I 
118TH CONGRESS 
1ST SESSION H. R. 2940 
To amend title III of the Public Health Service Act to establish a program 
to develop antimicrobial innovations targeting the most challenging patho-
gens and most threatening infections, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 27, 2023 
Mr. FERGUSON (for himself, Mr. PETERS, Mr. LATURNER, and Mr. LEVIN) 
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce, and in addition to the Committees on Oversight and 
Accountability, Ways and Means, and the Budget, for a period to be sub-
sequently determined by the Speaker, in each case for consideration of 
such provisions as fall within the jurisdiction of the committee concerned 
A BILL 
To amend title III of the Public Health Service Act to 
establish a program to develop antimicrobial innovations 
targeting the most challenging pathogens and most 
threatening infections, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Pioneering Anti-
microbial Subscriptions To End Upsurging Resistance Act 
of 2023’’ or the ‘‘PASTEUR Act of 2023’’. 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
SEC. 2. DEVELOPING ANTIMICROBIAL INNOVATIONS. 
Title III of the Public Health Service Act (42 U.S.C. 
241 et seq.) is amended by adding at the end the fol-
lowing: 
‘‘PART W—DEVELOPING ANTIMICROBIAL 
INNOVATIONS 
‘‘SEC. 399OO. ESTABLISHMENT OF COMMITTEE; SUBSCRIP-
TION MODEL; ADVISORY GROUP. 
‘‘(a) IN GENERAL.—Not later than 60 days after the 
date of enactment of this part, the Secretary shall estab-
lish a Committee on Critical Need Antimicrobials and ap-
point members to the Committee. 
‘‘(b) MEMBERS.— 
‘‘(1) IN GENERAL.—The Committee shall con-
sist of at least one representative from each of the 
National Institute of Allergy and Infectious Dis-
eases, the Centers for Disease Control and Preven-
tion, the Biomedical Advanced Research and Devel-
opment Authority, the Food and Drug Administra-
tion, the Centers for Medicare & Medicaid Services, 
the Veterans Health Administration, and the De-
partment of Defense. 
‘‘(2) CHAIR.—The Secretary shall appoint as 
the Chair of the Committee a non-voting, inde-
pendent member who may not be a member of the 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
Committee or from an organization represented 
under paragraph (1). 
‘‘(3) CONSULTATION.—The Secretary shall con-
sult with the Under Secretary of Veterans Affairs 
for Health and Secretary of Defense when appoint-
ing members from the Veterans Health Administra-
tion and the Department of Defense. 
‘‘(c) DUTIES.—Not later than 1 year after the ap-
pointment of all initial members of the Committee, the 
Secretary, in collaboration with the Committee, and in 
consultation with the Critical Need Antimicrobials Advi-
sory Group established under subsection (g), shall do the 
following: 
‘‘(1) Develop a list of infections for which new 
antimicrobial drug development is needed, taking 
into account organisms, sites of infection, and type 
of infections for which there is an unmet medical 
need, findings from the most recent report entitled 
‘Antibiotic Resistance Threats in the United States’ 
issued by the Centers for Disease Control and Pre-
vention, or an anticipated unmet medical need, in-
cluding a potential global health security threat. For 
the list developed under this paragraph, the Sec-
retary, in collaboration with the Committee, may use 
the infection list in such most recent Antibiotic Re-
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
sistance Threats in the United States report for up 
to 3 years following the date of enactment of this 
part and subsequently update the list under this 
paragraph in accordance with subsection (e). 
‘‘(2) Develop regulations, for purposes of sub-
section (d), outlining favored characteristics of crit-
ical need antimicrobial drugs, that are evidence 
based, clinically focused, and designed to treat the 
infections described in paragraph (1), and estab-
lishing criteria for how each such characteristic or 
combinations of multiple characteristics will adjust 
the monetary value of a subscription contract award-
ed under subsection (f) or section 399OO–2. The fa-
vored characteristics shall be weighed for purposes 
of such monetary value of the subscription contract 
such that meeting certain characteristics, or meeting 
more than one such characteristic, increases the 
monetary value of the subscription contract. Such 
favored characteristics of an antimicrobial drug shall 
include— 
‘‘(A) treating infections on the list under 
paragraph (1); 
‘‘(B) improving clinical outcomes for pa-
tients with multi-drug-resistant infections; 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
‘‘(C) being a first-approved antimicrobial 
drug that has the potential to address, or has 
the evidence of addressing, unmet medical 
needs for the treatment of a serious or life- 
threatening infection, and, to a lesser extent, 
second and third drugs that treat such infec-
tions; 
‘‘(D) route of administration, especially 
through oral administration; 
‘‘(E)(i) containing no active moiety (as de-
fined by the Secretary in section 314.3 of title 
21, Code of Federal Regulations (or any suc-
cessor regulations)) that has been approved in 
any other application under section 505(b) of 
the Federal Food, Drug, and Cosmetic Act or 
intending to be the subject of a new biological 
product 
license 
application 
under 
section 
351(a); 
‘‘(ii) being a member of a new class of 
drugs with a novel target or novel mode of ac-
tion that are distinctly different from the target 
or mode of any antimicrobial drug approved 
under section 505 of such Act or licensed under 
section 351, including reduced toxicity; or 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
‘‘(iii) not being affected by cross-resistance 
to any antimicrobial drug approved under such 
section 505 or licensed under such section 351; 
‘‘(F) addressing a multi-drug resistant in-
fection through a novel chemical scaffold or 
mechanism of action; 
‘‘(G) having received a transitional sub-
scription contract under subsection (f); and 
‘‘(H) any other characteristic the Com-
mittee or the Critical Need Antimicrobial Advi-
sory Group established under subsection (g) de-
termines necessary. 
‘‘(d) REGULATIONS.— 
‘‘(1) IN GENERAL.—Not later than 18 months 
after the appointment of the initial members of the 
Committee, the Secretary shall issue proposed regu-
lations which shall include— 
‘‘(A) a process by which the sponsors can 
apply for an antimicrobial drug to become a 
critical need antimicrobial drug under section 
399OO–1; 
‘‘(B) how subscription contracts under sec-
tion 399OO–2 shall be established and paid; 
‘‘(C) the favored characteristics under sub-
section (c)(2), how such characteristics will be 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
weighed, and the minimum number and kind of 
favored characteristics needed for an anti-
microbial drug to be designated a critical need 
antimicrobial drug; and 
‘‘(D) other elements of the subscription 
contract process, in accordance with this part. 
‘‘(2) 
DEVELOPMENT
OF
FINAL
REGULA-
TIONS.—Before finalizing the regulations under 
paragraph (1), the Secretary shall solicit public com-
ment and hold public meetings for the period begin-
ning on the date on which the proposed regulations 
are issued and ending on the date that is 150 days 
after such date of issuance. The Secretary shall fi-
nalize and publish such regulations not later than 
150 days after the close of such period of public 
comment and meetings. 
‘‘(3) 
COMMITTEE
RECOMMENDATIONS.—In 
issuing regulations under this subsection, the Sec-
retary shall consider the recommendations of the 
Committee under subsection (c)(2). 
‘‘(e) LIST OF INFECTIONS.—The Secretary, in col-
laboration with the Committee, shall update the list of in-
fections under subsection (c)(1) at least every 2 years fol-
lowing the development of the initial list under that sub-
section. 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
‘‘(f) TRANSITIONAL SUBSCRIPTION CONTRACTS.— 
‘‘(1) IN GENERAL.—Not earlier than 30 days 
after the date of enactment of this part and ending 
on the date that the Secretary finalizes the regula-
tions under subsection (d), the Secretary may use up 
to 10 percent of the amount appropriated under sec-
tion 399OO–4(a) to engage in transitional subscrip-
tion contracts of up to 5 years in length with anti-
microbial developers, as determined by the Sec-
retary, that have developed antimicrobial drugs 
treating infections listed in the most recent report 
entitled ‘Antibiotic Resistance Threats in the United 
States’ issued by the Centers for Disease Control 
and Prevention, and may include antimicrobial drugs 
that are qualified infectious disease products (as de-
fined in section 505E(g) of the Federal Food, Drug, 
and Cosmetic Act), innovative biological products, or 
innovative drugs that achieve improved clinical out-
comes. Such a contract may authorize the contractor 
to use funds made available under the contract for 
completion of postmarketing clinical studies, manu-
facturing, and other preclinical and clinical efforts. 
‘‘(2) REQUIREMENTS.— 
‘‘(A) 
IN
GENERAL.—The 
Secretary, 
through the office described in paragraph (4), 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
may enter into a contract under paragraph 
(1)— 
‘‘(i) if the Secretary determines that 
the antimicrobial drug is intended to treat 
an infection for which there is an unmet 
clinical need, an anticipated clinical need, 
or drug resistance; 
‘‘(ii) subject to terms including— 
‘‘(I) that the Secretary shall 
cease any payment installments under 
a transitional subscription contract if 
the sponsor does not— 
‘‘(aa) 
ensure 
commercial 
availability of the antimicrobial 
drug within 30 days of receiving 
first payment under the contract; 
‘‘(bb) identify, track, and 
publicly report drug resistance 
data, and trends using available 
data related to the antimicrobial 
drug; 
‘‘(cc) develop and implement 
education and communications 
strategies, including communica-
tions for individuals with limited 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
English proficiency and individ-
uals with disabilities, for health 
care professionals and patients 
about appropriate use of the 
antimicrobial drug; 
‘‘(dd) submit a plan for reg-
istering the antimicrobial drug in 
additional countries where an 
unmet medical need exists, which 
such plan may be consistent with 
the Stewardship and Access Plan 
(SAP) 
Development 
Guide 
(2021); 
‘‘(ee) subject to subpara-
graph (B), ensure a reliable drug 
supply chain, thus leading to an 
interruption of the supply of the 
antimicrobial drug in the United 
States for more than 60 days; or 
‘‘(ff) 
make 
meaningful 
progress toward completion of 
Food and Drug Administration- 
required postmarketing studies, 
including such studies that are 
evidence based; and 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
‘‘(II) other terms as determined 
by the Secretary; and 
‘‘(iii) if— 
‘‘(I) a phase 3 clinical study has 
been initiated for the antimicrobial 
drug; or 
‘‘(II) the antimicrobial drug has 
been approved under section 505(c) of 
the Federal Food, Drug, and Cos-
metic Act or licensed under section 
351(a). 
‘‘(B) WAIVER.—The requirement under 
subparagraph (A)(ii)(I)(ee) may be waived in 
the case that an emergency prohibits access to 
a reliable drug supply chain. 
‘‘(3) TRANSITIONAL
GUIDANCE.—Not later 
than 120 days after the appointment of the initial 
members of the Committee, the Secretary shall 
issue, in consultation with the Committee, transi-
tional guidance outlining the characteristics of anti-
microbial drugs that are eligible for transitional sub-
scription contracts under paragraph (1), the require-
ments to enter into a transitional subscription con-
tract under paragraph (2), and the process by which 
drug developers can enter into transitional subscrip-
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
tion contracts with the Secretary under this sub-
section. 
‘‘(4) PAYMENT OFFICE AND MECHANISM.—Not 
later than 30 days after the date of enactment of 
this part, the Secretary shall establish within the 
Administration for Strategic Preparedness and Re-
sponse an office to manage the transitional subscrip-
tion contracts, including eligibility, requirements, 
and contract amounts, during the period described 
in paragraph (1). 
‘‘(g) CRITICAL NEED ANTIMICROBIAL ADVISORY 
GROUP.— 
‘‘(1) IN
GENERAL.—Not later than 30 days 
after the appointment of all initial members of the 
Committee, the Secretary, in collaboration with the 
Committee, shall establish a Critical Need Anti-
microbial Advisory Group (referred to in this sub-
section as the ‘Advisory Group’) and appoint mem-
bers to the Advisory Group. 
‘‘(2) MEMBERS.—The members of the Advisory 
Group shall include— 
‘‘(A) not fewer than 6 individuals who 
are— 
‘‘(i) infectious disease specialists; or 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
‘‘(ii) other health experts with exper-
tise in researching antimicrobial resistance, 
health economics, or commercializing anti-
microbial drugs; and 
‘‘(B) not fewer than 5 patient advocates. 
‘‘(3) CHAIR.—The Secretary shall appoint as 
Chair of the Advisory Group a non-voting, inde-
pendent member who may not be a member rep-
resented under paragraph (2). 
‘‘(4) CONFLICTS OF INTEREST.—In appointing 
members under paragraph (2) and a Chair under 
paragraph (3), the Secretary shall ensure that no 
member receives compensation in any manner from 
a commercial or for-profit entity that develops 
antimicrobials or that might benefit from anti-
microbial development. 
‘‘(5) APPLICABILITY OF FACA.—Except as oth-
erwise provided in this subsection, chapter 10 of title 
5, United States Code, (commonly known as the 
Federal Advisory Committee Act) shall apply to the 
Advisory Group. 
‘‘SEC. 399OO–1. DESIGNATION OF ANTIMICROBIAL DRUG AS 
CRITICAL NEED ANTIMICROBIAL DRUG. 
‘‘(a) IN GENERAL.— 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
‘‘(1) SUBMISSION OF REQUEST.—The sponsor 
of an application under section 505(b) of the Fed-
eral Food, Drug, and Cosmetic Act or section 351(a) 
for an antimicrobial drug may request that the Sec-
retary designate the drug as a critical need anti-
microbial. A request for such designation may be 
submitted after the Secretary grants for such drug 
an investigational new drug exemption under section 
505(i) of the Federal Food, Drug, and Cosmetic Act 
or section 351(a)(3), and shall be submitted not 
later than 5 years after the date of approval under 
section 505(c) of the Federal Food, Drug, and Cos-
metic Act or licensure under section 351(a). 
‘‘(2) CONTENT OF REQUEST.—A request under 
paragraph (1) shall include information, such as 
clinical, preclinical, and postmarketing data, a list of 
the favorable characteristics described in section 
399OO(c)(2), and any other material that the Sec-
retary in consultation with the Committee requires. 
‘‘(3) REVIEW BY SECRETARY.—The Secretary 
shall promptly review all requests for designation 
submitted under this subsection, assess all required 
application components, and determine if the anti-
microbial drug is likely to meet the favorable charac-
teristics identified in the application upon the com-
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
pletion of clinical development. After review, the Sec-
retary shall approve or deny each request for des-
ignation not later than 90 days after receiving a re-
quest. If the Secretary approves a request, it shall 
publish the value of the contract that the critical 
need antimicrobial developer would be eligible to re-
ceive if such developer successfully demonstrates 
that the drug meets the maximum value of the fa-
vored characteristics listed in the application. 
‘‘(4) LENGTH
OF
DESIGNATION
PERIOD.—A 
designation granted under this section shall be in ef-
fect for a period of 10 years after the date that the 
designation is approved, and shall remain in effect 
for such period even if the infection treated by such 
drug is later removed from the list of infections 
under section 399OO(c)(1). 
‘‘(5) SUBSEQUENT REVIEWS.—Not earlier than 
2 years after a designation approval or denial under 
paragraph (3), the sponsor may request a subse-
quent review to re-evaluate the value of a contract 
to include any new information. 
‘‘(b) DEVELOPMENT OF DESIGNATED DRUGS.—If a 
critical need antimicrobial designation is granted during 
clinical development of an antimicrobial drug, the Sec-
retary may work with the sponsor to maximize the oppor-
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
tunity for the sponsor to successfully demonstrate that the 
antimicrobial drug possesses the favored characteristics 
identified under section 399OO(c)(2). 
‘‘(c) APPROPRIATE USE OF CRITICAL NEED ANTI-
MICROBIAL.— 
‘‘(1) IN GENERAL.—The sponsor of an anti-
microbial drug that receives designation under sub-
section (a) shall, within 90 days of such designation, 
submit to the Secretary a plan for appropriate use 
of diagnostics, in order for the Secretary and Com-
mittee to consider such plan in developing clinical 
guidelines. An appropriate use plan— 
‘‘(A) shall include— 
‘‘(i) the appropriate use of the drug; 
and 
‘‘(ii) the appropriate use of diagnostic 
tools, where available, or a plan to coordi-
nate development of diagnostic tools as 
necessary; and 
‘‘(B) may be developed in partnership with 
the Secretary, infectious disease experts, diag-
nostic experts or developers, laboratory experts, 
or another entity. 
‘‘(2) CONSULTATION.—The Secretary shall con-
sult with relevant professional societies and the Crit-
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00016
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
ical Need Antimicrobial Advisory Group established 
under section 399OO(g) to ensure that clinical 
guidelines issued by the Secretary under paragraph 
(3), with respect to an antimicrobial drug designated 
under subsection (a), includes the use of appropriate 
diagnostic approaches, taking into consideration the 
diagnostic plan submitted by a sponsor under para-
graph (1). 
‘‘SEC. 399OO–2. ESTABLISHMENT OF SUBSCRIPTION CON-
TRACT OFFICE; SUBSCRIPTION CONTRACTS. 
‘‘(a) SUBSCRIPTION CONTRACT OFFICE.— 
‘‘(1) IN GENERAL.—Not later than 180 days 
after the date of enactment of this part, the Sec-
retary shall establish within the Administration for 
Strategic Preparedness and Response an office, to 
be known as the ‘Subscription Contract Office’, the 
head of which shall be the Director (referred to in 
this section as the ‘Director’). 
‘‘(2) PURPOSE.—The purpose of the Office es-
tablished under paragraph (1) shall be to manage 
the establishment and payment of subscription con-
tracts awarded under this section, including eligi-
bility, requirements, and contract amounts. 
‘‘(b) APPLICATION
FOR
A
SUBSCRIPTION
CON-
TRACT.— 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00017
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
‘‘(1) SUBMISSION OF APPLICATIONS.—After ap-
proval under section 505(c) of the Federal Food, 
Drug, and Cosmetic Act or licensure under section 
351(a), the sponsor of an antimicrobial drug des-
ignated as a critical need antimicrobial under section 
399OO–1 may submit an application for a subscrip-
tion contract to the Director, under a procedure es-
tablished by the Director. 
‘‘(2) REVIEW OF APPLICATIONS.—The Director, 
in consultation with the Committee, shall— 
‘‘(A) review all applications for subscrip-
tion contracts under paragraph (1) and assess 
all required application components; 
‘‘(B) determine the extent to which the 
critical need antimicrobial drug covered by the 
application meets the favored characteristics 
identified under section 399OO(c)(2); and 
‘‘(C) deny any application for a drug that 
does not meet the minimum number and kind 
of favored characteristics needed for the drug to 
be designated as a critical need antimicrobial 
based on the regulations issue under section 
399OO(d). 
‘‘(c) REQUIREMENTS.—As a condition of entering 
into a subscription contract under this section, the sponsor 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00018
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
of the critical need antimicrobial drug covered by the ap-
plication shall agree to— 
‘‘(1) ensure commercial availability of the anti-
microbial drug within 30 days of receiving first pay-
ment under the contract, and sufficient supply for 
susceptibility device manufacturers; 
‘‘(2) identify, track, and publicly report drug 
resistance data, and trends using available data re-
lated to the antimicrobial drug; 
‘‘(3) develop and implement education and com-
munications strategies, including communications 
for individuals with limited English proficiency and 
individuals with disabilities, for health care profes-
sionals and patients about appropriate use of the 
antimicrobial drug; 
‘‘(4) submit an appropriate use assessment to 
the Secretary, the Committee, the Administrator of 
the Food and Drug Administration, and the Director 
of the Centers for Disease Control and Prevention 
every 2 years regarding use of the antimicrobial 
drug, including how the drug is being marketed; 
‘‘(5) submit a plan for registering the drug in 
additional countries where an unmet medical need 
exists; 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00019
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
‘‘(6) ensure a reliable drug supply chain, where 
any interruption to the supply chain will not last for 
more than 60 days in the United States; 
‘‘(7) complete any postmarketing studies re-
quired by the Food and Drug Administration in a 
timely manner; 
‘‘(8) produce the drug at a reasonable volume 
determined with the Director to ensure patient ac-
cess to the drug; 
‘‘(9) abide by the manufacturing and environ-
mental best practices in the supply chain for the 
control of discharge of antimicrobial active pharma-
ceutical ingredients to ensure minimal discharge 
into, or contamination of, the environment by anti-
microbial agents or products as a result of the man-
ufacturing process; and 
‘‘(10) abide by such other terms as the Director 
may require. 
‘‘(d) MONETARY VALUE.— 
‘‘(1) IN GENERAL.—The Director, in consulta-
tion with the Committee, shall assign a monetary 
value to each subscription contract under this sec-
tion based on the regulations developed under sec-
tion 399OO(d). 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00020
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
‘‘(2) CONSIDERATIONS.—In assigning a mone-
tary value to a subscription contract under para-
graph (1), the Director shall take into account the 
favored characteristic or combination of favored 
characteristics of the drug covered by the contract, 
as determined by the Director, in consultation with 
the Committee, under subsection (b)(2)(B). 
‘‘(e) AMOUNT OF CONTRACTS.— 
‘‘(1) IN
GENERAL.—A subscription contract 
under this section shall be for the sale to the Sec-
retary of any quantity of the antimicrobial drug cov-
ered by the contract needed over the term of the 
contract, at a price agreed on by the sponsor and 
the Director, based on the monetary value assigned 
to the contract under subsection (d). 
‘‘(2) MINIMUM AND MAXIMUM AMOUNT.—The 
total projected amount to be paid by the Director 
under a subscription contract under this section 
shall be not less than $750,000,000 and not more 
than $3,000,000,000, adjusted for inflation. 
‘‘(f) TERM.— 
‘‘(1) INITIAL TERM.—The initial term of a sub-
scription contract under this section shall be— 
‘‘(A) not less than 5 years; and 
‘‘(B) not greater than the greater of— 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00021
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
‘‘(i) 10 years; and 
‘‘(ii) the remaining period of time dur-
ing which the sponsor has patent protec-
tions or a remaining exclusivity period with 
respect to the antimicrobial drug in the 
United States, as listed in the publication 
of the Food and Drug Administration enti-
tled ‘Approved Drug Products with Thera-
peutic Equivalence Evaluations’. 
‘‘(2) EFFECT.—A subscription contract shall 
remain in effect for the period described in para-
graph (1) even if the infection treated by the anti-
microbial drug covered by the subscription contract 
is later removed from the list of infections under 
section 399OO(c)(1). 
‘‘(3) EXTENSION OF CONTRACTS.—The Direc-
tor may extend a subscription contract with a spon-
sor under this subsection beyond the initial contract 
period. A single contract extension may be in effect 
not later than the date on which all periods of exclu-
sivity granted by the Food and Drug Administration 
expire and shall be in an amount not to exceed 
$25,000,000 per year. All other terms of an ex-
tended contract shall be the same as the terms of 
the initial contract. The total amount of funding 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00022
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
used on such contract extensions shall be no more 
than $1,000,000,000, and shall be allocated from 
the amount made available under section 399OO– 
4(a). 
‘‘(4) MODIFICATION OF CONTRACTS.—The Di-
rector or sponsor, 1 year after the start of the con-
tract period under this subsection and every 2 years 
thereafter, may request a modification of the 
amount of the contract based on information that 
adjusts 
favored 
characteristics 
in 
section 
399OO(c)(2). 
‘‘(g) PAYMENTS.— 
‘‘(1) IN GENERAL.—Not later than 180 days 
after the date on which a subscription contract is 
granted under subsection (a), the Director shall pro-
vide payments for drugs purchased under the con-
tract in installments established by the Director, in 
consultation with the sponsor of the antimicrobial 
drug and in accordance with subsection (j). 
‘‘(2) TIMING OF PAYMENTS.—The Director— 
‘‘(A) may make payments under paragraph 
(1) in equal annual installments; and 
‘‘(B) shall not make such payments more 
frequently than twice per year. 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00023
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
‘‘(3) OPTION.—The sponsor shall have the op-
tion to receive 50 percent of the payment amount 
due in the last year of the contract during the first 
year of the contract in order to offset costs of estab-
lishing manufacturing capacity. 
‘‘(4) FUNDING.—Payments under this sub-
section shall be allocated from the amount made 
available under section 399OO–4(a). 
‘‘(5) ADJUSTMENT.—In the case of an anti-
microbial drug that received a transitional subscrip-
tion contract under section 399OO(f), the amount of 
a subscription contract for such drug under this sec-
tion shall be reduced by the amount of the transi-
tional subscription contract under such section 
399OO(f) for such drug. 
‘‘(h) USE OF CONTRACT FUNDS.—Funds received by 
the sponsor under a subscription contract under this sec-
tion shall be used— 
‘‘(1) to meet the requirements described in sub-
section (c); and 
‘‘(2) to support the completion of post-
marketing clinical studies, manufacturing, other pre-
clinical and clinical activities, or other activities 
agreed to by the Director and sponsor in the con-
tract. 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00024
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
‘‘(i) CONTRACTS
FOR GENERIC
AND BIOSIMILAR 
VERSIONS.—Notwithstanding any other provision of this 
part, the Director may award a subscription contract 
under this section to a manufacturer of a generic or bio-
similar version of an antimicrobial drug for which a sub-
scription contract has been awarded under this section. 
Such contracts shall be awarded in accordance with a pro-
cedure, including for determining the terms and amounts 
of such contracts, established by the Director. 
‘‘(j) ANTIMICROBIAL DRUG SPONSOR REVENUE LIM-
ITATIONS.— 
‘‘(1) REQUIREMENT.— 
‘‘(A) IN GENERAL.—With respect to a pay-
ment installment under a subscription contract 
entered into under this section, the net revenue 
from sales of the applicable antimicrobial drug 
for beneficiaries or enrollees in Federal health 
care programs during the period covered by the 
payment installment shall be subtracted from 
the payment installment. 
‘‘(B) PAYMENT.—The amount calculated 
under subparagraph (A) shall be paid by the 
Secretary to the relevant Federal health care 
program (or its trust fund) at the time of the 
applicable installment payment. 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00025
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
‘‘(C) COORDINATION.—The Director shall 
coordinate with the relevant agencies of the 
Federal Government, including the Centers for 
Medicare and Medicaid Services, to carry out 
this subsection in a manner that ensures mini-
mal disruption to how a health care provider 
currently 
acquires 
applicable 
antimicrobial 
drugs. 
‘‘(2) REGULATIONS.— 
‘‘(A) IN GENERAL.—To carry out this sub-
section, the Secretary shall promulgate regula-
tions to identify the Federal health care pro-
grams applicable under this section, including 
Medicare part A and Medicaid, and to establish 
the methodology and data collection require-
ments necessary to calculate the amount under 
paragraph (1)(A). 
‘‘(B) METHODOLOGY.—Any methodology 
established for the collection of data and cal-
culation of the amount under paragraph (1)(A) 
shall take into account any legally mandated or 
voluntary discounts and rebates provided by the 
manufacturer of the applicable antimicrobial 
drug to the Federal health care programs that 
pay for such drug, on the condition that the 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00026
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
Secretary may presume that discounts not de-
scribed in subclauses (I) and (II) of subpara-
graph (C)(ii) are captured in the price deter-
mined under subparagraph (C)(i)(II). 
‘‘(C) ESTIMATING
ANNUAL
NET
REV-
ENUE.— 
‘‘(i) IN
GENERAL.—In determining 
the net revenue from sales of the applica-
ble antimicrobial drug for beneficiaries or 
enrollees in Federal health care programs 
for the purpose of calculating the amount 
under paragraph (1)(A), the Secretary 
shall determine such net revenue amount 
by multiplying— 
‘‘(I) the total number of billing 
units of such antimicrobial drugs re-
ported under the process described in 
subparagraph (D)(ii) for the applica-
ble payment installment period; by 
‘‘(II) the average sales price (as 
defined in section 1847A(c) of the So-
cial Security Act), the average manu-
facturer price (as defined in section 
1927(k)(1) of the Social Security 
Act), or another pricing metric used 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00027
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
in Federal health care programs, for 
such antimicrobial drugs. 
‘‘(ii) REQUIREMENT.—The Secretary 
shall adjust the amount determined under 
clause (i)(II) to account for— 
‘‘(I) rebates, discounts, add-on 
payments, or other adjustments pro-
vided under— 
‘‘(aa) section 340B; or 
‘‘(bb) section 1927 of the 
Social Security Act; or 
‘‘(II) negotiated price concessions 
described 
in 
section 
1860D– 
2(d)(1)(B) of the Social Security Act 
that are not captured in the applicable 
price. 
‘‘(D) CODING.— 
‘‘(i) IN
GENERAL.—In promulgating 
regulations under subparagraph (A), the 
Secretary shall, as appropriate, establish 
and assign codes, under existing or new 
coding systems, to identify units of the ap-
plicable antimicrobial drug for beneficiaries 
or enrollees in Federal health care pro-
grams. 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00028
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
‘‘(ii) CODING USE REQUIREMENTS.— 
In promulgating regulations under sub-
paragraph (A), the Secretary shall require 
hospitals (or other providers or suppliers) 
that administer applicable antimicrobial 
drugs in the inpatient or outpatient setting 
to report on their claims to such Federal 
health care programs the billing units of 
such antimicrobial drugs used in the care 
of beneficiaries or enrollees in each Federal 
health care program, regardless of whether 
payment for those units are separately re-
imbursed. 
‘‘(3) DEFINITIONS.—In this subsection: 
‘‘(A) 
APPLICABLE
ANTIMICROBIAL 
DRUG.—The 
term 
‘applicable 
antimicrobial 
drug’ means an antimicrobial drug for which 
the sponsor of such drug receives a subscription 
contract under subsection (a). 
‘‘(B) FEDERAL HEALTH CARE PROGRAM.— 
The term ‘Federal health care program’ has the 
meaning given such term in section 1128B(f) of 
the Social Security Act, except that, for pur-
poses of this subsection, such term includes the 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00029
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
health insurance program under chapter 89 of 
title 5, United States Code. 
‘‘(k) FAILURE TO ADHERE TO TERMS.—The Sec-
retary shall cease any payment installments under a con-
tract under this section if— 
‘‘(1) the sponsor— 
‘‘(A) permanently withdraws the anti-
microbial drug from the market in the United 
States; 
‘‘(B) fails to meet the requirements de-
scribed in subsection (c); or 
‘‘(C) does not complete a postmarket study 
required by the Food and Drug Administration 
during the term of the contract; 
‘‘(2) the annual international and private insur-
ance market revenues with respect to an anti-
microbial drug (not counting any subscription reve-
nues from any source pursuant to a contract under 
this section or other international or private entities) 
exceed 5 times the average annual amount of the 
subscription contract paid by the Secretary as cer-
tified by the sponsor annually; or 
‘‘(3) if the total revenue of the sponsor from 
government programs that pay for drugs subject to 
a contract agreement entered into pursuant to this 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00030
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
section for a year exceeds the amount of the sub-
scription contract paid by the Secretary for that 
year. 
‘‘(l) PRIVATE PAYER AND INTERNATIONAL PAYER 
PARTICIPATION.—The Secretary shall make efforts to in-
crease the participation of domestic private payors and 
international payors in subscription contracts or other 
types of value-based arrangements that are similar to the 
subscription contracts authorized under this section. 
‘‘(m) EFFECT.—Nothing in this section permits the 
Secretary to use evidence from comparative clinical effec-
tiveness research in a manner that treats extending the 
life of an elderly, disabled, or terminally ill individual as 
of lower value than extending the life of an individual who 
is younger, nondisabled, or not terminally ill in deter-
mining the value of an antimicrobial drug or a subscrip-
tion contract (or a transitional subscription contract), in-
cluding in such a way that would limit patient access. 
‘‘SEC. 399OO–3. ENCOURAGING APPROPRIATE USE OF 
ANTIMICROBIALS AND COMBATING RESIST-
ANCE. 
‘‘(a) ESTABLISHMENT OF HEALTH FACILITY GRANT 
PROGRAM.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this part, the Secretary 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00031
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
shall establish a grant program under the Centers 
for Disease Control and Prevention to support hos-
pital, skilled nursing facility, and other health care 
facility efforts— 
‘‘(A) to judiciously use antimicrobial drugs, 
such as by establishing or implementing appro-
priate use programs, including infectious dis-
ease telehealth programs, using appropriate di-
agnostic tools, partnering with academic hos-
pitals, increasing health care-associated infec-
tion reporting and prevention efforts, and moni-
toring antimicrobial resistance; and 
‘‘(B) to participate in the National 
Healthcare Safety Network Antimicrobial Use 
and Resistance Module or the Emerging Infec-
tions Program Healthcare-Associated Infections 
Community Interface activity of the Centers for 
Disease Control and Prevention or a similar re-
porting program, as specified by the Secretary, 
relating to antimicrobial drugs. 
‘‘(2) PRIORITIZATION.—In awarding grants 
under paragraph (1), the Secretary shall prioritize 
health care facilities without an existing program to 
judiciously use antimicrobial drugs, subsection (d) 
hospitals (as defined in subparagraph (B) of section 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00032
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
1886(d)(2) of the Social Security Act that are lo-
cated in rural areas (as defined in subparagraph (D) 
of such section), critical access hospitals (as defined 
in section 1861(mm)(1) of such Act), hospitals serv-
ing Tribal-populations, and safety-net hospitals. 
‘‘(b) SURVEILLANCE
AND REPORTING
OF ANTI-
MICROBIAL USE AND RESISTANCE.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of the Centers for Disease 
Control and Prevention, shall use the National 
Healthcare Safety Network and other appropriate 
surveillance systems to assess trends in antimicrobial 
resistance and antibiotic and antifungal use, such 
as— 
‘‘(A) appropriate conditions and measures 
causally related to antimicrobial resistance, in-
cluding types of infections, the source or body 
sites of infections, the demographic information 
of patients with infections, and infection onset 
in a community or hospital setting, increased 
lengths of hospital stay, increased costs, and 
rates of mortality; and 
‘‘(B) changes in bacterial and fungal re-
sistance 
to 
antimicrobial 
drugs, 
including 
changes in percent resistance, prevalence of 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00033
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
antimicrobial-resistant infections, rates of mor-
tality, and other such changes. 
‘‘(2) ANTIMICROBIAL
USE
DATA.—The Sec-
retary, acting through the Director of the Centers 
for Disease Control and Prevention, shall obtain reli-
able 
and 
comparable 
human 
antibiotic 
and 
antifungal drug consumption data (including, as 
available and appropriate, volume antimicrobial dis-
tribution data and antibiotic and antifungal use 
data, including prescription data) by State or metro-
politan areas. To accomplish this, the Centers for 
Disease Control and Prevention may work with, as 
appropriate, Federal departments and agencies (in-
cluding the Department of Veterans Affairs, the De-
partment of Defense, the Department of Homeland 
Security, the Bureau of Prisons, the Indian Health 
Service, and the Centers for Medicare & Medicaid 
Services), private vendors, health care organizations, 
pharmacy benefit managers, and other entities. 
‘‘(3) 
ANTIMICROBIAL
RESISTANCE
TREND 
DATA.—The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention, 
shall intensify and expand efforts to collect anti-
microbial resistance data and encourage adoption of 
the Antibiotic Use and Resistance Module within the 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00034
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
National Healthcare Safety Network among all 
health care facilities across the continuum of care, 
including, as appropriate, acute care hospitals, dialy-
sis facilities, nursing homes, ambulatory surgical 
centers, and other ambulatory health care settings in 
which antimicrobial drugs are routinely prescribed. 
The Secretary shall seek to collect such data from 
electronic medication administration reports and lab-
oratory systems to produce the reports described in 
paragraph (4). 
‘‘(4) PUBLIC AVAILABILITY OF DATA.—Begin-
ning on the date that is 2 years after the date of 
enactment of this part, the Secretary, acting 
through the Director of the Centers for Disease 
Control and Prevention, shall, for the purposes of 
improving the monitoring of important trends in 
antimicrobial use and resistance, and, as appro-
priate, patient outcomes in relation to antimicrobial 
resistance— 
‘‘(A) make the data described under this 
subsection publicly available through reports 
and web updates issued on a regular basis that 
is not less than annually; and 
‘‘(B) examine opportunities to make such 
data available in near real time. 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00035
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
‘‘(c) PUBLICATION OF CLINICAL GUIDELINES.—Not 
later than 1 year after the date the Secretary makes the 
first designation under section 399OO–1(a), and not less 
than every 3 years thereafter, the Secretary shall publish 
at least one update to clinical guidelines in consultation 
with relevant professional societies. As appropriate, guide-
line updates shall include each antimicrobial drug that has 
been approved under section 505(c) of the Federal Food, 
Drug, and Cosmetic Act or licensed under section 351(a) 
and that has been designated under section 399OO–1(a), 
which guidelines shall set forth the evidence-based rec-
ommendations for prescribing the drug for the relevant in-
fection time, in accordance with the available evidence 
after consultation under section 399OO–1(c)(2), as appro-
priate. 
‘‘(d) FUNDING.—The Secretary may use not more 
than 5 percent of the amounts appropriated under section 
399OO–4(a) to carry out this section. 
‘‘SEC. 399OO–4. APPROPRIATIONS. 
‘‘(a) IN GENERAL.—To carry out this part, there are 
hereby appropriated to the Secretary, out of amounts in 
the Treasury not otherwise appropriated, $6,000,000,000 
for fiscal year 2024, to remain available until expended. 
‘‘(b) EMERGENCY DESIGNATION.— 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00036
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
‘‘(1) IN GENERAL.—The amounts provided by 
this section are designated as an emergency require-
ment pursuant to section 4(g) of the Statutory Pay- 
As-You-Go Act of 2010. 
‘‘(2) DESIGNATION IN SENATE.—In the Senate, 
this section is designated as an emergency require-
ment pursuant to section 4112(a) of H. Con. Res. 
71 (115th Congress), the concurrent resolution on 
the budget for fiscal year 2018. 
‘‘SEC. 399OO–5. STUDIES AND REPORTS. 
‘‘(a) IN GENERAL.—Not later than 6 years after the 
date of enactment of this part, the Comptroller General 
of the United States shall complete a study on the effec-
tiveness of this part in developing priority antimicrobial 
drugs. Such study shall examine the indications for, usage 
of, development of resistance with respect to, and private 
and societal value of critical need antimicrobial drugs, and 
the impact of the programs under this part on markets 
of critical need antimicrobial drugs. The Comptroller Gen-
eral shall report to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives 
on the findings of such study. 
‘‘(b) ANTIBIOTIC USE IN THE UNITED STATES; AN-
NUAL REPORTS.—The Director of the Centers for Disease 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00037
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
Control and Prevention shall, each year, update the report 
entitled ‘Antibiotic Use in the United States’ to include 
updated information on progress and opportunities with 
respect to data, programs, and resources for prescribers 
to promote appropriate use of antimicrobial drugs. 
‘‘(c) REPORT ON ANTIMICROBIAL PROPHYLACTICS.— 
Not later than 3 years after the date of enactment of this 
part, the Director of the Centers for Disease Control and 
Prevention shall publish a report on antimicrobial prophy-
lactics. 
‘‘SEC. 399OO–6. DEFINITIONS. 
‘‘In this part— 
‘‘(1) the term ‘antimicrobial drug’— 
‘‘(A) means, subject to subparagraph (B), 
a product that is— 
‘‘(i) a drug that directly inhibits rep-
lication of or kills bacteria or fungi, or acts 
on the substances produced by such bac-
teria or fungi, relevant to the proposed in-
dication at concentrations likely to be at-
tainable in humans to achieve the intended 
therapeutic effect; or 
‘‘(ii) a biological product that acts di-
rectly on bacteria or fungi or on the sub-
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00038
Fmt 6652
Sfmt 6201
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS
stances produced by such bacteria or fungi; 
and 
‘‘(B) does not include— 
‘‘(i) a drug that achieves the effect de-
scribed by subparagraph (A)(i) only at a 
concentration that cannot reasonably be 
studied in humans because of its antici-
pated toxicity; or 
‘‘(ii) a vaccine; and 
‘‘(2) the term ‘Committee’ means the Com-
mittee on Critical Need Antimicrobials established 
under section 399OO(a).’’. 
Æ 
VerDate Sep 11 2014 
22:35 May 08, 2023
Jkt 039200
PO 00000
Frm 00039
Fmt 6652
Sfmt 6301
E:\BILLS\H2940.IH
H2940
kjohnson on DSK79L0C42PROD with BILLS