[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 934 Reported in Senate (RS)]
<DOC>
Calendar No. 76
115th CONGRESS
1st Session
S. 934
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.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 25, 2017
Mr. Alexander (for himself and Mrs. Murray) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
May 11, 2017
Reported by Mr. Alexander, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
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,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``FDA Reauthorization Act of
2017''.</DELETED>
<DELETED>SEC. 2. TABLE OF CONTENTS.</DELETED>
<DELETED> The table of contents for this Act is as
follows:</DELETED>
<DELETED>Sec. 1. Short title.
<DELETED>Sec. 2. Table of contents.
<DELETED>TITLE I--FEES RELATING TO DRUGS
<DELETED>Sec. 101. Short title; finding.
<DELETED>Sec. 102. Authority to assess and use drug fees.
<DELETED>Sec. 103. Reauthorization; reporting requirements.
<DELETED>Sec. 104. Sunset dates.
<DELETED>Sec. 105. Effective date.
<DELETED>Sec. 106. Savings clause.
<DELETED>TITLE II--FEES RELATING TO DEVICES
<DELETED>Sec. 201. Short title; findings.
<DELETED>Sec. 202. Definitions.
<DELETED>Sec. 203. Authority to assess and use device fees.
<DELETED>Sec. 204. Reauthorization; reporting requirements.
<DELETED>Sec. 205. Conformity assessment pilot program.
<DELETED>Sec. 206. Reauthorization of review.
<DELETED>Sec. 207. Electronic format for submissions.
<DELETED>Sec. 208. Savings clause.
<DELETED>Sec. 209. Effective date.
<DELETED>Sec. 210. Sunset clause.
<DELETED>TITLE III--FEES RELATING TO GENERIC DRUGS
<DELETED>Sec. 301. Short title; finding.
<DELETED>Sec. 302. Definitions.
<DELETED>Sec. 303. Authority to assess and use human generic drug fees.
<DELETED>Sec. 304. Reauthorization; reporting requirements.
<DELETED>Sec. 305. Sunset dates.
<DELETED>Sec. 306. Effective date.
<DELETED>Sec. 307. Savings clause.
<DELETED>TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
<DELETED>Sec. 401. Short title; finding.
<DELETED>Sec. 402. Definitions.
<DELETED>Sec. 403. Authority to assess and use biosimilar fees.
<DELETED>Sec. 404. Reauthorization; reporting requirements.
<DELETED>Sec. 405. Sunset dates.
<DELETED>Sec. 406. Effective date.
<DELETED>Sec. 407. Savings clause.
<DELETED>TITLE V--REAUTHORIZATION OF OTHER PROGRAMS
<DELETED>Sec. 501. Reauthorization of provision relating to exclusivity
of certain drugs containing single
enantiomers.
<DELETED>Sec. 502. Reauthorization of pediatric humanitarian device
exceptions.
<DELETED>Sec. 503. Reauthorization of the critical path public-private
partnerships.
<DELETED>Sec. 504. Reauthorization of pediatric device consortia.
<DELETED>Sec. 505. Reauthorization of orphan grants program.
<DELETED>TITLE I--FEES RELATING TO DRUGS</DELETED>
<DELETED>SEC. 101. SHORT TITLE; FINDING.</DELETED>
<DELETED> (a) Short Title.--This title may be cited as the
``Prescription Drug User Fee Amendments of 2017''.</DELETED>
<DELETED> (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 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.</DELETED>
<DELETED>SEC. 102. AUTHORITY TO ASSESS AND USE DRUG FEES.</DELETED>
<DELETED> (a) Types of Fees.--</DELETED>
<DELETED> (1) In general.--Section 736(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is amended--
</DELETED>
<DELETED> (A) in the matter preceding paragraph (1),
by striking ``fiscal year 2013'' and inserting ``fiscal
year 2018'';</DELETED>
<DELETED> (B) in the heading of paragraph (1), by
striking ``and supplement'';</DELETED>
<DELETED> (C) in paragraph (1), by striking ``or a
supplement'' and ``or supplement'' each place either
appears;</DELETED>
<DELETED> (D) in paragraph (1)(A)--</DELETED>
<DELETED> (i) in clause (i), by striking
``(c)(4)'' and inserting ``(c)(5)'';
and</DELETED>
<DELETED> (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.'';</DELETED>
<DELETED> (E) in the heading of paragraph (1)(C), by
striking ``or supplement'';</DELETED>
<DELETED> (F) in paragraph (1)(F)--</DELETED>
<DELETED> (i) in the heading, by striking
``or indication''; and</DELETED>
<DELETED> (ii) by striking the second
sentence;</DELETED>
<DELETED> (G) by striking paragraph (2) (relating to
a prescription drug establishment fee);</DELETED>
<DELETED> (H) by redesignating paragraph (3) as
paragraph (2);</DELETED>
<DELETED> (I) in the heading of paragraph (2), as so
redesignated, by striking ``Prescription drug product
fee'' and inserting ``Prescription drug program
fee'';</DELETED>
<DELETED> (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.'';</DELETED>
<DELETED> (K) in subparagraph (B) of such paragraph
(2)--</DELETED>
<DELETED> (i) in the heading of subparagraph
(B), by inserting after ``Exception'' the
following: ``for certain prescription drug
products''; and</DELETED>
<DELETED> (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</DELETED>
<DELETED> (L) by adding at the end of such paragraph
(2) the following:</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(C) Limitation.--An establishment shall
be assessed only one fee per fiscal year under this
section.''.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(b) Fee Revenue Amounts.--</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) the annual base revenue for the
fiscal year (as determined under paragraph
(3));</DELETED>
<DELETED> ``(B) the dollar amount equal to the
inflation adjustment for the fiscal year (as determined
under subsection (c)(1));</DELETED>
<DELETED> ``(C) the dollar amount equal to the
capacity planning adjustment for the fiscal year (as
determined under subsection (c)(2));</DELETED>
<DELETED> ``(D) the dollar amount equal to the
operating reserve adjustment for the fiscal year, if
applicable (as determined under subsection
(c)(3));</DELETED>
<DELETED> ``(E) the dollar amount equal to the
additional direct cost adjustment for the fiscal year
(as determined under subsection (c)(4)); and</DELETED>
<DELETED> ``(F) additional dollar amounts for each
fiscal year as follows:</DELETED>
<DELETED> ``(i) $20,077,793 for fiscal year
2018;</DELETED>
<DELETED> ``(ii) $21,317,472 for fiscal year
2019;</DELETED>
<DELETED> ``(iii) $16,953,329 for fiscal
year 2020;</DELETED>
<DELETED> ``(iv) $5,426,896 for fiscal year
2021; and</DELETED>
<DELETED> ``(v) $2,769,609 for fiscal year
2022.</DELETED>
<DELETED> ``(2) Types of fees.--Of the total revenue amount
determined for a fiscal year under paragraph (1)--</DELETED>
<DELETED> ``(A) 20 percent shall be derived from
human drug application fees under subsection (a)(1);
and</DELETED>
<DELETED> ``(B) 80 percent shall be derived from
prescription drug program fees under subsection
(a)(2).</DELETED>
<DELETED> ``(3) Annual base revenue.--For purposes of
paragraph (1), the dollar amount of the annual base revenue for
a fiscal year shall be--</DELETED>
<DELETED> ``(A) for fiscal year 2018, $878,590,000;
and</DELETED>
<DELETED> ``(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).''.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(c) Adjustments; Annual Fee Setting.--</DELETED>
<DELETED> ``(1) Inflation adjustment.--</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(i) such annual base revenue for
the fiscal year under subsection (b)(1)(A);
and</DELETED>
<DELETED> ``(ii) the inflation adjustment
percentage under subparagraph (B).</DELETED>
<DELETED> ``(B) Inflation adjustment percentage.--
The inflation adjustment percentage under this
subparagraph for a fiscal year is equal to the sum of--
</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Capacity planning adjustment.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(B) Interim methodology.--</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(I) the annual base
revenue for such year, as adjusted for
inflation under paragraph (1);
and</DELETED>
<DELETED> ``(II) the adjustment
percentage under clause (ii).</DELETED>
<DELETED> ``(ii) Adjustment percentage.--The
adjustment percentage under this clause for a
fiscal year is the weighted change in the 3-
year average ending in the most recent year for
which data are available, over the 3-year
average ending in the previous year, for--
</DELETED>
<DELETED> ``(I) the total number of
human drug applications, efficacy
supplements, and manufacturing
supplements submitted to the
Secretary;</DELETED>
<DELETED> ``(II) the total number of
active commercial investigational new
drug applications; and</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(C) Capacity planning methodology.--
</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(I) replace the interim
methodology under subparagraph
(B);</DELETED>
<DELETED> ``(II) incorporate such
approaches and attributes as the
Secretary determines appropriate;
and</DELETED>
<DELETED> ``(III) be effective
beginning with the first fiscal year
for which fees are set after such
capacity planning methodology is
established.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(E) 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.</DELETED>
<DELETED> ``(3) Operating reserve adjustment.--</DELETED>
<DELETED> ``(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 for not more than 14 weeks of
operating reserves of carryover user fees for the
process for the review of human drug
applications.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(4) Additional direct cost adjustment.--
</DELETED>
<DELETED> ``(A) In general.--The Secretary shall, in
addition to adjustments under paragraphs (1), (2), and
(3), further increase the fee revenue and fees--
</DELETED>
<DELETED> ``(i) for fiscal year 2018, by
$8,730,000; and</DELETED>
<DELETED> ``(ii) for fiscal year 2019 and
subsequent fiscal years, by the amount
determined under subparagraph (B).</DELETED>
<DELETED> ``(B) Amount.--The amount determined under
this subparagraph is--</DELETED>
<DELETED> ``(i) $8,730,000, multiplied
by</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) establish, for the next fiscal year,
human drug application fees and prescription drug
program fees under subsection (a), based on the revenue
amounts established under subsection (b) and the
adjustments provided under this subsection;
and</DELETED>
<DELETED> ``(B) publish such fee revenue and fees in
the Federal Register.</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (d) Fee Waiver or Reduction.--Section 736(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended--
</DELETED>
<DELETED> (1) in paragraph (1)--</DELETED>
<DELETED> (A) by inserting ``or'' at the end of
subparagraph (B);</DELETED>
<DELETED> (B) by striking subparagraph (C);
and</DELETED>
<DELETED> (C) by redesignating subparagraph (D) as
subparagraph (C);</DELETED>
<DELETED> (2) by striking paragraph (3) (relating to use of
standard costs);</DELETED>
<DELETED> (3) by redesignating paragraph (4) as paragraph
(3); and</DELETED>
<DELETED> (4) in paragraph (3), as so redesignated--
</DELETED>
<DELETED> (A) in subparagraphs (A) and (B), by
striking ``paragraph (1)(D)'' and inserting ``paragraph
(1)(C)''; and</DELETED>
<DELETED> (B) in subparagraph (B)--</DELETED>
<DELETED> (i) by striking clause
(ii);</DELETED>
<DELETED> (ii) by striking ``shall pay''
through ``(i) application fees'' and inserting
``shall pay application fees''; and</DELETED>
<DELETED> (iii) by striking ``; and'' at the
end and inserting a period.</DELETED>
<DELETED> (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''.</DELETED>
<DELETED> (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''.</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (1) in paragraph (3)--</DELETED>
<DELETED> (A) by striking ``2013 through 2017'' and
inserting ``2018 through 2022''; and</DELETED>
<DELETED> (B) by striking ``and paragraph (4) of
this subsection''; and</DELETED>
<DELETED> (2) by striking paragraph (4).</DELETED>
<DELETED> (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''.</DELETED>
<DELETED>SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS.</DELETED>
<DELETED> Section 736B of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379h-2) is amended--</DELETED>
<DELETED> (1) in subsection (a)(1)--</DELETED>
<DELETED> (A) in the matter before subparagraph (A),
by striking ``2013'' and inserting ``2018'';
and</DELETED>
<DELETED> (B) in subparagraph (A), by striking
``Prescription Drug User Fee Amendments of 2012'' and
inserting ``Prescription Drug User Fee Amendments of
2017'';</DELETED>
<DELETED> (2) in subsection (b), by striking ``2013'' and
inserting ``2018''; and</DELETED>
<DELETED> (3) in subsection (d), by striking ``2017'' each
place it appears and inserting ``2022''.</DELETED>
<DELETED>SEC. 104. SUNSET DATES.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED>SEC. 105. EFFECTIVE DATE.</DELETED>
<DELETED> The amendments made by this title shall take effect on
October 1, 2017, or the date of the enactment of this Act, whichever is
later, except that fees under part 2 of subchapter C of chapter VII of
the Federal Food, Drug, and Cosmetic Act shall be assessed for all
human drug applications received on or after October 1, 2017,
regardless of the date of the enactment of this Act.</DELETED>
<DELETED>SEC. 106. SAVINGS CLAUSE.</DELETED>
<DELETED> 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.</DELETED>
<DELETED>TITLE II--FEES RELATING TO DEVICES</DELETED>
<DELETED>SEC. 201. SHORT TITLE; FINDINGS.</DELETED>
<DELETED> (a) Short Title.--This title may be cited as the ``Medical
Device User Fee Amendments of 2017''.</DELETED>
<DELETED> (b) Findings.--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.</DELETED>
<DELETED>SEC. 202. DEFINITIONS.</DELETED>
<DELETED> Section 737 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379i) is amended--</DELETED>
<DELETED> (1) by redesignating paragraphs (8) through (13)
as paragraphs (9) through (14), respectively;</DELETED>
<DELETED> (2) by inserting after paragraph (7) the following
new paragraph:</DELETED>
<DELETED> ``(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.'';</DELETED>
<DELETED> (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</DELETED>
<DELETED> (4) in paragraph (11) (as redesignated by
paragraph (1)), by striking ``2011'' and inserting
``2016''.</DELETED>
<DELETED>SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.</DELETED>
<DELETED> (a) Types of Fees.--Section 738(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is amended--</DELETED>
<DELETED> (1) in paragraph (1), by striking ``fiscal year
2013'' and inserting ``fiscal year 2018''; and</DELETED>
<DELETED> (2) in paragraph (2)--</DELETED>
<DELETED> (A) in subparagraph (A)--</DELETED>
<DELETED> (i) in the matter preceding clause
(i), by striking ``October 1, 2012'' and
inserting ``October 1, 2017'';</DELETED>
<DELETED> (ii) in clause (viii), by striking
``2'' and inserting ``3.4''; and</DELETED>
<DELETED> (iii) by adding at the end the
following new clause:</DELETED>
<DELETED> ``(xi) For a de novo
classification request, a fee equal to 30
percent of the fee that applies under clause
(i).''; and</DELETED>
<DELETED> (B) in subparagraph (B)(v)(I), by striking
``or premarket notification submission'' and inserting
``premarket notification submission, or de novo
classification request''.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(b) Fee Amounts.--</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(2) Base fee amounts specified.--For purposes of
paragraph (1), the base fee amounts specified in this paragraph
are as follows:</DELETED>
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
``Fee Type Year 2018 Year 2019 Year 2020 Year 2021 Year 2022
----------------------------------------------------------------------------------------------------------------
Premarket Application.................................... $294,000 $300,000 $310,000 $328,000 $329,000
Establishment Registration............................... $4,375 $4,548 $4,760 $4,975 $4,978
----------------------------------------------------------------------------------------------------------------
<DELETED> ``(3) Total revenue amounts specified.--For
purposes of paragraph (1), the total revenue amounts specified
in this paragraph are as follows:</DELETED>
<DELETED> ``(A) $183,280,756 for fiscal year
2018.</DELETED>
<DELETED> ``(B) $190,654,875 for fiscal year
2019.</DELETED>
<DELETED> ``(C) $200,132,014 for fiscal year
2020.</DELETED>
<DELETED> ``(D) $211,748,789 for fiscal year
2021.</DELETED>
<DELETED> ``(E) $213,687,660 for fiscal year
2022.''.</DELETED>
<DELETED> (c) Annual Fee Setting; Adjustments.--Section 738(c) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is
amended--</DELETED>
<DELETED> (1) in paragraph (1), by striking ``2012'' and
inserting ``2017'';</DELETED>
<DELETED> (2) in paragraph (2)--</DELETED>
<DELETED> (A) in subparagraph (A), by striking
``2014'' and inserting ``2018'';</DELETED>
<DELETED> (B) by striking subparagraph (B) and
inserting the following new subparagraph:</DELETED>
<DELETED> ``(B) Applicable inflation adjustment.--
The applicable inflation adjustment for fiscal year
2018 and each subsequent fiscal year is the product
of--</DELETED>
<DELETED> ``(i) the base inflation
adjustment under subparagraph (C) for such
fiscal year; and</DELETED>
<DELETED> ``(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.'';</DELETED>
<DELETED> (C) in subparagraph (C), in the heading,
by striking ``to total revenue amounts''; and</DELETED>
<DELETED> (D) by amending subparagraph (D) to read
as follows:</DELETED>
<DELETED> ``(D) Adjustment to base fee amounts.--For
each of fiscal years 2018 through 2022, the Secretary
shall--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (3) in paragraph (3)--</DELETED>
<DELETED> (A) by striking ``2014 through 2017'' and
inserting ``2018 through 2022''; and</DELETED>
<DELETED> (B) by striking ``further adjusted'' and
inserting ``increased''.</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (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</DELETED>
<DELETED> (2) in paragraph (2)(C)--</DELETED>
<DELETED> (A) by striking ``supplement, or'' and
inserting ``supplement,''; and</DELETED>
<DELETED> (B) by inserting ``, or a de novo
classification request'' after ``class III
device''.</DELETED>
<DELETED> (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''.</DELETED>
<DELETED> (f) Fee Waiver or Reduction.--</DELETED>
<DELETED> (1) Repeal.--Section 738 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j) is amended by striking
subsection (f).</DELETED>
<DELETED> (2) Conforming changes.--</DELETED>
<DELETED> (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)''.</DELETED>
<DELETED> (B) Section 738 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j), as amended by
paragraph (1), is further amended--</DELETED>
<DELETED> (i) by redesignating subsections
(g) through (l) as subsections (f) through
(k);</DELETED>
<DELETED> (ii) in subsection (a)(2)(A), by
striking ``(d), (e), and (f)'' and inserting
``(d) and (e)''; and</DELETED>
<DELETED> (iii) in subsection (a)(3)(A), by
striking ``and subsection (f)''.</DELETED>
<DELETED> (g) Effect of Failure To Pay Fees.--Subsection (f)(1), as
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j) is amended--</DELETED>
<DELETED> (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</DELETED>
<DELETED> (2) by striking ``all fees'' and inserting ``all
such fees''.</DELETED>
<DELETED> (h) Conditions.--Subsection (g)(1)(A), as 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''.</DELETED>
<DELETED> (i) Crediting and Availability of Fees.--Subsection (h),
as redesignated, of section 738 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j) is amended--</DELETED>
<DELETED> (1) in paragraph (3)--</DELETED>
<DELETED> (A) by striking ``2013 through 2017'' and
inserting ``2018 through 2022''; and</DELETED>
<DELETED> (B) by striking ``subsection (c)'' and all
that follows through the period at the end and
inserting ``subsection (c).''; and</DELETED>
<DELETED> (2) by striking paragraph (4).</DELETED>
<DELETED>SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.</DELETED>
<DELETED> (a) Performance Reports.--Section 738A(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-1(a)) is amended--
</DELETED>
<DELETED> (1) in paragraph (1)--</DELETED>
<DELETED> (A) in subparagraph (A)--</DELETED>
<DELETED> (i) by striking ``2013'' and
inserting ``2018''; and</DELETED>
<DELETED> (ii) by striking ``the Medical
Device User Fee Amendments of 2012'' and
inserting ``Medical Device User Fee Amendments
of 2017''; and</DELETED>
<DELETED> (B) in subparagraph (B), by striking ``the
Medical Device User Fee Amendments of 2012'' and
inserting ``Medical Device User Fee Amendments of
2017''; and</DELETED>
<DELETED> (2) in paragraph (2), by striking ``2013 through
2017'' and inserting ``2018 through 2022''.</DELETED>
<DELETED> (b) Reauthorization.--Section 738A(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--</DELETED>
<DELETED> (1) in paragraph (1), by striking ``2017'' and
inserting ``2022''; and</DELETED>
<DELETED> (2) in paragraph (5), by striking ``2017'' and
inserting ``2022''.</DELETED>
<DELETED>SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(d) Pilot Accreditation Scheme for Conformity
Assessment.--</DELETED>
<DELETED> ``(1) In general.--The Secretary shall establish a
pilot program under which--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Secretarial review of accredited laboratory
determinations.--The Secretary may--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(3) Implementation and reporting.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(B) Pilot program guidance.--The
Secretary shall--</DELETED>
<DELETED> ``(i) not later than September 30,
2019, issue draft guidance regarding the goals
and implementation of the pilot program under
this subsection; and</DELETED>
<DELETED> ``(ii) not later than September
30, 2021, issue final guidance with respect to
the implementation of such program.</DELETED>
<DELETED> ``(C) Pilot program initiation.--Not later
than September 30, 2020, the Secretary shall initiate
the pilot program under this subsection.</DELETED>
<DELETED> ``(D) Report.--The Secretary shall make
available on the website of the Food and Drug
Administration an annual report on the progress of the
pilot program under this subsection.</DELETED>
<DELETED> ``(4) Sunset.--As of October 1, 2022--</DELETED>
<DELETED> ``(A) the authority for accreditation
bodies to accredit testing laboratories pursuant to
paragraph (1)(A) shall cease to have force or
effect;</DELETED>
<DELETED> ``(B) the Secretary--</DELETED>
<DELETED> ``(i) may not accept a
determination pursuant to paragraph (1)(B) made
by a testing laboratory after such date;
and</DELETED>
<DELETED> ``(ii) may accept such a
determination made prior to such
date;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(D) the Secretary may take actions in
accordance with paragraph (2) with respect to the
determinations made prior to such date and recognition
of the accreditation of testing laboratories pursuant
to determinations made prior to such date.''.</DELETED>
<DELETED>SEC. 206. REAUTHORIZATION OF REVIEW.</DELETED>
<DELETED> Section 523 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360m) is amended--</DELETED>
<DELETED> (1) in subsection (a)(3)--</DELETED>
<DELETED> (A) in subparagraph (A), by striking
clauses (ii) and (iii) and inserting the
following:</DELETED>
<DELETED> ``(ii) a device classified under
section 513(f)(2) or designated under section
515C(d); or</DELETED>
<DELETED> ``(iii) a device that is of a
type, or subset of a type, listed as not
eligible for review under subparagraph
(B)(iii).'';</DELETED>
<DELETED> (B) by striking subparagraph (B) and
inserting the following:</DELETED>
<DELETED> ``(B) Designation for review.--The
Secretary shall--</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(I) the risk of the
device type, or subset of such device
type; and</DELETED>
<DELETED> ``(II) whether the device
type, or subset of such device type, is
permanently implantable, life
sustaining, or life
supporting;</DELETED>
<DELETED> ``(ii) not later than 24 months
after the date on which the Secretary issues
such draft guidance, finalize such guidance;
and</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (C) by adding at the end the
following:</DELETED>
<DELETED> ``(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.'';</DELETED>
<DELETED> (2) in subsection (b)--</DELETED>
<DELETED> (A) in paragraph (2)--</DELETED>
<DELETED> (i) by striking subparagraph (D);
and</DELETED>
<DELETED> (ii) by redesignating subparagraph
(E) as subparagraph (D); and</DELETED>
<DELETED> (B) in paragraph (3)--</DELETED>
<DELETED> (i) by redesignating subparagraph
(E) as subparagraph (F);</DELETED>
<DELETED> (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</DELETED>
<DELETED> (iii) by inserting after
subparagraph (D) the following new
subparagraph:</DELETED>
<DELETED> ``(E) The operations of such person shall
be in accordance with generally accepted professional
and ethical business practices.''; and</DELETED>
<DELETED> (3) in subsection (c), by striking ``2017'' and
inserting ``2022''.</DELETED>
<DELETED>SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS.</DELETED>
<DELETED> 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:</DELETED>
<DELETED> ``(3) Presubmissions and submissions solely in
electronic format.--</DELETED>
<DELETED> ``(A) In general.--Beginning on October 1,
2021 (or such later date as may be specified by the
Secretary under subparagraph (B)), 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 guidance issued under subparagraph
(C).</DELETED>
<DELETED> ``(B) Extension.--The Secretary may, if
the Secretary determines an extension of the date
specified in subparagraph (A) is necessary for the
development and adoption of the electronic format
referred to in such paragraph, extend such date until
such later date as the Secretary may specify, but in no
event later than April 1, 2023.</DELETED>
<DELETED> ``(C) Guidance.--The Secretary shall, not
later than January 1, 2021, or such later date as may
be specified by the Secretary under subparagraph (B),
issue guidance providing for--</DELETED>
<DELETED> ``(i) any further standards for
the submission by electronic format required
under subparagraph (A);</DELETED>
<DELETED> ``(ii) a timetable for the
establishment by the Secretary of such further
standards; and</DELETED>
<DELETED> ``(iii) set forth criteria for
waivers of and exemptions from the requirements
of this subsection.''.</DELETED>
<DELETED>SEC. 208. SAVINGS CLAUSE.</DELETED>
<DELETED> 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.</DELETED>
<DELETED>SEC. 209. EFFECTIVE DATE.</DELETED>
<DELETED> 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.</DELETED>
<DELETED>SEC. 210. SUNSET CLAUSE.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (c) Previous Sunset Provision.--</DELETED>
<DELETED> (1) In general.--Effective October 1, 2017,
section 207(a) of the Medical Device User Fee Amendments of
2012 (Public Law 112-144) is repealed.</DELETED>
<DELETED> (2) Conforming amendment.--The Food and Drug
Administration Safety and Innovation Act (Public Law 112-144)
is amended in the table of contents in section 2 by striking
the item relating to section 207.</DELETED>
<DELETED>TITLE III--FEES RELATING TO GENERIC DRUGS</DELETED>
<DELETED>SEC. 301. SHORT TITLE; FINDING.</DELETED>
<DELETED> (a) Short Title.--This title may be cited as the ``Generic
Drug User Fee Amendments of 2017''.</DELETED>
<DELETED> (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.</DELETED>
<DELETED>SEC. 302. DEFINITIONS.</DELETED>
<DELETED> Section 744A of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-41) is amended--</DELETED>
<DELETED> (1) in paragraph (1)(B), by striking ``application
for a positron emission tomography drug.'' and inserting
``application--</DELETED>
<DELETED> ``(i) for a positron emission
tomography drug; or</DELETED>
<DELETED> ``(ii) submitted by a State or
Federal governmental entity for a drug that is
not distributed commercially.'';</DELETED>
<DELETED> (2) by redesignating paragraphs (5) through (12)
as paragraphs (6) through (13), respectively; and</DELETED>
<DELETED> (3) by inserting after paragraph (4) the
following:</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED>SEC. 303. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG
FEES.</DELETED>
<DELETED> (a) Types of Fees.--Section 744B(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-42(a)) is amended--</DELETED>
<DELETED> (1) in the matter preceding paragraph (1), by
striking ``fiscal year 2013'' and inserting ``fiscal year
2018'';</DELETED>
<DELETED> (2) in paragraph (1), by adding at the end the
following:</DELETED>
<DELETED> ``(E) Sunset.--This paragraph shall cease
to be effective October 1, 2022.'';</DELETED>
<DELETED> (3) in paragraph (2)--</DELETED>
<DELETED> (A) by amending subparagraph (C) to read
as follows:</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (B) in subparagraph (E)--</DELETED>
<DELETED> (i) in clause (i)--</DELETED>
<DELETED> (I) by striking ``no later
than the date'' and inserting ``on the
earlier of--</DELETED>
<DELETED> ``(I) the
date'';</DELETED>
<DELETED> (II) by striking the
period and inserting ``; or'';
and</DELETED>
<DELETED> (III) by adding at the end
the following:</DELETED>
<DELETED> ``(II) the date on which
the drug master file holder requests
the initial completeness assessment.'';
and</DELETED>
<DELETED> (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)'';</DELETED>
<DELETED> (4) in paragraph (3)--</DELETED>
<DELETED> (A) in the heading, by striking ``and
prior approval supplement'';</DELETED>
<DELETED> (B) in subparagraph (A), by striking ``or
a prior approval supplement to an abbreviated new drug
application'';</DELETED>
<DELETED> (C) by amending subparagraphs (B) and (C)
to read as follows:</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.'';</DELETED>
<DELETED> (D) in subparagraph (D)--</DELETED>
<DELETED> (i) in the heading, by inserting
``, is withdrawn prior to being received, or is
no longer received'' after ``received'';
and</DELETED>
<DELETED> (ii) by striking ``The Secretary
shall'' and all that follows through the period
and inserting the following:</DELETED>
<DELETED> ``(i) Applications not considered
to have been received and applications
withdrawn prior to being received.--The
Secretary shall refund 75 percent of the fee
paid under subparagraph (A) for any abbreviated
new drug application that the Secretary
considers not to have been received within the
meaning of section 505(j)(5)(A) for a cause
other than failure to pay fees, or that has
been withdrawn prior to being received within
the meaning of section 505(j)(5)(A).</DELETED>
<DELETED> ``(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).'';</DELETED>
<DELETED> (E) in subparagraph (E), by striking ``or
prior approval supplement''; and</DELETED>
<DELETED> (F) in the matter preceding clause (i) of
subparagraph (F)--</DELETED>
<DELETED> (i) by striking ``2012'' and
inserting ``2017''; and</DELETED>
<DELETED> (ii) by striking ``subsection
(d)(3)'' and inserting ``subsection
(d)(2)'';</DELETED>
<DELETED> (5) in paragraph (4)--</DELETED>
<DELETED> (A) in subparagraph (A)--</DELETED>
<DELETED> (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'';</DELETED>
<DELETED> (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'';</DELETED>
<DELETED> (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</DELETED>
<DELETED> (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</DELETED>
<DELETED> (B) by amending subparagraphs (C) and (D)
to read as follows:</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(i) the first business day on or
after October 1 of each such year; or</DELETED>
<DELETED> ``(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.'';</DELETED>
<DELETED> (6) by redesignating paragraph (5) as paragraph
(6); and</DELETED>
<DELETED> (7) by inserting after paragraph (4) the
following:</DELETED>
<DELETED> ``(5) Generic drug applicant program fee.--
</DELETED>
<DELETED> ``(A) In general.--A generic drug
applicant program fee shall be assessed annually as
described in subsection (b)(2)(E).</DELETED>
<DELETED> ``(B) Amount.--The amount of fees
established under subparagraph (A) shall be established
under subsection (d).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(i) the first business day on or
after October 1 of each such fiscal year;
or</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (b) Fee Revenue Amounts.--Section 744B(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(b)) is amended--
</DELETED>
<DELETED> (1) in paragraph (1)--</DELETED>
<DELETED> (A) in subparagraph (A)--</DELETED>
<DELETED> (i) in the heading, by striking
``2013'' and inserting ``2018'';</DELETED>
<DELETED> (ii) by striking ``2013'' and
inserting ``2018'';</DELETED>
<DELETED> (iii) by striking ``$299,000,000''
and inserting ``$493,600,000''; and</DELETED>
<DELETED> (iv) by striking ``Of that
amount'' and all that follows through the end
of clause (ii); and</DELETED>
<DELETED> (B) in subparagraph (B)--</DELETED>
<DELETED> (i) in the heading, by striking
``2014 through 2017'' and inserting ``2019
through 2022'';</DELETED>
<DELETED> (ii) by striking ``2014 through
2017'' and inserting ``2019 through
2022'';</DELETED>
<DELETED> (iii) by striking ``paragraphs (2)
through (4)'' and inserting ``paragraphs (2)
through (5)''; and</DELETED>
<DELETED> (iv) by striking ``$299,000,000''
and inserting ``$493,600,000''; and</DELETED>
<DELETED> (2) in paragraph (2)--</DELETED>
<DELETED> (A) in the matter preceding subparagraph
(A)--</DELETED>
<DELETED> (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</DELETED>
<DELETED> (ii) by striking ``through (4)''
and inserting ``through (5)'';</DELETED>
<DELETED> (B) in subparagraph (A), by striking ``Six
percent'' and inserting ``Five percent'';</DELETED>
<DELETED> (C) by amending subparagraphs (B) and (C)
to read as follows:</DELETED>
<DELETED> ``(B) Thirty-three percent shall be
derived from fees under subsection (a)(3) (relating to
abbreviated new drug applications).</DELETED>
<DELETED> ``(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.'';</DELETED>
<DELETED> (D) in subparagraph (D)--</DELETED>
<DELETED> (i) by striking ``Fourteen
percent'' and inserting ``Seven
percent'';</DELETED>
<DELETED> (ii) by striking ``not less than
$15,000 and not more than $30,000'' and
inserting ``$15,000''; and</DELETED>
<DELETED> (iii) by striking ``, as
determined'' and all that follows through the
period at the end and inserting a period;
and</DELETED>
<DELETED> (E) by adding at the end the
following:</DELETED>
<DELETED> ``(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:</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (c) Adjustments.--Section 744B(c) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-42(c)) is amended--</DELETED>
<DELETED> (1) in paragraph (1)--</DELETED>
<DELETED> (A) by striking ``2014'' and inserting
``2019'';</DELETED>
<DELETED> (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</DELETED>
<DELETED> (C) by striking the flush text following
subparagraph (C); and</DELETED>
<DELETED> (2) in paragraph (2)--</DELETED>
<DELETED> (A) by striking ``2017'' each place it
appears and inserting ``2022''; and</DELETED>
<DELETED> (B) by striking ``2018'' and inserting
``2023''.</DELETED>
<DELETED> (d) Annual Fee Setting.--Section 744B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-42) is amended--</DELETED>
<DELETED> (1) in subsection (c)(2), by striking ``Such fees
may only be used in fiscal year 2018.''; and</DELETED>
<DELETED> (2) in subsection (d)--</DELETED>
<DELETED> (A) by striking paragraphs (1) and (2) and
inserting the following:</DELETED>
<DELETED> ``(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).'';</DELETED>
<DELETED> (B) by redesignating paragraph (3) as
paragraph (2); and</DELETED>
<DELETED> (C) 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)''.</DELETED>
<DELETED> (e) Identification of Facilities.--Section 744B(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(f)) is
amended--</DELETED>
<DELETED> (1) by striking paragraph (1);</DELETED>
<DELETED> (2) by redesignating paragraphs (2) through (4) as
paragraphs (1) through (3), respectively;</DELETED>
<DELETED> (3) in paragraph (1) (as so redesignated)--
</DELETED>
<DELETED> (A) by striking ``paragraph (4)'' and
inserting ``paragraph (3)''; and</DELETED>
<DELETED> (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</DELETED>
<DELETED> (4) in paragraph (2), as so redesignated--
</DELETED>
<DELETED> (A) in the heading, by striking ``Contents
of notice'' and inserting ``Information required to be
submitted'';</DELETED>
<DELETED> (B) in the matter preceding subparagraph
(A), by striking ``paragraph (2)'' and inserting
``paragraph (1)'';</DELETED>
<DELETED> (C) in subparagraph (A), by striking ``or
intended to be identified'';</DELETED>
<DELETED> (D) in subparagraph (D), by striking
``and'' at the end;</DELETED>
<DELETED> (E) in subparagraph (E), by striking the
period and inserting ``; and''; and</DELETED>
<DELETED> (F) by adding at the end the
following:</DELETED>
<DELETED> ``(F) whether the facility is a contract
manufacturing organization facility.''.</DELETED>
<DELETED> (f) Effect of Failure To Pay Fees.--Section 744B(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379-42(g)) is amended--
</DELETED>
<DELETED> (1) in paragraph (1), by adding at the end the
following: ``This paragraph shall cease to be effective on
October 1, 2022.'';</DELETED>
<DELETED> (2) in paragraph (2)(C)(ii), by striking ``of
505(j)(5)(A)'' and inserting ``of section 505(j)(5)(A)'';
and</DELETED>
<DELETED> (3) by adding at the end the following:</DELETED>
<DELETED> ``(5) Generic drug applicant program fee.--
</DELETED>
<DELETED> ``(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:</DELETED>
<DELETED> ``(i) The Secretary shall place
the person on a publicly available arrears
list.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(B) Application of penalties.--The
penalties under subparagraph (A) shall apply until the
fee required under subsection (a)(5) is
paid.''.</DELETED>
<DELETED> (g) Limitations.--Section 744B(h)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379-42(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''.</DELETED>
<DELETED> (h) Crediting and Availability of Fees.--Section 744B(i)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379-42(i)) is
amended--</DELETED>
<DELETED> (1) in paragraph (2)--</DELETED>
<DELETED> (A) by striking subparagraph (C) (relating
to fee collection during first program year);</DELETED>
<DELETED> (B) in subparagraph (D)--</DELETED>
<DELETED> (i) in the heading, by striking
``in subsequent years''; and</DELETED>
<DELETED> (ii) by striking ``(after fiscal
year 2013)''; and</DELETED>
<DELETED> (C) by redesignating subparagraph (D) as
subparagraph (C); and</DELETED>
<DELETED> (2) in paragraph (3), by striking ``fiscal years
2013 through 2017'' and inserting ``fiscal years 2018 through
2022''.</DELETED>
<DELETED> (i) Information on Abbreviated New Drug Applications Held
by Applicants and Their Affiliates.--Section 744B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379-42) is amended by adding at the
end the following:</DELETED>
<DELETED> ``(o) Information on Abbreviated New Drug Applications
Owned by Applicants and Their Affiliates.--</DELETED>
<DELETED> ``(1) In general.--By April 1 of each year, each
person that owns an abbreviated new drug application, or any
affiliate of such person, shall submit to the Secretary a list
of--</DELETED>
<DELETED> ``(A) all approved abbreviated new drug
applications owned by such person; and</DELETED>
<DELETED> ``(B) if any affiliate of such person also
owns an abbreviated new drug application, all approved
abbreviated new drug applications owned by any such
affiliate.</DELETED>
<DELETED> ``(2) Format and method.--The Secretary shall
specify in guidance the format and method for submission of
lists under this subsection.''.</DELETED>
<DELETED>SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS.</DELETED>
<DELETED> Section 744C of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-43) is amended--</DELETED>
<DELETED> (1) in subsection (a)--</DELETED>
<DELETED> (A) by striking ``2013'' and inserting
``2018''; and</DELETED>
<DELETED> (B) by striking ``Generic Drug User Fee
Amendments of 2012'' and inserting ``Generic Drug User
Fee Amendments of 2017'';</DELETED>
<DELETED> (2) in subsection (b), by striking ``2013'' and
inserting ``2018''; and</DELETED>
<DELETED> (3) in subsection (d), by striking ``2017'' each
place it appears and inserting ``2022''.</DELETED>
<DELETED>SEC. 305. SUNSET DATES.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (c) Previous Sunset Provision.--Effective October 1, 2017,
subsections (a) and (b) of section 304 of the Food and Drug
Administration Safety and Innovation Act (Public Law 112-144) are
repealed.</DELETED>
<DELETED>SEC. 306. EFFECTIVE DATE.</DELETED>
<DELETED> 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.</DELETED>
<DELETED>SEC. 307. SAVINGS CLAUSE.</DELETED>
<DELETED> 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 on or
after October 1, 2012, but before October 1, 2017, were received by the
Food and Drug Administration within the meaning of 505(j)(5)(A) of such
Act (21 U.S.C. 355(j)(5)(A)), prior approval supplements that were
submitted, and drug master files for Type II active pharmaceutical
ingredients that were first referenced with respect to assessing and
collecting any fee required by such part for a fiscal year prior to
fiscal year 2018.</DELETED>
<DELETED>TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL
PRODUCTS</DELETED>
<DELETED>SEC. 401. SHORT TITLE; FINDING.</DELETED>
<DELETED> (a) Short Title.--This title may be cited as the
``Biosimilar User Fee Amendments of 2017''.</DELETED>
<DELETED> (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.</DELETED>
<DELETED>SEC. 402. DEFINITIONS.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(1) The term `adjustment factor' applicable to a
fiscal year is the Consumer Price Index for all urban consumers
(all items; United States city average) for October of the
preceding fiscal year divided by such Index for October
2011.''.</DELETED>
<DELETED> (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''.</DELETED>
<DELETED>SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR
FEES.</DELETED>
<DELETED> (a) Types of Fees.--Section 744H(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-52(a)) is amended--</DELETED>
<DELETED> (1) in the matter preceding paragraph (1), by
striking ``fiscal year 2013'' and inserting ``fiscal year
2018'';</DELETED>
<DELETED> (2) in the heading of paragraph (1), by striking
``Biosimilar'' and inserting ``Biosimilar biological
product'';</DELETED>
<DELETED> (3) in paragraph (1)(A)(i), by striking
``(b)(1)(A)'' and inserting ``(c)(5)'';</DELETED>
<DELETED> (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'';</DELETED>
<DELETED> (5) in paragraph (1)(B)(ii), by striking ``annual
biosimilar biological product development program fee'' and
inserting ``annual biosimilar biological product development
fee'';</DELETED>
<DELETED> (6) in paragraph (1)(B)(iii), by striking ``annual
biosimilar development program fee'' and inserting ``annual
biosimilar biological product development fee'';</DELETED>
<DELETED> (7) in paragraph (1)(B), by adding at the end the
following:</DELETED>
<DELETED> ``(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
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.'';</DELETED>
<DELETED> (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,'';</DELETED>
<DELETED> (9) in paragraph (1)(D)--</DELETED>
<DELETED> (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'';</DELETED>
<DELETED> (B) in clause (i)(I), by inserting after
``grants a request'' the following: ``by such person'';
and</DELETED>
<DELETED> (C) in clause (i)(II), by inserting after
``discontinued)'' the following: ``by such
person'';</DELETED>
<DELETED> (10) in the heading of paragraph (1)(E), by
striking ``biosimilar development program'';</DELETED>
<DELETED> (11) in the heading of subparagraph (F) of
paragraph (1), by striking ``biosimilar development program
fees'' and inserting ``biosimilar biological product
development fees'';</DELETED>
<DELETED> (12) in paragraph (1)(F)--</DELETED>
<DELETED> (A) in the heading of subparagraph (F), by
striking ``biosimilar development program'' before
``fees''; and</DELETED>
<DELETED> (B) by amending clause (i) to read as
follows:</DELETED>
<DELETED> ``(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).'';</DELETED>
<DELETED> (13) in paragraph (2)--</DELETED>
<DELETED> (A) in the heading of paragraph (2), by
striking ``and supplement'';</DELETED>
<DELETED> (B) by amending subparagraphs (A) and (B)
to read as follows:</DELETED>
<DELETED> ``(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:</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(B) Rule of applicability; treatment of
certain previously paid fees.--Any person who pays a
fee under subparagraph (A), (B), or (D) of paragraph
(1) for a product before October 1, 2017, but submits a
biosimilar biological product application for that
product after such date, shall--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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).'';</DELETED>
<DELETED> (C) in the heading of subparagraph (D), by
striking ``or supplement''; and</DELETED>
<DELETED> (D) in subparagraphs (C) through (F)--
</DELETED>
<DELETED> (i) by striking ``or supplement''
each place it appears; and</DELETED>
<DELETED> (ii) in subparagraph (D), by
striking ``or a supplement''; and</DELETED>
<DELETED> (14) by amending paragraph (3) to read as
follows:</DELETED>
<DELETED> ``(3) Biosimilar biological product program fee.--
</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(i) is identified in such a
biosimilar biological product application
approved as of October 1 of such fiscal year;
and</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(B) Due date.--The biosimilar biological
product program fee for a fiscal year shall be due on
the later of--</DELETED>
<DELETED> ``(i) the first business day on or
after October 1 of each such year; or</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(b) Fee Revenue Amounts.--</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) $45,000,000; and</DELETED>
<DELETED> ``(B) the dollar amount equal to the
fiscal year 2018 adjustment (as determined under
subsection (c)(4)).</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) the annual base revenue for the
fiscal year (as determined under paragraph
(4));</DELETED>
<DELETED> ``(B) the dollar amount equal to the
inflation adjustment for the fiscal year (as determined
under subsection (c)(1));</DELETED>
<DELETED> ``(C) the dollar amount equal to the
capacity planning adjustment for the fiscal year (as
determined under subsection (c)(2)); and</DELETED>
<DELETED> ``(D) the dollar amount equal to the
operating reserve adjustment for the fiscal year, if
applicable (as determined under subsection
(c)(3)).</DELETED>
<DELETED> ``(3) Allocation of revenue amount among fees;
limitations on fee amounts.--</DELETED>
<DELETED> ``(A) Allocation.--The Secretary shall
determine the percentage of the total revenue amount
for a fiscal year to be derived from, respectively--
</DELETED>
<DELETED> ``(i) initial and annual
biosimilar development fees and reactivation
fees under subsection (a)(1);</DELETED>
<DELETED> ``(ii) biosimilar biological
product application fees under subsection
(a)(2); and</DELETED>
<DELETED> ``(iii) biosimilar biological
product program fees under subsection
(a)(3).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).''.</DELETED>
<DELETED> (c) Adjustments; Annual Fee Setting.--Section 744H of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended--
</DELETED>
<DELETED> (1) by redesignating subsections (c) through (h)
as subsections (d) through (i), respectively;</DELETED>
<DELETED> (2) in subsections (a)(2)(F) and (g), by striking
``subsection (c)'' and inserting ``subsection (d)'';</DELETED>
<DELETED> (3) in subsection (a)(4)(A), by striking
``subsection (b)(1)(F)'' and inserting ``subsection (c)(5)'';
and</DELETED>
<DELETED> (4) by inserting after subsection (b) the
following:</DELETED>
<DELETED> ``(c) Adjustments; Annual Fee Setting.--</DELETED>
<DELETED> ``(1) Inflation adjustment.--</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(i) such annual base revenue for
the fiscal year under subsection (b);
and</DELETED>
<DELETED> ``(ii) the inflation adjustment
percentage under subparagraph (B).</DELETED>
<DELETED> ``(B) Inflation adjustment percentage.--
The inflation adjustment percentage under this
subparagraph for a fiscal year is equal to the sum of--
</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Capacity planning adjustment.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(B) Capacity planning methodology.--
</DELETED>
<DELETED> ``(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
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.</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(I) incorporate such
approaches and attributes as the
Secretary determines appropriate;
and</DELETED>
<DELETED> ``(II) be effective
beginning with the first fiscal year
for which fees are set after such
capacity planning methodology is
established.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(3) Operating reserve adjustment.--</DELETED>
<DELETED> ``(A) Interim application; fee
reduction.--Until the first fiscal year for which the
capacity planning adjustment under paragraph (2) is
effective, the Secretary may, in addition to the
adjustment under paragraph (1), reduce the fee revenue
and fees under this section for a fiscal year as the
Secretary determines appropriate for long-term
financial planning purposes.</DELETED>
<DELETED> ``(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)--</DELETED>
<DELETED> ``(i) reduce the fee revenue and
fees under this section as the Secretary
determines appropriate for long-term financial
planning purposes; or</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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) establishing fee revenue and fees for the
fiscal year involved.</DELETED>
<DELETED> ``(4) Fiscal year 2018 adjustment.--</DELETED>
<DELETED> ``(A) In general.--For fiscal year 2018,
the Secretary shall adjust the fee revenue and fees
under this section in such amount (if any) as needed to
reflect an updated assessment of the workload for the
process for the review of biosimilar biological product
applications.</DELETED>
<DELETED> ``(B) Methodology.--The Secretary shall
publish under paragraph (5) a description of the
methodology used to calculate the fiscal year 2018
adjustment under this paragraph in the Federal Register
notice establishing fee revenue and fees for fiscal
year 2018.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(B) publish such fee revenue and fees in
the Federal Register.</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (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--
</DELETED>
<DELETED> (1) by striking subparagraph (B);</DELETED>
<DELETED> (2) by striking ``shall pay--'' and all that
follows through ``application fees'' and inserting ``shall pay
application fees''; and</DELETED>
<DELETED> (3) by striking ``; and'' at the end and inserting
a period.</DELETED>
<DELETED> (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''.</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (1) in paragraph (2)--</DELETED>
<DELETED> (A) by striking subparagraph (C) (relating
to fee collection during first program year) and
inserting the following:</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (B) in subparagraph (D)--</DELETED>
<DELETED> (i) in the heading, by striking
``in subsequent years''; and</DELETED>
<DELETED> (ii) by striking ``(after fiscal
year 2013)''; and</DELETED>
<DELETED> (2) in paragraph (3), by striking ``2013 through
2017'' and inserting ``2018 through 2022''.</DELETED>
<DELETED>SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.</DELETED>
<DELETED> Section 744I of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-53) is amended--</DELETED>
<DELETED> (1) in subsection (a)--</DELETED>
<DELETED> (A) by striking ``2013'' and inserting
``2018''; and</DELETED>
<DELETED> (B) by striking ``Biosimilar User Fee Act
of 2012'' and inserting ``Biosimilar User Fee
Amendments of 2017'';</DELETED>
<DELETED> (2) in subsection (b), by striking ``2013'' and
inserting ``2018'';</DELETED>
<DELETED> (3) by striking subsection (d);</DELETED>
<DELETED> (4) by redesignating subsection (e) as subsection
(d); and</DELETED>
<DELETED> (5) in subsection (d), as so redesignated, by
striking ``2017'' each place it appears and inserting
``2022''.</DELETED>
<DELETED>SEC. 405. SUNSET DATES.</DELETED>
<DELETED> (a) Authorization.--Sections 744G and 744H of the Federal
Food, Drug, and Cosmetic Act, as amended by section 403 of this Act,
shall cease to be effective October 1, 2022.</DELETED>
<DELETED> (b) Reporting Requirements.--Section 744I of the Federal
Food, Drug, and Cosmetic Act, as amended by section 404 of this Act,
shall cease to be effective January 31, 2023.</DELETED>
<DELETED> (c) Previous Sunset Provision.--</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED>SEC. 406. EFFECTIVE DATE.</DELETED>
<DELETED> 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.</DELETED>
<DELETED>SEC. 407. SAVINGS CLAUSE.</DELETED>
<DELETED> 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.</DELETED>
<DELETED>TITLE V--REAUTHORIZATION OF OTHER PROGRAMS</DELETED>
<DELETED>SEC. 501. REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY
OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.</DELETED>
<DELETED> 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''.</DELETED>
<DELETED>SEC. 502. REAUTHORIZATION OF PEDIATRIC HUMANITARIAN DEVICE
EXCEPTIONS.</DELETED>
<DELETED> Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking
``2017'' and inserting ``2022''.</DELETED>
<DELETED>SEC. 503. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE
PARTNERSHIPS.</DELETED>
<DELETED> 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''.</DELETED>
<DELETED>SEC. 504. REAUTHORIZATION OF PEDIATRIC DEVICE
CONSORTIA.</DELETED>
<DELETED> Section 305(e) of Pediatric Medical Device Safety and
Improvement Act of 2007 (Public Law 110-85; 42 U.S.C. 282 note) is
amended by striking ``2013 through 2017'' and inserting ``2018 through
2022''.</DELETED>
<DELETED>SEC. 505. REAUTHORIZATION OF ORPHAN GRANTS PROGRAM.</DELETED>
<DELETED> 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''.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``FDA Reauthorization Act of 2017''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--FEES RELATING TO DRUGS
Sec. 101. Short title; finding.
Sec. 102. Authority to assess and use drug fees.
Sec. 103. Reauthorization; reporting requirements.
Sec. 104. Sunset dates.
Sec. 105. Effective date.
Sec. 106. Savings clause.
TITLE II--FEES RELATING TO DEVICES
Sec. 201. Short title; findings.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Conformity assessment pilot program.
Sec. 206. Reauthorization of review.
Sec. 207. Electronic format for submissions.
Sec. 208. Savings clause.
Sec. 209. Effective date.
Sec. 210. Sunset clause.
TITLE III--FEES RELATING TO GENERIC DRUGS
Sec. 301. Short title; finding.
Sec. 302. Definitions.
Sec. 303. Authority to assess and use human generic drug fees.
Sec. 304. Reauthorization; reporting requirements.
Sec. 305. Sunset dates.
Sec. 306. Effective date.
Sec. 307. Savings clause.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Sec. 401. Short title; finding.
Sec. 402. Definitions.
Sec. 403. Authority to assess and use biosimilar fees.
Sec. 404. Reauthorization; reporting requirements.
Sec. 405. Sunset dates.
Sec. 406. Effective date.
Sec. 407. Savings clause.
TITLE V--PEDIATRIC DRUGS AND DEVICES
Sec. 501. Pediatric devices.
Sec. 502. Pediatric drug development.
Sec. 503. Guidance on molecular targets in pediatric oncology.
Sec. 504. Best pharmaceuticals for children.
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. Guidance regarding bioequivalence.
Sec. 605. Patient experience data.
Sec. 606. Communications plans.
Sec. 607. Protecting and strengthening the drug supply chain.
Sec. 608. Technical corrections.
TITLE VII--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS
Sec. 701. Risk-based inspections for devices.
Sec. 702. Improvements to inspections process.
Sec. 703. Reauthorization of inspection program.
Sec. 704. Certificates to foreign governments for devices.
Sec. 705. Facilitating international harmonization.
Sec. 706. Notification of guidance related to lab-developed tests.
Sec. 707. Diagnostic imaging devices intended for use with contrast
agents.
Sec. 708. Diagnostic clarity.
Sec. 709. Appropriate classification of device accessories.
Sec. 710. Device pilot projects.
Sec. 711. Regulation of over-the-counter hearing aids.
TITLE VIII--ADDITIONAL PROVISIONS
Sec. 801. GAO report.
Sec. 802. Streamlining and improving consistency in performance
reporting.
Sec. 803. Analysis of use of funds.
Sec. 804. Information on technology contracting.
Sec. 805. Facilities management.
Sec. 806. Expanded access.
Sec. 807. Technical corrections.
TITLE IX--GENERIC DRUG ACCESS
Subtitle A--Removing Regulatory Barriers to Competition
Sec. 901. Improving access to generic drugs.
Sec. 902. Reporting on pending generic drug applications, priority
review applications, and inspections.
Subtitle B--Incentivizing Competition
Sec. 911. Expediting generic competition.
Sec. 912. List of generic drugs with limited competition.
Sec. 913. Suitability petitions.
Sec. 914. Inspections.
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 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
(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; and
``(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).''.
(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 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) 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 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 the next 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
(B) in subparagraph (B)--
(i) by striking clause (ii);
(ii) by striking ``shall pay'' through
``(i) application fees'' and inserting ``shall
pay application fees''; and
(iii) by striking ``; and'' at the end and
inserting a period.
(e) Effect of Failure To Pay Fees.--Section 736(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(e)) is amended by striking
``all fees'' and inserting ``all such fees''.
(f) Limitations.--Section 736(f)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(f)(2)) is amended by striking
``supplements, prescription drug establishments, and prescription drug
products'' and inserting ``prescription drug program fees''.
(g) Crediting and Availability of Fees.--Section 736(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)) is amended--
(1) in paragraph (3)--
(A) by striking ``2013 through 2017'' and inserting
``2018 through 2022''; and
(B) by striking ``and paragraph (4) of this
subsection''; and
(2) by striking paragraph (4).
(h) Orphan Drugs.--Section 736(k) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(k)) is amended by striking ``product and
establishment fees'' each place it appears and inserting ``prescription
drug program fees''.
SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h-2) is amended--
(1) in subsection (a)(1)--
(A) in the matter before subparagraph (A), by
striking ``2013'' and inserting ``2018''; and
(B) in subparagraph (A), by striking ``Prescription
Drug User Fee Amendments of 2012'' and inserting
``Prescription Drug User Fee Amendments of 2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018''; and
(3) in subsection (d), by striking ``2017'' each place it
appears and inserting ``2022''.
SEC. 104. SUNSET DATES.
(a) Authorization.--Sections 735 and 736 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective
October 1, 2022.
(b) Reporting Requirements.--Section 736B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h-2) shall cease to be effective
January 31, 2023.
(c) Previous Sunset Provision.--Effective October 1, 2017,
subsections (a) and (b) of section 105 of the Food and Drug
Administration Safety and Innovation Act (Public Law 112-144) are
repealed.
SEC. 105. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, or the date of the enactment of this Act, whichever is later,
except that fees under part 2 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act shall be assessed for all human
drug applications received on or after October 1, 2017, 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; FINDINGS.
(a) Short Title.--This title may be cited as the ``Medical Device
User Fee Amendments of 2017''.
(b) Findings.--The Congress finds that the fees authorized under
the amendments made by this title will be dedicated toward expediting
the process for the review of device applications and for assuring the
safety and effectiveness of devices, as set forth in the goals
identified for purposes of part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act in the letters from the Secretary
of Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the Chairman
of the Committee on Energy and Commerce of the House of
Representatives, as set forth in the Congressional Record.
SEC. 202. DEFINITIONS.
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''.
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)--
(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:
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
``Fee Type Year 2018 Year 2019 Year 2020 Year 2021 Year 2022
----------------------------------------------------------------------------------------------------------------
Premarket Application.................................... $294,000 $300,000 $310,000 $328,000 $329,000
Establishment Registration............................... $4,375 $4,548 $4,760 $4,975 $4,978
----------------------------------------------------------------------------------------------------------------
``(3) Total revenue amounts specified.--For purposes of
paragraph (1), the total revenue amounts specified in this
paragraph are as follows:
``(A) $183,280,756 for fiscal year 2018.
``(B) $190,654,875 for fiscal year 2019.
``(C) $200,132,014 for fiscal year 2020.
``(D) $211,748,789 for fiscal year 2021.
``(E) $213,687,660 for fiscal year 2022.''.
(c) Annual Fee Setting; Adjustments.--Section 738(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is amended--
(1) in paragraph (1), by striking ``2012'' and inserting
``2017'';
(2) in paragraph (2)--
(A) in subparagraph (A), by striking ``2014'' and
inserting ``2018'';
(B) by striking subparagraph (B) and 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.'';
(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 changes.--
(A) Section 515(c)(4)(A) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360e(c)(4)(A)) is amended
by striking ``738(h)'' and inserting ``738(g)''.
(B) Section 738 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j), as amended by paragraph
(1), is further 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
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j) is amended--
(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 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
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
``Medical Device User Fee Amendments of 2017'';
and
(B) in subparagraph (B), by striking ``the Medical
Device User Fee Amendments of 2012'' and inserting
``Medical Device User Fee Amendments of 2017''; and
(2) in paragraph (2), by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.
(b) Reauthorization.--Section 738A(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--
(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.
``(2) Secretarial review of accredited laboratory
determinations.--The Secretary may--
``(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 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 prior to such date and recognition of the
accreditation of testing laboratories pursuant to
determinations made prior to such date.''.
SEC. 206. REAUTHORIZATION OF REVIEW.
Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360m) is amended--
(1) in subsection (a)(3)--
(A) in subparagraph (A), by striking clauses (ii)
and (iii) and inserting the following:
``(ii) a device classified under section
513(f)(2) or designated under section 515C(d);
``(iii) a device that is intended to be
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 a
specific life sustaining or life
supporting device;
``(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
(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 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) set forth 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.
SEC. 209. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, or the date of the enactment of this Act, whichever is later,
except that fees under part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act shall be assessed for all
submissions listed in section 738(a)(2)(A) of such Act received on or
after October 1, 2017, regardless of the date of the enactment of this
Act.
SEC. 210. SUNSET CLAUSE.
(a) Authorization.--Sections 737 and 738 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be effective
October 1, 2022.
(b) Reporting Requirements.--Section 738A (21 U.S.C. 739j-1) of the
Federal Food, Drug, and Cosmetic Act (regarding reauthorization and
reporting requirements) shall cease to be effective January 31, 2023.
(c) Previous Sunset Provision.--
(1) In general.--Effective October 1, 2017, section 207(a)
of the Medical Device User Fee Amendments of 2012 (Public Law
112-144) is 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 207.
TITLE III--FEES RELATING TO GENERIC DRUGS
SEC. 301. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Generic Drug
User Fee Amendments of 2017''.
(b) Finding.--The Congress finds that the fees authorized by the
amendments made in this title will be dedicated to human generic drug
activities, as set forth in the goals identified for 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.''.
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 received and applications withdrawn prior
to being received.--The Secretary shall refund
75 percent of the fee paid under subparagraph
(A) for any abbreviated new drug application
that the Secretary considers not to have been
received within the meaning of section
505(j)(5)(A) for a cause other than failure to
pay fees, or that has been 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.'';
(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).
``(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'';
(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''; and
(B) by striking ``2018'' and inserting ``2023''.
(d) Annual Fee Setting.--Section 744B of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-42) is amended--
(1) in subsection (c)(2), by striking ``Such fees may only
be used in fiscal year 2018.''; and
(2) in subsection (d)--
(A) 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).'';
(B) by redesignating paragraph (3) as paragraph
(2); and
(C) 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. 379-42(g)) is amended--
(1) in paragraph (1), by adding at the end the following:
``This paragraph shall cease to be effective on October 1,
2022.'';
(2) in paragraph (2)(C)(ii), by striking ``of
505(j)(5)(A)'' and inserting ``of section 505(j)(5)(A)''; and
(3) by adding at the end the following:
``(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. 379-42(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. 379-42(i)) is amended--
(1) in paragraph (2)--
(A) by striking subparagraph (C) (relating to fee
collection during first program year);
(B) in subparagraph (D)--
(i) in the heading, by striking ``in
subsequent years''; and
(ii) by striking ``(after fiscal year
2013)''; and
(C) by redesignating subparagraph (D) as
subparagraph (C); and
(2) in paragraph (3), by striking ``fiscal years 2013
through 2017'' and inserting ``fiscal years 2018 through
2022''.
(i) Information on Abbreviated New Drug Applications Held by
Applicants and Their Affiliates.--Section 744B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379-42) is amended by adding at the
end the following:
``(o) Information on Abbreviated New Drug Applications Owned by
Applicants and Their Affiliates.--
``(1) In general.--By April 1 of each year, each person
that owns an abbreviated new drug application, or any affiliate
of such person, shall submit to the Secretary a list of--
``(A) all approved abbreviated new drug
applications owned by such person; and
``(B) if any affiliate of such person also owns an
abbreviated new drug application, all affiliates that
own any such abbreviated new drug application and all
approved abbreviated new drug applications owned by any
such affiliate.
``(2) Format and method.--The Secretary shall specify in
guidance the format and method for submission of lists under
this subsection.''.
SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-43) is amended--
(1) in subsection (a)--
(A) by striking ``2013'' and inserting ``2018'';
and
(B) by striking ``Generic Drug User Fee Amendments
of 2012'' and inserting ``Generic Drug User Fee
Amendments of 2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018''; and
(3) in subsection (d), by striking ``2017'' each place it
appears and inserting ``2022''.
SEC. 305. SUNSET DATES.
(a) Authorization.--Sections 744A and 744B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-41; 379j-42) shall cease to be
effective October 1, 2022.
(b) Reporting Requirements.--Section 744C of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-43) shall cease to be effective
January 31, 2023.
(c) Previous Sunset Provision.--Effective October 1, 2017,
subsections (a) and (b) of section 304 of the Food and Drug
Administration Safety and Innovation Act (Public Law 112-144) are
repealed.
SEC. 306. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, or the date of the enactment of this Act, whichever is later,
except that fees under part 7 of 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 on or
after October 1, 2012, but before October 1, 2017, were received by the
Food and Drug Administration within the meaning of 505(j)(5)(A) of such
Act (21 U.S.C. 355(j)(5)(A)), prior approval supplements that were
submitted, and drug master files for Type II active pharmaceutical
ingredients that were first referenced with respect to assessing and
collecting any fee required by such part for a fiscal year prior to
fiscal year 2018.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
SEC. 401. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Biosimilar User
Fee Amendments of 2017''.
(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 all urban consumers (all
items; United States city average) (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 divided by such index for September 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'';
(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 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 the heading of subparagraph (F) of paragraph (1),
by striking ``biosimilar development program fees'' and
inserting ``biosimilar biological product development fees'';
(12) in paragraph (1)(F)--
(A) in the heading of subparagraph (F), by striking
``biosimilar development program'' before ``fees''; 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).'';
(13) in paragraph (2)--
(A) in the heading of paragraph (2), by striking
``and supplement'';
(B) by amending subparagraphs (A) and (B) to read
as follows:
``(A) In general.--Each person that 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).
``(B) Rule of applicability; treatment of certain
previously paid fees.--Any person who pays a fee under
subparagraph (A), (B), or (D) of paragraph (1) for a
product before October 1, 2017, but submits a
biosimilar biological product application for that
product after such date, shall--
``(i) be subject to any biosimilar
biological product application fees that may be
assessed at the time when such biosimilar
biological product application is 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''; and
(D) in subparagraphs (C) through (F)--
(i) by striking ``or supplement'' each
place it appears; and
(ii) in subparagraph (D), by striking ``or
a supplement''; and
(14) 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
``(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
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;
(2) in subsections (a)(2)(F) and (g), 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
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 long-term financial planning
purposes.
``(B) General application and methodology.--
Beginning with the first fiscal year for which the
capacity planning adjustment under paragraph (2) is
effective, the Secretary may, in addition to the
adjustments under 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) 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 assessment of the workload for the
process for the review of biosimilar biological product
applications.
``(B) Methodology.--The Secretary shall publish
under paragraph (5) a description of the methodology
used to calculate the fiscal year 2018 adjustment under
this paragraph in the Federal Register notice
establishing fee 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 ``shall pay--'' and all that follows
through ``application fees'' and inserting ``shall pay
application fees''; and
(3) by striking ``; and'' at the end and inserting a
period.
(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''.
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, as amended by section 403 of this Act, shall
cease to be effective October 1, 2022.
(b) Reporting Requirements.--Section 744I of the Federal Food,
Drug, and Cosmetic Act, as amended by section 404 of this Act, shall
cease to be effective January 31, 2023.
(c) Previous Sunset Provision.--
(1) In general.--Effective October 1, 2017, section 404 of
the Food and Drug Administration Safety and Innovation Act
(Public Law 112-144) is repealed.
(2) Conforming amendment.--The Food and Drug Administration
Safety and Innovation Act (Public Law 112-144) is amended in
the table of contents in section 2 by striking the item
relating to section 404.
SEC. 406. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, or the date of the enactment of this Act, whichever is later,
except that fees under part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act shall be assessed for all
biosimilar biological product applications received on or after October
1, 2017, regardless of the date of the enactment of this Act.
SEC. 407. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 8 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act, as in effect on the day before the date of the 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.
TITLE V--PEDIATRIC DRUGS AND DEVICES
SEC. 501. PEDIATRIC DEVICES.
(a) Pediatric Use of Devices.--Section 515A of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360e-1) is amended--
(1) in subsection (a)(3)--
(A) by redesignating subparagraphs (B) through (D)
as subparagraphs (D) through (F), respectively;
(B) by inserting after subparagraph (A) the
following:
``(B) an assessment of pediatric device labeling
needs based on a review of real world evidence
collected on the off-label use of medical devices in
children, using data available to the Secretary;
``(C) the number of devices that receive a
humanitarian use exemption under section 520(m);'';
(C) in subparagraph (E), as so redesignated, by
striking ``; and'' and inserting ``;'';
(D) in subparagraph (F) (as so redesignated), by
striking ``(B), and (C).'' and inserting ``(C), (D),
and (E); and''; and
(E) by adding at the end the following:
``(G) the number of devices for which extrapolation
was used to support the approval of pediatric labeling
of such devices.
For the items described in this paragraph, such report shall
disaggregate the number of devices by pediatric
subpopulation.'';
(2) by redesignating subsection (c) as subsection (d); and
(3) by inserting after subsection (b), the following:
``(c) Pediatric Device Innovation.--
``(1) In general.--The Secretary shall, not later than 1
year after the date of enactment of the FDA Reauthorization Act
of 2017, establish within the Center for Devices and
Radiological Health a structure to--
``(A) provide assistance to device manufacturers
that would result in the development, approval, and
labeling of medical devices for children;
``(B) oversee an internal pediatrics team that--
``(i) is comprised of employees of the Food
and Drug Administration with expertise in
pediatrics and appropriate expertise pertaining
to the relevant devices under review; and
``(ii) provides expertise and consultation,
to all applicable divisions within the Center
for Devices and Radiological Health, on--
``(I) the application of subsection
(b), section 520(m), section 510(k),
and section 522 of this Act and section
402 of the Public Health Service Act to
pediatric devices; and
``(II) pediatrics, as it pertains
to reviewing devices;
``(C) coordinate pediatric activities within the
Center for Devices and Radiological Health; and
``(D) collaborate with other programs, offices, and
centers of the Food and Drug Administration, including
the consortia program authorized under section 305 of
the Pediatric Medical Device Safety and Improvement Act
of 2007.
``(2) Staff.--Such structure shall include a chief
pediatric medical officer and other appropriate individuals, as
the Secretary determines necessary.''.
(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;
(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 ``2017'' and inserting
``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 regarding opportunities
and barriers to the development, approval, and labeling of
pediatric medical devices. Such meeting shall include
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 children that would result in the
approval and labeling of medical devices for children;
(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 manufactures in developing
devices for children that are approved and labeled for
their use; and
(E) identify current barriers to pediatric device
development and incentives to address such barriers.
(3) Report.--Not later than 6 months after the meeting
described in paragraph (1), the Secretary of Health and Human
Services 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, and publish,
including on the Internet website of the Food and Drug
Administration, a report that summarizes and responds to the
recommendations raised in such meeting.
SEC. 502. PEDIATRIC DRUG DEVELOPMENT.
(a) Early Meeting on Pediatric Study Plan.--
(1) 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 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, 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 any scientific
or operational challenges that may be
the basis of a deferral under
subsection (a)(3) or a full or partial
waiver under subsection (a)(4);''.
(2) Conforming changes.--Section 505B(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)) is amended--
(A) in the heading of paragraph (2), by striking
``meeting'' and inserting ``meetings'';
(B) in the heading of paragraph (2)(C), by striking
``Meeting'' and inserting ``Meetings'';
(C) 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
(D) in paragraph (3) by striking ``meeting under
paragraph (2)(C)(i)'' and inserting ``meeting under
paragraph (2)(C)(i)(II)''.
(b) 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.''.
(c) 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 of a proposed pediatric study request
or a sponsor's proposed amendment to a written request for
pediatric studies within 120 calendar days of the
submission.''.
(2) Conforming amendments.--
(A) FFDCA.--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) PHSA.--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)''.
(d) Study.--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, 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 subsection (a);
(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 the Federal Food, Drug, and Cosmetic 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).
(e) 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.
(f) 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 all letters and responses to such
letters issued under this paragraph.''.
(g) 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''.
SEC. 503. GUIDANCE ON MOLECULAR TARGETS IN PEDIATRIC ONCOLOGY.
(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, shall issue guidance on the development
of oncology drugs or biological products directed at molecular targets,
including for pediatric populations.
(b) Collaboration; Public Meeting.--In developing the guidance
under subsection (a), 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 180
days after the date of enactment of this Act to solicit feedback from
physicians and researchers (including pediatric oncologists), patients,
and other stakeholders to provide input on development of the guidance.
The Secretary shall seek input at such meeting on--
(1) the scientific data necessary to determine when an
oncology drug or biological product directed at a molecular
target is sufficient to support pediatric clinical development
given the ethical, practical, and other barriers to clinical
investigations in the pediatric population;
(2) how to determine relevancy of a molecular target to the
growth or progression of a pediatric cancer, including the
clinical data necessary to make such a determination;
(3) how to overcome the challenges related to pediatric
oncology drug development, including issues related to
conducting clinical trials in pediatric rare cancers with small
patient populations;
(4) the advantages and disadvantages of innovative clinical
trial designs in addressing the development of oncology drugs
or biological products directed at molecular targets in
pediatric cancer patients; and
(5) 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.
SEC. 504. BEST PHARMACEUTICALS FOR CHILDREN.
Section 409I of the Public Health Service Act (42 U.S.C. 284m) is
amended--
(1) in subsection (a)(2)(A)(ii), by inserting ``and
identification of biomarkers for such diseases, disorders, or
conditions,'' after ``biologics,'';
(2) in subsection (c)--
(A) in paragraph (6)(B)--
(i) by striking ``shall be assigned a
docket number by the Commissioner of Food and
Drugs'' and inserting ``, not later than 90
days after submission, shall be posted on the
Internet website of the Food and Drug
Administration in an accessible manner''; and
(ii) by striking ``become part of the
docket file with respect to each of the drugs''
and inserting ``be posted on the Internet
website of the Food and Drug Administration'';
and
(B) in paragraph (7)--
(i) in the matter preceding subparagraph
(A), by striking ``submitted'' and inserting
``posted''; and
(ii) in subparagraph (C), by striking ``(i)
place'' and all that follows through the period
at the end and inserting ``publish through
posting on the Internet website of the Food and
Drug Administration a summary of the report and
a copy of any requested labeling changes.'';
(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''.
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. GUIDANCE REGARDING BIOEQUIVALENCE.
(a) In General.--In accordance with subsection (b), the Secretary
of Health and Human Services, acting through the Commissioner of Food
and Drugs, shall issue product-specific guidance that--
(1) applies to complex non-biologic drugs; and
(2) outlines how to demonstrate bioequivalence to the
reference drug, in order to facilitate generic development for
such drugs.
(b) Deadline for Issuing Guidance.--After the date of enactment of
this Act, the Secretary of Health and Human Services, acting through
the Commissioner of Food and Drugs, shall publish a guidance, for each
complex non-biologic drug that is approved under section 505(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)), not less than
2 years prior to the earliest date on which an abbreviated new drug
application may be submitted pursuant to section 505(j) of the Federal,
Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) that references such
drug.
(c) Applicability.--This section applies to guidances for
abbreviated new drug applications that reference new drug applications
first approved on or after October 1, 2017.
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 ``physical
and psychosocial impacts of such disease or condition, related therapy,
or clinical investigation''.
SEC. 606. COMMUNICATIONS 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 the meaning of terms related to drug
formulations or properties that are described in the
drug labeling, 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. 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(j), 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,
the manufacturer has not authorized the drug to be marketed in the
United States, and the manufacturer has not 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 selling or dispensing, or holding for sale or
dispensing, a drug that is a counterfeit drug shall be fined under
title 18, United States Code, imprisoned for not more than 10 years, or
both, unless the person acted in good faith and had no reason to
believe the drug was a counterfeit drug.''.
SEC. 608. TECHNICAL CORRECTIONS.
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). Until such time as the Secretary
promulgates regulations in accordance with this subsection, any
definitions set forth in regulations implementing this section that
were promulgated prior to the date of enactment of the FDA
Reauthorization Act of 2017 shall continue to apply.''.
TITLE VII--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS
SEC. 701. RISK-BASED INSPECTIONS FOR DEVICES.
(a) In General.--Section 510(h) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(h)) is amended--
(1) by striking paragraph (2) and inserting the following:
``(2) Risk-based schedule for devices.--
``(A) In general.--The Secretary, acting through
one or more officers or employees duly 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.''; and
(2) in paragraph (4)--
(A) in the matter preceding subparagraph (A), by
striking ``paragraph (3)'' and inserting ``paragraph
(2) or (3)''; and
(B) in subparagraph (C), by inserting ``or device''
after ``drug''.
(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.
(a) Inspection Procedure.--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 that are not for-cause
inspections, the Secretary shall review existing processes and
standards for inspections of domestic and foreign device
establishments, and update such processes and standards to ensure
uniform processes and standards, with exceptions as appropriate. Such
processes and standards shall include--
``(A) announcing the inspection to the establishment within
a reasonable time before such inspection, which shall include
notification to the owner, operator, or agent in charge of the
establishment regarding the type and nature of the inspection;
``(B) providing a reasonable estimate of the timeframe for
the duration of the inspection, an opportunity for advancing
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 records that will be requested in
order to expedite the inspection; and
``(C) providing for requirements with respect to the
frequency and conditions of 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) Nothing in this subsection affects the authority of the
Secretary to conduct inspections otherwise permitted under this Act in
order to ensure compliance.''.
(b) Report Responses.--Section 704(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 374(b)) is amended--
(1) by striking ``Upon completion'' and inserting ``(1)
Upon completion''; and
(2) by adding at the end the following:
``(2) In the case of establishments registered under section 510
that have received a report pursuant to paragraph (1), and for which
the owner, operator, or agent in charge of such establishment submits a
timely response to such report that includes a request for feedback to
the actions proposed in such response, and which involves a public
health priority, the Secretary shall provide nonbinding feedback
regarding such proposed actions within 45 days of receipt of such
request.''.
(c) Guidance.--
(1) Draft guidance.--Not later than 1 year after the date
of enactment of this Act, the Secretary of Health and Human
Services shall issue draft guidance that--
(A) specifies how the Food and Drug Administration
will implement the process described in subsection (h)
of section 704 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 374), as amended by this section, and
the requirements described in subsection (b)(2) of such
section;
(B) provides standard methods for communications
described in such subsections;
(C) establishes standard timeframes over
consecutive days applicable to both domestic and
foreign inspections, to which each inspector shall
adhere unless an investigator can identify to the
establishment a reason that more time is needed; and
(D) identifies practices for investigators and
device establishments to facilitate the continuity of
inspections.
(2) Final guidance.--Not later than 18 months after the
close of the comment period on the draft guidance under
paragraph (1), the Secretary shall issue final guidance
consistent with such paragraph.
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.
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, the Secretary shall provide a substantive summary
of the specific grounds for noncompliance identified.
``(III) With respect to a device manufactured in an establishment
that has received a report under section 704(b), the Secretary shall
not deny a request for certification with respect to a device pursuant
to subparagraph (A)(ii) if the Secretary and the owner, operator, or
agent in charge of such establishment have 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 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.''; and
(2) by moving the margins of subparagraphs (C) and (D) 4
ems to the left.
SEC. 705. FACILITATING INTERNATIONAL HARMONIZATION.
Section 704(g) of the Federal Food, Drug and Cosmetic Act (21
U.S.C. 374) is amended by adding at the end the following:
``(15) Notwithstanding any other provision of this
subsection, for purposes of conducting inspections of
establishments that manufacture, prepare, propagate, compound,
or process devices except types of devices licensed under
section 351 of the Public Health Service Act, which inspections
are required under section 510(h) or are inspections of such
establishments required to register pursuant to section 510(i),
the Secretary may recognize auditing organizations that are
recognized by organizations established by governments to
facilitate international harmonization. Nothing in this
paragraph affects the authority of the Secretary to inspect any
device establishment pursuant to this Act. Nothing in this
paragraph affects the authority of the Secretary to determine
the official classification of an inspection.''.
SEC. 706. NOTIFICATION OF GUIDANCE RELATED TO LAB-DEVELOPED TESTS.
Section 1143 of the Food and Drug Administration Safety and
Innovation Act (Public Law 112-144) is amended--
(1) in subsection (a), by striking ``60'' and inserting
``90''; and
(2) in subsection (b), by striking ``5'' and inserting
``10''.
SEC. 707. DIAGNOSTIC IMAGING DEVICES INTENDED FOR USE WITH CONTRAST
AGENTS.
Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360j) is amended by adding at the end the following:
``(p)(1) The Secretary may approve an application or supplement to
an application under section 515 for an applicable medical imaging
device, may make a substantial equivalence determination as to an
applicable medical imaging device for which a report or a supplement to
a report has been submitted under section 510(k), or may grant a
request under section 513(f)(2) for an applicable medical imaging
device if the requirements of this subsection and other applicable
premarket requirements are met, and the indications and conditions of
use proposed in such application or notification involve 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 such contrast agent, unless the Secretary
determines, based on information contained in the application
or report, that the difference does not adversely affect the
safety or 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, unless the Secretary determines, based on
information contained in the device application, request, or
report, that any difference does not affect the safety or
effectiveness of the contrast agent when used with the device;
``(C) in a patient population different from the patient
population in the approved labeling for such contrast agent,
unless the Secretary determines, based on information contained
in the application or report, that the difference does not
adversely affect the safety or effectiveness of the contrast
agent when used with the device; or
``(D) in an imaging modality, such as ultrasound, magnetic
resonance, x-ray, fluorescent imaging technology, or diagnostic
radiopharmaceutical-based technology that is different from
those described in the approved labeling of the contrast agent.
``(2) An applicable medical imaging device that is eligible for
approval under section 515, clearance under section 510(k), or
classification under section 513(f)(2), or approval, clearance, or
classification as described in paragraph (1) shall be subject only to
such requirements of this Act that are applicable to devices.
``(3) An application under section 515, report under section
510(k), or classification under section 513(f)(2) for an applicable
medical imaging device intended for use in conjunction with a contrast
agent to which clause (ii) or (iii) of section 505(c)(3)(E) applies
shall refer to such contrast agent in such application, report, or
request by trade or brand name, rather than to the international
nonproprietary name.
``(4) In conducting a review of an application or report submitted
for an applicable medical imaging device, the agency center charged
with the premarket review of devices center may consult with the agency
center charged with the premarket review of drugs and biological
products.
``(5) 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 a use that is not described in
the indications and usage section of the approved labeling of
such contrast agent or the approved labeling of any contrast
agent in such class, as applicable; 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 sections 315.2 and 601.30 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.''.
SEC. 708. DIAGNOSTIC CLARITY.
Not later than 18 months after the date of enactment of this Act,
the Secretary of Health and Human Services (referred to in this section
as the ``Secretary'') shall update guidance with respect to the
circumstances under which reagents, new instruments, or new
combinations of instruments may be added to groups of instruments that
have been cleared under section 510(k) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(k)). The updated guidance shall provide
standard definitions and describe procedures for sponsors seeking to
add a new instrument, reagent, or combination of instruments to a
cleared group of instruments to submit information to the Secretary
demonstrating that the new reagent, new instrument, or new combination
of instruments does not alter the assay's performance, as applicable.
The Secretary shall consult with affected entities and other
stakeholders in updating the guidance.
SEC. 709. APPROPRIATE CLASSIFICATION OF DEVICE ACCESSORIES.
Section 513(b)(9) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360c(b)(9)) is amended--
(1) by striking ``(9) The Secretary'' and inserting
``(9)(A) The Secretary''; and
(2) by adding at the end the following:
``(B) The classification of any accessory classified prior to
December 13, 2016, based on the intended use or uses of such accessory,
shall continue to apply, unless otherwise determined by the Secretary
under section 515(e)(1).
``(C)(i) If an accessory has been cleared or approved based on the
classification of another device with which such accessory is intended
to be used and the Secretary has established a classification for such
accessory based on the intended use or uses of the accessory, in
accordance with subparagraph (A), the manufacturer of such accessory
may identify the classification so established for such accessory in a
written notification to the Secretary.
``(ii) Unless the Secretary notifies a manufacturer within 30
calendar days of receipt of a written notification described in clause
(i) that the Secretary does not agree that the classification
identified in such written notification is appropriate for the
accessory, the accessory shall be automatically reclassified in
accordance with the classification identified in such written
notification.
``(iii) A written notification that the Secretary disagrees with
the classification identified in a written notification described in
clause (ii) shall include a detailed description and justification for
the determination to disagree.
``(D)(i) A manufacturer of an accessory that has not been
classified by the Secretary based on the intended use or uses of the
accessory as described in subparagraph (A), and for which the Secretary
has not established a classification for the accessory type as a stand-
alone device, may submit to the Secretary a written recommendation for
the appropriate classification of such accessory based on its intended
use or uses. Such submission shall include such information to support
the recommendation as the Secretary may require.
``(ii) The Secretary shall respond to a submission under clause (i)
within 60 calendar days of receiving the submission by approving or
denying the recommended classification of the accessory. If the
Secretary does not agree with the recommendation for classification
submitted by the sponsor, the response shall include a detailed
description and justification for such determination to disagree. The
Secretary shall provide an opportunity for a manufacturer to meet with
appropriate personnel to discuss appropriate classification of such
accessory prior to submitting a written recommendation.
``(E)(i) At the time a sponsor submits an application for premarket
approval pursuant to section 515(c) or a report pursuant to 510(k), the
sponsor of such application or report may include a recommendation and
supporting information for the proper classification of an accessory
pursuant to subparagraph (A), if applicable. If such accessory type has
not been classified by the Secretary based on its intended use or uses
as a stand-alone device as described in subparagraph (A), the Secretary
shall--
``(I) approve or deny such application pursuant to section
515(d), or find such report substantially equivalent or not
substantially equivalent pursuant to section 510(k); and
``(II) approve or deny the classification of the accessory
proposed in such application or report.
``(F) A manufacturer may at any time use the classification process
described in section 513(f)(2) to obtain classification of an
accessory.''.
SEC. 710. DEVICE PILOT PROJECTS.
(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) Pilot Projects.--
``(1) In general.--In order to provide timely and reliable
information on the safety and effectiveness of cleared or
approved devices, 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 device or device type, or
continue existing projects, in accordance with paragraph (3),
that meet all of the following requirements:
``(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 not included in such project.
``(C) Are 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 consumer groups and device manufacturers.
``(D) Use electronic health data including claims
data, patient survey data, and any other data, as the
Secretary determines appropriate.
``(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 has received public
recommendations in accordance with paragraph
(2)(B) and has determined to meet one of the
criteria under clauses (i) through (iii) and is
appropriate for a project under this
subsection.
``(2) Participation.--The Secretary shall establish the
conditions and processes for--
``(A) authorizing voluntary participation of a
manufacturer of a device in the pilot project described
in paragraph (1); and
``(B) facilitating public recommendations for
devices to be prioritized under the pilot project
described in paragraph (1), including requirements for
the data necessary to support such recommendation.
``(3) Implementation.--The Secretary may satisfy the
requirements of paragraphs (1) and (2) by continuing or
expanding existing projects, or by beginning new projects, that
meet the criteria of subparagraphs (A) through (E) of paragraph
(1) or 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 additional conditions:
``(A) If such public or private entities are a
component of another organization, the entities have
established appropriate security measures to maintain
the confidentiality and privacy of the data described
in paragraph (1)(D) and the entity shall not make an
unauthorized disclosure of such data to the other
components of the organization in breach of such
confidentiality and privacy requirements.
``(B) In the case of the termination or nonrenewal
of such contracts, cooperative agreements, grants, or
other appropriate agreements, the entities shall comply
with each of the following:
``(i) Continue to comply with the
confidentiality and privacy requirements under
this subsection with respect to all data
disclosed to the entity.
``(ii) Return any data disclosed to such
entity under this subsection to which it would
not otherwise have access or, if returning the
data is not practicable, destroy the data.
``(C) Have at least one of the following
qualifications:
``(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 in place to support electronic
data and operational standards to provide
security for such data, as appropriate.
``(iii) Experience with, and expertise on,
the development of device safety and
effectiveness research and surveillance using
electronic health data.
``(iv) Other expertise which the Secretary
determines necessary to fulfill the activities
under this subsection.
``(4) Review of contract in the event of a merger or
acquisition.--The Secretary shall review a contract with a
qualified entity under this subsection in the event of a merger
or acquisition of the entity in order to ensure that the
requirements under this subsection will continue to be met.
``(5) Report to congress.--Not later than 18 months after
the date of enactment of the FDA Reauthorization Act of 2017,
and annually thereafter, the Secretary 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 a report containing a description of the pilot
projects being conducted pursuant to this subsection, including
for each pilot project--
``(A) how the project is being implemented in
accordance with paragraph (3) and the contractor or
grantee as applicable;
``(B) the number of manufacturers that have agreed
to participate;
``(C) the data sources used;
``(D) the devices or device categories involved;
and
``(E) the number of patients involved.
``(6) Compliance with requirements for records or reports
on devices.--The participation of a manufacturer in a pilot
project under this subsection shall not affect the eligibility
of such manufacturer to participate in any quarterly reporting
program implemented under this Act. The Secretary may determine
that, for the specified time period to be determined by the
Secretary, a manufacturer's participation in a pilot project
under this subsection may meet certain other 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 the pilot public, to the extent possible, if
collected pursuant to this section or section 522.
``(7) Privacy requirements.--With respect to the pilot
projects conducted pursuant to this subsection--
``(A) individual identifiable health information
shall not be disclosed when presenting any information
from such project; and
``(B) such projects shall comply with 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.
``(8) Other compliance.--Any pilot program undertaken in
coordination with the comprehensive system described in
paragraph (1)(C), including pilot projects under this
subsection, that relates to the use of real world evidence for
devices shall comply with paragraph (1)(B), the conditions
listed in subparagraphs (A) and (B) of paragraph (3), and
paragraphs (4), (5), (6), and (7).
``(9) Sunset.--This subsection shall cease to have force or
effect on 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.
SEC. 711. 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 707, is further
amended by adding at the end the following:
``(q) Regulation of Over-the-Counter Hearing Aids.--
``(1) Definition.--In this subsection, the term `over-the-
counter hearing aid' means a device that--
``(A) 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);
``(B) is intended to be used by adults over the age
of 18 to compensate for perceived mild to moderate
hearing impairment;
``(C) 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;
``(D) may--
``(i) use wireless technology; or
``(ii) include tests for self-assessment of
hearing loss; and
``(E) 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.
``(2) Regulation.--An over-the-counter hearing aid shall be
subject to the regulations promulgated in accordance with
section 711(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 efficacy of over-the-
counter 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 the over-the-counter hearing aid, including how
consumers may report adverse events, any conditions or
contraindications, and any advisements to consult
promptly with a licensed physician; 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 over-the-
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, or
order specifically applicable to hearing products that would
restrict or interfere with the servicing, marketing, sale,
dispensing, use, customer support, or distribution of over-the-
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 over-
the-counter hearing aids.
(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) Study.--Not later than 3 years after the date of enactment of
this Act, the Comptroller General of the United States shall submit to
Congress a report evaluating consumer experience with hearing health
care, hearing screening in the primary care setting, and consumer
adoption, usage, and outcomes related to hearing technology. The
Comptroller General shall update such report not later than 2 years
after the final regulations described in subsection (b) are issued, and
shall evaluate how implementation of such regulations has impacted
hearing health care, including recommendations for improving consumer
access to appropriate hearing health care.
TITLE VIII--ADDITIONAL PROVISIONS
SEC. 801. GAO REPORT.
(a) In General.--Not later than September 30, 2018, the Comptroller
General of the United States shall issue a report, after consultation
with patients and drug and medical device manufacturers, regarding the
implementation of sections 569A and 569B of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-8a, 360bbb-8b). Such report shall assess
the progress the Food and Drug Administration has made on--
(1) working with other regulatory authorities of similar
standing to foster and encourage uniform, scientifically driven
clinical trial standards with respect to medical products
around the world;
(2) providing consistent parallel scientific advice to
manufacturers seeking simultaneous global development and
approval of new medical products, in coordination with
regulatory authorities of similar standing; and
(3) facilitating the use of foreign clinical trial data to
minimize duplicative clinical trials.
(b) Additional Requirements.--The report under subsection (a) shall
include specific examples, if possible and available, and a list of
activities at the Food and Drug Administration regarding the
harmonization of premarket medical product requirements.
SEC. 802. STREAMLINING AND IMPROVING CONSISTENCY IN PERFORMANCE
REPORTING.
(a) PDUFA.--Section 736B(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379h-2(a)) is amended--
(1) in paragraph (1)(B)--
(A) in clause (vi), by inserting ``and the number
of designations and denials issued by the agency for
such applications'' before the semicolon;
(B) in clause (vii), by striking ``; and'' and
inserting ``and the number of designations and denials
issued by the agency for such applications; and''; and
(C) in clause (viii) by striking the period and
inserting ``and the number of designations and denials
issued by the agency for such applications.''; and
(2) by inserting after paragraph (2) the following:
``(3) Real time reporting.--
``(A) In general.--Beginning with fiscal year 2018,
every 30 calendar days, the Secretary shall post the
data described in subparagraph (B) on the Internet
website of the Food and Drug Administration and remove
duplicative data from the annual performance report.
``(B) Data.--The following data is required to be
posted in accordance with subparagraph (A):
``(i) The number and titles of draft and
final guidance issued by the Center for Drug
Evaluation and Research or the Center for
Biologics Evaluation and Research, and the
justification for the issuance and finalization
of each such guidance.
``(ii) The number and titles of public
meetings held by the Center for Drug Evaluation
and Research and the Center for Biologics
Evaluation and Research each fiscal year.
``(iii) The list of standard new drug
applications and biologics license
applications, by fiscal year of receipt.
``(iv) The number of filed applications by
each review division.
``(4) Capacity planning and improved time reporting.--
Beginning with fiscal year 2020, the Secretary shall include in
the annual report under paragraph (1)--
``(A) the number of full-time equivalents agreed
upon in the letters described in section 101(b) of the
Prescription Drug User Fee Amendments of 2017 and the
number of appropriated full time equivalents 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) identification by name of all time reporting
categories that Food and Drug Administration uses for
capacity planning and time reporting with respect to
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,
pursuant to the `resource capacity planning and
modernized time reporting implementation plan' in the
letters described in section 101(b) of the Prescription
Drug User Fee Amendments of 2017;
``(C) the processes by which 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 require
reporting on the amount of an employee's time that is
dedicated to the review of human drug applications, as
required by the letters described in section 101(b) of
the Prescription Drug User Fee Amendments of 2017,
including information regarding employees dedicated to
such activities on a full-time basis, and employees
dedicated to such activities on a part-time basis; and
``(D) 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
described in subparagraph (C) (both full-time
equivalents and employees dedicated to such activities
on a part-time basis) for whom time reporting is
required as described in subparagraph (C), and the
number of such employees required to estimate time
dedicated to the review of human drug applications.''.
(b) MDUFA.--Section 738A(a)(1)(A) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-1(a)(1)(A)) is 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, for each review
division--
``(I) the number of premarket
applications filed under section 515
per fiscal year for each review
division, and the number of approvable
letters, major deficiency letters, not
approvable letters, and denials for
such applications;
``(II) the number of reports filed
under section 510(k) per fiscal year
for each review division and the number
of devices cleared or not substantially
equivalent for such reports; and
``(III) the number of expedited
access pathway designations for a
fiscal year for each review division
and the number of cleared or approved
devices or denials for such
applications.
``(iii) Real time reporting.--
``(I) In general.--Beginning with
fiscal year 2018, the Secretary shall,
every 30 calendar days, post the data
described in subclause (II) on the
Internet website of the Food and Drug
Administration and remove duplicative
data from the annual report under this
subparagraph.
``(II) Data.--The following data is
required to be posted in accordance
with subclause (I):
``(aa) The number and
titles of draft and final
guidance issued by the Center
for Devices and Radiological
Health and the justification
for the issuance and
finalization of such guidance.
``(bb) The number and
titles of public meetings held
by the Center for Devices and
Radiological Health each fiscal
year.''.
(c) GDUFA.--Section 744C(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j-43(a)) is 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 Office of Generic Drugs in achieving the goals,
and future plans for meeting the goals, including--
``(A) the number of original abbreviated new drug
applications filed per fiscal year;
``(B) the number of amendments to abbreviated new
drug applications filed per fiscal year; and
``(C) the number of actions taken delineated by the
type of action, including final approvals, tentative
approvals, complete response letters, and the number of
`refuse to receive' letters issued by the Food and Drug
Administration per fiscal year.
``(3) Real time reporting.--
``(A) In general.--Beginning with fiscal year 2018,
the Secretary shall, every 30 calendar days, post the
data described in subparagraph (B) on the Internet
website of the Food and Drug Administration and remove
duplicative data from the annual report under this
subsection.
``(B) Data.--The following data is required to be
posted in accordance with subparagraph (A):
``(i) The number and titles of draft and
final guidance issued by the Office of Generic
Drugs and the justification for the issuance
and finalization of such guidance.
``(ii) The number and titles of public
meetings held by the Office of Generic Drugs
each fiscal year.''.
(d) BsUFA.--Section 744I(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j-53(a)) is 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 Center for Biologics Evaluation and Research 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 or complete response letters 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 or complete response
letters issued by the agency for such applications.
``(3) Real time reporting.--
``(A) In general.--Beginning with fiscal year 2018,
the Secretary shall, every 30 calendar days, post the
data described in subparagraph (B) on the Internet
website of the Food and Drug Administration and remove
duplicative data from the annual report under this
subsection.
``(B) Data.--The following data is required to be
posted in accordance with subparagraph (A):
``(i) The number and titles of draft and
final guidance issued by the Center for Drug
Evaluation and Research and the Center for
Biologics Evaluation and Research and the
justification for the issuance and finalization
of such guidance.
``(ii) The number and titles of public
meetings held by the Center for Drug Evaluation
and Research and the Center for Biologic
Evaluation and Research each fiscal year.''.
``(4) Capacity planning and time reporting.--Beginning with
fiscal year 2020, the Secretary shall include in the annual
report under paragraph (1)--
``(A) the number of full-time equivalents agreed
upon in the letters described in section 401(b) of the
Biosimilar User Fee Amendments of 2017 and the number
of appropriated full time equivalents 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) identification by name of all time reporting
categories that the Food and Drug Administration uses
for capacity planning and time reporting under the
`resource capacity planning and modernized time
reporting implementation plan' in the letters described
in section 401(b) of the Biosimilar User Fee Amendments
of 2017 for 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;
``(C) the process by which 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 require
reporting on the amount of an employee's time that is
dedicated to the review of biosimilar biological
product applications, required pursuant to the letters
described in section 401(b) of the Biosimilar User Fee
Amendments of 2017, including information regarding
both employees dedicated to such activities on a full-
time basis, and employees dedicated to such activities
on a part-time basis; and
``(D) 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 actual number of
employees described in subparagraph (C) (both full-time
equivalents and employees dedicated to such activities
on a part-time basis) for whom time reporting is
required as described in subparagraph (C), and the
number of such employees required to estimate time
dedicated to the review of biosimilar biological
product applications.''.
SEC. 803. ANALYSIS OF USE OF FUNDS.
(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 802(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 number of human
drug applications filed and the number of approvals or
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;
``(ii) such applications pending with the
Center for Drug Evaluation and Research and the
Center for Biologics Evaluation and Research
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 corresponding fiscal year and the
future plans of the Food and Drug
Administration to meet these goals; and
``(iii) the most common causes within the
agency for missing such goals.
``(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 corresponding fiscal year.
``(C) External or other circumstances impacting the
Center for Drug Evaluation and Research, the Center for
Biologics Evaluation and Research, or the Food and Drug
Administration, that impacted the ability of the agency
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) 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 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 upon submission of the performance report
in subsection (a) for the corresponding fiscal year. 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 corresponding fiscal year have been met, the
corrective action report shall include a summary of goals met,
and recommendations on ways in which the Secretary can improve
and streamline the human drug application review process.
``(2) Goals missed.--For each of the goals identified in
the letters described in section 101(b) of the Prescription
Drug User Fee Amendments of 2017 for the corresponding fiscal
year that the Secretary determines to not have been met, the
corrective action report shall include a detailed justification
for such determination and--
``(A) a detailed description of the circumstances
under which each drug application that missed the
review goal time was approved during the first cycle
review, as applicable;
``(B) aggregate data on the circumstances for all
unapproved drug applications for which the review goal
time was missed; and
``(C) the performance enhancement goals that were
not achieved during the previous fiscal year and a
detailed description of efforts the agency has put in
place for the current fiscal year to improve the
ability of the agency to meet each such goal, while
maintaining standards of approval, for the current
fiscal year.
``(d) Enhanced Communication.--
``(1) Communications with congress.--Each fiscal year, as
applicable, representatives from the Center for Drug Evaluation
and Research and the Center for Biologics Evaluation and
Research 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, representatives from the Center for Drug
Evaluation and Research and the Center for Biologics Evaluation
and Research 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.
``(3) Publicly available updates.--The Secretary shall
provide an update on progress made for the corrective action
report during the following fiscal year on the publically
available Internet website of the Food and Drug Administration
every 30 business days.''.
(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 802(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:
``(I) The difference between the
number of premarket applications filed
under section 515 and applications
filed under section 510(k) and the
number of major deficiency letters, not
approvable letters, and denials for
such applications issued by the agency,
accounting for--
``(aa) such applications
filed during one fiscal year
for which a decision is not
scheduled to be made until the
following fiscal year;
``(bb) such applications
pending with the Center for
Devices and Radiological Health
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
corresponding fiscal year and
the future plans of the Food
and Drug Administration to meet
these goals; and
``(cc) the most common
causes within the agency for
missing such goals.
``(II) Relevant data to determine
whether the Center Devices and
Radiological Health have met
performance enhancement goals
identified by the letters described in
section 201(b) of the Medical Device
User Fee Amendments of 2017 for the
corresponding fiscal year.
``(III) External or other
circumstances impacting the Center
Devices and Radiological Health or the
Food and Drug Administration that
impacted the ability of the agency 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, 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 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
upon submission of the performance report in paragraph (1)(A)
for the corresponding fiscal year. 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
corresponding fiscal year have been met, the corrective
action report shall include a summary of goals met, and
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 Device User Fee Amendments of 2017 for
the corresponding fiscal year that the Secretary
determines to not have been met, the corrective action
report shall include a detailed justification for such
determination and--
``(i) a detailed description of the
circumstances under which each application or
report submitted under section 515 or section
510(k) missed the review goal time but was
approved during the first cycle review, as
applicable;
``(ii) aggregate data on the circumstances
for all unapproved medical device applications
for which the review goal time was missed; and
``(iii) the performance enhancement goals
that were not achieved during the previous
fiscal year and a detailed description of
efforts the agency has put in place for the
current fiscal year to improve the ability of
the agency to meet each such goal, while
maintaining standards of approval, for the
current fiscal year.
``(3) Enhanced communication.--
``(A) Communications with congress.--Each fiscal
year, as applicable, representatives from the Center
for Devices and Radiological Health 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, representatives from the
Center for Devices and Radiological Health 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) Publicly available updates.--The Secretary
shall provide an update on progress made for the
corrective action report during the following fiscal
year on the publically available Internet website of
the Food and Drug Administration every 30 business
days.''.
(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 802(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 number of
abbreviated new drug applications filed and the number
of approvals or 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;
``(ii) such applications pending with the
Office of Generic Drugs 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 corresponding fiscal
year and the future plans of the Food and Drug
Administration to meet these goals; and
``(iii) the most common causes within the
agency for missing such goals.
``(B) Relevant data to determine whether the Office
of Generic Drugs 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 corresponding fiscal year.
``(C) External or other circumstances impacting the
Office of Generic Drugs or the Food and Drug
Administration that impacted the ability of the agency
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) 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 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 upon submission of the performance report
in subsection (a) for the corresponding fiscal year. 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 corresponding fiscal year have been met, the corrective
action report shall include a summary of goals met, and
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 corresponding fiscal year
that the Secretary determines to not have been met, the
corrective action report shall include a detailed justification
for such determination and--
``(A) a detailed description of the circumstances
under which each abbreviated new drug application
missed the review goal time but was approved during the
first cycle review, as applicable;
``(B) aggregate data on the circumstances for all
unapproved abbreviated new drug applications for which
the review goal time was missed; and
``(C) the performance enhancement goals that were
not achieved during the previous fiscal year and a
detailed description of efforts the agency has put in
place for the current fiscal year to improve the
ability of the agency to meet each such goal for the
current fiscal year.
``(d) Enhanced Communication.--
``(1) Communications with congress.--Each fiscal year, as
applicable, representatives from the Office of Generic 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, representatives from the Center for Drug
Evaluation and Research 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.
``(3) Publicly available updates.--The Secretary shall
provide an update on progress made for the corrective action
report during the following fiscal year on the publically
available Internet website of the Food and Drug Administration
every 30 business days.''.
(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 802(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 number of
biosimilar biological product applications and
supplements filed and the number of approvals or
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;
``(ii) such applications pending with the
Center for Drug Evaluation and Research or the
Center for Biologics Evaluation and Research
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
corresponding fiscal year and the future plans
of the Food and Drug Administration to meet
these goals; and
``(iii) the most common causes within the
agency for missing such goals.
``(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 corresponding fiscal year.
``(C) External or other circumstances impacting the
Center for Drug Evaluation and Research, the Center for
Biologics Evaluation and Research, and the Food and
Drug Administration that impacted the ability of the
agency 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) 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 upon
submission of the performance report in subsection (a) for the
corresponding fiscal year. 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 401(b) of the Biosimilar User Fee Amendments of 2017
for the corresponding fiscal year have been met, the corrective
action report shall include a summary of goals met, and
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 corresponding fiscal year that
the Secretary determines to not have been met, the corrective
action report shall include a detailed justification for such
determination and--
``(A) a detailed description of the circumstances
under which each biosimilar biological product
application missed the review goal time but was
approved during the first cycle review, as applicable;
``(B) aggregate data on the circumstances for all
biosimilar biological product applications for which
the review goal time was missed; and
``(C) the performance enhancement goals that were
not achieved during the previous fiscal year and a
detailed description of efforts the agency has put in
place for the current fiscal year to improve the
ability of the agency to meet each such goal for the
current fiscal year.
``(d) Enhanced Communication.--
``(1) Communications with congress.--Each fiscal year, as
applicable, representatives from the Center for Drug Evaluation
and Research and the Center for Biologics Evaluation and
Research 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, representatives from the Center for Drug
Evaluation and Research and the Center for Biologics Evaluation
and Research 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.
``(3) Publicly available updates.--The Secretary shall
provide an update on progress made for the corrective action
report during the following fiscal year on the publically
available Internet website of the Food and Drug Administration
every 30 business days.''.
SEC. 804. INFORMATION ON TECHNOLOGY CONTRACTING.
Section 736B(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379h-2(b)) is amended--
(1) by striking ``report on the'' and inserting ``report
on--
``(1) the'';
(2) by striking the period at the end and inserting ``;
and'';
(3) by adding at the end the following:
``(2) the amount of the fees collected that are invested in
the information technology infrastructure of the Food and Drug
Administration, the entities receiving contracts to develop
such infrastructure, the length of such contracts (including
renewals), and the progress such entities have made toward
meeting the goals described in such contracts.''.
SEC. 805. 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 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;
(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.
(C) Recommendations.--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 agency may allocate the
expenses described in clauses (i) and (ii), as
informed by the analysis under subparagraph
(B).
(2) Report.--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 September 30, 2020,
containing the results of the study under paragraph (1).
(b) Administration.--
(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 only include
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 only include 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 only include 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 only include
leasing and necessary scientific equipment.''.
SEC. 806. EXPANDED ACCESS.
(a) Patient Access to Experimental Treatments.--
(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 180 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 provide a publicly
available report on the topics discussed at the meeting
described in subparagraph (A) within 30 days of such
meeting. Such topics shall include discussion of--
(i) the rationale for, and potential
barriers for patients created by, clinical
trial inclusion and exclusion criteria;
(ii) how patient populations most likely to
be affected by a drug can benefit from the
results of trials that employ alternative
designs, as well as potential risks associated
with alternative clinical trial 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
(III) the impact of exclusion
criteria on the enrollment in clinical
trials of infants and children,
pregnant and lactating women, seniors,
individuals with advanced disease, and
individuals with co-morbid conditions;
(iv) clinical trial designs and methods
that increase enrollment of more diverse
patient populations while facilitating the
collection of data to support substantial
evidence of safety and effectiveness; and
(v) how changes to clinical trial inclusion
and exclusion criteria may impact the
complexity of the clinical trial design and
length of clinical trials, and potential
approaches to mitigating those impacts to
ensure that the ability to demonstrate safety
and effectiveness is not hindered through
potential changes in eligibility criteria.
(2) Report.--Not later than 1 year after the Secretary
issues a report on the topics discussed at the public meeting
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
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 document entitled ``Expanded Access to
Investigational Drugs for Treatment Use--Questions and
Answers'', issued by the Food and Drug Administration
in June 2016, has 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 released or updated under section 561 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb) have improved access for individual patients
who do not qualify for clinical trials of such
investigational drugs, and what barriers to such access
remain;
(D) an assessment of how patients and health care
providers navigate different avenues 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 180 days after the
publication of the report under paragraph (1), the
Secretary, acting through the Commissioner of Food and
Drugs, shall issue one or more draft guidances
regarding eligibility criteria for clinical trials. Not
later than 18 months 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, especially with respect to
drugs for the treatment of serious and life-
threatening conditions or diseases for which
there is an unmet medical need; and
(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 supporting findings of
substantial evidence of safety and
effectiveness.
(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 for individual pediatric and adult patient expanded
access protocol under 561(b) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb(b)). Such guidance or regulation may include a
description of the conditions under which an institutional review board
chair (or designee) may review individual patient expanded access
protocol submitted under section 505(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(i)) for a drug and how centralized
institutional review boards may facilitate the use of expanded access
protocols. The Secretary shall update any relevant forms associated
with individual patient expanded access protocol 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.''.
SEC. 807. TECHNICAL CORRECTIONS.
(a) Cross-reference.--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) 506G.--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''.
TITLE IX--GENERIC DRUG ACCESS
Subtitle A--Removing Regulatory Barriers to Competition
SEC. 901. IMPROVING ACCESS TO 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:
``(11)(A) The Secretary shall prioritize the review of, and act
within 240 calendar days of the date of the submission of, an original
abbreviated new drug application submitted for review under this
subsection, or on a supplement to such an application, that is for a
drug--
``(i) for which there are not more than 3 approved drugs
listed under paragraph (7), except that the review of an
application submitted more than 30 months in advance of the
last applicable expiration date for a patent for which a
certification under paragraph (2)(A)(vii)(III) has been
submitted, or of the expiration date for an applicable period
of exclusivity under this Act, will not be expedited; or
``(ii) that has been included on the list under section
506E.
``(B) The Secretary shall require the applicant, not later than 60
days prior to the submission of an application described in
subparagraph (A), to provide complete, accurate information regarding
facilities involved in manufacturing processes and testing, including
facilities in corresponding Type II active pharmaceutical ingredients
drug master files submitted with an application and sites or
organizations involved in bioequivalence and clinical studies used to
support the application, in order to make a determination regarding
whether an inspection of an establishment is necessary.
``(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 provide review status updates to
applicants regarding applications under this subsection, as
appropriate, including when the application is awaiting final
regulatory action by the office charged with review.
``(13) The Secretary shall publish on the Internet website of the
Food and Drug Administration a list of all drugs approved under
subsection (b) for which all patents and periods of exclusivity under
this Act have expired. Such list shall be updated at least once every
180 days.''.
SEC. 902. REPORTING ON PENDING GENERIC DRUG APPLICATIONS, PRIORITY
REVIEW APPLICATIONS, AND INSPECTIONS.
(a) In General.--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 (referred to in this section
as the ``Secretary'') shall post on the Internet website of the Food
and Drug Administration a report that provides--
(1) the number of applications filed under section 505(j)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))
awaiting action by the applicant, including such applications
that were filed prior to October 1, 2014;
(2) the number of applications filed under section 505(j)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))
awaiting action by the Secretary, including such applications
that were filed prior to October 1, 2014;
(3) 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 covered
by the report;
(4) the mean and median approval and tentative approval
times for applications covered by the report;
(5) the number of applications described in paragraphs (1),
(2), and (3) that are subject to priority review; and
(6) the number of such applications on which the Secretary
has taken action pursuant to section 506H(b) of the Federal
Food, Drug, and Cosmetic Act, as added by section 911.
(b) Annual Report on Priority Review Applications.--
(1) In general.--The Secretary shall submit to the
Committee on Health, Education, Labor, and Pensions and the
Special Committee on Aging of the Senate and the Committee on
Energy and Commerce of the House of Representatives an annual
report, not later than March 31 of each year, on the following:
(A) The number of applications filed under section
505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)) that are subject to priority review
during the most recent calendar year and are awaiting
action by the applicant.
(B) The number of applications filed under section
505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)) that are subject to priority review
during the most recent calendar year and are awaiting
action by the Secretary.
(C) The number of applications filed under section
505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)) that are subject to priority review
during the most recent calendar year and have been
approved by the Secretary.
(D) For each of subparagraphs (A) through (C), the
number of such applications--
(i) for which there are not more than 3
approved drugs listed under section 505(j)(7)
of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(7)); and
(ii) the number of such applications that
are for a drug on the drug shortage list under
section 506E of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356e).
(c) Annual Report on Inspections.--Not later than March 1 of each
year, the Secretary shall post on the Internet website of the Food and
Drug Administration--
(1) the average and median amount of time, following a
request by staff of the Food and Drug Administration reviewing
an application or report submitted under an applicable section
described in subparagraph (A), (B), or (C), to schedule and
complete inspections of facilities necessary for--
(A) approval of a drug under section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
(B) approval of a device under section 515 of such
Act (21 U.S.C. 360e); and
(C) clearance of a device under section 510(k) of
such Act (21 U.S.C. 360(k)); and
(2) the average and median amount of time to schedule and
complete for-cause inspections of facilities of drugs and
devices.
Subtitle B--Incentivizing Competition
SEC. 911. EXPEDITING GENERIC COMPETITION.
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:
``SEC. 506H. EXPEDITING GENERIC DRUG DEVELOPMENT.
``(a) In General.--The Secretary shall, at the request of an
applicant, expedite the development and review of an application under
subsection (j) of section 505 for a drug--
``(1) for which there are not more than 3 approved drug
products listed under section 505(j)(7); or
``(2) that is included on the list under section 506E.
``(b) Request From Sponsors.--A request to expedite the development
and review of an application under subsection (a) shall be submitted by
the applicant prior to the submission of such application.
``(c) Other Applications.--Nothing in this section shall prevent
the Secretary from expediting the development and review of other
applications as the Secretary determines appropriate.
``(d) Additional Communication.--The Secretary shall take such
actions as are appropriate to expedite the development and review of
the application for approval of a drug described in subsection (a),
including, as appropriate--
``(1) holding meetings with the sponsor and the review team
throughout the development of the drug prior to submission of
the application;
``(2) providing timely advice to, and interactive
communication with, the sponsor regarding the development of
the application to ensure that the collection of nonclinical
and clinical data necessary for approval is as efficient as
practicable;
``(3) in the case of a complex product, assigning a cross-
disciplinary project lead for the review team to facilitate an
efficient review of the development program and application,
including manufacturing inspections; and
``(4) in the case of a complex product, including drug-
device combinations, involving senior managers and experienced
review staff, as appropriate, in a collaborative, cross-
disciplinary review.
``(e) Reporting Requirement.--A sponsor of a drug expedited under
this section shall report to the Secretary, one year following approval
of an application under section 505(j), on whether the approved drug
has been marketed in interstate commerce since approval.''.
SEC. 912. LIST OF GENERIC 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 911, the following:
``SEC. 506I. DRUG LISTING.
``(a) Removal, Withdrawal, or Transfer.--The holder of an
application approved under subsection (b) or (j) of section 505 shall
notify the Secretary within 180 days of removing the drug that is the
subject of such application from interstate commerce, withdrawing such
approved application, or transferring such approved application, and a
reason for such removal, withdrawal, or transfer. If compliance with
this subsection within such 180-day period is not practicable, then the
holder shall comply as soon as practicable. The Secretary shall cross-
reference information listed pursuant to section 506C where applicable
to avoid duplicative reporting.
``(b) Drugs With Limited Competition.--
``(1) Information.--The Secretary shall--
``(A) maintain information with respect to
applications approved under section 505(j); and
``(B) publish on the Internet website of the Food
and Drug Administration such information under
subparagraph (A) with respect to drugs for which there
are 3 or fewer application holders; and
``(C) update the information published pursuant to
subparagraph (B) every 180 days.
``(2) Contents.--The public information maintained and
published under paragraph (1)(B) shall include--
``(A) the name of the drug, name of the holder of
the approved application, and the marketing status for
each drug; and
``(B) an indication of whether the Secretary
considers the drug to be for the treatment or
prevention of a serious disease or medical condition,
for which there is no alternative drug that is judged
by medical professionals to be an adequate substitute
available in adequate supply.
``(c) Public Health Exception.--The Secretary may choose not to
make information collected under this section publicly available if the
Secretary determines that disclosure of such information would
adversely affect the public health.
``(d) Notification.--When the Secretary first publishes the
information under subsection (b), the Secretary shall notify relevant
Federal agencies, including the Centers for Medicare & Medicaid
Services and the Federal Trade Commission, that the information has
been published and will be updated regularly.''.
SEC. 913. SUITABILITY PETITIONS.
(a) In General.--It is the sense of the Senate 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.
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 902(b)--
(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. 914. INSPECTIONS.
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)), as amended by section 901, is further amended by adding
at the end the following:
``(14) If the Secretary issues feedback pursuant to section
704(b)(2) with respect to information submitted in response to a report
under section 704(b)(1), and a report that was issued under section
704(b)(1) is the only obstacle to approval of an application under this
subsection or the Secretary determines that the public health benefit
of approving an application under this subsection outweighs any risk to
public health, the Secretary shall, within 45 days of notification by
the applicant that necessary changes have been made to the
establishment to address any findings or deficiencies identified
previously by the Secretary--
``(A) re-inspect the establishment with respect to which
the report was issued; or
``(B) make a determination regarding the response to such
report and review of such application.''.
Calendar No. 76
115th CONGRESS
1st Session
S. 934
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A BILL
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.
_______________________________________________________________________
May 11, 2017
Reported with an amendment