gage in transitional subscription contracts of up to 
3 years in length with antimicrobial developers, as 
determined by the Secretary, 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 dis-
ease products (as defined in section 505E(g) of the 
Federal Food, Drug, and Cosmetic Act), innovative 
biological products, or innovative drugs that achieve 
a clinical outcome through immunomodulation. Such 
a contract may authorize the contractor to use funds 
made available under the contract for completion of 
postmarketing clinical studies, manufacturing, and 
other preclinical and clinical efforts. 
‘‘(2) REQUIREMENTS.— 
‘‘(A) 
IN
GENERAL.—The 
Secretary, 
through the office described in paragraph (4), 
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 
VerDate Sep 11 2014 
20:39 Jul 22, 2021
Jkt 019200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H3932.IH
H3932
pbinns on DSKJLVW7X2PROD with BILLS
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 and 
Federal availability of the anti-
microbial 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 
English proficiency and individ-
uals with disabilities, for health 
care professionals and patients 
VerDate Sep 11 2014 
20:39 Jul 22, 2021
Jkt 019200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H3932.IH
H3932
pbinns on DSKJLVW7X2PROD with BILLS
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 
‘‘(II) other terms as determined 
by the Secretary; and 
‘‘(iii) if— 
VerDate Sep 11 2014 
20:39 Jul 22, 2021
Jkt 019200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H3932.IH
H3932
pbinns on DSKJLVW7X2PROD with BILLS
‘‘(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 antimicrobial drugs 
that are eligible for transitional subscription con-
tracts under paragraph (1), the requirements to 
enter into a transitional subscription contract under 
paragraph (2), and the process by which drug devel-
opers can enter into transitional subscription con-
tracts with the Secretary under this subsection. 
‘‘(4) PAYMENT OFFICE AND MECHANISM.—Not 
later than 30 days after the date of enactment of 
VerDate Sep 11 2014 
20:39 Jul 22, 2021
Jkt 019200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H3932.IH
H3932
pbinns on DSKJLVW7X2PROD with BILLS
this part, the Secretary shall determine the agency 
or office in the Department of Health and Human 
Services that will 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 
‘‘(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. 
VerDate Sep 11 2014 
20:39 Jul 22, 2021
Jkt 019200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H3932.IH
H3932
pbinns on DSKJLVW7X2PROD with BILLS
‘‘(3) CHAIR.—The Secretary shall appoint one 
of the members of the Advisory Group to serve as 
the Chair. 
‘‘(4) CONFLICTS OF INTEREST.—In appointing 
members under paragraph (2), 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 
antimicrobial development. 
‘‘(5) APPLICABILITY OF FACA.—Except as oth-
erwise provided in this subsection, the Federal Advi-
sory Committee Act shall apply to the Advisory 
Group. 
‘‘SEC. 399PP. CRITICAL NEED ANTIMICROBIAL DRUG APPLI-
CATION AND PAYMENT THROUGH SUBSCRIP-
TION CONTRACTS. 
‘‘(a) IN GENERAL.— 
‘‘(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 
VerDate Sep 11 2014 
20:39 Jul 22, 2021
Jkt 019200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H3932.IH
H3932
pbinns on DSKJLVW7X2PROD with BILLS
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-
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 
VerDate Sep 11 2014 
20:39 Jul 22, 2021
Jkt 019200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6201
E:\BILLS\H3932.IH
H3932
pbinns on DSKJLVW7X2PROD with BILLS
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.—No sooner than 
2 years after a designation approval or denial under 
subsection (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-
tunity for the sponsor to successfully demonstrate that the 
antimicrobial drug possesses the favored characteristics of 
high-monetary valued products identified under section 
399OO(c)(2). 
‘‘(c) APPROPRIATE USE OF CRITICAL NEED ANTI-
MICROBIAL.— 
VerDate Sep 11 2014 
20:39 Jul 22, 2021
Jkt 019200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6201
E:\BILLS\H3932.IH
H3932
pbinns on DSKJLVW7X2PROD with BILLS
‘‘(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, such as diagnostic 
testing for biomarkers related to anti-
microbial-resistant pathogens, or other tar-
geted diagnostic approaches, to inform use 
of the drug; 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-
ical Need Antimicrobial Advisory Group established 
under section 399OO(g) to ensure that clinical 
guidelines issued by the Secretary under paragraph 
VerDate Sep 11 2014 
20:39 Jul 22, 2021
Jkt 019200
PO 00000
Frm 00016
Fmt 6652
Sfmt 6201
E:\BILLS\H3932.IH
H3932
pbinns on DSKJLVW7X2PROD with BILLS
(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). 
‘‘(3) PUBLICATION OF CLINICAL GUIDELINES.— 
Not later than 1 year after the Secretary makes the 
first designation under subsection (a), and not less 
than every 3 years thereafter, the Secretary shall 
publish clinical guidelines in consultation with rel-
evant professional societies with respect to each anti-
microbial drug that has been approved or licensed as 
described in subsection (a)(1) and that has been des-
ignated under subsection (a), which guidelines shall 
set forth the evidence-based recommendations for 
prescribing the drug, in accordance with the submis-
sions of the sponsor under paragraph (1) and after 
consultation under paragraph (2), as appropriate. 
‘‘SEC. 399QQ. SUBSCRIPTION CONTRACTS. 
‘‘(a) APPLICATION
FOR
A
SUBSCRIPTION
CON-
TRACT.— 
‘‘(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-
VerDate Sep 11 2014 
20:39 Jul 22, 2021
Jkt 019200
PO 00000
Frm 00017
Fmt 6652
Sfmt 6201
E:\BILLS\H3932.IH
H3932
pbinns on DSKJLVW7X2PROD with BILLS
ignated as a critical need antimicrobial under section 
399PP may submit an application for a subscription 
contract with the Secretary, under a procedure es-
tablished by the Secretary. 
‘‘(2) REVIEW
OF
APPLICATIONS.—The Sec-
retary shall, in consultation with the Committee— 
‘‘(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 meets the favored 
characteristics 
identified 
under 
section 
399OO(c)(2), and deny any application for a 
drug that meets none of such characteristics; 
and 
‘‘(C) assign a monetary value to the con-
tract based on the regulations developed under 
section 399OO(d). 
‘‘(b) CRITERIA.—To qualify for a subscription con-
tract under this section, the sponsor of an antimicrobial 
drug designated as a critical need antimicrobial shall agree 
to— 
‘‘(1) ensure commercial and Federal availability 
of the antimicrobial drug within 30 days of receiving 
VerDate Sep 11 2014 
20:39 Jul 22, 2021
Jkt 019200
PO 00000
Frm 00018
Fmt 6652
Sfmt 6201
E:\BILLS\H3932.IH
H3932
pbinns on DSKJLVW7X2PROD with BILLS