I 
116TH CONGRESS 
2D SESSION 
H. R. 8920 
To establish a program to develop antimicrobial innovations targeting the 
most challenging pathogens and most threatening infections. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 9, 2020 
Mr. MICHAEL F. DOYLE of Pennsylvania (for himself and Mr. FERGUSON) in-
troduced the following bill; which was referred to the Committee on En-
ergy and Commerce, and in addition to the Committees on Ways and 
Means, Veterans’ Affairs, Armed Services, the Judiciary, Homeland Secu-
rity, and Natural Resources, for a period to be subsequently determined 
by the Speaker, in each case for consideration of such provisions as fall 
within the jurisdiction of the committee concerned 
A BILL 
To establish a program to develop antimicrobial innovations 
targeting the most challenging pathogens and most 
threatening infections. 
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 Up surging Resistance 
Act of 2020’’ or ‘‘The PASTEUR Act’’. 
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SEC. 2. ESTABLISHMENT OF COMMITTEE; SUBSCRIPTION 
MODEL; ADVISORY GROUP. 
(a) IN GENERAL.—Not later than 60 days after the 
date of enactment of this Act, the Secretary shall establish 
a Committee on Critical Need Antimicrobials and appoint 
members to the Committee. 
(b) MEMBERS.— 
(1) IN GENERAL.—The Committee shall consist 
of at least one representative from each of the Na-
tional Institute of Allergy and Infectious Diseases, 
the Centers for Disease Control and Prevention, the 
Biomedical Advanced Research and Development 
Authority, the Food and Drug Administration, the 
Centers for Medicare & Medicaid Services, the Vet-
erans Health Administration, and the Department of 
Defense. 
(2) CHAIR.—The Secretary shall appoint one of 
the members of the Committee to serve as the Chair 
of the Committee. 
(c) DUTIES.—Not later than 1 year after the appoint-
ment of all initial members of the Committee, the Sec-
retary, in collaboration with the Committee, and in con-
sultation with the Critical Need Antimicrobials Advisory 
Group established under subsection (g), shall do the fol-
lowing: 
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(1) Develop a list of prioritized infections for 
which new antimicrobial drug development is needed, 
taking into account 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 Prevention, or an anticipated unmet 
medical need. For the list developed under this para-
graph, the Secretary, in collaboration with the Com-
mittee, may use the infection list in such most re-
cent report for up to 3 years following the date of 
enactment of this Act and subsequently update the 
list under this paragraph in accordance with sub-
section (e). 
(2) Develop regulations, in accordance with 
subsection (d), outlining favored characteristics of 
critical 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 will 
adjust the monetary value of a subscription contract 
awarded under subsection (f) or section 4. The fa-
vored characteristics shall be weighed for purposes 
of such monetary value such that meeting certain 
characteristics, or meeting more than one such char-
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acteristic, increases the monetary value. Such fa-
vored 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; 
(C) being a first-approved drug that treats 
certain multi-drug resistant infections, and, to a 
lesser extent, second and third drugs that treat 
such infections; 
(D) addressing an infection located in an 
organ or other location that is challenging to 
treat; 
(E) addressing a multi-drug resistant in-
fection through a novel chemical scaffold or 
mechanism of action, especially through oral 
administration; 
(F) having received a transitional subscrip-
tion contract under subsection (f); and 
(G) any other characteristic the Secretary, 
in collaboration with the Committee, determines 
necessary. 
(d) REGULATIONS.— 
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(1) IN GENERAL.—Not later than 1 year after 
the appointment of the initial members of the Com-
mittee, the Secretary shall issue proposed regula-
tions 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 3; 
(B) how subscription contracts under such 
section shall be established and paid; 
(C) the favored characteristics under sub-
section (c)(2), how such characteristics will be 
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 con-
tract process, in accordance with this Act. 
(2) DEVELOPMENT OF FINAL REGULATIONS.— 
Before finalizing the regulations under paragraph 
(1), the Secretary shall solicit public comment and 
hold public meetings for the period beginning on the 
date on which the proposed regulations are issued 
and ending on the date that is 120 days after such 
date of issuance, and shall finalize and publish the 
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regulations 60 days after the close of such period of 
public comment and meetings. 
(3) SUBSCRIPTION
CONTRACT
OFFICE.—Not 
later than 6 months after the date of enactment of 
this Act, the Secretary shall propose an agency or 
office in the Department of Health and Human 
Services to manage the establishment and payment 
of subscription contracts awarded under section 4, 
including eligibility, requirements, and contract 
amounts. The Secretary shall solicit public comment 
and finalize the agency or office no later than 45 
days following the proposed agency or office. 
(e) LIST OF INFECTIONS.—The Secretary, in collabo-
ration with the Committee, shall update the list of infec-
tions under subsection (c)(1) at least every 2 years. 
(f) TRANSITIONAL SUBSCRIPTION CONTRACTS.— 
(1) IN
GENERAL.—Not earlier than 30 days 
after the date of enactment of this Act and ending 
on the date that the Secretary finalizes the subscrip-
tion contract regulations under subsection (d), the 
Secretary may use up to $1,000,000,000 of the 
amount appropriated under section 6(a) to engage in 
transitional subscription contracts of up to 3 years 
in length with antimicrobial developers, as deter-
mined by the Secretary, that have developed anti-
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