144 
‘‘(B) all stock-based performance metrics 
used by the manufacturer to determine execu-
tive compensation for each of the 12-month pe-
riods described in subsection (b)(1)(A)(i) or 
(b)(1)(C)(i) or the 36-month periods described 
in subsection (b)(1)(A)(ii) or (b)(1)(C)(ii), as 
applicable; and 
‘‘(C) any additional information the manu-
facturer chooses to provide related to drug pric-
ing decisions, such as total expenditures on— 
‘‘(i) drug research and development; 
or 
‘‘(ii) clinical trials, including on drugs 
that failed to receive approval by the Food 
and Drug Administration; and 
‘‘(3) such other related information as the Sec-
retary considers appropriate and as specified by the 
Secretary. 
‘‘(d) INFORMATION PROVIDED.—The manufacturer 
of a qualifying drug that is required to submit a report 
under subsection (b), shall ensure that such report and 
any explanation for, and description of, each price increase 
described in subsection (c)(1) shall be truthful, not mis-
leading, and accurate. 
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‘‘(e) CIVIL MONETARY PENALTY.—Any manufac-
turer of a qualifying drug that fails to submit a report 
for the drug as required by this section, following notifica-
tion by the Secretary to the manufacturer that the manu-
facturer is not in compliance with this section, shall be 
subject to a civil monetary penalty of $75,000 for each 
day on which the violation continues. 
‘‘(f) FALSE INFORMATION.—Any manufacturer that 
submits a report for a drug as required by this section 
that knowingly provides false information in such report 
is subject to a civil monetary penalty in an amount not 
to exceed $100,000 for each item of false information. 
‘‘(g) PUBLIC POSTING.— 
‘‘(1) IN GENERAL.—Subject to paragraph (4), 
the Secretary shall post each report submitted under 
subsection (b) on the public website of the Depart-
ment of Health and Human Services the day the 
price increase of a qualifying drug is scheduled to go 
into effect. 
‘‘(2) FORMAT.—In developing the format in 
which reports will be publicly posted under para-
graph (1), the Secretary shall consult with stake-
holders, including beneficiary groups, and shall seek 
feedback from consumer advocates and readability 
experts on the format and presentation of the con-
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tent of such reports to ensure that such reports 
are— 
‘‘(A) user-friendly to the public; and 
‘‘(B) written in plain language that con-
sumers can readily understand. 
‘‘(3) LIST.—In addition to the reports sub-
mitted under subsection (b), the Secretary shall also 
post a list of each qualifying drug with respect to 
which the manufacturer was required to submit such 
a report in the preceding year and whether such 
manufacturer was required to submit such report 
based on a qualifying price increase or whether such 
drug meets the criteria under subsection (b)(1)(B). 
‘‘(4) PROTECTED
INFORMATION.—In carrying 
out this section, the Secretary shall enforce applica-
ble law concerning the protection of confidential 
commercial information and trade secrets. 
‘‘SEC. 1150E. ANNUAL REPORT TO CONGRESS. 
‘‘(a) IN GENERAL.—Subject to subsection (b), the 
Secretary shall submit to the Committees on Energy and 
Commerce and Ways and Means of the House of Rep-
resentatives and the Committees on Health, Education, 
Labor, and Pensions and Finance of the Senate, and post 
on the public website of the Department of Health and 
Human Services in a way that is user-friendly to the pub-
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lic and written in plain language that consumers can read-
ily understand, an annual report— 
‘‘(1) summarizing the information reported pur-
suant to section 1150D; 
‘‘(2) including copies of the reports and sup-
porting detailed economic analyses submitted pursu-
ant to such section; 
‘‘(3) detailing the costs and expenditures in-
curred by the Department of Health and Human 
Services in carrying out section 1150D; and 
‘‘(4) explaining how the Department of Health 
and Human Services is improving consumer and 
provider information about drug value and drug 
price transparency. 
‘‘(b) PROTECTED INFORMATION.—In carrying out 
this section, the Secretary shall enforce applicable law con-
cerning the protection of confidential commercial informa-
tion and trade secrets.’’. 
TITLE V—NIH, FDA, AND 
OVERDOSE EPIDEMIC FUNDING 
Subtitle A—Biomedical Innovation 
Expansion 
SEC. 501. NIH INNOVATION INITIATIVES. 
(a) NIH INNOVATION ACCOUNT.— 
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(1) IN GENERAL.—Section 1001(b) of the 21st 
Century Cures Act (Public Law 114–255) is amend-
ed by adding at the end the following: 
‘‘(5) SUPPLEMENTAL
FUNDING
AND
ADDI-
TIONAL ACTIVITIES.— 
‘‘(A) IN
GENERAL.—In addition to the 
funds made available under paragraph (2), 
there are authorized to be appropriated, and 
are hereby appropriated, to the Account, out of 
any monies in the Treasury not otherwise ap-
propriated, to be available until expended with-
out further appropriation, the following: 
‘‘(i) 
For 
fiscal 
year 
2022, 
$255,400,000. 
‘‘(ii) 
For 
fiscal 
year 
2023, 
$160,400,000. 
‘‘(iii) 
For 
fiscal 
year 
2024, 
$414,600,000. 
‘‘(iv) 
For 
fiscal 
year 
2025, 
$547,000,000. 
‘‘(v) 
For 
fiscal 
year 
2026, 
$948,000,000. 
‘‘(vi) 
For 
fiscal 
year 
2027, 
$842,400,000. 
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‘‘(vii) 
For 
fiscal 
year 
2028, 
$1,089,600,000. 
‘‘(viii) 
For 
fiscal 
year 
2029, 
$1,115,600,000. 
‘‘(ix) 
For 
fiscal 
year 
2030, 
$1,170,600,000. 
‘‘(x) 
For 
fiscal 
year 
2031, 
$956,400,000. 
‘‘(B) SUPPLEMENTAL FUNDING FOR CER-
TAIN PROJECTS.—Of the total amounts made 
available under subparagraph (A) for each of 
fiscal years 2022 through 2031, a total amount 
not to exceed the following shall be made avail-
able for the following categories of NIH Innova-
tion Projects: 
‘‘(i) For projects described in para-
graph (4)(A), an amount not to exceed a 
total of $2,070,600,000 as follows: 
‘‘(I) For each of fiscal years 
2022 and 2024, $50,000,000. 
‘‘(II) 
For 
fiscal 
year 
2025, 
$100,000,000. 
‘‘(III) For each of fiscal years 
2026 and 2027, $300,000,000. 
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‘‘(IV) For each of fiscal years 
2028 through 2030, $317,000,000. 
‘‘(V) 
For 
fiscal 
year 
2031, 
$319,600,000. 
‘‘(ii) For projects described in para-
graph (4)(B), an amount not to exceed a 
total of $2,041,900,000 as follows: 
‘‘(I) For each of fiscal years 
2022 and 2024, $50,000,000. 
‘‘(II) 
For 
fiscal 
year 
2025, 
$128,000,000. 
‘‘(III) For fiscal year 2026, 
$209,000,000. 
‘‘(IV) For fiscal year 2027, 
$100,000,000. 
‘‘(V) 
For 
fiscal 
year 
2028, 
$325,000,000. 
‘‘(VI) For fiscal year 2029, 
$350,000,000. 
‘‘(VII) For fiscal year 2030, 
$400,000,000. 
‘‘(VIII) For fiscal year 2031, 
$429,900,000. 
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‘‘(iii) For projects described in para-
graph (4)(C), an amount not to exceed a 
total of $1,558,400,000 as follows: 
‘‘(I) For each of fiscal years 
2024 and 2025, $151,200,000. 
‘‘(II) For each of fiscal years 
2026 through 2030, $251,200,000. 
‘‘(iv) For projects described in para-
graph (4)(D), an amount not to exceed 
$15,400,000 for each of fiscal years 2022 
through 2031. 
‘‘(C) 
ADDITIONAL
NIH
INNOVATION 
PROJECTS.—In addition to funding NIH Inno-
vation Projects pursuant to subparagraph (B), 
of the total amounts made available under sub-
paragraph (A), a total amount not to exceed 
the following shall be made available for the fol-
lowing categories of NIH Innovation Projects: 
‘‘(i) To support research related to 
combating antimicrobial resistance and an-
tibiotic resistant bacteria, including re-
search into new treatments, diagnostics, 
and vaccines, research, in consultation with 
the Centers for Disease Control and Pre-
vention, into stewardship, and the develop-
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ment of strategies, in coordination with the 
Biomedical Advanced Research and Devel-
opment Authority under section 319L of 
the Public Health Service Act, to support 
commercialization of new antibiotics, not 
to exceed a total of $1,144,500,000, as fol-
lows: 
‘‘(I) For each of fiscal years 
2022 through 2025, $100,000,000. 
‘‘(II) For each of fiscal years 
2026 and 2027, $120,000,000. 
‘‘(III) For each of fiscal years 
2028 through 2030, $125,000,000. 
‘‘(IV) For fiscal year 2031, 
$129,500,000. 
‘‘(ii) To support research and re-
search activities related to rare diseases or 
conditions, including studies or analyses 
that help to better understand the natural 
history of a rare disease or condition and 
translational studies related to rare dis-
eases or conditions, not to exceed a total of 
$530,600,000, as follows: 
‘‘(I) 
For 
fiscal 
year 
2022, 
$40,000,000. 
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‘‘(II) 
For 
fiscal 
year 
2023, 
$45,000,000. 
‘‘(III) For fiscal year 2024, 
$48,000,000. 
‘‘(IV) For each of fiscal years 
2025 and 2026, $52,400,000. 
‘‘(V) 
For 
fiscal 
year 
2027, 
$55,800,000. 
‘‘(VI) For fiscal year 2028, 
$56,000,000. 
‘‘(VII) For fiscal year 2029, 
$57,000,000. 
‘‘(VIII) For each of fiscal years 
2030 and 2031, $62,000,000.’’. 
(2) CONFORMING AMENDMENTS.—Section 1001 
of the 21st Century Cures Act (Public Law 114– 
255) is amended— 
(A) in subsection (a), by striking ‘‘sub-
section (b)(4)’’ and inserting ‘‘subsections 
(b)(4) and (b)(5)’’; 
(B) in subsection (b)(1), by striking ‘‘para-
graph (4)’’ and inserting ‘‘paragraphs (4) and 
(5)’’; 
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(C) in subsection (c)(2)(A)(ii), by inserting 
‘‘or pursuant to subsection (b)(5)’’ after ‘‘sub-
section (b)(3)’’; and 
(D) in subsection (d), by inserting ‘‘or pur-
suant to subsection (b)(5)’’ after ‘‘subsection 
(b)(3)’’. 
(b) WORKPLAN.—Section 1001(c)(1) of the 21st 
Century Cures Act (Public Law 114–255) is amended by 
adding at the end the following: 
‘‘(D) UPDATES.—The Director of NIH 
shall, after seeking recommendations in accord-
ance with the process described in subpara-
graph (C), update the work plan submitted 
under this subsection for each of fiscal years 
2022 through 2031 to reflect the amendments 
made to this section by the Elijah E. Cum-
mings Lower Drug Costs Now Act.’’. 
(c) ANNUAL REPORTS.—Section 1001(c)(2)(A) of the 
21st Century Cures Act (Public Law 114–255) is amend-
ed by striking ‘‘2027’’ and inserting ‘‘2031’’. 
(d) SUNSET.—Section 1001(e) of the 21st Century 
Cures Act (Public Law 114–255) is amended by striking 
‘‘September 30, 2026’’ and inserting ‘‘September 30, 
2031’’. 
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SEC. 502. NIH CLINICAL TRIAL. 
Part A of title IV of the Public Health Service Act 
(42 U.S.C. 281 et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 404O. CLINICAL TRIAL ACCELERATION PILOT INITIA-
TIVE. 
‘‘(a) ESTABLISHMENT
OF PILOT PROGRAM.—The 
Secretary, acting through the Director of the National In-
stitutes of Health, shall, not later than 2 years after the 
date of enactment of this Act, establish and implement 
a pilot program to award multi-year contracts to eligible 
entities to support phase II clinical trials and phase III 
clinical trials— 
‘‘(1) to promote innovation in treatments and 
technologies supporting the advanced research and 
development and production of high need cures; and 
‘‘(2) to provide support for the development of 
medical products and therapies. 
‘‘(b) ELIGIBLE ENTITIES.—To be eligible to receive 
assistance under the pilot program established under sub-
section (a), an entity shall— 
‘‘(1) be seeking to market a medical product or 
therapy that is the subject of clinical trial or trials 
to be supported using such assistance; 
‘‘(2) be a public or private entity, which may 
include a private or public research institution, a 
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contract research organization, an institution of 
higher education (as defined in section 101 of the 
Higher Education Act of 1965 (20 U.S.C. 1001)), a 
medical center, a biotechnology company, or an aca-
demic research institution; and 
‘‘(3) comply with requirements of the Federal 
Food, Drug, and Cosmetic Act and section 351 of 
this Act, as applicable, at all stages of development, 
manufacturing, review, approval, and safety surveil-
lance of a medical product. 
‘‘(c) DUTIES.—The Secretary, acting through the Di-
rector of National Institutes of Health, shall— 
‘‘(1) in establishing the pilot program under 
subsection (a), consult with— 
‘‘(A) the Director of the National Center 
for Advancing Translational Sciences and the 
other national research institutes in considering 
their requests for new or expanded clinical trial 
support efforts; and 
‘‘(B) the Commissioner of Food and Drugs 
and any other head of a Federal agency as the 
Secretary determines to be appropriate to en-
sure coordination and efficiently advance clin-
ical trial activities; 
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‘‘(2) in implementing the pilot program under 
subsection (a), consider consulting with patients and 
patient advocates; and 
‘‘(3) in awarding contracts under the pilot pro-
gram under subsection (a), consider— 
‘‘(A) the expected health impacts of the 
clinical trial or trials to be supported under the 
contract; and 
‘‘(B) the degree to which the medical prod-
uct or therapy that is the subject of such clin-
ical trial or trials is a high need cure. 
‘‘(d) EXCLUSION.—A contract may not be awarded 
under the pilot program under subsection (a) if the drug 
that is the subject of the clinical trial or trials to be sup-
ported under the contract is a drug designated under sec-
tion 526 of the Federal Food, Drug, and Cosmetic Act 
as a drug for a rare disease or condition. 
‘‘(e) NIH CLINICAL
TRIAL
ACCELERATOR
AC-
COUNT.— 
‘‘(1) ESTABLISHMENT.—There is established in 
the Treasury an account, to be known as the ‘NIH 
Clinical Trial Accelerator Account’ (referred to in 
this section as the ‘Account’), for purposes of car-
rying out this section. 
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‘‘(2) TRANSFER
OF
DIRECT
SPENDING
SAV-
INGS.—There shall be transferred to the Account 
from 
the 
general 
fund 
of 
the 
Treasury, 
$400,000,000 for each of fiscal years 2022 through 
2026, to be available until expended without further 
appropriation. 
‘‘(3) WORK PLAN.—Not later than 180 days 
after the date of enactment of this Act, the Sec-
retary shall submit to the Committee on Energy and 
Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate a work plan that includes the 
proposed implementation of this section and the pro-
posed allocation of funds in the Account. 
‘‘(f) REPORTS TO CONGRESS.—Not later than Octo-
ber 1 of each fiscal year, the Secretary shall submit to 
the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a report on— 
‘‘(1) the implementation of this section; 
‘‘(2) any available results on phase II clinical 
trials and phase III clinical trials supported under 
this section during such fiscal year; and 
‘‘(3) the extent to which Federal funds are obli-
gated to support such clinical trials, including the 
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specific amount of such support and awards pursu-
ant to an allocation from the Account under sub-
section (e). 
‘‘(g) DEFINITIONS.—In this section: 
‘‘(1) PHASE
II
CLINICAL
TRIAL.—The term 
‘phase II clinical trial’ means a phase II clinical in-
vestigation, as described in section 312.21 of title 
21, Code of Federal Regulations (or any successor 
regulations). 
‘‘(2) PHASE III CLINICAL TRIALS.—The term 
‘phase III clinical trial’ means a phase III clinical 
investigation, as described in section 312.21 of title 
21, Code of Federal Regulations (or any successor 
regulations). 
‘‘(3) HIGH NEED CURE.—The term ‘high need 
cure’ has the meaning given such term in section 
480(a)(3).’’. 
SEC. 503. INNOVATION NETWORK. 
Part A of title IV of the Public Health Service Act 
(42 U.S.C. 281 et seq.), as amended by section 502, is 
further amended by adding at the end the following: 
‘‘SEC. 404P. INNOVATION NETWORK. 
‘‘(a) FUNDS.—The Director of NIH shall award 
grants or contracts to eligible entities to develop, expand, 
and enhance the commercialization of biomedical products. 
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‘‘(b) ELIGIBLE ENTITY.—In this section, the term 
‘eligible entity’ means an entity receiving funding under— 
‘‘(1) the Small Business Innovation Research 
program of the National Institutes of Health; or 
‘‘(2) the Small Business Technology Transfer 
program of the National Institutes of Health. 
‘‘(c) USE OF FUNDS.—An eligible entity shall use the 
funds received through such grant or contract to sup-
port— 
‘‘(1) the Commercialization Readiness Pilot 
program of the National Institutes of Health; 
‘‘(2) the Innovation Corps program of the Na-
tional Institutes of Health; 
‘‘(3) the Commercialization Accelerator pro-
gram of the National Institutes of Health; 
‘‘(4) the Commercialization Assistance program 
of the National Institutes of Health; and 
‘‘(5) such other programs and activities as the 
Director of NIH determines to be appropriate, to 
support the commercialization stage of research, 
later stage research and development, technology 
transfer, and commercialization technical assistance. 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
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$100,000,000 for each of fiscal years 2022 through 2026, 
to be available until expended.’’. 
Subtitle B—Investing in Safety and 
Innovation 
SEC. 511. FOOD AND DRUG ADMINISTRATION. 
(a) FDA INNOVATION ACCOUNT.— 
(1) IN GENERAL.—Section 1002(b) of the 21st 
Century Cures Act (Public Law 114–255) is amend-
ed— 
(A) in paragraph (1), by striking ‘‘para-
graph (4)’’ and inserting ‘‘paragraphs (4) and 
(5)’’; and 
(B) by adding at the end the following new 
paragraph: 
‘‘(5) SUPPLEMENTAL
FUNDING
AND
ADDI-
TIONAL ACTIVITIES.— 
‘‘(A) IN
GENERAL.—In addition to the 
funds made available under paragraph (2), 
there are authorized to be appropriated, and 
are hereby appropriated, to the Account, out of 
any monies in the Treasury not otherwise ap-
propriated, to be available until expended with-
out further appropriation, the following: 
‘‘(i) 
For 
fiscal 
year 
2022, 
$417,500,000. 
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‘‘(ii) For each of fiscal years 2023 
and 2024, $157,500,000. 
‘‘(iii) For each of fiscal years 2025 
through 2027, $152,500,000. 
‘‘(iv) For each of fiscal years 2028 
through 2031, $202,500,000. 
‘‘(B) SUPPLEMENTAL FUNDING FOR CER-
TAIN ACTIVITIES.—Of the total amounts made 
available under subparagraph (A) for each of 
fiscal years 2028 through 2031, a total amount 
not to exceed $50,000,000 for each such fiscal 
year, shall be made available for the activities 
under subtitles A through F (including the 
amendments made by such subtitles) of title III 
of this Act and section 1014 (relating to Inter-
center Institutes) of the Federal Food, Drug, 
and Cosmetic Act. 
‘‘(C) ADDITIONAL
FDA
ACTIVITIES.—In 
addition to funding activities pursuant to sub-
paragraph (B), of the total amounts made 
available under subparagraph (A), a total 
amount not to exceed the following shall be 
made available for the following categories of 
activities: 
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‘‘(i) For modernization of the tech-
nical infrastructure of the Food and Drug 
Administration, including enhancements 
such as interoperability across the agency, 
and additional capabilities to develop an 
advanced information technology infra-
structure to support the agency’s regu-
latory mission: 
‘‘(I) 
For 
fiscal 
year 
2022, 
$180,000,000. 
‘‘(II) For each of fiscal years 
2023 through 2031, $60,000,000. 
‘‘(ii) For support for continuous man-
ufacturing of drugs and biological prod-
ucts, including complex biological products 
such as regenerative medicine therapies, 
through grants to institutions of higher 
education and nonprofit organizations and 
other appropriate mechanisms, for each of 
fiscal 
years 
2022 
through 
2031, 
$20,000,000. 
‘‘(iii) For support for the Commis-
sioner of Food and Drugs to engage ex-
perts, such as through the formation and 
operation of public-private partnerships or 
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other appropriate collaborative efforts, to 
advance the development and delivery of 
individualized human gene therapy prod-
ucts: 
‘‘(I) 
For 
fiscal 
year 
2022, 
$50,000,000. 
‘‘(II) For each of fiscal years 
2023 through 2031, $10,000,000. 
‘‘(iv) For support for inspections, en-
forcement, and quality surveillance activi-
ties across the Food and Drug Administra-
tion, including foreign and domestic in-
spections across products, for each of fiscal 
years 2022 through 2031, $20,000,000. 
‘‘(v) For support for activities of the 
Food and Drug Administration related to 
customs and border protection to provide 
improvements to technologies, inspection 
capacity, and sites of import (including 
international mail facilities) in which the 
Food and Drug Administration operates, 
for each of fiscal years 2022 through 
2031, $10,000,000. 
‘‘(vi) To further advance the develop-
ment of a coordinated postmarket surveil-
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lance system for all medical products, in-
cluding drugs, biological products, and de-
vices, linked to electronic health records in 
furtherance of the Food and Drug Admin-
istration’s postmarket surveillance capabili-
ties: 
‘‘(I) 
For 
fiscal 
year 
2022, 
$112,500,000. 
‘‘(II) For each of fiscal years 
2023 through 2031, $12,500,000. 
‘‘(vii) For support for Food and Drug 
Administration activities to keep pace with 
the projected product development of re-
generative therapies, including cellular and 
somatic cell gene therapy products: 
‘‘(I) For each of fiscal years 
2022 through 2024, $10,000,000. 
‘‘(II) For each of fiscal years 
2025 through 2031, $5,000,000. 
‘‘(viii) For carrying out section 714A 
of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379d–3a; relating to hiring 
authority for scientific, technical, and pro-
fessional personnel), for each of fiscal 
years 2022 through 2031, $2,500,000. 
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‘‘(ix) For the Food and Drug Admin-
istration to support improvements to the 
technological infrastructure for reporting 
and analysis of adverse events associated 
with the use of drugs and biological prod-
ucts, for each of fiscal years 2022 through 
2031, $12,500,000.’’. 
(2) CONFORMING AMENDMENTS.—Section 1002 
of the 21st Century Cures Act (Public Law 114– 
255) is amended— 
(A) in subsection (a), by inserting before 
the period at the end the following: ‘‘or pursu-
ant to subparagraph (A) of subsection (b)(5) to 
carry out the activities described in subpara-
graphs (B) and (C) of such subsection’’; and 
(B) in subsection (d)— 
(i) by inserting ‘‘or pursuant to sub-
paragraph (A) of subsection (b)(5)’’ after 
‘‘subsection (b)(3)’’; and 
(ii) by striking ‘‘subsection (b)(4)’’ 
and inserting ‘‘subsections (b)(4) and 
(b)(5)’’. 
(b) ANNUAL REPORT.—Section 1002(c)(2)(A) of the 
21st Century Cures Act (Public Law 114–255) is amend-
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ed, in the matter preceding clause (i), by striking ‘‘2026’’ 
and inserting ‘‘2032’’. 
(c) SUNSET.—Section 1002(e) of the 21st Century 
Cures Act (Public Law 114–255) is amended by striking 
‘‘September 30, 2025’’ and inserting ‘‘September 30, 
2030’’. 
SEC. 512. STUDY ON HIGH-RISK, HIGH-REWARD DRUGS. 
(a) IN GENERAL.—Not later than 180 days after the 
date of enactment of this Act, the Secretary of Health and 
Human Services shall conduct a study to identify— 
(1) diseases or conditions that lack a treatment 
approved by the Food and Drug Administration and 
instances in which development of a treatment for 
such diseases or conditions could fill an unmet med-
ical need for the treatment of a serious or life- 
threatening disease or condition or a rare disease or 
condition; and 
(2) appropriate incentives that would lead to 
the development, approval, and marketing of such 
treatments. 
(b) REPORT TO CONGRESS; RECOMMENDATIONS.— 
Not later than one year after the date of enactment of 
this Act, the Secretary shall submit to the Congress a re-
port that includes— 
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(1) findings from the study under subsection 
(a); and 
(2) recommendations regarding legislation nec-
essary to create appropriate incentives identified 
pursuant to subsection (a)(2). 
Subtitle C—Overdose Epidemic 
Response 
SEC. 521. OVERDOSE EPIDEMIC RESPONSE FUND. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall use any funds made available pursuant to 
subsection (b) to carry out the programs and activities de-
scribed in subsection (c) to address the overdose and sub-
stance use disorder epidemic. Such funds shall be in addi-
tion to any funds which are otherwise available to carry 
out such programs and activities. 
(b) OPIOID EPIDEMIC RESPONSE FUND.— 
(1) ESTABLISHMENT OF ACCOUNT.—There is 
established in the Treasury an account, to be known 
as the Opioid Epidemic Response Fund (referred to 
in this section as the ‘‘Fund’’), for purposes of fund-
ing the programs and activities described in sub-
section (c). 
(2) FUNDING.—There is authorized to be ap-
propriated, and there is appropriated, to the Fund, 
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out of any monies in the Treasury not otherwise ap-
propriated $2,000,000,000 for each of fiscal years 
2022 through 2026. 
(3) AVAILABILITY.—Amounts made available by 
paragraph (2) shall be made available to the agen-
cies specified in subsection (c) in accordance with 
such subsection. Amounts made available to an 
agency pursuant to the preceding sentence for a fis-
cal year shall remain available until expended. 
(c) PROGRAMS
AND
ACTIVITIES.—Of the total 
amount in the Fund for each of fiscal years 2022 through 
2026, such amount shall be allocated as follows: 
(1) SAMHSA.—For the Substance Abuse and 
Mental Health Services Administration to carry out 
programs and activities pursuant to section 522, 
$1,500,000,000 for each of fiscal years 2022 
through 2026. 
(2) CDC.—For the Centers for Disease Control 
and Prevention to carry out programs and activities 
pursuant to section 523, $120,000,000 for each of 
fiscal years 2022 through 2026. 
(3) FDA.—For the Food and Drug Adminis-
tration to carry out programs and activities pursu-
ant to section 524, $10,000,000 for each of fiscal 
years 2022 through 2026. 
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(4) NIH.—For the National Institutes of 
Health to carry out programs and activities pursu-
ant to section 525, $240,000,000 for each of fiscal 
years 2022 through 2026. 
(5) HRSA.—For the Health Resources and 
Services Administration to carry out programs and 
activities pursuant to section 526, $90,000,000 for 
each of fiscal years 2022 through 2026. 
(6) ACF.—For the Administration for Children 
and Families to carry out programs and activities 
pursuant to section 527, $40,000,000 for each of 
fiscal years 2022 through 2026. 
(d) ACCOUNTABILITY AND OVERSIGHT.— 
(1) WORK PLAN.— 
(A) IN
GENERAL.—Not later than 180 
days after the date of enactment of this Act, 
the Secretary of Health and Human Services 
shall submit to the Committee on Health, Edu-
cation, Labor, and Pensions and the Committee 
on Appropriations of the Senate and the Com-
mittee on Energy and Commerce, the Com-
mittee on Appropriations, and the Committee 
on Education and Labor of the House of Rep-
resentatives, a work plan including the proposed 
allocation of funds made available pursuant to 
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subsection (b) for each of fiscal years 2022 
through 2026 and the contents described in 
subparagraph (B). 
(B) CONTENTS.—The work plan submitted 
under subparagraph (A) shall include— 
(i) the amount of money to be obli-
gated or expended out of the Fund in each 
fiscal year for each program and activity 
described in subsection (c); and 
(ii) a description and justification of 
each such program and activity. 
(2) ANNUAL REPORTS.—Not later than October 
1 of each of fiscal years 2023 through 2027, the 
Secretary of Health and Human Services shall sub-
mit to the Committee on Health, Education, Labor, 
and Pensions and the Committee on Appropriations 
of the Senate and the Committee on Energy and 
Commerce, the Committee on Appropriations, and 
the Committee on Education and Labor of the 
House of Representatives, a report including— 
(A) the amount of money obligated or ex-
pended out of the Fund in the prior fiscal year 
for each program and activity described in sub-
section (c); 
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(B) a description of all programs and ac-
tivities using funds made available pursuant to 
subsection (b); and 
(C) how the programs and activities are re-
sponding to the opioid and substance use dis-
order epidemic. 
(e) LIMITATIONS.—Notwithstanding any authority in 
this subtitle or any appropriations Act, any funds made 
available pursuant to subsection (b) may not be used for 
any purpose other than the programs and activities de-
scribed in subsection (c). 
SEC. 522. SUBSTANCE ABUSE AND MENTAL HEALTH SERV-
ICES ADMINISTRATION. 
(a) IN GENERAL.—The entirety of the funds made 
available pursuant to section 521(c)(1) shall be for the As-
sistant Secretary for Mental Health and Substance Use 
to continue to award the State Opioid Response Grants 
funded by the heading ‘‘Substance Abuse And Mental 
Health Services Administration—Substance Abuse Treat-
ment’’ in title II of the Departments of Labor, Health and 
Human Services, and Education, and Related Agencies 
Appropriations Act, 2018 (Public Law 115–141). Subject 
to subsections (b) and (c), such grants shall be awarded 
in the same manner and subject to the same conditions 
as were applicable to such grants for fiscal year 2018. 
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(b) REQUIREMENT
THAT
TREATMENT
BE
EVI-
DENCE-BASED.—As a condition on receipt of a grant pur-
suant to subsection (a), a grantee shall agree that— 
(1) treatments, practices, or interventions fund-
ed through the grant will be evidence-based; and 
(2) such treatments, practices, and interven-
tions will include medication-assisted treatment for 
individuals diagnosed with opioid use disorder, using 
drugs only if the drugs have been approved or li-
censed by the Food and Drug Administration under 
section 505 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355) or section 351 of the 
Public Health Service Act (42 U.S.C. 262). 
(c) RESERVATIONS.—Of the amount made available 
pursuant to section 521(c)(1) for a fiscal year— 
(1) not less than $75,000,000 shall be reserved 
to make grants under subsection (a) to Indian 
Tribes or Tribal organizations; and 
(2) not less than $50,000,000 shall be reserved 
to make grants under subsection (a) to political sub-
divisions of States, such as counties, cities, or towns. 
SEC. 523. CENTERS FOR DISEASE CONTROL AND PREVEN-
TION. 
(a) ADDRESSING OPIOID USE DISORDER.—The en-
tirety of the funds made available pursuant to section 
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521(c)(2) shall be for the Director of the Centers for Dis-
ease Control and Prevention, pursuant to applicable au-
thorities in the Public Health Service Act (42 U.S.C. 201 
et seq.), to continue and expand programs of the Centers 
for Disease Control and Prevention to address opioid and 
substance use disorder, including by— 
(1) improving the timeliness and quality of data 
on the opioid use disorder epidemic, including im-
provement of— 
(A) data on fatal and nonfatal overdoses; 
(B) syndromic surveillance; 
(C) data on long-term sequelae (including 
neonatal abstinence syndrome); and 
(D) cause of death reporting related to 
substance abuse or opioid overdose; 
(2) expanding and strengthening evidence-based 
prevention and education strategies; 
(3) supporting responsible prescribing practices, 
including through development and dissemination of 
prescriber guidelines; 
(4) improving access to and use of effective pre-
vention, treatment, and recovery support, including 
through grants and the provision of technical assist-
ance to States and localities; 
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(5) strengthening partnerships with first re-
sponders, including to protect their safety; 
(6) considering the needs of vulnerable popu-
lations; 
(7) addressing infectious diseases linked to the 
opioid crisis; 
(8) strengthening prescription drug monitoring 
programs; and 
(9) providing financial and technical assistance 
to State and local health department efforts to treat 
and prevent substance use disorder. 
(b) LIMITATION.—Of the funds made available pur-
suant to section 521(c)(2) for carrying out this section, 
not more than 20 percent may be used for intramural pur-
poses. 
SEC. 524. FOOD AND DRUG ADMINISTRATION. 
The entirety of the funds made available pursuant to 
section 521(c)(3) shall be for the Commissioner of Food 
and Drugs, pursuant to applicable authorities in the Pub-
lic Health Service Act (42 U.S.C. 201 et seq.) or the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.) and other applicable law, to support widespread inno-
vation in non-opioid and non-addictive medical products 
for pain treatment, access to opioid addiction treatments, 
appropriate use of approved opioids, and efforts to reduce 
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illicit importation of opioids. Such support may include the 
following: 
(1) Facilitating the development of non-opioid 
and non-addictive pain treatments. 
(2) Advancing guidance documents for sponsors 
of non-opioid pain products. 
(3) Developing evidence to inform the potential 
for nonprescription overdose therapies. 
(4) Examining expanded labeling indications for 
medication-assisted treatment. 
(5) Conducting public education and outreach, 
including public workshops or public meetings, re-
garding the benefits of medication-assisted treat-
ment, including all drugs approved by the Food and 
Drug Administration, and device treatment options 
approved or cleared by the Food and Drug Adminis-
tration. 
(6) Exploring the expansion and possible man-
datory nature of prescriber education regarding pain 
management and appropriate opioid prescribing 
through authorities under section 505–1 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355– 
1). 
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(7) Examining options to limit the duration of 
opioid prescriptions for acute pain, including 
through packaging options. 
(8) Increasing staff and infrastructure capacity 
to inspect and analyze packages at international 
mail facilities and pursue criminal investigations. 
SEC. 525. NATIONAL INSTITUTES OF HEALTH. 
The entirety of the funds made available pursuant to 
section 521(c)(4) shall be for the Director of the National 
Institutes of Health, pursuant to applicable authorities in 
the Public Health Service Act (42 U.S.C. 201 et seq.), 
to carry out activities related to— 
(1) accelerating research for addressing the 
opioid use disorder epidemic, including developing 
non-opioid medications and interventions, including 
non-addictive medications, to manage pain, as well 
as developing medications and interventions to treat 
and to prevent substance use disorders; 
(2) conducting and supporting research on 
which treatments (in terms of pain management as 
well as treating and preventing substance use dis-
orders) are optimal for which patients; and 
(3) conducting and supporting research on cre-
ating longer-lasting or faster-acting antidotes for 
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