[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2430 Placed on Calendar Senate (PCS)]
<DOC>
Calendar No. 174
115th CONGRESS
1st Session
H. R. 2430
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 13, 2017
Received; read the first time
July 17, 2017
Read the second time and placed on the calendar
_______________________________________________________________________
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user-fee programs for prescription drugs, medical devices, generic
drugs, and biosimilar biological products, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``FDA Reauthorization Act of 2017''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--FEES RELATING TO DRUGS
Sec. 101. Short title; finding.
Sec. 102. Authority to assess and use drug fees.
Sec. 103. Reauthorization; reporting requirements.
Sec. 104. Sunset dates.
Sec. 105. Effective date.
Sec. 106. Savings clause.
TITLE II--FEES RELATING TO DEVICES
Sec. 201. Short title; finding.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Conformity assessment pilot program.
Sec. 206. Reauthorization of review.
Sec. 207. Electronic format for submissions.
Sec. 208. Savings clause.
Sec. 209. Effective date.
Sec. 210. Sunset dates.
TITLE III--FEES RELATING TO GENERIC DRUGS
Sec. 301. Short title; finding.
Sec. 302. Definitions.
Sec. 303. Authority to assess and use human generic drug fees.
Sec. 304. Reauthorization; reporting requirements.
Sec. 305. Sunset dates.
Sec. 306. Effective date.
Sec. 307. Savings clause.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Sec. 401. Short title; finding.
Sec. 402. Definitions.
Sec. 403. Authority to assess and use biosimilar fees.
Sec. 404. Reauthorization; reporting requirements.
Sec. 405. Sunset dates.
Sec. 406. Effective date.
Sec. 407. Savings clause.
TITLE V--PEDIATRIC DRUGS AND DEVICES
Sec. 501. Best pharmaceuticals for children.
Sec. 502. Pediatric devices.
Sec. 503. Early meeting on pediatric study plan.
Sec. 504. Development of drugs and biological products for pediatric
cancers.
Sec. 505. Additional provisions on development of drugs and biological
products for pediatric use.
TITLE VI--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS
Sec. 601. Reauthorization of provision relating to exclusivity of
certain drugs containing single
enantiomers.
Sec. 602. Reauthorization of the critical path public-private
partnerships.
Sec. 603. Reauthorization of orphan grants program.
Sec. 604. Protecting and strengthening the drug supply chain.
Sec. 605. Patient experience data.
Sec. 606. Communication plans.
Sec. 607. Orphan drugs.
Sec. 608. Pediatric information added to labeling.
Sec. 609. Sense of Congress on lowering the cost of prescription drugs.
Sec. 610. Expanded access.
Sec. 611. Tropical disease product application.
TITLE VII--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS
Sec. 701. Risk-based inspections for devices.
Sec. 702. Improvements to inspections process for device
establishments.
Sec. 703. Reauthorization of inspection program.
Sec. 704. Certificates to foreign governments for devices.
Sec. 705. Facilitating international harmonization.
Sec. 706. Fostering innovation in medical imaging.
Sec. 707. Risk-based classification of accessories.
Sec. 708. Device pilot projects.
Sec. 709. Regulation of over-the-counter hearing aids.
Sec. 710. Report on servicing of devices.
TITLE VIII--IMPROVING GENERIC DRUG ACCESS
Sec. 801. Priority review of generic drugs.
Sec. 802. Enhancing regulatory transparency to enhance generic
competition.
Sec. 803. Competitive generic therapies.
Sec. 804. Accurate information about drugs with limited competition.
Sec. 805. Suitability petitions.
Sec. 806. Inspections.
Sec. 807. Reporting on pending generic drug applications and priority
review applications.
Sec. 808. Incentivizing competitive generic drug development.
Sec. 809. GAO study of issues regarding first cycle approvals of
generic medicines.
TITLE IX--ADDITIONAL PROVISIONS
Sec. 901. Technical corrections.
Sec. 902. Annual report on inspections.
Sec. 903. Streamlining and improving consistency in performance
reporting.
Sec. 904. Analysis of use of funds.
Sec. 905. Facilities management.
TITLE I--FEES RELATING TO DRUGS
SEC. 101. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Prescription
Drug User Fee Amendments of 2017''.
(b) Finding.--The Congress finds that the fees authorized by the
amendments made in this title will be dedicated toward 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.
``(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''.
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; FINDING.
(a) Short Title.--This title may be cited as the ``Medical Device
User Fee Amendments of 2017''.
(b) Finding.--The Congress finds that the fees authorized under the
amendments made by this title will be dedicated toward expediting the
process for the review of device applications and for assuring the
safety and effectiveness of devices, as set forth in the goals
identified for purposes of part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act in the letters from the Secretary
of Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the Chairman
of the Committee on Energy and Commerce of the House of
Representatives, as set forth in the Congressional Record.
SEC. 202. DEFINITIONS.
(a) In General.--Section 737 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379i) is amended--
(1) by redesignating paragraphs (8) through (13) as
paragraphs (9) through (14), respectively;
(2) by inserting after paragraph (7) the following new
paragraph:
``(8) The term `de novo classification request' means a
request made under section 513(f)(2)(A) with respect to the
classification of a device.'';
(3) in subparagraph (D) of paragraph (10) (as redesignated
by paragraph (1)), by striking ``and submissions'' and
inserting ``submissions, and de novo classification requests'';
and
(4) in paragraph (11) (as redesignated by paragraph (1)),
by striking ``2011'' and inserting ``2016''.
(b) Conforming Amendment.--Section 714(b)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379d-3(b)(1)) is amended by striking
``737(8)'' and inserting ``737(9)''.
SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.
(a) Types of Fees.--Section 738(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(a)) is amended--
(1) in paragraph (1), by striking ``fiscal year 2013'' and
inserting ``fiscal year 2018''; and
(2) in paragraph (2)--
(A) in subparagraph (A)--
(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).
SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Reports.--Section 738A(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-1(a)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) by striking ``2013'' and inserting
``2018''; and
(ii) by striking ``the Medical Device User
Fee Amendments of 2012'' and inserting ``the
Medical Device User Fee Amendments of 2017'';
and
(B) in subparagraph (B), by striking ``the Medical
Device User Fee Amendments Act of 2012'' and inserting
``the Medical Device User Fee Amendments of 2017''; and
(2) in paragraph (2), by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.
(b) Reauthorization.--Section 738A(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--
(1) in paragraph (1), by striking ``2017'' and inserting
``2022''; and
(2) in paragraph (5), by striking ``2017'' and inserting
``2022''.
SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.
(a) In General.--Section 514 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360d) is amended by adding at the end the
following:
``(d) Pilot Accreditation Scheme for Conformity Assessment.--
``(1) In general.--The Secretary shall establish a pilot
program under which--
``(A) testing laboratories may be accredited, by
accreditation bodies meeting criteria specified by the
Secretary, to assess the conformance of a device with
certain standards recognized under this section; and
``(B) subject to paragraph (2), determinations by
testing laboratories so accredited that a device
conforms with such standard or standards shall be
accepted by the Secretary for purposes of demonstrating
such conformity under this section unless the Secretary
finds that a particular such determination shall not be
so accepted.
``(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.''.
SEC. 206. REAUTHORIZATION OF REVIEW.
Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360m) is amended--
(1) in subsection (a)(3)--
(A) in subparagraph (A), by striking clauses (ii)
and (iii) and inserting the following:
``(ii) a device classified under section
513(f)(2) or designated under section 515C(d);
``(iii) a device that is intended to be
permanently implantable, life sustaining, or
life supporting, unless otherwise determined by
the Secretary in accordance with subparagraph
(B)(i)(II) and listed as eligible for review
under subparagraph (B)(iii); or
``(iv) a device that is of a type, or
subset of a type, listed as not eligible for
review under 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''.
SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS.
Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379k-1(b)) is amended by adding at the end the following new
paragraph:
``(3) Presubmissions and submissions solely in electronic
format.--
``(A) In general.--Beginning on such date as the
Secretary specifies in final guidance issued under
subparagraph (C), presubmissions and submissions for
devices described in paragraph (1) (and any appeals of
action taken by the Secretary with respect to such
presubmissions or submissions) shall be submitted
solely in such electronic format as specified by the
Secretary in such guidance.
``(B) Draft guidance.--The Secretary shall, not
later than October 1, 2019, issue draft guidance
providing for--
``(i) any further standards for the
submission by electronic format required under
subparagraph (A);
``(ii) a timetable for the establishment by
the Secretary of such further standards; and
``(iii) criteria for waivers of and
exemptions from the requirements of this
subsection.
``(C) Final guidance.--The Secretary shall, not
later than 1 year after the close of the public comment
period on the draft guidance issued under subparagraph
(B), issue final guidance.''.
SEC. 208. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 3 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379i et seq.), as in effect on the day before the date of
the enactment of this title, shall continue to be in effect with
respect to the submissions listed in section 738(a)(2)(A) of such Act
(as defined in such part as of such day) that on or after October 1,
2012, but before October 1, 2017, were accepted by the Food and Drug
Administration for filing with respect to assessing and collecting any
fee required by such part for a fiscal year prior to fiscal year 2018.
SEC. 209. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, or the date of the enactment of this Act, whichever is later,
except that fees under part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act shall be assessed for all
submissions listed in section 738(a)(2)(A) of such Act received on or
after October 1, 2017, regardless of the date of the enactment of this
Act.
SEC. 210. SUNSET DATES.
(a) Authorization.--Sections 737 and 738 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be effective
October 1, 2022.
(b) Reporting Requirements.--Section 738A (21 U.S.C. 739j-1) of the
Federal Food, Drug, and Cosmetic Act (regarding reauthorization and
reporting requirements) shall cease to be effective January 31, 2023.
(c) Previous Sunset Provision.--Effective October 1, 2017, section
207(a) of the Food and Drug Administration Safety and Innovation Act
(Public Law 112-144) is repealed.
TITLE III--FEES RELATING TO GENERIC DRUGS
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. 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.''.
SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-43) is amended--
(1) in subsection (a)--
(A) by striking ``2013'' and inserting ``2018'';
and
(B) by striking ``Generic Drug User Fee Amendments
of 2012'' and inserting ``Generic Drug User Fee
Amendments of 2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018''; and
(3) in subsection (d), by striking ``2017'' each place it
appears and inserting ``2022''.
SEC. 305. SUNSET DATES.
(a) Authorization.--Sections 744A and 744B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-41; 379j-42) shall cease to be
effective October 1, 2022.
(b) Reporting Requirements.--Section 744C of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-43) shall cease to be effective
January 31, 2023.
(c) Previous Sunset Provision.--
(1) In general.--Effective October 1, 2017, section 304 of
the Food and Drug Administration Safety and Innovation Act
(Public Law 112-144) is repealed.
(2) Conforming amendment.--The Food and Drug Administration
Safety and Innovation Act (Public Law 112-144) is amended in
the table of contents in section 2 by striking the item
relating to section 304.
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 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.
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) 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 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''.
SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-53) is amended--
(1) in subsection (a)--
(A) by striking ``2013'' and inserting ``2018'';
and
(B) by striking ``Biosimilar User Fee Act of 2012''
and inserting ``Biosimilar User Fee Amendments of
2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018'';
(3) by striking subsection (d);
(4) by redesignating subsection (e) as subsection (d); and
(5) in subsection (d), as so redesignated, by striking
``2017'' each place it appears and inserting ``2022''.
SEC. 405. SUNSET DATES.
(a) Authorization.--Sections 744G and 744H of the Federal Food,
Drug, and Cosmetic Act shall cease to be effective October 1, 2022.
(b) Reporting Requirements.--Section 744I of the Federal Food,
Drug, and Cosmetic Act shall cease to be effective January 31, 2023.
(c) Previous Sunset Provision.--
(1) In general.--Effective October 1, 2017, section 404 of
the Food and Drug Administration Safety and Innovation Act
(Public Law 112-144) is repealed.
(2) Conforming amendment.--The Food and Drug Administration
Safety and Innovation Act (Public Law 112-144) is amended in
the table of contents in section 2 by striking the item
relating to section 404.
SEC. 406. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, or the date of the enactment of this Act, whichever is later,
except that fees under part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act shall be assessed for all
biosimilar biological product applications received on or after October
1, 2017, regardless of the date of the enactment of this Act.
SEC. 407. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 8 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act, as in effect on the day before the date of the enactment of this
title, shall continue to be in effect with respect to biosimilar
biological product applications and supplements (as defined in such
part as of such day) that were accepted by the Food and Drug
Administration for filing on or after October 1, 2012, but before
October 1, 2017, with respect to assessing and collecting any fee
required by such part for a fiscal year prior to fiscal year 2018.
TITLE V--PEDIATRIC DRUGS AND DEVICES
SEC. 501. BEST PHARMACEUTICALS FOR CHILDREN.
Section 409I of the Public Health Service Act (42 U.S.C. 284m) is
amended--
(1) in subsection (a)(2)(A)(ii), by inserting ``and
identification of biomarkers for such diseases, disorders, or
conditions,'' after ``biologics,'';
(2) in subsection (c)--
(A) in paragraph (6)--
(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''.
SEC. 502. PEDIATRIC DEVICES.
(a) Pediatric Use of Devices.--Section 515A(a)(3) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360e-1(a)(3)) is amended--
(1) by redesignating subparagraphs (B) through (D) as
subparagraphs (D) through (F), respectively;
(2) by inserting after subparagraph (A) the following:
``(B) any information, based on a review of data
available to the Secretary, regarding devices used in
pediatric patients but not labeled for such use for
which the Secretary determines that approved pediatric
labeling could confer a benefit to pediatric patients;
``(C) the number of pediatric devices that receive
a humanitarian use exemption under section 520(m);'';
(3) in subparagraph (E), as so redesignated, by striking
``; and'' and inserting ``;'';
(4) in subparagraph (F) (as so redesignated), by striking
``(B), and (C).'' and inserting ``(C), (D), and (E);''; and
(5) by adding at the end the following:
``(G) the number of devices for which the Secretary
relied on data with respect to adults to support a
determination of a reasonable assurance of safety and
effectiveness in pediatric patients; and
``(H) the number of devices for which the Secretary
relied on data from one pediatric subpopulation to
support a determination of a reasonable assurance of
safety and effectiveness in another pediatric
subpopulation.
For the items described in this paragraph, such report shall
disaggregate the number of devices by pediatric
subpopulation.''.
(b) Humanitarian Device Exemption.--Section 520(m) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is amended--
(1) in paragraph (4)--
(A) in subparagraph (B), by inserting ``or an
appropriate local committee'' after ``review
committee'' each place such term appears; and
(B) in the matter following subparagraph (B), by
inserting ``or an appropriate local committee'' after
``review committee'' each place such term appears; and
(2) in paragraph (6)(A)(iv), by striking ``2017'' and
inserting ``2022''.
(c) Demonstration Grants for Improving Pediatric Availability.--
Section 305 of the Pediatric Medical Device Safety and Improvement Act
of 2007 (Public Law 110-85; 42 U.S.C. 282 note)) is amended--
(1) in subsection (c)--
(A) in paragraph (4), by striking ``and'' at the
end;
(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.
SEC. 503. EARLY MEETING ON PEDIATRIC STUDY PLAN.
(a) In General.--Clause (i) of section 505B(e)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(2)(C)) is amended to
read as follows:
``(i) shall meet with the applicant--
``(I) if requested by the applicant
with respect to a drug or biological
product that is intended to treat a
serious or life-threatening disease or
condition, to discuss preparation of
the initial 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)''.
SEC. 504. DEVELOPMENT OF DRUGS AND BIOLOGICAL PRODUCTS FOR PEDIATRIC
CANCERS.
(a) Molecular Targets Regarding Cancer Drugs and Biological
Products.--Section 505B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by redesignating subparagraphs (A) and
(B) as clauses (i) and (ii), respectively, and
adjusting the margins accordingly;
(ii) by striking ``A person'' and inserting
the following:
``(A) General requirements.--Except with respect to
an application for which subparagraph (B) applies, a
person'';
(iii) in clause (i), as so redesignated, by
striking ``, or'' at the end and inserting ``;
or''; and
(iv) by adding after subparagraph (A), as
so designated by clause (ii), the following:
``(B) Certain molecularly targeted cancer
indications.--A person that submits, on or after the
date that is 3 years after the date of enactment of the
FDA Reauthorization Act of 2017, an original
application for a new active ingredient under section
505 of this Act or section 351 of the Public Health
Service Act, shall submit with the application reports
on the investigation described in paragraph (3) if the
drug or biological product that is the subject of the
application is--
``(i) intended for the treatment of an
adult cancer; and
``(ii) directed at a molecular target that
the Secretary determines to be substantially
relevant to the growth or progression of a
pediatric cancer.'';
(B) in paragraph (2)(A), by striking ``paragraph
(1)'' and inserting ``paragraph (1)(A)'';
(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.
SEC. 505. ADDITIONAL PROVISIONS ON DEVELOPMENT OF DRUGS AND BIOLOGICAL
PRODUCTS FOR PEDIATRIC USE.
(a) Informing Internal Review Committee.--Section 505A(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(f)) is amended by
adding at the end the following:
``(7) Informing internal review committee.--The 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.''
TITLE VI--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS
SEC. 601. REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF
CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.
Section 505(u)(4) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(u)(4)) is amended by striking ``2017'' and inserting
``2022''.
SEC. 602. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE
PARTNERSHIPS.
Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-5(f)) is amended by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.
SEC. 603. REAUTHORIZATION OF ORPHAN GRANTS PROGRAM.
Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended
by striking ``2013 through 2017'' and inserting ``2018 through 2022''.
SEC. 604. PROTECTING AND STRENGTHENING THE DRUG SUPPLY CHAIN.
(a) Diverted Drugs.--Paragraph (1) of section 801(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is amended--
(1) by striking ``(d)(1) Except as'' and inserting
``(d)(1)(A) Except as''; and
(2) by adding at the end the following:
``(B) Except as authorized by the Secretary in the case of a drug
that appears on the drug shortage list under section 506E or in the
case of importation pursuant to section 804, no drug that is subject to
section 503(b)(1) may be imported into the United States for commercial
use if such drug is manufactured outside the United States, unless the
manufacturer has authorized the drug to be marketed in the United
States and has caused the drug to be labeled to be marketed in the
United States.''.
(b) Counterfeit Drugs.--Subsection (b) of section 303 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by
adding at the end the following:
``(8) Notwithstanding subsection (a), any person who violates
section 301(i)(3) by knowingly making, selling or dispensing, or
holding for sale or dispensing, a counterfeit drug shall be imprisoned
for not more than 10 years or fined in accordance with title 18, United
States Code, or both.''.
SEC. 605. PATIENT EXPERIENCE DATA.
Section 569C(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb-8c(c)(2)(A)) is amended by striking ``impact of such
disease or condition, or a related therapy,'' and inserting ``impact
(including physical and psychosocial impacts) of such disease or
condition, or a related therapy or clinical investigation''.
SEC. 606. COMMUNICATION PLANS.
Section 505-1(e)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355-1(e)(3)) is amended--
(1) in subparagraph (B), by striking ``; or'';
(2) in subparagraph (C), by striking the period and
inserting ``; or''; and
(3) by adding at the end the following:
``(D) disseminating information to health care
providers about drug formulations or properties,
including information about the limitations or patient
care implications of such formulations or properties,
and how such formulations or properties may be related
to serious adverse drug events associated with use of
the drug.''.
SEC. 607. ORPHAN DRUGS.
(a) In General.--Section 527 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360cc) is amended--
(1) in subsection (a), in the matter following paragraph
(2), by striking ``such drug for such disease or condition''
and inserting ``the same drug for the same disease or
condition'';
(2) in subsection (b)--
(A) in the matter preceding paragraph (1), by
striking ``If an application'' and all that follows
through ``such license if'' and inserting ``During the
7-year period described in subsection (a) for an
approved application under section 505 or license under
section 351 of the Public Health Service Act, the
Secretary may approve an application or issue a license
for a drug that is otherwise the same, as determined by
the Secretary, as the already approved drug for the
same rare disease or condition if'';
(B) in paragraph (1), by striking ``notice'' and
all that follows through ``assure'' and inserting ``of
exclusive approval or licensure notice and opportunity
for the submission of views, that during such period
the holder of the exclusive approval or licensure
cannot ensure''; and
(C) in paragraph (2), by striking ``such holder
provides'' and inserting ``the holder provides''; and
(3) by adding at the end the following:
``(c) Condition of Clinical Superiority.--
``(1) In general.--If a sponsor of a drug that is
designated under section 526 and is otherwise the same, as
determined by the Secretary, as an already approved or licensed
drug is seeking exclusive approval or exclusive licensure
described in subsection (a) for the same rare disease or
condition as the already approved drug, the Secretary shall
require such sponsor, as a condition of such exclusive approval
or licensure, to demonstrate that such drug is clinically
superior to any already approved or licensed drug that is the
same drug.
``(2) Definition.--For purposes of paragraph (1), the term
`clinically superior' with respect to a drug means that the
drug provides a significant therapeutic advantage over and
above an already approved or licensed drug in terms of greater
efficacy, greater safety, or by providing a major contribution
to patient care.
``(d) Regulations.--The Secretary may promulgate regulations for
the implementation of subsection (c). Beginning on the date of
enactment of the FDA Reauthorization Act of 2017, until such time as
the Secretary promulgates regulations in accordance with this
subsection, the Secretary may apply any definitions set forth in
regulations that were promulgated prior to such date of enactment, to
the extent such definitions are not inconsistent with the terms of this
section, as amended by such Act.
``(e) Demonstration of Clinical Superiority Standard.--To assist
sponsors in demonstrating clinical superiority as described in
subsection (c), the Secretary--
``(1) upon the designation of any drug under section 526,
shall notify the sponsor of such drug in writing of the basis
for the designation, including, as applicable, any plausible
hypothesis offered by the sponsor and relied upon by the
Secretary that the drug is clinically superior to a previously
approved drug; and
``(2) upon granting exclusive approval or licensure under
subsection (a) on the basis of a demonstration of clinical
superiority as described in subsection (c), shall publish a
summary of the clinical superiority findings.''.
(b) Rule of Construction.--Nothing in the amendments made by
subsection (a) shall affect any determination under sections 526 and
527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb,
360cc) made prior to the date of enactment of the FDA Reauthorization
Act of 2017.
SEC. 608. PEDIATRIC INFORMATION ADDED TO LABELING.
Section 505A(o) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a(o)) is amended--
(1) in the subsection heading, by striking ``under section
505(j)'';
(2) in paragraph (1)--
(A) by striking ``under section 505(j)'' and
inserting ``under subsection (b)(2) or (j) of section
505''; and
(B) by striking ``or by exclusivity under clause
(iii) or (iv) of section 505(j)(5)(F)'' and inserting
``, or by exclusivity under clause (iii) or (iv) of
section 505(j)(5)(F), clause (iii) or (iv) of section
505(c)(3)(E), or section 527(a), or by an extension of
such exclusivity under this section or section 505E'';
(3) in paragraph (2), in the matter preceding subparagraph
(A)--
(A) by inserting ``clauses (iii) and (iv) of
section 505(c)(3)(E), or section 527,'' after ``section
505(j)(5)(F),''; and
(B) by striking ``drug approved under section
505(j)'' and inserting ``drug approved pursuant to an
application submitted under subsection (b)(2) or (j) of
section 505''; and
(4) by amending paragraph (3) to read as follows:
``(3) Preservation of pediatric exclusivity and
extensions.--This subsection does not affect--
``(A) the availability or scope of exclusivity
under--
``(i) this section;
``(ii) section 505 for pediatric
formulations; or
``(iii) section 527;
``(B) the availability or scope of an extension to
any such exclusivity, including an extension under this
section or section 505E;
``(C) the question of the eligibility for approval
under section 505 of any application described in
subsection (b)(2) or (j) of such section that omits any
other aspect of labeling protected by exclusivity
under--
``(i) clause (iii) or (iv) of section
505(j)(5)(F);
``(ii) clause (iii) or (iv) of section
505(c)(3)(E); or
``(iii) section 527(a); or
``(D) except as expressly provided in paragraphs
(1) and (2), the operation of section 505 or section
527.''.
SEC. 609. SENSE OF CONGRESS ON LOWERING THE COST OF PRESCRIPTION DRUGS.
It is the sense of the Congress that the Secretary of Health and
Human Services should commit to engaging with the House of
Representatives and the Senate to take administrative actions and enact
legislative changes that--
(1) will lower the cost of prescription drugs for consumers
and reduce the burden of such cost on taxpayers; and
(2) in lowering such cost, will--
(A) balance the need to encourage innovation with
the need to improve affordability; and
(B) strive to increase competition in the
pharmaceutical market, prevent anticompetitive
behavior, and promote the timely availability of
affordable, high-quality generic drugs and biosimilars.
SEC. 610. EXPANDED ACCESS.
(a) Patient Access to Investigational Drugs.--
(1) Public meeting.--
(A) In general.--The Secretary of Health and Human
Services (referred to in this section as the
``Secretary''), acting through the Commissioner of Food
and Drugs, in coordination with the Director of the
National Institutes of Health, and in consultation with
patients, health care providers, drug sponsors,
bioethicists, and other stakeholders, shall, not later
than 270 days after the date of enactment of this Act,
convene a public meeting to discuss clinical trial
inclusion and exclusion criteria to inform the guidance
under paragraph (3). The Secretary shall inform the
Comptroller General of the United States of the date
when the public meeting will take place.
(B) Topics.--The Secretary shall make available on
the internet website of the Food and Drug
Administration a report on the topics discussed at the
meeting described in subparagraph (A) within 90 days of
such meeting. Such topics shall include discussion of--
(i) the rationale for, and potential
barriers for patients created by, research
clinical trial inclusion and exclusion
criteria;
(ii) how appropriate patient populations
can benefit from the results of trials that
employ alternative designs;
(iii) barriers to participation in clinical
trials, including--
(I) information regarding any
potential risks and benefits of
participation;
(II) regulatory, geographical, and
socioeconomic barriers; and
(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.''.
SEC. 611. TROPICAL DISEASE PRODUCT APPLICATION.
(a) In General.--Subparagraph (A) of section 524(a)(4) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(4)) is
amended--
(1) in clause (i), by striking ``and'' at the end; and
(2) by adding at the end the following:
``(iii) that contains reports of one or
more new clinical investigations (other than
bioavailability studies) that are essential to
the approval of the application and conducted
or sponsored by the sponsor of such
application; and
``(iv) that contains an attestation from
the sponsor of the application that such
reports were not submitted as part of an
application for marketing approval or licensure
by a regulatory authority in India, Brazil,
Thailand, or any country that is a member of
the Pharmaceutical Inspection Convention or the
Pharmaceutical Inspection Cooperation Scheme
prior to September 27, 2007.''.
(b) Effective Date.--The amendments made by subsection (a) shall
apply to human drug applications submitted after September 30, 2017.
TITLE VII--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS
SEC. 701. RISK-BASED INSPECTIONS FOR DEVICES.
(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)''.
SEC. 702. IMPROVEMENTS TO INSPECTIONS PROCESS FOR DEVICE
ESTABLISHMENTS.
(a) In General.--Section 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374) is amended by adding at the end the
following:
``(h)(1) In the case of inspections other than for-cause
inspections, the Secretary shall review processes and standards
applicable to inspections of domestic and foreign device establishments
in effect as of the date of the enactment of this subsection, and
update such processes and standards through the adoption of uniform
processes and standards applicable to such inspections. Such uniform
processes and standards shall provide for--
``(A) exceptions to such processes and standards, as
appropriate;
``(B) announcing the inspection of the establishment within
a reasonable time before such inspection occurs, including by
providing to the owner, operator, or agent in charge of the
establishment a notification regarding the type and nature of
the inspection;
``(C) a reasonable estimate of the timeframe for the
inspection, an opportunity for advance communications between
the officers or employees carrying out the inspection under
subsection (a)(1) and the owner, operator, or agent in charge
of the establishment concerning appropriate working hours
during the inspection, and, to the extent feasible, advance
notice of some records that will be requested; and
``(D) regular communications during the inspection with the
owner, operator, or agent in charge of the establishment
regarding inspection status, which may be recorded by either
party with advance notice and mutual consent.
``(2)(A) The Secretary shall, with respect to a request described
in subparagraph (B), provide nonbinding feedback with respect to such
request not later than 45 days after the Secretary receives such
request.
``(B) A request described in this subparagraph is a request for
feedback--
``(i) that is made by the owner, operator, or agent in
charge of such establishment in a timely manner; and
``(ii) with respect to actions proposed to be taken by a
device establishment in a response to a report received by such
establishment pursuant to subsection (b) that involve a public
health priority, that implicate systemic or major actions, or
relate to emerging safety issues (as determined by the
Secretary).
``(3) Nothing in this subsection affects the authority of the
Secretary to conduct inspections otherwise permitted under this Act in
order to ensure compliance with this Act.''.
(b) Guidance.--
(1) Draft guidance.--Not later than 18 months after the
date of enactment of this Act, the Secretary of Health and
Human Services, acting through the Commissioner of Food and
Drugs, shall issue draft guidance that--
(A) specifies how the Food and Drug Administration
will implement the processes and standards described in
paragraph (1) of subsection (h) of section 704 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374),
as added by subsection (a), and the requirements
described in paragraph (2) of such subsection (h);
(B) provides for standardized methods for
communications described in such paragraphs;
(C) establishes, with respect to inspections of
both domestic and foreign device establishments (as
referred to in section 510(h)(2) of the Federal Food,
Drug, and Cosmetic Act, as amended by subsection (a)),
a standard timeframe for such inspections--
(i) that occurs over consecutive days; and
(ii) to which each investigator conducting
such an inspection shall adhere unless the
investigator identifies to the establishment
involved a reason that more time is needed to
conduct such investigation; and
(D) identifies practices for investigators and
device establishments to facilitate the continuity of
inspections of such establishments.
(2) Final guidance.--Not later than 1 year after providing
notice and opportunity for public comment on the draft guidance
issued under paragraph (1), the Secretary of Health and Human
Services shall issue final guidance to implement subsection (h)
of section 704 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 374), as added by subsection (a).
(c) Adulterated Devices.--Subsection (j) of section 501 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended by
inserting ``or device'' after ``drug''.
SEC. 703. REAUTHORIZATION OF INSPECTION PROGRAM.
Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 374(g)(11)) is amended by striking ``October 1, 2017'' and
inserting ``October 1, 2022''.
SEC. 704. CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES.
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.
SEC. 705. FACILITATING INTERNATIONAL HARMONIZATION.
Section 704(g) of the Federal Food, Drug and Cosmetic Act (21
U.S.C. 374) is amended by adding at the end the following:
``(15)(A) Notwithstanding any other provision of this subsection,
the Secretary may recognize auditing organizations that are recognized
by organizations established by governments to facilitate international
harmonization for purposes of conducting inspections of--
``(i) establishments that manufacture, prepare, propagate,
compound, or process devices (other than types of devices
licensed under section 351 of the Public Health Service Act),
as required under section 510(h); or
``(ii) establishments required to register pursuant to
section 510(i).
``(B) Nothing in this paragraph affects--
``(i) the authority of the Secretary to inspect any device
establishment pursuant to this Act; or
``(ii) the authority of the Secretary to determine the
official classification of an inspection.''.
SEC. 706. FOSTERING INNOVATION IN MEDICAL IMAGING.
(a) Approval of Applications for Certain Diagnostic 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).''.
SEC. 707. RISK-BASED CLASSIFICATION OF ACCESSORIES.
(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.
SEC. 708. DEVICE PILOT PROJECTS.
(a) Postmarket Pilot.--Section 519 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360i) is amended by adding at the end the
following:
``(i) 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.
SEC. 709. REGULATION OF OVER-THE-COUNTER HEARING AIDS.
(a) In General.--Section 520 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j), as amended by section 708, is further
amended by adding at the end the following:
``(q) Regulation of Over-the-Counter Hearing Aids.--
``(1) Definition.--
``(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)).
SEC. 710. REPORT ON SERVICING OF DEVICES.
(a) In General.--Not later than 270 days after the date of
enactment of this Act, the Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, shall post on the
internet website of the Food and Drug Administration a report on the
continued quality, safety, and effectiveness of devices (as defined in
section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(h))) with respect to servicing (as defined in subsection (c)).
(b) Contents.--The report submitted under subsection (a) shall
contain--
(1) the status of, and findings to date, with respect to,
the proposed rule entitled ``Refurbishing, Reconditioning,
Rebuilding, Remarketing, Remanufacturing, and Servicing of
Medical Devices Performed by Third-Party Entities and Original
Equipment Manufacturers; Request for Comments'' published in
the Federal Register by the Food and Drug Administration on
March 4, 2016 (81 Fed. Reg. 11477);
(2) information presented during the October 2016 public
workshop entitled ``Refurbishing, Reconditioning, Rebuilding,
Remarketing, Remanufacturing, and Servicing of Medical Devices
Performed by Third-Party Entities and Original Equipment
Manufacturers'';
(3) a description of the statutory and regulatory authority
of the Food and Drug Administration with respect to the
servicing of devices conducted by any entity, including
original equipment manufacturers and third party entities;
(4) details regarding how the Food and Drug Administration
currently regulates devices with respect to servicing to ensure
safety and effectiveness, how the agency could improve such
regulation using the authority described in paragraph (3), and
whether additional authority is recommended;
(5) information on actions the Food and Drug Administration
could take under the authority described in paragraphs (3) and
(4) to assess the servicing of devices, including the size,
scope, location, and composition of third party entities;
(6) information on actions the Food and Drug Administration
could take to track adverse events caused by servicing errors
performed by any entity, including original equipment
manufacturers and third party entities;
(7) information regarding the regulation by States, the
Joint Commission, or other regulatory bodies of device
servicing performed by any entity, including original equipment
manufacturers and third party entities; and
(8) any additional information determined by the Secretary
(acting through the Commissioner) to be relevant to ensuring
the quality, safety, and effectiveness of devices with respect
to servicing.
(c) Servicing Defined.--In this section, the term ``servicing''
includes, with respect to a device, refurbishing, reconditioning,
rebuilding, remarketing, repairing, remanufacturing, or other servicing
of the device.
TITLE VIII--IMPROVING GENERIC DRUG ACCESS
SEC. 801. PRIORITY REVIEW OF GENERIC DRUGS.
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)) is amended by adding at the end the following:
``(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.''.
SEC. 802. ENHANCING REGULATORY TRANSPARENCY TO ENHANCE GENERIC
COMPETITION.
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), as amended by section 801, is further amended by adding at
the end the following:
``(13) Upon the request of an applicant regarding one or more
specified pending applications under this subsection, the Secretary
shall, as appropriate, provide review status updates indicating the
categorical status of the applications by each relevant review
discipline.''.
SEC. 803. COMPETITIVE GENERIC THERAPIES.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506G
the following:
``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.
SEC. 804. ACCURATE INFORMATION ABOUT DRUGS WITH LIMITED COMPETITION.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351 et seq.) is amended by inserting after section 506H, as added by
section 803, the following:
``SEC. 506I. PROMPT REPORTS OF MARKETING STATUS.
``(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).''.
SEC. 805. SUITABILITY PETITIONS.
(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.
SEC. 806. INSPECTIONS.
Within 6 months of the date of enactment of this Act, the Secretary
of Health and Human Services shall develop and implement a protocol for
expediting review of timely responses to reports of observations from
an inspection under section 704 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 374). Such protocol shall--
(1) apply to responses to such reports pertaining to
applications submitted under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355)--
(A) for which the approval is dependent upon
remediation of conditions identified in the report;
(B) for which concerns related to observations from
an inspection under such section 704 are the only
barrier to approval; and
(C) where the drug that is the subject of the
application is a drug--
(i) for which there are not more than 3
other approved applications under section
505(j) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)) that reference the same
listed drug and for which there are less than 6
abbreviated new drug applications tentatively
approved; or
(ii) that is included on the list under
section 506E of such Act (21 U.S.C. 356e);
(2) address expedited re-inspection of facilities, as
appropriate; and
(3) establish a 6-month timeline for completion of review
of such responses to such reports.
SEC. 807. REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND PRIORITY
REVIEW APPLICATIONS.
Not later than 180 calendar days after the date of enactment of
this Act, and quarterly thereafter until October 1, 2022, the Secretary
of Health and Human Services shall post on the internet website of the
Food and Drug Administration a report that provides, with respect to
the months covered by the report--
(1) with respect to applications filed under section 505(j)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))
that, during the most recent calendar year, were subject to
priority review under paragraph (11) of such section 505(j) (as
added by section 801) or expedited development and review under
section 506H of the Federal Food, Drug, and Cosmetic Act (as
added by section 803), the numbers of such applications (with
denotation of such applications that were filed prior to
October 1, 2014) that are--
(A) awaiting action by the applicant;
(B) awaiting action by the Secretary; and
(C) approved by the Secretary;
(2) the number of applications filed under section 505(j)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))
and prior approval supplements withdrawn in each month;
(3) the mean and median approval and tentative approval
times and the number of review cycles for such applications;
(4) the number and type of meetings requested and held
under such section 506H (as added by section 803); and
(5) the number of such applications on which the Secretary
has taken action pursuant to subsection (c) of such section
506H (as added by section 803) and any effect such section 506H
may have on the length of time for approval of applications
under such section 505(j) and the number of review cycles for
such approvals.
SEC. 808. INCENTIVIZING COMPETITIVE GENERIC DRUG DEVELOPMENT.
Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(5)) is amended--
(1) in subparagraph (B), by adding at the end the
following:
``(v) 180-day exclusivity period for competitive generic
therapies.--
``(I) Effectiveness of application.--Subject to
subparagraph (D)(iv), if the application is for a drug
that is the same as a competitive generic therapy for
which any first approved applicant has commenced
commercial marketing, the application shall be made
effective on the date that is 180 days after the date
of the first commercial marketing of the competitive
generic therapy (including the commercial marketing of
the listed drug) by any first approved applicant.
``(II) Limitation.--The exclusivity period under
subclause (I) shall not apply with respect to a
competitive generic therapy that has previously
received an exclusivity period under subclause (I).
``(III) Definitions.--In this clause and
subparagraph (D)(iv):
``(aa) The term `competitive generic
therapy' means a drug--
``(AA) that is designated as a
competitive generic therapy under
section 506H; and
``(BB) for which there are no
unexpired patents or exclusivities on
the list of products described in
section 505(j)(7)(A) at the time of
submission.
``(bb) The term `first approved applicant'
means any applicant that has submitted an
application that--
``(AA) is for a competitive generic
therapy that is approved on the first
day on which any application for such
competitive generic therapy is
approved;
``(BB) is not eligible for a 180-
day exclusivity period under clause
(iv) for the drug that is the subject
of the application for the competitive
generic therapy; and
``(CC) is not for a drug for which
all drug versions have forfeited
eligibility for a 180-day 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.''.
SEC. 809. GAO STUDY OF ISSUES REGARDING FIRST CYCLE APPROVALS OF
GENERIC MEDICINES.
(a) Study by GAO.--The Comptroller General of the United States
shall conduct a study to determine the following:
(1) The rate of first cycle approvals and tentative
approvals for applications submitted under section 505(j) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))
during the period beginning on October 1, 2012, and ending on
September 30, 2017. The rate of first cycle approvals and
tentative approvals shall be determined and reported per each
GDUFA cohort year during this period.
(2) If the rate determined pursuant to paragraph (1) for
any GDUFA cohort year is lower than 20 percent, the reasons
contributing to the relatively low rate of first cycle
approvals and tentative approvals for generic drug applications
shall be itemized, assessed, and reported. In making the
assessment required by this paragraph, the Comptroller General
shall consider, among other things, the role played by--
(A) the Food and Drug Administration's
implementation of approval standards for generic drug
applications;
(B) the extent to which those approval standards
are communicated clearly to industry and applied
consistently during the review process;
(C) the procedures for reviewing generic drug
applications, including timelines for review activities
by the Food and Drug Administration;
(D) the extent to which those procedures are
followed consistently (and those timelines are met) by
the Food and Drug Administration;
(E) the processes and practices for communication
between the Food and Drug Administration and sponsors
of generic drug applications; and
(F) the completeness and quality of original
generic drug applications submitted to the Food and
Drug Administration.
(3) Taking into account the determinations made pursuant to
paragraphs (1) and (2) and any review process improvements
implemented pursuant to this Act, whether there are ways the
review process for generic drugs could be improved to increase
the rate of first cycle approvals and tentative approvals for
generic drug applications. In making this determination, the
Comptroller General shall consider, among other things, options
for increasing review efficiency and communication
effectiveness.
(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.
TITLE IX--ADDITIONAL PROVISIONS
SEC. 901. 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) 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''.
SEC. 902. ANNUAL REPORT ON INSPECTIONS.
Not later than March 1 of each year, the Secretary of Health and
Human Services shall post on the internet website of the Food and Drug
Administration information related to inspections of facilities
necessary for approval of a drug under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355), approval of a device under
section 515 of such Act (21 U.S.C. 360e), or clearance of a device
under section 510(k) of such Act (21 U.S.C. 360(k)) that were conducted
during the previous calendar year. Such information shall include the
following:
(1) The median time following a request from staff of the
Food and Drug Administration reviewing an application or report
to the beginning of the inspection, and the median time from
the beginning of an inspection to the issuance of a report
pursuant to section 704(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374(b)).
(2) The median time from the issuance of a report pursuant
to such section 704(b) to the sending of a warning letter,
issuance of an import alert, or holding of a regulatory meeting
for inspections for which the Secretary concluded that
regulatory or enforcement action was indicated.
(3) The median time from the sending of a warning letter,
issuance of an import alert, or holding of a regulatory meeting
to resolution of the regulatory or enforcement action indicated
for inspections for which the Secretary concluded that such
action was indicated.
(4) The number of times that a facility was issued a report
pursuant to such section 704(b) and approval of an application
was delayed due to the issuance of a withhold recommendation.
SEC. 903. STREAMLINING AND IMPROVING CONSISTENCY IN PERFORMANCE
REPORTING.
(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.''.
SEC. 904. ANALYSIS OF USE OF FUNDS.
(a) PDUFA Reports.--
(1) Analysis in pdufa performance reports.--Section 736B(a)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h-
2(a)), as amended by section 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.''.
SEC. 905. FACILITIES MANAGEMENT.
(a) Evaluation.--
(1) Study.--The Comptroller General of the United States
shall conduct a study on the expenses incurred by the Food and
Drug Administration related to facility maintenance and
renovation in fiscal years 2012 through 2019. The study under
this paragraph shall include the following:
(A) A review of purchases and expenses
differentiated by appropriated funds, and resources
authorized by the Food and Drug Administration Safety
and Innovation Act (Public Law 112-144) and this Act,
as applicable, that contributed to--
(i) the maintenance of scientific equipment
and any existing facility plan or plans to
maintain previously purchased scientific
equipment;
(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.''.
Passed the House of Representatives July 12, 2017.
Attest:
KAREN L. HAAS,
Clerk.
Calendar No. 174
115th CONGRESS
1st Session
H. R. 2430
_______________________________________________________________________
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.
_______________________________________________________________________
July 17, 2017
Read the second time and placed on the calendar