[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2430 Introduced in House (IH)]
<DOC>
115th CONGRESS
1st Session
H. R. 2430
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user-fee programs for prescription drugs, medical devices, generic
drugs, and biosimilar biological products, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 16, 2017
Mr. Walden (for himself, Mr. Pallone, Mr. Burgess, and Mr. Gene Green
of Texas) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user-fee programs for prescription drugs, medical devices, generic
drugs, and biosimilar biological products, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``FDA Reauthorization Act of 2017''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--FEES RELATING TO DRUGS
Sec. 101. Short title; finding.
Sec. 102. Authority to assess and use drug fees.
Sec. 103. Reauthorization; reporting requirements.
Sec. 104. Sunset dates.
Sec. 105. Effective date.
Sec. 106. Savings clause.
TITLE II--FEES RELATING TO DEVICES
Sec. 201. Short title; findings.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Conformity assessment pilot program.
Sec. 206. Reauthorization of review.
Sec. 207. Electronic format for submissions.
Sec. 208. Savings clause.
Sec. 209. Effective date.
Sec. 210. Sunset clause.
TITLE III--FEES RELATING TO GENERIC DRUGS
Sec. 301. Short title; finding.
Sec. 302. Definitions.
Sec. 303. Authority to assess and use human generic drug fees.
Sec. 304. Reauthorization; reporting requirements.
Sec. 305. Sunset dates.
Sec. 306. Effective date.
Sec. 307. Savings clause.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Sec. 401. Short title; finding.
Sec. 402. Definitions.
Sec. 403. Authority to assess and use biosimilar fees.
Sec. 404. Reauthorization; reporting requirements.
Sec. 405. Sunset dates.
Sec. 406. Effective date.
Sec. 407. Savings clause.
TITLE V--REAUTHORIZATION OF OTHER PROGRAMS
Sec. 501. Reauthorization of provision relating to exclusivity of
certain drugs containing single
enantiomers.
Sec. 502. Reauthorization of pediatric humanitarian device exceptions.
Sec. 503. Reauthorization of the critical path public-private
partnerships.
Sec. 504. Reauthorization of pediatric device consortia.
Sec. 505. Reauthorization of orphan grants program.
Sec. 506. Reauthorization of inspection program.
Sec. 507. Reauthorization of pediatric study of drugs.
TITLE VI--ADDITIONAL PROVISIONS
Sec. 601. Technical corrections.
TITLE I--FEES RELATING TO DRUGS
SEC. 101. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Prescription
Drug User Fee Amendments of 2017''.
(b) Finding.--The Congress finds that the fees authorized by the
amendments made in this title will be dedicated toward expediting the
drug development process and the process for the review of human drug
applications, including postmarket drug safety activities, as set forth
in the goals identified for purposes of part 2 of subchapter C of
chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters
from the Secretary of Health and Human Services to the Chairman of the
Committee on Health, Education, Labor, and Pensions of the Senate and
the Chairman of the Committee on Energy and Commerce of the House of
Representatives, as set forth in the Congressional Record.
SEC. 102. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--
(1) In general.--Section 736(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h(a)) is amended--
(A) in the matter preceding paragraph (1), by
striking ``fiscal year 2013'' and inserting ``fiscal
year 2018'';
(B) in the heading of paragraph (1), by striking
``and supplement'';
(C) in paragraph (1), by striking ``or a
supplement'' and ``or supplement'' each place either
appears;
(D) in paragraph (1)(A)--
(i) in clause (i), by striking ``(c)(4)''
and inserting ``(c)(5)''; and
(ii) in clause (ii), by striking ``A fee
established'' and all that follows through
``are required.'' and inserting the following:
``A fee established under subsection (c)(5) for
a human drug application for which clinical
data (other than bioavailability or
bioequivalence studies) with respect to safety
or effectiveness are not required for
approval.'';
(E) in the heading of paragraph (1)(C), by striking
``or supplement'';
(F) in paragraph (1)(F)--
(i) in the heading, by striking ``or
indication''; and
(ii) by striking the second sentence;
(G) by striking paragraph (2) (relating to a
prescription drug establishment fee);
(H) by redesignating paragraph (3) as paragraph
(2);
(I) in the heading of paragraph (2), as so
redesignated, by striking ``Prescription drug product
fee'' and inserting ``Prescription drug program fee'';
(J) in subparagraph (A) of such paragraph (2), by
amending the first sentence to read as follows:
``Except as provided in subparagraphs (B) and (C), each
person who is named as the applicant in a human drug
application, and who, after September 1, 1992, had
pending before the Secretary a human drug application
or supplement, shall pay the annual prescription drug
program fee established for a fiscal year under
subsection (c)(5) for each prescription drug product
that is identified in such a human drug application
approved as of October 1 of such fiscal year.'';
(K) in subparagraph (B) of such paragraph (2)--
(i) in the heading of subparagraph (B), by
inserting after ``Exception'' the following:
``for certain prescription drug products''; and
(ii) by striking ``A prescription drug
product shall not be assessed a fee'' and
inserting ``A prescription drug program fee
shall not be assessed for a prescription drug
product''; and
(L) by adding at the end of such paragraph (2) the
following:
``(C) Limitation.--A person who is named as the
applicant in an approved human drug application shall
not be assessed more than 5 prescription drug program
fees for a fiscal year for prescription drug products
identified in such approved human drug application.''.
(2) Conforming amendment.--Subparagraph (C) of section
740(a)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-12(a)(3)) is amended to read as follows:
``(C) Limitation.--An establishment shall be
assessed only one fee per fiscal year under this
section.''.
(b) Fee Revenue Amounts.--Subsection (b) of section 736 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended to
read as follows:
``(b) Fee Revenue Amounts.--
``(1) In general.--For each of the fiscal years 2018
through 2022, fees under subsection (a) shall, except as
provided in subsections (c), (d), (f), and (g), be established
to generate a total revenue amount under such subsection that
is equal to the sum of--
``(A) the annual base revenue for the fiscal year
(as determined under paragraph (3));
``(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined under
subsection (c)(1));
``(C) the dollar amount equal to the capacity
planning adjustment for the fiscal year (as determined
under subsection (c)(2));
``(D) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if applicable
(as determined under subsection (c)(3));
``(E) the dollar amount equal to the additional
direct cost adjustment for the fiscal year (as
determined under subsection (c)(4)); and
``(F) additional dollar amounts for each fiscal
year as follows:
``(i) $20,077,793 for fiscal year 2018;
``(ii) $21,317,472 for fiscal year 2019;
``(iii) $16,953,329 for fiscal year 2020;
``(iv) $5,426,896 for fiscal year 2021; and
``(v) $2,769,609 for fiscal year 2022.
``(2) Types of fees.--Of the total revenue amount
determined for a fiscal year under paragraph (1)--
``(A) 20 percent shall be derived from human drug
application fees under subsection (a)(1); and
``(B) 80 percent shall be derived from prescription
drug program fees under subsection (a)(2).
``(3) Annual base revenue.--For purposes of paragraph (1),
the dollar amount of the annual base revenue for a fiscal year
shall be--
``(A) for fiscal year 2018, $878,590,000; and
``(B) for fiscal years 2019 through 2022, the
dollar amount of the total revenue amount established
under paragraph (1) for the previous fiscal year, not
including any adjustments made under subsection (c)(3)
or (c)(4).''.
(c) Adjustments; Annual Fee Setting.--Subsection (c) of section 736
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended
to read as follows:
``(c) Adjustments; Annual Fee Setting.--
``(1) Inflation adjustment.--
``(A) In general.--For purposes of subsection
(b)(1)(B), the dollar amount of the inflation
adjustment to the annual base revenue for each fiscal
year shall be equal to the product of--
``(i) such annual base revenue for the
fiscal year under subsection (b)(1)(A); and
``(ii) the inflation adjustment percentage
under subparagraph (B).
``(B) Inflation adjustment percentage.--The
inflation adjustment percentage under this subparagraph
for a fiscal year is equal to the sum of--
``(i) the average annual percent change in
the cost, per full-time equivalent position of
the Food and Drug Administration, of all
personnel compensation and benefits paid with
respect to such positions for the first 3 years
of the preceding 4 fiscal years, multiplied by
the proportion of personnel compensation and
benefits costs to total costs of the process
for the review of human drug applications (as
defined in section 735(6)) for the first 3
years of the preceding 4 fiscal years; and
``(ii) the average annual percent change
that occurred in the Consumer Price Index for
urban consumers (Washington-Baltimore, DC-MD-
VA-WV; Not Seasonally Adjusted; All items;
Annual Index) for the first 3 years of the
preceding 4 years of available data multiplied
by the proportion of all costs other than
personnel compensation and benefits costs to
total costs of the process for the review of
human drug applications (as defined in section
735(6)) for the first 3 years of the preceding
4 fiscal years.
``(2) Capacity planning adjustment.--
``(A) In general.--For each fiscal year, after the
annual base revenue established in subsection (b)(1)(A)
is adjusted for inflation in accordance with paragraph
(1), such revenue shall be adjusted further for such
fiscal year, in accordance with this paragraph, to
reflect changes in the resource capacity needs of the
Secretary for the process for the review of human drug
applications.
``(B) Interim methodology.--
``(i) In general.--Until the capacity
planning methodology described in subparagraph
(C) is effective, the adjustment under this
paragraph for a fiscal year shall be based on
the product of--
``(I) the annual base revenue for
such year, as adjusted for inflation
under paragraph (1); and
``(II) the adjustment percentage
under clause (ii).
``(ii) Adjustment percentage.--The
adjustment percentage under this clause for a
fiscal year is the weighted change in the 3-
year average ending in the most recent year for
which data are available, over the 3-year
average ending in the previous year, for--
``(I) the total number of human
drug applications, efficacy
supplements, and manufacturing
supplements submitted to the Secretary;
``(II) the total number of active
commercial investigational new drug
applications; and
``(III) the total number of formal
meetings scheduled by the Secretary,
and written responses issued by the
Secretary in lieu of such formal
meetings, as identified in section I.H
of the letters described in section
101(b) of the Prescription Drug User
Fee Amendments of 2017.
``(C) Capacity planning methodology.--
``(i) Development; evaluation and report.--
The Secretary shall obtain, through a contract
with an independent accounting or consulting
firm, a report evaluating options and
recommendations for a new methodology to
accurately assess changes in the resource and
capacity needs of the process for the review of
human drug applications. The capacity planning
methodological options and recommendations
presented in such report shall utilize and be
informed by personnel time reporting data as an
input. The report shall be published for public
comment no later than the end of fiscal year
2020.
``(ii) Establishment and implementation.--
After review of the report described in clause
(i) and any public comments thereon, the
Secretary shall establish a capacity planning
methodology for purposes of this paragraph,
which shall--
``(I) replace the interim
methodology under subparagraph (B);
``(II) incorporate such approaches
and attributes as the Secretary
determines appropriate; and
``(III) be effective beginning with
the first fiscal year for which fees
are set after such capacity planning
methodology is established.
``(D) Limitation.--Under no circumstances shall an
adjustment under this paragraph result in fee revenue
for a fiscal year that is less than the sum of the
amounts under subsections (b)(1)(A) (the annual base
revenue for the fiscal year) and (b)(1)(B) (the dollar
amount of the inflation adjustment for the fiscal
year).
``(E) Publication in federal register.--The
Secretary shall publish in the Federal Register notice
under paragraph (5) the fee revenue and fees resulting
from the adjustment and the methodologies under this
paragraph.
``(3) Operating reserve adjustment.--
``(A) Increase.--For fiscal year 2018 and
subsequent fiscal years, the Secretary may, in addition
to adjustments under paragraphs (1) and (2), further
increase the fee revenue and fees if such an adjustment
is necessary to provide for not more than 14 weeks of
operating reserves of carryover user fees for the
process for the review of human drug applications.
``(B) Decrease.--If the Secretary has carryover
balances for such process in excess of 14 weeks of such
operating reserves, the Secretary shall decrease such
fee revenue and fees to provide for not more than 14
weeks of such operating reserves.
``(C) Notice of rationale.--If an adjustment under
subparagraph (A) or (B) is made, the rationale for the
amount of the increase or decrease (as applicable) in
fee revenue and fees shall be contained in the annual
Federal Register notice under paragraph (5)
establishing fee revenue and fees for the fiscal year
involved.
``(4) Additional direct cost adjustment.--
``(A) In general.--The Secretary shall, in addition
to adjustments under paragraphs (1), (2), and (3),
further increase the fee revenue and fees--
``(i) for fiscal year 2018, by $8,730,000;
and
``(ii) for fiscal year 2019 and subsequent
fiscal years, by the amount determined under
subparagraph (B).
``(B) Amount.--The amount determined under this
subparagraph is--
``(i) $8,730,000, multiplied by
``(ii) the Consumer Price Index for urban
consumers (Washington-Baltimore, DC-MD-VA-WV;
Not Seasonally Adjusted; All Items; Annual
Index) for the most recent year of available
data, divided by such Index for 2016.
``(5) Annual fee setting.--The Secretary shall, not later
than 60 days before the start of each fiscal year that begins
after September 30, 2017--
``(A) establish, for the next fiscal year, human
drug application fees and prescription drug program
fees under subsection (a), based on the revenue amounts
established under subsection (b) and the adjustments
provided under this subsection; and
``(B) publish such fee revenue and fees in the
Federal Register.
``(6) Limit.--The total amount of fees charged, as adjusted
under this subsection, for a fiscal year may not exceed the
total costs for such fiscal year for the resources allocated
for the process for the review of human drug applications.''.
(d) Fee Waiver or Reduction.--Section 736(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended--
(1) in paragraph (1)--
(A) by inserting ``or'' at the end of subparagraph
(B);
(B) by striking subparagraph (C); and
(C) by redesignating subparagraph (D) as
subparagraph (C);
(2) by striking paragraph (3) (relating to use of standard
costs);
(3) by redesignating paragraph (4) as paragraph (3); and
(4) in paragraph (3), as so redesignated--
(A) in subparagraphs (A) and (B), by striking
``paragraph (1)(D)'' and inserting ``paragraph
(1)(C)''; and
(B) in subparagraph (B)--
(i) by striking clause (ii);
(ii) by striking ``shall pay'' through
``(i) application fees'' and inserting ``shall
pay application fees''; and
(iii) by striking ``; and'' at the end and
inserting a period.
(e) Effect of Failure To Pay Fees.--Section 736(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(e)) is amended by striking
``all fees'' and inserting ``all such fees''.
(f) Limitations.--Section 736(f)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(f)(2)) is amended by striking
``supplements, prescription drug establishments, and prescription drug
products'' and inserting ``prescription drug program fees''.
(g) Crediting and Availability of Fees.--Section 736(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)) is amended--
(1) in paragraph (3)--
(A) by striking ``2013 through 2017'' and inserting
``2018 through 2022''; and
(B) by striking ``and paragraph (4) of this
subsection''; and
(2) by striking paragraph (4).
(h) Orphan Drugs.--Section 736(k) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(k)) is amended by striking ``product and
establishment fees'' each place it appears and inserting ``prescription
drug program fees''.
SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h-2) is amended--
(1) in subsection (a)(1)--
(A) in the matter before subparagraph (A), by
striking ``2013'' and inserting ``2018''; and
(B) in subparagraph (A), by striking ``Prescription
Drug User Fee Amendments of 2012'' and inserting
``Prescription Drug User Fee Amendments of 2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018''; and
(3) in subsection (d), by striking ``2017'' each place it
appears and inserting ``2022''.
SEC. 104. SUNSET DATES.
(a) Authorization.--Sections 735 and 736 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective
October 1, 2022.
(b) Reporting Requirements.--Section 736B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h-2) shall cease to be effective
January 31, 2023.
(c) Previous Sunset Provision.--Effective October 1, 2017,
subsections (a) and (b) of section 105 of the Food and Drug
Administration Safety and Innovation Act (Public Law 112-144) are
repealed.
SEC. 105. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, or the date of the enactment of this Act, whichever is later,
except that fees under part 2 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act shall be assessed for all human
drug applications received on or after October 1, 2017, regardless of
the date of the enactment of this Act.
SEC. 106. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 2 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act, as in effect on the day before the date of the enactment of this
title, shall continue to be in effect with respect to human drug
applications and supplements (as defined in such part as of such day)
that on or after October 1, 2012, but before October 1, 2017, were
accepted by the Food and Drug Administration for filing with respect to
assessing and collecting any fee required by such part for a fiscal
year prior to fiscal year 2018.
TITLE II--FEES RELATING TO DEVICES
SEC. 201. SHORT TITLE; FINDINGS.
(a) Short Title.--This title may be cited as the ``Medical Device
User Fee Amendments of 2017''.
(b) Findings.--The Congress finds that the fees authorized under
the amendments made by this title will be dedicated toward expediting
the process for the review of device applications and for assuring the
safety and effectiveness of devices, as set forth in the goals
identified for purposes of part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act in the letters from the Secretary
of Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the Chairman
of the Committee on Energy and Commerce of the House of
Representatives, as set forth in the Congressional Record.
SEC. 202. DEFINITIONS.
Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379i) is amended--
(1) by redesignating paragraphs (8) through (13) as
paragraphs (9) through (14), respectively;
(2) by inserting after paragraph (7) the following new
paragraph:
``(8) The term `de novo classification request' means a
request made under section 513(f)(2)(A) with respect to the
classification of a device.'';
(3) in subparagraph (D) of paragraph (10) (as redesignated
by paragraph (1)), by striking ``and submissions'' and
inserting ``submissions, and de novo classification requests'';
and
(4) in paragraph (11) (as redesignated by paragraph (1)),
by striking ``2011'' and inserting ``2016''.
SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.
(a) Types of Fees.--Section 738(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(a)) is amended--
(1) in paragraph (1), by striking ``fiscal year 2013'' and
inserting ``fiscal year 2018''; and
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by
striking ``October 1, 2012'' and inserting
``October 1, 2017'';
(ii) in clause (viii), by striking ``2''
and inserting ``3.4''; and
(iii) by adding at the end the following
new clause:
``(xi) For a de novo classification
request, a fee equal to 30 percent of the fee
that applies under clause (i).''; and
(B) in subparagraph (B)(v)(I), by striking ``or
premarket notification submission'' and inserting
``premarket notification submission, or de novo
classification request''.
(b) Fee Amounts.--Section 738(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(b)) is amended to read as follows:
``(b) Fee Amounts.--
``(1) In general.--Subject to subsections (c), (d), (e),
and (h), for each of fiscal years 2018 through 2022, fees under
subsection (a) shall be derived from the base fee amounts
specified in paragraph (2), to generate the total revenue
amounts specified in paragraph (3).
``(2) Base fee amounts specified.--For purposes of
paragraph (1), the base fee amounts specified in this paragraph
are as follows:
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
``Fee Type Year 2018 Year 2019 Year 2020 Year 2021 Year 2022
----------------------------------------------------------------------------------------------------------------
Premarket Application.................................... $294,000 $300,000 $310,000 $328,000 $329,000
Establishment Registration............................... $4,375 $4,548 $4,760 $4,975 $4,978
----------------------------------------------------------------------------------------------------------------
``(3) Total revenue amounts specified.--For purposes of
paragraph (1), the total revenue amounts specified in this
paragraph are as follows:
``(A) $183,280,756 for fiscal year 2018.
``(B) $190,654,875 for fiscal year 2019.
``(C) $200,132,014 for fiscal year 2020.
``(D) $211,748,789 for fiscal year 2021.
``(E) $213,687,660 for fiscal year 2022.''.
(c) Annual Fee Setting; Adjustments.--Section 738(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is amended--
(1) in paragraph (1), by striking ``2012'' and inserting
``2017'';
(2) in paragraph (2)--
(A) in subparagraph (A), by striking ``2014'' and
inserting ``2018'';
(B) by striking subparagraph (B) and inserting the
following new subparagraph:
``(B) Applicable inflation adjustment.--The
applicable inflation adjustment for fiscal year 2018
and each subsequent fiscal year is the product of--
``(i) the base inflation adjustment under
subparagraph (C) for such fiscal year; and
``(ii) the product of the base inflation
adjustment under subparagraph (C) for each of
the fiscal years preceding such fiscal year,
beginning with fiscal year 2016.'';
(C) in subparagraph (C), in the heading, by
striking ``to total revenue amounts''; and
(D) by amending subparagraph (D) to read as
follows:
``(D) Adjustment to base fee amounts.--For each of
fiscal years 2018 through 2022, the Secretary shall--
``(i) adjust the base fee amounts specified
in subsection (b)(2) for such fiscal year by
multiplying such amounts by the applicable
inflation adjustment under subparagraph (B) for
such year; and
``(ii) if the Secretary determines
necessary, increase (in addition to the
adjustment under clause (i)) such base fee
amounts, on a uniform proportionate basis, to
generate the total revenue amounts under
subsection (b)(3), as adjusted for inflation
under subparagraph (A).''; and
(3) in paragraph (3)--
(A) by striking ``2014 through 2017'' and inserting
``2018 through 2022''; and
(B) by striking ``further adjusted'' and inserting
``increased''.
(d) Small Businesses; Fee Waiver and Fee Reduction Regarding
Premarket Approval Fees.--Section 738(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(d)) is amended--
(1) in paragraph (1), by striking ``specified in clauses
(i) through (v) and clauses (vii), (ix), and (x)'' and
inserting ``specified in clauses (i) through (vii) and clauses
(ix), (x), and (xi)''; and
(2) in paragraph (2)(C)--
(A) by striking ``supplement, or'' and inserting
``supplement,''; and
(B) by inserting ``, or a de novo classification
request'' after ``class III device''.
(e) Small Businesses; Fee Reduction Regarding Premarket
Notification Submissions.--Section 738(e)(2)(C) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j(e)(2)(C)) is amended by striking
``50'' and inserting ``25''.
(f) Fee Waiver or Reduction.--
(1) Repeal.--Section 738 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j) is amended by striking subsection
(f).
(2) Conforming changes.--
(A) Section 515(c)(4)(A) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360e(c)(4)(A)) is amended
by striking ``738(h)'' and inserting ``738(g)''.
(B) Section 738 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j), as amended by paragraph
(1), is further amended--
(i) by redesignating subsections (g)
through (l) as subsections (f) through (k);
(ii) in subsection (a)(2)(A), by striking
``(d), (e), and (f)'' and inserting ``(d) and
(e)''; and
(iii) in subsection (a)(3)(A), by striking
``and subsection (f)''.
(g) Effect of Failure To Pay Fees.--Subsection (f)(1), as
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j) is amended--
(1) by striking ``or periodic reporting concerning a class
III device'' and inserting ``periodic reporting concerning a
class III device, or de novo classification request''; and
(2) by striking ``all fees'' and inserting ``all such
fees''.
(h) Conditions.--Subsection (g)(1)(A), as redesignated, of section
738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is
amended by striking ``$280,587,000'' and inserting ``$320,825,000''.
(i) Crediting and Availability of Fees.--Subsection (h), as
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j) is amended--
(1) in paragraph (3)--
(A) by striking ``2013 through 2017'' and inserting
``2018 through 2022''; and
(B) by striking ``subsection (c)'' and all that
follows through the period at the end and inserting
``subsection (c).''; and
(2) by striking paragraph (4).
SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Reports.--Section 738A(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-1(a)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) by striking ``2013'' and inserting
``2018''; and
(ii) by striking ``the Medical Device User
Fee Amendments of 2012'' and inserting
``Medical Device User Fee Amendments of 2017'';
and
(B) in subparagraph (B), by striking ``the Medical
Device User Fee Amendments of 2012'' and inserting
``Medical Device User Fee Amendments of 2017''; and
(2) in paragraph (2), by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.
(b) Reauthorization.--Section 738A(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--
(1) in paragraph (1), by striking ``2017'' and inserting
``2022''; and
(2) in paragraph (5), by striking ``2017'' and inserting
``2022''.
SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.
(a) In General.--Section 514 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360d) is amended by adding at the end the
following:
``(d) Pilot Accreditation Scheme for Conformity Assessment.--
``(1) In general.--The Secretary shall establish a pilot
program under which--
``(A) testing laboratories may be accredited, by
accreditation bodies meeting criteria specified by the
Secretary, to assess the conformance of a device with
certain standards recognized under this section; and
``(B) subject to paragraph (2), determinations by
testing laboratories so accredited that a device
conforms with such standard or standards shall be
accepted by the Secretary for purposes of demonstrating
such conformity under this section unless the Secretary
finds that a particular such determination shall not be
so accepted.
``(2) Secretarial review of accredited laboratory
determinations.--The Secretary may--
``(A) review determinations by testing laboratories
accredited pursuant to this subsection, including by
conducting periodic audits of such determinations or
processes of accredited bodies or testing laboratories
and, following such review, taking additional measures
under this Act, such as suspension or withdrawal of
accreditation of such testing laboratory under
paragraph (1)(A) or requesting additional information
with respect to such device, as the Secretary
determines appropriate; and
``(B) if the Secretary becomes aware of information
materially bearing on safety or effectiveness of a
device assessed for conformity by a testing laboratory
so accredited, take such additional measures under this
Act as the Secretary determines appropriate, such as
suspension or withdrawal of accreditation of such
testing laboratory under paragraph (1)(A), or
requesting additional information with regard to such
device.
``(3) Implementation and reporting.--
``(A) Public meeting.--The Secretary shall publish
in the Federal Register a notice of a public meeting to
be held no later than September 30, 2018, to discuss
and obtain input and recommendations from stakeholders
regarding the goals and scope of, and a suitable
framework and procedures and requirements for, the
pilot program under this subsection.
``(B) Pilot program guidance.--The Secretary
shall--
``(i) not later than September 30, 2019,
issue draft guidance regarding the goals and
implementation of the pilot program under this
subsection; and
``(ii) not later than September 30, 2021,
issue final guidance with respect to the
implementation of such program.
``(C) Pilot program initiation.--Not later than
September 30, 2020, the Secretary shall initiate the
pilot program under this subsection.
``(D) Report.--The Secretary shall make available
on the website of the Food and Drug Administration an
annual report on the progress of the pilot program
under this subsection.
``(4) Sunset.--As of October 1, 2022--
``(A) the authority for accreditation bodies to
accredit testing laboratories pursuant to paragraph
(1)(A) shall cease to have force or effect;
``(B) the Secretary--
``(i) may not accept a determination
pursuant to paragraph (1)(B) made by a testing
laboratory after such date; and
``(ii) may accept such a determination made
prior to such date;
``(C) except for purposes of accepting a
determination described in subparagraph (B)(ii), the
Secretary shall not continue to recognize the
accreditation of testing laboratories accredited under
paragraph (1)(A); and
``(D) the Secretary may take actions in accordance
with paragraph (2) with respect to the determinations
made prior to such date and recognition of the
accreditation of testing laboratories pursuant to
determinations made prior to such date.''.
SEC. 206. REAUTHORIZATION OF REVIEW.
Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360m) is amended--
(1) in subsection (a)(3)--
(A) in subparagraph (A), by striking clauses (ii)
and (iii) and inserting the following:
``(ii) a device classified under section
513(f)(2) or designated under section 515C(d);
or
``(iii) 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;
``(ii) not later than 24 months after the
date on which the Secretary issues such draft
guidance, finalize such guidance; and
``(iii) beginning on the date such guidance
is finalized, designate and post on the
Internet website of the Food and Drug
Administration, an updated list of class I and
class II device types, or subsets of such
device types, and the Secretary's determination
with respect to whether each such device type,
or subset of a device type, is eligible or not
eligible for review by an accredited person
under this section based on the factors
described in clause (i).''; and
(C) by adding at the end the following:
``(C) Interim rule.--Until the date on which the
updated list is designated and posted in accordance
with subparagraph (B)(iii), the list in effect on the
date of enactment the Medical Device User Fee
Amendments of 2017 shall be in effect.'';
(2) in subsection (b)--
(A) in paragraph (2)--
(i) by striking subparagraph (D); and
(ii) by redesignating subparagraph (E) as
subparagraph (D); and
(B) in paragraph (3)--
(i) by redesignating subparagraph (E) as
subparagraph (F);
(ii) in subparagraph (F) (as so
redesignated), by striking ``The operations
of'' and all that follows through ``it will--''
and inserting ``Such person shall agree, at a
minimum, to include in its request for
accreditation a commitment to, at the time of
accreditation, and at any time it is performing
any review pursuant to this section--''; and
(iii) by inserting after subparagraph (D)
the following new subparagraph:
``(E) The operations of such person shall be in
accordance with generally accepted professional and
ethical business practices.''; and
(3) in subsection (c), by striking ``2017'' and inserting
``2022''.
SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS.
Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379k-1(b)) is amended by adding at the end the following new
paragraph:
``(3) Presubmissions and submissions solely in electronic
format.--
``(A) In general.--Beginning 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 12 months after the close of the public
comment period on the draft guidance issued under
subparagraph (B), issue final guidance described in
clauses (i) through (iii) of such subparagraph.''.
SEC. 208. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 3 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379i et seq.), as in effect on the day before the date of
the enactment of this title, shall continue to be in effect with
respect to the submissions listed in section 738(a)(2)(A) of such Act
(as defined in such part as of such day) that on or after October 1,
2012, but before October 1, 2017, were accepted by the Food and Drug
Administration for filing with respect to assessing and collecting any
fee required by such part for a fiscal year prior to fiscal year 2018.
SEC. 209. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, or the date of the enactment of this Act, whichever is later,
except that fees under part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act shall be assessed for all
submissions listed in section 738(a)(2)(A) of such Act received on or
after October 1, 2017, regardless of the date of the enactment of this
Act.
SEC. 210. SUNSET CLAUSE.
(a) Authorization.--Sections 737 and 738 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be effective
October 1, 2022.
(b) Reporting Requirements.--Section 738A (21 U.S.C. 739j-1) of the
Federal Food, Drug, and Cosmetic Act (regarding reauthorization and
reporting requirements) shall cease to be effective January 31, 2023.
(c) Previous Sunset Provision.--
(1) In general.--Effective October 1, 2017, section 207(a)
of the Medical Device User Fee Amendments of 2012 (Public Law
112-144) is repealed.
(2) Conforming amendment.--The Food and Drug Administration
Safety and Innovation Act (Public Law 112-144) is amended in
the table of contents in section 2 by striking the item
relating to section 207.
TITLE III--FEES RELATING TO GENERIC DRUGS
SEC. 301. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Generic Drug
User Fee Amendments of 2017''.
(b) Finding.--The Congress finds that the fees authorized by the
amendments made in this title will be dedicated to human generic drug
activities, as set forth in the goals identified for purposes of part 7
of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act, in the letters from the Secretary of Health and Human Services to
the Chairman of the Committee on Health, Education, Labor, and Pensions
of the Senate and the Chairman of the Committee on Energy and Commerce
of the House of Representatives, as set forth in the Congressional
Record.
SEC. 302. DEFINITIONS.
Section 744A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-41) is amended--
(1) in paragraph (1)(B), by striking ``application for a
positron emission tomography drug.'' and inserting
``application--
``(i) for a positron emission tomography
drug; or
``(ii) submitted by a State or Federal
governmental entity for a drug that is not
distributed commercially.'';
(2) by redesignating paragraphs (5) through (12) as
paragraphs (6) through (13), respectively; and
(3) by inserting after paragraph (4) the following:
``(5) The term `contract manufacturing organization
facility' means a manufacturing facility of a finished dosage
form of a drug approved pursuant to an abbreviated new drug
application, where such manufacturing facility is not
identified in an approved abbreviated new drug application held
by the owner of such facility or an affiliate of such owner or
facility.''.
SEC. 303. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.
(a) Types of Fees.--Section 744B(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-42(a)) is amended--
(1) in the matter preceding paragraph (1), by striking
``fiscal year 2013'' and inserting ``fiscal year 2018'';
(2) in paragraph (1), by adding at the end the following:
``(E) Sunset.--This paragraph shall cease to be
effective October 1, 2022.'';
(3) in paragraph (2)--
(A) by amending subparagraph (C) to read as
follows:
``(C) Notice.--Not later than 60 days before the
start of each of fiscal years 2018 through 2022, the
Secretary shall publish in the Federal Register the
amount of the drug master file fee established by this
paragraph for such fiscal year.''; and
(B) in subparagraph (E)--
(i) in clause (i)--
(I) by striking ``no later than the
date'' and inserting ``on the earlier
of--
``(I) the date'';
(II) by striking the period and
inserting ``; or''; and
(III) by adding at the end the
following:
``(II) the date on which the drug
master file holder requests the initial
completeness assessment.''; and
(ii) in clause (ii), by striking ``notice
provided for in clause (i) or (ii) of
subparagraph (C), as applicable'' and inserting
``notice provided for in subparagraph (C)'';
(4) in paragraph (3)--
(A) in the heading, by striking ``and prior
approval supplement'';
(B) in subparagraph (A), by striking ``or a prior
approval supplement to an abbreviated new drug
application'';
(C) by amending subparagraphs (B) and (C) to read
as follows:
``(B) Notice.--Not later than 60 days before the
start of each of fiscal years 2018 through 2022, the
Secretary shall publish in the Federal Register the
amount of the fees under subparagraph (A) for such
fiscal year.
``(C) Fee due date.--The fees required by
subparagraphs (A) and (F) shall be due no later than
the date of submission of the abbreviated new drug
application or prior approval supplement for which such
fee applies.'';
(D) in subparagraph (D)--
(i) in the heading, by inserting ``, is
withdrawn prior to being received, or is no
longer received'' after ``received''; and
(ii) by striking ``The Secretary shall''
and all that follows through the period and
inserting the following:
``(i) Applications not considered to have
been received and applications withdrawn prior
to being received.--The Secretary shall refund
75 percent of the fee paid under subparagraph
(A) for any abbreviated new drug application
that the Secretary considers not to have been
received within the meaning of section
505(j)(5)(A) for a cause other than failure to
pay fees, or that has been withdrawn prior to
being received within the meaning of section
505(j)(5)(A).
``(ii) Applications no longer received.--
The Secretary shall refund 100 percent of the
fee paid under subparagraph (A) for any
abbreviated new drug application if the
Secretary initially receives the application
under section 505(j)(5)(A) and subsequently
determines that an exclusivity period for a
listed drug should have prevented the Secretary
from receiving such application, such that the
abbreviated new drug application is no longer
received within the meaning of section
505(j)(5)(A).'';
(E) in subparagraph (E), by striking ``or prior
approval supplement''; and
(F) in the matter preceding clause (i) of
subparagraph (F)--
(i) by striking ``2012'' and inserting
``2017''; and
(ii) by striking ``subsection (d)(3)'' and
inserting ``subsection (d)(2)'';
(5) in paragraph (4)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i) and
in clause (iii), by striking ``, or intended to
be identified, in at least one generic drug
submission that is pending or'' and inserting
``in at least one generic drug submission that
is'';
(ii) in clause (i), by striking ``or
intended to be identified in at least one
generic drug submission that is pending or''
and inserting ``in at least one generic drug
submission that is'';
(iii) in clause (ii), by striking
``produces,'' and all that follows through
``such a'' and inserting ``is identified in at
least one generic drug submission in which the
facility is approved to produce one or more
active pharmaceutical ingredients or in a Type
II active pharmaceutical ingredient drug master
file referenced in at least one such''; and
(iv) in clause (iii), by striking ``to fees
under both such clauses'' and inserting ``only
to the fee attributable to the manufacture of
the finished dosage forms''; and
(B) by amending subparagraphs (C) and (D) to read
as follows:
``(C) Notice.--Within the timeframe specified in
subsection (d)(1), the Secretary shall publish in the
Federal Register the amount of the fees under
subparagraph (A) for such fiscal year.
``(D) Fee due date.--For each of fiscal years 2018
through 2022, the fees under subparagraph (A) for such
fiscal year shall be due on the later of--
``(i) the first business day on or after
October 1 of each such year; or
``(ii) the first business day after the
enactment of an appropriations Act providing
for the collection and obligation of fees for
such year under this section for such year.'';
(6) by redesignating paragraph (5) as paragraph (6); and
(7) by inserting after paragraph (4) the following:
``(5) Generic drug applicant program fee.--
``(A) In general.--A generic drug applicant program
fee shall be assessed annually as described in
subsection (b)(2)(E).
``(B) Amount.--The amount of fees established under
subparagraph (A) shall be established under subsection
(d).
``(C) Notice.--Within the timeframe specified in
subsection (d)(1), the Secretary shall publish in the
Federal Register the amount of the fees under
subparagraph (A) for such fiscal year.
``(D) Fee due date.--For each of fiscal years 2018
through 2022, the fees under subparagraph (A) for such
fiscal year shall be due on the later of--
``(i) the first business day on or after
October 1 of each such fiscal year; or
``(ii) the first business day after the
date of enactment of an appropriations Act
providing for the collection and obligation of
fees for such fiscal year under this section
for such fiscal year.''.
(b) Fee Revenue Amounts.--Section 744B(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-42(b)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) in the heading, by striking ``2013''
and inserting ``2018'';
(ii) by striking ``2013'' and inserting
``2018'';
(iii) by striking ``$299,000,000'' and
inserting ``$493,600,000''; and
(iv) by striking ``Of that amount'' and all
that follows through the end of clause (ii);
and
(B) in subparagraph (B)--
(i) in the heading, by striking ``2014
through 2017'' and inserting ``2019 through
2022'';
(ii) by striking ``2014 through 2017'' and
inserting ``2019 through 2022'';
(iii) by striking ``paragraphs (2) through
(4)'' and inserting ``paragraphs (2) through
(5)''; and
(iv) by striking ``$299,000,000'' and
inserting ``$493,600,000''; and
(2) in paragraph (2)--
(A) in the matter preceding subparagraph (A)--
(i) by striking ``paragraph (1)(A)(ii) for
fiscal year 2013 and paragraph (1)(B) for each
of fiscal years 2014 through 2017'' and
inserting ``such paragraph for a fiscal year'';
and
(ii) by striking ``through (4)'' and
inserting ``through (5)'';
(B) in subparagraph (A), by striking ``Six
percent'' and inserting ``Five percent'';
(C) by amending subparagraphs (B) and (C) to read
as follows:
``(B) Thirty-three percent shall be derived from
fees under subsection (a)(3) (relating to abbreviated
new drug applications).
``(C) Twenty percent shall be derived from fees
under subsection (a)(4)(A)(i) (relating to generic drug
facilities). The amount of the fee for a contract
manufacturing organization facility shall be equal to
one-third the amount of the fee for a facility that is
not a contract manufacturing organization facility. The
amount of the fee for a facility located outside the
United States and its territories and possessions shall
be $15,000 higher than the amount of the fee for a
facility located in the United States and its
territories and possessions.'';
(D) in subparagraph (D)--
(i) by striking ``Fourteen percent'' and
inserting ``Seven percent'';
(ii) by striking ``not less than $15,000
and not more than $30,000'' and inserting
``$15,000''; and
(iii) by striking ``, as determined'' and
all that follows through the period at the end
and inserting a period; and
(E) by adding at the end the following:
``(E)(i) Thirty-five percent shall be derived from
fees under subsection (a)(5) (relating to generic drug
applicant program fees). For purposes of this
subparagraph, if a person has affiliates, a single
program fee shall be assessed with respect to that
person, including its affiliates, and may be paid by
that person or any one of its affiliates. The Secretary
shall determine the fees as follows:
``(I) If a person (including its
affiliates) owns at least one but not more than
5 approved abbreviated new drug applications on
the due date for the fee under this subsection,
the person (including its affiliates) shall be
assessed a small business generic drug
applicant program fee equal to one-tenth of the
large size operation generic drug applicant
program fee.
``(II) If a person (including its
affiliates) owns at least 6 but not more than
19 approved abbreviated new drug applications
on the due date for the fee under this
subsection, the person (including its
affiliates) shall be assessed a medium size
operation generic drug applicant program fee
equal to two-fifths of the large size operation
generic drug applicant program fee.
``(III) If a person (including its
affiliates) owns 20 or more approved
abbreviated new drug applications on the due
date for the fee under this subsection, the
person (including its affiliates) shall be
assessed a large size operation generic drug
applicant program fee.
``(ii) For purposes of this subparagraph, an
abbreviated new drug application shall be deemed not to
be approved if the applicant has submitted a written
request for withdrawal of approval of such abbreviated
new drug application by April 1 of the previous fiscal
year.''.
(c) Adjustments.--Section 744B(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-42(c)) is amended--
(1) in paragraph (1)--
(A) by striking ``2014'' and inserting ``2019'';
(B) by inserting ``to equal the product of the
total revenues established in such notice for the prior
fiscal year multiplied'' after ``a fiscal year,''; and
(C) by striking the flush text following
subparagraph (C); and
(2) in paragraph (2)--
(A) by striking ``2017'' each place it appears and
inserting ``2022'';
(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. 379-42(g)) is amended--
(1) in paragraph (1), by adding at the end the following:
``This paragraph shall cease to be effective on October 1,
2022.'';
(2) in paragraph (2)(C)(ii), by striking ``of
505(j)(5)(A)'' and inserting ``of section 505(j)(5)(A)''; and
(3) by adding at the end the following:
``(5) Generic drug applicant program fee.--
``(A) In general.--A person who fails to pay a fee
as required under subsection (a)(5) by the date that is
20 calendar days after the due date, as specified in
subparagraph (D) of such subsection, shall be subject
to the following:
``(i) The Secretary shall place the person
on a publicly available arrears list.
``(ii) Any abbreviated new drug application
submitted by the generic drug applicant or an
affiliate of such applicant shall not be
received, within the meaning of section
505(j)(5)(A).
``(iii) All drugs marketed pursuant to any
abbreviated new drug application held by such
applicant or an affiliate of such applicant
shall be deemed misbranded under section
502(aa).
``(B) Application of penalties.--The penalties
under subparagraph (A) shall apply until the fee
required under subsection (a)(5) is paid.''.
(g) Limitations.--Section 744B(h)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379-42(h)(2)) is amended by striking ``for Type
II active pharmaceutical ingredient drug master files, abbreviated new
drug applications and prior approval supplements, and generic drug
facilities and active pharmaceutical ingredient facilities''.
(h) Crediting and Availability of Fees.--Section 744B(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379-42(i)) is amended--
(1) in paragraph (2)--
(A) by striking subparagraph (C) (relating to fee
collection during first program year);
(B) in subparagraph (D)--
(i) in the heading, by striking ``in
subsequent years''; and
(ii) by striking ``(after fiscal year
2013)''; and
(C) by redesignating subparagraph (D) as
subparagraph (C); and
(2) in paragraph (3), by striking ``fiscal years 2013
through 2017'' and inserting ``fiscal years 2018 through
2022''.
(i) Information on Abbreviated New Drug Applications Owned by
Applicants and Their Affiliates.--Section 744B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379-42) is amended by adding at the
end the following:
``(o) Information on Abbreviated New Drug Applications Owned by
Applicants and Their Affiliates.--
``(1) In general.--By April 1 of each year, each person
that owns an abbreviated new drug application, or any affiliate
of such person, shall submit, on behalf of the person and its
affiliates, 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 applications and all
approved abbreviated new drug applications owned by any
such affiliate.
``(2) Format and method.--The Secretary shall specify in
guidance the format and method for submission of lists under
this subsection.''.
SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-43) is amended--
(1) in subsection (a)--
(A) by striking ``2013'' and inserting ``2018'';
and
(B) by striking ``Generic Drug User Fee Amendments
of 2012'' and inserting ``Generic Drug User Fee
Amendments of 2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018''; and
(3) in subsection (d), by striking ``2017'' each place it
appears and inserting ``2022''.
SEC. 305. SUNSET DATES.
(a) Authorization.--Sections 744A and 744B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-41; 379j-42) shall cease to be
effective October 1, 2022.
(b) Reporting Requirements.--Section 744C of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-43) shall cease to be effective
January 31, 2023.
(c) Previous Sunset Provision.--Effective October 1, 2017,
subsections (a) and (b) of section 304 of the Food and Drug
Administration Safety and Innovation Act (Public Law 112-144) are
repealed.
SEC. 306. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, or the date of the enactment of this Act, whichever is later,
except that fees under part 7 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act shall be assessed for all
abbreviated new drug applications received on or after October 1, 2017,
regardless of the date of the enactment of this Act.
SEC. 307. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 7 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act, as in effect on the day before the date of the enactment of this
title, shall continue to be in effect with respect to abbreviated new
drug applications (as defined in such part as of such day) that on or
after October 1, 2012, but before October 1, 2017, were received by the
Food and Drug Administration within the meaning of 505(j)(5)(A) of such
Act (21 U.S.C. 355(j)(5)(A)), prior approval supplements that were
submitted, and drug master files for Type II active pharmaceutical
ingredients that were first referenced with respect to assessing and
collecting any fee required by such part for a fiscal year prior to
fiscal year 2018.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
SEC. 401. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Biosimilar User
Fee Amendments of 2017''.
(b) Finding.--The Congress finds that the fees authorized by the
amendments made in this title will be dedicated to expediting the
process for the review of biosimilar biological product applications,
including postmarket safety activities, as set forth in the goals
identified for purposes of part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary
of Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the Chairman
of the Committee on Energy and Commerce of the House of
Representatives, as set forth in the Congressional Record.
SEC. 402. DEFINITIONS.
(a) Adjustment Factor.--Section 744G(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-51(1)) is amended to read as follows:
``(1) The term `adjustment factor' applicable to a fiscal
year is the Consumer Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted;
All items; Annual Index) for October of the preceding fiscal
year divided by such Index for October 2011.''.
(b) Biosimilar Biological Product.--Section 744G(3) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(3)) is amended by
striking ``means a product'' and inserting ``means a specific strength
of a biological product in final dosage form''.
SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.
(a) Types of Fees.--Section 744H(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-52(a)) is amended--
(1) in the matter preceding paragraph (1), by striking
``fiscal year 2013'' and inserting ``fiscal year 2018'';
(2) in the heading of paragraph (1), by striking
``Biosimilar'' and inserting ``Biosimilar biological product'';
(3) in paragraph (1)(A)(i), by striking ``(b)(1)(A)'' and
inserting ``(c)(5)'';
(4) in paragraph (1)(B)(i), by striking ``(b)(1)(B) for
biosimilar biological product development'' and inserting
``(c)(5) for the biosimilar biological product development
program'';
(5) in paragraph (1)(B)(ii), by striking ``annual
biosimilar biological product development program fee'' and
inserting ``annual biosimilar biological product development
fee'';
(6) in paragraph (1)(B)(iii), by striking ``annual
biosimilar development program fee'' and inserting ``annual
biosimilar biological product development fee'';
(7) in paragraph (1)(B), by adding at the end the
following:
``(iv) Refund.--If a person submits a
marketing application for a biosimilar
biological product before October 1 of a fiscal
year and such application is accepted for
filing on or after October 1 of such fiscal
year, the person may request a refund equal to
the annual biosimilar development fee paid by
the person for the product for such fiscal
year. To qualify for consideration for a refund
under this clause, a person shall submit to the
Secretary a written request for such refund not
later than 180 days after the marketing
application is accepted for filing.'';
(8) in paragraph (1)(C), by striking ``for a product
effective October 1 of a fiscal year by,'' and inserting ``for
a product, effective October 1 of a fiscal year, by,'';
(9) in paragraph (1)(D)--
(A) in clause (i) in the matter preceding subclause
(I), by inserting ``, if the person seeks to resume
participation in such program,'' before ``pay a fee'';
(B) in clause (i)(I), by inserting after ``grants a
request'' the following: ``by such person''; and
(C) in clause (i)(II), by inserting after
``discontinued)'' the following: ``by such person'';
(10) in the heading of paragraph (1)(E), by striking
``biosimilar development program'';
(11) in the heading of subparagraph (F) of paragraph (1),
by striking ``biosimilar development program fees'' and
inserting ``biosimilar biological product development fees'';
(12) in paragraph (1)(F)--
(A) in the heading of subparagraph (F), by striking
``biosimilar development program'' before ``fees''; and
(B) by amending clause (i) to read as follows:
``(i) Refunds.--Except as provided in
subparagraph (B)(iv), the Secretary shall not
refund any initial or annual biosimilar
biological product development fee paid under
subparagraph (A) or (B), or any reactivation
fee paid under subparagraph (D).'';
(13) in paragraph (2)--
(A) in the heading of paragraph (2), by striking
``and supplement'';
(B) by amending subparagraphs (A) and (B) to read
as follows:
``(A) In general.--Each person that submits, on or
after October 1, 2017, a biosimilar biological product
application shall be subject to the following fees:
``(i) A fee established under subsection
(c)(5) for a biosimilar biological product
application for which clinical data (other than
comparative bioavailability studies) with
respect to safety or effectiveness are required
for approval.
``(ii) A fee established under subsection
(c)(5) for a biosimilar biological product
application for which clinical data (other than
comparative bioavailability studies) with
respect to safety or effectiveness are not
required for approval. Such fee shall be equal
to half of the amount of the fee described in
clause (i).
``(B) Rule of applicability; treatment of certain
previously paid fees.--Any person who pays a fee under
subparagraph (A), (B), or (D) of paragraph (1) for a
product before October 1, 2017, but submits a
biosimilar biological product application for that
product after such date, shall--
``(i) be subject to any biosimilar
biological product application fees that may be
assessed at the time when such biosimilar
biological product application is submitted;
and
``(ii) be entitled to no reduction of such
application fees based on the amount of fees
paid for that product before October 1, 2017,
under such subparagraph (A), (B), or (D).'';
(C) in the heading of subparagraph (D), by striking
``or supplement''; and
(D) in subparagraphs (C) through (F)--
(i) by striking ``or supplement'' each
place it appears; and
(ii) in subparagraph (D), by striking ``or
a supplement''; and
(14) by amending paragraph (3) to read as follows:
``(3) Biosimilar biological product program fee.--
``(A) In general.--Each person who is named as the
applicant in a biosimilar biological product
application shall pay the annual biosimilar biological
product program fee established for a fiscal year under
subsection (c)(5) for each biosimilar biological
product that--
``(i) is identified in such a biosimilar
biological product application approved as of
October 1 of such fiscal year; and
``(ii) as of October 1 of such fiscal year,
does not appear on a list, developed and
maintained by the Secretary, of discontinued
biosimilar biological products.
``(B) Due date.--The biosimilar biological product
program fee for a fiscal year shall be due on the later
of--
``(i) the first business day on or after
October 1 of each such year; or
``(ii) the first business day after the
enactment of an appropriations Act providing
for the collection and obligation of fees for
such year under this section.
``(C) One fee per product per year.--The biosimilar
biological product program fee shall be paid only once
for each product for each fiscal year.
``(D) Limitation.--A person who is named as the
applicant in a biosimilar biological product
application shall not be assessed more than 5
biosimilar biological product program fees for a fiscal
year for biosimilar biological products identified in
such biosimilar biological product application.''.
(b) Fee Revenue Amounts.--Subsection (b) of section 744H of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended to
read as follows:
``(b) Fee Revenue Amounts.--
``(1) Fiscal year 2018.--For fiscal year 2018, fees under
subsection (a) shall be established to generate a total revenue
amount equal to the sum of--
``(A) $45,000,000; and
``(B) the dollar amount equal to the fiscal year
2018 adjustment (as determined under subsection
(c)(4)).
``(2) Subsequent fiscal years.--For each of the fiscal
years 2019 through 2022, fees under subsection (a) shall,
except as provided in subsection (c), be established to
generate a total revenue amount equal to the sum of--
``(A) the annual base revenue for the fiscal year
(as determined under paragraph (4));
``(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined under
subsection (c)(1));
``(C) the dollar amount equal to the capacity
planning adjustment for the fiscal year (as determined
under subsection (c)(2)); and
``(D) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if applicable
(as determined under subsection (c)(3)).
``(3) Allocation of revenue amount among fees; limitations
on fee amounts.--
``(A) Allocation.--The Secretary shall determine
the percentage of the total revenue amount for a fiscal
year to be derived from, respectively--
``(i) initial and annual biosimilar
development fees and reactivation fees under
subsection (a)(1);
``(ii) biosimilar biological product
application fees under subsection (a)(2); and
``(iii) biosimilar biological product
program fees under subsection (a)(3).
``(B) Limitations on fee amounts.--Until the first
fiscal year for which the capacity planning adjustment
under subsection (c)(2) is effective, the amount of any
fee under subsection (a) for a fiscal year after fiscal
year 2018 shall not exceed 125 percent of the amount of
such fee for fiscal year 2018.
``(C) Biosimilar biological product development
fees.--The initial biosimilar biological product
development fee under subsection (a)(1)(A) for a fiscal
year shall be equal to the annual biosimilar biological
product development fee under subsection (a)(1)(B) for
that fiscal year.
``(D) Reactivation fee.--The reactivation fee under
subsection (a)(1)(D) for a fiscal year shall be equal
to twice the amount of the annual biosimilar biological
product development fee under subsection (a)(1)(B) for
that fiscal year.
``(4) Annual base revenue.--For purposes of paragraph (2),
the dollar amount of the annual base revenue for a fiscal year
shall be the dollar amount of the total revenue amount for the
previous fiscal year, excluding any adjustments to such revenue
amount under subsection (c)(3).''.
(c) Adjustments; Annual Fee Setting.--Section 744H of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended--
(1) by redesignating subsections (c) through (h) as
subsections (d) through (i), respectively;
(2) in subsections (a)(2)(F) and (g), by striking
``subsection (c)'' and inserting ``subsection (d)'';
(3) in subsection (a)(4)(A), by striking ``subsection
(b)(1)(F)'' and inserting ``subsection (c)(5)''; and
(4) by inserting after subsection (b) the following:
``(c) Adjustments; Annual Fee Setting.--
``(1) Inflation adjustment.--
``(A) In general.--For purposes of subsection
(b)(2)(B), the dollar amount of the inflation
adjustment to the annual base revenue for each fiscal
year shall be equal to the product of--
``(i) such annual base revenue for the
fiscal year under subsection (b); and
``(ii) the inflation adjustment percentage
under subparagraph (B).
``(B) Inflation adjustment percentage.--The
inflation adjustment percentage under this subparagraph
for a fiscal year is equal to the sum of--
``(i) the average annual percent change in
the cost, per full-time equivalent position of
the Food and Drug Administration, of all
personnel compensation and benefits paid with
respect to such positions for the first 3 years
of the preceding 4 fiscal years, multiplied by
the proportion of personnel compensation and
benefits costs to total costs of the process
for the review of biosimilar biological product
applications (as defined in section 744G(13))
for the first 3 years of the preceding 4 fiscal
years; and
``(ii) the average annual percent change
that occurred in the Consumer Price Index for
urban consumers (Washington-Baltimore, DC-MD-
VA-WV; Not Seasonally Adjusted; All items;
Annual Index) for the first 3 years of the
preceding 4 years of available data multiplied
by the proportion of all costs other than
personnel compensation and benefits costs to
total costs of the process for the review of
biosimilar biological product applications (as
defined in section 744G(13)) for the first 3
years of the preceding 4 fiscal years.
``(2) Capacity planning adjustment.--
``(A) In general.--Beginning with the fiscal year
described in subparagraph (B)(ii)(II), the Secretary
shall, in addition to the adjustment under paragraph
(1), further increase the fee revenue and fees under
this section for a fiscal year to reflect changes in
the resource capacity needs of the Secretary for the
process for the review of biosimilar biological product
applications.
``(B) Capacity planning methodology.--
``(i) Development; evaluation and report.--
The Secretary shall obtain, through a contract
with an independent accounting or consulting
firm, a report evaluating options and
recommendations for a new methodology to
accurately assess changes in the resource and
capacity needs of the process for the review of
biosimilar biological product applications. The
capacity planning methodological options and
recommendations presented in such report shall
utilize and be informed by personnel time
reporting data as an input. The report shall be
published for public comment not later than
September 30, 2020.
``(ii) Establishment and implementation.--
After review of the report described in clause
(i) and receipt and review of public comments
thereon, the Secretary shall establish a
capacity planning methodology for purposes of
this paragraph, which shall--
``(I) incorporate such approaches
and attributes as the Secretary
determines appropriate; and
``(II) be effective beginning with
the first fiscal year for which fees
are set after such capacity planning
methodology is established.
``(C) Limitation.--Under no circumstances shall an
adjustment under this paragraph result in fee revenue
for a fiscal year that is less than the sum of the
amounts under subsections (b)(2)(A) (the annual base
revenue for the fiscal year) and (b)(2)(B) (the dollar
amount of the inflation adjustment for the fiscal
year).
``(D) Publication in federal register.--The
Secretary shall publish in the Federal Register notice
under paragraph (5) the fee revenue and fees resulting
from the adjustment and the methodologies under this
paragraph.
``(3) Operating reserve adjustment.--
``(A) Interim application; fee reduction.--Until
the first fiscal year for which the capacity planning
adjustment under paragraph (2) is effective, the
Secretary may, in addition to the adjustment under
paragraph (1), reduce the fee revenue and fees under
this section for a fiscal year as the Secretary
determines appropriate for long-term financial planning
purposes.
``(B) General application and methodology.--
Beginning with the first fiscal year for which the
capacity planning adjustment under paragraph (2) is
effective, the Secretary may, in addition to the
adjustments under paragraphs (1) and (2)--
``(i) reduce the fee revenue and fees under
this section as the Secretary determines
appropriate for long-term financial planning
purposes; or
``(ii) increase the fee revenue and fees
under this section if such an adjustment is
necessary to provide for not more than 21 weeks
of operating reserves of carryover user fees
for the process for the review of biosimilar
biological product applications.
``(C) Federal register notice.--If an adjustment
under subparagraph (A) or (B) is made, the rationale
for the amount of the increase or decrease (as
applicable) in fee revenue and fees shall be contained
in the annual Federal Register notice under paragraph
(5) establishing fee revenue and fees for the fiscal
year involved.
``(4) Fiscal year 2018 adjustment.--
``(A) In general.--For fiscal year 2018, the
Secretary shall adjust the fee revenue and fees under
this section in such amount (if any) as needed to
reflect an updated assessment of the workload for the
process for the review of biosimilar biological product
applications.
``(B) Methodology.--The Secretary shall publish
under paragraph (5) a description of the methodology
used to calculate the fiscal year 2018 adjustment under
this paragraph in the Federal Register notice
establishing fee revenue and fees for fiscal year 2018.
``(C) Limitation.--No adjustment under this
paragraph shall result in an increase in fee revenue
and fees under this section in excess of $9,000,000.
``(5) Annual fee setting.--For fiscal year 2018 and each
subsequent fiscal year, the Secretary shall, not later than 60
days before the start of each such fiscal year--
``(A) establish, for the fiscal year, initial and
annual biosimilar biological product development fees
and reactivation fees under subsection (a)(1),
biosimilar biological product application fees under
subsection (a)(2), and biosimilar biological product
program fees under subsection (a)(3), based on the
revenue amounts established under subsection (b) and
the adjustments provided under this subsection; and
``(B) publish such fee revenue and fees in the
Federal Register.
``(6) Limit.--The total amount of fees assessed for a
fiscal year under this section may not exceed the total costs
for such fiscal year for the resources allocated for the
process for the review of biosimilar biological product
applications.''.
(d) Application Fee Waiver for Small Business.--Subsection (d)(1)
of section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-52), as redesignated by subsection (c)(1), is amended--
(1) by striking subparagraph (B);
(2) by striking ``shall pay--'' and all that follows
through ``application fees'' and inserting ``shall pay
application fees''; and
(3) by striking ``; and'' at the end and inserting a
period.
(e) Effect of Failure To Pay Fees.--Subsection (e) of section 744H
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), as
redesignated by subsection (c)(1), is amended by striking ``all fees''
and inserting ``all such fees''.
(f) Crediting and Availability of Fees.--Subsection (f) of section
744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52),
as redesignated by subsection (c)(1), is amended--
(1) in paragraph (2)--
(A) by striking subparagraph (C) (relating to fee
collection during first program year) and inserting the
following:
``(C) Compliance.--The Secretary shall be
considered to have met the requirements of subparagraph
(B) in any fiscal year if the costs described in such
subparagraph are not more than 15 percent below the
level specified in such subparagraph.''; and
(B) in subparagraph (D)--
(i) in the heading, by striking ``in
subsequent years''; and
(ii) by striking ``(after fiscal year
2013)''; and
(2) in paragraph (3), by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.
SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-53) is amended--
(1) in subsection (a)--
(A) by striking ``2013'' and inserting ``2018'';
and
(B) by striking ``Biosimilar User Fee Act of 2012''
and inserting ``Biosimilar User Fee Amendments of
2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018'';
(3) by striking subsection (d);
(4) by redesignating subsection (e) as subsection (d); and
(5) in subsection (d), as so redesignated, by striking
``2017'' each place it appears and inserting ``2022''.
SEC. 405. SUNSET DATES.
(a) Authorization.--Sections 744G and 744H of the Federal Food,
Drug, and Cosmetic Act, as amended by section 403 of this Act, shall
cease to be effective October 1, 2022.
(b) Reporting Requirements.--Section 744I of the Federal Food,
Drug, and Cosmetic Act, as amended by section 404 of this Act, shall
cease to be effective January 31, 2023.
(c) Previous Sunset Provision.--
(1) In general.--Effective October 1, 2017, section 404 of
the Food and Drug Administration Safety and Innovation Act
(Public Law 112-144) is repealed.
(2) Conforming amendment.--The Food and Drug Administration
Safety and Innovation Act (Public Law 112-144) is amended in
the table of contents in section 2 by striking the item
relating to section 404.
SEC. 406. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, or the date of the enactment of this Act, whichever is later,
except that fees under part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act shall be assessed for all
biosimilar biological product applications received on or after October
1, 2017, regardless of the date of the enactment of this Act.
SEC. 407. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 8 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act, as in effect on the day before the date of the enactment of this
title, shall continue to be in effect with respect to biosimilar
biological product applications and supplements (as defined in such
part as of such day) that were accepted by the Food and Drug
Administration for filing on or after October 1, 2012, but before
October 1, 2017, with respect to assessing and collecting any fee
required by such part for a fiscal year prior to fiscal year 2018.
TITLE V--REAUTHORIZATION OF OTHER PROGRAMS
SEC. 501. REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF
CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.
Section 505(u)(4) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(u)(4)) is amended by striking ``2017'' and inserting
``2022''.
SEC. 502. REAUTHORIZATION OF PEDIATRIC HUMANITARIAN DEVICE EXCEPTIONS.
Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking ``2017'' and
inserting ``2022''.
SEC. 503. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE
PARTNERSHIPS.
Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-5(f)) is amended by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.
SEC. 504. REAUTHORIZATION OF PEDIATRIC DEVICE CONSORTIA.
Section 305(e) of Pediatric Medical Device Safety and Improvement
Act of 2007 (Public Law 110-85; 42 U.S.C. 282 note) is amended by
striking ``2013 through 2017'' and inserting ``2018 through 2022''.
SEC. 505. REAUTHORIZATION OF ORPHAN GRANTS PROGRAM.
Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended
by striking ``2013 through 2017'' and inserting ``2018 through 2022''.
SEC. 506. REAUTHORIZATION OF INSPECTION PROGRAM.
Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 374(g)(11)) is amended by striking ``October 1, 2017'' and
inserting ``October 1, 2022''.
SEC. 507. REAUTHORIZATION OF PEDIATRIC STUDY OF DRUGS.
Section 409I(e)(1) of the Public Health Service Act (42 U.S.C.
284m(e)(1)) is amended by striking ``2013 through 2017'' and inserting
``2018 through 2022''.
TITLE VI--ADDITIONAL PROVISIONS
SEC. 601. TECHNICAL CORRECTIONS.
(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) 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.
(f) Section 515B(f)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e-3(f)(2)), as redesignated by subsection (d)(2) of this
section, is amended by striking ``a proposed guidance'' and inserting
``a draft version of that guidance''.
(g) 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''.
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