I 
117TH CONGRESS 
1ST SESSION H. R. 3932 
To establish a program to develop antimicrobial innovations targeting the 
most challenging pathogens and most threatening infections. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 16, 2021 
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, and Homeland 
Security, for a period to be subsequently determined by the Speaker, in 
each case for consideration of such provisions as fall within the jurisdic-
tion 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 2021’’ or the ‘‘PASTEUR Act of 2021’’. 
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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 one 
of the members of the Committee to serve as the 
Chair of the Committee. 
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‘‘(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 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, in accordance with 
subsection (d), outlining favored characteristics of 
critical need antimicrobial drugs, that are evidence 
based, clinically focused, and designed to treat the 
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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 399QQ. The 
favored characteristics shall be weighed for purposes 
of such monetary value such that meeting certain 
characteristics, or meeting more than one such char-
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 antimicrobial 
drug that has the potential to address unmet 
medical needs for the treatment of a serious or 
life-threatening infection, and, to a lesser ex-
tent, second and third drugs that treat such in-
fections; 
‘‘(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-
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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 original 
biologics license application under section 
351(a); 
‘‘(ii) being a member of a new class of 
drugs with a novel target and 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; 
‘‘(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 Sec-
retary, in collaboration with the Committee, de-
termines 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 
399PP; 
‘‘(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 
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 120 days 
after such date of issuance. The Secretary shall fi-
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nalize and publish such regulations not later than 
120 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 part, 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 
399QQ, including eligibility, requirements, and con-
tract amounts. The Secretary shall solicit public 
comment and finalize the agency or office no later 
than 45 days following the proposed agency or of-
fice. Such agency or office shall be referred to as the 
‘Subscription Contract Office’. 
‘‘(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. 
‘‘(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 subscrip-
tion contract regulations under subsection (d), the 
Secretary may use up to $1,000,000,000 of the 
amount appropriated under section 399SS(a) to en-
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