[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2430 Reported in House (RH)]
<DOC>
Union Calendar No. 138
115th CONGRESS
1st Session
H. R. 2430
[Report No. 115-201]
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user-fee programs for prescription drugs, medical devices, generic
drugs, and biosimilar biological products, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 16, 2017
Mr. Walden (for himself, Mr. Pallone, Mr. Burgess, and Mr. Gene Green
of Texas) introduced the following bill; which was referred to the
Committee on Energy and Commerce
July 11, 2017
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed
in italic]
[For text of introduced bill, see copy of bill as introduced on May 16,
2017]
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user-fee programs for prescription drugs, medical devices, generic
drugs, and biosimilar biological products, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``FDA Reauthorization Act of 2017''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--FEES RELATING TO DRUGS
Sec. 101. Short title; finding.
Sec. 102. Authority to assess and use drug fees.
Sec. 103. Reauthorization; reporting requirements.
Sec. 104. Sunset dates.
Sec. 105. Effective date.
Sec. 106. Savings clause.
TITLE II--FEES RELATING TO DEVICES
Sec. 201. Short title; findings.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Conformity assessment pilot program.
Sec. 206. Reauthorization of review.
Sec. 207. Electronic format for submissions.
Sec. 208. Savings clause.
Sec. 209. Effective date.
Sec. 210. Sunset clause.
TITLE III--FEES RELATING TO GENERIC DRUGS
Sec. 301. Short title; finding.
Sec. 302. Definitions.
Sec. 303. Authority to assess and use human generic drug fees.
Sec. 304. Reauthorization; reporting requirements.
Sec. 305. Sunset dates.
Sec. 306. Effective date.
Sec. 307. Savings clause.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Sec. 401. Short title; finding.
Sec. 402. Definitions.
Sec. 403. Authority to assess and use biosimilar fees.
Sec. 404. Reauthorization; reporting requirements.
Sec. 405. Sunset dates.
Sec. 406. Effective date.
Sec. 407. Savings clause.
TITLE V--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS
Sec. 501. Reauthorization of provision relating to exclusivity of
certain drugs containing single
enantiomers.
Sec. 502. Reauthorization of orphan grants program.
Sec. 503. Reauthorization of pediatric study of drugs.
Sec. 504. Protecting and strengthening the drug supply chain.
Sec. 505. Sense of Congress on lowering the cost of prescription drugs.
TITLE VI--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS
Subtitle A--Improving the Process for Inspections of Device
Establishments
Sec. 601. Risk-based inspections for devices.
Sec. 602. Recognition of foreign government inspections.
Sec. 603. Improvements to inspections process for device
establishments.
Sec. 604. Certificates to foreign governments for devices.
Sec. 605. Facilitating international harmonization.
Sec. 606. Reauthorization of inspection program.
Subtitle B--Other Provisions
Sec. 611. Reauthorization of pediatric humanitarian device exceptions.
Sec. 612. Reauthorization of pediatric device consortia.
Sec. 613. Regulation of over-the-counter hearing aids.
Sec. 614. Report on ensuring quality, safety, and continued
effectiveness of devices that have been
serviced.
Sec. 615. Device pilot projects to generate reliable and timely safety
and active surveillance data.
Sec. 616. Risk-based classification of accessories.
TITLE VII--GENERIC DRUG ACCESS AND COMPETITION
Sec. 701. Competitive Generic Therapies.
Sec. 702. Enhancing regulatory transparency To enhance generic
competition.
Sec. 703. Incentivizing competitive generic therapy development.
Sec. 704. Tropical disease product application.
Sec. 705. GAO study of issues regarding first cycle approvals of
generic medicines.
TITLE VIII--FOSTERING INNOVATION IN MEDICAL IMAGING
Sec. 801. Approval of applications for certain diagnostic medical
imaging devices.
Sec. 802. Applications for approval of contrast agents intended for use
with certain diagnostic medical imaging
devices.
TITLE IX--ADDITIONAL PROVISIONS
Sec. 901. Technical corrections.
Sec. 902. Reauthorization of the critical path public-private
partnerships.
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) the fee revenue and fees resulting
from the adjustment and the methodologies under this
paragraph.
``(3) Operating reserve adjustment.--
``(A) Increase.--For fiscal year 2018 and
subsequent fiscal years, the Secretary may, in addition
to adjustments under paragraphs (1) and (2), further
increase the fee revenue and fees if such an adjustment
is necessary to provide for not more than 14 weeks of
operating reserves of carryover user fees for the
process for the review of human drug applications.
``(B) Decrease.--If the Secretary has carryover
balances for such process in excess of 14 weeks of such
operating reserves, the Secretary shall decrease such
fee revenue and fees to provide for not more than 14
weeks of such operating reserves.
``(C) Notice of rationale.--If an adjustment under
subparagraph (A) or (B) is made, the rationale for the
amount of the increase or decrease (as applicable) in
fee revenue and fees shall be contained in the annual
Federal Register notice under paragraph (5)
establishing fee revenue and fees for the fiscal year
involved.
``(4) Additional direct cost adjustment.--
``(A) In general.--The Secretary shall, in addition
to adjustments under paragraphs (1), (2), and (3),
further increase the fee revenue and fees--
``(i) for fiscal year 2018, by $8,730,000;
and
``(ii) for fiscal year 2019 and subsequent
fiscal years, by the amount determined under
subparagraph (B).
``(B) Amount.--The amount determined under this
subparagraph is--
``(i) $8,730,000, multiplied by
``(ii) the Consumer Price Index for urban
consumers (Washington-Baltimore, DC-MD-VA-WV;
Not Seasonally Adjusted; All Items; Annual
Index) for the most recent year of available
data, divided by such Index for 2016.
``(5) Annual fee setting.--The Secretary shall, not later
than 60 days before the start of each fiscal year that begins
after September 30, 2017--
``(A) establish, for the next fiscal year, human
drug application fees and prescription drug program
fees under subsection (a), based on the revenue amounts
established under subsection (b) and the adjustments
provided under this subsection; and
``(B) publish such fee revenue and fees in the
Federal Register.
``(6) Limit.--The total amount of fees charged, as adjusted
under this subsection, for a fiscal year may not exceed the
total costs for such fiscal year for the resources allocated
for the process for the review of human drug applications.''.
(d) Fee Waiver or Reduction.--Section 736(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended--
(1) in paragraph (1)--
(A) by inserting ``or'' at the end of subparagraph
(B);
(B) by striking subparagraph (C); and
(C) by redesignating subparagraph (D) as
subparagraph (C);
(2) by striking paragraph (3) (relating to use of standard
costs);
(3) by redesignating paragraph (4) as paragraph (3); and
(4) in paragraph (3), as so redesignated--
(A) in subparagraphs (A) and (B), by striking
``paragraph (1)(D)'' and inserting ``paragraph
(1)(C)''; and
(B) in subparagraph (B)--
(i) by striking clause (ii);
(ii) by striking ``shall pay'' through
``(i) application fees'' and inserting ``shall
pay application fees''; and
(iii) by striking ``; and'' at the end and
inserting a period.
(e) Effect of Failure To Pay Fees.--Section 736(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(e)) is amended by striking
``all fees'' and inserting ``all such fees''.
(f) Limitations.--Section 736(f)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(f)(2)) is amended by striking
``supplements, prescription drug establishments, and prescription drug
products'' and inserting ``prescription drug program fees''.
(g) Crediting and Availability of Fees.--Section 736(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)) is amended--
(1) in paragraph (3)--
(A) by striking ``2013 through 2017'' and inserting
``2018 through 2022''; and
(B) by striking ``and paragraph (4) of this
subsection''; and
(2) by striking paragraph (4).
(h) Orphan Drugs.--Section 736(k) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(k)) is amended by striking ``product and
establishment fees'' each place it appears and inserting ``prescription
drug program fees''.
SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h-2) is amended--
(1) in subsection (a)(1)--
(A) in the matter before subparagraph (A), by
striking ``2013'' and inserting ``2018''; and
(B) in subparagraph (A), by striking ``Prescription
Drug User Fee Amendments of 2012'' and inserting
``Prescription Drug User Fee Amendments of 2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018''; and
(3) in subsection (d), by striking ``2017'' each place it
appears and inserting ``2022''.
SEC. 104. SUNSET DATES.
(a) Authorization.--Sections 735 and 736 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective
October 1, 2022.
(b) Reporting Requirements.--Section 736B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h-2) shall cease to be effective
January 31, 2023.
(c) Previous Sunset Provision.--Effective October 1, 2017,
subsections (a) and (b) of section 105 of the Food and Drug
Administration Safety and Innovation Act (Public Law 112-144) are
repealed.
SEC. 105. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, or the date of the enactment of this Act, whichever is later,
except that fees under part 2 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act shall be assessed for all human
drug applications received on or after October 1, 2017, regardless of
the date of the enactment of this Act.
SEC. 106. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 2 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act, as in effect on the day before the date of the enactment of this
title, shall continue to be in effect with respect to human drug
applications and supplements (as defined in such part as of such day)
that on or after October 1, 2012, but before October 1, 2017, were
accepted by the Food and Drug Administration for filing with respect to
assessing and collecting any fee required by such part for a fiscal
year prior to fiscal year 2018.
TITLE II--FEES RELATING TO DEVICES
SEC. 201. SHORT TITLE; FINDINGS.
(a) Short Title.--This title may be cited as the ``Medical Device
User Fee Amendments of 2017''.
(b) Findings.--The Congress finds that the fees authorized under
the amendments made by this title will be dedicated toward expediting
the process for the review of device applications and for assuring the
safety and effectiveness of devices, as set forth in the goals
identified for purposes of part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act in the letters from the Secretary
of Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the Chairman
of the Committee on Energy and Commerce of the House of
Representatives, as set forth in the Congressional Record.
SEC. 202. DEFINITIONS.
Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379i) is amended--
(1) by redesignating paragraphs (8) through (13) as
paragraphs (9) through (14), respectively;
(2) by inserting after paragraph (7) the following new
paragraph:
``(8) The term `de novo classification request' means a
request made under section 513(f)(2)(A) with respect to the
classification of a device.'';
(3) in subparagraph (D) of paragraph (10) (as redesignated
by paragraph (1)), by striking ``and submissions'' and
inserting ``submissions, and de novo classification requests'';
and
(4) in paragraph (11) (as redesignated by paragraph (1)),
by striking ``2011'' and inserting ``2016''.
SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.
(a) Types of Fees.--Section 738(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(a)) is amended--
(1) in paragraph (1), by striking ``fiscal year 2013'' and
inserting ``fiscal year 2018''; and
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by
striking ``October 1, 2012'' and inserting
``October 1, 2017'';
(ii) in clause (viii), by striking ``2''
and inserting ``3.4''; and
(iii) by adding at the end the following
new clause:
``(xi) For a de novo classification
request, a fee equal to 30 percent of the fee
that applies under clause (i).''; and
(B) in subparagraph (B)(v)(I), by striking ``or
premarket notification submission'' and inserting
``premarket notification submission, or de novo
classification request''.
(b) Fee Amounts.--Section 738(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(b)) is amended to read as follows:
``(b) Fee Amounts.--
``(1) In general.--Subject to subsections (c), (d), (e),
and (h), for each of fiscal years 2018 through 2022, fees under
subsection (a) shall be derived from the base fee amounts
specified in paragraph (2), to generate the total revenue
amounts specified in paragraph (3).
``(2) Base fee amounts specified.--For purposes of
paragraph (1), the base fee amounts specified in this paragraph
are as follows:
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
``Fee Type Year 2018 Year 2019 Year 2020 Year 2021 Year 2022
----------------------------------------------------------------------------------------------------------------
Premarket Application.................................... $294,000 $300,000 $310,000 $328,000 $329,000
Establishment Registration............................... $4,375 $4,548 $4,760 $4,975 $4,978
----------------------------------------------------------------------------------------------------------------
``(3) Total revenue amounts specified.--For purposes of
paragraph (1), the total revenue amounts specified in this
paragraph are as follows:
``(A) $183,280,756 for fiscal year 2018.
``(B) $190,654,875 for fiscal year 2019.
``(C) $200,132,014 for fiscal year 2020.
``(D) $211,748,789 for fiscal year 2021.
``(E) $213,687,660 for fiscal year 2022.''.
(c) Annual Fee Setting; Adjustments.--Section 738(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is amended--
(1) in paragraph (1), by striking ``2012'' and inserting
``2017'';
(2) in paragraph (2)--
(A) in subparagraph (A), by striking ``2014'' and
inserting ``2018'';
(B) by striking subparagraph (B) and inserting the
following new subparagraph:
``(B) Applicable inflation adjustment.--The
applicable inflation adjustment for fiscal year 2018
and each subsequent fiscal year is the product of--
``(i) the base inflation adjustment under
subparagraph (C) for such fiscal year; and
``(ii) the product of the base inflation
adjustment under subparagraph (C) for each of
the fiscal years preceding such fiscal year,
beginning with fiscal year 2016.'';
(C) in subparagraph (C), in the heading, by
striking ``to total revenue amounts''; and
(D) by amending subparagraph (D) to read as
follows:
``(D) Adjustment to base fee amounts.--For each of
fiscal years 2018 through 2022, the Secretary shall--
``(i) adjust the base fee amounts specified
in subsection (b)(2) for such fiscal year by
multiplying such amounts by the applicable
inflation adjustment under subparagraph (B) for
such year; and
``(ii) if the Secretary determines
necessary, increase (in addition to the
adjustment under clause (i)) such base fee
amounts, on a uniform proportionate basis, to
generate the total revenue amounts under
subsection (b)(3), as adjusted for inflation
under subparagraph (A).''; and
(3) in paragraph (3)--
(A) by striking ``2014 through 2017'' and inserting
``2018 through 2022''; and
(B) by striking ``further adjusted'' and inserting
``increased''.
(d) Small Businesses; Fee Waiver and Fee Reduction Regarding
Premarket Approval Fees.--Section 738(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(d)) is amended--
(1) in paragraph (1), by striking ``specified in clauses
(i) through (v) and clauses (vii), (ix), and (x)'' and
inserting ``specified in clauses (i) through (vii) and clauses
(ix), (x), and (xi)''; and
(2) in paragraph (2)(C)--
(A) by striking ``supplement, or'' and inserting
``supplement,''; and
(B) by inserting ``, or a de novo classification
request'' after ``class III device''.
(e) Small Businesses; Fee Reduction Regarding Premarket
Notification Submissions.--Section 738(e)(2)(C) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j(e)(2)(C)) is amended by striking
``50'' and inserting ``25''.
(f) Fee Waiver or Reduction.--
(1) Repeal.--Section 738 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j) is amended by striking subsection
(f).
(2) Conforming changes.--
(A) Section 515(c)(4)(A) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360e(c)(4)(A)) is amended
by striking ``738(h)'' and inserting ``738(g)''.
(B) Section 738 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j), as amended by paragraph
(1), is further amended--
(i) by redesignating subsections (g)
through (l) as subsections (f) through (k);
(ii) in subsection (a)(2)(A), by striking
``(d), (e), and (f)'' and inserting ``(d) and
(e)''; and
(iii) in subsection (a)(3)(A), by striking
``and subsection (f)''.
(g) Effect of Failure To Pay Fees.--Subsection (f)(1), as
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j) is amended--
(1) by striking ``or periodic reporting concerning a class
III device'' and inserting ``periodic reporting concerning a
class III device, or de novo classification request''; and
(2) by striking ``all fees'' and inserting ``all such
fees''.
(h) Conditions.--Subsection (g)(1)(A), as redesignated, of section
738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is
amended by striking ``$280,587,000'' and inserting ``$320,825,000''.
(i) Crediting and Availability of Fees.--Subsection (h), as
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j) is amended--
(1) in paragraph (3)--
(A) by striking ``2013 through 2017'' and inserting
``2018 through 2022''; and
(B) by striking ``subsection (c)'' and all that
follows through the period at the end and inserting
``subsection (c).''; and
(2) by striking paragraph (4).
SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Reports.--Section 738A(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-1(a)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) by striking ``2013'' and inserting
``2018''; and
(ii) by striking ``the Medical Device User
Fee Amendments of 2012'' and inserting ``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 website of the Food and Drug Administration an
annual report on the progress of the pilot program
under this subsection.
``(4) Sunset.--As of October 1, 2022--
``(A) the authority for accreditation bodies to
accredit testing laboratories pursuant to paragraph
(1)(A) shall cease to have force or effect;
``(B) the Secretary--
``(i) may not accept a determination
pursuant to paragraph (1)(B) made by a testing
laboratory after such date; and
``(ii) may accept such a determination made
prior to such date;
``(C) except for purposes of accepting a
determination described in subparagraph (B)(ii), the
Secretary shall not continue to recognize the
accreditation of testing laboratories accredited under
paragraph (1)(A); and
``(D) the Secretary may take actions in accordance
with paragraph (2) with respect to the determinations
made prior to such date and recognition of the
accreditation of testing laboratories pursuant to
determinations made prior to such date.''.
SEC. 206. REAUTHORIZATION OF REVIEW.
Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360m) is amended--
(1) in subsection (a)(3)--
(A) in subparagraph (A), by striking clauses (ii)
and (iii) and inserting the following:
``(ii) a device classified under section
513(f)(2) or designated under section 515C(d);
or
``(iii) a device that is of a type, or
subset of a type, listed as not eligible for
review under subparagraph (B)(iii).'';
(B) by striking subparagraph (B) and inserting the
following:
``(B) Designation for review.--The Secretary
shall--
``(i) issue draft guidance on the factors
the Secretary will use in determining whether a
class I or class II device type, or subset of
such device types, is eligible for review by an
accredited person, including--
``(I) the risk of the device type,
or subset of such device type; and
``(II) whether the device type, or
subset of such device type, is
permanently implantable, life
sustaining, or life supporting;
``(ii) not later than 24 months after the
date on which the Secretary issues such draft
guidance, finalize such guidance; and
``(iii) beginning on the date such guidance
is finalized, designate and post on the
internet website of the Food and Drug
Administration, an updated list of class I and
class II device types, or subsets of such
device types, and the Secretary's determination
with respect to whether each such device type,
or subset of a device type, is eligible or not
eligible for review by an accredited person
under this section based on the factors
described in clause (i).''; and
(C) by adding at the end the following:
``(C) Interim rule.--Until the date on which the
updated list is designated and posted in accordance
with subparagraph (B)(iii), the list in effect on the
date of enactment the Medical Device User Fee
Amendments of 2017 shall be in effect.'';
(2) in subsection (b)--
(A) in paragraph (2)--
(i) by striking subparagraph (D); and
(ii) by redesignating subparagraph (E) as
subparagraph (D); and
(B) in paragraph (3)--
(i) by redesignating subparagraph (E) as
subparagraph (F);
(ii) in subparagraph (F) (as so
redesignated), by striking ``The operations
of'' and all that follows through ``it will--''
and inserting ``Such person shall agree, at a
minimum, to include in its request for
accreditation a commitment to, at the time of
accreditation, and at any time it is performing
any review pursuant to this section--''; and
(iii) by inserting after subparagraph (D)
the following new subparagraph:
``(E) The operations of such person shall be in
accordance with generally accepted professional and
ethical business practices.''; and
(3) in subsection (c), by striking ``2017'' and inserting
``2022''.
SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS.
Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379k-1(b)) is amended by adding at the end the following new
paragraph:
``(3) Presubmissions and submissions solely in electronic
format.--
``(A) In general.--Beginning on such date as the
Secretary specifies in final guidance issued under
subparagraph (C), presubmissions and submissions for
devices described in paragraph (1) (and any appeals of
action taken by the Secretary with respect to such
presubmissions or submissions) shall be submitted
solely in such electronic format as specified by the
Secretary in such guidance.
``(B) Draft guidance.--The Secretary shall, not
later than October 1, 2019, issue draft guidance
providing for--
``(i) any further standards for the
submission by electronic format required under
subparagraph (A);
``(ii) a timetable for the establishment by
the Secretary of such further standards; and
``(iii) criteria for waivers of and
exemptions from the requirements of this
subsection.
``(C) Final guidance.--The Secretary shall, not
later than 12 months after the close of the public
comment period on the draft guidance issued under
subparagraph (B), issue final guidance described in
clauses (i) through (iii) of such subparagraph.''.
SEC. 208. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 3 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379i et seq.), as in effect on the day before the date of
the enactment of this title, shall continue to be in effect with
respect to the submissions listed in section 738(a)(2)(A) of such Act
(as defined in such part as of such day) that on or after October 1,
2012, but before October 1, 2017, were accepted by the Food and Drug
Administration for filing with respect to assessing and collecting any
fee required by such part for a fiscal year prior to fiscal year 2018.
SEC. 209. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, or the date of the enactment of this Act, whichever is later,
except that fees under part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act shall be assessed for all
submissions listed in section 738(a)(2)(A) of such Act received on or
after October 1, 2017, regardless of the date of the enactment of this
Act.
SEC. 210. SUNSET CLAUSE.
(a) Authorization.--Sections 737 and 738 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be effective
October 1, 2022.
(b) Reporting Requirements.--Section 738A (21 U.S.C. 739j-1) of the
Federal Food, Drug, and Cosmetic Act (regarding reauthorization and
reporting requirements) shall cease to be effective January 31, 2023.
(c) Previous Sunset Provision.--Effective October 1, 2017, section
207(a) of the Medical Device User Fee Amendments of 2012 (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. 379-42(g)) is amended--
(1) in paragraph (1), by adding at the end the following:
``This paragraph shall cease to be effective on October 1,
2022.'';
(2) in paragraph (2)(C)(ii), by striking ``of
505(j)(5)(A)'' and inserting ``of section 505(j)(5)(A)''; and
(3) by adding at the end the following:
``(5) Generic drug applicant program fee.--
``(A) In general.--A person who fails to pay a fee
as required under subsection (a)(5) by the date that is
20 calendar days after the due date, as specified in
subparagraph (D) of such subsection, shall be subject
to the following:
``(i) The Secretary shall place the person
on a publicly available arrears list.
``(ii) Any abbreviated new drug application
submitted by the generic drug applicant or an
affiliate of such applicant shall not be
received, within the meaning of section
505(j)(5)(A).
``(iii) All drugs marketed pursuant to any
abbreviated new drug application held by such
applicant or an affiliate of such applicant
shall be deemed misbranded under section
502(aa).
``(B) Application of penalties.--The penalties
under subparagraph (A) shall apply until the fee
required under subsection (a)(5) is paid.''.
(g) Limitations.--Section 744B(h)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379-42(h)(2)) is amended by striking ``for Type
II active pharmaceutical ingredient drug master files, abbreviated new
drug applications and prior approval supplements, and generic drug
facilities and active pharmaceutical ingredient facilities''.
(h) Crediting and Availability of Fees.--Section 744B(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379-42(i)) is amended--
(1) in paragraph (2)--
(A) by striking subparagraph (C) (relating to fee
collection during first program year);
(B) in subparagraph (D)--
(i) in the heading, by striking ``in
subsequent years''; and
(ii) by striking ``(after fiscal year
2013)''; and
(C) by redesignating subparagraph (D) as
subparagraph (C); and
(2) in paragraph (3), by striking ``fiscal years 2013
through 2017'' and inserting ``fiscal years 2018 through
2022''.
(i) Information on Abbreviated New Drug Applications Owned by
Applicants and Their Affiliates.--Section 744B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379-42) is amended by adding at the
end the following:
``(o) Information on Abbreviated New Drug Applications Owned by
Applicants and Their Affiliates.--
``(1) In general.--By April 1 of each year, each person
that owns an abbreviated new drug application, or any affiliate
of such person, shall submit, on behalf of the person and its
affiliates, to the Secretary a list of--
``(A) all approved abbreviated new drug
applications owned by such person; and
``(B) if any affiliate of such person also owns an
abbreviated new drug application, all affiliates that
own any such abbreviated new drug applications and all
approved abbreviated new drug applications owned by any
such affiliate.
``(2) Format and method.--The Secretary shall specify in
guidance the format and method for submission of lists under
this subsection.''.
SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-43) is amended--
(1) in subsection (a)--
(A) by striking ``2013'' and inserting ``2018'';
and
(B) by striking ``Generic Drug User Fee Amendments
of 2012'' and inserting ``Generic Drug User Fee
Amendments of 2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018''; and
(3) in subsection (d), by striking ``2017'' each place it
appears and inserting ``2022''.
SEC. 305. SUNSET DATES.
(a) Authorization.--Sections 744A and 744B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-41; 379j-42) shall cease to be
effective October 1, 2022.
(b) Reporting Requirements.--Section 744C of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-43) shall cease to be effective
January 31, 2023.
(c) Previous Sunset Provision.--Effective October 1, 2017,
subsections (a) and (b) of section 304 of the Food and Drug
Administration Safety and Innovation Act (Public Law 112-144) are
repealed.
SEC. 306. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, or the date of the enactment of this Act, whichever is later,
except that fees under part 7 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act shall be assessed for all
abbreviated new drug applications received on or after October 1, 2017,
regardless of the date of the enactment of this Act.
SEC. 307. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 7 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act, as in effect on the day before the date of the enactment of this
title, shall continue to be in effect with respect to abbreviated new
drug applications (as defined in such part as of such day) that on or
after October 1, 2012, but before October 1, 2017, were received by the
Food and Drug Administration within the meaning of 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 with respect to assessing and
collecting any fee required by such part for a fiscal year prior to
fiscal year 2018.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
SEC. 401. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Biosimilar User
Fee Amendments of 2017''.
(b) Finding.--The Congress finds that the fees authorized by the
amendments made in this title will be dedicated to expediting the
process for the review of biosimilar biological product applications,
including postmarket safety activities, as set forth in the goals
identified for purposes of part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary
of Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the Chairman
of the Committee on Energy and Commerce of the House of
Representatives, as set forth in the Congressional Record.
SEC. 402. DEFINITIONS.
(a) Adjustment Factor.--Section 744G(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-51(1)) is amended to read as follows:
``(1) The term `adjustment factor' applicable to a fiscal
year is the Consumer Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted;
All items; Annual Index) for October of the preceding fiscal
year divided by such Index for October 2011.''.
(b) Biosimilar Biological Product.--Section 744G(3) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(3)) is amended by
striking ``means a product'' and inserting ``means a specific strength
of a biological product in final dosage form''.
SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.
(a) Types of Fees.--Section 744H(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-52(a)) is amended--
(1) in the matter preceding paragraph (1), by striking
``fiscal year 2013'' and inserting ``fiscal year 2018'';
(2) in the heading of paragraph (1), by striking
``Biosimilar'' and inserting ``Biosimilar biological product'';
(3) in paragraph (1)(A)(i), by striking ``(b)(1)(A)'' and
inserting ``(c)(5)'';
(4) in paragraph (1)(B)(i), by striking ``(b)(1)(B) for
biosimilar biological product development'' and inserting
``(c)(5) for the biosimilar biological product development
program'';
(5) in paragraph (1)(B)(ii), by striking ``annual
biosimilar biological product development program fee'' and
inserting ``annual biosimilar biological product development
fee'';
(6) in paragraph (1)(B)(iii), by striking ``annual
biosimilar development program fee'' and inserting ``annual
biosimilar biological product development fee'';
(7) in paragraph (1)(B), by adding at the end the
following:
``(iv) Refund.--If a person submits a
marketing application for a biosimilar
biological product before October 1 of a fiscal
year and such application is accepted for
filing on or after October 1 of such fiscal
year, the person may request a refund equal to
the annual biosimilar development fee paid by
the person for the product for such fiscal
year. To qualify for consideration for a refund
under this clause, a person shall submit to the
Secretary a written request for such refund not
later than 180 days after the marketing
application is accepted for filing.'';
(8) in paragraph (1)(C), by striking ``for a product
effective October 1 of a fiscal year by,'' and inserting ``for
a product, effective October 1 of a fiscal year, by,'';
(9) in paragraph (1)(D)--
(A) in clause (i) in the matter preceding subclause
(I), by inserting ``, if the person seeks to resume
participation in such program,'' before ``pay a fee'';
(B) in clause (i)(I), by inserting after ``grants a
request'' the following: ``by such person''; and
(C) in clause (i)(II), by inserting after
``discontinued)'' the following: ``by such person'';
(10) in the heading of paragraph (1)(E), by striking
``biosimilar development program'';
(11) in paragraph (1)(F)--
(A) in the subparagraph heading, by striking
``biosimilar development program'' before ``fees''; and
(B) by amending clause (i) to read as follows:
``(i) Refunds.--Except as provided in
subparagraph (B)(iv), the Secretary shall not
refund any initial or annual biosimilar
biological product development fee paid under
subparagraph (A) or (B), or any reactivation
fee paid under subparagraph (D).'';
(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 subparagraphs (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
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) establishing fee revenue and fees for the fiscal
year involved.
``(4) Fiscal year 2018 adjustment.--
``(A) In general.--For fiscal year 2018, the
Secretary shall adjust the fee revenue and fees under
this section in such amount (if any) as needed to
reflect an updated assessment of the workload for the
process for the review of biosimilar biological product
applications.
``(B) Methodology.--The Secretary shall publish
under paragraph (5) a description of the methodology
used to calculate the fiscal year 2018 adjustment under
this paragraph in the Federal Register notice
establishing fee revenue and fees for fiscal year 2018.
``(C) Limitation.--No adjustment under this
paragraph shall result in an increase in fee revenue
and fees under this section in excess of $9,000,000.
``(5) Annual fee setting.--For fiscal year 2018 and each
subsequent fiscal year, the Secretary shall, not later than 60
days before the start of each such fiscal year--
``(A) establish, for the fiscal year, initial and
annual biosimilar biological product development fees
and reactivation fees under subsection (a)(1),
biosimilar biological product application fees under
subsection (a)(2), and biosimilar biological product
program fees under subsection (a)(3), based on the
revenue amounts established under subsection (b) and
the adjustments provided under this subsection; and
``(B) publish such fee revenue and fees in the
Federal Register.
``(6) Limit.--The total amount of fees assessed for a
fiscal year under this section may not exceed the total costs
for such fiscal year for the resources allocated for the
process for the review of biosimilar biological product
applications.''.
(d) Application Fee Waiver for Small Business.--Subsection (d)(1)
of section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-52), as redesignated by subsection (c)(1), is amended--
(1) by striking subparagraph (B);
(2) by striking ``shall pay--'' and all that follows
through ``application fees'' and inserting ``shall pay
application fees''; and
(3) by striking ``; and'' at the end and inserting a
period.
(e) Effect of Failure To Pay Fees.--Subsection (e) of section 744H
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), as
redesignated by subsection (c)(1), is amended by striking ``all fees''
and inserting ``all such fees''.
(f) Crediting and Availability of Fees.--Subsection (f) of section
744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52),
as redesignated by subsection (c)(1), is amended--
(1) in paragraph (2)--
(A) by striking subparagraph (C) (relating to fee
collection during first program year) and inserting the
following:
``(C) Compliance.--The Secretary shall be
considered to have met the requirements of subparagraph
(B) in any fiscal year if the costs described in such
subparagraph are not more than 15 percent below the
level specified in such subparagraph.''; and
(B) in subparagraph (D)--
(i) in the heading, by striking ``in
subsequent years''; and
(ii) by striking ``(after fiscal year
2013)''; and
(2) in paragraph (3), by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.
SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-53) is amended--
(1) in subsection (a)--
(A) by striking ``2013'' and inserting ``2018'';
and
(B) by striking ``Biosimilar User Fee Act of 2012''
and inserting ``Biosimilar User Fee Amendments of
2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018'';
(3) by striking subsection (d);
(4) by redesignating subsection (e) as subsection (d); and
(5) in subsection (d), as so redesignated, by striking
``2017'' each place it appears and inserting ``2022''.
SEC. 405. SUNSET DATES.
(a) Authorization.--Sections 744G and 744H of the Federal Food,
Drug, and Cosmetic Act, as amended by section 403 of this Act, shall
cease to be effective October 1, 2022.
(b) Reporting Requirements.--Section 744I of the Federal Food,
Drug, and Cosmetic Act, as amended by section 404 of this Act, shall
cease to be effective January 31, 2023.
(c) Previous Sunset Provision.--
(1) In general.--Effective October 1, 2017, section 404 of
the Food and Drug Administration Safety and Innovation Act
(Public Law 112-144) is repealed.
(2) Conforming amendment.--The Food and Drug Administration
Safety and Innovation Act (Public Law 112-144) is amended in
the table of contents in section 2 by striking the item
relating to section 404.
SEC. 406. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, or the date of the enactment of this Act, whichever is later,
except that fees under part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act shall be assessed for all
biosimilar biological product applications received on or after October
1, 2017, regardless of the date of the enactment of this Act.
SEC. 407. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 8 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act, as in effect on the day before the date of the enactment of this
title, shall continue to be in effect with respect to biosimilar
biological product applications and supplements (as defined in such
part as of such day) that were accepted by the Food and Drug
Administration for filing on or after October 1, 2012, but before
October 1, 2017, with respect to assessing and collecting any fee
required by such part for a fiscal year prior to fiscal year 2018.
TITLE V--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS
SEC. 501. REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF
CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.
Section 505(u)(4) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(u)(4)) is amended by striking ``2017'' and inserting
``2022''.
SEC. 502. REAUTHORIZATION OF 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. 503. REAUTHORIZATION OF PEDIATRIC STUDY OF DRUGS.
Section 409I(e)(1) of the Public Health Service Act (42 U.S.C.
284m(e)(1)) is amended by striking ``2013 through 2017'' and inserting
``2018 through 2022''.
SEC. 504. 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 in effect under section 506E, no
drug that would be subject to section 503(b), and which is manufactured
outside the United States and intended by the manufacturer or labeled
to be marketed outside the United States, may be imported into the
United States for sale or commercial use.''.
(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. 505. 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.
TITLE VI--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS
Subtitle A--Improving the Process for Inspections of Device
Establishments
SEC. 601. RISK-BASED INSPECTIONS FOR DEVICES.
Paragraph (2) of section 510(h) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(h)) is amended to read as follows:
``(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 which the
United States recognizes for purposes of
inspecting device establishments.''.
SEC. 602. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.
Subsection (a)(1) of section 809 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 384e(a)(1)) is amended by inserting ``or
510(h)(2) (as applicable)'' before the semicolon at the end.
SEC. 603. 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 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 in order to
expedite the inspection; 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 limits 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 section, the Secretary of Health and
Human Services shall issue draft guidance that--
(A) specifies how the Food and Drug Administration
will implement the process described in 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;
(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).
SEC. 604. CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES.
(a) In General.--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) If the Secretary denies a request made under subparagraph
(A)(ii) for certification with respect to a device, 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 clause (i) is
based on--
``(I) 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
``(II) an establishment being considered out of compliance
with part 820, title 21, Code of Federal Regulations,
the Secretary shall provide a substantive summary of the specific
grounds for noncompliance so identified, if such grounds have not been
previously communicated to the manufacturer.
``(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 under subparagraph (A)(ii) based
exclusively 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.
``(F)(i) The Secretary shall provide a process for a person who is
denied a certification as described in subparagraph (E)(i) to request a
review that conforms to the standards of section 517A(b).
``(ii) Notwithstanding any previous review conducted pursuant to
clause (i), a person who has been denied a certification for a device
as described in subparagraph (E)(i) may, at any time, request a review
of that denial in order to present new information relating to actions
taken by such person to address the reasons identified by the Secretary
for such denial, including evidence that corrective actions are being
or have been implemented to address the grounds for noncompliance
identified by the Secretary under subparagraph (E)(ii).
``(G)(i) This paragraph applies to requests for certification on
behalf of any device establishment registered under section 510,
whether the establishment is located in the United States or another
country.
``(ii) The Secretary may charge a fee for the issuance of a
certification described in clause (i), and such fee is subject to the
same conditions and requirements as a fee charged under subparagraph
(B) for a certification issued under such subparagraph.''; and
(2) by moving the margins of subparagraphs (C) and (D) 4
ems to the left.
(b) Guidance.--Not later than 1 year after date of the enactment of
this section, the Secretary of Health and Human Services shall issue
guidance providing for a process to carry out subparagraph (F) of
section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 381(e)(4)), as added by subsection (a). Not later than 12 months
after the comment period closes for the draft guidance, the Secretary
shall issue final guidance.
SEC. 605. FACILITATING INTERNATIONAL HARMONIZATION.
Section 704(g) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 374(g)) is amended by adding at the end the following:
``(15) Notwithstanding any other provision of this subsection, for
purposes of conducting inspections of establishments that manufacture,
prepare, propagate, compound, or process devices except types of
devices licensed under section 351 of the Public Health Service Act,
which inspections are required under section 510(h) or are inspections
of such establishments required to register pursuant to section 510(i),
the Secretary may recognize auditing organizations that are recognized
by organizations established by governments to facilitate international
harmonization. Nothing in this paragraph affects the authority of the
Secretary to inspect any device establishment pursuant to this Act.
Nothing in this paragraph affects the authority of the Secretary to
determine the official classification of an inspection.''.
SEC. 606. 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''.
Subtitle B--Other Provisions
SEC. 611. REAUTHORIZATION OF PEDIATRIC HUMANITARIAN DEVICE EXCEPTIONS.
Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking ``2017'' and
inserting ``2022''.
SEC. 612. REAUTHORIZATION OF PEDIATRIC DEVICE CONSORTIA.
Section 305(e) of the Pediatric Medical Device Safety and
Improvement Act of 2007 (Public Law 110-85; 42 U.S.C. 282 note)) is
amended by striking ``2013 through 2017'' and inserting ``2018 through
2022''.
SEC. 613. 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) is amended by adding at the end the
following:
``(p) Regulation of Over-the-Counter Hearing Aids.--
``(1) Definition.--
``(A) In this subsection, the term `over-the-
counter hearing aid' means a device--
``(i) that 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) that is intended to be used by
adults over the age of 18 to compensate for
perceived mild to moderate hearing impairment;
``(iii) that, 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) that may--
``(I) use wireless technology; or
``(II) include tests for self-
assessment of hearing loss; and
``(v) that 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) 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 613(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 (p) of
section 520 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360j) as amended by subsection (a), and, not later than
180 days after the date on which the public comment period on
the proposed regulations closes, shall issue such final
regulations.
(2) Requirements.--In promulgating the regulations under
paragraph (1), the Secretary shall--
(A) include requirements that provide reasonable
assurances of the safety and efficacy of over-the-
counter hearing aids;
(B) include requirements that establish or adopt
output limits appropriate for over-the-counter hearing
aids;
(C) include requirements for appropriate labeling
of the over-the-counter hearing aid, including
requirements that such labeling include a conspicuous
statement that the device is only intended for adults
over the age of 18, 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 physician; and
(D) describe the requirements under which the sale
of over-the-counter hearing aids is permitted, without
the supervision, prescription, or other order,
involvement, or intervention of a licensed person, to
consumers through in-person transactions, by mail, or
online.
(3) Premarket notification.--The Secretary shall make
findings under section 510(m) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(m)) to determine whether over-the-
counter hearing aids (as defined in section 520(p) 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(p) 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 (p)(1) of section 520 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j)).
SEC. 614. REPORT ON ENSURING QUALITY, SAFETY, AND CONTINUED
EFFECTIVENESS OF DEVICES THAT HAVE BEEN SERVICED.
(a) In General.--Not later than 180 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 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 on how the Food and Drug Administration intends to ensure the
quality, safety, and continued effectiveness of devices (as defined in
section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301(h))) with respect to which servicing (as defined in subsection (c))
has been performed by any entity engaging in such servicing.
(b) Contents.--The report submitted under subsection (a) shall
contain--
(1) the status of, and findings to date with respect to,
the notice entitled ``Refurbishing, Reconditioning, Rebuilding,
Remarketing, Remanufacturing, and Servicing of Medical Devices
Performed by Third-Party Entities and Original Equipment
Manufacturers; Request for Comments'' published by the Food and
Drug Administration on April 25, 2016 (81 Fed. Reg. 24041 et
seq.), including how the Food and Drug Administration intends
to define the specific activities performed on a device by the
manufacturer of the device or other entities;
(2) a description of the statutory or regulatory authority
of the Food and Drug Administration used to oversee and
regulate servicing conducted with respect to devices;
(3) details on how the Food and Drug Administration intends
to protect the public health by ensuring consistent quality,
safety, and continued effectiveness of devices with respect to
which servicing has been performed by any entity engaging in
such servicing;
(4) information on how the Food and Drug Administration can
better understand the device servicing industry, including the
size, scope, location, and composition of entities performing
such servicing and the rate of adverse events related to such
servicing;
(5) information regarding the current regulation by States,
the Joint Commission, or other regulatory bodies of servicing
conducted with respect to devices by all entities, including
original equipment manufacturers, third-party entities, and
hospitals; and
(6) any additional information determined by the Secretary
(acting through the Commissioner) to be relevant to ensuring
the quality, safety, and continued effectiveness of devices
with respect to which servicing has been performed, including
whether additional Federal statutory authority is necessary to
ensure such quality, safety, and continued effectiveness.
(c) Servicing Defined.--In this section, the term ``servicing''
includes, with respect to a device, refurbishing, reconditioning,
rebuilding, remarketing, remanufacturing, repairing, or other servicing
of the device by a person other than the manufacturer of the device.
SEC. 615. DEVICE PILOT PROJECTS TO GENERATE RELIABLE AND TIMELY SAFETY
AND ACTIVE SURVEILLANCE DATA.
(a) In General.--Section 519 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360i) is amended by adding at the end the
following:
``(i) Pilot Projects To Generate Reliable and Timely Safety and
Active Surveillance Data.--
``(1) In general.--The Secretary shall, not later than one
year after the date of the enactment of the FDA Reauthorization
Act of 2017, initiate one or more pilot projects relating 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), in
which a manufacturer or manufacturers of a device or device
type voluntarily participate. Any such project shall meet each
of the following criteria:
``(A) The project is 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) The project informs, to the extent
applicable, the development of methods, systems, data
criteria, and programs that could be used to support
safety and active surveillance activities for any
device.
``(C) The project shall be designed and conducted
in coordination with a comprehensive system for
evaluating device technology that operates under a
governing board with appropriate representation of
stakeholders, including patient groups and device
manufacturers.
``(D) The project uses electronic health data
including, as appropriate, claims data, patient survey
data, and any other data, as the Secretary determines
appropriate.
``(E) The project prioritizes 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
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) under this subparagraph
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 shall not affect the eligibility
of such manufacturer to participate in any quarterly reporting
program with respect to devices carried out under section 519
or 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 section 519 or 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.--
``(A) In general.--No pilot project under this
subsection undertaken in coordination with the
comprehensive system described in paragraph (1)(C),
shall allow for an entity participating in such
program, other than the Secretary or the Secretary's
designee, to make determinations of safety or
effectiveness, or substantial equivalence, for purposes
of the Act.
``(B) No use of fees.--Pilot projects initiated
under this subsection may not primarily utilize funds
collected pursuant to the Medical Device User Fee
Amendments of 2017.
``(8) Other projects required to comply.--Paragraphs
(1)(B), (4)(A)(i), (4)(A)(ii), (5), and (6) shall apply with
respect to any pilot program 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, may 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 added by subsection
(a)--
(1) for purposes of informing premarket and postmarket
decisionmaking for multiple device types; and
(2) to determine whether the methods, systems, and programs
carried out through such pilot projects efficiently generate
reliable and timely evidence about the effectiveness of the
surveillance of devices with respect to safety.
SEC. 616. 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 section shall preclude the Secretary's ability to
initiate the classification of an accessory through regulation or
written order, as appropriate.
``(C)(i) In the case of an accessory that has been granted
marketing authorization as part of a submission under section 515(c),
510(k), or paragraph (2) of this subsection with another device with
which such accessory is intended to be used, and with respect to which
the Secretary has issued a written order classifying such accessory
type distinct from another device in accordance with subparagraph (A),
the manufacturer or importer of such accessory may, in lieu of
submitting a request for classification of such accessory, submit a
written request to the Secretary identifying such classification. A
request under this clause shall include such information to support the
request as may be specified by the Secretary.
``(ii) A request under clause (i) shall include a recommendation
for the proper classification of the accessory pursuant to subparagraph
(A), and 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).
``(iii) The Secretary shall respond to a request under clause (i)
within 90 calendar days by granting or denying the request for
reclassification of the accessory.
``(iv) Within 30 calendar days after granting a request submitted
under clause (i), the Secretary shall publish a notice in the Federal
Register announcing such response.
``(v) A written notification that the Secretary disagrees with the
classification recommended in a request pursuant to clause (ii) shall
include a detailed description and justification for the determination
to disagree.
``(D)(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.
``(E) 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,
and that have not been classified by the Secretary based on the risks
and appropriate level of regulatory controls in accordance with
subparagraph (A):
``(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 deems appropriate, pursuant to this paragraph, the
Secretary shall publish in the Federal Register a notice
proposing a list of such accessories that the Secretary
believes may be suitable for a distinct classification in class
I and the proposed regulations for such classifications. In
developing such lists, the Secretary shall consider
recommendations from sponsors of device submissions and other
stakeholders for accessories to be included on such lists. 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) or (C),
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 90 calendar days after receiving
such submission by granting or denying the request for
classification of the accessory, and the Secretary shall by
written order classify such accessory or deny 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.
``(F) 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.
TITLE VII--GENERIC DRUG ACCESS AND COMPETITION
SEC. 701. 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 shall, at the request of the
sponsor of a drug that is designated as a competitive generic therapy
pursuant to subsection (b), expedite the development and review of such
drug pursuant to section 505(j).
``(b) Designation Process.--
``(1) Request.--The sponsor of a drug 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
shall--
``(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 a drug
under subsection (a), the Secretary shall, as requested by the sponsor,
take actions including the following:
``(1) Hold meetings with the sponsor 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 sponsor 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,
including with respect to drug-device combination products and
other complex products.
``(4) Assign a cross-disciplinary project lead for the Food
and Drug Administration review team--
``(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 sponsor.
``(d) 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 product, there is not more than one approved drug
product on the list of products described in section
505(j)(7)(A) (not including products 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 the provisions of 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 provisions.
(B) Contents.--The guidance issued under this
subsection 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 will
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.--
(A) In general.--If the Secretary of Health and
Human Services determines that it is necessary to amend
the regulations under title 21, Code of Federal
Regulations, in order to implement section 506H of the
Federal Food, Drug, and Cosmetic Act, as added by
subsection (a), the Secretary shall amend such
regulations not later than 2 years after the date of
enactment of this Act.
(B) Procedure.--In carrying out subparagraph (A),
and in issuing any other regulations to implement such
section 506H, the Secretary shall--
(i) issue a notice of proposed rulemaking
that includes the proposed regulation;
(ii) provide a period of not less than 60
days for comments on the proposed regulation;
and
(iii) publish the final regulation not less
than 30 days before the effective date of the
regulation.
SEC. 702. ENHANCING REGULATORY TRANSPARENCY TO ENHANCE GENERIC
COMPETITION.
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) is amended by adding at the end the following:
``(11) Upon the request of an applicant regarding one or more
specified pending applications under this subsection, the Secretary
shall--
``(A) by telephone or electronic mail, provide review
status updates; and
``(B) indicate in such updates the categorical status of
the applications by each relevant review discipline.''.
SEC. 703. INCENTIVIZING COMPETITIVE GENERIC THERAPY 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 blocking
exclusivities on the list of products
described in section 505(j)(7)(A) at
the time of approval.
``(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. 704. TROPICAL DISEASE PRODUCT APPLICATION.
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.''.
SEC. 705. 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 generic drug applications submitted 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
(DMF) 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 VIII--FOSTERING INNOVATION IN MEDICAL IMAGING
SEC. 801. APPROVAL OF APPLICATIONS FOR CERTAIN DIAGNOSTIC MEDICAL
IMAGING DEVICES.
Section 520 of the Federal Food, Drug, and Cosmetic Act (42 U.S.C.
360j), as amended by section 613, is further amended by adding at the
end the following:
``(q) Diagnostic Imaging Devices Intended for Use With Contrast
Agents.--
``(1) 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 the indications and conditions of use
proposed in such application, notification, or request involve
the use of a contrast agent that is not--
``(A) in a concentration, rate of administration,
or route of administration that is different from those
described in the approved labeling of 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 (such as an
ultrasound, an x-ray, diagnostic radiopharmaceutical-
based technologies, fluorescent imaging technology, or
magnetic resonance) that is different from those
described in the approved labeling of the contrast
agent.
``(2) 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) 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) For purposes of this subsection and section 505(y)--
``(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.''.
SEC. 802. 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) 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 the use of
the contrast agent for a new indication and conditions of 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(q)(1).
``(2) 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) For purposes of this subsection--
``(A) the term `new indication' means a use of a
contrast agent that is described in the approved
labeling of an applicable medical imaging device
described in section 520(q), but that is not described
in the approved labeling of the contrast agent; and
``(B) the term `applicable medical imaging device'
and `contrast agent' have the meanings given such terms
in section 520(q).''.
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) Effective as of the enactment of the 21st Century Cures Act
(Public Law 114-255)--
(1) section 3051(a) of such Act is amended by striking ``by
inserting after section 515B'' and inserting ``by inserting
after section 515A''; and
(2) section 515C of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e-3), as inserted by such section 3051(a), is
redesignated as section 515B.
(f) Section 515B(f)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e-3(f)(2)), as redesignated by subsection (e)(2) of this
section, is amended by striking ``a proposed guidance'' and inserting
``a draft version of that guidance''.
(g) Section 513(b)(5)(D) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360c(b)(5)(D)) is amended by striking ``medical device
submissions'' and inserting ``medical devices that may be specifically
the subject of a review by a classification panel''.
SEC. 902. 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''.
Union Calendar No. 138
115th CONGRESS
1st Session
H. R. 2430
[Report No. 115-201]
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user-fee programs for prescription drugs, medical devices, generic
drugs, and biosimilar biological products, and for other purposes.
_______________________________________________________________________
July 11, 2017
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed