[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2430 Enrolled Bill (ENR)]
H.R.2430
One Hundred Fifteenth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday,
the third day of January, two thousand and seventeen
An Act
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user-fee programs for prescription drugs, medical devices, generic
drugs, and biosimilar biological products, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

c11f4fdb25cef51f794f8c29ee6883ff8bf5995dc085c9e03c80f03b9641bf32

This Act may be cited as the ``FDA Reauthorization Act of 2017''.

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The table of contents for this Act is as follows:

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a56adc954303e35a4ba56c45aabd6a287f5cf361c27c873e1b55e663e91f2be5

TITLE V

-PEDIATRIC DRUGS AND DEVICES

b415c5b8d0ed1ab8d52fac0f53aea1dea679e4b3dff1151b4f43d0c227e2db72

certain drugs containing single enantiomers.

efa2af9b18b1eee523c153d8209f1a02f06240fe1e86ddf728fcfef5a08696ca

TITLE VI

-REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS

c01ecdd9161d4416d8eeee0c8f6fed566d1f8636f54e26812d51e765aa82c8aa

d89d1b3572ab03e9a4f5c263ec94bcc770b55db0fffb3cd19586c94c4268426b

TITLE VIII

-IMPROVING GENERIC DRUG ACCESS

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c30361d85604c4c6b6831fcd190abccf3a16c6fc39c40621ad2d088a3ce88f0b

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TITLE IX

-ADDITIONAL PROVISIONS

(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.

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TITLE I

-FEES RELATING TO DRUGS

(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.
``(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) of
the fee revenue and fees resulting from the adjustment and the
methodologies under this paragraph.
``(3) Operating reserve adjustment.--
``(A) Increase.--For fiscal year 2018 and subsequent fiscal
years, the Secretary may, in addition to adjustments under
paragraphs (1) and (2), further increase the fee revenue and
fees if such an adjustment is necessary to provide for not more
than 14 weeks of operating reserves of carryover user fees for
the process for the review of human drug applications.
``(B) Decrease.--If the Secretary has carryover balances
for such process in excess of 14 weeks of such operating
reserves, the Secretary shall decrease such fee revenue and
fees to provide for not more than 14 weeks of such operating
reserves.
``(C) Notice of rationale.--If an adjustment under
subparagraph (A) or (B) is made, the rationale for the amount
of the increase or decrease (as applicable) in fee revenue and
fees shall be contained in the annual Federal Register notice
under paragraph (5) establishing fee revenue and fees for the
fiscal year involved.
``(4) Additional direct cost adjustment.--
``(A) In general.--The Secretary shall, in addition to
adjustments under paragraphs (1), (2), and (3), further
increase the fee revenue and fees--
``(i) for fiscal year 2018, by $8,730,000; and
``(ii) for fiscal year 2019 and subsequent fiscal
years, by the amount determined under subparagraph (B).
``(B) Amount.--The amount determined under this
subparagraph is--
``(i) $8,730,000, multiplied by
``(ii) the Consumer Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; Not Seasonally
Adjusted; All Items; Annual Index) for the most recent year
of available data, divided by such Index for 2016.
``(5) Annual fee setting.--The Secretary shall, not later than
60 days before the start of each fiscal year that begins after
September 30, 2017--
``(A) establish, for each such fiscal year, human drug
application fees and prescription drug program fees under
subsection (a), based on the revenue amounts established under
subsection (b) and the adjustments provided under this
subsection; and
``(B) publish such fee revenue and fees in the Federal
Register.
``(6) Limit.--The total amount of fees charged, as adjusted
under this subsection, for a fiscal year may not exceed the total
costs for such fiscal year for the resources allocated for the
process for the review of human drug applications.''.
(d) Fee Waiver or Reduction.--Section 736(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended--
(1) in paragraph (1)--
(A) by inserting ``or'' at the end of subparagraph (B);
(B) by striking subparagraph (C); and
(C) by redesignating subparagraph (D) as subparagraph (C);
(2) by striking paragraph (3) (relating to use of standard
costs);
(3) by redesignating paragraph (4) as paragraph (3); and
(4) in paragraph (3), as so redesignated--
(A) in subparagraphs (A) and (B), by striking ``paragraph
(1)(D)'' and inserting ``paragraph (1)(C)''; and
(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''.

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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''.

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(a) Authorization.--Sections 735 and 736 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective
October 1, 2022.
(b) Reporting Requirements.--Section 736B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h-2) shall cease to be effective
January 31, 2023.
(c) Previous Sunset Provision.--Effective October 1, 2017,
subsections (a) and (b) of section 105 of the Food and Drug
Administration Safety and Innovation Act (Public Law 112-144) are
repealed.

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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.

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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.

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(a) Short Title.--This title may be cited as the ``Medical Device
User Fee Amendments of 2017''.
(b) Finding.--The Congress finds that the fees authorized under the
amendments made by this title will be dedicated toward expediting the
process for the review of device applications and for assuring the
safety and effectiveness of devices, as set forth in the goals
identified for purposes of part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act in the letters from the Secretary
of Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the Chairman
of the Committee on Energy and Commerce of the House of
Representatives, as set forth in the Congressional Record.

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TITLE II

-FEES RELATING TO DEVICES

(a) In General.--Section 737 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379i) is amended--
(1) by redesignating paragraphs (8) through (13) as paragraphs
(9) through (14), respectively;
(2) by inserting after paragraph (7) the following new
paragraph:
``(8) The term `de novo classification request' means a request
made under section 513(f)(2)(A) with respect to the classification
of a device.'';
(3) in subparagraph (D) of paragraph (10) (as redesignated by
paragraph (1)), by striking ``and submissions'' and inserting
``submissions, and de novo classification requests''; and
(4) in paragraph (11) (as redesignated by paragraph (1)), by
striking ``2011'' and inserting ``2016''.
(b) Conforming Amendment.--Section 714(b)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379d-3(b)(1)) is amended by striking
``737(8)'' and inserting ``737(9)''.

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(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 amendments.--
(A) Section 515(c)(4)(A) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360e(c)(4)(A)) is amended by striking
``738(h)'' and inserting ``738(g)''.
(B) Section 738 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j), as amended by paragraph (1), is further
amended--
(i) by redesignating subsections (g) through (l) as
subsections (f) through (k);
(ii) in subsection (a)(2)(A), by striking ``(d), (e),
and (f)'' and inserting ``(d) and (e)''; and
(iii) in subsection (a)(3)(A), by striking ``and
subsection (f)''.
(g) Effect of Failure To Pay Fees.--Subsection (f)(1), as so
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j) is amended--
(1) by striking ``or periodic reporting concerning a class III
device'' and inserting ``periodic reporting concerning a class III
device, or de novo classification request''; and
(2) by striking ``all fees'' and inserting ``all such fees''.
(h) Conditions.--Subsection (g)(1)(A), as so redesignated, of
section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j) is amended by striking ``$280,587,000'' and inserting
``$320,825,000''.
(i) Crediting and Availability of Fees.--Subsection (h), as so
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j) is amended--
(1) in paragraph (3)--
(A) by striking ``2013 through 2017'' and inserting ``2018
through 2022''; and
(B) by striking ``subsection (c)'' and all that follows
through the period at the end and inserting ``subsection
(c).''; and
(2) by striking paragraph (4).

9ef957e8c1a849185a63d03acf01d349462aea59d144e6209982d6f09a9cc386

(a) Performance Reports.--Section 738A(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-1(a)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) by striking ``2013'' and inserting ``2018''; and
(ii) by striking ``the Medical Device User Fee
Amendments of 2012'' and inserting ``the Medical Device
User Fee Amendments of 2017''; and
(B) in subparagraph (B), by striking ``the Medical Device
User Fee Amendments Act of 2012'' and inserting ``the Medical
Device User Fee Amendments of 2017''; and
(2) in paragraph (2), by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.
(b) Reauthorization.--Section 738A(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--
(1) in paragraph (1), by striking ``2017'' and inserting
``2022''; and
(2) in paragraph (5), by striking ``2017'' and inserting
``2022''.

ae5f5c7c07f402bed6f0ab883f92d22ab80b6ebefcecb82bbe9947acd1abfc2f

(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
internet website of the Food and Drug Administration an annual
report on the progress of the pilot program under this
subsection.
``(4) Sunset.--As of October 1, 2022--
``(A) the authority for accreditation bodies to accredit
testing laboratories pursuant to paragraph (1)(A) shall cease
to have force or effect;
``(B) the Secretary--
``(i) may not accept a determination pursuant to
paragraph (1)(B) made by a testing laboratory after such
date; and
``(ii) may accept such a determination made prior to
such date;
``(C) except for purposes of accepting a determination
described in subparagraph (B)(ii), the Secretary shall not
continue to recognize the accreditation of testing laboratories
accredited under paragraph (1)(A); and
``(D) the Secretary may take actions in accordance with
paragraph (2) with respect to the determinations made prior to
such date and recognition of the accreditation of testing
laboratories pursuant to determinations made prior to such
date.''.

8786f9e8da40cf72e0b4ff9f8155d92cc9ad3db046e9d4b67bd0f07ee0e28857

Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360m) is amended--
(1) in subsection (a)(3)--
(A) in subparagraph (A), by striking clauses (ii) and (iii)
and inserting the following:
``(ii) a device classified under section 513(f)(2) or
designated under section 515C(d);
``(iii) a device that is intended to be permanently
implantable, life sustaining, or life supporting, unless
otherwise determined by the Secretary in accordance with
subparagraph (B)(i)(II) and listed as eligible for review
under subparagraph (B)(iii); or
``(iv) a device that is of a type, or subset of a type,
listed as not eligible for review under subparagraph
(B)(iii).'';
(B) by striking subparagraph (B) and inserting the
following:
``(B) Designation for review.--The Secretary shall--
``(i) issue draft guidance on the factors the Secretary
will use in determining whether a class I or class II
device type, or subset of such device types, is eligible
for review by an accredited person, including--
``(I) the risk of the device type, or subset of
such device type; and
``(II) whether the device type, or subset of such
device type, is permanently implantable, life
sustaining, or life supporting, and whether there is a
detailed public health justification for permitting the
review by an accredited person of such device type or
subset;
``(ii) not later than 24 months after the date on which
the Secretary issues such draft guidance, finalize such
guidance; and
``(iii) beginning on the date such guidance is
finalized, designate and post on the internet website of
the Food and Drug Administration, an updated list of class
I and class II device types, or subsets of such device
types, and the Secretary's determination with respect to
whether each such device type, or subset of a device type,
is eligible or not eligible for review by an accredited
person under this section based on the factors described in
clause (i).''; and
(C) by adding at the end the following:
``(C) Interim rule.--Until the date on which the updated
list is designated and posted in accordance with subparagraph
(B)(iii), the list in effect on the date of enactment the
Medical Device User Fee Amendments of 2017 shall be in
effect.'';
(2) in subsection (b)--
(A) in paragraph (2)--
(i) by striking subparagraph (D); and
(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''.

57437fd1d106ac61f525245e9b385930240148ede02af6046a9a5b8c42e6602c

Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379k-1(b)) is amended by adding at the end the following new
paragraph:
``(3) Presubmissions and submissions solely in electronic
format.--
``(A) In general.--Beginning on such date as the Secretary
specifies in final guidance issued under subparagraph (C),
presubmissions and submissions for devices described in
paragraph (1) (and any appeals of action taken by the Secretary
with respect to such presubmissions or submissions) shall be
submitted solely in such electronic format as specified by the
Secretary in such guidance.
``(B) Draft guidance.--The Secretary shall, not later than
October 1, 2019, issue draft guidance providing for--
``(i) any further standards for the submission by
electronic format required under subparagraph (A);
``(ii) a timetable for the establishment by the
Secretary of such further standards; and
``(iii) criteria for waivers of and exemptions from the
requirements of this subsection.
``(C) Final guidance.--The Secretary shall, not later than
1 year after the close of the public comment period on the
draft guidance issued under subparagraph (B), issue final
guidance.''.

b13126fcd4eb081c612f9c1b953cacc30370709f8725e8cca46d10aa76725f43

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.

87dba552e451df0de8956b89a11c98f1f07f11cd301f6ae41411569ffa261db2

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.

09ad435680365d3dd7e851d57bc863156247768efd91713b16b178ee8f746187

(a) Authorization.--Sections 737 and 738 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be effective
October 1, 2022.
(b) Reporting Requirements.--Section 738A (21 U.S.C. 739j-1) of the
Federal Food, Drug, and Cosmetic Act (regarding reauthorization and
reporting requirements) shall cease to be effective January 31, 2023.
(c) Previous Sunset Provision.--Effective October 1, 2017, section
207(a) of the Food and Drug Administration Safety and Innovation Act
(Public Law 112-144) is repealed.

8567e488e879ebee8610e641fc0a5d679643710d1d0612b373ccc3d4ca37ac33

(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.

b8f047c239d410c398a6c6afb8b23f19362347e4cb0632bfa7fcd451a1335505

TITLE III

-FEES RELATING TO GENERIC DRUGS

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.''.

331ca21c5955349b36f76c35902a8d18cac4c2b82fa97aad461f0110ba622559

(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'';
(B) by striking ``the first 3 months of fiscal year 2018''
and inserting ``the first 3 months of fiscal year 2023''; and
(C) by striking ``Such fees may only be used in fiscal year
2018.''.
(d) Annual Fee Setting.--Section 744B(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-42(d)) is amended--
(1) by striking paragraphs (1) and (2) and inserting the
following:
``(1) Fiscal years 2018 through 2022.--Not more than 60 days
before the first day of each of fiscal years 2018 through 2022, the
Secretary shall establish the fees described in paragraphs (2)
through (5) of subsection (a), based on the revenue amounts
established under subsection (b) and the adjustments provided under
subsection (c).'';
(2) by redesignating paragraph (3) as paragraph (2); and
(3) in paragraph (2) (as so redesignated), in the matter
preceding subparagraph (A), by striking ``fees under paragraphs (1)
and (2)'' and inserting ``fee under paragraph (1)''.
(e) Identification of Facilities.--Section 744B(f) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(f)) is amended--
(1) by striking paragraph (1);
(2) by redesignating paragraphs (2) through (4) as paragraphs
(1) through (3), respectively;
(3) in paragraph (1) (as so redesignated)--
(A) by striking ``paragraph (4)'' and inserting ``paragraph
(3)''; and
(B) by striking ``Such information shall'' and all that
follows through the end of subparagraph (B) and inserting
``Such information shall, for each fiscal year, be submitted,
updated, or reconfirmed on or before June 1 of the previous
fiscal year.''; and
(4) in paragraph (2), as so redesignated--
(A) in the heading, by striking ``Contents of notice'' and
inserting ``Information required to be submitted'';
(B) in the matter preceding subparagraph (A), by striking
``paragraph (2)'' and inserting ``paragraph (1)'';
(C) in subparagraph (A), by striking ``or intended to be
identified'';
(D) in subparagraph (D), by striking ``and'' at the end;
(E) in subparagraph (E), by striking the period and
inserting ``; and''; and
(F) by adding at the end the following:
``(F) whether the facility is a contract manufacturing
organization facility.''.
(f) Effect of Failure To Pay Fees.--Section 744B(g) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(g)) is amended--
(1) in paragraph (1), by adding at the end the following:
``This paragraph shall cease to be effective on October 1, 2022.'';
(2) in paragraph (2)(C)(ii), by striking ``of 505(j)(5)(A)''
and inserting ``of section 505(j)(5)(A)''; and
(3) by adding at the end the following:
``(5) Generic drug applicant program fee.--
``(A) In general.--A person who fails to pay a fee as
required under subsection (a)(5) by the date that is 20
calendar days after the due date, as specified in subparagraph
(D) of such subsection, shall be subject to the following:
``(i) The Secretary shall place the person on a
publicly available arrears list.
``(ii) Any abbreviated new drug application submitted
by the generic drug applicant or an affiliate of such
applicant shall not be received, within the meaning of
section 505(j)(5)(A).
``(iii) All drugs marketed pursuant to any abbreviated
new drug application held by such applicant or an affiliate
of such applicant shall be deemed misbranded under section
502(aa).
``(B) Application of penalties.--The penalties under
subparagraph (A) shall apply until the fee required under
subsection (a)(5) is paid.''.
(g) Limitations.--Section 744B(h)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-42(h)(2)) is amended by striking ``for
Type II active pharmaceutical ingredient drug master files, abbreviated
new drug applications and prior approval supplements, and generic drug
facilities and active pharmaceutical ingredient facilities''.
(h) Crediting and Availability of Fees.--Section 744B(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(i)) is
amended--
(1) in paragraph (2)--
(A) in subparagraph (A), by striking ``subparagraphs (C)
and (D)'' and inserting ``subparagraph (C)'';
(B) by striking subparagraph (C) (relating to fee
collection during first program year);
(C) in subparagraph (D)--
(i) in the heading, by striking ``in subsequent
years''; and
(ii) by striking ``(after fiscal year 2013)''; and
(D) by redesignating subparagraph (D) as subparagraph (C);
and
(2) in paragraph (3), by striking ``fiscal years 2013 through
2017'' and inserting ``fiscal years 2018 through 2022''.
(i) Information on Abbreviated New Drug Applications Owned by
Applicants and Their Affiliates.--Section 744B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-42) is amended by adding at the
end the following:
``(o) Information on Abbreviated New Drug Applications Owned by
Applicants and Their Affiliates.--
``(1) In general.--By April 1 of each year, each person that
owns an abbreviated new drug application, or a designated affiliate
of such person, shall submit, on behalf of the person and the
affiliates of such person, to the Secretary a list of--
``(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.''.

cabe182bc820fa84a0bc18c5e464f3c43e7aab34debb1a9073ed53d0585d1d50

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''.

b6abdf77004d62e2529c8a5677ae4b6c230223029a21854ef435250fa332d803

(a) Authorization.--Sections 744A and 744B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-41; 379j-42) shall cease to be
effective October 1, 2022.
(b) Reporting Requirements.--Section 744C of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-43) shall cease to be effective
January 31, 2023.
(c) Previous Sunset Provision.--
(1) In general.--Effective October 1, 2017, section 304 of the
Food and Drug Administration Safety and Innovation Act (Public Law
112-144) is repealed.
(2) Conforming amendment.--The Food and Drug Administration
Safety and Innovation Act (Public Law 112-144) is amended in the
table of contents in section 2 by striking the item relating to
section 304.

e2f71f2f94d30335ec3f35dba2f752b438b2e07dfd98940c89c977100c8940f0

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.

786e1cf5b33b1bd05053bfb3bfb4fad91048986b9ba49df07394b02dd20a43e9

Notwithstanding the amendments made by this title, part 7 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act, as in effect on the day before the date of the enactment of this
title, shall continue to be in effect with respect to abbreviated new
drug applications (as defined in such part as of such day) that were
received by the Food and Drug Administration within the meaning of
section 505(j)(5)(A) of such Act (21 U.S.C. 355(j)(5)(A)), prior
approval supplements that were submitted, and drug master files for
Type II active pharmaceutical ingredients that were first referenced on
or after October 1, 2012, but before October 1, 2017, with respect to
assessing and collecting any fee required by such part for a fiscal
year prior to fiscal year 2018.

0d83538e037ca42a7d79250da5f88d0e323e159e3645fbc30eb9febad2a3ce5b

(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.

dfd4aa929302085a5afc7b0a52ecaa5428d662a1c916e0ec7db08e2054c982ae

TITLE IV

-FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

(a) Adjustment Factor.--Section 744G(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-51(1)) is amended to read as follows:
``(1) The term `adjustment factor' applicable to a fiscal year
is the Consumer Price Index for urban consumers (Washington-
Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items) for
October of the preceding fiscal year divided by such Index for
October 2011.''.
(b) Biosimilar Biological Product.--Section 744G(3) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(3)) is amended by
striking ``means a product'' and inserting ``means a specific strength
of a biological product in final dosage form''.

7994c469152b7a21d78c93dcd32bf8373280478117b830bea2847879ed9a39d5

(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
biological product development fee paid by the person for
the product for such fiscal year. To qualify for
consideration for a refund under this clause, a person
shall submit to the Secretary a written request for such
refund not later than 180 days after the marketing
application is accepted for filing.'';
(8) in paragraph (1)(C), by striking ``for a product effective
October 1 of a fiscal year by,'' and inserting ``for a product,
effective October 1 of a fiscal year, by,'';
(9) in paragraph (1)(D)--
(A) in clause (i) in the matter preceding subclause (I), by
inserting ``, if the person seeks to resume participation in
such program,'' before ``pay a fee'';
(B) in clause (i)(I), by inserting after ``grants a
request'' the following: ``by such person''; and
(C) in clause (i)(II), by inserting after ``discontinued)''
the following: ``by such person'';
(10) in the heading of paragraph (1)(E), by striking
``biosimilar development program'';
(11) in paragraph (1)(F)--
(A) in the subparagraph heading, by striking ``biosimilar
development program''; and
(B) by amending clause (i) to read as follows:
``(i) Refunds.--Except as provided in subparagraph
(B)(iv), the Secretary shall not refund any initial or
annual biosimilar biological product development fee paid
under subparagraph (A) or (B), or any reactivation fee paid
under subparagraph (D).'';
(12) in paragraph (2)--
(A) in the paragraph heading, by striking ``and
supplement'';
(B) by amending subparagraphs (A) and (B) to read as
follows:
``(A) In general.--Each person that submits, on or after
October 1, 2017, a biosimilar biological product application
shall be subject to the following fees:
``(i) A fee established under subsection (c)(5) for a
biosimilar biological product application for which
clinical data (other than comparative bioavailability
studies) with respect to safety or effectiveness are
required for approval.
``(ii) A fee established under subsection (c)(5) for a
biosimilar biological product application for which
clinical data (other than comparative bioavailability
studies) with respect to safety or effectiveness are not
required for approval. Such fee shall be equal to half of
the amount of the fee described in clause (i).
``(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'';
(D) in subparagraphs (C) through (F), by striking ``or
supplement'' each place it appears; and
(E) in subparagraph (D), by striking ``or a supplement'';
(13) by amending paragraph (3) to read as follows:
``(3) Biosimilar biological product program fee.--
``(A) In general.--Each person who is named as the
applicant in a biosimilar biological product application shall
pay the annual biosimilar biological product program fee
established for a fiscal year under subsection (c)(5) for each
biosimilar biological product that--
``(i) is identified in such a biosimilar biological
product application approved as of October 1 of such fiscal
year; and
``(ii) as of October 1 of such fiscal year, does not
appear on a list, developed and maintained by the
Secretary, of discontinued biosimilar biological products.
``(B) Due date.--The biosimilar biological product program
fee for a fiscal year shall be due on the later of--
``(i) the first business day on or after October 1 of
each such year; or
``(ii) the first business day after the enactment of an
appropriations Act providing for the collection and
obligation of fees for such year under this section.
``(C) One fee per product per year.--The biosimilar
biological product program fee shall be paid only once for each
product for each fiscal year.
``(D) Limitation.--A person who is named as the applicant
in a biosimilar biological product application shall not be
assessed more than 5 biosimilar biological product program fees
for a fiscal year for biosimilar biological products identified
in such biosimilar biological product application.''.
(b) Fee Revenue Amounts.--Subsection (b) of section 744H of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended to
read as follows:
``(b) Fee Revenue Amounts.--
``(1) Fiscal year 2018.--For fiscal year 2018, fees under
subsection (a) shall be established to generate a total revenue
amount equal to the sum of--
``(A) $45,000,000; and
``(B) the dollar amount equal to the fiscal year 2018
adjustment (as determined under subsection (c)(4)).
``(2) Subsequent fiscal years.--For each of the fiscal years
2019 through 2022, fees under subsection (a) shall, except as
provided in subsection (c), be established to generate a total
revenue amount equal to the sum of--
``(A) the annual base revenue for the fiscal year (as
determined under paragraph (4));
``(B) the dollar amount equal to the inflation adjustment
for the fiscal year (as determined under subsection (c)(1));
``(C) the dollar amount equal to the capacity planning
adjustment for the fiscal year (as determined under subsection
(c)(2)); and
``(D) the dollar amount equal to the operating reserve
adjustment for the fiscal year, if applicable (as determined
under subsection (c)(3)).
``(3) Allocation of revenue amount among fees; limitations on
fee amounts.--
``(A) Allocation.--The Secretary shall determine the
percentage of the total revenue amount for a fiscal year to be
derived from, respectively--
``(i) initial and annual biosimilar biological product
development fees and reactivation fees under subsection
(a)(1);
``(ii) biosimilar biological product application fees
under subsection (a)(2); and
``(iii) biosimilar biological product program fees
under subsection (a)(3).
``(B) Limitations on fee amounts.--Until the first fiscal
year for which the capacity planning adjustment under
subsection (c)(2) is effective, the amount of any fee under
subsection (a) for a fiscal year after fiscal year 2018 shall
not exceed 125 percent of the amount of such fee for fiscal
year 2018.
``(C) Biosimilar biological product development fees.--The
initial biosimilar biological product development fee under
subsection (a)(1)(A) for a fiscal year shall be equal to the
annual biosimilar biological product development fee under
subsection (a)(1)(B) for that fiscal year.
``(D) Reactivation fee.--The reactivation fee under
subsection (a)(1)(D) for a fiscal year shall be equal to twice
the amount of the annual biosimilar biological product
development fee under subsection (a)(1)(B) for that fiscal
year.
``(4) Annual base revenue.--For purposes of paragraph (2), the
dollar amount of the annual base revenue for a fiscal year shall be
the dollar amount of the total revenue amount for the previous
fiscal year, excluding any adjustments to such revenue amount under
subsection (c)(3).''.
(c) Adjustments; Annual Fee Setting.--Section 744H of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended--
(1) by redesignating subsections (c) through (h) as subsections
(d) through (i), respectively;
(2) in subsections (a)(2)(F) and (h) (as redesignated by
paragraph (1)), by striking ``subsection (c)'' and inserting
``subsection (d)'';
(3) in subsection (a)(4)(A), by striking ``subsection
(b)(1)(F)'' and inserting ``subsection (c)(5)''; and
(4) by inserting after subsection (b) the following:
``(c) Adjustments; Annual Fee Setting.--
``(1) Inflation adjustment.--
``(A) In general.--For purposes of subsection (b)(2)(B),
the dollar amount of the inflation adjustment to the annual
base revenue for each fiscal year shall be equal to the product
of--
``(i) such annual base revenue for the fiscal year
under subsection (b); and
``(ii) the inflation adjustment percentage under
subparagraph (B).
``(B) Inflation adjustment percentage.--The inflation
adjustment percentage under this subparagraph for a fiscal year
is equal to the sum of--
``(i) the average annual percent change in the cost,
per full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and benefits
paid with respect to such positions for the first 3 years
of the preceding 4 fiscal years, multiplied by the
proportion of personnel compensation and benefits costs to
total costs of the process for the review of biosimilar
biological product applications (as defined in section
744G(13)) for the first 3 years of the preceding 4 fiscal
years; and
``(ii) the average annual percent change that occurred
in the Consumer Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; Not Seasonally
Adjusted; All items; Annual Index) for the first 3 years of
the preceding 4 years of available data multiplied by the
proportion of all costs other than personnel compensation
and benefits costs to total costs of the process for the
review of biosimilar biological product applications (as
defined in section 744G(13)) for the first 3 years of the
preceding 4 fiscal years.
``(2) Capacity planning adjustment.--
``(A) In general.--Beginning with the fiscal year described
in subparagraph (B)(ii)(II), the Secretary shall, in addition
to the adjustment under paragraph (1), further increase the fee
revenue and fees under this section for a fiscal year to
reflect changes in the resource capacity needs of the Secretary
for the process for the review of biosimilar biological product
applications.
``(B) Capacity planning methodology.--
``(i) Development; evaluation and report.--The
Secretary shall obtain, through a contract with an
independent accounting or consulting firm, a report
evaluating options and recommendations for a new
methodology to accurately assess changes in the resource
and capacity needs of the process for the review of
biosimilar biological product applications. The 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)(B) establishing fee revenue and fees for
the fiscal year involved.
``(4) Fiscal year 2018 adjustment.--
``(A) In general.--For fiscal year 2018, the Secretary
shall adjust the fee revenue and fees under this section in
such amount (if any) as needed to reflect an updated assessment
of the workload for the process for the review of biosimilar
biological product applications.
``(B) Methodology.--The Secretary shall publish under
paragraph (5)(B) a description of the methodology used to
calculate the fiscal year 2018 adjustment under this paragraph
in the Federal Register notice establishing fee revenue and
fees for fiscal year 2018.
``(C) Limitation.--No adjustment under this paragraph shall
result in an increase in fee revenue and fees under this
section in excess of $9,000,000.
``(5) Annual fee setting.--For fiscal year 2018 and each
subsequent fiscal year, the Secretary shall, not later than 60 days
before the start of each such fiscal year--
``(A) establish, for the fiscal year, initial and annual
biosimilar biological product development fees and reactivation
fees under subsection (a)(1), biosimilar biological product
application fees under subsection (a)(2), and biosimilar
biological product program fees under subsection (a)(3), based
on the revenue amounts established under subsection (b) and the
adjustments provided under this subsection; and
``(B) publish such fee revenue and fees in the Federal
Register.
``(6) Limit.--The total amount of fees assessed for a fiscal
year under this section may not exceed the total costs for such
fiscal year for the resources allocated for the process for the
review of biosimilar biological product applications.''.
(d) Application Fee Waiver for Small Business.--Subsection (d)(1)
of section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-52), as redesignated by subsection (c)(1), is amended--
(1) by striking subparagraph (B);
(2) by striking ``; and'' at the end of subparagraph (A) and
inserting a period; and
(3) by striking ``shall pay--'' and all that follows through
``application fees'' and inserting ``shall pay application fees''.
(e) Effect of Failure To Pay Fees.--Subsection (e) of section 744H
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), as
redesignated by subsection (c)(1), is amended by striking ``all fees''
and inserting ``all such fees''.
(f) Crediting and Availability of Fees.--Subsection (f) of section
744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52),
as redesignated by subsection (c)(1), is amended--
(1) in paragraph (2)--
(A) by striking subparagraph (C) (relating to fee
collection during first program year) and inserting the
following:
``(C) Compliance.--The Secretary shall be considered to
have met the requirements of subparagraph (B) in any fiscal
year if the costs described in such subparagraph are not more
than 15 percent below the level specified in such
subparagraph.''; and
(B) in subparagraph (D)--
(i) in the heading, by striking ``in subsequent
years''; and
(ii) by striking ``(after fiscal year 2013)''; and
(2) in paragraph (3), by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.

61f5b29b9956766f7231a0598db9ebf9c2b73623045ee5e7c42c83c0ff12f3fe

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''.

f1127cebc1af819496a5bb05016ba57980332b3731d49bf39c38a062d4c04bab

(a) Authorization.--Sections 744G and 744H of the Federal Food,
Drug, and Cosmetic Act shall cease to be effective October 1, 2022.
(b) Reporting Requirements.--Section 744I of the Federal Food,
Drug, and Cosmetic Act shall cease to be effective January 31, 2023.
(c) Previous Sunset Provision.--
(1) In general.--Effective October 1, 2017, section 404 of the
Food and Drug Administration Safety and Innovation Act (Public Law
112-144) is repealed.
(2) Conforming amendment.--The Food and Drug Administration
Safety and Innovation Act (Public Law 112-144) is amended in the
table of contents in section 2 by striking the item relating to
section 404.

9b27d3627e5977d7718ff8f76b446d45a29965a7f5c99a221ef4efb35567ae6a

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.

2ebce1a9d949778ac4d6e4b62fdc4493a0f8e10c3502ad6d798755c2e0a90294

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.

c3e9373157db4dbde7f0da468bb3c9e588565c48682546309463574a46974828

Section 409I of the Public Health Service Act (42 U.S.C. 284m) is
amended--
(1) in subsection (a)(2)(A)(ii), by inserting ``and
identification of biomarkers for such diseases, disorders, or
conditions,'' after ``biologics,'';
(2) in subsection (c)--
(A) in paragraph (6)--
(i) by amending subparagraph (B) to read as follows:
``(B) Availability of reports.--
``(i) In general.--Each report submitted under
subparagraph (A) shall be considered to be in the public
domain (subject to section 505A(d)(4) of the Federal Food,
Drug, and Cosmetic Act) and not later than 90 days after
submission of such report, shall be--
``(I) posted on the internet website of the
National Institutes of Health in a manner that is
accessible and consistent with all applicable Federal
laws and regulations, including such laws and
regulations for the protection of--
``(aa) human research participants, including
with respect to privacy, security, informed
consent, and protected health information; and
``(bb) proprietary interests, confidential
commercial information, and intellectual property
rights; and
``(II) assigned a docket number by the Commissioner
of Food and Drugs and made available for the submission
of public comments.
``(ii) Submission of comments.--An interested person
may submit written comments concerning such pediatric
studies to the Commissioner of Food and Drugs, and the
submitted comments shall become part of the docket file
with respect to each of the drugs.''; and
(ii) in subparagraph (C), by striking ``appropriate
action'' and all that follows through the period and
inserting ``action in a timely and appropriate manner in
response to the reports submitted under subparagraph (A),
and shall begin such action upon receipt of the report
under subparagraph (A), in accordance with paragraph
(7).''; and
(B) in paragraph (7)--
(i) in the matter preceding subparagraph (A), by
striking ``During'' and inserting ``Within'';
(ii) in subparagraph (C)(i), by striking ``place'' and
all that follows through ``and of'' and inserting ``include
in the public docket file a reference to the location of
the report on the internet website of the National
Institutes of Health and a copy of''; and
(iii) in clause (ii), by striking ``in the Federal
Register and'';
(3) by striking subsection (d);
(4) by redesignating subsection (e) as subsection (d); and
(5) in paragraph (1) of subsection (d), as so redesignated, by
striking ``2013 through 2017'' and inserting ``2018 through 2022''.

fcfcd3a91469bc02aea72e4caa94f30250664781a3ab0dad6d06b2b4344bdde3

(a) Pediatric Use of Devices.--Section 515A(a)(3) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360e-1(a)(3)) is amended--
(1) by redesignating subparagraphs (B) through (D) as
subparagraphs (D) through (F), respectively;
(2) by inserting after subparagraph (A) the following:
``(B) any information, based on a review of data available
to the Secretary, regarding devices used in pediatric patients
but not labeled for such use for which the Secretary determines
that approved pediatric labeling could confer a benefit to
pediatric patients;
``(C) the number of pediatric devices that receive a
humanitarian use exemption under section 520(m);'';
(3) in subparagraph (E), as so redesignated, by striking ``;
and'' and inserting ``;'';
(4) in subparagraph (F) (as so redesignated), by striking
``(B), and (C).'' and inserting ``(C), (D), and (E);''; and
(5) by adding at the end the following:
``(G) the number of devices for which the Secretary relied
on data with respect to adults to support a determination of a
reasonable assurance of safety and effectiveness in pediatric
patients; and
``(H) the number of devices for which the Secretary relied
on data from one pediatric subpopulation to support a
determination of a reasonable assurance of safety and
effectiveness in another pediatric subpopulation.
For the items described in this paragraph, such report shall
disaggregate the number of devices by pediatric subpopulation.''.
(b) Humanitarian Device Exemption.--Section 520(m) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is amended--
(1) in paragraph (4)--
(A) in subparagraph (B), by inserting ``or an appropriate
local committee'' after ``review committee'' each place such
term appears; and
(B) in the matter following subparagraph (B), by inserting
``or an appropriate local committee'' after ``review
committee'' each place such term appears; and
(2) in paragraph (6)(A)(iv), by striking ``2017'' and inserting
``2022''.
(c) Demonstration Grants for Improving Pediatric Availability.--
Section 305 of the Pediatric Medical Device Safety and Improvement Act
of 2007 (Public Law 110-85; 42 U.S.C. 282 note)) is amended--
(1) in subsection (c)--
(A) in paragraph (4), by striking ``and'' at the end;
(B) in paragraph (5), by striking the period and inserting
``; and''; and
(C) by adding at the end the following:
``(6) providing regulatory consultation to device sponsors in
support of the submission of an application for a pediatric device,
where appropriate.''; and
(2) in subsection (e), by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.
(d) Meeting on Pediatric Device Development.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services
shall convene a public meeting on the development, approval or
clearance, and labeling of pediatric medical devices. The Secretary
shall invite to such meeting representatives from the medical
device industry, academia, recipients of funding under section 305
of the Pediatric Medical Device Safety and Improvement Act of 2007
(Public Law 110-85; 42 U.S.C. 282 note), medical provider
organizations, and organizations representing patients and
consumers.
(2) Topics.--The meeting described in paragraph (1) shall
include consideration of ways to--
(A) improve research infrastructure and research networks
to facilitate the conduct of clinical studies of devices for
pediatric populations that would result in the approval or
clearance, and labeling, of medical devices for such
populations;
(B) appropriately use extrapolation under section 515A(b)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-
1(b));
(C) enhance the appropriate use of postmarket registries
and data to increase pediatric medical device labeling;
(D) increase Food and Drug Administration assistance to
medical device manufacturers in developing devices for
pediatric populations that are approved or cleared, and
labeled, for their use; and
(E) identify current barriers to pediatric device
development and incentives to address such barriers.
(3) Report.--The report submitted under section 515A(a)(3) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-1(a)(3))
with respect to the calendar year in which the meeting described in
paragraph (1) is held shall include a summary of, and responses to,
recommendations raised in such meeting.

a524e9e383caa1bed5384ae714aa0b911a9bc86c819d87d217d0cdde2c47b8d0

(a) In General.--Clause (i) of section 505B(e)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(2)(C)) is amended to
read as follows:
``(i) shall meet with the applicant--
``(I) if requested by the applicant with respect to
a drug or biological product that is intended to treat
a serious or life-threatening disease or condition, to
discuss preparation of the initial pediatric study
plan, not later than the end-of-Phase 1 meeting (as
such term is used in section 312.82(b) of title 21,
Code of Federal Regulations, or successor regulations)
or within 30 calendar days of receipt of such request,
whichever is later;
``(II) to discuss the initial pediatric study plan
as soon as practicable, but not later than 90 calendar
days after the receipt of such plan under subparagraph
(A); and
``(III) to discuss the bases for the deferral under
subsection (a)(4) or a full or partial waiver under
subsection (a)(5);''.
(b) Conforming Changes.--Section 505B(e) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355c(e)) is amended--
(1) in the heading of paragraph (2), by striking ``meeting''
and inserting ``meetings'';
(2) in the heading of paragraph (2)(C), by striking ``Meeting''
and inserting ``Meetings'';
(3) in clauses (ii) and (iii) of paragraph (2)(C), by striking
``no meeting'' each place it appears and inserting ``no meeting
under clause (i)(II)''; and
(4) in paragraph (3) by striking ``meeting under paragraph
(2)(C)(i)'' and inserting ``meeting under paragraph
(2)(C)(i)(II)''.

1e6adc2d59cd4eded1871a1ffb55113e07e63e9067523a46556bfc3a5b97fed9

PEDIATRIC CANCERS.
(a) Molecular Targets Regarding Cancer Drugs and Biological
Products.--Section 505B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by redesignating subparagraphs (A) and (B) as
clauses (i) and (ii), respectively, and adjusting the
margins accordingly;
(ii) by striking ``A person'' and inserting the
following:
``(A) General requirements.--Except with respect to an
application for which subparagraph (B) applies, a person'';
(iii) in clause (i), as so redesignated, by striking
``, or'' at the end and inserting ``; or''; and
(iv) by adding after subparagraph (A), as so designated
by clause (ii), the following:
``(B) Certain molecularly targeted cancer indications.--A
person that submits, on or after the date that is 3 years after
the date of enactment of the FDA Reauthorization Act of 2017,
an original application for a new active ingredient under
section 505 of this Act or section 351 of the Public Health
Service Act, shall submit with the application reports on the
investigation described in paragraph (3) if the drug or
biological product that is the subject of the application is--
``(i) intended for the treatment of an adult cancer;
and
``(ii) directed at a molecular target that the
Secretary determines to be substantially relevant to the
growth or progression of a pediatric cancer.'';
(B) in paragraph (2)(A), by striking ``paragraph (1)'' and
inserting ``paragraph (1)(A)'';
(C) by redesignating paragraphs (3) and (4) as paragraphs
(4) and (5), respectively;
(D) by inserting after paragraph (2) the following:
``(3) Molecularly targeted pediatric cancer investigation.--
``(A) In general.--With respect to a drug or biological
product described in paragraph (1)(B), the investigation
described in this paragraph is a molecularly targeted pediatric
cancer investigation, which shall be designed to yield
clinically meaningful pediatric study data, gathered using
appropriate formulations for each age group for which the study
is required, regarding dosing, safety, and preliminary efficacy
to inform potential pediatric labeling.
``(B) Extrapolation of data.--Paragraph (2)(B) shall apply
to investigations described in this paragraph to the same
extent and in the same manner as paragraph (2)(B) applies with
respect to the assessments required under paragraph (1)(A).
``(C) Deferrals and waivers.--Deferrals and waivers under
paragraphs (4) and (5) shall apply to investigations described
in this paragraph to the same extent and in the same manner as
such deferrals and waivers apply with respect to the
assessments under paragraph (2)(B).'';
(E) in paragraph (4), as so redesignated--
(i) by striking ``assessments required under paragraph
(1)'' each place it appears and inserting ``assessments
required under paragraph (1)(A) or reports on the
investigation required under paragraph (1)(B)'';
(ii) in subparagraph (A)(ii)(I), by inserting ``or
reports on the investigation'' after ``assessments'';
(iii) in subparagraph (B)(ii), by striking ``assessment
under paragraph (1)'' and inserting ``assessment under
paragraph (1)(A) or reports on the investigation under
paragraph (1)(B)''; and
(iv) in subparagraph (C)(ii)(II), by inserting ``or
investigation'' after ``assessment''; and
(F) in paragraph (5), as so redesignated, by inserting ``or
reports on the investigation'' after ``assessments'' each place
it appears;
(2) in subsection (d)--
(A) by striking ``subsection (a)(3)'' each place it appears
and inserting ``subsection (a)(4)'';
(B) by inserting ``and Reports on the Investigation'' after
``Submission of Assessments'' in the heading; and
(C) by inserting ``or the investigation described in
subsection (a)(3)'' after ``assessment described in subsection
(a)(2)'' each place it appears;
(3) in subsection (e)--
(A) in paragraph (1), by inserting ``or the investigation
described in subsection (a)(3)'' after ``under subsection
(a)(2)''; and
(B) in paragraph (2)(A)(i), by inserting ``or the
investigation described in subsection (a)(3)'' after ``under
subsection (a)(2)''; and
(4) by adding at the end the following:
``(m) List of Primary Molecular Targets.--
``(1) In general.--Within one year of the date of enactment of
the FDA Reauthorization Act of 2017, the Secretary shall establish
and update regularly, and shall publish on the internet website of
the Food and Drug Administration--
``(A) a list of molecular targets considered, on the basis
of data the Secretary determines to be adequate, to be
substantially relevant to the growth and progression of a
pediatric cancer, and that may trigger the requirements under
this section; and
``(B) a list of molecular targets of new cancer drugs and
biological products in development for which pediatric cancer
study requirements under this section will be automatically
waived.
``(2) Consultation.--In establishing the lists described in
paragraph (1), the Secretary shall consult the National Cancer
Institute, members of the internal committee under section 505C,
and the Pediatric Oncology Subcommittee of the Oncologic Drugs
Advisory Committee, and shall take into account comments from the
meeting under subsection (c).
``(3) Rule of construction.--Nothing in paragraph (1) shall be
construed--
``(A) to require the inclusion of a molecular target on the
list published under such paragraph as a condition for
triggering the requirements under subsection (a)(1)(B) with
respect to a drug or biological product directed at such
molecular target; or
``(B) to authorize the disclosure of confidential
commercial information, as prohibited under section 301(j) of
this Act or section 1905 of title 18, United States Code.''.
(b) Orphan Drugs.--Section 505B(k) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355c(k)) is amended to read as follows:
``(k) Relation to Orphan Drugs.--
``(1) In general; exemption for orphan indications.--Unless the
Secretary requires otherwise by regulation and except as provided
in paragraph (2), this section does not apply to any drug or
biological product for an indication for which orphan designation
has been granted under section 526.
``(2) Applicability despite orphan designation of certain
indications.--This section shall apply with respect to a drug or
biological product for which an indication has been granted orphan
designation under 526 if the investigation described in subsection
(a)(3) applies to the drug or biological product as described in
subsection (a)(1)(B).''.
(c) Meeting, Consultation, and Guidance.--
(1) Meeting.--The Secretary of Health and Human Services
(referred to in this subsection as the ``Secretary''), acting
through the Commissioner of Food and Drugs and in collaboration
with the Director of the National Cancer Institute, shall convene a
public meeting not later than 1 year after the date of enactment of
this Act to solicit feedback from physicians and researchers
(including pediatric oncologists and rare disease specialists),
patients, and other stakeholders to provide input on development of
the guidance under paragraph (2) and the list under subsection (m)
of section 505B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c), as added by subsection (a). The Secretary shall seek
input at such meeting on--
(A) the data necessary to determine that there is
scientific evidence that a drug or biological product is
directed at a molecular target that is considered to be
substantially relevant to the growth or progression of a
pediatric cancer;
(B) the data necessary to determine that there is
scientific evidence that a molecular target is considered to be
substantially relevant to the growth or progression of a
pediatric cancer;
(C) the data needed to meet the requirement of conducting
an investigation described in section 505B(a)(3) of the Federal
Food, Drug, and Cosmetic Act, as amended by subsection (a);
(D) considerations when developing the list under section
505B(m) of the Federal Food, Drug, and Cosmetic Act that
contains molecular targets shared between different tumor
types;
(E) the process the Secretary shall utilize to update
regularly a list of molecular targets that may trigger a
pediatric study under section 505B of the Federal Food, Drug,
and Cosmetic Act, as so amended, and how often such updates
shall occur;
(F) how to overcome the challenges related to pediatric
cancer drug and biological product development, including
issues related to the ethical, practical, and other barriers to
conducting clinical trials in pediatric cancer with small
patient populations;
(G) scientific or operational challenges associated with
performing an investigation described in section 505B(a)(1)(B)
of the Federal Food, Drug, and Cosmetic Act, including the
effect on pediatric studies currently underway in a pediatric
patient population, treatment of a pediatric patient
population, and the ability to complete adult clinical trials;
(H) the advantages and disadvantages of innovative clinical
trial designs in addressing the development of cancer drugs or
biological products directed at molecular targets in pediatric
cancer patients;
(I) the ways in which the Secretary can improve the current
process outlined under sections 505A and 505B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) to
encourage additional research and development of pediatric
cancer treatments;
(J) the ways in which the Secretary might streamline and
improve the written request process, including when studies
contained in a request under such section 505A are not feasible
due to the ethical, practical, or other barriers to conducting
clinical trials in pediatric cancer populations;
(K) how the Secretary will facilitate collaboration among
pediatric networks, academic centers and experts in pediatric
cancer to conduct an investigation described in such section
505B(a)(3);
(L) how the Secretary may facilitate collaboration among
sponsors of same-in-class drugs and biological products that
would be subject to the requirements for an investigation under
such section 505B based on shared molecular targets; and
(M) the ways in which the Secretary will help to mitigate
the risks, if any, of discouraging the research and development
of orphan drugs when implementing such section 505B as amended.
(2) Guidance.--Not later than 2 years after the date of
enactment of this Act, the Secretary, acting through the
Commissioner of Food and Drugs, shall issue final guidance on
implementation of the amendments to section 505B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c) regarding molecularly
targeted cancer drugs made by this section, including--
(A) the scientific criteria, types of data, and regulatory
considerations for determining whether a molecular target is
substantially relevant to the growth or progression of a
pediatric cancer and would trigger an investigation under
section 505B of the Federal Food, Drug, and Cosmetic Act, as
amended;
(B) the process by which the Secretary will engage with
sponsors to discuss determinations, investigation requirements,
deferrals, waivers, and any other issues that need to be
resolved to ensure that any required investigation based on a
molecular target can be reasonably conducted;
(C) the scientific or operational challenges for which the
Secretary may issue deferrals or waivers for an investigation
described in subsection (a)(3) of such section 505B, including
adverse impacts on current pediatric studies underway in a
pediatric patient population, studies involving drugs
designated as orphan drugs, treatment of a pediatric patient
population, or the ability to complete adult clinical trials;
(D) how the Secretary and sponsors will facilitate
collaboration among pediatric networks, academic centers, and
experts in pediatric cancer to conduct an investigation
described in subsection (a)(3) of such section 505B;
(E) scientific and regulatory considerations for study
designs, including the applicability of innovative clinical
trial designs for pediatric cancer drug and biological product
developments under sections 505A and 505B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355a, 355c);
(F) approaches to streamline and improve the amendment
process, including when studies contained in a request under
such section 505A are not feasible due to the ethical,
practical, or other barriers to conducting clinical trials in
pediatric cancer populations;
(G) the process for submission of an initial pediatric
study plan for the investigation described in section
505B(a)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c(a)(3)), including the process for a sponsor to meet
and reach agreement with the Secretary on the initial pediatric
study plan; and
(H) considerations for implementation of such section 505B,
as so amended, and waivers of the requirements of such section
505B with regard to molecular targets for which several drugs
or biological products may be under investigation.
(d) Report to Congress.--Section 508(b) of the Food and Drug
Administration Safety and Innovation Act (21 U.S.C. 355c-1(b)) is
amended--
(1) in paragraph (10), by striking ``; and'' and inserting
``;''; and
(2) by striking paragraph (11) and inserting the following:
``(11) an assessment of the impact of the amendments to such
section 505B made by the FDA Reauthorization Act of 2017 on
pediatric research and labeling of drugs and biological products
and pediatric labeling of molecularly targeted drugs and biological
products for the treatment of cancer;
``(12) an assessment of the efforts of the Secretary to
implement the plan developed under section 505C-1 of the Federal
Food, Drug, and Cosmetic Act, regarding earlier submission of
pediatric studies under sections 505A and 505B of such Act and
section 351(m) of the Public Health Service Act, including--
``(A) the average length of time after the approval of an
application under section 505(b)(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(b)(1)) or section 351(a) of the
Public Health Service Act (42 U.S.C. 262(a)) before studies
conducted pursuant to such section 505A, 505B, or section
351(m) are completed, submitted, and incorporated into
labeling;
``(B) the average length of time after the receipt of a
proposed pediatric study request before the Secretary responds
to such request;
``(C) the average length of time after the submission of a
proposed pediatric study request before the Secretary issues a
written request for such studies;
``(D) the number of written requests issued for each
investigational new drug or biological product prior to the
submission of an application under section 505(b)(1) of the
Federal Food, Drug, and Cosmetic Act or section 351(a) of the
Public Health Service Act; and
``(E) the average number, and range of numbers, of
amendments to written requests issued, and the time the
Secretary requires to review and act on proposed amendments to
written requests;
``(13) a list of sponsors of applications or holders of
approved applications who received exclusivity under such section
505A or such section 351(m) after receiving a letter issued under
such section 505B(d)(1) for any drug or biological product before
the studies referred to in such letter were completed and
submitted;
``(14) a list of assessments and investigations required under
such section 505B;
``(15) how many requests under such section 505A for molecular
targeted cancer drugs, as defined by subsection (a)(1)(B) of such
section 505B, approved prior to 3 years after the date of enactment
of the FDA Reauthorization Act of 2017, have been issued by the
Food and Drug Administration, and how many such requests have been
completed; and
``(16) the Secretary's assessment of the overall impact of the
amendments made by section 504 of the FDA Reauthorization Act of
2017 on the conduct and effectiveness of pediatric cancer research
and the orphan drug program, as well any subsequent
recommendations.''.
(e) Rule of Construction.--Nothing in this section, including the
amendments made by this section, shall limit the authority of the
Secretary of Health and Human Services to issue written requests under
section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a) or section 351(m) of the Public Health Service Act (42 U.S.C.
262(m)), or to negotiate or implement amendments to such requests
proposed by the an applicant.
(f) GAO Report.--
(1) In general.--Beginning on the date that is 5 years after
the date of enactment of this Act, the Comptroller General of the
United States shall conduct a study of the effectiveness of
requiring assessments and investigations described in section 505B
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c), as
amended by this section, in the development of drugs and biological
products for pediatric cancer indications. The Comptroller General
shall examine--
(A) the indications and associated molecular targets
studied in assessments and investigations required for drugs or
biological products intended for the treatment of an adult
cancer;
(B) the indication for which the study was requested as
compared to the indication requested under the new drug
application filed by the sponsor;
(C) the number of pediatric cancer indications for which
assessments and investigations have been required under such
section 505B;
(D) the number of requests for deferral and waiver of
pediatric assessments and investigations required under such
section and the number of such deferral and waiver requests
granted and denied;
(E) the number of orphan-designated indications for drugs
and biological products for which assessments and
investigations were required under such section;
(F) the number of drugs and biological products approved
for the treatment of cancer in the pediatric population for
which the supportive studies were required to be conducted
under such section;
(G) the number of written requests made under section 505A
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a)
relating to investigations required under subsection (a)(1)(B)
of such section 505B; and
(H) any additional considerations by the Secretary
regarding the effectiveness of requiring pediatric assessments
described in such section 505B in the development of drugs and
biological products for pediatric cancer indications.
(2) Review.--The study under paragraph (1) shall include a
review of the Food and Drug Administration's use of the authority
under section 505B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c), as amended by this section, including the amendments
to the deferral and waiver criteria under such section and how such
criteria have been applied.
(3) Consultation.--In conducting the study under paragraph (1),
the Comptroller General of the United States shall consult with
appropriate stakeholders that may be required to conduct the trials
under section 505B of the Federal Food, Drug, and Cosmetic Act, and
the ability of such stakeholders to adhere to the requests issued
by the Food and Drug Administration.
(4) Report.--Not later than the date that is 6 years after the
date of enactment of this Act, the Comptroller General of the
United States shall submit a report containing the results of the
study under paragraph (1) to the Secretary of Health and Human
Services, the Committee on Health, Education, Labor, and Pensions
of the Senate, and the Committee on Energy and Commerce of the
House of Representatives.

f56ede1eef87738959057c579214f9316cf74520a015a3e6c2c626f875593fa9

BIOLOGICAL PRODUCTS FOR PEDIATRIC USE.
(a) Informing Internal Review Committee.--Section 505A(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(f)) is amended by
adding at the end the following:
``(7) Informing internal review committee.--The Secretary shall
provide to the committee referred to in paragraph (1) any response
issued to an applicant or holder with respect to a proposed
pediatric study request.''.
(b) Action on Submissions.--
(1) In general.--Section 505A(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355a(d)) is amended--
(A) by redesignating paragraphs (3) through (5) as
paragraphs (4) through (6), respectively; and
(B) by inserting after paragraph (2) the following:
``(3) Action on submissions.--The Secretary shall review and
act upon a submission by a sponsor or holder of a proposed
pediatric study request or a proposed amendment to a written
request for pediatric studies within 120 calendar days of the
submission.''.
(2) Conforming amendments.--
(A) Federal food, drug, and cosmetic act.--Section 505A of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a), as
amended by paragraph (1), is further amended by striking
subsection ``(d)(3)'' each place it appears and inserting
``(d)(4)''.
(B) Public health service act.--Paragraphs (2), (3), and
(4) of section 351(m) of the Public Health Service Act (42
U.S.C. 262(m)) are amended by striking ``section 505A(d)(3)''
each place it appears and inserting ``section 505A(d)(4)''.
(c) Plan.--The Secretary of Health and Human Services, acting
through the internal review committee established under section 505C of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355d) shall, not
later than one year after the date of enactment of this Act, develop
and implement a plan to achieve, when appropriate, earlier submission
of pediatric studies under section 505A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355a) or section 351(m) of the Public Health
Service Act (42 U.S.C. 262(m)). Such plan shall include recommendations
to achieve--
(1) earlier discussion of proposed pediatric study requests and
written requests with sponsors, and if appropriate, discussion of
such requests at the meeting required under section 505B(e)(2)(C)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355c(e)(2)(C)), as amended by section 503(a);
(2) earlier issuance of written requests for a pediatric study
under such section 505A, including for investigational new drugs
prior to the submission of an application under section 505(b)(1)
of such Act (21 U.S.C. 355(b)(1)); and
(3) shorter timelines, when appropriate, for the completion of
studies pursuant to a written request under such section 505A or
such section 351(m).
(d) Neonatology Expertise.--
(1) In general.--Section 6(d) of the Best Pharmaceuticals for
Children Act (21 U.S.C. 393a(d)) is amended by striking ``For the
5-year period beginning on the date of enactment of this
subsection, at'' and inserting ``At''.
(2) Draft guidance.--Not later than 2 years after the date of
enactment of this Act, the Secretary shall issue draft guidance on
clinical pharmacology considerations for neonatal studies for drugs
and biological products.
(e) Submission of Assessments.--Section 505B(d)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)(1)) is amended by
adding at the end the following: ``The Secretary shall inform the
Pediatric Advisory Committee of letters issued under this paragraph and
responses to such letters.''.
(f) Internal Committee.--Section 505C of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355d) is amended by inserting ``or
pediatric rare diseases'' after ``psychiatry''.
(g) Report on Labeling of Orphan Drugs.--
(1) In general.--Not later than 2 years after the date of the
enactment of this Act, the Secretary of Health and Human Services
shall submit to the Committee on Health, Education, Labor and
Pensions of the Senate and the Committee on Energy and Commerce of
the House of Representatives, and make publicly available,
including through posting on the internet website of the Food and
Drug Administration, a report on the lack of information in the
labeling of drugs for indications that have received an orphan
designation under section 526 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb) with respect to the use of such
drugs pediatric populations.
(2) Contents.--The report described in paragraph (1) shall
include--
(A) a list of drugs for which--
(i) an indication was granted an orphan designation
under section 526 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb);
(ii) an application described under section 505B(a)(1)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355c(a)(1)) for such indication was submitted to the
Secretary of Health and Human Services on or after April 1,
1999; and
(iii) the labeling for such indication lacks important
pediatric information, including information related to
safety, dosing, and effectiveness;
(B) a description of the lack of information referred to in
subparagraph (A)(iii) for each drug for an indication on such
list; and
(C) Federal policy recommendations to improve the labeling
of drugs for indications that have received an orphan
designation under such section 526 with respect to the use of
such drugs pediatric populations.''

d8a81c9c618ca51d97eb3b479204326f7c59ef819842158f7b1a9fca8a3ba690

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''.

4a83e0ec85a1cb767e76d4c74906bf739101d5ee770fee2800cb189cea213feb

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''.

5f17d96f1dde15cfc508a2ca23eb96c233b5402490135e7e720cadb3eebb2144

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''.

28c8fd098ecbf0759d65d7b043bb09f5a72fafc6efc828e5be426bf8734ade77

(a) Diverted Drugs.--Paragraph (1) of section 801(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is amended--
(1) by striking ``(d)(1) Except as'' and inserting ``(d)(1)(A)
Except as''; and
(2) by adding at the end the following:
``(B) Except as authorized by the Secretary in the case of a drug
that appears on the drug shortage list under section 506E or in the
case of importation pursuant to section 804, no drug that is subject to
section 503(b)(1) may be imported into the United States for commercial
use if such drug is manufactured outside the United States, unless the
manufacturer has authorized the drug to be marketed in the United
States and has caused the drug to be labeled to be marketed in the
United States.''.
(b) Counterfeit Drugs.--Subsection (b) of section 303 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by
adding at the end the following:
``(8) Notwithstanding subsection (a), any person who violates
section 301(i)(3) by knowingly making, selling or dispensing, or
holding for sale or dispensing, a counterfeit drug shall be imprisoned
for not more than 10 years or fined in accordance with title 18, United
States Code, or both.''.

5f2f11999352b91bbd8de7c601230403db99b337bb3b40d108d2c1d528c6216f

Section 569C(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb-8c(c)(2)(A)) is amended by striking ``impact of such
disease or condition, or a related therapy,'' and inserting ``impact
(including physical and psychosocial impacts) of such disease or
condition, or a related therapy or clinical investigation''.

72adeedfbf226d69f9c0a1e6e430feba2fa60bcc0c7274ff7999671ab2018b57

Section 505-1(e)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355-1(e)(3)) is amended--
(1) in subparagraph (B), by striking ``; or'';
(2) in subparagraph (C), by striking the period and inserting
``; or''; and
(3) by adding at the end the following:
``(D) disseminating information to health care providers
about drug formulations or properties, including information
about the limitations or patient care implications of such
formulations or properties, and how such formulations or
properties may be related to serious adverse drug events
associated with use of the drug.''.

ba9dccb0a394d8a8738d9b30fb41a6c12ce015f714403213d5f6f21cbb56ae25

(a) In General.--Section 527 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360cc) is amended--
(1) in subsection (a), in the matter following paragraph (2),
by striking ``such drug for such disease or condition'' and
inserting ``the same drug for the same disease or condition'';
(2) in subsection (b)--
(A) in the matter preceding paragraph (1), by striking ``If
an application'' and all that follows through ``such license
if'' and inserting ``During the 7-year period described in
subsection (a) for an approved application under section 505 or
license under section 351 of the Public Health Service Act, the
Secretary may approve an application or issue a license for a
drug that is otherwise the same, as determined by the
Secretary, as the already approved drug for the same rare
disease or condition if'';
(B) in paragraph (1), by striking ``notice'' and all that
follows through ``assure'' and inserting ``of exclusive
approval or licensure notice and opportunity for the submission
of views, that during such period the holder of the exclusive
approval or licensure cannot ensure''; and
(C) in paragraph (2), by striking ``such holder provides''
and inserting ``the holder provides''; and
(3) by adding at the end the following:
``(c) Condition of Clinical Superiority.--
``(1) In general.--If a sponsor of a drug that is designated
under section 526 and is otherwise the same, as determined by the
Secretary, as an already approved or licensed drug is seeking
exclusive approval or exclusive licensure described in subsection
(a) for the same rare disease or condition as the already approved
drug, the Secretary shall require such sponsor, as a condition of
such exclusive approval or licensure, to demonstrate that such drug
is clinically superior to any already approved or licensed drug
that is the same drug.
``(2) Definition.--For purposes of paragraph (1), the term
`clinically superior' with respect to a drug means that the drug
provides a significant therapeutic advantage over and above an
already approved or licensed drug in terms of greater efficacy,
greater safety, or by providing a major contribution to patient
care.
``(d) Regulations.--The Secretary may promulgate regulations for
the implementation of subsection (c). Beginning on the date of
enactment of the FDA Reauthorization Act of 2017, until such time as
the Secretary promulgates regulations in accordance with this
subsection, the Secretary may apply any definitions set forth in
regulations that were promulgated prior to such date of enactment, to
the extent such definitions are not inconsistent with the terms of this
section, as amended by such Act.
``(e) Demonstration of Clinical Superiority Standard.--To assist
sponsors in demonstrating clinical superiority as described in
subsection (c), the Secretary--
``(1) upon the designation of any drug under section 526, shall
notify the sponsor of such drug in writing of the basis for the
designation, including, as applicable, any plausible hypothesis
offered by the sponsor and relied upon by the Secretary that the
drug is clinically superior to a previously approved drug; and
``(2) upon granting exclusive approval or licensure under
subsection (a) on the basis of a demonstration of clinical
superiority as described in subsection (c), shall publish a summary
of the clinical superiority findings.''.
(b) Rule of Construction.--Nothing in the amendments made by
subsection (a) shall affect any determination under sections 526 and
527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb,
360cc) made prior to the date of enactment of the FDA Reauthorization
Act of 2017.

87b571a5552a7eb1f8b030d881beeb3b539dd33663ffd7e60619aa9ed47273e5

Section 505A(o) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a(o)) is amended--
(1) in the subsection heading, by striking ``under section
505(j)'';
(2) in paragraph (1)--
(A) by striking ``under section 505(j)'' and inserting
``under subsection (b)(2) or (j) of section 505''; and
(B) by striking ``or by exclusivity under clause (iii) or
(iv) of section 505(j)(5)(F)'' and inserting ``, or by
exclusivity under clause (iii) or (iv) of section 505(j)(5)(F),
clause (iii) or (iv) of section 505(c)(3)(E), or section
527(a), or by an extension of such exclusivity under this
section or section 505E'';
(3) in paragraph (2), in the matter preceding subparagraph
(A)--
(A) by inserting ``clauses (iii) and (iv) of section
505(c)(3)(E), or section 527,'' after ``section
505(j)(5)(F),''; and
(B) by striking ``drug approved under section 505(j)'' and
inserting ``drug approved pursuant to an application submitted
under subsection (b)(2) or (j) of section 505''; and
(4) by amending paragraph (3) to read as follows:
``(3) Preservation of pediatric exclusivity and extensions.--
This subsection does not affect--
``(A) the availability or scope of exclusivity under--
``(i) this section;
``(ii) section 505 for pediatric formulations; or
``(iii) section 527;
``(B) the availability or scope of an extension to any such
exclusivity, including an extension under this section or
section 505E;
``(C) the question of the eligibility for approval under
section 505 of any application described in subsection (b)(2)
or (j) of such section that omits any other aspect of labeling
protected by exclusivity under--
``(i) clause (iii) or (iv) of section 505(j)(5)(F);
``(ii) clause (iii) or (iv) of section 505(c)(3)(E); or
``(iii) section 527(a); or
``(D) except as expressly provided in paragraphs (1) and
(2), the operation of section 505 or section 527.''.

1407a3ca8617530bd8e2d77aae536c05a5ab674da139937b57733cb613a38fe4

DRUGS.
It is the sense of the Congress that the Secretary of Health and
Human Services should commit to engaging with the House of
Representatives and the Senate to take administrative actions and enact
legislative changes that--
(1) will lower the cost of prescription drugs for consumers and
reduce the burden of such cost on taxpayers; and
(2) in lowering such cost, will--
(A) balance the need to encourage innovation with the need
to improve affordability; and
(B) strive to increase competition in the pharmaceutical
market, prevent anticompetitive behavior, and promote the
timely availability of affordable, high-quality generic drugs
and biosimilars.

25d913c446428f8c11489c1284f4321d62673c5377def1881aa86f8e5800ef6a

(a) Patient Access to Investigational Drugs.--
(1) Public meeting.--
(A) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), acting
through the Commissioner of Food and Drugs, in coordination
with the Director of the National Institutes of Health, and in
consultation with patients, health care providers, drug
sponsors, bioethicists, and other stakeholders, shall, not
later than 270 days after the date of enactment of this Act,
convene a public meeting to discuss clinical trial inclusion
and exclusion criteria to inform the guidance under paragraph
(3). The Secretary shall inform the Comptroller General of the
United States of the date when the public meeting will take
place.
(B) Topics.--The Secretary shall make available on the
internet website of the Food and Drug Administration a report
on the topics discussed at the meeting described in
subparagraph (A) within 90 days of such meeting. Such topics
shall include discussion of--
(i) the rationale for, and potential barriers for
patients created by, research clinical trial inclusion and
exclusion criteria;
(ii) how appropriate patient populations can benefit
from the results of trials that employ alternative designs;
(iii) barriers to participation in clinical trials,
including--
(I) information regarding any potential risks and
benefits of participation;
(II) regulatory, geographical, and socioeconomic
barriers; and
(III) the impact of exclusion criteria on the
enrollment in clinical trials of particular
populations, including infants and children, pregnant
and lactating women, seniors, individuals with advanced
disease, and individuals with co-morbid conditions;
(iv) clinical trial designs and methods, including
expanded access trials, that increase enrollment of more
diverse patient populations, when appropriate, while
facilitating the collection of data to establish safe use
and support substantial evidence of effectiveness,
including data obtained from expanded access trials; and
(v) how changes to clinical trial inclusion and
exclusion criteria may impact the complexity and length of
clinical trials, the data necessary to demonstrate safety
and effectiveness, and potential approaches to mitigating
those impacts.
(2) Report.--Not later than 1 year after the Secretary issues
the report under paragraph (1)(B), the Comptroller General of the
United States shall report to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives on individual access to
investigational drugs through the expanded access program under
section 561(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb(b)). The report shall include--
(A) a description of actions taken by manufacturers and
distributors under section 561A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-0);
(B) consideration of whether Form FDA 3926 and the guidance
documents titled ``Expanded Access to Investigational Drugs for
Treatment Use--Questions and Answers'' and ``Individual Patient
Expanded Access Applications: Form FDA 3926'', issued by the
Food and Drug Administration in June 2016, have reduced
application burden with respect to individuals and physicians
seeking access to investigational new drugs pursuant to section
561(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb) and improved clarity for patients, physicians, and drug
manufacturers about such process;
(C) consideration of whether the guidance or regulations
issued to implement section 561 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb) have improved access for
individual patients to investigational drugs who do not qualify
for clinical trials of such investigational drugs, and what
barriers to such access remain;
(D) an assessment of methods patients and health care
providers use to engage with the Food and Drug Administration
or drug sponsors on expanded access; and
(E) an analysis of the Secretary's report under paragraph
(1)(B).
(3) Guidance.--
(A) In general.--Not later than 1 year after the
publication of the report under paragraph (1)(B), the
Secretary, acting through the Commissioner of Food and Drugs,
shall issue one or more draft guidances regarding eligibility
criteria for clinical trials. Not later than 1 year after the
public comment period on each such draft guidance ends, the
Secretary shall issue a revised draft guidance or final
guidance.
(B) Contents.--The guidance documents described in
subparagraph (A) shall address methodological approaches that a
manufacturer or sponsor of an investigation of a new drug may
take to--
(i) broaden eligibility criteria for clinical trials
and expanded access trials, especially with respect to
drugs for the treatment of serious and life-threatening
conditions or diseases for which there is an unmet medical
need;
(ii) develop eligibility criteria for, and increase
trial recruitment to, clinical trials so that enrollment in
such trials more accurately reflects the patients most
likely to receive the drug, as applicable and as
appropriate, while establishing safe use and supporting
findings of substantial evidence of effectiveness; and
(iii) use the criteria described in clauses (i) and
(ii) in a manner that is appropriate for drugs intended for
the treatment of rare diseases or conditions.
(b) Improving Institutional Review Board Review of Single Patient
Expanded Access Protocol.--Not later than 1 year after the date of
enactment of this Act, the Secretary, acting through the Commissioner
of Food and Drugs, shall issue guidance or regulations, or revise
existing guidance or regulations, to streamline the institutional
review board review of individual patient expanded access protocols
submitted under 561(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb(b)). To facilitate the use of expanded access protocols,
any guidance or regulations so issued or revised may include a
description of the process for any person acting through a physician
licensed in accordance with State law to request that an institutional
review board chair (or designated member of the institutional review
board) review a single patient expanded access protocol submitted under
such section 561(b) for a drug. The Secretary shall update any relevant
forms associated with individual patient expanded access requests under
such section 561(b) as necessary.
(c) Expanded Access Policy Transparency.--Section 561A(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-0(f)) is
amended--
(1) in the matter preceding paragraph (1), by striking
``later'' and inserting ``earlier'';
(2) by striking paragraph (1);
(3) by redesignating paragraph (2) as paragraph (1);
(4) in paragraph (1) as so redesignated, by striking the period
at the end and inserting ``; or''; and
(5) by adding at the end the following:
``(2) as applicable, 15 days after the drug receives a
designation as a breakthrough therapy, fast track product, or
regenerative advanced therapy under subsection (a), (b), or (g),
respectively, of section 506.''.

763b67dc7e03189afe3db54aca0c8398f0af378bf75d8b3e9c05d66c161d2d5c

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

eae801f2140190f79167e205b92bafbfadce02454176d389addd8f56f7b8a522

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

4ebbea76586b7f7c806fcf35dfaa2232561af177e2b10577ca2c99007ed87038

TITLE VII

-DEVICE INSPECTION AND REGULATORY IMPROVEMENTS

ESTABLISHMENTS.
(a) In General.--Section 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374) is amended by adding at the end the
following:
``(h)(1) In the case of inspections other than for-cause
inspections, the Secretary shall review processes and standards
applicable to inspections of domestic and foreign device establishments
in effect as of the date of the enactment of this subsection, and
update such processes and standards through the adoption of uniform
processes and standards applicable to such inspections. Such uniform
processes and standards shall provide for--
``(A) exceptions to such processes and standards, as
appropriate;
``(B) announcing the inspection of the establishment within a
reasonable time before such inspection occurs, including by
providing to the owner, operator, or agent in charge of the
establishment a notification regarding the type and nature of the
inspection;
``(C) a reasonable estimate of the timeframe for the
inspection, an opportunity for advance communications between the
officers or employees carrying out the inspection under subsection
(a)(1) and the owner, operator, or agent in charge of the
establishment concerning appropriate working hours during the
inspection, and, to the extent feasible, advance notice of some
records that will be requested; and
``(D) regular communications during the inspection with the
owner, operator, or agent in charge of the establishment regarding
inspection status, which may be recorded by either party with
advance notice and mutual consent.
``(2)(A) The Secretary shall, with respect to a request described
in subparagraph (B), provide nonbinding feedback with respect to such
request not later than 45 days after the Secretary receives such
request.
``(B) A request described in this subparagraph is a request for
feedback--
``(i) that is made by the owner, operator, or agent in charge
of such establishment in a timely manner; and
``(ii) with respect to actions proposed to be taken by a device
establishment in a response to a report received by such
establishment pursuant to subsection (b) that involve a public
health priority, that implicate systemic or major actions, or
relate to emerging safety issues (as determined by the Secretary).
``(3) Nothing in this subsection affects the authority of the
Secretary to conduct inspections otherwise permitted under this Act in
order to ensure compliance with this Act.''.
(b) Guidance.--
(1) Draft guidance.--Not later than 18 months after the date of
enactment of this Act, the Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, shall issue
draft guidance that--
(A) specifies how the Food and Drug Administration will
implement the processes and standards described in paragraph
(1) of subsection (h) of section 704 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 374), as added by subsection (a),
and the requirements described in paragraph (2) of such
subsection (h);
(B) provides for standardized methods for communications
described in such paragraphs;
(C) establishes, with respect to inspections of both
domestic and foreign device establishments (as referred to in
section 510(h)(2) of the Federal Food, Drug, and Cosmetic Act,
as amended by subsection (a)), a standard timeframe for such
inspections--
(i) that occurs over consecutive days; and
(ii) to which each investigator conducting such an
inspection shall adhere unless the investigator identifies
to the establishment involved a reason that more time is
needed to conduct such investigation; and
(D) identifies practices for investigators and device
establishments to facilitate the continuity of inspections of
such establishments.
(2) Final guidance.--Not later than 1 year after providing
notice and opportunity for public comment on the draft guidance
issued under paragraph (1), the Secretary of Health and Human
Services shall issue final guidance to implement subsection (h) of
section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
374), as added by subsection (a).
(c) Adulterated Devices.--Subsection (j) of section 501 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended by
inserting ``or device'' after ``drug''.

24551ae4687df85374eaf0825f38813682c0c5963a7502c789ed7b9042369110

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''.

87c8655076389c64457d6cdf20ae2b7740053e87001fc0c0a5dbf222159a47f4

Subsection (e)(4) of section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381(e)(4)) is amended--
(1) by adding at the end the following:
``(E)(i)(I) If the Secretary denies a request for certification
under subparagraph (A)(ii) with respect to a device manufactured in an
establishment (foreign or domestic) registered under section 510, the
Secretary shall provide in writing to the person seeking such
certification the basis for such denial, and specifically identify the
finding upon which such denial is based.
``(II) If the denial of a request as described in subclause (I) is
based on grounds other than an injunction proceeding pursuant to
section 302, seizure action pursuant to section 304, or a recall
designated Class I or Class II pursuant to part 7, title 21, Code of
Federal Regulations, and is based on the facility being out of
compliance with part 820 of title 21, Code of Federal Regulations, the
Secretary shall provide a substantive summary of the specific grounds
for noncompliance identified by the Secretary.
``(III) With respect to a device manufactured in an establishment
that has received a report under section 704(b), the Secretary shall
not deny a request for certification as described in subclause (I) with
respect to a device based solely on the issuance of that report if the
owner, operator, or agent in charge of such establishment has agreed to
a plan of correction in response to such report.
``(ii)(I) The Secretary shall provide a process for a person who is
denied a certification as described in clause (i)(I) to request a
review that conforms to the standards of section 517A(b).
``(II) Notwithstanding any previous review conducted pursuant to
subclause (I), a person who has been denied a certification as
described in clause (i)(I) may at any time request a review in order to
present new information relating to actions taken by such person to
address the reasons identified by the Secretary for the denial of
certification, including evidence that corrective actions are being or
have been implemented to address grounds for noncompliance identified
by the Secretary.
``(III) Not later than 1 year after the date of enactment of the
FDA Reauthorization Act of 2017, the Secretary shall issue guidance
providing for a process to carry out this subparagraph. Not later than
1 year after the close of the comment period for such guidance, the
Secretary shall issue final guidance.
``(iii)(I) Subject to subclause (II), this subparagraph applies to
requests for certification on behalf of any device establishment
registered under section 510, whether the establishment is located
inside or outside of the United States, and regardless of whether such
devices are to be exported from the United States.
``(II) If an establishment described in subclause (I) is not
located within the United States and does not demonstrate that the
devices manufactured, prepared, propagated, compounded, or processed at
such establishment are to be exported from the United States, this
subparagraph shall apply only if--
``(aa) the establishment has been inspected by the Secretary
within 3 years of the date of the request; or
``(bb) the establishment participates in an audit program in
which the United States participates or the United States
recognizes, an audit under such program has been conducted, and the
findings of such audit are provided to the Secretary within 3 years
of the date of the request.''; and
(2) by moving the margins of subparagraphs (C) and (D) 4 ems to
the left.

af6f1d6abb01f4f1e1724772792e17bdc1212798e578f76864f203d2b6f70704

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

7c45f56fb6ee79ba445a21659ba33cb89103dc8e83deff5f6d3620c2911f9a04

(a) Approval of Applications for Certain Diagnostic Medical Imaging
Devices.--Section 520 of the Federal Food, Drug, and Cosmetic Act (42
U.S.C. 360j) is amended by adding at the end the following:
``(p) Diagnostic Imaging Devices Intended for Use With Contrast
Agents.--
``(1) In general.--The Secretary may, subject to the succeeding
provisions of this subsection, approve an application (or a
supplement to such an application) submitted under section 515 with
respect to an applicable medical imaging device, or, in the case of
an applicable medical imaging device for which a notification is
submitted under section 510(k), may make a substantial equivalence
determination with respect to an applicable medical imaging device,
or may grant a request submitted under section 513(f)(2) for an
applicable medical imaging device, if such application,
notification, or request involves the use of a contrast agent that
is not--
``(A) in a concentration, rate of administration, or route
of administration that is different from those described in the
approved labeling of the contrast agent, except that the
Secretary may approve such application, make such substantial
equivalence determination, or grant such request if the
Secretary determines that such differences in concentration,
rate of administration, or route of administration exist but do
not adversely affect the safety and effectiveness of the
contrast agent when used with the device;
``(B) in a region, organ, or system of the body that is
different from those described in the approved labeling of the
contrast agent, except that the Secretary may approve such
application, make such substantial equivalence determination,
or grant such request if the Secretary determines that such
differences in region, organ, or system of the body exist but
do not adversely affect the safety and effectiveness of the
contrast agent when used with the device;
``(C) in a patient population that is different from those
described in the approved labeling of the contrast agent,
except that the Secretary may approve such application, make
such substantial equivalence determination, or grant such
request if the Secretary determines such differences in patient
population exist but do not adversely affect the safety and
effectiveness of the contrast agent when used with the device;
or
``(D) in an imaging modality that is different from those
described in the approved labeling of the contrast agent.
``(2) Premarket review.--The agency center charged with
premarket review of devices shall have primary jurisdiction with
respect to the review of an application, notification, or request
described in paragraph (1). In conducting such review, such agency
center may--
``(A) consult with the agency center charged with the
premarket review of drugs or biological products; and
``(B) review information and data provided to the Secretary
by the sponsor of a contrast agent in an application submitted
under section 505 of this Act or section 351 of the Public
Health Service Act, so long as the sponsor of such contrast
agent has provided to the sponsor of the applicable medical
imaging device that is the subject of such review a right of
reference and the application is submitted in accordance with
this subsection.
``(3) Applicable requirements.--An application submitted under
section 515, a notification submitted under section 510(k), or a
request submitted under section 513(f)(2), as described in
paragraph (1), with respect to an applicable medical imaging device
shall be subject to the requirements of such respective section.
Such application, notification, or request shall only be subject to
the requirements of this Act applicable to devices.
``(4) Definitions.--For purposes of this subsection--
``(A) the term `applicable medical imaging device' means a
device intended to be used in conjunction with a contrast agent
(or class of contrast agents) for an imaging use that is not
described in the approved labeling of such contrast agent (or
the approved labeling of any contrast agent in the same class
as such contrast agent); and
``(B) the term `contrast agent' means a drug that is
approved under section 505 or licensed under section 351 of the
Public Health Service Act, is intended for use in conjunction
with an applicable medical imaging device, and--
``(i) is a diagnostic radiopharmaceutical, as defined
in section 315.2 and 601.31 of title 21, Code of Federal
Regulations (or any successor regulations); or
``(ii) is a diagnostic agent that improves the
visualization of structure or function within the body by
increasing the relative difference in signal intensity
within the target tissue, structure, or fluid.''.
(b) Applications for Approval of Contrast Agents Intended for Use
With Certain Diagnostic Medical Imaging Devices.--Section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by
adding at the end the following:
``(y) Contrast Agents Intended for Use With Applicable Medical
Imaging Devices.--
``(1) In general.--The sponsor of a contrast agent for which an
application has been approved under this section may submit a
supplement to the application seeking approval for a new use
following the authorization of a premarket submission for an
applicable medical imaging device for that use with the contrast
agent pursuant to section 520(p)(1).
``(2) Review of supplement.--In reviewing a supplement
submitted under this subsection, the agency center charged with the
premarket review of drugs may--
``(A) consult with the center charged with the premarket
review of devices; and
``(B) review information and data submitted to the
Secretary by the sponsor of an applicable medical imaging
device pursuant to section 515, 510(k), or 513(f)(2) so long as
the sponsor of such applicable medical imaging device has
provided to the sponsor of the contrast agent a right of
reference.
``(3) Definitions.--For purposes of this subsection--
``(A) the term `new use' means a use of a contrast agent
that is described in the approved labeling of an applicable
medical imaging device described in section 520(p), but that is
not described in the approved labeling of the contrast agent;
and
``(B) the terms `applicable medical imaging device' and
`contrast agent' have the meanings given such terms in section
520(p).''.

1cfeec87e6010eec203d5bc5dec47453e509e925448824c66e307fba88bcc0ce

(a) In General.--Subsection (f) of section 513 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end
the following new paragraph:
``(6)(A) Subject to the succeeding subparagraphs of this paragraph,
the Secretary shall, by written order, classify an accessory under this
section based on the risks of the accessory when used as intended and
the level of regulatory controls necessary to provide a reasonable
assurance of safety and effectiveness of the accessory, notwithstanding
the classification of any other device with which such accessory is
intended to be used.
``(B) The classification of any accessory distinct from another
device by regulation or written order issued prior to December 13,
2016, shall continue to apply unless and until the accessory is
reclassified by the Secretary, notwithstanding the classification of
any other device with which such accessory is intended to be used.
Nothing in this paragraph shall preclude the Secretary's authority to
initiate the classification of an accessory through regulation or
written order, as appropriate.
``(C)(i) In the case of a device intended to be used with an
accessory, where the accessory has been included in an application for
premarket approval of such device under section 515 or a report under
section 510(k) for clearance of such device and the Secretary has not
classified such accessory distinctly from another device in accordance
with subparagraph (A), the person filing the application or report (as
applicable) at the time such application or report is filed--
``(I) may include a written request for the proper
classification of the accessory pursuant to subparagraph (A);
``(II) shall include in any such request such information as
may be necessary for the Secretary to evaluate, based on the least
burdensome approach, the appropriate class for the accessory under
subsection (a); and
``(III) shall, if the request under subclause (I) is requesting
classification of the accessory in class II, include in the
application an initial draft proposal for special controls, if
special controls would be required pursuant to subsection
(a)(1)(B).
``(ii) The Secretary's response under section 515(d) or section
510(n) (as applicable) to an application or report described in clause
(i) shall also contain the Secretary's granting or denial of the
request for classification of the accessory involved.
``(iii) The Secretary's evaluation of an accessory under clause (i)
shall constitute an order establishing a new classification for such
accessory for the specified intended use or uses of such accessory and
for any accessory with the same intended use or uses as such accessory.
``(D) For accessories that have been granted marketing
authorization as part of a submission for another device with which the
accessory involved is intended to be used, through an application for
such other device under section 515(c), a report under section 510(k),
or a request for classification under paragraph (2) of this subsection,
the following shall apply:
``(i) Not later than the date that is one year after the date
of enactment of the FDA Reauthorization Act of 2017 and at least
once every 5 years thereafter, and as the Secretary otherwise
determines appropriate, pursuant to this paragraph, the Secretary
shall publish in the Federal Register a notice proposing a list of
such accessories that the Secretary determines may be suitable for
a distinct classification in class I and the proposed regulations
for such classifications. In developing such list, the Secretary
shall consider recommendations from sponsors of device submissions
and other stakeholders for accessories to be included on such list.
The notices shall provide for a period of not less than 60 calendar
days for public comment. Within 180 days after the end of the
comment period, the Secretary shall publish in the Federal Register
a final action classifying such suitable accessories into class I.
``(ii) A manufacturer or importer of an accessory that has been
granted such marketing authorization may submit to the Secretary a
written request for the appropriate classification of the accessory
based on the risks and appropriate level of regulatory controls as
described in subparagraph (A), and shall, if the request is
requesting classification of the accessory in class II, include in
the submission an initial draft proposal for special controls, if
special controls would be required pursuant to subsection
(a)(1)(B). Such request shall include such information as may be
necessary for the Secretary to evaluate, based on the least
burdensome approach, the appropriate class for the accessory under
subsection (a). The Secretary shall provide an opportunity for a
manufacturer or importer to meet with appropriate personnel of the
Food and Drug Administration to discuss the appropriate
classification of such accessory prior to submitting a written
request under this clause for classification of the accessory.
``(iii) The Secretary shall respond to a request made under
clause (ii) not later than 85 calendar days after receiving such
request by issuing a written order classifying the accessory or
denying the request. If the Secretary does not agree with the
recommendation for classification submitted by the manufacturer or
importer, the response shall include a detailed description and
justification for such determination. Within 30 calendar days after
granting such a request, the Secretary shall publish a notice in
the Federal Register announcing such response.
``(E) Nothing in this paragraph may be construed as precluding a
manufacturer of an accessory of a new type from using the
classification process described in subsection (f)(2) to obtain
classification of such accessory in accordance with the criteria and
requirements set forth in that subsection.''.
(b) Conforming Change.--Section 513(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360c(b)) is amended by striking paragraph
(9) (relating to classification of an accessory).
(c) Effective Date.--The amendments made by subsections (a) and (b)
shall take effect on the date that is 60 days after the date of
enactment of this Act.

1c21aaa3020c9723062301a258058f0d6a99dc15a94015aa355d8bbe41178be0

(a) Postmarket Pilot.--Section 519 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360i) is amended by adding at the end the
following:
``(i) Postmarket Pilot.--
``(1) In general.--In order to provide timely and reliable
information on the safety and effectiveness of devices approved
under section 515, cleared under section 510(k), or classified
under section 513(f)(2), including responses to adverse events and
malfunctions, and to advance the objectives of part 803 of title
21, Code of Federal Regulations (or successor regulations), and
advance the objectives of, and evaluate innovative new methods of
compliance with, this section and section 522, the Secretary shall,
within one year of the date of enactment of the FDA Reauthorization
Act of 2017, initiate one or more pilot projects for voluntary
participation by a manufacturer or manufacturers of a device or
device type, or continue existing projects, in accordance with
paragraph (3), that--
``(A) are designed to efficiently generate reliable and
timely safety and active surveillance data for use by the
Secretary or manufacturers of the devices that are involved in
the pilot project;
``(B) inform the development of methods, systems, data
criteria, and programs that could be used to support safety and
active surveillance activities for devices included or not
included in such project;
``(C) may be designed and conducted in coordination with a
comprehensive system for evaluating medical device technology
that operates under a governing board with appropriate
representation of stakeholders, including patient groups and
device manufacturers;
``(D) use electronic health data including claims data,
patient survey data, or any other data, as the Secretary
determines appropriate; and
``(E) prioritize devices and device types that meet one or
more of the following criteria:
``(i) Devices and device types for which the collection
and analysis of real world evidence regarding a device's
safety and effectiveness is likely to advance public
health.
``(ii) Devices and device types that are widely used.
``(iii) Devices and device types, the failure of which
has significant health consequences.
``(iv) Devices and device types for which the
Secretary--
``(I) has received public recommendations in
accordance with paragraph (2)(B); and
``(II) has determined to meet one or more of the
criteria under clause (i), (ii), or (iii) and is
appropriate for such a pilot project.
``(2) Participation.--The Secretary shall establish the
conditions and processes--
``(A) under which a manufacturer of a device may
voluntarily participate in a pilot project described in
paragraph (1); and
``(B) for facilitating public recommendations for devices
to be prioritized under such a pilot project, including
requirements for the data necessary to support such a
recommendation.
``(3) Continuation of ongoing projects.--The Secretary may
continue or expand projects, with respect to providing timely and
reliable information on the safety and effectiveness of devices
approved under section 515, cleared under section 510(k), or
classified under section 513(f)(2), that are being carried out as
of the date of the enactment of the FDA Reauthorization Act of
2017. The Secretary shall, beginning on such date of enactment,
take such steps as may be necessary--
``(A) to ensure such projects meet the requirements of
subparagraphs (A) through (E) of paragraph (1); and
``(B) to increase the voluntary participation in such
projects of manufacturers of devices and facilitate public
recommendations for any devices prioritized under such a
project.
``(4) Implementation.--
``(A) Contracting authority.--The Secretary may carry out a
pilot project meeting the criteria specified in subparagraphs
(A) through (E) of paragraph (1) or a project continued or
expanded under paragraph (3) by entering into contracts,
cooperative agreements, grants, or other appropriate agreements
with public or private entities that have a significant
presence in the United States and meet the following
conditions:
``(i) If such an entity is a component of another
organization, the entity and the organization have
established an agreement under which appropriate security
measures are implemented to maintain the confidentiality
and privacy of the data described in paragraph (1)(D) and
such agreement ensures that the entity will not make an
unauthorized disclosure of such data to the other
components of the organization in breach of requirements
with respect to confidentiality and privacy of such data
established under such security measures.
``(ii) In the case of the termination or nonrenewal of
such a contract, cooperative agreement, grant, or other
appropriate agreement, the entity or entities involved
shall comply with each of the following:
``(I) The entity or entities shall continue to
comply with the requirements with respect to
confidentiality and privacy referred to in clause (i)
with respect to all data disclosed to the entity under
such an agreement.
``(II) The entity or entities shall return any data
disclosed to such entity pursuant to this subsection
and to which it would not otherwise have access or, if
returning such data is not practicable, destroy the
data.
``(iii) The entity or entities shall have one or more
qualifications with respect to--
``(I) research, statistical, epidemiologic, or
clinical capability and expertise to conduct and
complete the activities under this subsection,
including the capability and expertise to provide the
Secretary access to de-identified data consistent with
the requirements of this subsection;
``(II) an information technology infrastructure to
support electronic data and operational standards to
provide security for such data, as appropriate;
``(III) experience with, and expertise on, the
development of research on, and surveillance of, device
safety and effectiveness using electronic health data;
or
``(IV) such other expertise which the Secretary
determines necessary to carry out such a project.
``(B) Review of contract in the event of a merger or
acquisition.--The Secretary shall review any contract,
cooperative agreement, grant, or other appropriate agreement
entered into under this paragraph with an entity meeting the
conditions specified in subparagraph (A) in the event of a
merger or acquisition of the entity in order to ensure that the
requirements specified in this subsection will continue to be
met.
``(5) Compliance with requirements for records or reports on
devices.--The participation of a manufacturer in pilot projects
under this subsection or a project continued or expanded under
paragraph (3) shall not affect the eligibility of such manufacturer
to participate in any quarterly reporting program with respect to
devices carried out under this section 519 or section 522. The
Secretary may determine that, for a specified time period to be
determined by the Secretary, a manufacturer's participation in a
pilot project under this subsection or a project continued or
expanded under paragraph (3) may meet the applicable requirements
of this section or section 522, if--
``(A) the project has demonstrated success in capturing
relevant adverse event information; and
``(B) the Secretary has established procedures for making
adverse event and safety information collected from such
project public, to the extent possible.
``(6) Privacy requirements.--With respect to the disclosure of
any health information collected through a project conducted under
this subsection--
``(A) individually identifiable health information so
collected shall not be disclosed when presenting any
information from such project; and
``(B) any such disclosure shall be made in compliance with
regulations issued pursuant to section 264(c) of the Health
Insurance Portability and Accountability Act of 1996 (42 U.S.C.
1320d-2 note) and sections 552 and 552a of title 5, United
States Code.
``(7) Limitations.--No pilot project under this subsection, or
in coordination with the comprehensive system described in
paragraph (1)(C), may allow for an entity participating in such
project, other than the Secretary, to make determinations of safety
or effectiveness, or substantial equivalence, for purposes of this
Act.
``(8) Other projects required to comply.--Paragraphs (1)(B),
(4)(A)(i), (4)(A)(ii), (5), (6), and (7) shall apply with respect
to any pilot project undertaken in coordination with the
comprehensive system described in paragraph (1)(C) that relates to
the use of real world evidence for devices in the same manner and
to the same extent as such paragraphs apply with respect to pilot
projects conducted under this subsection.
``(9) Report to congress.--Not later than 18 months after the
date of enactment of this Act, and annually thereafter, the
Secretary shall submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor and Pensions of the Senate a report containing a
description of the pilot projects being conducted under this
subsection and projects continued or expanded pursuant to paragraph
(3), including for each such project--
``(A) how the project is being implemented in accordance
with paragraph (4), including how such project is being
implemented through a contract, cooperative agreement, grant,
or other appropriate agreement, if applicable;
``(B) the number of manufacturers that have agreed to
participate in such project;
``(C) the data sources used to conduct such project;
``(D) the devices or device categories involved in such
project;
``(E) the number of patients involved in such project; and
``(F) the findings of the project in relation to device
safety, including adverse events, malfunctions, and other
safety information.
``(10) Sunset.--The Secretary may not carry out a pilot project
initiated by the Secretary under this subsection after October 1,
2022.''.
(b) Report.--Not later than January 31, 2021, the Secretary of
Health and Human Services, acting through the Commissioner of Food and
Drugs, shall conduct a review through an independent third party to
evaluate the strengths, limitations, and appropriate use of evidence
collected pursuant to real world evidence pilot projects described in
the letters described in section 201(b) of the Medical Device User Fee
Amendments of 2017 and subsection (i) of section 519 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360i), as amended by subsection
(a), for informing premarket and postmarket decisionmaking for multiple
device types, and to determine whether the methods, systems, and
programs in such pilot projects efficiently generate reliable and
timely evidence about the effectiveness or safety surveillance of
devices.

2fea31fb70834aa20118a91034c9973d3f02e41479d2672285055bf3a4bc7755

(a) In General.--Section 520 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j), as amended by section 708, is further
amended by adding at the end the following:
``(q) Regulation of Over-the-Counter Hearing Aids.--
``(1) Definition.--
``(A) In general.--In this subsection, the term `over-the-
counter hearing aid' means a device that--
``(i) uses the same fundamental scientific technology
as air conduction hearing aids (as defined in section
874.3300 of title 21, Code of Federal Regulations) (or any
successor regulation) or wireless air conduction hearing
aids (as defined in section 874.3305 of title 21, Code of
Federal Regulations) (or any successor regulation);
``(ii) is intended to be used by adults age 18 and
older to compensate for perceived mild to moderate hearing
impairment;
``(iii) through tools, tests, or software, allows the
user to control the over-the-counter hearing aid and
customize it to the user's hearing needs;
``(iv) may--
``(I) use wireless technology; or
``(II) include tests for self-assessment of hearing
loss; and
``(v) is available over-the-counter, without the
supervision, prescription, or other order, involvement, or
intervention of a licensed person, to consumers through in-
person transactions, by mail, or online.
``(B) Exception.--Such term does not include a personal
sound amplification product intended to amplify sound for
nonhearing impaired consumers in situations including hunting
and bird-watching.
``(2) Regulation.--An over-the-counter hearing aid shall be
subject to the regulations promulgated in accordance with section
709(b) of the FDA Reauthorization Act of 2017 and shall be exempt
from sections 801.420 and 801.421 of title 21, Code of Federal
Regulations (or any successor regulations).''.
(b) Regulations To Establish Category.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), not later than
3 years after the date of enactment of this Act, shall promulgate
proposed regulations to establish a category of over-the-counter
hearing aids, as defined in subsection (q) of section 520 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) as amended by
subsection (a), and, not later than 180 days after the date on
which the public comment period on the proposed regulations closes,
shall issue such final regulations.
(2) Requirements.--In promulgating the regulations under
paragraph (1), the Secretary shall--
(A) include requirements that provide reasonable assurances
of the safety and effectiveness of over-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 over-
the-counter hearing aids, including requirements that such
labeling include a conspicuous statement that the device is
only intended for adults age 18 and older, information on how
consumers may report adverse events, information on any
contraindications, conditions, or symptoms of medically
treatable causes of hearing loss, and advisements to consult
promptly with a licensed health care practitioner; and
(D) describe the requirements under which the sale of over-
the-counter hearing aids is permitted, without the supervision,
prescription, or other order, involvement, or intervention of a
licensed person, to consumers through in-person transactions,
by mail, or online.
(3) Premarket notification.--The Secretary shall make findings
under section 510(m) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360(m)) to determine whether 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, order, or
other requirement specifically related to hearing products that
would restrict or interfere with the servicing, marketing, sale,
dispensing, use, customer support, or distribution of 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.
(5) No effect on private remedies.--Nothing in this section
shall be construed to modify or otherwise affect the ability of any
person to exercise a private right of action under any State or
Federal product liability, tort, warranty, contract, or consumer
protection law.
(c) New Guidance Issued.--Not later than the date on which final
regulations are issued under subsection (b), the Secretary shall update
and finalize the draft guidance of the Department of Health and Human
Services entitled ``Regulatory Requirements for Hearing Aid Devices and
Personal Sound Amplification Products'', issued on November 7, 2013.
Such updated and finalized guidance shall clarify which products, on
the basis of claims or other marketing, advertising, or labeling
material, meet the definition of a device in section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321) and which products meet
the definition of a personal sound amplification product, as set forth
in such guidance.
(d) Report.--Not later than 2 years after the date on which the
final regulations described in subsection (b)(1) are issued, the
Secretary of Health and Human Services shall submit to Congress a
report analyzing any adverse events relating to over-the-counter
hearing aids (as defined in subsection (q)(1) of section 520 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j)).

64c76d68825321bde0c6620568857e89d61b4ac58e8b4803fc471df8b959a042

(a) In General.--Not later than 270 days after the date of
enactment of this Act, the Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, shall post on the
internet website of the Food and Drug Administration a report on the
continued quality, safety, and effectiveness of devices (as defined in
section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(h))) with respect to servicing (as defined in subsection (c)).
(b) Contents.--The report submitted under subsection (a) shall
contain--
(1) the status of, and findings to date, with respect to, the
proposed rule entitled ``Refurbishing, Reconditioning, Rebuilding,
Remarketing, Remanufacturing, and Servicing of Medical Devices
Performed by Third-Party Entities and Original Equipment
Manufacturers; Request for Comments'' published in the Federal
Register by the Food and Drug Administration on March 4, 2016 (81
Fed. Reg. 11477);
(2) information presented during the October 2016 public
workshop entitled ``Refurbishing, Reconditioning, Rebuilding,
Remarketing, Remanufacturing, and Servicing of Medical Devices
Performed by Third-Party Entities and Original Equipment
Manufacturers'';
(3) a description of the statutory and regulatory authority of
the Food and Drug Administration with respect to the servicing of
devices conducted by any entity, including original equipment
manufacturers and third party entities;
(4) details regarding how the Food and Drug Administration
currently regulates devices with respect to servicing to ensure
safety and effectiveness, how the agency could improve such
regulation using the authority described in paragraph (3), and
whether additional authority is recommended;
(5) information on actions the Food and Drug Administration
could take under the authority described in paragraphs (3) and (4)
to assess the servicing of devices, including the size, scope,
location, and composition of third party entities;
(6) information on actions the Food and Drug Administration
could take to track adverse events caused by servicing errors
performed by any entity, including original equipment manufacturers
and third party entities;
(7) information regarding the regulation by States, the Joint
Commission, or other regulatory bodies of device servicing
performed by any entity, including original equipment manufacturers
and third party entities; and
(8) any additional information determined by the Secretary
(acting through the Commissioner) to be relevant to ensuring the
quality, safety, and effectiveness of devices with respect to
servicing.
(c) Servicing Defined.--In this section, the term ``servicing''
includes, with respect to a device, refurbishing, reconditioning,
rebuilding, remarketing, repairing, remanufacturing, or other servicing
of the device.

506270b1754d44e6effc9c8148321a3da371b783fe18e089d4b61900d803636d

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

0d78a8dce7e06f869c045ec5ed7606104bc259e482fa76a0325a01654637b50c

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

d157a8a77acd301d7ccbc215f56f7fbe6dc4521111b9649e50b700ce986f2fe7

(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506G
the following:
``SEC. 506H. COMPETITIVE GENERIC THERAPIES.
``(a) In General.--The Secretary may, at the request of an
applicant of a drug that is designated as a competitive generic therapy
pursuant to subsection (b), expedite the development and review of an
abbreviated new drug application under section 505(j) for such drug.
``(b) Designation Process.--
``(1) Request.--The applicant may request the Secretary to
designate the drug as a competitive generic therapy.
``(2) Timing.--A request under paragraph (1) may be made
concurrently with, or at any time prior to, the submission of an
abbreviated new drug application for the drug under section 505(j).
``(3) Criteria.--A drug is eligible for designation as a
competitive generic therapy under this section if the Secretary
determines that there is inadequate generic competition.
``(4) Designation.--Not later than 60 calendar days after the
receipt of a request under paragraph (1), the Secretary may--
``(A) determine whether the drug that is the subject of the
request meets the criteria described in paragraph (3); and
``(B) if the Secretary finds that the drug meets such
criteria, designate the drug as a competitive generic therapy.
``(c) Actions.--In expediting the development and review of an
application under subsection (a), the Secretary may, as requested by
the applicant, take actions including the following:
``(1) Hold meetings with the applicant and the review team
throughout the development of the drug prior to submission of the
application for such drug under section 505(j).
``(2) Provide timely advice to, and interactive communication
with, the applicant regarding the development of the drug to ensure
that the development program to gather the data necessary for
approval is as efficient as practicable.
``(3) Involve senior managers and experienced review staff, as
appropriate, in a collaborative, coordinated review of such
application, including with respect to drug-device combination
products and other complex products.
``(4) Assign a cross-disciplinary project lead--
``(A) to facilitate an efficient review of the development
program and application, including manufacturing inspections;
and
``(B) to serve as a scientific liaison between the review
team and the applicant.
``(d) Reporting Requirement.--Not later than one year after the
date of the approval of an application under section 505(j) with
respect to a drug for which the development and review is expedited
under this section, the sponsor of such drug shall report to the
Secretary on whether the drug has been marketed in interstate commerce
since the date of such approval.
``(e) Definitions.--In this section:
``(1) The term `generic drug' means a drug that is approved
pursuant to section 505(j).
``(2) The term `inadequate generic competition' means, with
respect to a drug, there is not more than one approved drugs on the
list of drugs described in section 505(j)(7)(A) (not including
drugs on the discontinued section of such list) that is--
``(A) the reference listed drug; or
``(B) a generic drug with the same reference listed drug as
the drug for which designation as a competitive generic therapy
is sought.
``(3) The term `reference listed drug' means the listed drug
(as such term is used in section 505(j)) for the drug involved.''.
(b) Guidance; Amended Regulations.--
(1) In general.--
(A) Issuance.--The Secretary of Health and Human Services
shall--
(i) not later than 18 months after the date of
enactment of this Act, issue draft guidance on section 506H
of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a); and
(ii) not later than 1 year after the close of the
comment period for the draft guidance, issue final guidance
on such section 506H.
(B) Contents.--The guidance issued under this paragraph
shall--
(i) specify the process and criteria by which the
Secretary makes a designation under section 506H of the
Federal Food, Drug, and Cosmetic Act, as added by
subsection (a);
(ii) specify the actions the Secretary may take to
expedite the development and review of a competitive
generic therapy pursuant to such a designation; and
(iii) include good review management practices for
competitive generic therapies.
(2) Amended regulations.--The Secretary of Health and Human
Services shall issue or revise any regulations as may be necessary
to carry out this section not later than 2 years after the date of
enactment of this Act.

5aed5e5912918889b43d7ecc7d2d29edf5dadec903c07ef89aee835b5cf94632

COMPETITION.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351 et seq.) is amended by inserting after section 506H, as added by
section 803, the following:
``SEC. 506I. PROMPT REPORTS OF MARKETING STATUS.
``(a) Notification of Withdrawal.--The holder of an application
approved under subsection (c) or (j) of section 505 shall notify the
Secretary in writing 180 days prior to withdrawing the approved drug
from sale, or if 180 days is not practicable as soon as practicable but
not later than the date of withdrawal. The holder shall include with
such notice the--
``(1) National Drug Code;
``(2) identity of the drug by established name and by
proprietary name, if any;
``(3) new drug application number or abbreviated application
number;
``(4) strength of the drug;
``(5) date on which the drug is expected to no longer be
available for sale; and
``(6) reason for withdrawal of the drug.
``(b) Notification of Drug Not Available for Sale.--The holder of
an application approved under subsection (c) or (j) shall notify the
Secretary in writing within 180 calendar days of the date of approval
of the drug if the drug will not be available for sale within 180
calendar days of such date of approval. The holder shall include with
such notice the--
``(1) identity of the drug by established name and by
proprietary name, if any;
``(2) new drug application number or abbreviated application
number;
``(3) strength of the drug;
``(4) date on which the drug will be available for sale, if
known; and
``(5) reason for not marketing the drug after approval.
``(c) Additional One-time Report.--Within 180 days of the date of
enactment of this section, all holders of applications approved under
subsection (c) or (j) of section 505 shall review the information in
the list published under subsection 505(j)(7)(A) and shall notify the
Secretary in writing that--
``(1) all of the application holder's drugs in the active
section of the list published under subsection 505(j)(7)(A) are
available for sale; or
``(2) one or more of the application holder's drugs in the
active section of the list published under subsection 505(j)(7)(A)
have been withdrawn from sale or have never been available for
sale, and include with such notice the information required
pursuant to subsection (a) or (b), as applicable.
``(d) Failure to Meet Requirements.--If a holder of an approved
application fails to submit the information required under subsection
(a), (b), or (c), the Secretary may move the application holder's drugs
from the active section of the list published under subsection
505(j)(7)(A) to the discontinued section of the list, except that the
Secretary shall remove from the list in accordance with subsection
505(j)(7)(C) drugs the Secretary determines have been withdrawn from
sale for reasons of safety of effectiveness.
``(e) Updates.--The Secretary shall update the list published under
subsection 505(j)(7)(A) based on the information provided under
subsections (a), (b), and (c) by moving drugs that are not available
for sale from the active section to the discontinued section of the
list, except that drugs the Secretary determines have been withdrawn
from sale for reasons of safety or effectiveness shall be removed from
the list in accordance with subsection 505(j)(7)(C). The Secretary
shall make monthly updates to the list based on the information
provided pursuant to subsections (a) and (b), and shall update the list
based on the information provided under subsection (c) as soon as
practicable.
``(f) Limitation on Use of Notices.--Any notice submitted under
this section shall not be made public by the Secretary and shall be
used solely for the purpose of the updates described in subsection
(e).''.

7254a8a64a81bc48db8b627b86c02f74fa6cbcede861bba6a91297551669b30c

(a) In General.--It is the sense of Congress that the Food and Drug
Administration shall meet the requirement under section 505(j)(2)(C) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(C)) and
section 314.93(e) of title 21, Code of Federal Regulations, of
responding to suitability petitions within 90 days of submission.
(b) Report.--The Secretary of Health and Human Services shall
include in the annual reports under section 807--
(1) the number of pending petitions under section 505(j)(2)(C)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(2)(C)); and
(2) the number of such petitions pending a substantive response
for more than 180 days from the date of receipt.

412871a952862d4f73f66cfe4976c7280c9799b863fe8ba49bcd10a76ad5b667

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

8276ca528affd7778981b9058becbce13f083429b05a6c867dfd952b086b80cc

PRIORITY REVIEW APPLICATIONS.
Not later than 180 calendar days after the date of enactment of
this Act, and quarterly thereafter until October 1, 2022, the Secretary
of Health and Human Services shall post on the internet website of the
Food and Drug Administration a report that provides, with respect to
the months covered by the report--
(1) with respect to applications filed under section 505(j) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that,
during the most recent calendar year, were subject to priority
review under paragraph (11) of such section 505(j) (as added by
section 801) or expedited development and review under section 506H
of the Federal Food, Drug, and Cosmetic Act (as added by section
803), the numbers of such applications (with denotation of such
applications that were filed prior to October 1, 2014) that are--
(A) awaiting action by the applicant;
(B) awaiting action by the Secretary; and
(C) approved by the Secretary;
(2) the number of applications filed under section 505(j) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) and
prior approval supplements withdrawn in each month;
(3) the mean and median approval and tentative approval times
and the number of review cycles for such applications;
(4) the number and type of meetings requested and held under
such section 506H (as added by section 803); and
(5) the number of such applications on which the Secretary has
taken action pursuant to subsection (c) of such section 506H (as
added by section 803) and any effect such section 506H may have on
the length of time for approval of applications under such section
505(j) and the number of review cycles for such approvals.

559afcbf935949e84342f281fce1044c6a72be530c16a60c5baf7220315bbe23

Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(5)) is amended--
(1) in subparagraph (B), by adding at the end the following:
``(v) 180-day exclusivity period for competitive generic
therapies.--
``(I) Effectiveness of application.--Subject to
subparagraph (D)(iv), if the application is for a drug that is
the same as a competitive generic therapy for which any first
approved applicant has commenced commercial marketing, the
application shall be made effective on the date that is 180
days after the date of the first commercial marketing of the
competitive generic therapy (including the commercial marketing
of the listed drug) by any first approved applicant.
``(II) Limitation.--The exclusivity period under subclause
(I) shall not apply with respect to a competitive generic
therapy that has previously received an exclusivity period
under subclause (I).
``(III) Definitions.--In this clause and subparagraph
(D)(iv):
``(aa) The term `competitive generic therapy' means a
drug--
``(AA) that is designated as a competitive generic
therapy under section 506H; and
``(BB) for which there are no unexpired patents or
exclusivities on the list of products described in
section 505(j)(7)(A) at the time of submission.
``(bb) The term `first approved applicant' means any
applicant that has submitted an application that--
``(AA) is for a competitive generic therapy that is
approved on the first day on which any application for
such competitive generic therapy is approved;
``(BB) is not eligible for a 180-day exclusivity
period under clause (iv) for the drug that is the
subject of the application for the competitive generic
therapy; and
``(CC) is not for a drug for which all drug
versions have forfeited eligibility for a 180-day
exclusivity period under clause (iv) pursuant to
subparagraph (D).''; and
(2) in subparagraph (D), by adding at the end the following:
``(iv) Special forfeiture rule for competitive generic
therapy.--The 180-day exclusivity period described in
subparagraph (B)(v) shall be forfeited by a first approved
applicant if the applicant fails to market the competitive
generic therapy within 75 days after the date on which the
approval of the first approved applicant's application for
the competitive generic therapy is made effective.''.

54089add2369e8dc8a23197d9180efc28e5055df2066c82159ef311b0cecff8f

GENERIC MEDICINES.
(a) Study by GAO.--The Comptroller General of the United States
shall conduct a study to determine the following:
(1) The rate of first cycle approvals and tentative approvals
for applications submitted under section 505(j) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) during the period
beginning on October 1, 2012, and ending on September 30, 2017. The
rate of first cycle approvals and tentative approvals shall be
determined and reported per each GDUFA cohort year during this
period.
(2) If the rate determined pursuant to paragraph (1) for any
GDUFA cohort year is lower than 20 percent, the reasons
contributing to the relatively low rate of first cycle approvals
and tentative approvals for generic drug applications shall be
itemized, assessed, and reported. In making the assessment required
by this paragraph, the Comptroller General shall consider, among
other things, the role played by--
(A) the Food and Drug Administration's implementation of
approval standards for generic drug applications;
(B) the extent to which those approval standards are
communicated clearly to industry and applied consistently
during the review process;
(C) the procedures for reviewing generic drug applications,
including timelines for review activities by the Food and Drug
Administration;
(D) the extent to which those procedures are followed
consistently (and those timelines are met) by the Food and Drug
Administration;
(E) the processes and practices for communication between
the Food and Drug Administration and sponsors of generic drug
applications; and
(F) the completeness and quality of original generic drug
applications submitted to the Food and Drug Administration.
(3) Taking into account the determinations made pursuant to
paragraphs (1) and (2) and any review process improvements
implemented pursuant to this Act, whether there are ways the review
process for generic drugs could be improved to increase the rate of
first cycle approvals and tentative approvals for generic drug
applications. In making this determination, the Comptroller General
shall consider, among other things, options for increasing review
efficiency and communication effectiveness.
(b) Completion Date.--Not later than the expiration of the 2-year
period beginning on the date of enactment of this Act, the Comptroller
General shall complete the study under subsection (a) and submit a
report describing the findings and conclusions of the study to the
Secretary, the Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education, Labor, and
Pensions of the Senate.
(c) Definitions.--For purposes of this section:
(1) The term ``GDUFA cohort year'' means a fiscal year.
(2) The term ``generic drug'' means a drug that is approved or
is seeking approval under section 505(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)).
(3) The term ``generic drug application'' means an abbreviated
new drug application for the approval of a generic drug under
section 505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)).
(4) The term ``Secretary'' means the Secretary of Health and
Human Services.
(5)(A) The term ``first cycle approvals and tentative
approvals'' means the approval or tentative approval of a generic
drug application after the Food and Drug Administration's complete
review of the application and without issuance of one or more
complete response letters.
(B) For purposes of this paragraph, the term ``complete
response letter'' means a written communication to the sponsor of a
generic drug application or holder of a drug master file from the
Food and Drug Administration describing all of the deficiencies
that the Administration has identified in the generic drug
application (including pending amendments) or drug master file that
must be satisfactorily addressed before the generic drug
application can be approved.

d1d488f57ecb630ae27341f162bb0026c71f640f6c65d189c744ba09266f15c0

(a) Section 3075(a) of the 21st Century Cures Act (Public Law 114-
255) is amended--
(1) in the matter preceding paragraph (1), by striking ``as
amended by section 2074'' and inserting ``as amended by section
3102''; and
(2) in paragraph (2), by striking ``section 2074(1)(C)'' and
inserting ``section 3102(1)(C)''.
(b) Section 506G(b)(1)(A) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 356g(b)(1)(A)) is amended by striking ``identity'' and
inserting ``identify''.
(c) Section 505F(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355g(b)) is amended by striking ``randomized'' and inserting
``traditional''.
(d) Section 505F(d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355g(d)) is amended by striking ``2'' and inserting ``3''.
(e) Section 510(h)(6) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360(h)(6)) is amended by striking ``February 1'' and
replacing with ``May 1''.
(f) Effective as of the enactment of the 21st Century Cures Act
(Public Law 114-255)--
(1) section 3051(a) of such Act is amended by striking ``by
inserting after section 515B'' and inserting ``by inserting after
section 515A''; and
(2) section 515C of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e-3), as inserted by such section 3051(a), is
redesignated as section 515B.
(g) Section 515B(f)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e-3(f)(2)), as redesignated by subsection (e)(2) of this
section, is amended by striking ``a proposed guidance'' and inserting
``a draft version of that guidance''.
(h) Section 513(b)(5)(D) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360c(b)(5)(D)) is amended by striking ``medical device
submissions'' and inserting ``medical devices that may be specifically
the subject of a review by a classification panel''.

93242fa66eea770f26f510b4e473ccc3368bfb40e88e4406e81556dc963c5a31

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

497d61242572b72690872161baf60e883025d4c7b8e68708df077092f85d26ad

REPORTING.
(a) PDUFA.--Section 736B(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379h-2(a)), as amended by section 103, is further
amended by inserting after paragraph (2) the following:
``(3) Real time reporting.--
``(A) In general.--Not later than 30 calendar days after
the end of the second quarter of fiscal year 2018, and not
later than 30 calendar days after the end of each quarter of
each fiscal year thereafter, the Secretary shall post the data
described in subparagraph (B) on the internet website of the
Food and Drug Administration for such quarter and on a
cumulative basis for such fiscal year, and may remove
duplicative data from the annual performance report under this
subsection.
``(B) Data.--The Secretary shall post the following data in
accordance with subparagraph (A):
``(i) The number and titles of draft and final guidance
on topics related to the process for the review of human
drug applications, and whether such guidances were issued
as required by statute or pursuant to a commitment under
the letters described in section 101(b) of the Prescription
Drug User Fee Amendments of 2017.
``(ii) The number and titles of public meetings held on
topics related to the process for the review of human drug
applications, and whether such meetings were required by
statute or pursuant to a commitment under the letters
described in section 101(b) of the Prescription Drug User
Fee Amendments of 2017.
``(iii) The number of new drug applications and
biological licensing applications approved.
``(iv) The number of new drug applications and
biological licensing applications filed.
``(4) Rationale for pdufa program changes.--Beginning with
fiscal year 2020, the Secretary shall include in the annual report
under paragraph (1)--
``(A) data, analysis, and discussion of the changes in the
number of full-time equivalents hired as agreed upon in the
letters described in section 101(b) of the Prescription Drug
User Fee Amendments of 2017 and the number of full time
equivalents funded by budget authority at the Food and Drug
Administration by each division within the Center for Drug
Evaluation and Research, the Center for Biologics Evaluation
and Research, the Office of Regulatory Affairs, and the Office
of the Commissioner;
``(B) data, analysis, and discussion of the changes in the
fee revenue amounts and costs for the process for the review of
human drugs, including identifying drivers of such changes; and
``(C) for each of the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and Research, the
Office of Regulatory Affairs, and the Office of the
Commissioner, the number of employees for whom time reporting
is required and the number of employees for whom time reporting
is not required.''.
(b) MDUFA.--Section 738A(a)(1)(A) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-1(a)(1)(A)), as amended by section 204, is
further amended--
(1) by striking ``Beginning with'' and inserting the following:
``(i) General requirements.--Beginning with''; and
(2) by adding at the end the following:
``(ii) Additional information.--Beginning with fiscal
year 2018, the annual report under this subparagraph shall
include the progress of the Center for Devices and
Radiological Health in achieving the goals, and future
plans for meeting the goals, including--
``(I) the number of premarket applications filed
under section 515 per fiscal year for each review
division;
``(II) the number of reports submitted under
section 510(k) per fiscal year for each review
division; and
``(III) the number of expedited development and
priority review designations under section 515C per
fiscal year.
``(iii) Real time reporting.--
``(I) In general.--Not later than 30 calendar days
after the end of the second quarter of fiscal year
2018, and not later than 30 calendar days after the end
of each quarter of each fiscal year thereafter, the
Secretary shall post the data described in subclause
(II) on the internet website of the Food and Drug
Administration for such quarter and on a cumulative
basis for such fiscal year, and may remove duplicative
data from the annual report under this subparagraph.
``(II) Data.--The Secretary shall post the
following data in accordance with subclause (I):
``(aa) The number and titles of draft and final
guidance on topics related to the process for the
review of devices, and whether such guidances were
issued as required by statute or pursuant to the
letters described in section 201(b) of the Medical
Device User Fee Amendments of 2017; and
``(bb) The number and titles of public meetings
held on topics related to the process for the
review of devices, and if such meetings were
required by statute or pursuant to a commitment
under the letters described in section 201(b) of
the Medical Device User Fee Amendments of 2017.
``(iv) Rationale for mdufa program changes.--Beginning
with fiscal year 2020, the Secretary shall include in the
annual report under paragraph (1)--
``(I) data, analysis, and discussion of the changes
in the number of full-time equivalents hired as agreed
upon in the letters described in section 201(b) of the
Medical Device User Fee Amendments of 2017 and the
number of full time equivalents funded by budget
authority at the Food and Drug Administration by each
division within the Center for Devices and Radiological
Health, the Center for Biologics Evaluation and
Research, the Office of Regulatory Affairs, and the
Office of the Commissioner;
``(II) data, analysis, and discussion of the
changes in the fee revenue amounts and costs for the
process for the review of devices, including
identifying drivers of such changes; and
``(III) for each of the Center for Devices and
Radiological Health, the Center for Biologics
Evaluation and Research, the Office of Regulatory
Affairs, and the Office of the Commissioner, the number
of employees for whom time reporting is required and
the number of employees for whom time reporting is not
required.''.
(c) GDUFA.--Section 744C(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j-43(a)), as amended by section 304, is further
amended--
(1) by striking ``Beginning with'' and inserting the following:
``(1) General requirements.--Beginning with''; and
(2) by adding at the end the following:
``(2) Real time reporting.--
``(A) In general.--Not later than 30 calendar days after
the end of the second quarter of fiscal year 2018, and not
later than 30 calendar days after the end of each quarter of
each fiscal year thereafter, the Secretary shall post the data
described in subparagraph (B) on the internet website of the
Food and Drug Administration, and may remove duplicative data
from the annual report under this subsection.
``(B) Data.--The Secretary shall post the following data in
accordance with subparagraph (A):
``(i) The number and titles of draft and final guidance
on topics related to human generic drug activities and
whether such guidances were issued as required by statute
or pursuant to a commitment under the letters described in
section 301(b) of the Generic Drug User Fee Amendments of
2017.
``(ii) The number and titles of public meetings held on
topics related to human generic drug activities and whether
such meetings were required by statute or pursuant to a
commitment under the letters described in section 301(b) of
the Generic Drug User Fee Amendments of 2017.
``(3) Rationale for gdufa program changes.--Beginning with
fiscal year 2020, the Secretary shall include in the annual report
under paragraph (1)--
``(A) data, analysis, and discussion of the changes in the
number of full-time equivalents hired as agreed upon in the
letters described in section 301(b) of the Generic Drug User
Fee Amendments of 2017 and the number of full time equivalents
funded by budget authority at the Food and Drug Administration
by each division within the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and Research, the
Office of Regulatory Affairs, and the Office of the
Commissioner;
``(B) data, analysis, and discussion of the changes in the
fee revenue amounts and costs for human generic drug
activities, including identifying drivers of such changes; and
``(C) for each of the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and Research, the
Office of Regulatory Affairs, and the Office of the
Commissioner, the number of employees for whom time reporting
is required and the number of employees for whom time reporting
is not required.''.
(d) BsUFA.--Section 744I(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j-53(a)), as amended by section 404, is further
amended--
(1) by striking ``Beginning with'' and inserting the following:
``(1) General requirements.--Beginning with''; and
(2) by adding at the end the following:
``(2) Additional information.--Beginning with fiscal year 2018,
the report under this subsection shall include the progress of the
Food and Drug Administration in achieving the goals, and future
plans for meeting the goals, including--
``(A) information on all previous cohorts for which the
Secretary has not given a complete response on all biosimilar
biological product applications and supplements in the cohort;
``(B) the number of original biosimilar biological product
applications filed per fiscal year, and the number of approvals
issued by the agency for such applications; and
``(C) the number of resubmitted original biosimilar
biological product applications filed per fiscal year and the
number of approvals letters issued by the agency for such
applications.
``(3) Real time reporting.--
``(A) In general.--Not later than 30 calendar days after
the end of the second quarter of fiscal year 2018, and not
later than 30 calendar days after the end of each quarter of
each fiscal year thereafter, the Secretary shall post the data
described in subparagraph (B) for such quarter and on a
cumulative basis for the fiscal year on the internet website of
the Food and Drug Administration, and may remove duplicative
data from the annual report under this subsection.
``(B) Data.--The Secretary shall post the following data in
accordance with subparagraph (A):
``(i) The number and titles of draft and final guidance
on topics related to the process for the review of
biosimilars, and whether such guidances were required by
statute or pursuant to a commitment under the letters
described in section 401(b) of the Biosimilar User Fee
Amendments of 2017.
``(ii) The number and titles of public meetings held on
topics related to the process for the review of
biosimilars, and whether such meetings were required by
statute or pursuant to a commitment under the letters
described in section 401(b) of the Biosimilar User Fee
Amendments of 2017.
``(4) Rationale for bsufa program changes.--Beginning with
fiscal year 2020, the Secretary shall include in the annual report
under paragraph (1)--
``(A) data, analysis, and discussion of the changes in the
number of full-time equivalents hired as agreed upon in the
letters described in section 401(b) of the Biosimilar User Fee
Amendments of 2017 and the number of full time equivalents
funded by budget authority at the Food and Drug Administration
by each division within the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and Research, the
Office of Regulatory Affairs, and the Office of the
Commissioner;
``(B) data, analysis, and discussion of the changes in the
fee revenue amounts and costs for the process for the review of
biosimilar biological product applications, including
identifying drivers of such changes; and
``(C) for each of the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and Research, the
Office of Regulatory Affairs, and the Office of the
Commissioner, the number of employees for whom time reporting
is required and the number of employees for whom time reporting
is not required.''.

2eaf050582fecc9c6adbcdf6094e6cb192eab503ce6f767979852fd5c0b17ed3

(a) PDUFA Reports.--
(1) Analysis in pdufa performance reports.--Section 736B(a) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2(a)), as
amended by section 903(a), is further amended by adding at the end
the following:
``(5) Analysis.--For each fiscal year, the Secretary shall
include in the report under paragraph (1) an analysis of the
following:
``(A) The difference between the aggregate number of human
drug applications filed and the aggregate number of approvals,
accounting for--
``(i) such applications filed during one fiscal year
for which a decision is not scheduled to be made until the
following fiscal year;
``(ii) the aggregate number of applications for each
fiscal year that did not meet the goals identified in the
letters described in section 101(b) of the Prescription
Drug User Fee Amendments of 2017 for the applicable fiscal
year.
``(B) Relevant data to determine whether the Center for
Drug Evaluation and Research and the Center for Biologics
Evaluation and Research have met performance enhancement goals
identified in the letters described in section 101(b) of the
Prescription Drug User Fee Amendments of 2017 for the
applicable fiscal year.
``(C) The most common causes and trends of external or
other circumstances affecting the ability of the Center for
Drug Evaluation and Research, the Center for Biologics
Evaluation and Research, Office of Regulatory Affairs, and the
Food and Drug Administration to meet the review time and
performance enhancement goals identified in the letters
described in section 101(b) of the Prescription Drug User Fee
Amendments of 2017.''.
(2) Issuance of corrective action reports.--Section 736B of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2) is
amended--
(A) by redesignating subsections (c) and (d) as subsections
(e) and (f), respectively; and
(B) by inserting after subsection (b) the following:
``(c) Corrective Action Report.--Beginning with fiscal year 2018,
for each fiscal year for which fees are collected under this part, the
Secretary shall prepare and submit a corrective action report to the
Committee on Energy and Commerce and the Committee on Appropriations of
the House of Representatives and the Committee on Health, Education,
Labor, and Pensions and the Committee on Appropriations of the Senate.
The report shall include the following information, as applicable:
``(1) Goals met.--For each fiscal year, if the Secretary
determines, based on the analysis under subsection (a)(5), that
each of the goals identified in the letters described in section
101(b) of the Prescription Drug User Fee Amendments of 2017 for the
applicable fiscal year have been met, the corrective action report
shall include recommendations on ways in which the Secretary can
improve and streamline the human drug application review process.
``(2) Goals missed.--For any of the goals identified in the
letters described in section 101(b) of the Prescription Drug User
Fee Amendments of 2017 for the applicable fiscal year that the
Secretary determines to not have been met, the corrective action
report shall include--
``(A) a detailed justification for such determination and a
description, as applicable, of the types of circumstances and
trends under which human drug applications that missed the
review goal time were approved during the first cycle review,
or application review goals were missed; and
``(B) with respect to performance enhancement goals that
were not achieved, a description of efforts the Food and Drug
Administration has put in place for the fiscal year in which
the report is submitted to improve the ability of such agency
to meet each such goal for the such fiscal year.
``(d) Enhanced Communication.--
``(1) Communications with congress.--Each fiscal year, as
applicable and requested, representatives from the Centers with
expertise in the review of human drugs shall meet with
representatives from the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce of
the House of Representatives to report on the contents described in
the reports under this section.
``(2) Participation in congressional hearing.--Each fiscal
year, as applicable and requested, representatives from the Food
and Drug Administration shall participate in a public hearing
before the Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of the House of
Representatives, to report on the contents described in the reports
under this section. Such hearing shall occur not later than 120
days after the end of each fiscal year for which fees are collected
under this part.''.
(b) MDUFA Reports.--
(1) Analysis in mdufa performance reports.--Section
738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-1(a)(1)(A)), as amended by section 903(b), is further
amended by adding at the end the following:
``(iv) Analysis.--For each fiscal year, the Secretary
shall include in the report under clause (i) an analysis of
the following:
``(I) The difference between the aggregate number
of premarket applications filed under section 515 and
aggregate reports submitted under section 510(k) and
the aggregate number of major deficiency letters, not
approvable letters, and denials for such applications
issued by the agency, accounting for--
``(aa) the number of applications filed and
reports submitted during one fiscal year for which
a decision is not scheduled to be made until the
following fiscal year; and
``(bb) the aggregate number of applications for
each fiscal year that did not meet the goals as
identified by the letters described in section
201(b) of the Medical Device User Fee Amendments of
2017 for the applicable fiscal year.
``(II) Relevant data to determine whether the
Center for Devices and Radiological Health has met
performance enhancement goals identified by the letters
described in section 201(b) of the Medical Device User
Fee Amendments of 2017 for the applicable fiscal year.
``(III) The most common causes and trends for
external or other circumstances affecting the ability
of the Center for Devices and Radiological Health, the
Office of Regulatory Affairs, or the Food and Drug
Administration to meet review time and performance
enhancement goals identified by the letters described
in section 201(b) of the Medical Device User Fee
Amendments of 2017.''.
(2) Issuance of corrective action reports.--Section 738A(a) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-1(a)) is
amended--
(A) by redesignating paragraphs (2) and (3) as paragraphs
(4) and (5), respectively; and
(B) by inserting after paragraph (1) the following:
``(2) Corrective action report.--Beginning with fiscal year
2018, for each fiscal year for which fees are collected under this
part, the Secretary shall prepare and submit a corrective action
report to the Committee on Energy and Commerce and the Committee on
Appropriations of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions and the Committee on
Appropriations of the Senate. The report shall include the
following information, as applicable:
``(A) Goals met.--For each fiscal year, if the Secretary
determines, based on the analysis under paragraph (1)(A)(iv),
that each of the goals identified by the letters described in
section 201(b) of the Medical Device User Fee Amendments of
2017 for the applicable fiscal year have been met, the
corrective action report shall include recommendations on ways
in which the Secretary can improve and streamline the medical
device application review process.
``(B) Goals missed.--For each of the goals identified by
the letters described in section 201(b) of the Medical Device
User Fee Amendments of 2017 for the applicable fiscal year that
the Secretary determines to not have been met, the corrective
action report shall include--
``(i) a justification for such determination;
``(ii) a description of the types of circumstances, in
the aggregate, under which applications or reports
submitted under section 515 or notifications submitted
under section 510(k) missed the review goal times but were
approved during the first cycle review, as applicable;
``(iii) a summary and any trends with regard to the
circumstances for which a review goal was missed; and
``(iv) the performance enhancement goals that were not
achieved during the previous fiscal year and a description
of efforts the Food and Drug Administration has put in
place for the fiscal year in which the report is submitted
to improve the ability of such agency to meet each such
goal for the such fiscal year.
``(3) Enhanced communication.--
``(A) Communications with congress.--Each fiscal year, as
applicable and requested, representatives from the Centers with
expertise in the review of devices shall meet with
representatives from the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives to report on the
contents described in the reports under this section.
``(B) Participation in congressional hearing.--Each fiscal
year, as applicable and requested, representatives from the
Food and Drug Administration shall participate in a public
hearing before the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce
of the House of Representatives, to report on the contents
described in the reports under this section. Such hearing shall
occur not later than 120 days after the end of each fiscal year
for which fees are collected under this part.''.
(c) GDUFA Reports.--
(1) Analysis in gdufa performance reports.--Section 744C(a) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-43(a)), as
amended by section 903(c) is further amended by adding at the end
the following:
``(4) Analysis.--For each fiscal year, the Secretary shall
include in the report an analysis of the following:
``(A) The difference between the aggregate number of
abbreviated new drug applications filed and the aggregate
number of approvals or aggregate number of complete response
letters issued by the agency, accounting for--
``(i) such applications filed during one fiscal year
for which a decision is not scheduled to be made until the
following fiscal year; and
``(ii) the aggregate number of applications for each
fiscal year that did not meet the goals identified by the
letters described in section 301(b) of the Generic Drug
User Fee Amendments of 2017 for the applicable fiscal year.
``(B) Relevant data to determine whether the Food and Drug
Administration has met the performance enhancement goals
identified by the letters described in section 301(b) of the
Generic Drug User Fee Amendments of 2017 for the applicable
fiscal year.
``(C) The most common causes and trends for external or
other circumstances that affected the ability of the Secretary
to meet review time and performance enhancement goals
identified by the letters described in section 301(b) of the
Generic Drug User Fee Amendments of 2017.''.
(2) Issuance of corrective action reports.--Section 744C of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-43) is
amended--
(A) by redesignating subsections (c) and (d) as subsections
(e) and (f), respectively; and
(B) by inserting after subsection (b) the following:
``(c) Corrective Action Report.--Beginning with fiscal year 2018,
for each fiscal year for which fees are collected under this part, the
Secretary shall prepare and submit a corrective action report to the
Committee on Energy and Commerce and the Committee on Appropriations of
the House of Representatives and the Committee on Health, Education,
Labor, and Pensions and the Committee on Appropriations of the Senate.
The report shall include the following information, as applicable:
``(1) Goals met.--For each fiscal year, if the Secretary
determines, based on the analysis under subsection (a)(4), that
each of the goals identified by the letters described in section
301(b) of the Generic Drug User Fee Amendments of 2017 for the
applicable fiscal year have been met, the corrective action report
shall include recommendations on ways in which the Secretary can
improve and streamline the abbreviated new drug application review
process.
``(2) Goals missed.--For each of the goals identified by the
letters described in section 301(b) of the Generic Drug User Fee
Amendments of 2017 for the applicable fiscal year that the
Secretary determines to not have been met, the corrective action
report shall include--
``(A) a detailed justification for such determination and a
description, as applicable, of the types of circumstances and
trends under which abbreviated new drug applications missed the
review goal times but were approved during the first cycle
review, or review goals were missed; and
``(B) with respect to performance enhancement goals that
were not achieved, a detailed description of efforts the Food
and Drug Administration has put in place for the fiscal year in
which the report is submitted to improve the ability of such
agency to meet each such goal for the such fiscal year.
``(d) Enhanced Communication.--
``(1) Communications with congress.--Each fiscal year, as
applicable and requested, representatives from the Centers with
expertise in the review of human drugs shall meet with
representatives from the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce of
the House of Representatives to report on the contents described in
the reports under this section.
``(2) Participation in congressional hearing.--Each fiscal
year, as applicable and requested, representatives from the Food
and Drug Administration shall participate in a public hearing
before the Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of the House of
Representatives, to report on the contents described in the reports
under this section. Such hearing shall occur not later than 120
days after the end of each fiscal year for which fees are collected
under this part.''.
(d) BsUFA Reports.--
(1) Analysis in bsufa performance reports.--Section 744I(a) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-53(a)) as
amended by section 903(d) is further amended by adding at the end
the following:
``(5) Analysis.--For each fiscal year, the Secretary shall
include in the report an analysis of the following:
``(A) The difference between the aggregate number of
biosimilar biological product applications and supplements
filed and the aggregate number of approvals issued by the
agency, accounting for--
``(i) such applications filed during one fiscal year
for which a decision is not scheduled to be made until the
following fiscal year; and
``(ii) the aggregate number of applications for each
fiscal year that did not meet the goals identified by the
letters described in section 401(b) of the Biosimilar User
Fee Amendments of 2017 for the applicable fiscal year.
``(B) Relevant data to determine whether the Center for
Drug Evaluation and Research and the Center for Biologics
Evaluation and Research have met the performance enhancement
goals identified by the letters described in section 401(b) of
the Biosimilar User Fee Amendments of 2017 for the applicable
fiscal year.
``(C) The most common causes and trends for external or
other circumstances affecting the ability of the Secretary to
meet review time and performance enhancement goals identified
by the letters described in section 401(b) of the Biosimilar
User Fee Amendments of 2017.''.
(2) Issuance of corrective action reports.--Section 744I of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-53), as
amended by section 404, is further amended--
(A) by redesignating subsections (c) and (d) as subsections
(e) and (f), respectively; and
(B) by inserting after subsection (b) the following:
``(c) Corrective Action Report.--Beginning with fiscal year 2018,
and for each fiscal year for which fees are collected under this part,
the Secretary shall prepare and submit a corrective action report to
the Committee on Energy and Commerce and Committee on Appropriations of
the House of Representatives and the Committee on Health, Education,
Labor, and Pensions and Committee on Appropriations of the Senate. The
report shall include the following information, as applicable:
``(1) Goals met.--For each fiscal year, if the Secretary
determines, based on the analysis under subsection (a)(5), that
each of the goals identified by the letters described in section
401(b) of the Biosimilar User Fee Amendments of 2017 for the
applicable fiscal year have been met, the corrective action report
shall include recommendations on ways in which the Secretary can
improve and streamline the biosimilar biological product
application review process.
``(2) Goals missed.--For each of the goals identified by the
letters described in section 401(b) of the Biosimilar User Fee
Amendments of 2017 for the applicable fiscal year that the
Secretary determines to not have been met, the corrective action
report shall include--
``(A) a justification for such determination and a
description of the types of circumstances and trends, as
applicable, under which biosimilar biological product
applications missed the review goal times but were approved
during the first cycle review, or review goals were missed; and
``(B) with respect to performance enhancement goals that
were not achieved, a description of efforts the Food and Drug
Administration has put in place for the fiscal year in which
the report is submitted to improve the ability of such agency
to meet each such goal for the such fiscal year.
``(d) Enhanced Communication.--
``(1) Communications with congress.--Each fiscal year, as
applicable and requested, representatives from the Centers with
expertise in the review of human drugs shall meet with
representatives from the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce of
the House of Representatives to report on the contents described in
the reports under this section.
``(2) Participation in congressional hearing.--Each fiscal
year, as applicable and requested, representatives from the Food
and Drug Administration shall participate in a public hearing
before the Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of the House of
Representatives, to report on the contents described in the reports
under this section. Such hearing shall occur not later than 120
days after the end of each fiscal year for which fees are collected
under this part.''.

33aed9769b14123d408a32cbf88581f1d5ce3102a2ee539f17f87e73158b71d0

(a) Evaluation.--
(1) Study.--The Comptroller General of the United States shall
conduct a study on the expenses incurred by the Food and Drug
Administration related to facility maintenance and renovation in
fiscal years 2012 through 2019. The study under this paragraph
shall include the following:
(A) A review of purchases and expenses differentiated by
appropriated funds, and resources authorized by the Food and
Drug Administration Safety and Innovation Act (Public Law 112-
144) and this Act, as applicable, that contributed to--
(i) the maintenance of scientific equipment and any
existing facility plan or plans to maintain previously
purchased scientific equipment;
(ii) the renovation of facilities in the Center for
Drug Evaluation and Research, the Center for Biologics
Evaluation and Research, and the Center for Devices and
Radiological Health, and the purpose of such renovation
including the need for the renovation;
(iii) the assets purchased or repaired under the
``repair of facilities and acquisition'' authority under
parts 2, 3, 7, and 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et
seq.);
(iv) the maintenance and repair of facilities and
fixtures, including a description of any unanticipated
repairs and maintenance as well as scheduled repairs
maintenance, and the budget plan for the scheduled or
anticipated maintenance;
(v) the acquisition of furniture, a description of the
furniture purchased, and the purpose of the furniture
including purchases for the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and Research,
and the Center for Devices and Radiological Health; and
(vi) the acquisition of other necessary materials and
supplies by product category under the authority under
parts 2, 3, 7, and 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et
seq.).
(B) An analysis of the Food and Drug Administration's
ability to further its public health mission and review medical
products by incurring the expenses listed in clauses (i)
through (vi) of subparagraph (A). In conducting the analysis,
the Comptroller General shall request information from and
consult with appropriate employees, including staff and those
responsible for the fiscal decisions regarding facility
maintenance and renovation for the agency.
(2) Report.--
(A) In general.--The Comptroller General shall issue a
report to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce
of the House of Representatives not later than July 30, 2020,
containing the results of the study under paragraph (1).
(B) Recommendations.--As part of the report under this
paragraph, the Comptroller General may provide recommendations,
as applicable, on methods through which the Food and Drug
Administration may improve planning for--
(i) the maintenance, renovation, and repair of
facilities;
(ii) the purchase of furniture or other acquisitions;
and
(iii) ways the Food and Drug Administration may
allocate the expenses described in clauses (i) and (ii) of
paragraph (1)(A), as informed by the analysis under
paragraph (1)(B).
(b) Administration.--
(1) PDUFA.--Section 736(f) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(f)) is amended by adding at the end
the following:
``(3) Limitation.--Beginning on October 1, 2023, the
authorities under section 735(7)(C) shall include only expenditures
for leasing and necessary scientific equipment.''.
(2) MDUFA.--Section 738(h) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(h)) is amended by adding at the end
the following:
``(3) Limitation.--Beginning on October 1, 2023, the
authorities under section 737(9)(C) shall include only leasing and
necessary scientific equipment.''.
(3) GDUFA.--Section 744B(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-42(e)) is amended--
(A) in the subsection heading, by striking ``Limit'' and
inserting ``Limitations'';
(B) by striking ``The total amount'' and inserting the
following:
``(1) In general.--The total amount''; and
(C) by adding at the end the following:
``(2) Leasing and necessary equipment.--Beginning on October 1,
2023, the authorities under section 744A(11)(C) shall include only
leasing and necessary scientific equipment.''.
(4) BsUFA.--Section 744H(e)(2)(B) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-52(e)(2)(B)) is amended--
(A) in the subparagraph heading, by striking ``limitation''
and inserting ``limitations'';
(B) by striking ``The fees authorized'' and inserting the
following:
``(i) In general.--The fees authorized''; and
(C) by adding at the end the following:
``(ii) Leasing and necessary equipment.--Beginning on
October 1, 2023, the authorities under section 744G(9)(C)
shall include only leasing and necessary scientific
equipment.''.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.

68bd101208a22704e3ecec28401e7a38d8f4ede34221ce0ad0447bc9e118d218

FDA Reauthorization Act of 2017 — HR. 2430

Other Sections