microbial drugs treating infections listed in the most 
recent report entitled ‘‘Antibiotic Resistance Threats 
in the United States’’ issued by the Centers for Dis-
ease Control and Prevention, and may include anti-
microbial drugs that are qualified infectious disease 
products (as defined in section 505E(g) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
355f(g))), similarly innovative biologic antimicrobial 
drugs, or innovative drugs that achieve an anti-
microbial 
outcome 
through 
immunomodulation. 
Funds made available under such contracts may be 
used for a variety of purposes including to support 
the completion of postmarketing clinical studies, 
manufacturing, and other preclinical and clinical ef-
forts. 
(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 demonstrates a sig-
nificant clinical advancement in treating an 
infection for which there is an unmet clin-
ical need, an anticipated clinical need, or 
multidrug resistance; 
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(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 
about appropriate use of the 
antimicrobial drug; 
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(dd) submit a plan for reg-
istering the antimicrobial drug in 
additional countries where an 
unmet medical need exists; 
(ee) subject to subparagraph 
(B), ensure a reliable drug sup-
ply 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 
Federal Drug Administration-re-
quired postmarketing studies, in-
cluding such studies that are evi-
dence based; and 
(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-
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metic Act (21 U.S.C. 355(c)) or li-
censed under section 351(a) of the 
Public Health Service Act (42 U.S.C. 
262(a)). 
(B) WAIVER.—The requirement under sub-
paragraph (A)(ii)(I)(ee) may be waived in the 
case that an emergency prohibits access to a re-
liable drug supply chain. 
(3) TRANSITIONAL GUIDANCE.—Not later than 
30 days after the appointment of the initial mem-
bers of the Committee, the Secretary shall issue, in 
consultation with the Committee, transitional guid-
ance outlining the antimicrobial drugs that are eligi-
ble for transitional subscription contracts under 
paragraph (1), the requirements to enter into a 
transitional subscription contract under paragraph 
(2), and the process by which drug developers can 
enter into transitional subscription contracts with 
the Secretary under this subsection. 
(4) PAYMENT OFFICE AND MECHANISM.—Not 
later than 30 days after the date of enactment of 
this Act, 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, 
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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 Com-
mittee, the Secretary, in collaboration with the Com-
mittee, shall establish a Critical Need Antimicrobial 
Advisory Group (referred to in this subsection as the 
‘‘Advisory Group’’) and appoint members to the Ad-
visory Group. 
(2) MEMBERS.—The members of the Advisory 
Group shall include— 
(A) 6 individuals who are— 
(i) infectious disease specialists; or 
(ii) other health experts with expertise 
in researching antimicrobial resistance, 
health economics, or commercializing anti-
microbial drugs; and 
(B) not less than 5 patient advocates. 
(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 
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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 other-
wise provided in this subsection, the Federal Advi-
sory Committee Act (5 U.S.C. App.) shall apply to 
the Advisory Group. 
SEC. 3. CRITICAL NEED ANTIMICROBIAL DRUG APPLICA-
TION AND PAYMENT THROUGH SUBSCRIP-
TION CONTRACTS. 
(a) IN GENERAL.— 
(1) SUBMISSION OF REQUEST.—The sponsor of 
an application under section 505(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) 
or section 351(a) of the Public Health Service Act 
(42 U.S.C. 262(a)) for an antimicrobial drug may 
request that the Secretary designate the drug as a 
critical need antimicrobial. A request for such des-
ignation may be submitted after the Secretary 
grants for such drug an investigational new drug ex-
emption under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act or section 351(a)(3) of the 
Public Health Service Act, and shall be submitted 
not later than 5 years after the date of approval 
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under section 505(c) of the Federal Food, Drug, and 
Cosmetic Act or licensure under section 351(a) of 
the Public Health Service Act. 
(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 
2(c)(2), and any other material that the Secretary 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 no 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. 
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(4) LENGTH OF DESIGNATION PERIOD.—A des-
ignation granted under this section shall be in effect 
for a period of 10 years after the date that the des-
ignation 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 2(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 
2(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 submit an appropriate use plan to 
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the Secretary within 90 days of application approval 
for appropriate use of diagnostics for consideration 
by the Secretary and Committee to develop clinical 
guidelines. A diagnostic plan— 
(A) shall include— 
(i) the appropriate use of the drug; 
and 
(ii) the appropriate use of diagnostic 
tools such as diagnostic testing for bio-
markers related to antimicrobial-resistant 
pathogens, or other targeted diagnostic ap-
proaches, to inform use of the drug; and 
(B) may be developed in partnership with 
the Secretary, infectious disease experts, diag-
nostic experts, or another entity. 
(2) CONSULTATION.—The Secretary shall work 
with relevant professional societies and the Critical 
Need Antimicrobial Advisory Group established 
under section 2(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 diag-
nostic approaches, taking into consideration the di-
agnostic plan submitted by a sponsor under para-
graph (1). 
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(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 collaboration with rel-
evant professional societies with respect to each anti-
microbial drug designated under subsection (a) 
which shall set forth the evidence-based rec-
ommendations for prescribing the drug, in accord-
ance with the submissions of the sponsor under 
paragraph (1) and after consultation under para-
graph (2), as appropriate. 
SEC. 4. 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 (21 U.S.C. 355(c)) or licen-
sure under section 351(a) of the Public Health Serv-
ice Act (42 U.S.C. 262(a)), the sponsor of an anti-
microbial drug designated as a critical need anti-
microbial under section 3 may submit an application 
for a subscription contract with the Secretary, under 
a procedure established by the Secretary. 
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(2) REVIEW OF APPLICATIONS.—The Secretary 
shall, in consultation with the Committee— 
(A) review all applications for subscription 
contracts under paragraph (1) and assess all 
required application components; 
(B) determine the extent to which the crit-
ical need antimicrobial meets the favored char-
acteristics identified under section 2(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 2(d). 
(b) CRITERIA.—To qualify for a subscription contract 
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 
first payment under the contract, and sufficient sup-
ply for susceptibility device manufacturers; 
(2) identify, track, and publicly report drug re-
sistance data and trends using available data related 
to the antimicrobial drug; 
(3) develop and implement education and com-
munications strategies, including communications 
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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, Committee, Food and Drug Adminis-
tration, and Centers for Disease Control and Pre-
vention every 2 years regarding use of the anti-
microbial drug, including how the drug is being mar-
keted; 
(5) submit a plan for registering the drug in 
additional countries where an unmet medical need 
exists; 
(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 de-
termined with the Secretary to ensure patient access 
to the drug; 
(9) price the drug at a price that is not lower 
than a comparable generic drug; and 
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(10) abide by other terms as the Secretary may 
require. 
(c) TERM AND AMOUNT OF CONTRACTS.— 
(1) AMOUNTS.—A subscription contract under 
this section shall be for the sale to the Secretary of 
any quantity of the antimicrobial drug needed over 
the term of the contract under paragraph (2), at an 
agreed upon price, for a total projected amount de-
termined by the Secretary that is not less than 
$750,000,000 and not more than $3,000,000,000, 
adjusted for inflation, accounting for the favored 
characteristics of the drug, as determined by the 
Secretary, in consultation with the Committee, under 
subsection (a)(2), and shall be allocated from the 
amount made available under section 6(a). Not later 
than 6 months after the subscription contract is 
granted under subsection (a), the Secretary shall 
provide payments for purchased drugs in install-
ments established by the Secretary in consultation 
with the sponsor of the antimicrobial drug and in ac-
cordance with subsection (d)(3). Funds received by 
the sponsor may be used to support criteria quali-
fication under subsection (b), the completion of post-
marketing clinical studies, manufacturing, and other 
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preclinical and clinical activities agreed to by the 
Secretary and sponsor in the contract. 
(2) TERMS.— 
(A) INITIAL TERM.—The initial term of a 
contract under this subsection shall be no less 
than 5 years or greater than the greater of 10 
years or the remaining period of time during 
which the sponsor has patent protections or a 
remaining exclusivity period with respect to the 
antimicrobial drug in the United States, as list-
ed in the publication of the Food and Drug Ad-
ministration entitled ‘‘Approved Drug Products 
with Therapeutic Equivalence Evaluations’’. 
Payments may be in equal annual installments 
with the option to redeem 50 percent of the last 
year’s reimbursement in year 1 of the contract 
in order to offset costs of establishing manufac-
turing capacity, or another subscription ar-
rangement to which the Secretary and sponsor 
agree. Subscription contracts shall remain in ef-
fect for such period even if the infection treated 
by such antimicrobial drug is later removed 
from the list of infections under section 2(c)(1). 
(B) EXTENSION
OF
CONTRACTS.—The 
Secretary may extend subscription contracts be-
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yond the initial contract period with a generic 
or biosimilar brand manufacturer of the anti-
microbial drug receiving a subscription contract 
or the original drug manufacturer. A single 
contract extension may be in effect not later 
than the date on which all periods of exclusivity 
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 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 6. 
(C) MODIFICATION OF CONTRACTS.—The 
Secretary or sponsor, every 2 years after the 
start of the contract period under this sub-
section, may request a modification of the 
amount of the contract based on information 
that adjusts favored characteristics in section 
2(c)(2). 
(3) ADJUSTMENT.—In the case of an anti-
microbial drug that received a transitional subscrip-
tion contract under section 2(f), the amount of a 
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subscription contract for such drug under this sec-
tion shall be reduced by the amount of the transi-
tional subscription contract under such section 2(f) 
for such drug. 
(d) ANNUAL ANTIMICROBIAL DRUG SPONSOR REV-
ENUE LIMITATIONS.— 
(1) REPORTING REQUIREMENT.— 
(A) IN GENERAL.—Not later than a date 
determined appropriate by the Secretary fol-
lowing the end of each calendar year, the head 
(or a designee of such head) of each Federal 
agency carrying out a specified government pro-
gram shall, in accordance with this paragraph, 
report to the Secretary of Health and Human 
Services the total prescription drug sales for 
each applicable antimicrobial drug under con-
tract with respect to such program for such cal-
endar year. 
(B) MEDICARE
PART
D
PROGRAM.—For 
purposes of subparagraph (A), the Secretary 
shall report, for each applicable antimicrobial 
drug covered under part D of title XVIII of the 
Social Security Act (42 U.S.C. 1395w–101 et 
seq.), the product of— 
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