[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4535 Introduced in Senate (IS)]
<DOC>
117th CONGRESS
2d Session
S. 4535
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user-fee programs for prescription drugs, medical devices, generic
drugs, and biosimilar biological products, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 14, 2022
Mr. Burr introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
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; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Food and Drug
Administration Simple Reauthorization Act of 2022'' or the ``FDASRA Act
of 2022''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--FEES RELATING TO DRUGS
Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Reauthorization; reporting requirement.
Sec. 105. Sunset dates.
Sec. 106. Effective date.
Sec. 107. Savings clause.
TITLE II--FEES RELATING TO DEVICES
Sec. 201. Short title; finding.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirement.
Sec. 205. Accreditation programs.
Sec. 206. Sunset dates.
Sec. 207. Effective date.
Sec. 208. Savings clause.
TITLE III--FEES RELATING TO GENERIC DRUGS
Sec. 301. Short title; finding.
Sec. 302. Authority to assess and use human generic drug fees.
Sec. 303. Reauthorization; reporting requirements.
Sec. 304. Sunset dates.
Sec. 305. Effective date.
Sec. 306. 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 biological product
fees.
Sec. 404. Reauthorization; reporting requirements.
Sec. 405. Sunset dates.
Sec. 406. Effective date.
Sec. 407. Savings clause.
TITLE V--OTHER REAUTHORIZATIONS
Sec. 501. Reauthorization of the critical path public-private
partnership.
Sec. 502. Reauthorization of the best pharmaceuticals for children
program.
Sec. 503. Reauthorization of the humanitarian device exemption
incentive.
Sec. 504. Reauthorization of the pediatric device consortia program.
Sec. 505. Reauthorization of provision pertaining to drugs containing
single enantiomers.
Sec. 506. Reauthorization of orphan drug grants.
Sec. 507. Reauthorization of certain device inspections.
TITLE I--FEES RELATING TO DRUGS
SEC. 101. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Prescription
Drug User Fee Amendments of 2022''.
(b) Finding.--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 (21 U.S.C. 379g
et seq.), 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. DEFINITIONS.
Section 735 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379g) is amended--
(1) in paragraph (1), in the matter following subparagraph
(B), by striking ``an allergenic extract product, or'' and
inserting ``does not include an application with respect to an
allergenic extract product licensed before October 1, 2022,
does not include an application with respect to a standardized
allergenic extract product submitted pursuant to a notification
to the applicant from the Secretary regarding the existence of
a potency test that measures the allergenic activity of an
allergenic extract product licensed by the applicant before
October 1, 2022, does not include an application with respect
to'';
(2) in paragraph (3), in the matter following subparagraph
(C)--
(A) by inserting ``licensed before October 1, 2022,
a standardized allergenic extract product submitted
pursuant to a notification to the applicant from the
Secretary regarding the existence of a potency test
that measures the allergenic activity of an allergenic
extract product licensed by the applicant before
October 1, 2022,'' after ``an allergenic extract
product''; and
(B) by adding at the end the following: ``If a
written request to place a product in the discontinued
section of either of the lists described in
subparagraph (C) is submitted to the Secretary on
behalf of an applicant, and the request identifies the
date the product is, or will be, withdrawn from sale,
then, for purposes of assessing the prescription drug
program fee under section 736(a)(2), the Secretary
shall consider such product to have been included in
the discontinued section on the later of (i) the date
such request was received, or (ii) if the product will
be withdrawn from sale on a future date, such future
date when the product is withdrawn from sale. For
purposes of subparagraph (C), a product shall be
considered withdrawn from sale once the applicant has
ceased its own distribution of the product, whether or
not the applicant has ordered recall of all previously
distributed lots of the product, except that a routine,
temporary interruption in supply shall not render a
product withdrawn from sale.''; and
(3) by adding at the end the following:
``(12) The term `skin-test diagnostic product'--
``(A) means a product--
``(i) for prick, scratch, intradermal, or
subcutaneous administration;
``(ii) expected to produce a limited, local
reaction at the site of administration (if
positive), rather than a systemic effect;
``(iii) not intended to be a preventive or
therapeutic intervention; and
``(iv) intended to detect an immediate or
delayed-type skin hypersensitivity reaction to
aid in the diagnosis of--
``(I) an allergy to an
antimicrobial agent;
``(II) an allergy that is not to an
antimicrobial agent, if the diagnostic
product was authorized for marketing
prior to October 1, 2022; or
``(III) infection with fungal or
mycobacterial pathogens; and
``(B) includes positive and negative controls
required to interpret the results of a product
described in subparagraph (A).''.
SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--Section 736(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(a)) is amended--
(1) in the matter preceding paragraph (1), by striking
``2018'' and inserting ``2023'';
(2) in paragraph (1)--
(A) in subparagraph (A), by striking ``subsection
(c)(5)'' each place it appears and inserting
``subsection (c)(6)'';
(B) in subparagraph (C), by inserting ``prior to
approval'' after ``or was withdrawn''; and
(C) by adding at the end the following:
``(H) Exception for skin-test diagnostic
products.--A human drug application for a skin-test
diagnostic product shall not be subject to a fee under
subparagraph (A).''; and
(3) in paragraph (2)--
(A) in subparagraph (A)--
(i) by striking ``subsection (c)(5)'' and
inserting ``subsection (c)(6)'';
(ii) by striking ``Except as provided'' and
inserting the following:
``(i) Payment of fees.--Except as
provided''; and
(iii) by adding at the end the following:
``(ii) Previously discontinued drug
products.--If a drug product that is identified
in a human drug application approved as of
October 1 of a fiscal year is not a
prescription drug product as of that date
because the drug product is in the discontinued
section of a list identified in section 735(3),
and on any subsequent day during such fiscal
year the drug product is a prescription drug
product, then except as provided in
subparagraphs (B) and (C), each person who is
named as the applicant in a human drug
application with respect to such product, 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)(6) for such
prescription drug product. Such fee shall be
due on the last business day of such fiscal
year and shall be paid only once for each
product for a fiscal year in which the fee is
payable.''; and
(B) by amending subparagraph (B) to read as
follows:
``(B) Exception for certain prescription drug
products.--A prescription drug program fee shall not be
assessed for a prescription drug product under
subparagraph (A) if such product is--
``(i) a large volume parenteral product (a
sterile aqueous drug product packaged in a
single-dose container with a volume greater
than or equal to 100 mL, not including powders
for reconstitution or pharmacy bulk packages)
identified on the list compiled under section
505(j)(7);
``(ii) pharmaceutically equivalent (as
defined in section 314.3 of title 21, Code of
Federal Regulations (or any successor
regulations)), to another product on the list
of products compiled under section 505(j)(7)
(not including the discontinued section of such
list); or
``(iii) a skin-test diagnostic product.''.
(b) Fee Revenue Amounts.--Section 736(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h(b)) is amended--
(1) in paragraph (1)--
(A) in the matter preceding subparagraph (A), by
striking ``2018 through 2022'' and inserting ``2023
through 2027'';
(B) by redesignating subparagraphs (C) through (F)
as subparagraphs (D) through (G), respectively;
(C) by inserting after subparagraph (B) the
following:
``(C) The dollar amount equal to the strategic
hiring and retention adjustment for the fiscal year (as
determined under subsection (c)(2));'';
(D) in subparagraph (D), as so redesignated, by
striking ``(c)(2)'' and inserting ``(c)(3)'';
(E) in subparagraph (E), as so redesignated, by
striking ``(c)(3)'' and inserting ``(c)(4)'';
(F) in subparagraph (F), as so redesignated, by
striking ``(c)(4)'' and inserting ``(c)(5)''; and
(G) in subparagraph (G), as so redesignated, by
striking clauses (i) through (v) and inserting the
following:
``(i) $65,773,693 for fiscal year 2023.
``(ii) $25,097,671 for fiscal year 2024.
``(iii) $14,154,169 for fiscal year 2025.
``(iv) $4,864,860 for fiscal year 2026.
``(v) $1,314,620 for fiscal year 2027.'';
and
(2) in paragraph (3)--
(A) in subparagraph (A), by striking ``2018,
$878,590,000'' and inserting ``2023, $1,151,522,958'';
and
(B) in subparagraph (B)--
(i) by striking ``2019 through 2022'' and
inserting ``2024 through 2027''; and
(ii) by striking ``subsection (c)(3) or
(c)(4)'' and inserting ``subsection (c)(4) or
(c)(5)''.
(c) Adjustments; Annual Fee Setting.--Section 736(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended--
(1) in paragraph (1)(B)(ii), by striking ``Washington-
Baltimore, DC-MD-VA-WV'' and inserting ``Washington-Arlington-
Alexandria, DC-VA-MD-WV'';
(2) by redesignating paragraphs (2) through (6) as
paragraphs (3) through (7), respectively;
(3) by inserting after paragraph (1) the following:
``(2) Strategic hiring and retention adjustment.--For each
fiscal year, after the annual base revenue established in
subsection (b)(1)(A) is adjusted for inflation in accordance
with paragraph (1), the Secretary shall further increase the
fee revenue and fees--
``(A) for fiscal year 2023, by $9,000,000; and
``(B) for fiscal year 2024 and each subsequent
fiscal year, by $4,000,000.'';
(4) in paragraph (3), as so redesignated--
(A) in subparagraph (A)--
(i) by striking ``for inflation''; and
(ii) by striking ``paragraph (1)'' and
inserting ``paragraphs (1) and (2)'';
(B) by amending subparagraph (B) to read as
follows:
``(B) Methodology.--For purposes of this paragraph,
the Secretary shall employ the capacity planning
methodology utilized by the Secretary in setting fees
for fiscal year 2021, as described in the notice titled
`Prescription Drug User Fee Rates for Fiscal Year 2021'
(85 Fed. Reg. 46651; August 3, 2020). The workload
categories used in forecasting shall include only the
activities described in such notice and, as feasible,
additional activities that are directly related to the
direct review of applications and supplements,
including additional formal meeting types, the direct
review of postmarketing commitments and requirements,
the direct review of risk evaluation and mitigation
strategies, and the direct review of annual reports for
approved prescription drug products. Subject to the
exceptions in the preceding sentence, the Secretary
shall not include as workload categories in forecasting
any non-core review activities, including any
activities that the Secretary referenced for potential
future use in such notice but did not utilize in the
setting fees for fiscal year 2021.'';
(C) by striking subparagraph (C);
(D) by redesignating subparagraphs (D) and (E) as
subparagraphs (C) and (D), respectively;
(E) in subparagraph (C), as so redesignated--
(i) by striking ``year) and'' and inserting
``year),''; and
(ii) by striking the period and inserting
``, and subsection (b)(1)(C) (the dollar amount
of the strategic hiring and retention
adjustment).''; and
(F) in subparagraph (D), as so redesignated, by
striking ``paragraph (5)'' and inserting ``paragraph
(6)'';
(5) in paragraph (4), as so redesignated--
(A) by amending subparagraph (A) to read as
follows:
``(A) Increase.--For fiscal year 2023 and
subsequent fiscal years, the Secretary shall, in
addition to adjustments under paragraphs (1), (2), and
(3), further increase the fee revenue and fees if such
an adjustment is necessary to provide for at least the
following amounts of operating reserves of carryover
user fees for the process for the review of human drug
applications for each fiscal year, as follows:
``(i) For fiscal year 2023, at least 8
weeks of operating reserves.
``(ii) For fiscal year 2024, at least 9
weeks of operating reserves.
``(iii) For fiscal year 2025 and subsequent
fiscal years, at least 10 weeks of operating
reserves.''; and
(B) in subparagraph (C), by striking ``paragraph
(5)'' and inserting ``paragraph (6)'';
(6) by amending paragraph (5), as so redesignated, to read
as follows:
``(5) Additional direct cost adjustment.--The Secretary
shall, in addition to adjustments under paragraphs (1), (2),
(3), and (4), further increase the fee revenue and fees--
``(A) for fiscal year 2023, by $44,386,150; and
``(B) for fiscal years 2024 through 2027, by the
amount set forth in clauses (i) through (iv), as
applicable, multiplied by the Consumer Price Index for
urban consumers (Washington-Arlington-Alexandria, DC-
VA-MD-WV; Not Seasonally Adjusted; All Items; Annual
Index) for the most recent year of available data,
divided by such Index for 2021--
``(i) for fiscal year 2024, $60,967,993;
``(ii) for fiscal year 2025, $35,799,314;
``(iii) for fiscal year 2026, $35,799,314;
and
``(iv) for fiscal year 2027,
$35,799,314.''; and
(7) in paragraph (6), as so redesignated, by striking
``2017'' and inserting ``2022''.
(d) Crediting and Availability of Fees.--Section 736(g)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3)) is amended
by striking ``2018 through 2022'' and inserting ``2023 through 2027''.
(e) Written Requests for Waivers, Reductions, and Refunds.--Section
736(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(i))
is amended to read as follows:
``(i) Written Requests for Waivers, Reductions, Exemptions, and
Returns; Disputes Concerning Fees.--To qualify for consideration for a
waiver or reduction under subsection (d), an exemption under subsection
(k), or the return of any fee paid under this section, including if the
fee is claimed to have been paid in error, a person shall submit to the
Secretary a written request justifying such waiver, reduction,
exemption, or return not later than 180 days after such fee is due. A
request submitted under this paragraph shall include any legal
authorities under which the request is made.''.
(f) Orphan Drugs.--Section 736(k) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(k)) is amended--
(1) in paragraph (1)(B), by striking ``during the previous
year'' and inserting ``, as determined under paragraph (2)'';
and
(2) in paragraph (2), by striking ``that its gross annual
revenues'' and all that follows through the period at the end
and inserting ``supported by tax returns submitted to the
Internal Revenue Service, or, as necessary, by other
appropriate financial information, that its gross annual
revenues did not exceed $50,000,000 for the last calendar year
ending prior to the fiscal year for which the exemption is
requested.''.
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENT.
Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h-2) is amended--
(1) by striking ``2018'' each place it appears and
inserting ``2023'';
(2) by striking ``Prescription Drug User Fee Amendments of
2017'' each place it appears and inserting ``Prescription Drug
User Fee Amendments of 2022'';
(3) in subsection (a)(4), by striking ``2020'' and
inserting ``2023''; and
(4) in subsection (f), by striking ``2022'' each place it
appears and inserting ``2027''.
SEC. 105. 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, 2027.
(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, 2028.
(c) Previous Sunset Provision.--Effective October 1, 2022,
subsections (a) and (b) of section 104 of the FDA Reauthorization Act
of 2017 (Public Law 115-52) are repealed.
SEC. 106. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2022, 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 (21 U.S.C. 379g et seq.) shall be
assessed for all human drug applications received on or after October
1, 2022, regardless of the date of the enactment of this Act.
SEC. 107. 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
(21 U.S.C. 379g 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 human drug 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, 2017, but before
October 1, 2022, with respect to assessing and collecting any fee
required by such part for a fiscal year prior to fiscal year 2023.
TITLE II--FEES RELATING TO DEVICES
SEC. 201. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Medical Device
User Fee Amendments of 2022''.
(b) Finding.--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) in paragraph (9)--
(A) in the matter preceding subparagraph (A), by
striking ``and premarket notification submissions'' and
inserting ``premarket notification submissions, and de
novo classification requests'';
(B) in subparagraph (D), by striking ``and
submissions'' and inserting ``submissions, and de novo
classification requests'';
(C) in subparagraph (F), by striking ``and
premarket notification submissions'' and inserting
``premarket notification submissions, and de novo
classification requests'';
(D) in subparagraphs (G) and (H), by striking ``or
submissions'' each place it appears and inserting
``submissions, or requests''; and
(E) in subparagraph (K), by striking ``or premarket
notification submissions'' and inserting ``premarket
notification submissions, or de novo classification
requests''; and
(2) in paragraph (11), by striking ``2016'' and inserting
``2021''.
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 ``2018'' and inserting
``2023''; and
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by
striking ``2017'' and inserting ``2022'';
(ii) in clause (iii), by striking ``75
percent'' and inserting ``80 percent''; and
(iii) in clause (viii), by striking ``3.4
percent'' and inserting ``4.5 percent'';
(B) in subparagraph (B)(iii), by striking ``or
premarket notification submission'' and inserting
``premarket notification submission, or de novo
classification request''; and
(C) in subparagraph (C), by striking ``or periodic
reporting concerning a class III device'' and inserting
``periodic reporting concerning a class III device, 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--
(1) in paragraph (1), by striking ``2018 through 2022'' and
inserting ``2023 through 2027'';
(2) by amending the table in paragraph (2) to read as
follows:
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
``Fee Type Year 2023 Year 2024 Year 2025 Year 2026 Year 2027
----------------------------------------------------------------------------------------------------------------
Premarket Application................................... $425,000 $435,000 $445,000 $455,000 $470,000
Establishment Registration.............................. $6,250 $6,875 $7,100 $7,575 $8,465'';
----------------------------------------------------------------------------------------------------------------
and
(3) in paragraph (3), by amending subparagraphs (A) through
(E) to read as follows:
``(A) $312,606,000 for fiscal year 2023.
``(B) $335,750,000 for fiscal year 2024.
``(C) $350,746,400 for fiscal year 2025.
``(D) $366,486,300 for fiscal year 2026.
``(E) $418,343,000 for fiscal year 2027.''.
(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 ``2017'' and inserting
``2022'';
(2) in paragraph (2)--
(A) by striking ``2018'' each place it appears and
inserting ``2023'';
(B) in subparagraph (B)(ii), by striking ``2016''
and inserting ``2022'';
(C) in subparagraph (C)(i)(II), by striking
``Washington-Baltimore, DC-MD-VA-WV'' and inserting
``Washington-Arlington-Alexandria, DC-VA-MD-WV''; and
(D) in subparagraph (D), by striking ``2022'' and
inserting ``2027'';
(3) in paragraph (3), by striking ``2018 through 2022'' and
inserting ``2023 through 2027'';
(4) by redesignating paragraphs (4) and (5) as paragraphs
(7) and (8), respectively; and
(5) by inserting after paragraph (3) the following:
``(4) Performance improvement adjustment.--
``(A) In general.--For each of fiscal years 2025
through 2027, after the adjustment under paragraph (3),
the base establishment registration fee amounts for
such fiscal year shall be increased to reflect changes
in the resource needs of the Secretary due to improved
review performance goals for the process for the review
of device applications identified in the letters
described in section 201(b) of the Medical Device User
Fee Amendments of 2022, as the Secretary determines
necessary to achieve an increase in total fee
collections for such fiscal year, equal to the
following amounts, as applicable:
``(i) For fiscal year 2025, the product
of--
``(I) the amount determined under
subparagraph (B)(i)(I); and
``(II) the applicable inflation
adjustment under paragraph (2)(B) for
such fiscal year.
``(ii) For fiscal year 2026, the product
of--
``(I) the sum of the amounts
determined under subparagraphs
(B)(i)(II), (B)(ii)(I), and
(B)(iii)(I); and
``(II) the applicable inflation
adjustment under paragraph (2)(B) for
such fiscal year.
``(iii) For fiscal year 2027, the product
of--
``(I) the sum of the amounts
determined under subparagraphs
(B)(i)(III), (B)(ii)(II), and
(B)(iii)(II); and
``(II) the applicable inflation
adjustment under paragraph (2)(B) for
such fiscal year.
``(B) Amounts.--
``(i) Presubmission amount.--For purposes
of subparagraph (A), with respect to the
presubmission written feedback goal, the
amounts determined under this subparagraph are
as follows:
``(I) For fiscal year 2025,
$15,396,600 if the goal for fiscal year
2023 is met.
``(II) For fiscal year 2026--
``(aa) $15,396,600 if the
goal for fiscal year 2023 is
met and the goal for fiscal
year 2024 is missed; or
``(bb) $36,792,200 if the
goal for fiscal year 2024 is
met.
``(III) For fiscal year 2027--
``(aa) $15,396,600 if the
goal for fiscal year 2023 is
met and the goal for each of
fiscal years 2024 and 2025 is
missed;
``(bb) $36,792,200 if the
goal for fiscal year 2024 is
met and the goal for fiscal
year 2025 is missed; or
``(cc) $40,572,600 if the
goal for fiscal year 2025 is
met.
``(ii) De novo classification request
amount.--For purposes of subparagraph (A), with
respect to the de novo decision goal, the
amounts determined under this subparagraph are
as follows:
``(I) For fiscal year 2026,
$6,323,500 if the goal for fiscal year
2023 is met.
``(II) For fiscal year 2027--
``(aa) $6,323,500 if the
goal for fiscal year 2023 is
met and the goal for fiscal
year 2024 is missed; or
``(bb) $11,765,400 if the
goal for fiscal year 2024 is
met.
``(iii) Premarket notification and
premarket approval amount.--For purposes of
subparagraph (A), with respect to the 510(k)
decision goal, 510(k) shared outcome total time
to decision goal, PMA decision goal, and PMA
shared outcome total time to decision goal, the
amounts determined under this subparagraph are
as follows:
``(I) For fiscal year 2026,
$1,020,000 if the 4 goals for fiscal
year 2023 are met.
``(II) For fiscal year 2027--
``(aa) $1,020,000 if the 4
goals for fiscal year 2023 are
met and one or more of the 4
goals for fiscal year 2024 is
missed; or
``(bb) $3,906,000 if the 4
goals for fiscal year 2024 are
met.
``(C) Performance calculation.--For purposes of
this paragraph, performance of the following goals
shall be determined as specified in the letters
described in section 201(b) of the Medical Device User
Fee Amendments of 2022 and based on data available as
of the applicable dates as follows:
``(i) The performance of the presubmission
written feedback goal--
``(I) for fiscal year 2023, shall
be based on data available as of March
31, 2024;
``(II) for fiscal year 2024, shall
be based on data available as of March
31, 2025; and
``(III) for fiscal year 2025, shall
be based on data available as of March
31, 2026.
``(ii) The performance of the de novo
decision goal, 510(k) decision goal, 510(k)
shared outcome total time to decision goal, PMA
decision goal, and PMA shared outcome total
time to decision goal--
``(I) for fiscal year 2023, shall
be based on data available as of March
31, 2025; and
``(II) for fiscal year 2024, shall
be based on data available as of March
31, 2026.
``(D) Definitions.--For purposes of this paragraph,
the terms `presubmission written feedback goal', `de
novo decision goal', `510(k) decision goal', `510(k)
shared outcome total time to decision goal', `PMA
decision goal', and `PMA shared outcome total time to
decision goal' have the meanings given such terms in
the goals identified in the letters described in
section 201(b) of the Medical Device User Fee
Amendments of 2022.
``(5) Hiring adjustment.--
``(A) In general.--For each of fiscal years 2025
through 2027, after the adjustments under paragraphs
(3) and (4), if applicable, the base establishment
registration fee amounts shall be decreased as the
Secretary determines necessary to achieve a reduction
in total fee collections equal to the hiring adjustment
amount under subparagraph (B), if the number of hires
to support the process for the review of device
applications falls below the following thresholds for
the applicable fiscal years:
``(i) For fiscal year 2025, 85 percent of
the hiring goal specified in subparagraph (C)
for fiscal year 2023.
``(ii) For fiscal year 2026, 90 percent of
the hiring goal specified in subparagraph (C)
for fiscal year 2024.
``(iii) For fiscal year 2027, 90 percent of
the hiring goal specified in subparagraph (C)
for fiscal year 2025.
``(B) Hiring adjustment amount.--The hiring
adjustment amount for fiscal year 2025 and each
subsequent fiscal year is the product of--
``(i) the number of hires by which the
hiring goal specified in subparagraph (C) for
the fiscal year before the prior fiscal year
was missed;
``(ii) $72,877; and
``(iii) the applicable inflation adjustment
under paragraph (2)(B) for the fiscal year for
which the hiring goal was missed.
``(C) Hiring goals.--
``(i) In general.--For purposes of
subparagraph (B), the hiring goals for each of
fiscal years 2023 through 2025 are as follows:
``(I) For fiscal year 2023, 144
hires.
``(II) For fiscal year 2024, 42
hires.
``(III) For fiscal year 2025--
``(aa) 24 hires if the base
establishment registration fees
are not increased by the amount
determined under paragraph
(4)(A)(i); or
``(bb) 83 hires if the base
establishment registration fees
are increased by the amount
determined under paragraph
(4)(A)(i).
``(ii) Number of hires.--For purposes of
this paragraph, the number of hires for a
fiscal year shall be determined by the
Secretary, as set forth in the letters
described in section 201(b) of the Medical
Device User Fee Amendments of 2022.
``(6) Operating reserve adjustment.--
``(A) In general.--For each of fiscal years 2023
through 2027, after the adjustments under paragraphs
(3), (4), and (5), if applicable, if the Secretary has
operating reserves of carryover user fees for the
process for the review of device applications in excess
of the designated amount in subparagraph (B), the
Secretary shall decrease the base establishment
registration fee amounts to provide for not more than
such designated amount of operating reserves.
``(B) Designated amount.--Subject to subparagraph
(C), for each fiscal year, the designated amount in
this subparagraph is equal to the sum of--
``(i) 13 weeks of operating reserves of
carryover user fees; and
``(ii) the 1 month of operating reserves
described in paragraph (8).
``(C) Excluded amount.--For the period of fiscal
years 2023 through 2026, a total amount equal to
$118,000,000 shall not be considered part of the
designated amount under subparagraph (B) and shall not
be subject to the decrease under subparagraph (A).''.
(d) Conditions.--Section 738(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(g)) is amended--
(1) in paragraph (1)(A), by striking ``$320,825,000'' and
inserting ``$398,566,000''; and
(2) in paragraph (2), by inserting ``de novo classification
requests,'' after ``class III device,''.
(e) Authorization of Appropriations.--Section 738(h)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)(3)) is amended
to read as follows:
``(3) Authorization of appropriations.--
``(A) In general.--For each of the fiscal years
2023 through 2027, there is authorized to be
appropriated for fees under this section an amount
equal to the revenue amount determined in subparagraph
(B), less the amount of reductions determined in
subparagraph (C).
``(B) Revenue amount.--For purposes of this
paragraph, the revenue amount for each fiscal year is
the sum of--
``(i) the total revenue amount under
subsection (b)(3) for the fiscal year, as
adjusted under subsection (c)(2); and
``(ii) the performance improvement
adjustment amount for the fiscal year under
subsection (c)(4)(A), if applicable.
``(C) Amount of reductions.--For purposes of this
paragraph, the amount of reductions for each fiscal
year is the sum of--
``(i) the hiring adjustment amount for the
fiscal year under subsection (c)(5), if
applicable; and
``(ii) the operating reserve adjustment
amount for the fiscal year under subsection
(c)(6), if applicable.''.
SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENT.
(a) Performance Reports.--Section 738A(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-1(a)) is amended--
(1) by striking ``fiscal year 2018'' each place it appears
and inserting ``fiscal year 2023'';
(2) by striking ``Medical Device User Fee Amendments of
2017'' each place it appears and inserting ``Medical Device
User Fee Amendments of 2022'';
(3) in paragraph (1)--
(A) in subparagraph (A), by redesignating the
second clause (iv) (relating to analysis) as clause
(v); and
(B) in subparagraph (A)(iv) (relating to rationale
for MDUFA program changes), by striking ``fiscal year
2020'' and inserting ``fiscal year 2023''; and
(4) in paragraph (4), by striking ``2018 through 2022'' and
inserting ``2023 through 2027''.
(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 ``2022'' and inserting
``2027''; and
(2) in paragraph (5), by striking ``2022'' and inserting
``2027''.
SEC. 205. ACCREDITATION PROGRAMS.
(a) Accreditation Scheme for Conformity Assessment.--Section 514(d)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(d)) is
amended--
(1) in the subsection heading, by striking ``Pilot'';
(2) in paragraph (1)--
(A) in the matter preceding subparagraph (A), by
striking ``pilot'';
(B) in subparagraph (A)--
(i) by inserting ``meeting criteria
specified by the Secretary in guidance'' after
``testing laboratories'';
(ii) by inserting ``in guidance'' after
``by the Secretary''; and
(iii) by striking ``assess the conformance
of a device with'' and inserting ``conduct
testing to support the assessment of the
conformance of a device to''; and
(C) in subparagraph (B)--
(i) by striking ``determinations'' and
inserting ``results'';
(ii) by inserting ``to support'' after ``so
accredited''; and
(iii) by striking ``a particular such
determination'' and inserting ``particular such
results'';
(3) in paragraph (2)--
(A) in the paragraph heading, by striking
``determinations'' and inserting ``results'';
(B) in subparagraph (A)--
(i) by striking ``determinations by testing
laboratories'' and all that follows through
``such determinations or'' and inserting
``results by testing laboratories accredited
pursuant to this subsection, including by
conducting periodic audits of such results or
of the'';
(ii) by inserting a comma after ``or
testing laboratories'';
(iii) by inserting ``or recognition of an
accreditation body'' after ``accreditation of
such testing laboratory''; and
(iv) by striking ``such device'' and
inserting ``a device''; and
(C) in subparagraph (B)--
(i) by striking ``by a testing laboratory
so accredited'' and inserting ``under this
subsection''; and
(ii) by inserting ``or recognition of an
accreditation body'' before ``under paragraph
(1)(A)'';
(4) in paragraph (3)(C)--
(A) in the subparagraph heading, by inserting ``and
transition'' after ``initiation''; and
(B) by adding at the end the following: ``After
September 30, 2023, such pilot program will be
considered to be completed, and the Secretary shall
have the authority to continue operating a program
consistent with this subsection.''; and
(5) by striking paragraph (4).
(b) Accredited Persons.--Section 523(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360m(c)) is amended by striking ``2022''
and inserting ``2027''.
SEC. 206. SUNSET DATES.
(a) Authorization.--Sections 737 and 738 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379i; 379fj) shall cease to be effective
October 1, 2027.
(b) Reporting Requirements.--Section 738A of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-1) shall cease to be effective
January 31, 2028.
(c) Previous Sunset Provision.--Effective October 1, 2022,
subsections (a) and (b) of section 210 of the FDA Reauthorization Act
of 2017 (Public Law 115-52) are repealed.
SEC. 207. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2022, 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 (21 U.S.C. 379i et seq.) shall be
assessed for all submissions listed in section 738(a)(2)(A) of such Act
received on or after October 1, 2022, regardless of the date of the
enactment of this Act.
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,
2017, but before October 1, 2022, were received by the Food and Drug
Administration with respect to assessing and collecting any fee
required by such part for a fiscal year prior to fiscal year 2023.
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 2022''.
(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. 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
``2018'' and inserting ``2023'';
(2) in paragraph (2)(C), by striking ``fiscal years 2018
through 2022'' and inserting ``fiscal years 2023 through
2027'';
(3) in paragraph (3)(B), by striking ``fiscal years 2018
through 2022'' and inserting ``fiscal years 2023 through
2027'';
(4) in paragraph (4)(D), by striking ``fiscal years 2018
through 2022'' and inserting ``fiscal years 2023 through
2027''; and
(5) in paragraph (5)(D), by striking ``fiscal years 2018
through 2022'' and inserting ``fiscal years 2023 through
2027''.
(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 ``2018''
and inserting ``2023'';
(ii) by striking ``2018'' and inserting
``2023''; and
(iii) by striking ``$493,600,000'' and
inserting ``$582,500,000''; and
(B) in subparagraph (B)--
(i) in the heading, by striking ``2019
through 2022'' and inserting ``2024 through
2027'';
(ii) by striking ``For each'' and inserting
the following:
``(i) In general.--For each'';
(iii) by striking ``2019 through 2022'' and
inserting ``2024 through 2027'';
(iv) by striking ``$493,600,000'' and
inserting ``the base revenue amount under
clause (ii)''; and
(v) by adding at the end the following:
``(ii) Base revenue amount.--The base
revenue amount for a fiscal year is the total
revenue amount established under this paragraph
for the previous fiscal year, not including any
adjustments made for such previous fiscal year
under subsection (c)(3).''; and
(2) in paragraph (2)--
(A) in subparagraph (C), by striking ``one-third
the amount'' and inserting ``24 percent'';
(B) in subparagraph (D), by striking ``Seven'' and
inserting ``Six''; and
(C) in subparagraph (E)(i), by striking ``Thirty-
five'' and inserting ``Thirty-six''.
(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) in the matter preceding subparagraph (A)--
(i) by striking ``2019'' and inserting
``2024''; and
(ii) by striking ``the product of the total
revenues established in such notice for the
prior fiscal year'' and inserting ``the base
revenue amount for the fiscal year determined
under subsection (b)(1)(B)(ii)''; and
(B) in subparagraph (C), by striking ``Washington-
Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
Arlington-Alexandria, DC-VA-MD-WV''; and
(2) by striking paragraph (2) and inserting the following:
``(2) Capacity planning adjustment.--
``(A) In general.--Beginning with fiscal year 2024,
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, in
accordance with this paragraph, to reflect changes in
the resource capacity needs of the Secretary for human
generic drug activities.
``(B) Capacity planning methodology.--The Secretary
shall establish a capacity planning methodology for
purposes of this paragraph, which shall--
``(i) be derived from the methodology and
recommendations made in the report titled
`Independent Evaluation of the GDUFA Resource
Capacity Planning Adjustment Methodology:
Evaluation and Recommendations' as announced in
the Federal Register on August 3, 2020 (85 Fed.
Reg. 46658); and
``(ii) incorporate approaches and
attributes determined appropriate by the
Secretary, including those made in such report
recommendations, except the workload categories
used in forecasting resources shall only be
those specified in section VIII.B.2.e. of the
letters described in section 301(b) of the
Generic Drug User Fee Amendments of 2022.
``(C) Limitations.--
``(i) In general.--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 subsection
(b)(1)(B)(ii) (the base revenue amount for the
fiscal year) and paragraph (1) (the dollar
amount of the inflation adjustment for the
fiscal year).
``(ii) Additional limitation.--An
adjustment under this paragraph shall not
exceed 3 percent of the sum described in clause
(i) for the fiscal year, except that such
limitation shall be 4 percent if--
``(I) for purposes of an adjustment
for fiscal year 2024, the Secretary
determines that, during the period from
April 1, 2021, through March 31, 2023--
``(aa) the total number of
abbreviated new drug
applications submitted was
greater than or equal to 2,000;
or
``(bb) thirty-five percent
or more of abbreviated new drug
applications submitted related
to complex products (as that
term is defined in section XI
of the letters described in
section 301(b) of the Generic
Drug User Fee Amendments of
2022);
``(II) for purposes of an
adjustment for fiscal year 2025, the
Secretary determines that, during the
period from April 1, 2022, through
March 31, 2024--
``(aa) the total number of
abbreviated new drug
applications submitted was
greater than or equal to 2,300;
or
``(bb) thirty-five percent
or more of abbreviated new drug
applications submitted related
to complex products (as so
defined);
``(III) for purposes of an
adjustment for fiscal year 2026, the
Secretary determines that, during the
period from April 1, 2023, through
March 31, 2025--
``(aa) the total number of
abbreviated new drug
applications submitted was
greater than or equal to 2,300;
or
``(bb) thirty-five percent
or more of abbreviated new drug
applications submitted related
to complex products (as so
defined); and
``(IV) for purposes of an
adjustment for fiscal year 2027, the
Secretary determines that, during the
period from April 1, 2024, through
March 31, 2026--
``(aa) the total number of
abbreviated new drug
applications submitted was
greater than or equal to 2,300;
or
``(bb) thirty-five percent
or more of abbreviated new drug
applications submitted related
to complex products (as so
defined).
``(D) Publication in federal register.--The
Secretary shall publish in the Federal Register notice
under subsection (a), the fee revenue and fees
resulting from the adjustment and the methodology under
this paragraph.
``(3) Operating reserve adjustment.--
``(A) In general.--For fiscal year 2024 and
subsequent fiscal years, the Secretary may, in addition
to adjustments under paragraphs (1) and (2), further
increase the fee revenue and fees under this section if
such an adjustment is necessary to provide operating
reserves of carryover user fees for human generic drug
activities for not more than the number of weeks
specified in subparagraph (B).
``(B) Number of weeks.--The number of weeks
specified in this subparagraph is--
``(i) 8 weeks for fiscal year 2024;
``(ii) 9 weeks for fiscal year 2025; and
``(iii) 10 weeks for each of fiscal year
2026 and 2027.
``(C) Decrease.--If the Secretary has carryover
balances for human generic drug activities in excess of
12 weeks of the operating reserves referred to in
subparagraph (A), the Secretary shall decrease the fee
revenue and fees referred to in such subparagraph to
provide for not more than 12 weeks of such operating
reserves.
``(D) Rationale for adjustment.--If an adjustment
under this paragraph 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 subsection (a) publishing
the fee revenue and fees for the fiscal year
involved.''.
(d) Annual Fee Setting.--Section 744B(d)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-42(d)(1)) is amended--
(1) in the heading, by striking ``2018 through 2022'' and
inserting ``2023 through 2027'';
(2) by striking ``more'' and inserting ``later''; and
(3) by striking ``2018 through 2022'' and inserting ``2023
through 2027''.
(e) Effect of Failure To Pay Fees.--The heading of paragraph (3) of
section 744B(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-42(g)) is amended by striking ``and prior approval supplement
fee''.
(f) Crediting and Availability of Fees.--Section 744B(i)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(i)(3)) is
amended by striking ``2018 through 2022'' and inserting ``2023 through
2027''.
SEC. 303. 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 ``2018'' each place it appears and
inserting ``2023''; and
(B) by striking ``Generic Drug User Fee Amendments
of 2017'' each place it appears and inserting ``Generic
Drug User Fee Amendments of 2022'';
(2) in subsection (b), by striking ``2018'' and inserting
``2023'';
(3) in subsection (c)--
(A) by striking ``2018'' and inserting ``2023'';
and
(B) by striking ``Generic Drug User Fee Amendments
of 2017'' each place it appears and inserting ``Generic
Drug User Fee Amendments of 2022''; and
(4) in subsection (f)--
(A) in paragraph (1), by striking ``2022'' and
inserting ``2027''; and
(B) in paragraph (5), by striking ``January 15,
2022'' and inserting ``January 15, 2027''.
SEC. 304. 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, 2027.
(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, 2028.
(c) Previous Sunset Provision.--Effective October 1, 2022,
subsections (a) and (b) of section 305 of the FDA Reauthorization Act
of 2017 (Public Law 115-52) are repealed.
SEC. 305. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2022, 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 (21 U.S.C. 379j-41 et seq.) shall
be assessed for all abbreviated new drug applications received on or
after October 1, 2022, regardless of the date of the enactment of this
Act.
SEC. 306. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 7 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act, as in effect on the day before the date of the enactment of this
title, shall continue to be in effect with respect to abbreviated new
drug applications (as defined in such part as of such day) that were
received by the Food and Drug Administration within the meaning of
section 505(j)(5)(A) of such Act (21 U.S.C. 355(j)(5)(A)), prior
approval supplements that were submitted, and drug master files for
Type II active pharmaceutical ingredients that were first referenced on
or after October 1, 2017, but before October 1, 2022, with respect to
assessing and collecting any fee required by such part for a fiscal
year prior to fiscal year 2023.
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 2022''.
(b) Finding.--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 (21 U.S.C. 379j-51 et seq.), 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.
Section 744G of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-51) is amended--
(1) in paragraph (1)--
(A) by striking ``Washington-Baltimore, DC-MD-VA-
WV'' and inserting ``Washington-Arlington-Alexandria,
DC-VA-MD-WV'';
(B) by striking ``October of'' and inserting
``September of''; and
(C) by striking ``October 2011'' and inserting
``September 2011''; and
(2) in paragraph (4)(B)(iii)--
(A) by striking subclause (II); and
(B) by redesignating subclauses (III) and (IV) as
subclauses (II) and (III), respectively.
SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIOLOGICAL PRODUCT
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
``2018'' and inserting ``2023'';
(2) in paragraph (1)--
(A) in subparagraph (A)--
(i) in clause (iv)(I), by striking ``5
days'' and inserting ``7 days''; and
(ii) in clause (v)(II), by striking ``5
days'' and inserting ``7 days'';
(B) in subparagraph (B)--
(i) in clause (i), by inserting ``, except
that, in the case that such product (including,
where applicable, ownership of the relevant
investigational new drug application) is
transferred to a licensee, assignee, or
successor of such person, and written notice of
such transfer is provided to the Secretary,
such licensee, assignee or successor shall pay
the annual biosimilar biological product
development fee'' before the period;
(ii) in clause (iii)--
(I) in subclause (I), by striking
``; or'' and inserting a semicolon;
(II) in subclause (II), by striking
the period and inserting ``; or''; and
(III) by adding at the end the
following:
``(III) been administratively
removed from the biosimilar biological
product development program for the
product under subparagraph (E)(v).'';
and
(iii) in clause (iv), by striking
``accepted for filing on or after October 1 of
such fiscal year'' and inserting ``subsequently
accepted for filing'';
(C) in subparagraph (D)--
(i) in clause (i)--
(I) in the matter preceding
subclause (I), by striking ``shall, if
the person seeks to resume
participation in such program, pay''
and inserting ``or who has been
administratively removed from such
program for a product under
subparagraph (E)(v) shall, if the
person seeks to resume participation in
such program, pay all annual biosimilar
biological product development fees
previously assessed for such product
and still owed and'';
(II) in subclause (I)--
(aa) by striking ``5 days''
and inserting ``7 days''; and
(bb) by inserting ``or the
date of administrative removal,
as applicable'' after
``discontinued''; and
(III) in subclause (II), by
inserting ``or the date of
administrative removal, as applicable''
after ``discontinued''; and
(ii) in clause (ii), by inserting ``,
except that, in the case that such product
(including, where applicable, ownership of the
relevant investigational new drug application)
is transferred to a licensee, assignee, or
successor of such person, and written notice of
such transfer is provided to the Secretary,
such licensee, assignee or successor shall pay
the annual biosimilar biological product
development fee'' before the period at the end;
and
(D) in subparagraph (E), by adding at the end the
following:
``(v) Administrative removal from the
biosimilar biological product development
program.--If a person has failed to pay an
annual biosimilar biological product
development fee for a product as required under
subparagraph (B) for a period of 2 consecutive
fiscal years, the Secretary may
administratively remove such person from the
biosimilar biological product development
program for the product. At least 30 days prior
to administratively removing a person from the
biosimilar biological product development
program for a product under this clause, the
Secretary shall provide written notice to such
person of the intended administrative
removal.'';
(3) in paragraph (2)(D), by inserting ``prior to approval''
after ``withdrawn'';
(4) in paragraph (3)--
(A) in subparagraph (A)--
(i) in clause (i), by striking ``; and''
and inserting a semicolon;
(ii) by redesignating clause (ii) as clause
(iii); and
(iii) by inserting the following after
clause (i):
``(ii) may be dispensed only under
prescription pursuant to section 503(b); and'';
and
(B) by adding at the end the following:
``(E) Movement to discontinued list.--
``(i) Written request to place on
discontinued list.--
``(I) In general.--If a written
request to place a product on the list
of discontinued biosimilar biological
products referred to in subparagraph
(A)(iii) is submitted to the Secretary
on behalf of an applicant, and the
request identifies the date the product
is, or will be, withdrawn from sale,
then for purposes of assessing the
biosimilar biological product program
fee, the Secretary shall consider such
product to have been included on such
list on the later of--
``(aa) the date such
request was received; or
``(bb) if the product will
be withdrawn from sale on a
future date, such future date
when the product is withdrawn
from sale.
``(II) Withdrawn from sale
defined.--For purposes of this clause,
a product shall be considered withdrawn
from sale once the applicant has ceased
its own distribution of the product,
whether or not the applicant has
ordered recall of all previously
distributed lots of the product, except
that a routine, temporary interruption
in supply shall not render a product
withdrawn from sale.
``(ii) Products removed from discontinued
list.--If a biosimilar biological product that
is identified in a biosimilar biological
product application approved as of October 1 of
a fiscal year appears, as of October 1 of such
fiscal year, on the list of discontinued
biosimilar biological products referred to in
subparagraph (A)(iii), and on any subsequent
day during such fiscal year the biosimilar
biological product does not appear on such
list, except as provided in subparagraph (D),
each person who is named as the applicant in
the biosimilar biological product application
shall pay the annual biosimilar biological
product program fee established for a fiscal
year under subsection (c)(5) for such
biosimilar biological product. Notwithstanding
subparagraph (B), such fee shall be due on the
last business day of such fiscal year and shall
be paid only once for each product for each
fiscal year.''; and
(5) by striking paragraph (4).
(b) Fee Revenue Amounts.--Section 744H(b) of the Federal Food,
Drug, and Cosmetic Act ((21 U.S.C. 379j-52(b)) 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) in the paragraph heading, by striking
``Subsequent fiscal years'' and inserting ``In
general'';
(B) in the matter preceding subparagraph (A), by
striking ``2019 through 2022'' and inserting ``2023
through 2027'';
(C) in subparagraph (A), by striking ``paragraph
(4)'' and inserting ``paragraph (3)'';
(D) by redesignating subparagraphs (C) and (D) as
subparagraphs (D) and (E), respectively;
(E) by inserting after subparagraph (B) the
following:
``(C) the dollar amount equal to the strategic
hiring and retention adjustment (as determined under
subsection (c)(2));'';
(F) in subparagraph (D), as so redesignated, by
striking ``subsection (c)(2)); and'' and inserting
``subsection (c)(3));'';
(G) in subparagraph (E), as so redesignated, by
striking ``subsection (c)(3)).'' and inserting
``subsection (c)(4)); and''; and
(H) by adding at the end the following:
``(F) for fiscal years 2023 and 2024, additional
dollar amounts equal to--
``(i) $4,428,886 for fiscal year 2023; and
``(ii) $320,569 for fiscal year 2024.'';
(4) in paragraph (2), as so redesignated--
(A) in the paragraph heading, by striking ``;
limitations on fee amounts'';
(B) by striking subparagraph (B); and
(C) by redesignating subaparagraphs (C) and (D) as
subparagraphs (B) and (C), respectively; and
(5) by amending paragraph (3), as so redesignated, to read
as follows:
``(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 2023, $43,376,922; and
``(B) for fiscal years 2024 through 2027, the
dollar amount of the total revenue amount established
under paragraph (1) for the previous fiscal year,
excluding any adjustments to such revenue amount under
subsection (c)(4).''.
(c) Adjustments; Annual Fee Setting.--Section 744H(c) of the
Federal Food, Drug, and Cosmetic Act ((21 U.S.C. 379j-52(c)) is
amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by
striking ``subsection (b)(2)(B)'' and inserting
``subsection (b)(1)(B)''; and
(ii) in clause (i), by striking
``subsection (b)'' and inserting ``subsection
(b)(1)(A)''; and
(B) in subparagraph (B)(ii), by striking
``Washington-Baltimore, DC-MD-VA-WV'' and inserting
``Washington-Arlington-Alexandria, DC-VA-MD-WV'';
(2) by striking paragraph (4);
(3) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively;
(4) by inserting after paragraph (1) the following:
``(2) Strategic hiring and retention adjustment.--For each
fiscal year beginning in fiscal year 2023, after the annual
base revenue under subsection (b)(1)(A) is adjusted for
inflation in accordance with paragraph (1), the Secretary shall
further increase the fee revenue and fees by $150,000.'';
(5) in paragraph (3), as so redesignated--
(A) in subparagraph (A)--
(i) by striking ``Beginning with the fiscal
year described in subparagraph (B)(ii)(II)''
and inserting ``For each fiscal year''; and
(ii) by striking ``adjustment under
paragraph (1), further increase'' and inserting
``adjustments under paragraphs (1) and (2),
further adjust'';
(B) by amending subparagraph (B) to read as
follows:
``(B) Methodology.--For purposes of this paragraph,
the Secretary shall employ the capacity planning
methodology utilized by the Secretary in setting fees
for fiscal year 2021, as described in the notice titled
`Biosimilar User Fee Rates for Fiscal Year 2021' (85
Fed. Reg. 47220; August 4, 2020). The workload
categories used in forecasting shall include only the
activities described in such notice and, as feasible,
additional activities that are also directly related to
the direct review of biosimilar biological product
applications and supplements, including additional
formal meeting types and the direct review of
postmarketing commitments and requirements, the direct
review of risk evaluation and mitigation strategies,
and the direct review of annual reports for approved
biosimilar biological products. Subject to the
exceptions in the preceding sentence, the Secretary
shall not include as workload categories in forecasting
any non-core review activities, including any
activities that the Secretary referenced for potential
future use in such notice but did not utilize in
setting fees for fiscal year 2021.''; and
(C) in subparagraph (C)--
(i) by striking ``subsections (b)(2)(A)''
and inserting ``subsections (b)(1)(A)'';
(ii) by striking ``and (b)(2)(B)'' and
inserting ``, (b)(1)(B)''; and
(iii) by inserting ``, and (b)(1)(C) (the
dollar amount of the strategic hiring and
retention adjustment)'' before the period at
the end;
(6) by amending paragraph (4), as so redesignated, to read
as follows:
``(4) Operating reserve adjustment.--
``(A) Increase.--For fiscal year 2023 and
subsequent fiscal years, the Secretary shall, in
addition to adjustments under paragraphs (1), (2), and
(3), further increase the fee revenue and fees if such
an adjustment is necessary to provide for at least 10
weeks of operating reserves of carryover user fees for
the process for the review of biosimilar biological
product applications.
``(B) Decrease.--
``(i) Fiscal year 2023.--For fiscal year
2023, if the Secretary has carryover balances
for the process for the review of biosimilar
biological product applications in excess of 33
weeks of such operating reserves, the Secretary
shall decrease such fee revenue and fees to
provide for not more than 33 weeks of such
operating reserves.
``(ii) Fiscal year 2024.--For fiscal year
2024, if the Secretary has carryover balances
for the process for the review of biosimilar
biological product applications in excess of 27
weeks of such operating reserves, the Secretary
shall decrease such fee revenue and fees to
provide for not more than 27 weeks of such
operating reserves.
``(iii) Fiscal year 2025 and subsequent
fiscal years.--For fiscal year 2025 and
subsequent fiscal years, if the Secretary has
carryover balances for the process for the
review of biosimilar biological product
applications in excess of 21 weeks of such
operating reserves, the Secretary shall
decrease such fee revenue and fees to provide
for not more than 21 weeks of such operating
reserves.
``(C) Federal register notice.--If an adjustment
under subparagraph (A) or (B) is made, the rationale
for the amount of the increase or decrease (as
applicable) in fee revenue and fees shall be contained
in the annual Federal Register notice under paragraph
(5)(B) establishing fee revenue and fees for the fiscal
year involved.''; and
(7) in paragraph (5), in the matter preceding subparagraph
(A), by striking ``2018'' and inserting ``2023''.
(d) Crediting and Availability of Fees.--Section 744H(f)(3) of the
Federal Food, Drug, and Cosmetic Act ((21 U.S.C. 379j-52(f)(3)) is
amended by striking ``2018 through 2022'' and inserting ``2023 through
2027''.
(e) Written Requests for Waivers and Refunds.--Subsection (h) of
section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-52) is amended to read as follows:
``(h) Written Requests for Waivers and Returns; Disputes Concerning
Fees.--To qualify for consideration for a waiver under subsection (d),
or the return of any fee paid under this section, including if the fee
is claimed to have been paid in error, a person shall submit to the
Secretary a written request justifying such waiver or return and,
except as otherwise specified in this section, such written request
shall be submitted to the Secretary not later than 180 days after such
fee is due. A request submitted under this paragraph shall include any
legal authorities under which the request is made.''.
SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-53) is amended--
(1) by striking ``2018'' each place it appears and
inserting ``2023'';
(2) by striking ``Biosimilar User Fee Amendments of 2017''
each place it appears and inserting ``Biosimilar User Fee
Amendments of 2022'';
(3) in subsection (a)(4), by striking ``2020'' and
inserting ``2023''; and
(4) in subsection (f), by striking ``2022'' each place it
appears and inserting ``2027''.
SEC. 405. SUNSET DATES.
(a) Authorization.--Sections 744G and 744H of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-51, 379j-52) shall cease to be
effective October 1, 2027.
(b) Reporting Requirements.--Section 744I of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-53) shall cease to be effective
January 31, 2028.
(c) Previous Sunset Provision.--Effective October 1, 2022,
subsections (a) and (b) of section 405 of the FDA Reauthorization Act
of 2017 (Public Law 115-52) are repealed.
SEC. 406. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2022, 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 (21 U.S.C. 379j-51 et seq.) shall
be assessed for all biosimilar biological product applications received
on or after October 1, 2022, 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
(21 U.S.C. 379j-51 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 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, 2017, but
before October 1, 2022, with respect to assessing and collecting any
fee required by such part for a fiscal year prior to fiscal year 2023.
TITLE V--OTHER REAUTHORIZATIONS
SEC. 501. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE
PARTNERSHIP.
Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-5(f)) is amended by striking ``2018 through 2022'' and
inserting ``2023 through 2027''.
SEC. 502. REAUTHORIZATION OF THE BEST PHARMACEUTICALS FOR CHILDREN
PROGRAM.
Section 409I(d)(1) of the Public Health Service Act (42 U.S.C.
284m(d)(1)) is amended by striking ``2018 through 2022'' and inserting
``2023 through 2027''.
SEC. 503. REAUTHORIZATION OF THE HUMANITARIAN DEVICE EXEMPTION
INCENTIVE.
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 ``2022'' and
inserting ``2027''.
SEC. 504. REAUTHORIZATION OF THE PEDIATRIC DEVICE CONSORTIA PROGRAM.
Section 305(e) of the Food and Drug Administration Amendments Act
of 2007 (Public Law 110-85; 42 U.S.C. 282 note) is amended by striking
``$5,250,000 for each of fiscal years 2018 through 2022'' and inserting
``$7,000,000 for each of fiscal years 2023 through 2027''.
SEC. 505. REAUTHORIZATION OF PROVISION PERTAINING TO 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 ``October 1, 2022'' and
inserting ``October 1, 2027''.
SEC. 506. REAUTHORIZATION OF ORPHAN DRUG GRANTS.
Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended
by striking ``2018 through 2022'' and inserting ``2023 through 2027''.
SEC. 507. REAUTHORIZATION OF CERTAIN DEVICE INSPECTIONS.
Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 374(g)(11)) is amended by striking ``2022'' and inserting
``2027''.
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