[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7667 Introduced in House (IH)]
<DOC>
117th CONGRESS
2d Session
H. R. 7667
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 6, 2022
Ms. Eshoo (for herself, Mr. Guthrie, Mr. Pallone, and Mrs. Rodgers of
Washington) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user-fee programs for prescription drugs, medical devices, generic
drugs, and biosimilar biological products, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food and Drug Amendments of 2022''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of 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. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Reauthorization; reporting requirements.
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 requirements.
Sec. 205. Conformity assessment pilot program.
Sec. 206. Reauthorization of third-party review program.
Sec. 207. Savings clause.
Sec. 208. Effective date.
Sec. 209. Sunset dates.
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 fees.
Sec. 404. Reauthorization; reporting requirements.
Sec. 405. Sunset dates.
Sec. 406. Effective date.
Sec. 407. Savings clause.
TITLE V--IMPROVING DIVERSITY IN CLINICAL TRIALS
Sec. 501. Premarket reporting of diversity action plans for clinical
trials and studies.
Sec. 502. Evaluation of the need for FDA authority to mandate
postapproval studies or postmarket
surveillance due to insufficient
demographic subgroup data.
Sec. 503. Public workshops to enhance clinical trial diversity.
Sec. 504. Annual report on progress to increase diversity in clinical
trials and studies.
Sec. 505. Public meeting on clinical trial flexibilities initiated in
response to COVID-19 pandemic.
Sec. 506. Decentralized clinical trials.
TITLE VI--GENERIC DRUG COMPETITION
Sec. 601. Increasing transparency in generic drug applications.
Sec. 602. Enhancing access to affordable medicines.
TITLE VII--RESEARCH, DEVELOPMENT, AND SUPPLY CHAIN IMPROVEMENTS
Subtitle A--In General
Sec. 701. Animal testing alternatives.
Sec. 702. Emerging technology program.
Sec. 703. Improving the treatment of rare diseases and conditions.
Sec. 704. Antifungal research and development.
Sec. 705. Advancing qualified infectious disease product innovation.
Sec. 706. Advanced manufacturing technologies designation pilot
program.
Sec. 707. Public workshop on cell and gene therapies.
Sec. 708. Reauthorization of best pharmaceuticals for children.
Sec. 709. Reauthorization for humanitarian device exemption and
demonstration grants for improving
pediatric availability.
Sec. 710. Reauthorization of provision related to exclusivity of
certain drugs containing single
enantiomers.
Sec. 711. Reauthorization of the critical path public-private
partnership program.
Sec. 712. Reauthorization of orphan drug grants.
Subtitle B--Inspections
Sec. 721. Factory inspection.
Sec. 722. Uses of certain evidence.
Sec. 723. Improving FDA inspections.
Sec. 724. GAO report on inspections of foreign establishments
manufacturing drugs.
Sec. 725. Unannounced foreign facility inspections pilot program.
Sec. 726. Reauthorization of inspection program.
Sec. 727. Enhancing intra-agency coordination and public health
assessment with regard to compliance
activities.
Sec. 728. Reporting of mutual recognition agreements for inspections
and review activities.
Sec. 729. Enhancing transparency of drug facility inspection timelines.
TITLE VIII--TRANSPARENCY, PROGRAM INTEGRITY, AND REGULATORY
IMPROVEMENTS
Sec. 801. Prompt reports of marketing status by holders of approved
applications for biological products.
Sec. 802. Encouraging blood donation.
Sec. 803. Regulation of certain products as drugs.
Sec. 804. Postapproval studies and program integrity for accelerated
approval drugs.
Sec. 805. Facilitating the use of real world evidence.
Sec. 806. Medical devices advisory committee meetings.
Sec. 807. Ensuring cybersecurity of medical devices.
Sec. 808. Public docket on proposed modifications to approved
strategies.
Sec. 809. Facilitating exchange of product information prior to
approval.
Sec. 810. Bans of devices for one or more intended uses.
Sec. 811. Clarifying application of exclusive approval, certification,
or licensure for drugs designated for rare
diseases or conditions.
Sec. 812. GAO report on third-party review.
Sec. 813. Reauthorization of device pilot projects.
Sec. 814. Reporting on pending generic drug applications and priority
review applications.
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.--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. DEFINITIONS.
(a) Human Drug Application.--Section 735(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended 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''.
(b) Prescription Drug Product.--Section 735(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379g(3)) is amended--
(1) by redesignating subparagraphs (A), (B), and (C) as
clauses (i), (ii), and (iii), respectively;
(2) by striking ``(3) The term'' and inserting ``(3)(A) The
term'';
(3) by striking ``Such term does not include'' and
inserting the following:
``(B) Such term does not include'';
(4) by striking ``an allergenic extract product,'' and
inserting ``an allergenic extract product 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,'' ;
and
(5) by adding at the end the following:
``(C)(i) If a written request to place a product in
the discontinued section of either of the lists
referenced in subparagraph (A)(iii) is submitted to the
Secretary on behalf of an applicant, and the request
identifies the date the product is 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.
``(ii) For purposes of this subparagraph, 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.''.
(c) Skin-test Diagnostic Product.--Section 735 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379g) is amended 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.--
(1) Human drug application fee.--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 2018'' and inserting ``fiscal
year 2023''.
(B) in paragraph (1)(A), by striking ``(c)(5)''
each place it appears and inserting ``(c)(6)'';
(C) in paragraph (1)(C), by inserting ``prior to
approval'' after ``or was withdrawn''; and
(D) in paragraph (1), 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).''.
(2) Prescription drug program fee.--Section 736(a)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)(2))
is amended--
(A) in subparagraph (A)--
(i) by striking ``Except as provided in
subparagraphs (B) and (C)'' and inserting the
following:
``(i) Fee.--Except as provided in
subparagraphs (B) and (C)'';
(ii) by striking ``subsection (c)(5)'' and
inserting ``subsection (c)(6)''; and
(iii) by adding at the end the following:
``(ii) Special rule.--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 referenced in section
735(3)(A)(iii), 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 with respect to such product,
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 such 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
regulation)) 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.--
(1) In general.--Paragraph (1) of section 736(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is
amended to read as follows:
``(1) In general.--For each of the fiscal years 2023
through 2027, 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 strategic
hiring and reserve adjustment for the fiscal year (as
determined under subsection (c)(2));
``(D) the dollar amount equal to the capacity
planning adjustment for the fiscal year (as determined
under subsection (c)(3));
``(E) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if applicable
(as determined under subsection (c)(4));
``(F) the dollar amount equal to the additional
direct cost adjustment for the fiscal year (as
determined under subsection (c)(5)); and
``(G) additional dollar amounts for each fiscal
year as follows:
``(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.''.
(2) Annual base revenue.--Paragraph (3) of section 736(b)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b))
is amended 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, $1,151,522,958; 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, not
including any adjustments made under subsection (c)(4)
or (c)(5).''.
(c) Adjustments; Annual Fee Setting.--
(1) Inflation adjustment.--Section 736(c)(1)(B)(ii) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h(c)(1)(B)(ii)) is amended by striking ``Washington-
Baltimore, DC-MD-VA-WV'' and inserting ``Washington-Arlington-
Alexandria, DC-VA-MD-WV''.
(2) Strategic hiring and retention adjustment.--Section
736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h(c)) is amended--
(A) by redesignating paragraphs (2) through (6) as
paragraphs (3) through (7), respectively; and
(B) 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 by the following amounts:
``(A) For fiscal year 2023, $9,000,000.
``(B) For each of fiscal years 2024 through 2027,
$4,000,000.''.
(3) Capacity planning adjustment.--Paragraph (3), as
redesignated, of section 736(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows:
``(3) Capacity planning adjustment.--
``(A) In general.--For each fiscal year, after the
annual base revenue established in subsection (b)(1)(A)
is adjusted in accordance with paragraphs (1) and (2),
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) 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'
published in the Federal Register on August 3, 2020 (85
Fed. Reg. 46651). The workload categories used in
applying such methodology in forecasting shall include
only the activities described in that notice and, as
feasible, additional activities that are also 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 applying such methodology in forecasting any non-
core review activities, including those activities that
the Secretary referenced for potential future use in
such notice but did not utilize in setting fees for
fiscal year 2021.
``(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)(1)(A) (the annual base
revenue for the fiscal year), (b)(1)(B) (the dollar
amount of the inflation adjustment for the fiscal
year), and (b)(1)(C) (the dollar amount of the
strategic hiring and retention adjustment for the
fiscal year).
``(D) Publication in federal register.--The
Secretary shall publish in the Federal Register notice
under paragraph (6) of the fee revenue and fees
resulting from the adjustment and the methodologies
under this paragraph.''.
(4) Operating reserve adjustment.--Paragraph (4), as
redesignated, of section 736(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(c)) is amended--
(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 operating
reserves of carryover user fees for the process for the
review of human drug applications for each fiscal year
in at least the following amounts:
``(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)''.
(5) Additional direct cost adjustment.--Paragraph (5), as
redesignated, of section 736(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows:
``(5) Additional direct cost adjustment.--
``(A) Increase.--The Secretary shall, in addition
to adjustments under paragraphs (1), (2), (3), and (4),
further increase the fee revenue and fees--
``(i) for fiscal year 2023, by $44,386,150;
and
``(ii) for each of fiscal years 2024
through 2027, by the amount set forth in
clauses (i) through (iv) of subparagraph (B),
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.
``(B) Applicable amounts.--The amounts referred to
in subparagraph (A)(ii) are the following:
``(i) For fiscal year 2024, $60,967,993.
``(ii) For fiscal year 2025, $35,799,314.
``(iii) For fiscal year 2026, $35,799, 314.
``(iv) For fiscal year 2027,
$35,799,314.''.
(6) Annual fee setting.--Paragraph (6), as redesignated, of
section 736(c) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379h(c)) is amended by striking ``September 30, 2017''
and inserting ``September 30, 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 ``fiscal years 2018 through 2022'' and inserting ``fiscal
years 2023 through 2027''.
(e) Written Requests for Waivers, Reductions, Exemptions, and
Returns; Disputes Concerning Fees.--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--
``(1) not later than 180 days after such fee is due, submit
to the Secretary a written request justifying such waiver,
reduction, exemption, or return; and
``(2) include in the request 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) by amending paragraph (2) to read as follows:
``(2) Evidence of qualification.--An exemption under
paragraph (1) applies with respect to a drug only if the
applicant involved submits a certification that the applicant's
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. Such certification shall be supported
by--
``(A) tax returns submitted to the United States
Internal Revenue Service; or
``(B) as necessary, other appropriate financial
information.''.
SEC. 104. 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), by striking ``Beginning with
fiscal year 2018, not'' and inserting ``Not'';
(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)(3)(A), by striking ``Not later than
30 calendar days after the end of the second quarter of fiscal
year 2018, and not later than 30 calendar days after the end of
each quarter of each fiscal year thereafter'' and inserting
``Not later than 30 calendar days after the end of each quarter
of each fiscal year for which fees are collected under this
part'';
(4) in subsection (a)(3)(B), by adding at the end the
following:
``(v) For fiscal years 2023 and 2024, of
the meeting requests from sponsors for which
the Secretary has determined that a face-to-
face meeting is appropriate, the number of
face-to-face meetings requested by sponsors to
be conducted in person (in such manner as the
Secretary shall prescribe on the internet
website of the Food and Drug Administration),
and the number of such in-person meetings
granted by the Secretary.'';
(5) in subsection (a)(4), by striking ``Beginning with
fiscal year 2020, the'' and inserting ``The'';
(6) in subsection (b), by striking ``Beginning with fiscal
year 2018, not'' and inserting ``Not'';
(7) in subsection (c), by striking ``Beginning with fiscal
year 2018, for'' and inserting ``For''; and
(8) in subsection (f)--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by striking ``fiscal year 2022'' and
inserting ``fiscal year 2027''; and
(B) in paragraph (5), by striking ``January 15,
2022'' and inserting ``January 15, 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 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, 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, 2017, but before October 1, 2022, 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 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.--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 (21 U.S.C. 379i 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. 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
requests'';
(C) in subparagraph (F), by striking ``and
premarket notification submissions'' and inserting
``premarket notification submissions, and de novo
classification requests'';
(D) in each of subparagraphs (G) and (H), by
striking ``or submissions'' 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 ``fiscal year 2018'' and
inserting ``fiscal year 2023''; and
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by
striking ``October 1, 2017'' and inserting
``October 1, 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 paragraph (2) to read as follows:
``(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 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) by amending paragraph (3) to read as follows:
``(3) Total revenue amounts specified.--For purposes of
paragraph (1), the total revenue amounts specified in this
paragraph are 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) in subparagraph (A), by striking ``2018'' and
inserting ``2023'';
(B) in subparagraph (B)--
(i) in the matter preceding clause (i), by
striking ``fiscal year 2018'' and inserting
``fiscal year 2023''; and
(ii) in clause (ii), by striking ``fiscal
year 2016'' and inserting ``fiscal year 2022'';
(C) in subparagraph (C), by striking ``Washington-
Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
Arlington-Alexandria, DC-VA-MD-WV''.
(D) in subparagraph (D), in the matter preceding
clause (i), by striking ``fiscal years 2018 through
2022'' and inserting ``fiscal years 2023 through
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 adjustments under paragraphs
(2) and (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:
``(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) Pre-submission amount.--For purposes
of subparagraph (A), with respect to the pre-
submission written feedback goal, the amounts
determined under this subparagraph are as
follows:
``(I) For fiscal year 2025,
$15,396,600 if such goal for fiscal
year 2023 is met.
``(II) For fiscal year 2026:
``(aa) $15,396,600 if such
goal for fiscal year 2023 is
met and such goal for fiscal
year 2024 is not met.
``(bb) $36,792,200 if such
goal for fiscal year 2024 is
met.
``(III) For fiscal year 2027:
``(aa) $15,396,600 if such
goal for fiscal year 2023 is
met and such goal for each of
fiscal years 2024 and 2025 is
not met.
``(bb) $36,792,200 if such
goal for fiscal year 2024 is
met and such goal for fiscal
year 2025 is not met.
``(cc) $40,572,600 if such
goal for fiscal year 2025 is
met.
``(ii) De novo classification 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 such goal for fiscal year
2023 is met.
``(II) For fiscal year 2027--
``(aa) $6,323,500 if such
goal for fiscal year 2023 is
met and such goal for fiscal
year 2024 is not met.
``(bb) $11,765,400 if such
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 four goals for fiscal
year 2023 are met.
``(II) For fiscal year 2027:
``(aa) $1,020,000 if the
four goals for fiscal year 2023
are met and one or more of the
four goals for fiscal year 2024
is not met.
``(bb) $3,906,000 if the
four goals for fiscal year 2024
are met.
``(C) Performance calculation.--For purposes of
this paragraph, performance of the goals listed in
subparagraph (D) 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 following dates:
``(i) The performance of the pre-submission
written feedback goal shall be based on data
available as of--
``(I) for fiscal year 2023, March
31, 2024;
``(II) for fiscal year 2024, March
31, 2025; and
``(III) for fiscal year 2025, 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 shall be based on data
available as of--
``(I) for fiscal year 2023, March
31, 2025; and
``(II) for fiscal year 2024, March
31, 2026.
``(D) Goals defined.--For purposes of this
paragraph, the terms `pre-submission 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' refer to the goals identified by the
same names 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
(2), (3), and (4), if applicable, if the number of
hires to support the process for the review of device
applications falls below the thresholds specified in
subparagraph (B) for the applicable fiscal years, 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 (C).
``(B) Thresholds.--The thresholds specified in this
subparagraph are as follows:
``(i) For fiscal year 2025, the threshold
is 123 hires for fiscal year 2023.
``(ii) For fiscal year 2026, the threshold
is 38 hires for fiscal year 2024.
``(iii) For fiscal year 2027, the threshold
is--
``(I) 22 hires for fiscal year 2025
if the base establishment registration
fees are not increased by the amount
determined under paragraph (4)(A)(i);
or
``(II) 75 hires for fiscal year
2025 if such fees are so increased.
``(C) 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 (D) for
the fiscal year before the prior fiscal year
was not met;
``(ii) $72,877; and
``(iii) the applicable inflation adjustment
under paragraph (2)(B) for the fiscal year for
which the hiring goal was not met.
``(D) Hiring goals.--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:
``(I) 24 hires if the base
establishment registration fees are not
increased by the amount determined
under paragraph (4)(A)(i).
``(II) 83 hires if the base
establishment registration fees are
increased by the amount determined
under paragraph (4)(A)(i).
``(E) Number of hires.--For purposes of this
paragraph, the number of hires 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
(2), (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) 1 month of operating reserves
maintained pursuant to 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) Small Businesses.--Section 738 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j) is amended in each of subsections
(d)(2)(B)(iii) and (e)(2)(B)(iii) by inserting ``, if extant,'' after
``national taxing authority''.
(e) 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,''.
(f) Crediting and Availability of Fees.--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 fiscal years 2023
through 2027, there is authorized to be appropriated
for fees under this section an amount equal to the
revenue amount determined under subparagraph (B), less
the amount of reductions determined under 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 paragraphs (2) and (3) of
subsection (c); and
``(ii) the performance improvement
adjustment amount for the fiscal year under
subsection (c)(4), if applicable.
``(C) 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 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) 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), 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. CONFORMITY ASSESSMENT PILOT PROGRAM.
Section 514(d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360d(d)) is amended to read as follows:
``(d) Accreditation Scheme for Conformity Assessment.--
``(1) In general.--The Secretary shall establish a program
under which--
``(A) testing laboratories meeting criteria
specified in guidance by the Secretary may be
accredited by accreditation bodies meeting criteria
specified in guidance by the Secretary, to conduct
testing to support the assessment of the conformity of
a device to certain standards recognized under this
section; and
``(B) subject to paragraph (2), results from tests
conducted to support the assessment of conformity of
devices as described in subparagraph (A) conducted by
testing laboratories accredited pursuant to this
subsection shall be accepted by the Secretary for
purposes of demonstrating such conformity unless the
Secretary finds that certain results of such tests
should not be so accepted.
``(2) Secretarial review of accredited laboratory
results.--The Secretary may--
``(A) review the results of tests conducted by
testing laboratories accredited pursuant to this
subsection, including by conducting periodic audits of
such results or of the processes of accredited bodies
or testing laboratories;
``(B) following such review, take additional
measures under this Act, as the Secretary determines
appropriate, such as--
``(i) suspension or withdrawal of
accreditation of a testing laboratory or
recognition of an accreditation body under
paragraph (1)(A); or
``(ii) requesting additional information
with respect to a device; and
``(C) if the Secretary becomes aware of information
materially bearing on the safety or effectiveness of a
device for which an assessment of conformity was
supported by testing conducted by a testing laboratory
accredited under this subsection, take such additional
measures under this Act, as the Secretary determines
appropriate, such as--
``(i) suspension or withdrawal of
accreditation of a testing laboratory or
recognition of an accreditation body under
paragraph (1)(A); or
``(ii) requesting additional information
with regard to such device.
``(3) Implementation and reporting.--
``(A) Pilot program transition.--After September
30, 2023, the pilot program previously initiated under
this subsection, as in effect prior to the date of
enactment of the Medical Device User Fee Amendments of
2022, shall be considered to be completed, and the
Secretary may continue operating a program consistent
with this subsection.
``(B) Report.--The Secretary shall make available
on the internet website of the Food and Drug
Administration an annual report on the progress of the
pilot program under this subsection.''.
SEC. 206. REAUTHORIZATION OF THIRD-PARTY REVIEW PROGRAM.
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. 207. 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 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 2023.
SEC. 208. 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. 209. SUNSET DATES.
(a) Authorization.--Sections 737 and 738 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be effective
October 1, 2027.
(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, 2028.
(c) Previous Sunset Provisions.--Effective October 1, 2022,
subsections (a) and (b) of section 210 of the Medical Device User Fee
Amendments of 2017 (Public Law 115-52) are 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 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
``fiscal year 2018'' and inserting ``fiscal year 2023'';
(2) in paragraph (2)(C), by striking ``2018 through 2022''
and inserting ``2023 through 2027'';
(3) in paragraph (3)(B), by striking ``2018 through 2022''
and inserting ``2023 through 2027'';
(4) in paragraph (4)(D), by striking ``2018 through 2022''
and inserting ``2023 through 2027''; and
(5) in paragraph (5)(D), by striking ``2018 through 2022''
and inserting ``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) by amending subparagraph (B) to read as
follows:
``(B) Fiscal years 2024 through 2027.--
``(i) In general.--For each of the fiscal
years 2024 through 2027, fees under paragraphs
(2) through (5) of subsection (a) shall be
established to generate a total estimated
revenue amount under such subsection that is
equal to the base revenue amount for the fiscal
year under clause (ii), as adjusted pursuant to
subsection (c).
``(ii) Base revenue amount.--The base
revenue amount for a fiscal year referred to in
clause (i) is equal to 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 ``twenty-four percent'';
(B) in subparagraph (D), by striking ``Seven
percent'' and inserting ``Six percent''; and
(C) in subparagraph (E)(i), by striking ``Thirty-
five percent'' and inserting ``Thirty-six percent''.
(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 ``to equal the product of
the total revenues established in such notice
for the prior fiscal year multiplied'' and
inserting ``to equal the base revenue amount
for the fiscal year (as specified in subsection
(b)(1)(B)) multiplied''; 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' announced in
the Federal Register on August 3, 2020;
``(ii) incorporate approaches and
attributes determined appropriate by the
Secretary, including approaches and attributes
made in such report, except that in
incorporating such approaches and attributes
the workload categories used in forecasting
resources shall only be the workload categories
specified in section VIII.B.2.e. of the letters
described in section 301(b) of the Generic Drug
User Fee Amendments of 2022; and
``(iii) be effective beginning with fiscal
year 2024.
``(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) Percentage limitation.--An
adjustment under this paragraph shall not
exceed three percent of the sum described in
clause (i) for the fiscal year, except that
such limitation shall be four percent if--
``(I) for purposes of a fiscal year
2024 adjustment, 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 a fiscal
year 2025 adjustment, 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 a fiscal
year 2026 adjustment, 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 a fiscal
year 2027 adjustment, 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
referred to in 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 each
subsequent fiscal year, the Secretary may, in addition
to adjustments under paragraphs (1) and (2), further
increase the fee revenue and fees under this section
for such fiscal year 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) with
respect to that fiscal year.
``(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 paragraph heading, by striking ``2018 through
2022''and inserting ``2023 through 2027''; and
(2) by striking ``more than 60 days before the first day of
each of fiscal years 2018 through 2022'' and inserting ``later
than 60 days before the first day of each of fiscal years 2023
through 2027''.
(e) 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 ``fiscal years 2018 through 2022'' and inserting
``fiscal years 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)(1), by striking ``Beginning with
fiscal year 2018, not'' and inserting ``Not'';
(2) by striking ``Generic Drug User Fee Amendments of
2017'' each place it appears and inserting ``Generic Drug User
Fee Amendments of 2022'';
(3) in subsection (a)(2), by striking ``Not later than 30
calendar days after the end of the second quarter of fiscal
year 2018, and not later than 30 calendar days after the end of
each quarter of each fiscal year thereafter'' and inserting
``Not later than 30 calendar days after the end of each quarter
of each fiscal year for which fees are collected under this
part'';
(4) in subsection (a)(3), by striking ``Beginning with
fiscal year 2020, the'' and inserting ``The'';
(5) in subsection (b), by striking ``Beginning with fiscal
year 2018, not'' and inserting ``Not'';
(6) in subsection (c), by striking ``Beginning with fiscal
year 2018, for'' and inserting ``For''; and
(7) in subsection (f)--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by striking ``fiscal year 2022'' and
inserting ``fiscal year 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 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.--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-Arlington-Alexandria, DC-VA-MD-WV; Not Seasonally
Adjusted; All items; Annual Index) for September of the
preceding fiscal year divided by such Index for September
2011.''.
(b) Biosimilar Biological Product Application.--Section
744G(4)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-51(4)(B)(iii)) is amended--
(1) by striking subclause (II) (relating to an allergenic
extract product); and
(2) by redesignating subclauses (III) and (IV) as
subclauses (II) and (III), respectively.
SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.
(a) Types of Fees.--
(1) In general.--The matter preceding paragraph (1) in
section 744H(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-52(a)) is amended by striking ``fiscal year 2018''
and inserting ``fiscal year 2023''.
(2) Initial biosimilar biological product development
fee.--Clauses (iv)(I) and (v)(II) of section 744H(a)(1)(A) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
52(a)(1)(A)) are each amended by striking ``5 days'' and
inserting ``7 days''.
(3) Annual biosimilar biological product development fee.--
Section 744H(a)(1)(B) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j-52(a)(1)(B)) is amended--
(A) in clause (i), by inserting before the period
at the end the following: ``, except where 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, in which case such licensee, assignee, or
successor shall pay the annual biosimilar biological
product development fee'';
(B) in clause (iii)--
(i) in subclause (I), by striking ``or'' at
the end;
(ii) in subclause (II), by striking the
period at the end 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
(C) in clause (iv), by striking ``is accepted for
filing on or after October 1 of such fiscal year'' and
inserting ``is subsequently accepted for filing''.
(4) Reactivation fee.--Section 744H(a)(1)(D) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(a)(1)(D)) is
amended to read as follows:
``(D) Reactivation fee.--
``(i) In general.--A person that has
discontinued participation in the biosimilar
biological product development program for a
product under subparagraph (C), or who has been
administratively removed from the biosimilar
biological product development 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 a
fee (referred to in this section as
`reactivation fee') by the earlier of the
following:
``(I) Not later than 7 days after
the Secretary grants a request by such
person for a biosimilar biological
product development meeting for the
product (after the date on which such
participation was discontinued or the
date of administrative removal, as
applicable).
``(II) Upon the date of submission
(after the date on which such
participation was discontinued or the
date of administrative removal, as
applicable) by such person of an
investigational new drug application
describing an investigation that the
Secretary determines is intended to
support a biosimilar biological product
application for that product.
``(ii) Application of annual fee.--A person
that pays a reactivation fee for a product
shall pay for such product, beginning in the
next fiscal year, the annual biosimilar
biological product development fee under
subparagraph (B), except where 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, in
which case such licensee, assignee, or
successor shall pay the annual biosimilar
biological product development fee.''.
(5) Effect of failure to pay fees.--Section 744H(a)(1)(E)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
52(a)(1)(E)) is amended 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 two
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.''.
(6) Biosimilar biological product application fee.--Section
744H(a)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-52(a)(2)(D)) is amended by inserting after ``or was
withdrawn'' the following: ``prior to approval''.
(7) Biosimilar biological product program fee.--Section
744H(a)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-52(a)(3)) is amended--
(A) in subparagraph (A)--
(i) in clause (i), by striking ``and'' at
the end;
(ii) by redesignating clause (ii) as clause
(iii); and
(iii) by inserting after clause (i) the
following:
``(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) Date of inclusion.--If a written
request to place a product on the list
referenced in subparagraph (A) of discontinued
biosimilar biological products is submitted to
the Secretary on behalf of an applicant, and
the request identifies the date the product is
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--
``(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.
``(ii) Treatment as withdrawn from sale.--
For purposes of clause (i), 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.
``(iii) Special rule.--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 referenced in subparagraph (A) of
discontinued biosimilar biological products,
and on any subsequent day during such fiscal
year the biosimilar biological product does not
appear on such list, then except as provided in
subparagraph (D), each person who is named as
the applicant in a biosimilar biological
product application with respect to such
product 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 such product for
each fiscal year.''.
(8) Biosimilar biological product fee.--Section 744H(a) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(a))
is amended by striking paragraph (4).
(c) Fee Revenue Amounts.--Subsection (b) of section 744H of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended--
(1) by striking paragraph (1);
(2) by redesignating paragraphs (2) through (4) as
paragraphs (1) through (3), respectively;
(3) by amending paragraph (1) (as so redesignated) to read
as follows:
``(1) In general.--For each of the fiscal years 2023
through 2027, 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 (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 strategic
hiring and retention adjustment (as determined under
subsection (c)(2));
``(D) the dollar amount equal to the capacity
planning adjustment for the fiscal year (as determined
under subsection (c)(3));
``(E) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if applicable
(as determined under subsection (c)(4));
``(F) for fiscal year 2023 an additional amount of
$4,428,886; and
``(G) for fiscal year 2024 an additional amount of
$320,569.'';
(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 subparagraphs (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).''.
(d) 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 paragraphs (2) through (4) and inserting
the following:
``(2) Strategic hiring and retention adjustment.--For each
fiscal year, 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.
``(3) Capacity planning adjustment.--
``(A) In general.--For each fiscal year, the
Secretary shall, in addition to the adjustments under
paragraphs (1) and (2), further adjust 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) 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' published in the Federal Register on August
4, 2020 (85 Fed. Reg. 47220). The workload categories
used in applying such methodology in forecasting shall
include only the activities described in that 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, 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 applying
such methodology in forecasting any non-core review
activities, including those activities that the
Secretary referenced for potential future use in such
notice but did not utilize in setting fees for fiscal
year 2021.
``(C) Limitations.--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), (b)(1)(B) (the dollar
amount of the inflation adjustment for the fiscal
year), and (b)(1)(C) (the dollar amount of the
strategic hiring and retention adjustment).
``(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.
``(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 such process 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 such process 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 such process 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 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
(3) in paragraph (5), in the matter preceding subparagraph
(A), by striking ``2018'' and inserting ``2023''.
(e) Crediting and Availability of Fees.--Subsection (f)(3) of
section 744H 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''.
(f) Written Requests for Waivers and Returns; Disputes Concerning
Fees.--Section 744H(h) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-52(h)) 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 for 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) in subsection (a)(1), by striking ``Beginning with
fiscal year 2018, not'' and inserting ``Not'';
(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)(2), by striking ``Beginning with
fiscal year 2018, the'' and inserting ``The'';
(4) in subsection (a)(3)(A), by striking ``Not later than
30 calendar days after the end of the second quarter of fiscal
year 2018, and not later than 30 calendar days after the end of
each quarter of each fiscal year thereafter'' and inserting
``Not later than 30 calendar days after the end of each quarter
of each fiscal year for which fees are collected under this
part'';
(5) in subsection (b), by striking ``Not later than 120
days after the end of fiscal year 2018 and each subsequent
fiscal year for which fees are collected under this part'' and
inserting ``Not later than 120 days after the end of each
fiscal year for which fees are collected under this part'';
(6) in subsection (c), by striking ``Beginning with fiscal
year 2018, and for'' and inserting ``For''; and
(7) in subsection (f)--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by striking ``fiscal year 2022'' and
inserting ``fiscal year 2027''; and
(B) in paragraph (3), by striking ``January 15,
2022'' and inserting ``January 15, 2027''.
SEC. 405. SUNSET DATES.
(a) Authorization.--Sections 744G and 744H of the Federal Food,
Drug, and Cosmetic Act shall cease to be effective October 1, 2027.
(b) Reporting Requirements.--Section 744I of the Federal Food,
Drug, and Cosmetic Act 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 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, 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--IMPROVING DIVERSITY IN CLINICAL TRIALS
SEC. 501. PREMARKET REPORTING OF DIVERSITY ACTION PLANS FOR CLINICAL
TRIALS AND STUDIES.
(a) Drugs.--Section 505(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(i)) is amended by adding at the end the following:
``(5)(A) In order for a new drug to be exempt pursuant to this
subsection, the sponsor of a clinical investigation of such new drug
shall submit to the Secretary a diversity action plan.
``(B) Such diversity action plan shall include--
``(i) the sponsor's goals for enrollment in such clinical
investigation;
``(ii) the sponsor's rationale for such goals; and
``(iii) an explanation of how the sponsor intends to meet
such goals.
``(C) The sponsor shall, in such form and manner as specified in
the guidance required by section 524B, submit such diversity action
plan as soon as practicable during drug development, but not later
than--
``(i) one month prior to an End-of-Phase 2 meeting, as
described in section 312.47(b) of title 21, Code of Federal
Regulations (or successor regulations); or
``(ii) if there is no End-of-Phase 2 meeting, one month
prior to commencing enrollment for a Phase 3 study.
``(D) The Secretary may waive the requirement in subparagraph (A)
if the Secretary determines that a waiver is necessary based on what is
known about the prevalence of the disease in terms of the patient
population that may use the new drug.''.
(b) Biological Products.--Section 351(a)(3) of the Public Health
Service Act (42 U.S.C. 262(a)(3)) is amended--
(1) by striking ``(3) The Secretary'' and inserting
``(3)(A) The Secretary''; and
(2) by adding at the end the following:
``(B)(i) In order for a biological product to be exempt pursuant to
this paragraph, the sponsor of a clinical investigation of such
biological product shall submit to the Secretary a diversity action
plan.
``(ii) Such diversity action plan shall include--
``(I) the sponsor's goals for enrollment in such clinical
investigation;
``(II) the sponsor's rationale for such goals; and
``(III) an explanation of how the sponsor intends to meet
such goals.
``(iii) The sponsor shall, in such form and manner as specified in
the guidance required by section 524B, submit such diversity action
plan as soon as practicable during biological product development, but
not later than--
``(I) one month prior to an End-of-Phase 2 meeting, as
described in section 312.47(b) of title 21, Code of Federal
Regulations (or successor regulations); or
``(II) if there is no End-of-Phase 2 meeting, one month
prior to commencing enrollment for a Phase 3 study.
``(iv) The Secretary may waive the requirement in subparagraph (A)
if the Secretary determines that a waiver is necessary based on what is
known about the prevalence of the disease in terms of the patient
population that may use the biological product.''.
(c) Devices.--Section 520(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j(g)) is amended by adding at the end the
following:
``(9)(A) In order for a device to be exempt under this subsection,
the sponsor of a clinical investigation of such device shall submit to
the Secretary a diversity action plan the sponsor of a clinical
investigation of such device shall submit to the Secretary a diversity
action plan.
``(B) Such diversity action plan shall include--
``(i) the sponsor's goals for enrollment in such clinical
investigation;
``(ii) the sponsor's rationale for such goals; and
``(iii) an explanation of how the sponsor intends to meet
such goals.
``(C) Such diversity action plan shall be--
``(i) if submission of an application for an
investigational device exemption is required, submitted in such
application; and
``(ii) if submission of an application for investigational
device exemption is not required, submitted as soon as
practicable during device development, but no later than one
month prior to commencing enrollment for a study.
``(D) The Secretary may waive the requirement in subparagraph (A)
if the Secretary determines that a waiver is necessary based on what is
known about the prevalence of the disease in terms of the patient
population that may use the device.''.
(d) Guidance.--Subchapter A of chapter V of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the
end the following:
``SEC. 524B. GUIDANCE ON DIVERSITY ACTION PLANS FOR CLINICAL TRIALS AND
STUDIES.
``(a) In General.--The Secretary shall by guidance provide
recommendations relating to--
``(1) the format and content of the diversity action plans
required by sections 505(i)(5) and 520(g)(9) of this Act, and
section 351(a)(3) of the Public Health Service Act, pertaining
to the sponsor's goals for clinical trial enrollment,
disaggregated by age group, sex, race, geographic location, and
ethnicity, including with respect to--
``(A) the rationale for the sponsor's enrollment
goals, which may include--
``(i) the estimated prevalence in the
United States of the disease or condition for
which the drug or device is being developed or
investigated, if such estimated prevalence is
known or can be determined based on available
data;
``(ii) what is known about the disease or
condition for which the drug or device is being
developed or investigated;
``(iii) any relevant pharmacokinetic or
pharmacogenomic data;
``(iv) what is known about the patient
population for such disease or condition,
including, to the extent data is available--
``(I) demographic information,
including age group, sex, race,
geographic location and ethnicity;
``(II) co-morbidities frequently
affecting the patient population; and
``(III) potential barriers to
enrolling diverse participants, such as
patient population size and geographic
location; and
``(v) any other data or information the
sponsor deems relevant to selecting appropriate
enrollment goals, disaggregated by demographic
subgroup, such as the inclusion of pregnant and
lactating women;
``(B) an explanation for how the sponsor intends to
meet such goals, including demographic-specific
outreach and enrollment strategies, study-site
selection, clinical trial inclusion and exclusion
practices, and any diversity training for trial
personnel; and
``(C) procedures for the public posting of key
information from the diversity action plan that would
be useful to patients and providers on the sponsor's
website; and
``(2) how sponsors should include in regular reports to the
Secretary--
``(A) the sponsor's progress in meeting the goals
referred to in paragraph (1)(A); and
``(B) if the sponsor does not expect to meet such
goals--
``(i) any updates needed to be made to a
diversity action plan referred to in paragraph
(1) to help meet such goals; and
``(ii) the sponsor's reasons for why the
sponsor does not expect to meet such goals.
``(b) Issuance.--The Secretary shall--
``(1) not later than 12 months after the date of enactment
of this section, issue new draft guidance or update existing
draft guidance described in subsection (a); and
``(2) not later than 6 months after closing the comment
period on such draft guidance, finalize such guidance.''.
(e) Applicability.--Sections 505(i)(5) and 520(g)(9) of the Federal
Food, Drug, and Cosmetic Act, and section 351(a)(3)(B) of the Public
Health Service Act, as added by subsections (a), (b), and (c) of this
section, apply only with respect to clinical investigations with
respect to which enrollment commences after the date that is 180 days
after the publication of final guidance under section 524B(b)(2) of the
Federal Food, Drug, and Cosmetic Act, as added by subsection (d).
SEC. 502. EVALUATION OF THE NEED FOR FDA AUTHORITY TO MANDATE
POSTAPPROVAL STUDIES OR POSTMARKET SURVEILLANCE DUE TO
INSUFFICIENT DEMOGRAPHIC SUBGROUP DATA.
(a) In General.--Not later than 2 years after the date of
publication of final guidance pursuant to section 524B(b)(2) of the
Federal Food, Drug, and Cosmetic Act, as added by section 501(d) of
this Act, the Secretary of Health and Human Services shall commence an
evaluation to assess whether additions or changes to statutes or
regulations are needed to assure that sponsors conduct postapproval
studies or postmarket surveillance when they do not meet the enrollment
goals submitted in their diversity action plan under section 505(i)(5)
or 520(g)(9) of the Federal Food, Drug, and Cosmetic Act, or section
351(a)(3)(B) of the Public Health Service Act, as added by subsection
(a), (b), or (c) of section 501 of this Act.
(b) Determination and Reporting.--Not later than 180 days after the
commencement of the evaluation under subsection (a), the Secretary of
Health and Human Services shall submit a report to the Congress on the
outcome of the such evaluation, including any recommendations related
to additional needed authorities.
SEC. 503. PUBLIC WORKSHOPS TO ENHANCE CLINICAL TRIAL DIVERSITY.
(a) In General.--Not later than September 30, 2023, the Secretary
of Health and Human Services, in consultation with drug sponsors,
medical device manufacturers, patients, and other stakeholders, shall
convene one or more public workshops to solicit input from stakeholders
on increasing the enrollment of historically underrepresented
populations in clinical trials and encouraging clinical trial
participation that reflects the prevalence of the disease or condition
among demographic subgroups, and other topics, including--
(1) how and when to collect and present demographic
subgroup and disease or condition prevalence data from clinical
trials, including with respect to--
(A) such data intended to support postapproval
study requirements; and
(B) the utilization of real world evidence (as
defined in section 505F(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355g(b)));
(2) methodologies for assessing the diversity of a patient
population;
(3) methodologies for the dissemination of information to
the public on clinical trial enrollment demographic data;
(4) the establishment of goals for enrollment in clinical
trials with respect to the estimated prevalence in the United
States of the disease or condition for which the drug is being
developed or investigated, disaggregated by demographic
subgroup (including by age group, race, ethnicity, and sex);
and
(5) approaches to support inclusion of underrepresented
populations and to encourage clinical trial participation that
reflects the prevalence of the disease or condition in certain
demographic subgroups, including with respect to--
(A) the establishment of inclusion and exclusion
criteria for certain demographic subgroups, such as
pregnant and lactating women and individuals with
disabilities, including intellectual or developmental
disabilities;
(B) considerations regarding informed consent with
respect to individuals with intellectual or
developmental disabilities;
(C) clinical trial designs, including utilization
of decentralized trials or digital health tools;
(D) clinical endpoints;
(E) biomarker selection; and
(F) studying analysis.
(b) Public Docket.--The Secretary of Health and Human Services
shall establish a public comment period to receive written comments
related to the topics addressed during each public workshop convened
under this section. The public comment period shall remain open for 60
days following the date on which each public workshop is convened.
(c) Report.--Not later than 180 days after the date of each public
workshop convened under this section, the Secretary of Health and Human
Services shall make available on the public website of the Food and
Drug Administration a report on the topics discussed at such workshop.
The report shall include a summary of, and response to, recommendations
raised in such workshop.
SEC. 504. ANNUAL REPORT ON PROGRESS TO INCREASE DIVERSITY IN CLINICAL
TRIALS AND STUDIES.
(a) In General.--Beginning not later than 2 years after the date of
enactment of this Act, and each year thereafter, the Secretary of
Health and Human Services shall submit to the Congress, and publish on
the public website of the Food and Drug Administration, a report that--
(1) summarizes, in aggregate, the diversity action plans
received pursuant to section 505(i)(5) or 520(g)(9) of the
Federal Food, Drug, and Cosmetic Act, or section 351(a)(3)(B)
of the Public Health Service Act, as added by subsection (a),
(b), or (c) of section 501 of this Act; and
(2) contains information on--
(A) whether the clinical trials conducted with
respect to such applications met the demographic
subgroup enrollment goals from the diversity action
plan submitted for such applications;
(B) the reasons provided for why enrollment goals
from submitted diversity action plans were not met;
(C) any postmarket studies of a drug or device in a
demographic subgroup or subgroups required or
recommended by the Secretary based on inadequate
premarket clinical trial diversity, including the
status and completion date of any such study; and
(D) additional authorities, if any, the Secretary
plans to use or considers necessary to ensure
compliance with the requirements of the amendments made
by section 501.
(b) Confidentiality.--Nothing in this section shall be construed as
authorizing the Secretary of Health and Human Services to disclose any
information that is a trade secret or confidential information subject
to section 552(b)(4) of title 5, United States Code, or section 1905 of
title 18, United States Code.
SEC. 505. PUBLIC MEETING ON CLINICAL TRIAL FLEXIBILITIES INITIATED IN
RESPONSE TO COVID-19 PANDEMIC.
(a) In General.--Not later than 180 days after the date on which
the COVID-19 emergency period ends, the Secretary of Health and Human
Services shall convene a public meeting to discuss the recommendations
provided by the Food and Drug Administration during the COVID-19
emergency period to mitigate disruption of clinical trials, including
recommendations detailed in the March 2020 guidance entitled ``Conduct
of Clinical Trials of Medical Products During the COVID-19 Public
Health Emergency, Guidance for Industry, Investigators, and
Institutional Review Boards'', and any subsequent updates to such
guidance. The Secretary of Health and Human Services shall invite to
such meeting representatives from the pharmaceutical and medical device
industries who sponsored clinical trials during the COVID-19 emergency
period and organizations representing patients.
(b) Topics.--Not later than 90 days after the date on which the
public meeting under subsection (a) is convened, the Secretary of
Health and Human Services shall make available on the public website of
the Food and Drug Administration a report on the topics discussed at
such meeting. Such topics shall include discussion of--
(1) the actions drug sponsors took to utilize such
recommendations and the frequency at which such recommendations
were employed;
(2) the characteristics of the sponsors, trials, and
patient populations impacted by such recommendations;
(3) a consideration of how recommendations intended to
mitigate disruption of clinical trials during the COVID-19
emergency period, including any recommendations to consider
decentralized clinical trials when appropriate, may have
affected access to clinical trials for certain patient
populations, especially unrepresented racial and ethnic
minorities; and
(4) recommendations for incorporating certain clinical
trial disruption mitigation recommendations into current or
additional guidance to improve clinical trial access and
enrollment of diverse patient populations.
(c) COVID-19 Emergency Period Defined.--In this section, the term
``COVID-19 emergency period'' has the meaning given the term
``emergency period'' in section 1135(g)(1)(B) of the Social Security
Act (42 U.S.C. 1320b-5(g)(1)(B)).
SEC. 506. DECENTRALIZED CLINICAL TRIALS.
(a) Guidance.--The Secretary of Health and Human Services shall--
(1) not later than 12 months after the date of enactment of
this Act, issue draft guidance that addresses considerations
for decentralized clinical trials, including considerations
regarding the engagement, enrollment, and retention of a
meaningfully diverse clinical population, with respect to race,
ethnicity, age, gender, and geographic location, when
appropriate; and
(2) not later than 6 months after closing the comment
period on such draft guidance, finalize such guidance.
(b) Content of Guidance.--The guidance under subsection (a) shall
address the following:
(1) Recommendations for how digital health technology or
other remote assessment options, such as telehealth, could
support decentralized clinical trials, including guidance on
considerations for selecting technological platforms and
mediums, data collection and use, data integrity and security,
and communication to study participants through digital
technology.
(2) Recommendations for subject recruitment and retention,
including considerations for sponsors to minimize or reduce
burdens for clinical trial participants through the use of
digital heath technology, telehealth, local health care
providers and laboratories, or other means.
(3) Recommendations with respect to the evaluation of data
collected within a decentralized clinical trial setting.
(c) Definition.--In this section, the term ``decentralized clinical
trial'' means a clinical trial in which some or all of the trial-
related activities occur at a location separate from the investigator's
location.
TITLE VI--GENERIC DRUG COMPETITION
SEC. 601. INCREASING TRANSPARENCY IN GENERIC DRUG APPLICATIONS.
(a) In General.--Section 505(j)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(3)) is amended by adding at the end the
following:
``(H)(i) Upon request (in controlled correspondence or otherwise)
by a person that has submitted or intends to submit an abbreviated
application for a new drug under this subsection or on the Secretary's
own initiative during the review of such abbreviated application, the
Secretary shall inform the person whether such new drug is
qualitatively and quantitatively the same as the listed drug.
``(ii) If the Secretary determines that such new drug is not
qualitatively or quantitatively the same as the listed drug, the
Secretary shall identify and disclose to the person--
``(I) the ingredient or ingredients that cause the new drug
not to be qualitatively or quantitatively the same as the
listed drug; and
``(II) for any ingredient for which there is an identified
quantitative deviation, the amount of such deviation.
``(iii) If the Secretary determines that such new drug is
qualitatively and quantitatively the same as the listed drug, the
Secretary shall not change or rescind such determination after the
submission of an abbreviated application for such new drug under this
subsection unless--
``(I) the formulation of the listed drug has been changed
and the Secretary has determined that the prior listed drug
formulation was withdrawn for reasons of safety or
effectiveness; or
``(II) the Secretary makes a written determination that the
prior determination must be changed because an error has been
identified.
``(iv) If the Secretary makes a written determination described in
clause (iii)(II), the Secretary shall provide notice and a copy of the
written determination to the person making the request under clause
(i).
``(v) The disclosures required by this subparagraph are disclosures
authorized by law under section 1905 of title 18, United States
Code.''.
(b) Guidance.--
(1) In general.--Not later than one year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall issue guidance describing how the Secretary will
determine whether a new drug is qualitatively and
quantitatively the same as the listed drug (as such terms are
used in section 505(j)(3)(H) of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a)), including with
respect to assessing pH adjusters.
(2) Process.--In issuing guidance as required by paragraph
(1), the Secretary of Health and Human Services shall--
(A) publish draft guidance;
(B) provide a period of at least 60 days for
comment on the draft guidance; and
(C) after considering any comments received,
publish final guidance.
(c) Applicability.--Section 505(j)(3)(H) of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a), applies beginning on the
date of enactment of this Act, irrespective of the date on which the
guidance required by subsection (b) is finalized.
SEC. 602. ENHANCING ACCESS TO AFFORDABLE MEDICINES.
Section 505(j)(10)(A) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)(10)(A)) is amended by striking clauses (i) through
(iv) and inserting the following:
``(i) a revision to the labeling of the listed drug has
been approved by the Secretary within 90 days of when the
application is otherwise eligible for approval under this
subsection;
``(ii) the sponsor of the application agrees to submit
revised labeling for the drug that is the subject of the
application not later than 60 days after approval under this
subsection of the application; and
``(iii) the labeling revision described under clause (i)
does not include a change to the `Warnings' section of the
labeling.''.
TITLE VII--RESEARCH, DEVELOPMENT, AND SUPPLY CHAIN IMPROVEMENTS
Subtitle A--In General
SEC. 701. ANIMAL TESTING ALTERNATIVES.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) is amended--
(1) in subsection (b)(5)(B)(i)(II), by striking ``animal''
and inserting ``nonclinical tests'';
(2) in subsection (i)--
(A) in paragraph (1)(A), by striking ``preclinical
tests (including tests on animals)'' and inserting
``nonclinical tests''; and
(B) in paragraph (2)(B), by striking ``animal'' and
inserting ``nonclinical tests''; and
(3) after subsection (y), by inserting the following:
``(z) Nonclinical Test Defined.--For purposes of this section, the
term `nonclinical test' means a test conducted in vitro, in silico, or
in chemico, or a nonhuman in vivo test, that occurs before or during
the clinical trial phase of the investigation of the safety and
effectiveness of a drug. Such test may include the following:
``(1) Cell-based assays.
``(2) Organ chips and microphysiological systems.
``(3) Sophisticated computer modeling.
``(4) Other nonhuman or human biology-based test methods.
``(5) Animal tests.''.
SEC. 702. EMERGING TECHNOLOGY PROGRAM.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
201 et seq.) is amended by inserting after section 566 of such Act (21
U.S.C. 360bbb-5) the following:
``SEC. 566A. EMERGING TECHNOLOGY PROGRAM.
``(a) Program Establishment.--
``(1) In general.--The Secretary shall establish a program
to support the adoption of, and improve the development of,
innovative approaches to drug product design and manufacturing.
``(2) Actions.--In carrying out the program under paragraph
(1), the Secretary may--
``(A) facilitate and increase communication between
public and private entities, consortia, and individuals
with respect to innovative drug product design and
manufacturing;
``(B) solicit information regarding, and conduct or
support research on, innovative approaches to drug
product design and manufacturing;
``(C) convene meetings with representatives of
industry, academia, other Federal agencies,
international agencies, and other interested persons,
as appropriate;
``(D) convene working groups to support drug
product design and manufacturing research and
development;
``(E) support education and training for regulatory
staff and scientists related to innovative approaches
to drug product design and manufacturing;
``(F) advance regulatory science related to the
development and review of innovative approaches to drug
product design and manufacturing;
``(G) convene or participate in working groups to
support the harmonization of international regulatory
requirements related to innovative approaches to drug
product design and manufacturing; and
``(H) award grants or contracts to carry out or
support the program under paragraph (1).
``(3) Grants and contracts.--To seek a grant or contract
under this section, an entity shall submit an application--
``(A) in such form and manner as the Secretary may
require; and
``(B) containing such information as the Secretary
may require, including a description of--
``(i) how the entity will conduct the
activities to be supported through the grant or
contract; and
``(ii) how such activities will further
research and development related to, or
adoption of, innovative approaches to drug
product design and manufacturing.
``(b) Guidance.--The Secretary shall--
``(1) issue or update guidance to help facilitate the
adoption of, and advance the development of, innovative
approaches to drug product design and manufacturing; and
``(2) include in such guidance descriptions of--
``(A) any regulatory requirements related to the
development or review of technologies related to
innovative approaches to drug product design and
manufacturing, including updates and improvements to
such technologies after product approval; and
``(B) data that can be used to demonstrate the
identity, safety, purity, and potency of drugs
manufactured using such technologies.
``(c) Report to Congress.--Not later than 4 years after the date of
enactment of this section, 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--
``(1) an annual accounting of the allocation of funds made
available to carry out this section;
``(2) a description of how Food and Drug Administration
staff were utilized to carry out this section and, as
applicable, any challenges or limitations related to staffing;
``(3) the number of meetings held or participated in by the
Food and Drug Administration, including meetings convened as
part of a working group described in subparagraph (D) or (G) of
subsection (a)(2), and the topics of each such meeting; and
``(4) the number of drug products approved or licensed,
after the date of enactment of this section, using an
innovative approach to drug product design and manufacturing.
``(d) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $20,000,000 for each fiscal year
2023 through 2027.''.
SEC. 703. IMPROVING THE TREATMENT OF RARE DISEASES AND CONDITIONS.
(a) Report on Orphan Drug Program.--
(1) In general.--Not later than September 30, 2026, 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
summarizing the activities of the Food and Drug Administration
related to designating drugs under section 526 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) for a rare
disease or condition and approving such drugs under section 505
of such Act (21 U.S.C. 355) or licensing such drugs under
section 351 of the Public Health Service Act (42 U.S.C. 262),
including--
(A) the number of applications for such drugs under
section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) or licensing such drugs under section
351 of the Public Health Service Act (42 U.S.C. 262)
received by the Food and Drug Administration, the
number of such applications accepted and rejected for
filing, and the number of such applications pending,
approved, and disapproved by the Food and Drug
Administration;
(B) a description of trends in drug approvals for
rare diseases and conditions across review divisions at
the Food and Drug Administration;
(C) the extent to which the Food and Drug
Administration is consulting with external experts
pursuant to section 569(a)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360bbb-8(a)(2)) on
topics pertaining to drugs for a rare disease or
condition, including how and when any such consultation
is occurring; and
(D) the Food and Drug Administration's efforts to
promote best practices in the development of novel
treatments for rare diseases, including--
(i) reviewer training on rare disease-
related policies, methods, and tools; and
(ii) new regulatory science and coordinated
support for patient and stakeholder engagement.
(2) Public availability.--The Secretary shall make the
report under paragraph (1) available to the public, including
by posting the report on the website of the Food and Drug
Administration.
(3) Information disclosure.--Nothing in this subsection
shall be construed to authorize the disclosure of information
that is prohibited from disclosure under section 1905 of title
18, United States Code, or subject to withholding under
paragraph (4) of section 552(b), United States Code (commonly
referred to as the ``Freedom of Information Act'').
(b) Study on European Union Safety and Efficacy Reviews of Drugs
for Rare Diseases and Conditions.--
(1) In general.--The Secretary of Health and Human Services
shall enter into a contract with an appropriate entity to
conduct a study on processes for evaluating the safety and
efficacy of drugs for rare diseases or conditions in the United
States and the European Union, including--
(A) flexibilities, authorities, or mechanisms
available to regulators in the United States and the
European Union specific to rare diseases or conditions;
(B) the consideration and use of supplemental data
submitted during review processes in the United States
and the European Union, including data associated with
open label extension studies and expanded access
programs specific to rare diseases or conditions;
(C) an assessment of collaborative efforts between
United States and European Union regulators related
to--
(i) product development programs under
review;
(ii) policies under development recently
issued; and
(iii) scientific information related to
product development or regulation; and
(D) recommendations for how Congress can support
collaborative efforts described in subparagraph (C).
(2) Consultation.--The contract under paragraph (1) shall
provide for consultation with relevant stakeholders,
including--
(A) representatives from the Food and Drug
Administration and the European Medicines Agency;
(B) rare disease or condition patients; and
(C) patient groups that--
(i) represent rare disease or condition
patients; and
(ii) have international patient outreach.
(3) Report.--The contract under paragraph (1) shall provide
for, not later than 2 years after the date of enactment of this
Act--
(A) the completion of the study under paragraph
(1); and
(B) the submission of a report on the results of
such study to the Committee on Energy and Commerce of
the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate.
(4) Public availability.--The contract under paragraph (1)
shall provide for the appropriate entity referred to in
paragraph (1) to make the report under paragraph (3) available
to the public, including by posting the report on the website
of the appropriate entity.
(c) Public Meeting.--
(1) In general.--Not later than December 31, 2023, the
Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall convene one or more
public meetings to solicit input from stakeholders regarding
the approaches described in paragraph (2).
(2) Approaches.--The public meeting or meetings under
paragraph (1) shall address approaches to increasing and
improving engagement with rare disease or condition patients,
groups representing such patients, rare disease or condition
experts, and experts on small population studies, in order to
improve the understanding with respect to rare diseases or
conditions of--
(A) patient burden;
(B) treatment options; and
(C) side effects of treatments, including--
(i) comparing the side effects of
treatments; and
(ii) understanding the risks of side
effects relative to the health status of the
patient and the progression of the disease or
condition.
(3) Public docket.--The Secretary of Health and Human
Services shall establish a public docket to receive written
comments related to the approaches addressed during each public
meeting under paragraph (1). Such public docket shall remain
open for 60 days following the date of each such public
meeting.
(4) Reports.--Not later than 180 days after each public
meeting under paragraph (1), the Commissioner of Food and Drugs
shall develop and publish on the website of the Food and Drug
Administration a report on--
(A) the approaches discussed at the public meeting;
and
(B) any related recommendations.
(d) Consultation on the Science of Small Population Studies.--
Section 569(a)(2) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-8(b)) is amended by adding at the end the following:
``(C) Small population studies.--The external
experts on the list maintained pursuant to subparagraph
(A) may include experts on the science of small
population studies.''.
(e) Study on Sufficiency and Use of FDA Mechanisms for
Incorporating the Patient and Clinician Perspective in FDA Processes
Related to Applications Concerning Drugs for Rare Diseases or
Conditions.--
(1) In general.--The Comptroller General of the United
States shall conduct a study on the use of Food and Drug
Administration mechanisms and tools to ensure that patient and
physician perspectives are considered and incorporated
throughout the processes of the Food and Drug Administration--
(A) for approving or licensing under section 505 of
the Federal Food, Drug, or Cosmetic Act (21 U.S.C. 355)
or section 351 of the Public Health Service Act (42
U.S.C. 262) a drug designated as a drug for a rare
disease or condition under section 526 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bb); and
(B) in making any determination related to such a
drug's approval, including assessment of the drug's--
(i) safety or effectiveness; or
(ii) postapproval safety monitoring.
(2) Topics.--The study under paragraph (1) shall--
(A) identify and compare the processes that the
Food and Drug Administration has formally put in place
and utilized to gather external expertise (including
patients, patient groups, and physicians) on specific
applications for diseases or conditions affecting
20,000 or fewer patients in the United States and
specific applications for diseases or conditions
affecting 200,000 or fewer patients in the United
States;
(B) examine tools or mechanisms to improve efforts
and initiatives of the Food and Drug Administration to
collect and consider such external expertise with
respect to applications for diseases or conditions
affecting 20,000 or fewer patients in the United States
compared to applications for diseases or conditions
affecting 200,000 or fewer patients in the United
States throughout the application review and approval
or licensure processes, including within internal
benefit-risk assessments, advisory committee processes,
and postapproval safety monitoring; and
(C) examine processes or alternatives to address or
resolve conflicts of interest that impede the Food and
Drug Administration in gaining external expert input on
rare diseases or conditions with a limited set of
clinical and research experts.
(3) Report.--Not later than 2 years after the date of
enactment of this Act, the Comptroller General of the United
States shall--
(A) complete the study under paragraph (1);
(B) submit a report on the results of such study to
the Congress; and
(C) include in such report recommendations, if
appropriate, for changes to the processes and
authorities of the Food and Drug Administration to
improve the collection and consideration of external
expert opinions of patients, patient groups, and
physicians with expertise in rare diseases or
conditions, including any specific recommendations for
diseases or conditions affecting 20,000 or fewer
patients in the United States.
(f) Definition.--In this section, the term ``rare disease or
condition'' has the meaning given such term in section 526(a)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb(a)(2)).
SEC. 704. ANTIFUNGAL RESEARCH AND DEVELOPMENT.
(a) Draft Guidance.--Not later than 3 years after the date of the
enactment of this Act, the Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, shall issue draft
guidance for industry for the purposes of assisting entities seeking
approval under section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) or licensure under section 351 of the Public Health
Service Act (42 U.S.C. 262) of antifungal therapies designed to treat
coccidioidomycosis (commonly known as Valley Fever).
(b) Final Guidance.--Not later than 18 months after the close of
the public comment period on the draft guidance issued pursuant to
subsection (a), the Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall finalize the draft
guidance.
(c) Workshop.--To assist entities developing preventive vaccines
for fungal infections and coccidioidomycosis, the Secretary of Health
and Human Services shall hold a public workshop.
SEC. 705. ADVANCING QUALIFIED INFECTIOUS DISEASE PRODUCT INNOVATION.
(a) In General.--Section 505E of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355f) is amended--
(1) in subsection (c)--
(A) in paragraph (2), by striking ``or'' at the
end;
(B) in paragraph (3), by striking the period at the
end and inserting ``; or''; and
(C) by adding at the end the following:
``(4) an application pursuant to section 351(a) of the
Public Health Service Act.'';
(2) in subsection (d)(1), by inserting ``of this Act or
section 351(a) of the Public Health Service Act'' after
``section 505(b)''; and
(3) by amending subsection (g) to read as follows:
``(g) Qualified Infectious Disease Product.--The term `qualified
infectious disease product' means a drug, including an antibacterial or
antifungal drug or a biological product, for human use that--
``(1) acts directly on bacteria or fungi or on substances
produced by such bacteria or fungi; and
``(2) is intended to treat a serious or life-threatening
infection, including such an infection caused by--
``(A) an antibacterial or antifungal resistant
pathogen, including novel or emerging infectious
pathogens; or
``(B) qualifying pathogens listed by the Secretary
under subsection (f).''.
(b) Priority Review.--Section 524A(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360n-1(a)) is amended by inserting ``of
this Act or section 351(a) of the Public Health Service Act that
requires clinical data (other than bioavailability studies) to
demonstrate safety or effectiveness'' before the period at the end.
SEC. 706. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION PILOT
PROGRAM.
Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506J
(21 U.S.C. 356j) the following:
``SEC. 506K. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION PILOT
PROGRAM.
``(a) In General.--Not later than 1 year after the date of
enactment of this section, the Secretary shall initiate a pilot program
under which persons may request designation of an advanced
manufacturing technology as described in subsection (b).
``(b) Designation Process.--The Secretary shall establish a process
for the designation under this section of methods of manufacturing
drugs, including biological products, and active pharmaceutical
ingredients of such drugs, as advanced manufacturing technologies. A
method of manufacturing, or a combination of manufacturing methods, is
eligible for designation as an advanced manufacturing technology if
such method or combination of methods incorporates a novel technology,
or uses an established technique or technology in a novel way, that
will substantially improve the manufacturing process for a drug and
maintain equivalent or provide superior drug quality, including by--
``(1) reducing development time for a drug using the
designated manufacturing method; or
``(2) increasing or maintaining the supply of--
``(A) a drug that is described in section 506C(a)
and is intended to treat a serious or life-threatening
condition; or
``(B) a drug that is on the drug shortage list
under section 506E.
``(c) Evaluation and Designation of an Advanced Manufacturing
Technology.--
``(1) Submission.--A person who requests designation of a
method of manufacturing as an advanced manufacturing technology
under this section shall submit to the Secretary data or
information demonstrating that the method of manufacturing
meets the criteria described in subsection (b) in a particular
context of use. The Secretary may facilitate the development
and review of such data or information by--
``(A) providing timely advice to, and interactive
communication with, such person regarding the
development of the method of manufacturing; and
``(B) involving senior managers and experienced
staff of the Food and Drug Administration, as
appropriate, in a collaborative, cross-disciplinary
review of the method of manufacturing, as applicable.
``(2) Evaluation and designation.--Not later than 180
calendar days after the receipt of a request under paragraph
(1), the Secretary shall determine whether to designate such
method of manufacturing as an advanced manufacturing
technology, in a particular context of use, based on the data
and information submitted under paragraph (1) and the criteria
described in subsection (b).
``(d) Review of Advanced Manufacturing Technologies.--If the
Secretary designates a method of manufacturing as an advanced
manufacturing technology, the Secretary shall--
``(1) expedite the development and review of an application
submitted under section 505 of this Act or section 351 of the
Public Health Service Act, including supplemental applications,
for drugs that are manufactured using a designated advanced
manufacturing technology and could help mitigate or prevent a
shortage or improve manufacturing processes and maintain
equivalent or provide superior drug quality, as described in
subsection (b); and
``(2) allow the holder of an advanced technology
designation, or a person authorized by the advanced
manufacturing technology designation holder, to reference or
rely upon, in an application submitted under section 505 of
this Act or section 351 of the Public Health Service Act,
including a supplemental application, data and information
about the designated advanced manufacturing technology for use
in manufacturing drugs in the same context of use for which the
designation was granted.
``(e) Implementation and Evaluation of Advanced Manufacturing
Technologies Pilot.--
``(1) Public meeting.--The Secretary shall publish in the
Federal Register a notice of a public meeting, to be held not
later than 180 days after the date of enactment of this
section, to discuss, and obtain input and recommendations from
relevant stakeholders regarding--
``(A) the goals and scope of the pilot program, and
a suitable framework, procedures, and requirements for
such program; and
``(B) ways in which the Food and Drug
Administration will support the use of advanced
manufacturing technologies and other innovative
manufacturing approaches for drugs.
``(2) Pilot program guidance.--
``(A) In general.--The Secretary shall--
``(i) not later than 180 days after the
public meeting under paragraph (1), issue draft
guidance regarding the goals and implementation
of the pilot program under this section; and
``(ii) not later than 2 years after the
date of enactment of this section, issue final
guidance regarding the implementation of such
program.
``(B) Content.--The guidance described in
subparagraph (A) shall address--
``(i) the process by which a person may
request a designation under subsection (b);
``(ii) the data and information that a
person requesting such a designation is
required to submit under subsection (c), and
how the Secretary intends to evaluate such
submissions;
``(iii) the process to expedite the
development and review of applications under
subsection (d); and
``(iv) the criteria described in subsection
(b) for eligibility for such a designation.
``(3) Report.--Not later than 3 years after the date of
enactment of this section and annually thereafter, the
Secretary shall publish on the website of the Food and Drug
Administration and submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives a report
containing a description and evaluation of the pilot program
being conducted under this section, including the types of
innovative manufacturing approaches supported under the
program. Such report shall include the following:
``(A) The number of persons that have requested
designations and that have been granted designations.
``(B) The number of methods of manufacturing that
have been the subject of designation requests and that
have been granted designations.
``(C) The average number of calendar days for
completion of evaluations under subsection (c)(2).
``(D) An analysis of the factors in data
submissions that result in determinations to designate
and not to designate after evaluation under subsection
(c)(2).
``(E) The number of applications received under
section 505 of this Act or section 351 of the Public
Health Service Act, including supplemental
applications, that have included an advanced
manufacturing technology designated under this section,
and the number of such applications approved.
``(f) Sunset.--The Secretary--
``(1) may not consider any requests for designation
submitted under subsection (c) after October 1, 2029; and
``(2) may continue all activities under this section with
respect to advanced manufacturing technologies that were
designated pursuant to subsection (d) prior to such date, if
the Secretary determines such activities are in the interest of
the public health.''.
SEC. 707. PUBLIC WORKSHOP ON CELL AND GENE THERAPIES.
Not later than 3 years after the date of the enactment of this Act,
the Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall convene a public workshop with
relevant stakeholders to discuss best practices on generating
scientific data necessary to further facilitate the development of
human cell-, tissue-, and cellular-based medical products, and the
latest scientific information about such products.
SEC. 708. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHILDREN.
Section 409I(d)(1) of the Public Health Service Act (42 U.S.C.
284m) is amended by striking ``2018 through 2022'' and inserting ``2023
through 2027''.
SEC. 709. REAUTHORIZATION FOR HUMANITARIAN DEVICE EXEMPTION AND
DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC
AVAILABILITY.
(a) Humanitarian Device Exemption.--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''.
(b) Pediatric Medical Device Safety and Improvement Act.--Section
305(e) of the Pediatric Medical Device Safety and Improvement Act
(Public Law 110-85) is amended by striking ``2018 through 2022'' and
inserting ``2023 through 2027''.
SEC. 710. REAUTHORIZATION OF PROVISION RELATED 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 ``2022'' and inserting
``2027''.
SEC. 711. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE
PARTNERSHIP PROGRAM.
Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-5(f)) is amended by striking ``$6,000,000 for each of
fiscal years 2018 through 2022'' and inserting ``$10,000,000 for each
of fiscal years 2023 through 2027''.
SEC. 712. REAUTHORIZATION OF ORPHAN DRUG GRANTS.
Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is amended--
(1) in subsection (a)--
(A) by striking ``and (3)'' and inserting ``(3)'';
and
(B) by inserting before the period at the end the
following: ``, and (4) developing regulatory science
pertaining to the chemistry, manufacturing, regulatory
approval of, and controls of individualized medical
products to treat individuals with rare diseases or
conditions''; and
(2) in subsection (c), by striking ``2018 through 2022''
and inserting ``2023 through 2027''.
Subtitle B--Inspections
SEC. 721. FACTORY INSPECTION.
(a) In General.--Section 704(a)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374(a)(1)) is amended by striking ``restricted
devices'' each place it appears and inserting ``devices''.
(b) Records or Other Information.--
(1) Establishments.--Section 704(a)(4)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)(A)) is
amended--
(A) by striking ``an establishment that is engaged
in the manufacture, preparation, propagation,
compounding, or processing of a drug'' and inserting
``an establishment that is engaged in the manufacture,
preparation, propagation, compounding, or processing of
a drug or device, or that is subject to inspection
under paragraph 5(C),''; and
(B) by inserting after ``a sufficient description
of the records requested'' the following: ``and a
rationale for requesting such records or other
information in advance of, or in lieu of, an
inspection''.
(2) Guidance.--
(A) In general.--The Secretary of Health and Human
Services shall issue guidance describing--
(i) circumstances in which the Secretary
intends to issue requests for records or other
information in advance of, or in lieu of, an
inspection under section 704(a)(4) of the
Federal Food, Drug, and Cosmetic Act, as
amended by paragraph (1);
(ii) processes for responding to such
requests electronically or in physical form;
and
(iii) factors the Secretary intends to
consider in evaluating whether such records and
other information are provided within a
reasonable timeframe, within reasonable limits,
and in a reasonable manner, accounting for
resource and other limitations that may exist,
including for small businesses.
(B) Timing.--The Secretary of Health and Human
Services shall--
(i) not later than 1 year after the date of
enactment of this Act, issue draft guidance
under subparagraph (A); and
(ii) not later than 1 year after the close
of the comment period for such draft guidance,
issue final guidance under subparagraph (A).
(c) Bioresearch Monitoring Inspections.--
(1) In general.--Section 704(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 374(a)) is amended by adding at the
end the following:
``(5) Bioresearch Monitoring Inspections.--
``(A) In general.--The Secretary may, to ensure the
accuracy and reliability of studies and records or other
information described in subparagraph (B) and to assess
compliance with applicable requirements under this Act or the
Public Health Service Act, enter sites and facilities specified
in subparagraph (C) in order to inspect such records or other
information.
``(B) Information subject to inspection.--An inspection
under this paragraph shall extend to all records and other
information related to the studies and submissions described in
subparagraph (E), including records and information related to
the conduct, results, and analyses of, and the protection of
human and animal trial participants participating in, such
studies.
``(C) Sites and facilities subject to inspection.--
``(i) Sites and facilities described.--The sites
and facilities subject to inspection by the Secretary
under this paragraph are those owned or operated by a
person described in clause (ii) and which are (or were)
utilized by such person in connection with--
``(I) developing an application or other
submission to the Secretary under this Act or
the Public Health Service Act related to
marketing authorization for a product described
in paragraph (1);
``(II) preparing, conducting, or analyzing
the results of a study described in
subparagraph (E); or
``(III) holding any records or other
information described in subparagraph (B).
``(ii) Persons described.--A person described in
this clause is--
``(I) the sponsor of an application or
submission specified in clause (i)(I);
``(II) a person engaged in any activity
described in clause (i) on behalf of such a
sponsor, through a contract, grant, or other
business arrangement with such sponsor;
``(III) an institutional review board, or
other individual or entity, engaged by
contract, grant, or other business arrangement
with a nonsponsor in preparing, collecting, or
analyzing records or other information
described in subparagraph (B); or
``(IV) any person not otherwise described
in this clause that conducts, or has conducted,
a study described in subparagraph (E) yielding
records or other information described in
subparagraph (B).
``(D) Conditions of inspection.--
``(i) Access to information subject to
inspection.--Subject to clause (ii), an entity that
owns or operates any site or facility subject to
inspection under this paragraph shall provide the
Secretary with access to records and other information
described in subparagraph (B) that is held by or under
the control of such entity, including--
``(I) permitting the Secretary to record or
copy such information for purposes of this
paragraph;
``(II) providing the Secretary with access
to any electronic information system utilized
by such entity to hold, process, analyze, or
transfer any records or other information
described in subparagraph (B); and
``(III) permitting the Secretary to inspect
the facilities, equipment, written procedures,
processes, and conditions through which records
or other information described in subparagraph
(B) is or was generated, held, processed,
analyzed, or transferred.
``(ii) No effect on applicability of provisions for
protection of proprietary information or trade
secrets.--Nothing in clause (i) shall negate,
supersede, or otherwise affect the applicability of
provisions, under this or any other Act, preventing or
limiting the disclosure of confidential commercial
information or other information considered proprietary
or trade secret.
``(iii) Reasonableness of inspections.--An
inspection under this paragraph shall be conducted at
reasonable times and within reasonable limits and in a
reasonable manner.
``(E) Studies and submissions described.--The studies and
submissions described in this subparagraph are each of the
following:
``(i) Clinical and nonclinical studies submitted to
the Secretary in support of, or otherwise related to,
applications and other submissions to the Secretary
under this Act or the Public Health Service Act for
marketing authorization of a product described in
paragraph (1).
``(ii) Postmarket safety activities conducted under
this Act or the Public Health Service Act.
``(iii) Any other clinical investigation of--
``(I) a drug subject to section 505 or 512
of this Act or section 351 of the Public Health
Service Act; or
``(II) a device subject to section 520(g).
``(iv) Any other submissions made under this Act or
the Public Health Service Act with respect to which the
Secretary determines an inspection under this paragraph
is warranted in the interest of public health.
``(F) Clarification.--This paragraph clarifies the
authority of the Secretary to conduct inspections of the type
described in this paragraph and shall not be construed as a
basis for inferring that, prior to the date of enactment of
this paragraph, the Secretary lacked the authority to conduct
such inspections, including under this Act or the Public Health
Service Act.''.
(2) Review of processes and practices; guidance for
industry.--
(A) In general.--The Secretary of Health and Human
Services shall--
(i) review processes and practices in
effect as of the date of enactment of this Act
applicable to inspections of foreign and
domestic sites and facilities described in
subparagraph (C)(i) of section 704(a)(5) of the
Federal Food, Drug, and Cosmetic Act, as added
by paragraph (1); and
(ii) evaluate whether any updates are
needed to facilitate the consistency of such
processes and practices.
(B) Guidance.--
(i) In general.--The Secretary of Health
and Human Services shall issue guidance
describing the processes and practices
applicable to inspections of sites and
facilities described in subparagraph (C)(i) of
section 704(a)(5) of the Federal Food, Drug,
and Cosmetic Act, as added by paragraph (1),
including with respect to the types of records
and information required to be provided, best
practices for communication between the Food
and Drug Administration and industry in advance
of or during an inspection or request for
records or other information, and other
inspections-related conduct, to the extent not
specified in existing publicly available Food
and Drug Administration guides and manuals for
such inspections.
(ii) Timing.--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 under clause (i);
and
(II) not later than 1 year after
the close of the public comment period
for such draft guidance, issue final
guidance under clause (i).
SEC. 722. USES OF CERTAIN EVIDENCE.
Section 703 of the of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 373) is amended by adding at the end the following:
``(c) Applicability.--The limitations on the Secretary's use of
evidence obtained under this section, or any evidence which is directly
or indirectly derived from such evidence, in a criminal prosecution of
the person from whom such evidence was obtained shall not apply to
evidence obtained under authorities other than this section, unless
such limitations are specifically incorporated by reference in such
other authorities.''.
SEC. 723. IMPROVING FDA INSPECTIONS.
(a) Risk Factors for Establishments.--Section 510(h)(4) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)(4)) is amended--
(1) by redesignating subparagraph (F) as subparagraph (G);
and
(2) by inserting after subparagraph (E) the following:
``(F) The compliance history of establishments in
the country or region in which the establishment is
located that are subject to regulation under this Act,
including the history of violations related to products
exported from such country or region that are subject
to such regulation.''.
(b) Use of Records.--Section 704(a)(4) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 374) is amended--
(1) by redesignating subparagraph (C) as subparagraph (D);
and
(2) by inserting after subparagraph (B) the following:
``(C) The Secretary may rely on any records or other information
that the Secretary may inspect under this section to satisfy
requirements that may pertain to a preapproval or risk-based
surveillance inspection, or to resolve deficiencies found in such
inspections, if applicable and appropriate.''.
(c) Recognition of Foreign Government Inspections.--Section 809 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384e) is amended--
(1) in subsection (a)(1), by inserting ``preapproval or''
before ``risk-based inspections''; and
(2) by adding at the end the following:
``(c) Periodic Review.--
``(1) In general.--Beginning not later than 1 year after
the date of the enactment of the Food and Drug Amendments of
2022 the Secretary shall periodically assess whether additional
arrangements and agreements with a foreign government or an
agency of a foreign government, as allowed under this section,
are appropriate.
``(2) Reports to congress.--Beginning not later than 4
years after the date of the enactment of the Food and Drug
Amendments of 2022, and every 4 years 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 a report describing the findings
and conclusions of each review conducted under paragraph
(1).''.
SEC. 724. GAO REPORT ON INSPECTIONS OF FOREIGN ESTABLISHMENTS
MANUFACTURING DRUGS.
(a) In General.--Not later than 18 months after the date of the
enactment of this Act, the Comptroller General of the United States
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 inspections conducted by--
(1) the Secretary of Health and Human Services (in this
section referred to as the ``Secretary'') of foreign
establishments pursuant to subsections (h) and (i) of section
510 and 704 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360, 374); or
(2) a foreign government or an agency of a foreign
government pursuant to section 809 of such Act (21 U.S.C.
384e).
(b) Contents.--The report conducted under subsection (a) shall
include--
(1) what alternative tools, including remote inspections or
remote evaluations, other countries are utilizing to facilitate
inspections of foreign establishments;
(2) how frequently trusted foreign regulators conduct
inspections of foreign facilities that could be useful to the
Food and Drug Administration to review in lieu of its own
inspections;
(3) how frequently and under what circumstances, including
for what types of inspections, the Secretary utilizes existing
agreements or arrangements under section 809 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 384e) and whether the
use of such agreements could be appropriately expanded;
(4) whether the Secretary has accepted reports of
inspections of facilities in China and India conducted by
entities with which they have entered into such an agreement or
arrangement;
(5) what additional foreign governments or agencies of
foreign governments the Secretary has considered entering into
a mutual recognition agreement with and, if applicable, reasons
why the Secretary declined to enter into a mutual recognition
agreement with such foreign governments or agencies;
(6) what tools, if any, the Secretary used to facilitate
inspections of domestic facilities that could also be
effectively utilized to appropriately inspect foreign
facilities;
(7) what steps the Secretary has taken to identify and
evaluate tools and strategies the Secretary may use to continue
oversight with respect to inspections when in-person
inspections are disrupted;
(8) how the Secretary is considering incorporating
alternative tools into the inspection activities conducted
pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321 et seq.); and
(9) what steps the Secretary has taken to identify and
evaluate how the Secretary may use alternative tools to address
workforce shortages to carry out such inspection activities.
SEC. 725. UNANNOUNCED FOREIGN FACILITY INSPECTIONS PILOT PROGRAM.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall conduct a
pilot program under which the Secretary increases the conduct of
unannounced surveillance inspections of foreign human drug
establishments and evaluates the differences between such inspections
of domestic and foreign human drug establishments, including the impact
of announcing inspections to persons who own or operate foreign human
drug establishments in advance of an inspection. Such pilot program
shall evaluate--
(1) differences in the number and type of violations of
section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351(a)(2)(B)) identified during unannounced and
announced inspections of foreign human drug establishments and
any other significant differences between each type of
inspection;
(2) costs and benefits associated with conducting announced
and unannounced inspections of foreign human drug
establishments;
(3) barriers to conducting unannounced inspections of
foreign human drug establishments and any challenges to
achieving parity between domestic and foreign human drug
establishment inspections; and
(4) approaches for mitigating any negative effects of
conducting announced inspections of foreign human drug
establishments.
(b) Pilot Program Scope.--The inspections evaluated under the pilot
program under this section shall be routine surveillance inspections
and shall not include inspections conducted as part of the Secretary's
evaluation of a request for approval to market a drug submitted under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the
Public Health Service Act (42 U.S.C. 201 et seq.).
(c) Pilot Program Initiation.--The Secretary shall initiate the
pilot program under this section not later than 180 days after the date
of enactment of this Act.
(d) Report.--The Secretary shall, not later than 180 days following
the completion of the pilot program under this section, make available
on the website of the Food and Drug Administration a final report on
the pilot program under this section, including--
(1) findings and any associated recommendations with
respect to the evaluation under subsection (a), including any
recommendations to address identified barriers to conducting
unannounced inspections of foreign human drug establishments;
(2) findings and any associated recommendations regarding
how the Secretary may achieve parity between domestic and
foreign human drug inspections; and
(3) the number of unannounced inspections during the pilot
program that would not be unannounced under existing practices.
SEC. 726. 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 ``2022'' and inserting
``2027''.
SEC. 727. ENHANCING INTRA-AGENCY COORDINATION AND PUBLIC HEALTH
ASSESSMENT WITH REGARD TO COMPLIANCE ACTIVITIES.
(a) Coordination.--Section 506D of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356d) is amended by adding at the end the
following:
``(g) Coordination.--The Secretary shall ensure timely and
effective internal coordination and alignment among the field
investigators of the Food and Drug Administration and the staff of the
Center for Drug Evaluation and Research's Office of Compliance and Drug
Shortage Program regarding--
``(1) the reviews of reports shared pursuant to section
704(b)(2); and
``(2) any feedback or corrective or preventive actions in
response to such reports.''.
(b) Reporting.--
(1) In general.--Section 506C-1(a)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 356c-1(a)(2)) is amended to
read as follows:
``(2)(A) describes the communication between the field
investigators of the Food and Drug Administration and the staff
of the Center for Drug Evaluation and Research's Office of
Compliance and Drug Shortage Program, including the Food and
Drug Administration's procedures for enabling and ensuring such
communication;
``(B) provides the number of reports described in section
704(b)(2) that were required to be sent to the appropriate
offices of the Food and Drug Administration and the number of
such reports that were sent; and
``(C) describes the coordination and alignment activities
undertaken pursuant to section 506D(g);''.
(2) Applicability.--The amendment made by paragraph (1)
shall apply with respect to reports submitted on or after March
31, 2023.
SEC. 728. REPORTING OF MUTUAL RECOGNITION AGREEMENTS FOR INSPECTIONS
AND REVIEW ACTIVITIES.
(a) In General.--Not later than December 31, 2022, and annually
thereafter, the Secretary of Health and Human Services (referred to in
this section as the ``Secretary'') shall publish a report on the public
website of the Food and Drug Administration on the utilization of
agreements entered into pursuant to section 809 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 384e) or otherwise entered into by
the Secretary in the previous fiscal year to recognize inspections
between drug regulatory authorities across countries and international
regions with analogous review criteria to the Food and Drug
Administration, such as the Pharmaceutical Inspection Co-Operation
Scheme, the Mutual Recognition Agreement with the European Union, and
the Australia-Canada-Singapore-Switzerland Consortium.
(b) Content.--The report under subsection (a) shall include each of
the following:
(1) The total number of establishments that are registered
under section 510(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(i)), and the number of such establishments
in each region of interest.
(2) The total number of inspections conducted at
establishments described in paragraph (1), disaggregated by
inspections conducted--
(A) pursuant to an agreement or other recognition
described in subsection (a); and
(B) by employees or contractors of the Food and
Drug Administration.
(3) Of the inspections described in paragraph (2), the
total number of inspections in each region of interest.
(4) Of the inspections in each region of interest reported
pursuant to paragraph (3), the number of inspections in each
FDA inspection category.
(5) Of the number of inspections reported under each of
paragraphs (3) and (4)--
(A) the number of inspections which have been
conducted pursuant to an agreement or other recognition
described in subsection (a); and
(B) the number of inspections which have been
conducted by employees or contractors of the Food and
Drug Administration.
(c) Definitions.--In this subsection:
(1) FDA inspection category.--The term ``FDA inspection
category'' means the following inspection categories:
(A) Inspections to support approvals of changes to
the manufacturing process of drugs approved under
section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) or section 351 of the Public Health
Service Act (42 U.S.C. 262).
(B) Surveillance inspections.
(C) For-cause inspections.
(2) Region of interest.--The term ``region of interest''
means China, India, the European Union, and any other
geographic region as the Secretary determines appropriate.
SEC. 729. ENHANCING TRANSPARENCY OF DRUG FACILITY INSPECTION TIMELINES.
Section 902 of the FDA Reauthorization Act of 2017 (21 U.S.C. 355
note) is amended to read as follows:
``SEC. 902. ANNUAL REPORT ON INSPECTIONS.
``Not later than 120 days after the end of each fiscal year, the
Secretary of Health and Human Services shall post on the public website
of the Food and Drug Administration information related to inspections
of facilities, including inspections that are necessary for approval of
a drug under subsection (c) or (j) of section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355), approval of a device under
section 515 of such Act (21 U.S.C. 360e), or clearance of a device
under section 510(k) of such Act (21 U.S.C. 360(k)) that were conducted
during the previous fiscal year. Such information shall include the
following:
``(1) The median time following a request from staff of the
Food and Drug Administration reviewing an application or report
to the beginning of the inspection, including--
``(A) the median time for drugs described in
section 505(j)(11)(A)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(11)(A)(i));
``(B) the median time for drugs described in
section 506C(a) of such Act (21 U.S.C. 356c(a)) only;
and
``(C) the median time for drugs on the drug
shortage list in effect under section 506E of such Act
(21 U.S.C. 356f).
``(2) The median time from the issuance of a report
pursuant to section 704(b) of such Act (21 U.S.C. 374(b)) to
the sending of a warning letter, issuance of an import alert,
or holding of a regulatory meeting for inspections for which
the Secretary concluded that regulatory or enforcement action
was indicated, including the median time for each category of
drugs listed in subparagraphs (A) through (C) of paragraph (1).
``(3) The median time from the sending of a warning letter,
issuance of an import alert, or holding of a regulatory meeting
to resolution of the actions indicated to address the
conditions or practices observed during an inspection.
``(4) The number of facilities that were unable to
implement requested corrective or preventive actions following
a report pursuant to such section 704(b), resulting in a
withhold recommendation, including the number of such times for
each category of drugs listed in subparagraphs (A) through (C)
of paragraph (1).''.
TITLE VIII--TRANSPARENCY, PROGRAM INTEGRITY, AND REGULATORY
IMPROVEMENTS
SEC. 801. PROMPT REPORTS OF MARKETING STATUS BY HOLDERS OF APPROVED
APPLICATIONS FOR BIOLOGICAL PRODUCTS.
(a) In General.--Section 506I of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356i) is amended--
(1) in subsection (a)--
(A) in the matter preceding paragraph (1), by
striking ``The holder of an application approved under
subsection (c) or (j) of section 505'' and inserting
``The holder of an application approved under
subsection (c) or (j) of section 505 of this Act or
subsection (a) or (k) of section 351 of the Public
Health Service Act'';
(B) in paragraph (2), by striking ``established
name'' and inserting ``established name (for biological
products, by proper name)''; and
(C) in paragraph (3), by striking ``or abbreviated
application number'' and inserting ``, abbreviated
application number, or biologics license application
number''; and
(2) in subsection (b)--
(A) in the matter preceding paragraph (1), by
striking ``The holder of an application approved under
subsection (c) or (j)'' and inserting ``The holder of
an application approved under subsection (c) or (j) of
section 505 of this Act or subsection (a) or (k) of
section 351 of the Public Health Service Act'';
(B) in paragraph (1), by striking ``established
name'' and inserting ``established name (for biological
products, by proper name)''; and
(C) in paragraph (2), by striking ``or abbreviated
application number'' and inserting ``, abbreviated
application number, or biologics license application
number''.
(b) Additional One-Time Report.--Subsection (c) of section 506I of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356i) is amended to
read as follows:
``(c) Additional One-Time Report.--Within 180 days of the date of
enactment of the Food and Drug Amendments of 2022, all holders of
applications approved under subsection (a) or (k) of section 351 of the
Public Health Service Act shall review the information in the list
published under section 351(k)(9)(A) and shall submit a written notice
to the Secretary--
``(1) stating that all of the application holder's
biological products in the list published under section
351(k)(9)(a) that are not listed as discontinued are available
for sale; or
``(2) including the information required pursuant to
subsection (a) or (b), as applicable, for each of the
application holder's biological products that are in the list
published under section 351(k)(9)(a) and not listed as
discontinued, but have been discontinued from sale or never
have been available for sale.''.
(c) Purple Book.--Section 506I of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356i) is amended--
(1) by striking subsection (d) and inserting the following:
``(d) Failure to Meet Requirements.--If a holder of an approved
application fails to submit the information required under subsection
(a), (b), or (c), the Secretary may--
``(1) move the application holder's drugs from the active
section of the list published under section 505(j)(7)(A) to the
discontinued section of the list, except that the Secretary
shall remove from the list in accordance with section
505(j)(7)(C) drugs the Secretary determines have been withdrawn
from sale for reasons of safety of effectiveness; and
``(2) identify the application holder's biological products
as discontinued in the list published under section
351(k)(9)(A) of the Public Health Service Act, except that the
Secretary shall remove from the list in accordance with section
351(k)(9)(B) of such Act biological products for which the
license has been revoked or suspended for reasons of safety,
purity, or potency.''; and
(2) in subsection (e)--
(A) by inserting after the first sentence the
following: ``The Secretary shall update the list
published under section 351(k)(9)(A) of the Public
Health Service Act based on information provided under
subsections (a), (b), and (c) by identifying as
discontinued biological products that are not available
for sale, except that biological products for which the
license has been revoked or suspended for safety,
purity, or potency reasons shall be removed from the
list in accordance with section 351(k)(9)(B) of the
Public Health Service Act.'';
(B) by striking ``monthly updates to the list'' and
inserting ``monthly updates to the lists referred to in
the preceding sentences''; and
(C) by striking ``and shall update the list based
on'' and inserting ``and shall update such lists based
on''.
(d) Technical Corrections.--Section 506I(e) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 356i(e)) is amended--
(1) by striking ``subsection 505(j)(7)(A)'' and inserting
``section 505(j)(7)(A)''; and
(2) by striking ``subsection 505(j)(7)(C)'' and inserting
``section 505(j)(7)(C)''.
SEC. 802. ENCOURAGING BLOOD DONATION.
Section 3003 of the 21st Century Cures Act (21 U.S.C. 360bbb-8c
note) is amended to read as follows:
``SEC. 3003. STREAMLINING PATIENT AND BLOOD DONOR INPUT.
``Chapter 35 of title 44, United States Code, shall not apply to
the collection of information to which a response is voluntary, to
solicit--
``(1) the views and perspectives of patients under section
569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-8c) (as amended by section 3001) or section 3002; or
``(2) information from blood donors or potential blood
donors to support the development of recommendations by the
Secretary of Health and Human Services concerning blood
donation.''.
SEC. 803. REGULATION OF CERTAIN PRODUCTS AS DRUGS.
Section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
353) is amended by adding at the end the following:
``(h)(1) Any contrast agent, radioactive drug, or OTC monograph
drug shall be deemed to be a drug under section 201(g) and not a device
under section 201(h).
``(2) For purposes of this subsection:
``(A) The term `contrast agent' means a drug that is
intended for use in conjunction with an applicable medical
imaging device, and--
``(i) is a diagnostic radiopharmaceutical, as
defined in sections 315.2 and 601.31 of title 21, Code
of Federal Regulations (or any successor regulations);
or
``(ii) is a diagnostic agent that improves the
visualization of structure or function within the body
by increasing the relative difference in signal
intensity within the target tissue, structure, or
fluid.
``(B) The term `radioactive drug' has the meaning given
such term in section 310.3(n) of title 21, Code of Federal
Regulations (or any successor regulations), except that such
term does not include--
``(i) an implant or article similar to an implant;
``(ii) an article that applies radiation from
outside of the body; or
``(iii) the radiation source of an article
described in (i) or (ii).
``(C) The term `OTC monograph drug' has the meaning given
such term in section 744L.
``(3) Nothing in this subsection shall be construed as allowing for
the classification a product as a drug (as defined in section 201(g))
if such product--
``(A) is not described in paragraph (1); and
``(B) meets the definition of a device under section
201(h).''.
SEC. 804. POSTAPPROVAL STUDIES AND PROGRAM INTEGRITY FOR ACCELERATED
APPROVAL DRUGS.
(a) In General.--Section 506(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356(c)) is amended--
(1) by striking paragraph (2) and inserting the following:
``(2) Limitation.--
``(A) In general.--Approval of a product under this
subsection may be subject to 1 or both of the following
requirements:
``(i) That the sponsor conduct an
appropriate postapproval study or studies
(which may be augmented or supported by real
world evidence) to verify and describe the
predicted effect on irreversible morbidity or
mortality or other clinical benefit.
``(ii) That the sponsor submit copies of
all promotional materials related to the
product during the preapproval review period
and, following approval and for such period
thereafter as the Secretary determines to be
appropriate, at least 30 days prior to
dissemination of the materials.
``(B) Studies not required.--If the Secretary does
not require that the sponsor of a product approved
under accelerated approval conduct a postapproval study
under this paragraph, the Secretary shall publish on
the website of the Food and Drug Administration the
rationale for why such study is not appropriate or
necessary.
``(C) Postapproval study conditions.--Not later
than the time of approval of a product under
accelerated approval, the Secretary shall specify the
conditions for a postapproval study or studies required
to be conducted under this paragraph with respect to
such product, which may include enrollment targets, the
study protocol, and milestones, including the target
date of study completion.
``(D) Studies begun before approval.--The Secretary
may require such study or studies to be underway prior
to approval.''; and
(2) by striking paragraph (3) and inserting the following:
``(3) Expedited withdrawal of approval.--
``(A) In general.--The Secretary may withdraw
approval of a product approved under accelerated
approval using expedited procedures described in
subparagraph (B), if--
``(i) the sponsor fails to conduct any
required postapproval study of the product with
due diligence, including with respect to
conditions specified by the Secretary under
paragraph (2)(C);
``(ii) a study required to verify and
describe the predicted effect on irreversible
morbidity or mortality or other clinical
benefit of the product fails to verify and
describe such effect or benefit;
``(iii) other evidence demonstrates that
the product is not shown to be safe or
effective under the conditions of use; or
``(iv) the sponsor disseminates false or
misleading promotional materials with respect
to the product.
``(B) Expedited procedures described.--Expedited
procedures described in this subparagraph shall consist
of, prior to the withdrawal of accelerated approval--
``(i) providing the sponsor with--
``(I) due notice;
``(II) an explanation for the
proposed withdrawal;
``(III) an opportunity for a
meeting with the Commissioner of Food
and Drugs or the Commissioner's
designee; and
``(IV) an opportunity for written
appeal to--
``(aa) the Commissioner of
Food and Drugs; or
``(bb) a designee of the
Commissioner who has not
participated in the proposed
withdrawal of approval (other
than a meeting pursuant to
subclause (III)) and is not a
subordinate of an individual
(other than the Commissioner)
who participated in such
proposed withdrawal;
``(ii) providing an opportunity for public
comment on the notice proposing to withdraw
approval;
``(iii) the publication of a summary of the
public comments received, and the Secretary's
response to such comments, on the website of
the Food and Drug Administration; and
``(iv) convening and consulting an advisory
committee on issues related to the proposed
withdrawal, if requested by the sponsor and if
no such advisory committee has previously
advised the Secretary on such issues with
respect to the withdrawal of the product prior
to the sponsor's request.
``(4) Labeling.--
``(A) In general.--Subject to subparagraph (B), the
label for a product approved under accelerated approval
shall include--
``(i) a statement indicating that the
product was approved under accelerated
approval;
``(ii) a statement indicating that
continued approval of the product is subject to
postmarketing studies to verify clinical
benefit;
``(iii) identification of the surrogate or
intermediate endpoint or endpoints that
supported approval and any known limitations of
such surrogate or intermediate endpoint or
endpoints in determining clinical benefit; and
``(iv) a succinct description of the
product and any uncertainty about anticipated
clinical benefit and a discussion of available
evidence with respect to such clinical benefit.
``(B) Applicability.--The labeling requirements of
subparagraph (A) shall apply only to products approved
under accelerated approval for which the predicted
effect on irreversible morbidity or mortality or other
clinical benefit has not been verified.
``(5) Reporting.--Not later than September 30, 2025, 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
describing circumstances in which the Secretary considered real
world evidence submitted to support postapproval studies
required under this subsection that were completed after the
date of enactment of the Food and Drug Amendments of 2022.''.
(b) Reports of Postmarketing Studies.--Section 506B(a) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356b(a)) is amended--
(1) by redesignating paragraph (2) as paragraph (3); and
(2) by inserting after paragraph (1) the following:
``(2) Accelerated approval.--Notwithstanding paragraph (1),
a sponsor of a drug approved under accelerated approval shall
submit to the Secretary a report of the progress of any study
required under section 506(c), including progress toward any
agreed upon enrollment targets, milestones, and other
information as required by the Secretary, not later than 180
days after the approval of such drug and not less frequently
than every 180 days thereafter, until the study is completed or
terminated.''.
(c) Guidance.--
(1) In general.--The Secretary of Health and Human Services
shall issue guidance describing--
(A) how sponsor questions related to the
identification of novel surrogate or intermediate
clinical endpoints may be addressed in early-stage
development meetings with the Food and Drug
Administration;
(B) the use of novel clinical trial designs that
may be used to conduct appropriate postapproval studies
as may be required under section 506(c)(2)(A) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356(c)(2)(A)), as amended by subsection (a); and
(C) the expedited procedures described in section
506(c)(3)(B) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 356(c)(3)(B)).
(2) Final guidance.--The Secretary shall issue--
(A) draft guidance under paragraph (1) not later
than 18 months after the date of enactment of this Act;
and
(B) final guidance not later than 1 year after the
close of the public comment period on each draft
guidance.
(d) Rare Disease Endpoint Advancement Pilot.--
(1) In general.--The Secretary of Health and Human Services
shall establish a pilot program under which the Secretary will
establish procedures to provide increased interaction with
sponsors of rare disease drug development programs for purposes
of advancing the development of efficacy endpoints, including
surrogate and intermediate endpoints, for drugs intended to
treat rare diseases, including through--
(A) determining eligibility of participants for
such a program; and
(B) developing and implementing a process for
applying to, and participating in, such a program.
(2) Public workshops.--The Secretary shall conduct up to 3
public workshops, which shall be completed not later than
September 30, 2026, to discuss topics relevant to the
development of endpoints for rare diseases, which may include
discussions about--
(A) novel endpoints developed through the pilot
program established under this subsection; and
(B) as appropriate, the use of real world evidence
and real world data to support the validation of
efficacy endpoints, including surrogate and
intermediate endpoints, for rare diseases.
(3) Report.--Not later than September 30, 2027, 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
describing the outcomes of the pilot program established under
this subsection.
(4) Guidance.--Not later than September 30, 2027, the
Secretary shall issue guidance describing best practices and
strategies for development of efficacy endpoints, including
surrogate and intermediate endpoints, for rare diseases.
(5) Sunset.--The Secretary may not accept any new
application or request to participate in the program
established by this subsection on or after October 1, 2027.
SEC. 805. FACILITATING THE USE OF REAL WORLD EVIDENCE.
(a) Guidance.--Not later than 1 year after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
issue, or revise existing, guidance on considerations for the use of
real world data and real world evidence to support regulatory
decisionmaking, as follows:
(1) With respect to drugs, such guidance shall address--
(A) the use of such data and evidence to support
the approval of a drug application under section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) or a biological product application under section
351 of the Public Health Service Act (42 U.S.C. 262),
or to support an investigational use exemption under
section 505(i) of the Federal Food, Drug, and Cosmetic
Act or section 351(a)(3) of the Public Health Service
Act; and
(B) the use of such data and evidence obtained as a
result of the use of drugs authorized for emergency use
under section 564 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-3) in such applications,
submissions, or requests; and
(C) standards and methodologies which may be used
for collection and analysis of real world evidence
included in such applications, submissions, or
requests, as appropriate.
(2) With respect to devices, such guidance shall address--
(A) the use of such data and evidence to support
the approval, clearance, or classification of a device
pursuant to an application or submission submitted
under section 510(k), 513(f)(2), or 515 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360(k),
360c(f)(2), 360e), or to support an investigational use
exemption under section 520(g) of such Act (21 U.S.C.
360j(g)); and
(B) the use of such data and evidence obtained as a
result of the use of devices authorized for emergency
use under section 564 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-3), in such
applications, submissions, or requests; and
(C) standards and methodologies which may be used
for collection and analysis of real world evidence
included in such applications, submissions, or
requests, as appropriate.
(b) Report to Congress.--Not later than 2 years after the
termination of the public health emergency determination by the
Secretary of Health and Human Services under section 564 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3) on February 4, 2020,
with respect to the Coronavirus Disease 2019 (COVID-19), the Secretary
shall submit a report to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate on--
(1) the number of applications submitted for clearance or
approval under sections 505, 510(k), or 515 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k),
360c(f)(2), 360e) or section 351 of the Public Health Service
Act, for which an authorization under section 564 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3) was
previously granted;
(2) of the number of applications so submitted, the number
of such applications--
(A) for which real world evidence was submitted and
used to support a regulatory decision; and
(B) for which real world evidence was submitted and
determined to be insufficient to support a regulatory
decision; and
(3) a summary explanation of why, in the case of
applications described in paragraph (2)(B), real world evidence
could not be used to support regulatory decisions.
SEC. 806. MEDICAL DEVICES ADVISORY COMMITTEE MEETINGS.
(a) In General.--The Secretary shall convene one or more panels of
the Medical Devices Advisory Committee not less than once per year for
the purpose of providing advice to the Secretary on topics related to
medical devices in pandemic preparedness and response, including the
issues related to in vitro diagnostics.
(b) Required Panel Member.--A panel convened under subsection (a)
shall include at least 1 population health-specific representative.
(c) Sunset.--This section shall cease to be effective on October 1,
2027.
SEC. 807. ENSURING CYBERSECURITY OF MEDICAL DEVICES.
(a) In General.--Subchapter A of chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), as amended by section
501, is further amended by adding at the end the following:
``SEC. 524C. ENSURING CYBERSECURITY OF DEVICES.
``(a) In General.--For purposes of ensuring cybersecurity
throughout the lifecycle of a cyber device, any person who submits a
premarket submission for the cyber device shall include such
information as the Secretary may require to ensure that the cyber
device meets such cybersecurity requirements as the Secretary
determines to be appropriate to demonstrate a reasonable assurance of
safety and effectiveness, including at a minimum the cybersecurity
requirements under subsection (b).
``(b) Cybersecurity Requirements.--At a minimum, the manufacturer
of a cyber device shall meet the following cybersecurity requirements:
``(1) The manufacturer shall have a plan to appropriately
monitor, identify, and address in a reasonable time postmarket
cybersecurity vulnerabilities and exploits, including
coordinated vulnerability disclosure and procedures.
``(2) The manufacturer shall design, develop, and maintain
processes and procedures to ensure the device and related
systems are cybersecure, and shall make available updates and
patches to the cyber device and related systems throughout the
lifecycle of the cyber device to address--
``(A) on a reasonably justified regular cycle,
known unacceptable vulnerabilities; and
``(B) as soon as possible out of cycle, critical
vulnerabilities that could cause uncontrolled risks.
``(3) The manufacturer shall provide in the labeling of the
cyber device a software bill of materials, including
commercial, open-source, and off-the-shelf software components.
``(4) The manufacturer shall comply with such other
requirements as the Secretary may require to demonstrate
reasonable assurance of the safety and effectiveness of the
device for purposes of cybersecurity, which the Secretary may
require by an order published in the Federal Register.
``(c) Substantial Equivalence.--In making a determination of
substantial equivalence under section 513(i) for a cyber device, the
Secretary may--
``(1) find that cybersecurity information for the cyber
device described in the relevant premarket submission in the
cyber device's use environment is inadequate; and
``(2) issue a nonsubstantial equivalence determination
based on this finding.
``(d) Definition.--In this section:
``(1) Cyber device.--The term `cyber device' means a device
that--
``(A) includes software, including software as or
in a device;
``(B) is intended to connect to the internet; or
``(C) contains any such technological
characteristics that could be vulnerable to
cybersecurity threats.
``(2) Lifecycle of the cyber device.--The term `lifecycle
of the cyber device' includes the postmarket lifecycle of the
cyber device.
``(3) Premarket submission.--The term `premarket
submission' means any submission under section 510(k), 513,
515(c), 515(f), or 520(m).
``(e) Exemption.--The Secretary may identify devices or types of
devices that are exempt from meeting the cybersecurity requirements
established by this section and regulations promulgated pursuant to
this section. The Secretary shall publish in the Federal Register, and
update, as appropriate, a list of the devices and types of devices so
identified by the Secretary.''.
(b) Prohibited Act.--Section 301(q) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(q)) is amended by adding at the end the
following:
``(3) The failure to comply with any requirement under section 524C
(relating to ensuring device cybersecurity).''.
(c) Adulteration.--Section 501 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351) is amended by inserting after paragraph
(j) the following:
``(k) If it is a device subject to the requirements set forth in
section 524C (relating to ensuring device cybersecurity) and fails to
comply with any requirement under that section.''.
(d) Misbranding.--Section 502(t) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352(t)) is amended--
(1) by striking ``or (3)'' and inserting ``(3)''; and
(2) by inserting before the period at the end the
following: ``, or (4) to furnish a software bill of materials
as required under section 524C (relating to ensuring device
cybersecurity)''.
SEC. 808. PUBLIC DOCKET ON PROPOSED MODIFICATIONS TO APPROVED
STRATEGIES.
(a) In General.--Not later than 90 days after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
open a public docket for the submission of public comments regarding
factors related to patient access to a drug that is subject to a risk
evaluation and mitigation strategy and the administration or
prescribing of such drug by health care providers that should be taken
into consideration when a proposed modification to such strategy is
reviewed under section 505-1(h) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 255-1(h)). The Secretary may close such public docket
not earlier than 90 days after such docket is opened.
(b) GAO Report.--Not later than December 31, 2026, the Comptroller
General of the United States 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--
(1) the number of proposed modifications to an approved
risk evaluation and mitigation strategy the Secretary has
granted under section 505-1(h) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 255-1(h));
(2) any issues affecting patient access to the drug that is
subject to the strategy or considerations with respect to the
administration or prescribing of such drug by health care
providers that arose as a result of such modifications; and
(3) how such issues were resolved, as applicable.
SEC. 809. FACILITATING EXCHANGE OF PRODUCT INFORMATION PRIOR TO
APPROVAL.
(a) In General.--Section 502 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352) is amended
(1) in paragraph (a), by striking ``drug'' each place it
appears and inserting ``drug or device'';
(2) in paragraph (a)(2)(B), by striking ``under section 505
or under section 351 of the Public Health Service Act for such
drug'' and inserting ``under section 505, 510(k), 513, or 515
of this Act or section 351 of the Public Health Service Act'';
and
(3) by adding at the end the following:
``(gg)(1) Unless its labeling bears adequate directions for use in
accordance with paragraph (f), except that (in addition to drugs or
devices that conform with exemptions pursuant to such paragraph) no
drug or device shall be considered misbranded under such paragraph
through the provision of product information to a payor, formulary
committee, or other similar entity with knowledge and expertise in the
area of health care economic analysis carrying out its responsibilities
for the selection of drugs or devices for coverage or reimbursement if
the product information relates to an investigational drug or device or
investigational use of a drug or device that is approved, cleared,
granted marketing authorization, or licensed under section 505, 510(k),
513(f)(2), or 515 of this Act or section 351 of the Public Health
Service Act (as applicable), provided--
``(A) the product information includes--
``(i) a clear statement that the investigational
drug or device or investigational use of a drug or
device has not been approved, cleared, granted
marketing authorization, or licensed under section 505,
510(k), 513(f)(2), or 515 of this Act or section 351 of
the Public Health Service Act (as applicable) and that
the safety and effectiveness of the drug or device or
use has not been established;
``(ii) information related to the stage of
development of the drug or device involved, such as--
``(I) the status of any study or studies in
which the investigational drug or device or
investigational use is being investigated;
``(II) how the study or studies relate to
the overall plan for the development of the
drug or device; and
``(III) whether a premarket application,
premarket notification, or request for
classification for the investigational drug or
device or investigational use has been
submitted to the Secretary and when such a
submission is planned;
``(iii) in the case of information that includes
factual presentations of results from studies, which
shall not be selectively presented, a description of--
``(I) all material aspects of study design,
methodology, and results; and
``(II) all material limitations related to
the study design, methodology, and results;
``(iv) where applicable, a prominent statement
disclosing the indication or indications for which the
Food and Drug Administration has approved, granted
marketing authorization, cleared, or licensed the
product pursuant to section 505, 510(k), 513(f)(2), or
515 of this Act or section 351 of the Public Health
Service Act, and a copy of the most current approved
labeling; and
``(v) updated information, if previously
communicated information becomes materially outdated as
a result of significant changes or as a result of new
information regarding the product or its review status;
and
``(B) the product information does not include--
``(i) information that represents that an
unapproved product--
``(I) has been approved, cleared, granted
marketing authorization, or licensed under
section 505, 510(k), 513(f)(2), or 515 of this
Act or section 351 of the Public Health Service
Act (as applicable); or
``(II) has otherwise been determined to be
safe or effective for the purpose or purposes
for which the drug or device is being studied;
or
``(ii) information that represents that an
unapproved use of a drug or device that has been so
approved, granted marketing authorization, cleared, or
licensed--
``(I) is so approved, granted marketing
authorization, cleared, or licensed; or
``(II) that the product is safe or
effective for the use or uses for which the
drug or device is being studied.
``(2) For purposes of this subsection, the term `product
information' includes--
``(A) information describing the drug or device (such as
drug class, device description, and features);
``(B) information about the indication or indications being
investigated;
``(C) the anticipated timeline for a possible approval,
clearance, marketing authorization, or licensure pursuant to
section 505, 510(k), 513, or 515 of this Act or section 351 of
the Public Health Service Act;
``(D) drug or device pricing information;
``(E) patient utilization projections;
``(F) product-related programs or services; and
``(G) factual presentations of results from studies that do
not characterize or make conclusions regarding safety or
efficacy.''.
(b) GAO Study and Report.--Beginning on the date that is 5 years
and 6 months after the date of enactment of this Act, the Comptroller
General of the United States shall conduct a study on the provision and
use of information pursuant to section 502(gg) of the Federal Food,
Drug, and Cosmetic Act, as added by this subsection (a), between
manufacturers of drugs and devices (as defined in section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) and entities
described in such section 520(gg). Such study shall include an analysis
of the following:
(1) The types of information communicated between such
manufacturers and payors.
(2) The manner of communication between such manufacturers
and payors.
(3)(A) Whether such manufacturers file a submission for
approval, marketing authorization, clearance, or licensing of a
new drug or device or the new use of a drug or device that is
the subject of communication between such manufacturers and
payors under section 502(gg) of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a).
(B) How frequently the Food and Drug Administration
approves, grants marketing authorization, clears, or licenses
the new drug or device or new use.
(C) The timeframe between the initial communications
permitted under section 502(gg) of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), regarding an
investigational drug or device or investigational use, and the
initial marketing of such drug or device.
SEC. 810. BANS OF DEVICES FOR ONE OR MORE INTENDED USES.
(a) In General.--Section 516(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360f(a)) is amended--
(1) in paragraph (1), by inserting ``for one or more
intended use'' before the semicolon at the end; and
(2) in the matter following paragraph (2), by inserting
``for any such intended use or uses. A device that is banned
for one or more intended uses is not a legally marketed device
under section 1006 when intended for such use or uses'' after
``banned device''.
(b) Specific Devices Deemed Banned.--Section 516 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360f) is further amended by
adding at the end the following:
``(c) Specific Device Banned.--Electrical stimulation devices that
apply a noxious electrical stimulus to a person's skin intended to
reduce or cease self-injurious behavior or aggressive behavior are
deemed to be banned devices, as described in subsection (a). Such
devices are banned unless or until the Secretary promulgates a
regulation to make such devices no longer banned based on a finding
that such devices do not present an unreasonable and substantial risk
of illness or injury, or that such risk can be corrected or eliminated
by labeling.''.
SEC. 811. CLARIFYING APPLICATION OF EXCLUSIVE APPROVAL, CERTIFICATION,
OR LICENSURE FOR DRUGS DESIGNATED FOR RARE DISEASES OR
CONDITIONS.
Section 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360cc) is amended--
(1) in subsection (a), in the matter following paragraph
(2), by striking ``same disease or condition'' and inserting
``same indication or use for which the Secretary has approved
or licensed such drug'';
(2) in subsection (b)--
(A) in the matter preceding paragraph (1), by
striking ``same rare disease or condition'' and
inserting ``same indication or use for which the
Secretary has approved or licensed such drug''; and
(B) in paragraph (1), by striking ``with the
disease or condition for which the drug was
designated'' and inserting ``for whom the drug is
indicated''; and
(3) in subsection (c), by striking ``same rare disease or
condition'' and inserting ``same indication or use''.
SEC. 812. GAO REPORT ON THIRD-PARTY REVIEW.
Not later than September 30, 2026, the Comptroller General of the
United States 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 the third-party review
program described in section 523 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360m). Such report shall include--
(1) a description of the financial and staffing resources
used to carry out such program;
(2) a description of actions taken by the Secretary
pursuant section 523(b)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360m(b)(2)(C)); and
(3) the results of an audit of the performance of select
persons accredited under such program.
SEC. 813. REAUTHORIZATION OF DEVICE PILOT PROJECTS.
Section 519(i)(10) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360i(i)(10)) is amended by striking ``2022'' and inserting
``2027''.
SEC. 814. REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND PRIORITY
REVIEW APPLICATIONS.
Section 807 of the FDA Reauthorization Act of 2017 (Public Law 115-
52) is amended, in the matter preceding paragraph (1), by striking
``2022'' and inserting ``2027''.
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