H. R. 2617—1334 
and may be appropriate for inclusion in a stockpile by 
States, with consideration of threats that require the large- 
scale and simultaneous deployment of stockpiles, including 
the stockpile maintained by the Secretary pursuant to sub-
section (a), and long-term public health and medical 
response needs; 
‘‘(B) appropriate management of the contents of a stock-
pile, including management by vendors of reserve amounts 
of medical products and supplies intended to be delivered 
to the ownership of the State and appropriate disposition 
of excess products, as applicable; and 
‘‘(C) the procurement of medical products and medical 
supplies consistent with the requirements of chapter 83 
of title 41, United States Code (commonly referred to as 
the ‘Buy American Act’). 
‘‘(7) TECHNICAL ASSISTANCE.—The Secretary shall provide 
assistance to States, including technical assistance, as appro-
priate, in establishing, maintaining, improving, and utilizing 
a medical stockpile, including appropriate inventory manage-
ment and disposition of products. 
‘‘(8) REPORTING.— 
‘‘(A) STATE REPORTS.—Each entity receiving an award 
under paragraph (1) shall update, as appropriate, the plan 
established pursuant to paragraph (2)(A)(i) and submit to 
the Secretary an annual report on implementation of such 
plan, including any changes to the contents of the stockpile 
supported under such award. The Secretary shall use 
information obtained from such reports to inform the 
maintenance and management of the Strategic National 
Stockpile pursuant to subsection (a). 
‘‘(B) REPORTS TO CONGRESS.—Not later than 1 year 
after the initial issuance of awards pursuant to paragraph 
(1), and annually thereafter for the duration of the program 
established under this subsection, the Secretary shall 
submit to the Committee on Health, Education, Labor, 
and Pensions and the Committee on Appropriations of the 
Senate and the Committee on Energy and Commerce and 
the Committee on Appropriations of the House of Rep-
resentatives a report on such program, including— 
‘‘(i) Federal and State expenditures to support 
stockpiles under such program; 
‘‘(ii) activities conducted pursuant to paragraph 
(4); and 
‘‘(iii) any additional information from the States 
that the Secretary determines relevant. 
‘‘(9) AUTHORIZATION OF APPROPRIATIONS.—To carry out this 
subsection, 
there 
is 
authorized 
to 
be 
appropriated 
$3,500,000,000 for each of fiscal years 2023 and 2024, to remain 
available until expended.’’. 
(b) GAO REPORT.—Not later than 3 years after the date on 
which awards are first issued pursuant to subsection (i)(1) of section 
319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b), as 
added by subsection (a), the Comptroller General of the United 
States shall submit to the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives a report on the State
H. R. 2617—1335 
stockpiles established or maintained pursuant to this section. Such 
report shall include an assessment of— 
(1) coordination and communication between the Secretary 
of Health and Human Services and entities in receipt of an 
award under this section, or a lead entity designated by such 
entity; 
(2) technical assistance provided by the Secretary of Health 
and Human Services to such entities; and 
(3) the impact of such stockpiles on the ability of the 
State to prepare for and respond to a public health emergency, 
major disaster, or other emergency described in subsection (i)(1) 
of section 319F–2 of the Public Health Service Act (42 U.S.C. 
247d–6b), as added by subsection (a), including the availability 
and distribution of items from such State stockpile to health 
care entities and other applicable entities. 
SEC. 2410. STUDY ON INCENTIVES FOR DOMESTIC PRODUCTION OF 
GENERIC MEDICINES. 
(a) IN GENERAL.—The Secretary of Health and Human Services 
(referred to in this section as the ‘‘Secretary’’), acting through the 
Assistant Secretary for Planning and Evaluation of the Department 
of Health and Human Services shall— 
(1) conduct a study on the feasibility, including related 
to sustainment, and potential effectiveness, and utility of pro-
viding incentives for increased domestic production and capacity 
of specified generic medicines and their active pharmaceutical 
ingredients, which may include through applicable nonprofit 
or for-profit private entities; and 
(2) not later than 1 year after the date of enactment of 
this Act, submit a report on such study to the Committee 
on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Rep-
resentatives. 
(b) SPECIFIED GENERIC MEDICINE.—In this section, the term 
‘‘specified generic medicine’’ means a generic drug approved under 
section 505(j) of the Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)) that is — 
(1) used to prevent, mitigate, or treat a serious or life- 
threatening disease or condition, or used in a common procedure 
that could be life-threatening without such medicine; 
(2) an antibiotic or antifungal used to treat a serious or 
life threatening infectious disease; 
(3) critical to the public health during a public health 
emergency; or 
(4) life-supporting, life-sustaining, or intended for use in 
the prevention or treatment of a debilitating disease or condi-
tion. 
SEC. 2411. INCREASED MANUFACTURING CAPACITY FOR CERTAIN 
CRITICAL ANTIBIOTIC DRUGS. 
(a) PROGRAM.— 
(1) IN GENERAL.—The Secretary, in consultation with the 
Assistant Secretary for Preparedness and Response and 
Commissioner of Food and Drugs, may award contracts to 
increase the domestic manufacturing capacity of certain anti-
biotic drugs with identified supply chain vulnerabilities, or 
the active pharmaceutical ingredient or key starting material 
of such antibiotic drugs.
H. R. 2617—1336 
(2) ELIGIBLE ENTITIES.—To be eligible to receive an award 
under this subsection, an entity shall— 
(A) be a manufacturer that is in compliance with, 
or demonstrates capability to comply with, the relevant 
requirements of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.); and 
(B) prepare and submit to the Secretary an application 
at such time, and in such manner, and containing such 
information as the Secretary may require, including— 
(i) a description of proposed activities to be sup-
ported by an award under this subsection to increase 
manufacturing capacity for such antibiotic drug or 
drugs; 
(ii) the antibiotic drug or drugs, or related active 
pharmaceutical ingredients or key starting materials 
for such drug or drugs, that such entity intends to 
manufacture 
with 
any 
increased 
manufacturing 
capacity supported by an award under this subsection; 
(iii) any additional products such increased manu-
facturing capacity could be used to manufacture; 
(iv) a description of the current supply chain for 
such antibiotic drugs, including any existing and 
applicable 
manufacturing 
facilities, 
known 
vulnerabilities in the supply chain, known or potential 
supply limitations, such as foreign export restrictions, 
or subsidies from foreign governments, as applicable; 
(v) a description of how such entity may use 
advanced or flexible manufacturing in carrying out 
the terms of an award under this subsection; and 
(vi) a strategic plan regarding the maintenance, 
operation, and sustainment of such increased manufac-
turing capacity following the expiration of a contract 
under this subsection. 
(3) USE OF FUNDS.—A recipient of an award under this 
subsection shall use such funds to build, expand, upgrade, 
modify, or recommission a facility located in the United States, 
which may include the purchase or upgrade of equipment, 
as applicable, to support increased manufacturing capacity of 
certain antibiotic drugs for which supply chain vulnerabilities 
exist, or the active pharmaceutical ingredient or key starting 
material of such antibiotic drugs. 
(4) REPORTS.—An entity in receipt of an award under this 
subsection shall submit to the Secretary such reports as the 
Secretary may require related to increasing domestic manufac-
turing capacity of antibiotic drugs pursuant to a contract under 
this subsection, including actions taken to implement the stra-
tegic plan required under paragraph (2)(B)(vi). 
(5) CONTRACT TERMS.—The following shall apply to a con-
tract to support increased domestic manufacturing capacity 
under this subsection: 
(A) MILESTONE-BASED PAYMENTS.—The Secretary may 
provide payment, including advance payment or partial 
payment for significant milestones, if the Secretary makes 
a determination that such payment is necessary and appro-
priate. 
(B) REPAYMENT.—The contract shall provide that such 
payment is required to be repaid if there is a failure to
H. R. 2617—1337 
perform by the manufacturer under the contract; if the 
specified milestones are reached, an advance or partial 
payment shall not be required to be repaid. 
(C) CONTRACT DURATION.— 
(i) IN GENERAL.—Each contract shall be for a period 
not to exceed 5 years. 
(ii) NON-RENEWABILITY.—A contract shall not be 
renewable. 
(iii) NOTIFICATIONS
OF
EXTENSIONS
AND
TERMI-
NATIONS.—If the Secretary decides to terminate a con-
tract prior to its expiration, the Secretary shall notify 
the manufacturer within 90 days of such determina-
tion. 
(D) ADDITIONAL TERMS.—The Secretary, in any contract 
under this subsection— 
(i) may specify— 
(I) the amount of funding that will be dedi-
cated by the Secretary for supporting increased 
manufacturing capacity under such contract; and 
(II) the amount of manufacturing capacity that 
such eligible entity must meet; and 
(ii) shall provide a clear statement of defined Fed-
eral Government purpose limited to uses related to 
increasing domestic manufacturing capacity for anti-
biotic drugs to address identified supply chain 
vulnerabilities and challenges to establishing and 
maintaining domestic manufacturing capacity. 
(E) SUSTAINMENT.—Each contract shall provide for the 
eligible entity to update the strategic plan required under 
paragraph (2)(B)(vi) throughout the duration of such con-
tract, as required by the Secretary. 
(b) REPORT.—Not later than 2 years after the date of enactment 
of this Act and every year thereafter until the termination or 
expiration of all such contracts, the Secretary shall submit to the 
Committee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives a report on any activities supported under sub-
section (a), including— 
(1) the antibiotic drugs for which the Secretary prioritized 
awards under subsection (a), including a description of how 
the Secretary consulted with stakeholders to inform such 
prioritization; 
(2) information regarding each contract awarded pursuant 
to subsection (a), including— 
(A) the recipient of each such contract, including any 
recipients of a subaward; 
(B) the milestone and performance requirements 
pursuant to each such contract; 
(C) the duration of each such contract; 
(D) the amount of funding provided by the Secretary 
pursuant to each such contract, including any advanced 
or partial payments; 
(E) the antibiotic drugs supported through each such 
contract, including a description of the medical necessity 
of each such antibiotic drug and any supply chain 
vulnerabilities, limitations, and related characteristics