate, pursuant to this paragraph,
the Secretary shall publish in the Federal Register a notice
proposing a list of such accessories that the Secretary determines may be suitable for a distinct classification in class
I and the proposed regulations for such classifications. In developing such list, the Secretary shall consider recommendations
from sponsors of device submissions and other stakeholders
for accessories to be included on such list. The notices shall
provide for a period of not less than 60 calendar days for
public comment. Within 180 days after the end of the comment
period, the Secretary shall publish in the Federal Register
a final action classifying such suitable accessories into class
I.
‘‘(ii) A manufacturer or importer of an accessory that has
been granted such marketing authorization may submit to the
Secretary a written request for the appropriate classification
of the accessory based on the risks and appropriate level of
regulatory controls as described in subparagraph (A), and shall,
if the request is requesting classification of the accessory in
class II, include in the submission an initial draft proposal
for special controls, if special controls would be required pursuant to subsection (a)(1)(B). Such request shall include such
information as may be necessary for the Secretary to evaluate,
based on the least burdensome approach, the appropriate class
for the accessory under subsection (a). The Secretary shall
provide an opportunity for a manufacturer or importer to meet
with appropriate personnel of the Food and Drug Administration to discuss the appropriate classification of such accessory
prior to submitting a written request under this clause for
classification of the accessory.
‘‘(iii) The Secretary shall respond to a request made under
clause (ii) not later than 85 calendar days after receiving such
request by issuing a written order classifying the accessory
or denying the request. If the Secretary does not agree with
the recommendation for classification submitted by the manufacturer or importer, the response shall include a detailed
description and justification for such determination. Within
30 calendar days after granting such a request, the Secretary
shall publish a notice in the Federal Register announcing such
response.
‘‘(E) Nothing in this paragraph may be construed as precluding
a manufacturer of an accessory of a new type from using the
classification process described in subsection (f)(2) to obtain classification of such accessory in accordance with the criteria and
requirements set forth in that subsection.’’.

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Applicability.

Deadlines.
Federal Register,
publication.
Notice.
Lists.

Recommendations.
Notices.
Time period.
Public
information.

Evaluation.

Deadlines.

Determination.

Federal Register,
publication.
Notice.

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21 USC 360c
note.

PUBLIC LAW 115–52—AUG. 18, 2017

(b) CONFORMING CHANGE.—Section 513(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended by striking
paragraph (9) (relating to classification of an accessory).
(c) EFFECTIVE DATE.—The amendments made by subsections
(a) and (b) shall take effect on the date that is 60 days after
the date of enactment of this Act.
SEC. 708. DEVICE PILOT PROJECTS.

Deadline.

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(a) POSTMARKET PILOT.—Section 519 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360i) is amended by adding at the
end the following:
‘‘(i) POSTMARKET PILOT.—
‘‘(1) IN GENERAL.—In order to provide timely and reliable
information on the safety and effectiveness of devices approved
under section 515, cleared under section 510(k), or classified
under section 513(f)(2), including responses to adverse events
and malfunctions, and to advance the objectives of part 803
of title 21, Code of Federal Regulations (or successor regulations), and advance the objectives of, and evaluate innovative
new methods of compliance with, this section and section 522,
the Secretary shall, within one year of the date of enactment
of the FDA Reauthorization Act of 2017, initiate one or more
pilot projects for voluntary participation by a manufacturer
or manufacturers of a device or device type, or continue existing
projects, in accordance with paragraph (3), that—
‘‘(A) are designed to efficiently generate reliable and
timely safety and active surveillance data for use by the
Secretary or manufacturers of the devices that are involved
in the pilot project;
‘‘(B) inform the development of methods, systems, data
criteria, and programs that could be used to support safety
and active surveillance activities for devices included or
not included in such project;
‘‘(C) may be designed and conducted in coordination
with a comprehensive system for evaluating medical device
technology that operates under a governing board with
appropriate representation of stakeholders, including
patient groups and device manufacturers;
‘‘(D) use electronic health data including claims data,
patient survey data, or any other data, as the Secretary
determines appropriate; and
‘‘(E) prioritize devices and device types that meet one
or more of the following criteria:
‘‘(i) Devices and device types for which the collection and analysis of real world evidence regarding a
device’s safety and effectiveness is likely to advance
public health.
‘‘(ii) Devices and device types that are widely used.
‘‘(iii) Devices and device types, the failure of which
has significant health consequences.
‘‘(iv) Devices and device types for which the Secretary—
‘‘(I) has received public recommendations in
accordance with paragraph (2)(B); and
‘‘(II) has determined to meet one or more of
the criteria under clause (i), (ii), or (iii) and is
appropriate for such a pilot project.

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‘‘(2) PARTICIPATION.—The Secretary shall establish the
conditions and processes—
‘‘(A) under which a manufacturer of a device may voluntarily participate in a pilot project described in paragraph (1); and
‘‘(B) for facilitating public recommendations for devices
to be prioritized under such a pilot project, including
requirements for the data necessary to support such a
recommendation.
‘‘(3) CONTINUATION OF ONGOING PROJECTS.—The Secretary
may continue or expand projects, with respect to providing
timely and reliable information on the safety and effectiveness
of devices approved under section 515, cleared under section
510(k), or classified under section 513(f)(2), that are being carried out as of the date of the enactment of the FDA Reauthorization Act of 2017. The Secretary shall, beginning on such date
of enactment, take such steps as may be necessary—
‘‘(A) to ensure such projects meet the requirements
of subparagraphs (A) through (E) of paragraph (1); and
‘‘(B) to increase the voluntary participation in such
projects of manufacturers of devices and facilitate public
recommendations for any devices prioritized under such
a project.
‘‘(4) IMPLEMENTATION.—
‘‘(A) CONTRACTING AUTHORITY.—The Secretary may
carry out a pilot project meeting the criteria specified in
subparagraphs (A) through (E) of paragraph (1) or a project
continued or expanded under paragraph (3) by entering
into contracts, cooperative agreements, grants, or other
appropriate agreements with public or private entities that
have a significant presence in the United States and meet
the following conditions:
‘‘(i) If such an entity is a component of another
organization, the entity and the organization have
established an agreement under which appropriate
security measures are implemented to maintain the
confidentiality and privacy of the data described in
paragraph (1)(D) and such agreement ensures that
the entity will not make an unauthorized disclosure
of such data to the other components of the organization in breach of requirements with respect to confidentiality and privacy of such data established under such
security measures.
‘‘(ii) In the case of the termination or nonrenewal
of such a contract, cooperative agreement, grant, or
other appropriate agreement, the entity or entities
involved shall comply with each of the following:
‘‘(I) The entity or entities shall continue to
comply with the requirements with respect to confidentiality and privacy referred to in clause (i)
with respect to all data disclosed to the entity
under such an agreement.
‘‘(II) The entity or entities shall return any
data disclosed to such entity pursuant to this subsection and to which it would not otherwise have
access or, if returning such data is not practicable,
destroy the data.

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Effective date.

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Determination.

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‘‘(iii) The entity or entities shall have one or more
qualifications with respect to—
‘‘(I) research, statistical, epidemiologic, or clinical capability and expertise to conduct and complete the activities under this subsection, including
the capability and expertise to provide the Secretary access to de-identified data consistent with
the requirements of this subsection;
‘‘(II) an information technology infrastructure
to support electronic data and operational standards to provide security for such data, as appropriate;
‘‘(III) experience with, and expertise on, the
development of research on, and surveillance of,
device safety and effectiveness using electronic
health data; or
‘‘(IV) such other expertise which the Secretary
determines necessary to carry out such a project.
‘‘(B) REVIEW OF CONTRACT IN THE EVENT OF A MERGER
OR ACQUISITION.—The Secretary shall review any contract,
cooperative agreement, grant, or other appropriate agreement entered into under this paragraph with an entity
meeting the conditions specified in subparagraph (A) in
the event of a merger or acquisition of the entity in order
to ensure that the requirements specified in this subsection
will continue to be met.
‘‘(5) COMPLIANCE WITH REQUIREMENTS FOR RECORDS OR
REPORTS ON DEVICES.—The participation of a manufacturer in
pilot projects under this subsection or a project continued or
expanded under paragraph (3) shall not affect the eligibility
of such manufacturer to participate in any quarterly reporting
program with respect to devices carried out under this section
519 or section 522. The Secretary may determine that, for
a specified time period to be determined by the Secretary,
a manufacturer’s participation in a pilot project under this
subsection or a project continued or expanded under paragraph
(3) may meet the applicable requirements of this section or
section 522, if—
‘‘(A) the project has demonstrated success in capturing
relevant adverse event information; and
‘‘(B) the Secretary has established procedures for
making adverse event and safety information collected from
such project public, to the extent possible.
‘‘(6) PRIVACY REQUIREMENTS.—With respect to the disclosure of any health information collected through a project conducted under this subsection—
‘‘(A) individually identifiable health information so collected shall not be disclosed when presenting any information from such project; and
‘‘(B) any such disclosure shall be made in compliance
with regulations issued pursuant to section 264(c) of the
Health Insurance Portability and Accountability Act of
1996 (42 U.S.C. 1320d–2 note) and sections 552 and 552a
of title 5, United States Code.
‘‘(7) LIMITATIONS.—No pilot project under this subsection,
or in coordination with the comprehensive system described
in paragraph (1)(C), may allow for an entity participating in

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such project, other than the Secretary, to make determinations
of safety or effectiveness, or substantial equivalence, for purposes of this Act.
‘‘(8) OTHER PROJECTS REQUIRED TO COMPLY.—Paragraphs
(1)(B), (4)(A)(i), (4)(A)(ii), (5), (6), and (7) shall apply with
respect to any pilot project undertaken in coordination with
the comprehensive system described in paragraph (1)(C) that
relates to the use of real world evidence for devices in the
same manner and to the same extent as such paragraphs
apply with respect to pilot projects conducted under this subsection.
‘‘(9) REPORT TO CONGRESS.—Not later than 18 months after
the date of enactment of this Act, and annually thereafter,
the Secretary shall submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee
on Health, Education, Labor and Pensions of the Senate a
report containing a description of the pilot projects being conducted under this subsection and projects continued or
expanded pursuant to paragraph (3), including for each such
project—
‘‘(A) how the project is being implemented in accordance with paragraph (4), including how such project is
being implemented through a contract, cooperative agreement, grant, or other appropriate agreement, if applicable;
‘‘(B) the number of manufacturers that have agreed
to participate in such project;
‘‘(C) the data sources used to conduct such project;
‘‘(D) the devices or device categories involved in such
project;
‘‘(E) the number of patients involved in such project;
and
‘‘(F) the findings of the project in relation to device
safety, including adverse events, malfunctions, and other
safety information.
‘‘(10) SUNSET.—The Secretary may not carry out a pilot
project initiated by the Secretary under this subsection after
October 1, 2022.’’.
(b) REPORT.—Not later than January 31, 2021, the Secretary
of Health and Human Services, acting through the Commissioner
of Food and Drugs, shall conduct a review through an independent
third party to evaluate the strengths, limitations, and appropriate
use of evidence collected pursuant to real world evidence pilot
projects described in the letters described in section 201(b) of the
Medical Device User Fee Amendments of 2017 and subsection (i)
of section 519 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360i), as amended by subsection (a), for informing premarket
and postmarket decisionmaking for multiple device types, and to
determine whether the methods, systems, and programs in such
pilot projects efficiently generate reliable and timely evidence about
the effectiveness or safety surveillance of devices.

Applicability.

Review.
Determination.

SEC. 709. REGULATION OF OVER-THE-COUNTER HEARING AIDS.

(a) IN GENERAL.—Section 520 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j), as amended by section 708, is further
amended by adding at the end the following:
‘‘(q) REGULATION OF OVER-THE-COUNTER HEARING AIDS.—
‘‘(1) DEFINITION.—

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131 STAT. 1066

‘‘(A) IN GENERAL.—In this subsection, the term ‘overthe-counter hearing aid’ means a device that—
‘‘(i) uses the same fundamental scientific technology as air conduction hearing aids (as defined in
section 874.3300 of title 21, Code of Federal Regulations) (or any successor regulation) or wireless air
conduction hearing aids (as defined in section 874.3305
of title 21, Code of Federal Regulations) (or any successor regulation);
‘‘(ii) is intended to be used by adults age 18 and
older to compensate for perceived mild to moderate
hearing impairment;
‘‘(iii) through tools, tests, or software, allows the
user to control the over-the-counter hearing aid and
customize it to the user’s hearing needs;
‘‘(iv) may—
‘‘(I) use wireless technology; or
‘‘(II) include tests for self-assessment of
hearing loss; and
‘‘(v) is available over-the-counter, without the
supervision, prescription, or other order, involvement,
or intervention of a licensed person, to consumers
through in-person transactions, by mail, or online.
‘‘(B) EXCEPTION.—Such term does not include a personal sound amplification product intended to amplify
sound for nonhearing impaired consumers in situations
including hunting and bird-watching.
‘‘(2) REGULATION.—An over-the-counter hearing aid shall
be subject to the regulations promulgated in accordance with
section 709(b) of the FDA Reauthorization Act of 2017 and
shall be exempt from sections 801.420 and 801.421 of title
21, Code of Federal Regulations (or any successor regulations).’’.
(b) REGULATIONS TO ESTABLISH CATEGORY.—
(1) IN GENERAL.—The Secretary of Health and Human
Services (referred to in this section as the ‘‘Secretary’’), not
later than 3 years after the date of enactment of this Act,
shall promulgate proposed regulations to establish a category
of over-the-counter hearing aids, as defined in subsection (q)
of section 520 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360j) as amended by subsection (a), and, not later
than 180 days after the date on which the public comment
period on the proposed regulations closes, shall issue such
final regulations.
(2) REQUIREMENTS.—In promulgating the regulations under
paragraph (1), the Secretary shall—
(A) include requirements that provide reasonable
assurances of the safety and effectiveness of over-thecounter hearing aids;
(B) include requirements that establish or adopt output
limits appropriate for over-the-counter hearing aids;
(C) include requirements for appropriate labeling of
over-the-counter hearing aids, including requirements that
such labeling include a conspicuous statement that the
device is only intended for adults age 18 and older, information on how consumers may report adverse events, information on any contraindications, conditions, or symptoms of
medically treatable causes of hearing loss, and advisements

21 USC 360j
note.
Deadlines.

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to consult promptly with a licensed health care practitioner;
and
(D) describe the requirements under which the sale
of over-the-counter hearing aids is permitted, without the
supervision, prescription, or other order, involvement, or
intervention of a licensed person, to consumers through
in-person transactions, by mail, or online.
(3) PREMARKET NOTIFICATION.—The Secretary shall make
findings under section 510(m) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(m)) to determine whether overthe-counter hearing aids (as defined in section 520(q) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as
amended by subsection (a)) require a report under section
510(k) to provide reasonable assurance of safety and effectiveness.
(4) EFFECT ON STATE LAW.—No State or local government
shall establish or continue in effect any law, regulation, order,
or other requirement specifically related to hearing products
that would restrict or interfere with the servicing, marketing,
sale, dispensing, use, customer support, or distribution of overthe-counter hearing aids (as defined in section 520(q) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as
amended by subsection (a)) through in-person transactions, by
mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations promulgated under this
subsection, including any State or local requirement for the
supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access overthe-counter hearing aids.
(5) NO EFFECT ON PRIVATE REMEDIES.—Nothing in this
section shall be construed to modify or otherwise affect the
ability of any person to exercise a private right of action under
any State or Federal product liability, tort, warranty, contract,
or consumer protection law.
(c) NEW GUIDANCE ISSUED.—Not later than the date on which
final regulations are issued under subsection (b), the Secretary
shall update and finalize the draft guidance of the Department
of Health and Human Services entitled ‘‘Regulatory Requirements
for Hearing Aid Devices and Personal Sound Amplification Products’’, issued on November 7, 2013. Such updated and finalized
guidance shall clarify which products, on the basis of claims or
other marketing, advertising, or labeling material, meet the definition of a device in section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321) and which products meet the definition
of a personal sound amplification product, as set forth in such
guidance.
(d) REPORT.—Not later than 2 years after the date on which
the final regulations described in subsection (b)(1) are issued, the
Secretary of Health and Human Services shall submit to Congress
a report analyzing any adverse events relating to over-the-counter
hearing aids (as defined in subsection (q)(1) of section 520 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j)).

Determination.

Deadline.
Update.

SEC. 710. REPORT ON SERVICING OF DEVICES.

(a) IN GENERAL.—Not later than 270 days after the date of
enactment of this Act, the Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, shall post

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on the internet website of the Food and Drug Administration a
report on the continued quality, safety, and effectiveness of devices
(as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))) with respect to servicing (as defined
in subsection (c)).
(b) CONTENTS.—The report submitted under subsection (a) shall
contain—
(1) the status of, and findings to date, with respect to,
the proposed rule entitled ‘‘Refurbishing, Reconditioning,
Rebuilding, Remarketing, Remanufacturing, and Servicing of
Medical Devices Performed by Third-Party Entities and
Original Equipment Manufacturers; Request for Comments’’
published in the Federal Register by the Food and Drug
Administration on March 4, 2016 (81 Fed. Reg. 11477);
(2) information presented during the October 2016 public
workshop entitled ‘‘Refurbishing, Reconditioning, Rebuilding,
Remarketing, Remanufacturing, and Servicing of Medical
Devices Performed by Third-Party Entities and Original Equipment Manufacturers’’;
(3) a description of the statutory and regulatory authority
of the Food and Drug Administration with respect to the servicing of devices conducted by any entity, including original
equipment manufacturers and third party entities;
(4) details regarding how the Food and Drug Administration currently regulates devices with respect to servicing to
ensure safety and effectiveness, how the agency could improve
such regulation using the authority described in paragraph
(3), and whether additional authority is recommended;
(5) information on actions the Food and Drug Administration could take under the authority described in paragraphs
(3) and (4) to assess the servicing of devices, including the
size, scope, location, and composition of third party entities;
(6) information on actions the Food and Drug Administration could take to track adverse events caused by servicing
errors performed by any entity, including original equipment
manufacturers and third party entities;
(7) information regarding the regulation by States, the
Joint Commission, or other regulatory bodies of device servicing
performed by any entity, including original equipment manufacturers and third party entities; and
(8) any additional information determined by the Secretary
(acting through the Commissioner) to be relevant to ensuring
the quality, safety, and effectiveness of devices with respect
to servicing.
(c) SERVICING DEFINED.—In this section, the term ‘‘servicing’’
includes, with respect to a device, refurbishing, reconditioning,
rebuilding, remarketing, repairing, remanufacturing, or other servicing of the device.

TITLE VIII—IMPROVING GENERIC DRUG
ACCESS
SEC. 801. PRIORITY REVIEW OF GENERIC DRUGS.

Section 505(j) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)) is amended by adding at the end the following:

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‘‘(11)(A) Subject to subparagraph (B), the Secretary shall
prioritize the review of, and act within 8 months of the date of
the submission of, an original abbreviated new drug application
submitted for review under this subsection that is for a drug—
‘‘(i) for which there are not more than 3 approved drug
products listed under paragraph (7) and for which there are
no blocking patents and exclusivities; or
‘‘(ii) that has been included on the list under section 506E.
‘‘(B) To qualify for priority review under this paragraph, not
later than 60 days prior to the submission of an application
described in subparagraph (A) or that the Secretary may prioritize
pursuant to subparagraph (D), the applicant shall provide complete,
accurate information regarding facilities involved in manufacturing
processes and testing of the drug that is the subject of the application, including facilities in corresponding Type II active pharmaceutical ingredients drug master files referenced in an application
and sites or organizations involved in bioequivalence and clinical
studies used to support the application, to enable the Secretary
to make a determination regarding whether an inspection of a
facility is necessary. Such information shall include the relevant
(as determined by the Secretary) sections of such application, which
shall be unchanged relative to the date of the submission of such
application, except to the extent that a change is made to such
information to exclude a facility that was not used to generate
data to meet any application requirements for such submission
and that is not the only facility intended to conduct one or more
unit operations in commercial production. Information provided by
an applicant under this subparagraph shall not be considered the
submission of an application under this subsection.
‘‘(C) The Secretary may expedite an inspection or reinspection
under section 704 of an establishment that proposes to manufacture
a drug described in subparagraph (A).
‘‘(D) Nothing in this paragraph shall prevent the Secretary
from prioritizing the review of other applications as the Secretary
determines appropriate.
‘‘(12) The Secretary shall publish on the internet website of
the Food and Drug Administration, and update at least once every
6 months, a list of all drugs approved under subsection (c) for
which all patents and periods of exclusivity under this Act have
expired and for which no application has been approved under
this subsection.’’.

Deadlines.

Determination.

Web posting.
Update.
Deadline.
Lists.

SEC. 802. ENHANCING REGULATORY TRANSPARENCY TO ENHANCE
GENERIC COMPETITION.

Section 505(j) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355), as amended by section 801, is further amended
by adding at the end the following:
‘‘(13) Upon the request of an applicant regarding one or more
specified pending applications under this subsection, the Secretary
shall, as appropriate, provide review status updates indicating the
categorical status of the applications by each relevant review discipline.’’.

Review.
Updates.

SEC. 803. COMPETITIVE GENERIC THERAPIES.

(a) IN GENERAL.—Chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after
section 506G the following:

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21 USC 356h.

Deadline.

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‘‘SEC. 506H. COMPETITIVE GENERIC THERAPIES.

‘‘(a) IN GENERAL.—The Secretary may, at the request of an
applicant of a drug that is designated as a competitive generic
therapy pursuant to subsection (b), expedite the development and
review of an abbreviated new drug application under section 505(j)
for such drug.
‘‘(b) DESIGNATION PROCESS.—
‘‘(1) REQUEST.—The applicant may request the Secretary
to designate the drug as a competitive generic therapy.
‘‘(2) TIMING.—A request under paragraph (1) may be made
concurrently with, or at any time prior to, the submission
of an abbreviated new drug application for the drug under
section 505(j).
‘‘(3) CRITERIA.—A drug is eligible for designation as a
competitive generic therapy under this section if the Secretary
determines that there is inadequate generic competition.
‘‘(4) DESIGNATION.—Not later than 60 calendar days after
the receipt of a request under paragraph (1), the Secretary
may—
‘‘(A) determine whether the drug that is the subject
of the request meets the criteria described in paragraph
(3); and
‘‘(B) if the Secretary finds that the drug meets such
criteria, designate the drug as a competitive generic
therapy.
‘‘(c) ACTIONS.—In expediting the development and review of
an application under subsection (a), the Secretary may, as requested
by the applicant, take actions including the following:
‘‘(1) Hold meetings with the applicant and the review team
throughout the development of the drug prior to submission
of the application for such drug under section 505(j).
‘‘(2) Provide timely advice to, and interactive communication with, the applicant regarding the development of the drug
to ensure that the development program to gather the data
necessary for approval is as efficient as practicable.
‘‘(3) Involve senior managers and experienced review staff,
as appropriate, in a collaborative, coordinated review of such
application, including with respect to drug-device combination
products and other complex products.
‘‘(4) Assign a cross-disciplinary project lead—
‘‘(A) to facilitate an efficient review of the development
program and application, including manufacturing inspections; and
‘‘(B) to serve as a scientific liaison between the review
team and the applicant.
‘‘(d) REPORTING REQUIREMENT.—Not later than one year after
the date of the approval of an application under section 505(j)
with respect to a drug for which the development and review
is expedited under this section, the sponsor of such drug shall
report to the Secretary on whether the drug has been marketed
in interstate commerce since the date of such approval.
‘‘(e) DEFINITIONS.—In this section:
‘‘(1) The term ‘generic drug’ means a drug that is approved
pursuant to section 505(j).
‘‘(2) The term ‘inadequate generic competition’ means, with
respect to a drug, there is not more than one approved drugs
on the list of drugs described in section 505(j)(7)(A) (not

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131 STAT. 1071

including drugs on the discontinued section of such list) that
is—
‘‘(A) the reference listed drug; or
‘‘(B) a generic drug with the same reference listed
drug as the drug for which designation as a competitive
generic therapy is sought.
‘‘(3) The term ‘reference listed drug’ means the listed drug
(as such term is used in section 505(j)) for the drug involved.’’.
(b) GUIDANCE; AMENDED REGULATIONS.—
(1) IN GENERAL.—
(A) ISSUANCE.—The Secretary of Health and Human
Services shall—
(i) not later than 18 months after the date of
enactment of this Act, issue draft guidance on section
506H of the Federal Food, Drug, and Cosmetic Act,
as added by subsection (a); and
(ii) not later than 1 year after the close of the
comment period for the draft guidance, issue final guidance on such section 506H.
(B) CONTENTS.—The guidance issued under this paragraph shall—
(i) specify the process and criteria by which the
Secretary makes a designation under section 506H of
the Federal Food, Drug, and Cosmetic Act, as added
by subsection (a);
(ii) specify the actions the Secretary may take
to expedite the development and review of a competitive generic therapy pursuant to such a designation;
and
(iii) include good review management practices for
competitive generic therapies.
(2) AMENDED REGULATIONS.—The Secretary of Health and
Human Services shall issue or revise any regulations as may
be necessary to carry out this section not later than 2 years
after the date of enactment of this Act.

Deadlines.
21 USC 356h
note.

SEC. 804. ACCURATE INFORMATION ABOUT DRUGS WITH LIMITED
COMPETITION.

Chapter V of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351 et seq.) is amended by inserting after section 506H,
as added by section 803, the following:
‘‘SEC. 506I. PROMPT REPORTS OF MARKETING STATUS.

21 USC 356i.

‘‘(a) NOTIFICATION OF WITHDRAWAL.—The holder of an application approved under subsection (c) or (j) of section 505 shall notify
the Secretary in writing 180 days prior to withdrawing the approved
drug from sale, or if 180 days is not practicable as soon as practicable but not later than the date of withdrawal. The holder shall
include with such notice the—
‘‘(1) National Drug Code;
‘‘(2) identity of the drug by established name and by proprietary name, if any;
‘‘(3) new drug application number or abbreviated application number;
‘‘(4) strength of the drug;
‘‘(5) date on which the drug is expected to no longer be
available for sale; and
‘‘(6) reason for withdrawal of the drug.

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Review.
Notification.

Lists.

Lists.
Deadline.

PUBLIC LAW 115–52—AUG. 18, 2017

‘‘(b) NOTIFICATION OF DRUG NOT AVAILABLE FOR SALE.—The
holder of an application approved under subsection (c) or (j) shall
notify the Secretary in writing within 180 calendar days of the
date of approval of the drug if the drug will not be available
for sale within 180 calendar days of such date of approval. The
holder shall include with such notice the—
‘‘(1) identity of the drug by established name and by proprietary name, if any;
‘‘(2) new drug application number or abbreviated application number;
‘‘(3) strength of the drug;
‘‘(4) date on which the drug will be available for sale,
if known; and
‘‘(5) reason for not marketing the drug after approval.
‘‘(c) ADDITIONAL ONE-TIME REPORT.—Within 180 days of the
date of enactment of this section, all holders of applications
approved under subsection (c) or (j) of section 505 shall review
the information in the list published under subsection 505(j)(7)(A)
and shall notify the Secretary in writing that—
‘‘(1) all of the application holder’s drugs in the active section
of the list published under subsection 505(j)(7)(A) are available
for sale; or
‘‘(2) one or more of the application holder’s drugs in the
active section of the list published under subsection 505(j)(7)(A)
have been withdrawn from sale or have never been available
for sale, and include with such notice the information required
pursuant to subsection (a) or (b), as applicable.
‘‘(d) FAILURE TO MEET REQUIREMENTS.—If a holder of an
approved application fails to submit the information required under
subsection (a), (b), or (c), the Secretary may move the application
holder’s drugs from the active section of the list published under
subsection 505(j)(7)(A) to the discontinued section of the list, except
that the Secretary shall remove from the list in accordance with
subsection 505(j)(7)(C) drugs the Secretary determines have been
withdrawn from sale for reasons of safety of effectiveness.
‘‘(e) UPDATES.—The Secretary shall update the list published
under subsection 505(j)(7)(A) based on the information provided
under subsections (a), (b), and (c) by moving drugs that are not
available for sale from the active section to the discontinued section
of the list, except that drugs the Secretary determines have been
withdrawn from sale for reasons of safety or effectiveness shall
be removed from the list in accordance with subsection 505(j)(7)(C).
The Secretary shall make monthly updates to the list based on
the information provided pursuant to subsections (a) and (b), and
shall update the list based on the information provided under
subsection (c) as soon as practicable.
‘‘(f) LIMITATION ON USE OF NOTICES.—Any notice submitted
under this section shall not be made public by the Secretary and
shall be used solely for the purpose of the updates described in
subsection (e).’’.
SEC. 805. SUITABILITY PETITIONS.

Deadline.

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(a) IN GENERAL.—It is the sense of Congress that the Food
and Drug Administration shall meet the requirement under section
505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

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355(j)(2)(C)) and section 314.93(e) of title 21, Code of Federal Regulations, of responding to suitability petitions within 90 days of
submission.
(b) REPORT.—The Secretary of Health and Human Services
shall include in the annual reports under section 807—
(1) the number of pending petitions under section
505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(2)(C)); and
(2) the number of such petitions pending a substantive
response for more than 180 days from the date of receipt.
SEC. 806. INSPECTIONS.

Within 6 months of the date of enactment of this Act, the
Secretary of Health and Human Services shall develop and implement a protocol for expediting review of timely responses to reports
of observations from an inspection under section 704 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 374). Such protocol shall—
(1) apply to responses to such reports pertaining to applications submitted under section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355)—
(A) for which the approval is dependent upon remediation of conditions identified in the report;
(B) for which concerns related to observations from
an inspection under such section 704 are the only barrier
to approval; and
(C) where the drug that is the subject of the application
is a drug—
(i) for which there are not more than 3 other
approved applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))
that reference the same listed drug and for which
there are less than 6 abbreviated new drug applications
tentatively approved; or
(ii) that is included on the list under section 506E
of such Act (21 U.S.C. 356e);
(2) address expedited re-inspection of facilities, as appropriate; and
(3) establish a 6-month timeline for completion of review
of such responses to such reports.

Deadline.
Protocols.
Review.
21 USC 374 note.

Applicability.

Time period.

SEC. 807. REPORTING ON PENDING GENERIC DRUG APPLICATIONS
AND PRIORITY REVIEW APPLICATIONS.

Not later than 180 calendar days after the date of enactment
of this Act, and quarterly thereafter until October 1, 2022, the
Secretary of Health and Human Services shall post on the internet
website of the Food and Drug Administration a report that provides,
with respect to the months covered by the report—
(1) with respect to applications filed under section 505(j)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))
that, during the most recent calendar year, were subject to
priority review under paragraph (11) of such section 505(j)
(as added by section 801) or expedited development and review
under section 506H of the Federal Food, Drug, and Cosmetic
Act (as added by section 803), the numbers of such applications
(with denotation of such applications that were filed prior to
October 1, 2014) that are—
(A) awaiting action by the applicant;
(B) awaiting action by the Secretary; and

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PUBLIC LAW 115–52—AUG. 18, 2017
(C) approved by the Secretary;
(2) the number of applications filed under section 505(j)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))
and prior approval supplements withdrawn in each month;
(3) the mean and median approval and tentative approval
times and the number of review cycles for such applications;
(4) the number and type of meetings requested and held
under such section 506H (as added by section 803); and
(5) the number of such applications on which the Secretary
has taken action pursuant to subsection (c) of such section
506H (as added by section 803) and any effect such section
506H may have on the length of time for approval of applications under such section 505(j) and the number of review cycles
for such approvals.

SEC. 808. INCENTIVIZING COMPETITIVE GENERIC DRUG DEVELOPMENT.

Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)(5)) is amended—
(1) in subparagraph (B), by adding at the end the following:
‘‘(v) 180-DAY EXCLUSIVITY PERIOD FOR COMPETITIVE GENERIC
THERAPIES.—
‘‘(I) EFFECTIVENESS OF APPLICATION.—Subject to
subparagraph (D)(iv), if the application is for a drug that
is the same as a competitive generic therapy for which
any first approved applicant has commenced commercial
marketing, the application shall be made effective on the
date that is 180 days after the date of the first commercial
marketing of the competitive generic therapy (including
the commercial marketing of the listed drug) by any first
approved applicant.
‘‘(II) LIMITATION.—The exclusivity period under subclause (I) shall not apply with respect to a competitive
generic therapy that has previously received an exclusivity
period under subclause (I).
‘‘(III) DEFINITIONS.—In this clause and subparagraph
(D)(iv):
‘‘(aa) The term ‘competitive generic therapy’ means
a drug—
‘‘(AA) that is designated as a competitive
generic therapy under section 506H; and
‘‘(BB) for which there are no unexpired patents
or exclusivities on the list of products described
in section 505(j)(7)(A) at the time of submission.
‘‘(bb) The term ‘first approved applicant’ means
any applicant that has submitted an application that—
‘‘(AA) is for a competitive generic therapy that
is approved on the first day on which any application for such competitive generic therapy is
approved;
‘‘(BB) is not eligible for a 180-day exclusivity
period under clause (iv) for the drug that is the
subject of the application for the competitive
generic therapy; and
‘‘(CC) is not for a drug for which all drug
versions have forfeited eligibility for a 180-day

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exclusivity period under clause (iv) pursuant to
subparagraph (D).’’; and
(2) in subparagraph (D), by adding at the end the following:
‘‘(iv) SPECIAL FORFEITURE RULE FOR COMPETITIVE
GENERIC THERAPY.—The 180-day exclusivity period
described in subparagraph (B)(v) shall be forfeited by
a first approved applicant if the applicant fails to
market the competitive generic therapy within 75 days
after the date on which the approval of the first
approved applicant’s application for the competitive
generic therapy is made effective.’’.

Deadline.

SEC. 809. GAO STUDY OF ISSUES REGARDING FIRST CYCLE APPROVALS
OF GENERIC MEDICINES.

(a) STUDY BY GAO.—The Comptroller General of the United
States shall conduct a study to determine the following:
(1) The rate of first cycle approvals and tentative approvals
for applications submitted under section 505(j) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) during the
period beginning on October 1, 2012, and ending on September
30, 2017. The rate of first cycle approvals and tentative
approvals shall be determined and reported per each GDUFA
cohort year during this period.
(2) If the rate determined pursuant to paragraph (1) for
any GDUFA cohort year is lower than 20 percent, the reasons
contributing to the relatively low rate of first cycle approvals
and tentative approvals for generic drug applications shall be
itemized, assessed, and reported. In making the assessment
required by this paragraph, the Comptroller General shall consider, among other things, the role played by—
(A) the Food and Drug Administration’s implementation of approval standards for generic drug applications;
(B) the extent to which those approval standards are
communicated clearly to industry and applied consistently
during the review process;
(C) the procedures for reviewing generic drug applications, including timelines for review activities by the Food
and Drug Administration;
(D) the extent to which those procedures are followed
consistently (and those timelines are met) by the Food
and Drug Administration;
(E) the processes and practices for communication
between the Food and Drug Administration and sponsors
of generic drug applications; and
(F) the completeness and quality of original generic
drug applications submitted to the Food and Drug Administration.
(3) Taking into account the determinations made pursuant
to paragraphs (1) and (2) and any review process improvements
implemented pursuant to this Act, whether there are ways
the review process for generic drugs could be improved to
increase the rate of first cycle approvals and tentative approvals
for generic drug applications. In making this determination,
the Comptroller General shall consider, among other things,
options for increasing review efficiency and communication
effectiveness.

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Determination.
Time period.

Assessment.

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(b) COMPLETION DATE.—Not later than the expiration of the
2-year period beginning on the date of enactment of this Act,
the Comptroller General shall complete the study under subsection
(a) and submit a report describing the findings and conclusions
of the study to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on
Health, Education, Labor, and Pensions of the Senate.
(c) DEFINITIONS.—For purposes of this section:
(1) The term ‘‘GDUFA cohort year’’ means a fiscal year.
(2) The term ‘‘generic drug’’ means a drug that is approved
or is seeking approval under section 505(j) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(j)).
(3) The term ‘‘generic drug application’’ means an abbreviated new drug application for the approval of a generic drug
under section 505(j) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)).
(4) The term ‘‘Secretary’’ means the Secretary of Health
and Human Services.
(5)(A) The term ‘‘first cycle approvals and tentative
approvals’’ means the approval or tentative approval of a
generic drug application after the Food and Drug Administration’s complete review of the application and without issuance
of one or more complete response letters.
(B) For purposes of this paragraph, the term ‘‘complete
response letter’’ means a written communication to the sponsor
of a generic drug application or holder of a drug master file
from the Food and Drug Administration describing all of the
deficiencies that the Administration has identified in the
generic drug application (including pending amendments) or
drug master file that must be satisfactorily addressed before
the generic drug application can be approved.

Time period.
Reports.

TITLE IX—ADDITIONAL PROVISIONS
SEC. 901. TECHNICAL CORRECTIONS.
21 USC 355.

Effective date.
21 USC 360e–3
and note.

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(a) Section 3075(a) of the 21st Century Cures Act (Public Law
114–255) is amended—
(1) in the matter preceding paragraph (1), by striking ‘‘as
amended by section 2074’’ and inserting ‘‘as amended by section
3102’’; and
(2) in paragraph (2), by striking ‘‘section 2074(1)(C)’’ and
inserting ‘‘section 3102(1)(C)’’.
(b) Section 506G(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356g(b)(1)(A)) is amended by striking ‘‘identity’’
and inserting ‘‘identify’’.
(c) Section 505F(b) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355g(b)) is amended by striking ‘‘randomized’’ and
inserting ‘‘traditional’’.
(d) Section 505F(d) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355g(d)) is amended by striking ‘‘2’’ and inserting
‘‘3’’.
(e) Section 510(h)(6) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(h)(6)) is amended by striking ‘‘February 1’’
and replacing with ‘‘May 1’’.
(f) Effective as of the enactment of the 21st Century Cures
Act (Public Law 114–255)—

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(1) section 3051(a) of such Act is amended by striking
‘‘by inserting after section 515B’’ and inserting ‘‘by inserting
after section 515A’’; and
(2) section 515C of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e–3), as inserted by such section 3051(a),
is redesignated as section 515B.
(g) Section 515B(f)(2) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e–3(f)(2)), as redesignated by subsection (e)(2)
of this section, is amended by striking ‘‘a proposed guidance’’ and
inserting ‘‘a draft version of that guidance’’.
(h) Section 513(b)(5)(D) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360c(b)(5)(D)) is amended by striking ‘‘medical device
submissions’’ and inserting ‘‘medical devices that may be specifically
the subject of a review by a classification panel’’.

21 USC 360e–3.

SEC. 902. ANNUAL REPORT ON INSPECTIONS.

Web posting.
21 USC 355 note.

Not later than March 1 of each year, the Secretary of Health
and Human Services shall post on the internet website of the
Food and Drug Administration information related to inspections
of facilities necessary for approval of a drug under section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355),
approval of a device under section 515 of such Act (21 U.S.C.
360e), or clearance of a device under section 510(k) of such Act
(21 U.S.C. 360(k)) that were conducted during the previous calendar
year. Such information shall include the following:
(1) The median time following a request from staff of the
Food and Drug Administration reviewing an application or
report to the beginning of the inspection, and the median time
from the beginning of an inspection to the issuance of a report
pursuant to section 704(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374(b)).
(2) The median time from the issuance of a report pursuant
to such section 704(b) to the sending of a warning letter,
issuance of an import alert, or holding of a regulatory meeting
for inspections for which the Secretary concluded that regulatory or enforcement action was indicated.
(3) The median time from the sending of a warning letter,
issuance of an import alert, or holding of a regulatory meeting
to resolution of the regulatory or enforcement action indicated
for inspections for which the Secretary concluded that such
action was indicated.
(4) The number of times that a facility was issued a report
pursuant to such section 704(b) and approval of an application
was delayed due to the issuance of a withhold recommendation.
SEC. 903. STREAMLINING AND IMPROVING CONSISTENCY IN PERFORMANCE REPORTING.

Web postings.
Time periods.

(a) PDUFA.—Section 736B(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h–2(a)), as amended by section 103,
is further amended by inserting after paragraph (2) the following:
‘‘(3) REAL TIME REPORTING.—
‘‘(A) IN GENERAL.—Not later than 30 calendar days
after the end of the second quarter of fiscal year 2018,
and not later than 30 calendar days after the end of each
quarter of each fiscal year thereafter, the Secretary shall
post the data described in subparagraph (B) on the internet
website of the Food and Drug Administration for such
quarter and on a cumulative basis for such fiscal year,

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Effective date.
Analysis.

Effective date.

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and may remove duplicative data from the annual performance report under this subsection.
‘‘(B) DATA.—The Secretary shall post the following data
in accordance with subparagraph (A):
‘‘(i) The number and titles of draft and final guidance on topics related to the process for the review
of human drug applications, and whether such guidances were issued as required by statute or pursuant
to a commitment under the letters described in section
101(b) of the Prescription Drug User Fee Amendments
of 2017.
‘‘(ii) The number and titles of public meetings held
on topics related to the process for the review of human
drug applications, and whether such meetings were
required by statute or pursuant to a commitment under
the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.
‘‘(iii) The number of new drug applications and
biological licensing applications approved.
‘‘(iv) The number of new drug applications and
biological licensing applications filed.
‘‘(4) RATIONALE FOR PDUFA PROGRAM CHANGES.—Beginning
with fiscal year 2020, the Secretary shall include in the annual
report under paragraph (1)—
‘‘(A) data, analysis, and discussion of the changes in
the number of full-time equivalents hired as agreed upon
in the letters described in section 101(b) of the Prescription
Drug User Fee Amendments of 2017 and the number of
full time equivalents funded by budget authority at the
Food and Drug Administration by each division within
the Center for Drug Evaluation and Research, the Center
for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;
‘‘(B) data, analysis, and discussion of the changes in
the fee revenue amounts and costs for the process for
the review of human drugs, including identifying drivers
of such changes; and
‘‘(C) for each of the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and
Research, the Office of Regulatory Affairs, and the Office
of the Commissioner, the number of employees for whom
time reporting is required and the number of employees
for whom time reporting is not required.’’.
(b) MDUFA.—Section 738A(a)(1)(A) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j–1(a)(1)(A)), as amended by section
204, is further amended—
(1) by striking ‘‘Beginning with’’ and inserting the following:
‘‘(i) GENERAL REQUIREMENTS.—Beginning with’’;
and
(2) by adding at the end the following:
‘‘(ii) ADDITIONAL INFORMATION.—Beginning with
fiscal year 2018, the annual report under this subparagraph shall include the progress of the Center for
Devices and Radiological Health in achieving the goals,
and future plans for meeting the goals, including—

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‘‘(I) the number of premarket applications filed
under section 515 per fiscal year for each review
division;
‘‘(II) the number of reports submitted under
section 510(k) per fiscal year for each review division; and
‘‘(III) the number of expedited development
and priority review designations under section
515C per fiscal year.
‘‘(iii) REAL TIME REPORTING.—
‘‘(I) IN GENERAL.—Not later than 30 calendar
days after the end of the second quarter of fiscal
year 2018, and not later than 30 calendar days
after the end of each quarter of each fiscal year
thereafter, the Secretary shall post the data
described in subclause (II) on the internet website
of the Food and Drug Administration for such
quarter and on a cumulative basis for such fiscal
year, and may remove duplicative data from the
annual report under this subparagraph.
‘‘(II) DATA.—The Secretary shall post the following data in accordance with subclause (I):
‘‘(aa) The number and titles of draft and
final guidance on topics related to the process
for the review of devices, and whether such
guidances were issued as required by statute
or pursuant to the letters described in section
201(b) of the Medical Device User Fee Amendments of 2017; and
‘‘(bb) The number and titles of public
meetings held on topics related to the process
for the review of devices, and if such meetings
were required by statute or pursuant to a
commitment under the letters described in section 201(b) of the Medical Device User Fee
Amendments of 2017.
‘‘(iv) RATIONALE FOR MDUFA PROGRAM CHANGES.—
Beginning with fiscal year 2020, the Secretary shall
include in the annual report under paragraph (1)—
‘‘(I) data, analysis, and discussion of the
changes in the number of full-time equivalents
hired as agreed upon in the letters described in
section 201(b) of the Medical Device User Fee
Amendments of 2017 and the number of full time
equivalents funded by budget authority at the Food
and Drug Administration by each division within
the Center for Devices and Radiological Health,
the Center for Biologics Evaluation and Research,
the Office of Regulatory Affairs, and the Office
of the Commissioner;
‘‘(II) data, analysis, and discussion of the
changes in the fee revenue amounts and costs
for the process for the review of devices, including
identifying drivers of such changes; and
‘‘(III) for each of the Center for Devices and
Radiological Health, the Center for Biologics
Evaluation and Research, the Office of Regulatory

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Affairs, and the Office of the Commissioner, the
number of employees for whom time reporting is
required and the number of employees for whom
time reporting is not required.’’.
(c) GDUFA.—Section 744C(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j–43(a)), as amended by section 304,
is further amended—
(1) by striking ‘‘Beginning with’’ and inserting the following:
‘‘(1) GENERAL REQUIREMENTS.—Beginning with’’; and
(2) by adding at the end the following:
‘‘(2) REAL TIME REPORTING.—
‘‘(A) IN GENERAL.—Not later than 30 calendar days
after the end of the second quarter of fiscal year 2018,
and not later than 30 calendar days after the end of each
quarter of each fiscal year thereafter, the Secretary shall
post the data described in subparagraph (B) on the internet
website of the Food and Drug Administration, and may
remove duplicative data from the annual report under this
subsection.
‘‘(B) DATA.—The Secretary shall post the following data
in accordance with subparagraph (A):
‘‘(i) The number and titles of draft and final guidance on topics related to human generic drug activities
and whether such guidances were issued as required
by statute or pursuant to a commitment under the
letters described in section 301(b) of the Generic Drug
User Fee Amendments of 2017.
‘‘(ii) The number and titles of public meetings held
on topics related to human generic drug activities and
whether such meetings were required by statute or
pursuant to a commitment under the letters described
in section 301(b) of the Generic Drug User Fee Amendments of 2017.
‘‘(3) RATIONALE FOR GDUFA PROGRAM CHANGES.—Beginning
with fiscal year 2020, the Secretary shall include in the annual
report under paragraph (1)—
‘‘(A) data, analysis, and discussion of the changes in
the number of full-time equivalents hired as agreed upon
in the letters described in section 301(b) of the Generic
Drug User Fee Amendments of 2017 and the number of
full time equivalents funded by budget authority at the
Food and Drug Administration by each division within
the Center for Drug Evaluation and Research, the Center
for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;
‘‘(B) data, analysis, and discussion of the changes in
the fee revenue amounts and costs for human generic drug
activities, including identifying drivers of such changes;
and
‘‘(C) for each of the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and
Research, the Office of Regulatory Affairs, and the Office
of the Commissioner, the number of employees for whom
time reporting is required and the number of employees
for whom time reporting is not required.’’.

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(d) BSUFA.—Section 744I(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j–53(a)), as amended by section 404,
is further amended—
(1) by striking ‘‘Beginning with’’ and inserting the following:
‘‘(1) GENERAL REQUIREMENTS.—Beginning with’’; and
(2) by adding at the end the following:
‘‘(2) ADDITIONAL INFORMATION.—Beginning with fiscal year
2018, the report under this subsection shall include the progress
of the Food and Drug Administration in achieving the goals,
and future plans for meeting the goals, including—
‘‘(A) information on all previous cohorts for which the
Secretary has not given a complete response on all biosimilar biological product applications and supplements in
the cohort;
‘‘(B) the number of original biosimilar biological
product applications filed per fiscal year, and the number
of approvals issued by the agency for such applications;
and
‘‘(C) the number of resubmitted original biosimilar
biological product applications filed per fiscal year and
the number of approvals letters issued by the agency for
such applications.
‘‘(3) REAL TIME REPORTING.—
‘‘(A) IN GENERAL.—Not later than 30 calendar days
after the end of the second quarter of fiscal year 2018,
and not later than 30 calendar days after the end of each
quarter of each fiscal year thereafter, the Secretary shall
post the data described in subparagraph (B) for such
quarter and on a cumulative basis for the fiscal year on
the internet website of the Food and Drug Administration,
and may remove duplicative data from the annual report
under this subsection.
‘‘(B) DATA.—The Secretary shall post the following data
in accordance with subparagraph (A):
‘‘(i) The number and titles of draft and final guidance on topics related to the process for the review
of biosimilars, and whether such guidances were
required by statute or pursuant to a commitment under
the letters described in section 401(b) of the Biosimilar
User Fee Amendments of 2017.
‘‘(ii) The number and titles of public meetings held
on topics related to the process for the review of
biosimilars, and whether such meetings were required
by statute or pursuant to a commitment under the
letters described in section 401(b) of the Biosimilar
User Fee Amendments of 2017.
‘‘(4) RATIONALE FOR BSUFA PROGRAM CHANGES.—Beginning
with fiscal year 2020, the Secretary shall include in the annual
report under paragraph (1)—
‘‘(A) data, analysis, and discussion of the changes in
the number of full-time equivalents hired as agreed upon
in the letters described in section 401(b) of the Biosimilar
User Fee Amendments of 2017 and the number of full
time equivalents funded by budget authority at the Food
and Drug Administration by each division within the
Center for Drug Evaluation and Research, the Center for

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Biologics Evaluation and Research, the Office of Regulatory
Affairs, and the Office of the Commissioner;
‘‘(B) data, analysis, and discussion of the changes in
the fee revenue amounts and costs for the process for
the review of biosimilar biological product applications,
including identifying drivers of such changes; and
‘‘(C) for each of the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and
Research, the Office of Regulatory Affairs, and the Office
of the Commissioner, the number of employees for whom
time reporting is required and the number of employees
for whom time reporting is not required.’’.

SEC. 904. ANALYSIS OF USE OF FUNDS.

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(a) PDUFA REPORTS.—
(1) ANALYSIS IN PDUFA PERFORMANCE REPORTS.—Section
736B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h–2(a)), as amended by section 903(a), is further amended
by adding at the end the following:
‘‘(5) ANALYSIS.—For each fiscal year, the Secretary shall
include in the report under paragraph (1) an analysis of the
following:
‘‘(A) The difference between the aggregate number of
human drug applications filed and the aggregate number
of approvals, accounting for—
‘‘(i) such applications filed during one fiscal year
for which a decision is not scheduled to be made until
the following fiscal year;
‘‘(ii) the aggregate number of applications for each
fiscal year that did not meet the goals identified in
the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the
applicable fiscal year.
‘‘(B) Relevant data to determine whether the Center
for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met performance
enhancement goals identified in the letters described in
section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year.
‘‘(C) The most common causes and trends of external
or other circumstances affecting the ability of the Center
for Drug Evaluation and Research, the Center for Biologics
Evaluation and Research, Office of Regulatory Affairs, and
the Food and Drug Administration to meet the review
time and performance enhancement goals identified in the
letters described in section 101(b) of the Prescription Drug
User Fee Amendments of 2017.’’.
(2) ISSUANCE OF CORRECTIVE ACTION REPORTS.—Section
736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h–2) is amended—
(A) by redesignating subsections (c) and (d) as subsections (e) and (f), respectively; and
(B) by inserting after subsection (b) the following:
‘‘(c) CORRECTIVE ACTION REPORT.—Beginning with fiscal year
2018, for each fiscal year for which fees are collected under this
part, the Secretary shall prepare and submit a corrective action

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report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate. The report shall include
the following information, as applicable:
‘‘(1) GOALS MET.—For each fiscal year, if the Secretary
determines, based on the analysis under subsection (a)(5), that
each of the goals identified in the letters described in section
101(b) of the Prescription Drug User Fee Amendments of 2017
for the applicable fiscal year have been met, the corrective
action report shall include recommendations on ways in which
the Secretary can improve and streamline the human drug
application review process.
‘‘(2) GOALS MISSED.—For any of the goals identified in
the letters described in section 101(b) of the Prescription Drug
User Fee Amendments of 2017 for the applicable fiscal year
that the Secretary determines to not have been met, the corrective action report shall include—
‘‘(A) a detailed justification for such determination and
a description, as applicable, of the types of circumstances
and trends under which human drug applications that
missed the review goal time were approved during the
first cycle review, or application review goals were missed;
and
‘‘(B) with respect to performance enhancement goals
that were not achieved, a description of efforts the Food
and Drug Administration has put in place for the fiscal
year in which the report is submitted to improve the ability
of such agency to meet each such goal for the such fiscal
year.
‘‘(d) ENHANCED COMMUNICATION.—
‘‘(1) COMMUNICATIONS WITH CONGRESS.—Each fiscal year,
as applicable and requested, representatives from the Centers
with expertise in the review of human drugs shall meet with
representatives from the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives to report
on the contents described in the reports under this section.
‘‘(2) PARTICIPATION IN CONGRESSIONAL HEARING.—Each
fiscal year, as applicable and requested, representatives from
the Food and Drug Administration shall participate in a public
hearing before the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, to report on
the contents described in the reports under this section. Such
hearing shall occur not later than 120 days after the end
of each fiscal year for which fees are collected under this
part.’’.
(b) MDUFA REPORTS.—
(1) ANALYSIS IN MDUFA PERFORMANCE REPORTS.—Section
738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j–1(a)(1)(A)), as amended by section 903(b), is
further amended by adding at the end the following:
‘‘(iv) ANALYSIS.—For each fiscal year, the Secretary
shall include in the report under clause (i) an analysis
of the following:

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‘‘(I) The difference between the aggregate
number of premarket applications filed under section 515 and aggregate reports submitted under
section 510(k) and the aggregate number of major
deficiency letters, not approvable letters, and
denials for such applications issued by the agency,
accounting for—
‘‘(aa) the number of applications filed and
reports submitted during one fiscal year for
which a decision is not scheduled to be made
until the following fiscal year; and
‘‘(bb) the aggregate number of applications
for each fiscal year that did not meet the
goals as identified by the letters described in
section 201(b) of the Medical Device User Fee
Amendments of 2017 for the applicable fiscal
year.
‘‘(II) Relevant data to determine whether the
Center for Devices and Radiological Health has
met performance enhancement goals identified by
the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the
applicable fiscal year.
‘‘(III) The most common causes and trends
for external or other circumstances affecting the
ability of the Center for Devices and Radiological
Health, the Office of Regulatory Affairs, or the
Food and Drug Administration to meet review time
and performance enhancement goals identified by
the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017.’’.
(2) ISSUANCE OF CORRECTIVE ACTION REPORTS.—Section
738A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j–1(a)) is amended—
(A) by redesignating paragraphs (2) and (3) as paragraphs (4) and (5), respectively; and
(B) by inserting after paragraph (1) the following:
‘‘(2) CORRECTIVE ACTION REPORT.—Beginning with fiscal
year 2018, for each fiscal year for which fees are collected
under this part, the Secretary shall prepare and submit a
corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions and the Committee on Appropriations
of the Senate. The report shall include the following information, as applicable:
‘‘(A) GOALS MET.—For each fiscal year, if the Secretary
determines, based on the analysis under paragraph
(1)(A)(iv), that each of the goals identified by the letters
described in section 201(b) of the Medical Device User
Fee Amendments of 2017 for the applicable fiscal year
have been met, the corrective action report shall include
recommendations on ways in which the Secretary can
improve and streamline the medical device application
review process.
‘‘(B) GOALS MISSED.—For each of the goals identified
by the letters described in section 201(b) of the Medical

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131 STAT. 1085

Device User Fee Amendments of 2017 for the applicable
fiscal year that the Secretary determines to not have been
met, the corrective action report shall include—
‘‘(i) a justification for such determination;
‘‘(ii) a description of the types of circumstances,
in the aggregate, under which applications or reports
submitted under section 515 or notifications submitted
under section 510(k) missed the review goal times but
were approved during the first cycle review, as
applicable;
‘‘(iii) a summary and any trends with regard to
the circumstances for which a review goal was missed;
and
‘‘(iv) the performance enhancement goals that were
not achieved during the previous fiscal year and a
description of efforts the Food and Drug Administration
has put in place for the fiscal year in which the report
is submitted to improve the ability of such agency
to meet each such goal for the such fiscal year.
‘‘(3) ENHANCED COMMUNICATION.—
‘‘(A) COMMUNICATIONS WITH CONGRESS.—Each fiscal
year, as applicable and requested, representatives from
the Centers with expertise in the review of devices shall
meet with representatives from the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives to report on the contents described in the
reports under this section.
‘‘(B) PARTICIPATION IN CONGRESSIONAL HEARING.—Each
fiscal year, as applicable and requested, representatives
from the Food and Drug Administration shall participate
in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports
under this section. Such hearing shall occur not later than
120 days after the end of each fiscal year for which fees
are collected under this part.’’.
(c) GDUFA REPORTS.—
(1) ANALYSIS IN GDUFA PERFORMANCE REPORTS.—Section
744C(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j–43(a)), as amended by section 903(c) is further amended
by adding at the end the following:
‘‘(4) ANALYSIS.—For each fiscal year, the Secretary shall
include in the report an analysis of the following:
‘‘(A) The difference between the aggregate number of
abbreviated new drug applications filed and the aggregate
number of approvals or aggregate number of complete
response letters issued by the agency, accounting for—
‘‘(i) such applications filed during one fiscal year
for which a decision is not scheduled to be made until
the following fiscal year; and
‘‘(ii) the aggregate number of applications for each
fiscal year that did not meet the goals identified by
the letters described in section 301(b) of the Generic
Drug User Fee Amendments of 2017 for the applicable
fiscal year.

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‘‘(B) Relevant data to determine whether the Food
and Drug Administration has met the performance
enhancement goals identified by the letters described in
section 301(b) of the Generic Drug User Fee Amendments
of 2017 for the applicable fiscal year.
‘‘(C) The most common causes and trends for external
or other circumstances that affected the ability of the Secretary to meet review time and performance enhancement
goals identified by the letters described in section 301(b)
of the Generic Drug User Fee Amendments of 2017.’’.
(2) ISSUANCE OF CORRECTIVE ACTION REPORTS.—Section
744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j–43) is amended—
(A) by redesignating subsections (c) and (d) as subsections (e) and (f), respectively; and
(B) by inserting after subsection (b) the following:
‘‘(c) CORRECTIVE ACTION REPORT.—Beginning with fiscal year
2018, for each fiscal year for which fees are collected under this
part, the Secretary shall prepare and submit a corrective action
report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate. The report shall include
the following information, as applicable:
‘‘(1) GOALS MET.—For each fiscal year, if the Secretary
determines, based on the analysis under subsection (a)(4), that
each of the goals identified by the letters described in section
301(b) of the Generic Drug User Fee Amendments of 2017
for the applicable fiscal year have been met, the corrective
action report shall include recommendations on ways in which
the Secretary can improve and streamline the abbreviated new
drug application review process.
‘‘(2) GOALS MISSED.—For each of the goals identified by
the letters described in section 301(b) of the Generic Drug
User Fee Amendments of 2017 for the applicable fiscal year
that the Secretary determines to not have been met, the corrective action report shall include—
‘‘(A) a detailed justification for such determination and
a description, as applicable, of the types of circumstances
and trends under which abbreviated new drug applications
missed the review goal times but were approved during
the first cycle review, or review goals were missed; and
‘‘(B) with respect to performance enhancement goals
that were not achieved, a detailed description of efforts
the Food and Drug Administration has put in place for
the fiscal year in which the report is submitted to improve
the ability of such agency to meet each such goal for
the such fiscal year.
‘‘(d) ENHANCED COMMUNICATION.—
‘‘(1) COMMUNICATIONS WITH CONGRESS.—Each fiscal year,
as applicable and requested, representatives from the Centers
with expertise in the review of human drugs shall meet with
representatives from the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives to report
on the contents described in the reports under this section.

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‘‘(2) PARTICIPATION IN CONGRESSIONAL HEARING.—Each
fiscal year, as applicable and requested, representatives from
the Food and Drug Administration shall participate in a public
hearing before the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, to report on
the contents described in the reports under this section. Such
hearing shall occur not later than 120 days after the end
of each fiscal year for which fees are collected under this
part.’’.
(d) BSUFA REPORTS.—
(1) ANALYSIS IN BSUFA PERFORMANCE REPORTS.—Section
744I(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j–53(a)) as amended by section 903(d) is further amended
by adding at the end the following:
‘‘(5) ANALYSIS.—For each fiscal year, the Secretary shall
include in the report an analysis of the following:
‘‘(A) The difference between the aggregate number of
biosimilar biological product applications and supplements
filed and the aggregate number of approvals issued by
the agency, accounting for—
‘‘(i) such applications filed during one fiscal year
for which a decision is not scheduled to be made until
the following fiscal year; and
‘‘(ii) the aggregate number of applications for each
fiscal year that did not meet the goals identified by
the letters described in section 401(b) of the Biosimilar
User Fee Amendments of 2017 for the applicable fiscal
year.
‘‘(B) Relevant data to determine whether the Center
for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met the performance
enhancement goals identified by the letters described in
section 401(b) of the Biosimilar User Fee Amendments
of 2017 for the applicable fiscal year.
‘‘(C) The most common causes and trends for external
or other circumstances affecting the ability of the Secretary
to meet review time and performance enhancement goals
identified by the letters described in section 401(b) of the
Biosimilar User Fee Amendments of 2017.’’.
(2) ISSUANCE OF CORRECTIVE ACTION REPORTS.—Section
744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j–53), as amended by section 404, is further amended—
(A) by redesignating subsections (c) and (d) as subsections (e) and (f), respectively; and
(B) by inserting after subsection (b) the following:
‘‘(c) CORRECTIVE ACTION REPORT.—Beginning with fiscal year
2018, and for each fiscal year for which fees are collected under
this part, the Secretary shall prepare and submit a corrective action
report to the Committee on Energy and Commerce and Committee
on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and Committee
on Appropriations of the Senate. The report shall include the following information, as applicable:
‘‘(1) GOALS MET.—For each fiscal year, if the Secretary
determines, based on the analysis under subsection (a)(5), that
each of the goals identified by the letters described in section

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401(b) of the Biosimilar User Fee Amendments of 2017 for
the applicable fiscal year have been met, the corrective action
report shall include recommendations on ways in which the
Secretary can improve and streamline the biosimilar biological
product application review process.
‘‘(2) GOALS MISSED.—For each of the goals identified by
the letters described in section 401(b) of the Biosimilar User
Fee Amendments of 2017 for the applicable fiscal year that
the Secretary determines to not have been met, the corrective
action report shall include—
‘‘(A) a justification for such determination and a
description of the types of circumstances and trends, as
applicable, under which biosimilar biological product
applications missed the review goal times but were
approved during the first cycle review, or review goals
were missed; and
‘‘(B) with respect to performance enhancement goals
that were not achieved, a description of efforts the Food
and Drug Administration has put in place for the fiscal
year in which the report is submitted to improve the ability
of such agency to meet each such goal for the such fiscal
year.
‘‘(d) ENHANCED COMMUNICATION.—
‘‘(1) COMMUNICATIONS WITH CONGRESS.—Each fiscal year,
as applicable and requested, representatives from the Centers
with expertise in the review of human drugs shall meet with
representatives from the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives to report
on the contents described in the reports under this section.
‘‘(2) PARTICIPATION IN CONGRESSIONAL HEARING.—Each
fiscal year, as applicable and requested, representatives from
the Food and Drug Administration shall participate in a public
hearing before the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, to report on
the contents described in the reports under this section. Such
hearing shall occur not later than 120 days after the end
of each fiscal year for which fees are collected under this
part.’’.

Public
information.

Deadline.

SEC. 905. FACILITIES MANAGEMENT.

(a) EVALUATION.—
(1) STUDY.—The Comptroller General of the United States
shall conduct a study on the expenses incurred by the Food
and Drug Administration related to facility maintenance and
renovation in fiscal years 2012 through 2019. The study under
this paragraph shall include the following:
(A) A review of purchases and expenses differentiated
by appropriated funds, and resources authorized by the
Food and Drug Administration Safety and Innovation Act
(Public Law 112–144) and this Act, as applicable, that
contributed to—
(i) the maintenance of scientific equipment and
any existing facility plan or plans to maintain previously purchased scientific equipment;

Time period.

Review.

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(ii) the renovation of facilities in the Center for
Drug Evaluation and Research, the Center for Biologics
Evaluation and Research, and the Center for Devices
and Radiological Health, and the purpose of such renovation including the need for the renovation;
(iii) the assets purchased or repaired under the
‘‘repair of facilities and acquisition’’ authority under
parts 2, 3, 7, and 8 of subchapter C of chapter VII
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379f et seq.);
(iv) the maintenance and repair of facilities and
fixtures, including a description of any unanticipated
repairs and maintenance as well as scheduled repairs
maintenance, and the budget plan for the scheduled
or anticipated maintenance;
(v) the acquisition of furniture, a description of
the furniture purchased, and the purpose of the furniture including purchases for the Center for Drug
Evaluation and Research, the Center for Biologics
Evaluation and Research, and the Center for Devices
and Radiological Health; and
(vi) the acquisition of other necessary materials
and supplies by product category under the authority
under parts 2, 3, 7, and 8 of subchapter C of chapter
VII of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379f et seq.).
(B) An analysis of the Food and Drug Administration’s
ability to further its public health mission and review
medical products by incurring the expenses listed in clauses
(i) through (vi) of subparagraph (A). In conducting the
analysis, the Comptroller General shall request information
from and consult with appropriate employees, including
staff and those responsible for the fiscal decisions regarding
facility maintenance and renovation for the agency.
(2) REPORT.—
(A) IN GENERAL.—The Comptroller General shall issue
a report to the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives not later
than July 30, 2020, containing the results of the study
under paragraph (1).
(B) RECOMMENDATIONS.—As part of the report under
this paragraph, the Comptroller General may provide recommendations, as applicable, on methods through which
the Food and Drug Administration may improve planning
for—
(i) the maintenance, renovation, and repair of
facilities;
(ii) the purchase of furniture or other acquisitions;
and
(iii) ways the Food and Drug Administration may
allocate the expenses described in clauses (i) and (ii)
of paragraph (1)(A), as informed by the analysis under
paragraph (1)(B).
(b) ADMINISTRATION.—

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131 STAT. 1090

PUBLIC LAW 115–52—AUG. 18, 2017
(1) PDUFA.—Section 736(f) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h(f)) is amended by adding
at the end the following:
‘‘(3) LIMITATION.—Beginning on October 1, 2023, the
authorities under section 735(7)(C) shall include only expenditures for leasing and necessary scientific equipment.’’.
(2) MDUFA.—Section 738(h) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j(h)) is amended by adding
at the end the following:
‘‘(3) LIMITATION.—Beginning on October 1, 2023, the
authorities under section 737(9)(C) shall include only leasing
and necessary scientific equipment.’’.
(3) GDUFA.—Section 744B(e) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j–42(e)) is amended—
(A) in the subsection heading, by striking ‘‘LIMIT’’ and
inserting ‘‘LIMITATIONS’’;
(B) by striking ‘‘The total amount’’ and inserting the
following:
‘‘(1) IN GENERAL.—The total amount’’; and
(C) by adding at the end the following:
‘‘(2) LEASING AND NECESSARY EQUIPMENT.—Beginning on
October 1, 2023, the authorities under section 744A(11)(C) shall
include only leasing and necessary scientific equipment.’’.
(4) BSUFA.—Section 744H(e)(2)(B) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j–52(e)(2)(B)) is
amended—
(A) in the subparagraph heading, by striking ‘‘LIMITATION’’ and inserting ‘‘LIMITATIONS’’;
(B) by striking ‘‘The fees authorized’’ and inserting
the following:
‘‘(i) IN GENERAL.—The fees authorized’’; and
(C) by adding at the end the following:
‘‘(ii) LEASING AND NECESSARY EQUIPMENT.—Beginning on October 1, 2023, the authorities under section
744G(9)(C) shall include only leasing and necessary
scientific equipment.’’.

Effective date.

Effective date.

Effective date.

Effective date.

Approved August 18, 2017.

LEGISLATIVE HISTORY—H.R. 2430 (S. 934):
HOUSE REPORTS: No. 115–201 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD, Vol. 163 (2017):
July 12, considered and passed House.
Aug. 3, considered and passed Senate.

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