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-
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 
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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.— 
‘‘(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— 
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‘‘(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-
nalize and publish such regulations not later than 
120 days after the close of such period of public 
comment and meetings. 
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‘‘(3) SUBSCRIPTION
CONTRACT
OFFICE.—Not 
later than 6 months after the date of the 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 the enactment of this part and end-
ing on the date that the Secretary finalizes the sub-
scription 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-
gage in transitional subscription contracts of up to 
3 years in length with antimicrobial developers, as 
determined by the Secretary, that have developed 
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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 
clinical need, an anticipated clinical need, 
or drug resistance; 
‘‘(ii) subject to terms including— 
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‘‘(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; 
‘‘(dd) submit a plan for reg-
istering the antimicrobial drug in 
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‘‘(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 the enactment 
of this part, the Secretary shall determine the agen-
cy or office in the Department of Health and 
Human Services that will manage the transitional 
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subscription contracts, including eligibility, require-
ments, and contract amounts, during the period de-
scribed 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. 
‘‘(3) CHAIR.—The Secretary shall appoint one 
of the members of the Advisory Group to serve as 
the Chair. 
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‘‘(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 
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 
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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 
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-
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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 reevaluate 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.— 
‘‘(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-
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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 
(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). 
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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 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-
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. 
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‘‘(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 
first payment under the contract, and sufficient sup-
ply for susceptibility device manufacturers; 
‘‘(2) identify, track, and publicly report drug 
resistance data and trends using available data re-
lated to the antimicrobial drug; 
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‘‘(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, 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 
determined with the Secretary to ensure patient ac-
cess to the drug; 
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‘‘(9) price the drug at a price that is not lower 
than a comparable generic drug; 
‘‘(10) abide by the manufacturing and environ-
mental best practices in the supply chain to ensure 
that there is no discharge into, or contamination of, 
the environment by antimicrobial agents or products 
as a result of the manufacturing process; and 
‘‘(11) abide by other terms as the Secretary 
may require. 
‘‘(c) AMOUNT AND TERMS 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 399SS(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-
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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 shall be used to support criteria quali-
fication under subsection (b), the completion of post-
marketing clinical studies, manufacturing, other pre-
clinical and clinical activities, or other activities 
agreed to by the Secretary and sponsor in the con-
tract. 
‘‘(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-
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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 
399OO(c)(1). 
‘‘(B) EXTENSION
OF
CONTRACTS.—The 
Secretary may extend a subscription contract 
with a sponsor under this subsection beyond the 
initial contract period. A single contract exten-
sion 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 extended 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 399SS. 
‘‘(C) MODIFICATION OF CONTRACTS.—The 
Secretary or sponsor, 1 year after the start of 
the contract period under this subsection and 
every 2 years thereafter, may request a modi-
fication of the amount of the contract based on 
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information that adjusts favored characteristics 
in section 399OO(c)(2). 
‘‘(3) 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. 
‘‘(4) CONTRACTS
FOR
GENERIC
AND
BIO-
SIMILAR
VERSIONS.—Notwithstanding any other 
provision in this part, the Secretary may award a 
subscription contract under this section to a manu-
facturer of a generic or biosimilar version of an anti-
microbial drug for which a subscription contract has 
been awarded under this section. Such contracts 
shall be awarded in accordance with a procedure, in-
cluding for determining the terms and amounts of 
such contracts, established by the Secretary. 
‘‘(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, and not 
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earlier than 6 months after the end of each cal-
endar year, the head (or a designee of such 
head) of each Federal agency carrying out a 
specified government program shall, in accord-
ance with this paragraph, report to the Sub-
scription Contract Office established under sec-
tion 399OO(d)(3) the total prescription drug 
sales for each applicable antimicrobial drug 
under contract with respect to such program for 
such calendar 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, the product of— 
‘‘(i) the per-unit ingredient cost, as 
reported to the Secretary by prescription 
drug plans and Medicare Advantage pre-
scription drug plans, minus any per-unit 
rebate, discount, or other price concession 
provided by the sponsor of such applicable 
antimicrobial drug, as reported to the Sec-
retary by the prescription drug plans and 
the Medicare Advantage prescription drug 
plans; and 
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‘‘(ii) the number of units of such ap-
plicable antimicrobial drug paid for under 
such part D. 
‘‘(C) MEDICARE PART B PROGRAM.— 
‘‘(i) IN
GENERAL.—For purposes of 
subparagraph (A), the Secretary shall re-
port, for each applicable antimicrobial drug 
covered under part B of title XVIII of the 
Social Security Act, the product of— 
‘‘(I) the per-unit average sales 
price (as defined in section 1847A(c) 
of such Act) or the per-unit payment 
rate under such part B for a sepa-
rately paid prescription drug without 
a reported average sales price; and 
‘‘(II) the number of units of such 
applicable antimicrobial drug paid for 
under such part B. 
‘‘(ii) 
UNITS
AND
ALLOCATED 
PRICES.—The Secretary shall establish a 
process for determining the units and the 
allocated price for purposes of this sub-
paragraph 
for 
those 
applicable 
anti-
microbial drugs that are not separately 
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payable or for which National Drug Codes 
are not reported. 
‘‘(D) MEDICARE PART A PROGRAM.— 
‘‘(i) IN
GENERAL.—For purposes of 
subparagraph (A), the Secretary shall re-
port, for each applicable antimicrobial drug 
covered under part A of title XVIII of the 
Social Security Act, the product of— 
‘‘(I) the per-unit price under 
such part A for the antimicrobial 
drug; and 
‘‘(II) the number of units of such 
antimicrobial drug paid for under 
such part A. 
‘‘(ii) SPECIAL RULE.—For purposes of 
clause (i), the Secretary shall establish a 
process for determining the units and the 
allocated price for those prescription drugs 
that are not separately payable or for 
which National Drug Codes are not re-
ported in the diagnosis-related groups. 
‘‘(E) MEDICAID PROGRAM.—Under the au-
thority of section 1902(a)(6) of the Social Secu-
rity Act, the Secretary shall require each State 
that makes medical assistance available under 
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the State plan under title XIX of such Act (or 
any waiver of such plan) for an applicable anti-
microbial drug (including, if applicable, any 
such drug which is a covered outpatient drug 
under a rebate agreement entered into under 
section 1927 of such Act) to report, in a form 
consistent with a standard reporting format es-
tablished by the Secretary, not later than the 
date determined under subparagraph (A)— 
‘‘(i) information on the total number 
of units of each dosage form and strength 
and package size of each applicable anti-
microbial drug dispensed during the pre-
ceding calendar year under such State plan 
or waiver (including any such drugs dis-
pensed to an individual enrolled with a 
medicaid managed care organization or 
other specified entity (as such terms are 
defined in section 1903(m) of such Act)); 
and 
‘‘(ii) with respect to each dosage form 
and strength and package size of each such 
drug, the amount equal to— 
‘‘(I) the product of— 
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‘‘(aa) the total number of 
units dispensed under the State 
plan or waiver during the pre-
ceding calendar year (as deter-
mined under clause (i)); and 
‘‘(bb) the per-unit ingredient 
cost paid by the State for each 
such unit; minus 
‘‘(II) any discounts or other price 
concessions provided and rebates paid 
to the State with respect to the dos-
age form and strength and package 
size of such drug and such calendar 
year (including rebates paid under a 
rebate agreement under section 1927 
of such Act and any State supple-
mental rebates paid under a supple-
mental rebate agreement). 
‘‘(F) DEPARTMENT
OF
VETERANS
AF-
FAIRS.—For purposes of subparagraph (A), the 
Secretary of Veterans Affairs shall report the 
total amount paid for each applicable anti-
microbial drug procured by the Veterans Health 
Administration for individuals who receive 
health care from the Administration. 
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‘‘(G) DEPARTMENT
OF
DEFENSE
AND 
TRICARE PROGRAM.—For purposes of subpara-
graph (A), the Secretary of Defense shall report 
the sum of— 
‘‘(i) the total amount paid for each 
applicable antimicrobial drug procured by 
the Department of Defense for individuals 
who receive health care from the Depart-
ment; and 
‘‘(ii) for each applicable antimicrobial 
drug dispensed under the TRICARE retail 
pharmacy 
program 
under 
section 
1074g(a)(2)(E)(ii) of title 10, United 
States Code, the product of— 
‘‘(I) the per-unit ingredient cost, 
minus any per-unit rebate paid by the 
sponsor of the applicable antimicrobial 
drug; and 
‘‘(II) the number of units of such 
applicable antimicrobial drug dis-
pensed under such program. 
‘‘(H) DEPARTMENT OF HOMELAND SECU-
RITY.—For purposes of subparagraph (A), the 
Secretary of Homeland Security shall report the 
total amount paid for each applicable anti-
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microbial drug procured by the Department of 
Homeland Security for individuals who receive 
health care through a program carried out by 
the Department. 
‘‘(I) BUREAU OF PRISONS.—For purposes 
of subparagraph (A), the Director of the Bu-
reau of Prisons shall report the total amount 
paid for each applicable antimicrobial drug pro-
cured by the Bureau of Prisons for individuals 
who receive health care through the Bureau. 
‘‘(J) INDIAN HEALTH SERVICE.—For pur-
poses of subparagraph (A), the Secretary, act-
ing through the Indian Health Service, shall re-
port the total amount paid for each applicable 
antimicrobial drug procured by the Service for 
individuals who receive health care through the 
Service. 
‘‘(2) REGULATIONS.—Not later than 1 year 
after the date of the enactment of this part, the Sec-
retary, in consultation with the heads of Federal 
agencies carrying out specified government pro-
grams, shall issue regulations to assist such heads 
(or their designees) in carrying out the requirements 
under this section. 
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‘‘(3) SUBSCRIPTION CONTRACT ADJUSTMENT.— 
Pursuant to the contract entered into under this sec-
tion with respect to an applicable antimicrobial drug, 
for each year of the term of such contract, the Sec-
retary shall, not earlier than 6 months after the end 
of each calendar year, subtract from the payment in-
stallments determined for such contract under sub-
section (c)(1) for such year the revenue of the spon-
sor of such drug from the previous year from sales 
of the applicable antimicrobial drug reported under 
paragraph (1) for specified government programs. 
‘‘(4) 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) 
SPECIFIED
GOVERNMENT
PRO-
GRAM.—The term ‘specified government pro-
gram’ means— 
‘‘(i) the Medicare part D program 
under part D of title XVIII of the Social 
Security Act; 
‘‘(ii) the Medicare Part B program 
under part B of such title XVIII; 
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‘‘(iii) the Medicare Part A program 
under part A of such title XVIII; 
‘‘(iv) the Medicaid program estab-
lished under title XIX of the Social Secu-
rity Act and includes, with respect to a 
State, any waiver in effect with respect to 
such program; 
‘‘(v) any program under which pre-
scription drugs are procured by the De-
partment of Veterans Affairs; 
‘‘(vi) any program under which pre-
scription drugs are procured by the De-
partment of Defense; 
‘‘(vii) the TRICARE retail pharmacy 
program under section 1074g(a)(2)(E)(ii) 
of title 10, United States Code; 
‘‘(viii) any program under which pre-
scription drugs are procured by the De-
partment of Homeland Security; 
‘‘(ix) any program under which pre-
scription drugs are procured by the Bu-
reau of Prisons; or 
‘‘(x) any program under which pre-
scription drugs are procured by the Indian 
Health Service. 
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‘‘(e) 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 criteria under subsection 
(b); or 
‘‘(C) does not complete a postmarket study 
required by the Food and Drug Administration 
during the length of 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 
specified government programs, as defined in sub-
section (d)(4), for a year exceeds the amount of the 
subscription contract paid by the Secretary for that 
year. 
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‘‘(f) 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. 
‘‘SEC. 399RR. ENCOURAGING APPROPRIATE USE OF ANTI-
BIOTICS AND COMBATING RESISTANCE. 
‘‘(a) ESTABLISHMENT OF HOSPITAL GRANT PRO-
GRAM.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of the enactment of this part, the Secretary 
and the Director of the Centers for Disease Control 
and Prevention shall coordinate with the Adminis-
trator of the Health Resources and Services Admin-
istration, the Administrator of the Centers for Medi-
care & Medicaid Services, the National Coordinator 
for Health Information Technology, and other rel-
evant agencies, to establish a grant program under 
the Centers for Disease Control and Prevention to 
support hospital and other inpatient facility ef-
forts— 
‘‘(A) to judiciously use antimicrobial drugs, 
such as by establishing or implementing appro-
priate use programs, including infectious dis-
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ease telehealth programs, using appropriate di-
agnostic tools, partnering with academic hos-
pitals, increasing health care-associated infec-
tion reporting, and monitoring antimicrobial re-
sistance; 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 
hospitals without an existing program to judiciously 
use antimicrobial drugs, subsection (d) hospitals (as 
defined in subparagraph (B) of section 1886(d)(2) 
of the Social Security Act that are located in rural 
areas (as defined in subparagraph (D) of such sec-
tion), critical access hospitals (as defined in section 
1861(mm)(1) of such Act), hospitals serving Tribal- 
populations, and safety-net hospitals. 
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‘‘(3) FUNDING.—Of the amounts appropriated 
under section 399SS, the Secretary shall reserve 
$500,000,000 to carry out this subsection. 
‘‘(b) SURVEILLANCE AND REPORTING OF ANTIBIOTIC 
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— 
‘‘(A) appropriate conditions, outcomes, and 
measures causally related to antibacterial resist-
ance, including types of infections, the causes 
for infections, and whether infections are ac-
quired in a community or hospital setting, in-
creased lengths of hospital stay, increased costs, 
and rates of mortality; and 
‘‘(B) changes in bacterial resistance to 
antimicrobial drugs in relation to patient out-
comes, including changes in percent resistance, 
prevalence of antibiotic-resistant infections, and 
other such changes. 
‘‘(2) ANTIBIOTIC
USE
DATA.—The Secretary, 
acting through the Director of the Centers for Dis-
ease Control and Prevention, shall work with Fed-
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eral agencies (including the Department of Veterans 
Affairs, the Department 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 as appropriate to obtain reliable and 
comparable human antibiotic drug consumption data 
(including, as available and appropriate, volume an-
tibiotic distribution data and antibiotic use data, in-
cluding prescription data) by State or metropolitan 
areas. 
‘‘(3) ANTIBIOTIC RESISTANCE TREND DATA.— 
The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, shall in-
tensify and expand efforts to collect antibiotic resist-
ance data and encourage adoption of the Antibiotic 
Use and Resistance Module within the National 
Healthcare Safety Network among all health care fa-
cilities across the continuum of care, including, as 
appropriate, acute care hospitals, dialysis facilities, 
nursing homes, ambulatory surgical centers, and 
other ambulatory health care settings in which anti-
microbial drugs are routinely prescribed. The Sec-
retary shall seek to collect such data from electronic 
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medication administration reports and laboratory 
systems to produce the reports described in para-
graph (4). 
‘‘(4) PUBLIC
AVAILABILITY
OF
DATA.—The 
Secretary, acting through the Director of the Cen-
ters for Disease Control and Prevention, shall, for 
the purposes of improving the monitoring of impor-
tant trends in patient outcomes in relation to anti-
bacterial resistance— 
‘‘(A) make the data derived from surveil-
lance under this subsection publicly available 
through reports issued on a regular basis that 
is not less than annually; and 
‘‘(B) examine opportunities to make such 
data available in near real time. 
‘‘SEC. 399SS. 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, 
$11,000,000,000, for fiscal year 2022, to remain available 
until expended. 
‘‘(b) EMERGENCY DESIGNATION.— 
‘‘(1) IN GENERAL.—The amounts provided by 
this section are designated as an emergency require-
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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. 399TT. STUDIES AND REPORTS. 
‘‘(a) IN GENERAL.—Not later than 6 years after the 
date of the enactment of this part, the Comptroller Gen-
eral of the United States shall complete a study on the 
effectiveness of this part in developing priority anti-
microbial drugs. Such study shall examine the indications 
for, usage of, development of resistance with respect to, 
and private and societal value of critical need anti-
microbial drugs, and the impact of the programs under 
this part on patients and markets of critical need anti-
microbial drugs. The Comptroller General shall report to 
the Committee on Health, Education, Labor, and Pen-
sions 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 
Control and Prevention shall, each year, update the report 
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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 the enactment 
of this part, the Director of the Centers for Disease Con-
trol and Prevention shall publish a report on antimicrobial 
prophylactics. 
‘‘SEC. 399UU. 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 rel-
evant to the proposed indication at con-
centrations likely to be attainable in hu-
mans to achieve the intended therapeutic 
effect; or 
‘‘(ii) a biological product that acts di-
rectly on bacteria or fungi or on the sub-
stances produced by such bacteria or fungi; 
and 
‘‘(B) does not include— 
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‘‘(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.’’. 
TITLE II—PATIENTS AND 
CAREGIVERS 
SEC. 201. EDUCATIONAL PROGRAMS AND TRAINING FOR 
CAREGIVERS. 
Part D of title VII of the Public Health Service Act 
(42 U.S.C. 294 et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 760A. EDUCATIONAL PROGRAMS AND TRAINING FOR 
CAREGIVERS. 
‘‘(a) IN GENERAL.—The Secretary may award grants 
for educational programs and training for caregivers to 
learn skills to empower them— 
‘‘(1) to be a member of a care team; and 
‘‘(2) to complement a clinical visit. 
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‘‘(b) TYPES OF PROGRAMS AND TRAINING.—Edu-
cational programs and training funded under subsection 
(a) may include— 
‘‘(1) specialized training in medication adher-
ence and injections; 
‘‘(2) complementary strategies to ensure adher-
ence 
to 
physical, 
occupational, 
speech, 
and 
habilitative therapy regimens; 
‘‘(3) nutritional compliance; 
‘‘(4) caregiver psychosocial support (including 
cognitive-behavioral, supportive, and bereavement 
counseling); 
‘‘(5) caregiver health self-management; and 
‘‘(6) other services provided in the home. 
‘‘(c) NON-DUPLICATION.—The Secretary may not 
use the same requirements under this section for a grant, 
contract, or cooperative agreement under the Geriatric 
Workforce Enhancement Program under section 753 of 
the Public Health Service Act (42 U.S.C. 294c). 
‘‘(d) CAREGIVER DEFINED.—In this section, the 
term ‘caregiver’ means an adult family member or other 
individual who has a significant relationship with, and who 
provides a broad range of assistance to, an individual with 
a chronic or other health condition, disability, or func-
tional limitation. 
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‘‘(e) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there is authorized to be appro-
priated $25,000,000 for each of fiscal years 2022 through 
2024.’’. 
SEC. 202. INCREASING HEALTH LITERACY TO PROMOTE 
BETTER OUTCOMES FOR PATIENTS. 
(a) IN GENERAL.—Not later than one year after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services, acting through the Administrator of 
the Centers for Medicare & Medicaid Services, shall issue 
a request for information to solicit recommendations on 
ways the Centers for Medicare & Medicaid Services can 
work with stakeholders of the Federal health care pro-
grams (as defined in section 1128B(f) of the Social Secu-
rity Act (42 U.S.C. 1320a–7b(f))) to promote increased 
patient and family caregiver health literacy, including rec-
ommendations for— 
(1) identifying culturally competent, evidence- 
based interventions that have been proven to im-
prove health literacy in populations served by such 
programs; 
(2) identifying evidence-based health literacy 
approaches that can be used by the Medicare pro-
gram under title XVIII of the Social Security Act 
(42 U.S.C. 1395 et seq.), a State plan (or waiver of 
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(A) Negatively affects at least one major 
body system. 
(B) Represents a major disease burden in 
the United States. 
(C) Represents a leading cause of mor-
tality or disability in the United States. 
(D) According to the National Institutes of 
Health, 
affects 
at 
least 
an 
estimated 
50,000,000 Americans each year. 
(E) Contributes to increasing health care 
(personal, familial, private sector, and govern-
mental) expenditures and impacts the United 
States economy as a whole. 
(F) For which the SARS–CoV–2 virus ex-
acerbates symptoms or causes serious complica-
tions. 
(G) For which medical products are ap-
proved by the Food and Drug Administration 
at a much lower rate than products for other 
disease areas, including in abbreviated path-
ways. 
(2) One of the Institutes focuses on a group of 
diseases meeting the following criteria: 
(A) 
Affects, 
individually, 
fewer 
than 
200,000 people in the United States. 
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