3337 
† HR 2617 EAS2 
National Stockpile under section 319F–2(a) of the Public 
Health Service Act (42 U.S.C. 247d–6b(a)), or otherwise 
distributes medical countermeasures, as applicable, to 
States, territories, Indian Tribes and Tribal organizations 
(as such terms are defined under section 4 of the Indian 
Self-Determination and Education Assistance Act), and 
other applicable entities. Such guidance shall include infor-
mation related to processes by which to request access to 
the contents of the Strategic National Stockpile, factors con-
sidered by the Secretary when making deployment or dis-
tribution decisions, and processes and points of contact 
through which entities may contact the Secretary to address 
any issues related to products requested or received by such 
entity from the stockpile, and on other relevant topics. 
(b) ANNUAL MEETINGS.—Section 319F–2(a)(3) of the 
Public Health Service Act (42 U.S.C. 247d–6b(a)(3)) is 
amended— 
(1) in subparagraph (I), by striking ‘‘and’’ at 
the end; 
(2) in subparagraph (J), by striking the period 
at the end and inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(K) convene meetings, not less than once 
per year, with representatives from State, local, 
and Tribal health departments or officials, rel-
3338 
† HR 2617 EAS2 
evant industries, other Federal agencies, and 
other appropriate stakeholders, in a manner that 
does not compromise national security, to coordi-
nate and share information related to mainte-
nance and use of the stockpile, including a de-
scription of future countermeasure needs and ad-
ditions, modifications, and replenishments of the 
contents of the stockpile, and considerations re-
lated to the manufacturing and procurement of 
products consistent with the requirements of the 
with the requirements of chapter 83 of title 41, 
United States Code (commonly referred to as the 
‘Buy American Act’), as appropriate.’’. 
SEC. 2405. IMPROVING SUPPLY CHAIN FLEXIBILITY FOR 
THE STRATEGIC NATIONAL STOCKPILE. 
(a) IN GENERAL.—Section 319F–2 of the Public 
Health Service Act (42 U.S.C. 247d–6b) is amended— 
(1) in subsection (a)— 
(A) in paragraph (3)(F), by striking ‘‘as re-
quired by the Secretary of Homeland Security’’ 
and inserting ‘‘at the discretion of the Secretary, 
in consultation with, or at the request of, the 
Secretary of Homeland Security,’’; 
(B) by redesignating paragraphs (5) and 
(6) as paragraphs (6) and (7), respectively;
3339 
† HR 2617 EAS2 
(C) by inserting after paragraph (4) the fol-
lowing: 
‘‘(5) VENDOR-MANAGED INVENTORY AND WARM- 
BASE SURGE CAPACITY.— 
‘‘(A) IN
GENERAL.—For the purposes of 
maintaining the stockpile under paragraph (1) 
and carrying out procedures under paragraph 
(3), the Secretary may enter into contracts or co-
operative agreements with vendors, which may 
include manufacturers or distributors of medical 
products, with respect to medical products in-
tended to be delivered to the ownership of the 
Federal Government. Each such contract or coop-
erative agreement shall be subject to such terms 
and conditions as the Secretary may specify, in-
cluding terms and conditions with respect to— 
‘‘(i) procurement, maintenance, stor-
age, and delivery of products, in alignment 
with inventory management and other ap-
plicable best practices, under such contract 
or cooperative agreement, which may con-
sider, as appropriate, costs of transporting 
and handling such products; or 
‘‘(ii) maintenance of domestic manu-
facturing capacity and capabilities of such
3340 
† HR 2617 EAS2 
products to ensure additional reserved pro-
duction capacity and capabilities are avail-
able, and that such capacity and capabili-
ties are able to support the rapid manufac-
ture, purchase, storage, and delivery of such 
products, as required by the Secretary to 
prepare for, or respond to, an existing or 
potential public health emergency. 
‘‘(B) REPORT.—Not later than 2 years after 
the date of enactment of the PREVENT 
Pandemics Act, and annually thereafter, the Sec-
retary shall submit to the Committee on Health, 
Education, Labor, and Pensions and the Com-
mittee on Appropriations of the Senate and the 
Committee on Energy and Commerce and the 
Committee on Appropriations of the House of 
Representatives a report on any contracts or co-
operative agreements entered into under sub-
paragraph (A) for purposes of establishing and 
maintaining vendor-managed inventory or re-
serve manufacturing capacity and capabilities 
for products intended for the stockpile, including 
a description of— 
‘‘(i) the amount of each award; 
‘‘(ii) the recipient of each award;
3341 
† HR 2617 EAS2 
‘‘(iii) the product or products covered 
through each award; and 
‘‘(iv) how the Secretary works with 
each recipient to ensure situational aware-
ness related to the manufacturing capacity 
for, or inventory of, such products and co-
ordinates the distribution and deployment 
of such products, as appropriate and appli-
cable.’’; and 
(D) in subparagraph (A) of paragraph (6), 
as so redesignated— 
(i) in clause (viii), by striking ‘‘; and’’ 
and inserting a semicolon; 
(ii) in clause (ix), by striking the pe-
riod and inserting ‘‘; and’’; and 
(iii) by adding at the end the fol-
lowing: 
‘‘(x) with respect to reports issued in 
2027 or any subsequent year, an assessment 
of selected contracts or cooperative agree-
ments entered into pursuant to paragraph 
(5).’’; and 
(2) in subsection (c)(2)(C), by striking ‘‘on an 
annual basis’’ and inserting ‘‘not later than March 
15 of each year’’.
3342 
† HR 2617 EAS2 
(b) AUTHORIZATION
OF APPROPRIATIONS.—Section 
319F–2(f)(1) of the Public Health Service Act (42 U.S.C. 
247d–6b(f)(1)) is amended by striking ‘‘$610,000,000 for 
each of fiscal years 2019 through 2023’’ and inserting 
‘‘$610,000,000 for each of fiscal years 2019 through 2021, 
and $750,000,000 for each of fiscal years 2022 and 2023’’. 
SEC. 2406. REIMBURSEMENT FOR CERTAIN SUPPLIES. 
Paragraph (7) of section 319F–2(a) of the Public 
Health Service Act (42 U.S.C. 247d–6b(a)), as so redesig-
nated by section 405(a)(1)(B), is amended to read as fol-
lows: 
‘‘(7) 
REIMBURSEMENT
FOR
CERTAIN
SUP-
PLIES.— 
‘‘(A) IN GENERAL.—The Secretary may, at 
appropriate intervals, make available for pur-
chase excess contents procured for, and main-
tained within, the stockpile under paragraph (1) 
to any Federal agency or State, local, or Tribal 
government. The Secretary shall make such con-
tents available for purchase only if— 
‘‘(i) such contents are in excess of what 
is required for appropriate maintenance of 
such stockpile; 
‘‘(ii) the Secretary determines that the 
costs for maintaining such excess contents
3343 
† HR 2617 EAS2 
are not appropriate to expend to meet the 
needs of the stockpile; and 
‘‘(iii) the Secretary determines that 
such action does not compromise national 
security and is in the national interest. 
‘‘(B) REIMBURSEMENT AND COLLECTION.— 
The Secretary may require reimbursement for 
contents that are made available under subpara-
graph (A), in an amount that reflects the cost of 
acquiring and maintaining such contents and 
the costs incurred to make available such con-
tents in the time and manner specified by the 
Secretary. Amounts collected under this sub-
section shall be credited to the appropriations ac-
count or fund that incurred the costs to procure 
such contents, and shall remain available, with-
out further appropriation, until expended, for 
the purposes of the appropriation account or 
fund so credited. 
‘‘(C) RULE OF CONSTRUCTION.—This para-
graph shall not be construed to preclude transfers 
of contents in the stockpile under other authori-
ties. 
‘‘(D) REPORT.—Not later than 2 years after 
the date of enactment of the PREVENT
3344 
† HR 2617 EAS2 
Pandemics Act, and annually thereafter, the Sec-
retary shall submit to the Committee on Health, 
Education, Labor, and Pensions and the Com-
mittee on Appropriations of the Senate and the 
Committee on Energy and Commerce and the 
Committee on Appropriations of the House of 
Representatives a report on the use of the author-
ity provided under this paragraph, including de-
tails of each action taken pursuant to this para-
graph, the account or fund to which any collected 
amounts have been credited, and how the Sec-
retary has used such amounts. 
‘‘(E) SUNSET.—The authority under this 
paragraph shall terminate on September 30, 
2028.’’. 
SEC. 2407. ACTION REPORTING ON STOCKPILE DEPLETION. 
Section 319 of the Public Health Service Act (42 
U.S.C. 247d), as amended by section 2223, is further 
amended by adding at the end the following: 
‘‘(h) STOCKPILE DEPLETION REPORTING.—The Sec-
retary shall, not later than 30 days after the deployment 
of contents of the Strategic National Stockpile under section 
319F–2(a) to respond to a public health emergency declared 
by the Secretary under this section or an emergency or 
major disaster declared by the President under the Robert
3345 
† HR 2617 EAS2 
T. Stafford Disaster Relief and Emergency Assistance Act, 
and every 30 days thereafter until the expiration or termi-
nation of such public health emergency, emergency, or 
major disaster, submit a report to the Committee on Health, 
Education, Labor, and Pensions and the Committee on Ap-
propriations of the Senate and the Committee on Energy 
and Commerce and the Committee on Appropriations of the 
House of Representatives on— 
‘‘(1) the deployment of the contents of the stock-
pile in response to State, local, and Tribal requests; 
‘‘(2) the amount of such products that remain 
within the stockpile following such deployment; and 
‘‘(3) plans to replenish such products, as appro-
priate, including related timeframes and any barriers 
or limitations to replenishment.’’. 
SEC. 2408. PROVISION OF MEDICAL COUNTERMEASURES TO 
INDIAN PROGRAMS AND FACILITIES. 
(a) CLARIFICATION.—Section 319F–2(a)(3) of the 
Public Health Service Act (42 U.S.C. 247d–6b(a)(3)) is 
amended— 
(1) in subparagraph (C), by striking ‘‘and local’’ 
and inserting ‘‘local, and Tribal’’; and 
(2) in subparagraph ( J), by striking ‘‘and 
local’’ and inserting ‘‘local, and Tribal’’.
3346 
† HR 2617 EAS2 
(b) DISTRIBUTION OF MEDICAL COUNTERMEASURES 
TO INDIAN TRIBES.—Title III of the Public Health Service 
Act (42 U.S.C. 241 et seq.) is amended by inserting after 
section 319F–4 the following: 
‘‘SEC. 319F–5. PROVISION OF MEDICAL COUNTERMEASURES 
TO INDIAN PROGRAMS AND FACILITIES. 
‘‘In the event that the Secretary deploys the contents 
of the Strategic National Stockpile under section 319F– 
2(a), or otherwise distributes medical countermeasures to 
States to respond to a public health emergency declared by 
the Secretary under section 319, the Secretary shall, in con-
sultation with the applicable States, make such contents or 
countermeasures directly available to Indian Tribes and 
Tribal organizations (as such terms are defined in section 
4 of the Indian Self-Determination and Education Assist-
ance Act (25 U.S.C. 5304), which may include through 
health programs or facilities operated by the Indian Health 
Service, that are affected by such public health emergency.’’. 
SEC. 2409. GRANTS FOR STATE STRATEGIC STOCKPILES. 
(a) Section 319F–2 of the Public Health Service Act 
(42 U.S.C. 247d–6b) is amended by adding at the end the 
following: 
‘‘(i) PILOT PROGRAM TO SUPPORT STATE MEDICAL 
STOCKPILES.—
3347 
† HR 2617 EAS2 
‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with the Assistant Secretary for Preparedness 
and Response and the Director of the Centers for Dis-
ease Control and Prevention, shall award grants or 
cooperative agreements to not fewer than 5 States, or 
consortia of States, with consideration given to dis-
tribution among the geographical regions of the 
United States, to establish, expand, or maintain a 
stockpile of appropriate drugs, vaccines and other bio-
logical products, medical devices, and other medical 
supplies determined by the State to be necessary to re-
spond to a public health emergency declared by the 
Governor of a State or by the Secretary under section 
319, or a major disaster or emergency declared by the 
President under section 401 or 501, respectively, of 
the Robert T. Stafford Disaster Relief and Emergency 
Assistance Act, in order to support the preparedness 
goals described in paragraphs (2) through (6) and (8) 
of section 2802(b). A recipient of such an award may 
not use award funds to support the stockpiling of se-
curity countermeasures (as defined in subsection 
(c)(1), unless the eligible entity provides justification 
for maintaining such countermeasures and the Sec-
retary determines such justification is appropriate 
and applicable.
3348 
† HR 2617 EAS2 
‘‘(2) REQUIREMENTS.— 
‘‘(A) APPLICATION.—To be eligible to re-
ceive an award under paragraph (1), an entity 
shall prepare, in consultation with appropriate 
health care entities and health officials within 
the jurisdiction of such State or States, and sub-
mit to the Secretary an application that con-
tains such information as the Secretary may re-
quire, including— 
‘‘(i) a plan for such stockpile, con-
sistent with paragraph (4), including— 
‘‘(I) a description of the activities 
such entity will carry out under the 
agreement; 
‘‘(II) an assurance that such enti-
ty will use funds under such award in 
alignment with the requirements of 
chapter 83 of title 41, United States 
Code (commonly referred to as the 
‘Buy American Act’); and 
‘‘(III) an outline of proposed ex-
penses; and 
‘‘(ii) a description of how such entity 
will coordinate with relevant entities in re-
ceipt of an award under section 319C–1 or
3349 
† HR 2617 EAS2 
319C–2 pursuant to paragraph (4), includ-
ing through promoting alignment between 
the stockpile plan established pursuant to 
clause (i) and applicable plans that are es-
tablished by such entity pursuant to section 
319C–1 or 319C–2. 
‘‘(B) MATCHING FUNDS.— 
‘‘(i) Subject to clause (ii), the Sec-
retary may not make an award under this 
subsection unless the applicant agrees, with 
respect to the costs to be incurred by the ap-
plicant in carrying out the purpose de-
scribed in this subsection, to make available 
non-Federal contributions toward such costs 
in an amount equal to— 
‘‘(I) for each of fiscal years 2023 
and 2024, not less than $1 for each 
$20 of Federal funds provided in the 
award; and 
‘‘(II) for fiscal year 2025 and 
each fiscal year thereafter, not less 
than $1 for each $10 of Federal funds 
provided in the award. 
‘‘(ii) WAIVER.—The Secretary may, 
upon the request of a State, waive the re-
3350 
† HR 2617 EAS2 
quirement under clause (i), in whole or in 
part, if the Secretary determines that ex-
traordinary economic conditions in the 
State in the fiscal year involved or in the 
previous fiscal year justify the waiver. A 
waiver provided by the Secretary under this 
subparagraph shall apply only to the fiscal 
year involved. 
‘‘(C) 
ADMINISTRATIVE
EXPENSES.—Not 
more than 10 percent of amounts received by an 
entity pursuant to an award under this sub-
section may be used for administrative expenses. 
‘‘(3) LEAD ENTITY.—An entity in receipt of an 
award under paragraph (1) may designate a lead en-
tity, which may be a public or private entity, as ap-
propriate, to manage the stockpile at the direction of 
the State or consortium of States. 
‘‘(4) USE OF FUNDS.—An entity in receipt of an 
award under paragraph (1) shall use such funds to— 
‘‘(A) purchase, store, and maintain a stock-
pile of appropriate drugs, vaccines and other bi-
ological products, medical devices, and other 
medical supplies to be used during a public 
health emergency, major disaster, or emergency 
described in paragraph (1), in such numbers,
3351 
† HR 2617 EAS2 
types, and amounts as the entity determines nec-
essary, consistent with such entity’s stockpile 
plan 
established 
pursuant 
to 
paragraph 
(2)(A)(i); 
‘‘(B) deploy the stockpile as required by the 
entity to respond to an actual or potential public 
health emergency, major disaster, or other emer-
gency described in paragraph (1); 
‘‘(C) replenish and make necessary addi-
tions or modifications to the contents of such 
stockpile, including to address potential deple-
tion; 
‘‘(D) in consultation with Federal, State, 
and local officials, take into consideration the 
availability, deployment, dispensing, and ad-
ministration requirements of medical products 
within the stockpile; 
‘‘(E) ensure that procedures are followed for 
inventory management and accounting, and for 
the physical security of the stockpile, as appro-
priate; 
‘‘(F) review and revise, as appropriate, the 
contents of the stockpile on a regular basis to en-
sure that, to the extent practicable, new tech-
nologies and medical products are considered;
3352 
† HR 2617 EAS2 
‘‘(G) carry out exercises, drills, and other 
training for purposes of stockpile deployment, 
dispensing, and administration of medical prod-
ucts, and for purposes of assessing the capability 
of such stockpile to address the medical supply 
needs of public health emergencies, major disas-
ters, or other emergencies described in paragraph 
(1) of varying types and scales, which may be 
conducted in accordance with requirements re-
lated to exercises, drills, and other training for 
recipients of awards under section 319C–1 or 
319C–2, as applicable; and 
‘‘(H) carry out other activities related to the 
State strategic stockpile as the entity determines 
appropriate, to support State efforts to prepare 
for, and respond to, public health threats. 
‘‘(5) SUPPLEMENT
NOT
SUPPLANT.—Awards 
under paragraph (1) shall supplement, not supplant, 
the maintenance and use of the Strategic National 
Stockpile by the Secretary under subsection (a). 
‘‘(6) GUIDANCE
FOR
STATES.—Not later than 
180 days after the date of enactment of this sub-
section, the Secretary, in consultation with States, 
health officials, and other relevant stakeholders, as ap-
propriate, shall issue guidance, and update such guid-
3353 
† HR 2617 EAS2 
ance as appropriate, for States related to maintain-
ing and replenishing a stockpile of medical products, 
which may include strategies and best practices re-
lated to— 
‘‘(A) types of medical products and medical 
supplies that are critical to respond to public 
health emergencies, and may be appropriate for 
inclusion in a stockpile by States, with consider-
ation of threats that require the large-scale and 
simultaneous deployment of stockpiles, including 
the stockpile maintained by the Secretary pursu-
ant to subsection (a), and long-term public 
health and medical response needs; 
‘‘(B) appropriate management of the con-
tents of a stockpile, including management by 
vendors of reserve amounts of medical products 
and supplies intended to be delivered to the own-
ership of the State and appropriate disposition 
of excess products, as applicable; and 
‘‘(C) the procurement of medical products 
and medical supplies consistent with the require-
ments of chapter 83 of title 41, United States 
Code (commonly referred to as the ‘Buy Amer-
ican Act’).
3354 
† HR 2617 EAS2 
‘‘(7) TECHNICAL
ASSISTANCE.—The Secretary 
shall provide assistance to States, including technical 
assistance, as appropriate, in establishing, maintain-
ing, improving, and utilizing a medical stockpile, in-
cluding appropriate inventory management and dis-
position of products. 
‘‘(8) REPORTING.— 
‘‘(A) STATE REPORTS.—Each entity receiv-
ing 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 there-
after 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 Appropria-
3355 
† HR 2617 EAS2 
tions of the Senate and the Committee on Energy 
and Commerce and the Committee on Appro-
priations of the House of Representatives a re-
port 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 rel-
evant. 
‘‘(9) AUTHORIZATION OF APPROPRIATIONS.—To 
carry out this subsection, there is authorized to be ap-
propriated $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 sub-
section (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 stock-
piles established or maintained pursuant to this section. 
Such report shall include an assessment of—
3356 
† HR 2617 EAS2 
(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 Sec-
retary of Health and Human Services to such enti-
ties; 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 PRODUC-
TION OF GENERIC MEDICINES. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’), acting through the Assistant Secretary for Plan-
ning 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 providing incentives for increased do-
3357 
† HR 2617 EAS2 
mestic production and capacity of specified generic 
medicines and their active pharmaceutical ingredi-
ents, which may include through applicable nonprofit 
or for-profit private entities; and 
(2) not later than 1 year after the date of enact-
ment of this Act, submit a report on such study 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. 
(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 Cos-
metic 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 with-
out such medicine; 
(2) an antibiotic or antifungal used to treat a se-
rious 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 debili-
tating disease or condition.
3358 
† HR 2617 EAS2 
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 manufac-
turing capacity of certain antibiotic drugs with iden-
tified supply chain vulnerabilities, or the active phar-
maceutical ingredient or key starting material of such 
antibiotic drugs. 
(2) ELIGIBLE ENTITIES.—To be eligible to re-
ceive an award under this subsection, an entity 
shall— 
(A) be a manufacturer that is in compli-
ance 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 Sec-
retary may require, including— 
(i) a description of proposed activities 
to be supported by an award under this
3359 
† HR 2617 EAS2 
subsection to increase manufacturing capac-
ity for such antibiotic drug or drugs; 
(ii) the antibiotic drug or drugs, or re-
lated active pharmaceutical ingredients or 
key starting materials for such drug or 
drugs, that such entity intends to manufac-
ture with any increased manufacturing ca-
pacity supported by an award under this 
subsection; 
(iii) any additional products such in-
creased manufacturing 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 sup-
ply chain, known or potential supply limi-
tations, 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
3376 
† HR 2617 EAS2 
ignated platform technology under subsection (d) was 
granted; or 
‘‘(2) the sponsor relying on such data and infor-
mation received a right of reference to such data and 
information from the sponsor described in paragraph 
(1). 
‘‘(g) CHANGES TO A DESIGNATED PLATFORM TECH-
NOLOGY.—A sponsor of more than one application ap-
proved under section 505(b) of this Act or section 351(a) 
of the Public Health Service Act for drugs that incorporate 
or utilize a designated platform technology may submit a 
single supplemental application for proposed changes to the 
designated platform technology that may be applicable to 
more than one such drug that incorporates or utilizes the 
same designated platform technology. Such supplemental 
application may cross-reference data and information sub-
mitted in other applications and may include one or more 
comparability protocols regarding how such changes to the 
platform technology would be made for each applicable drug 
or biological product. 
‘‘(h) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘platform technology’ means a 
well-understood and reproducible technology, which 
may include a nucleic acid sequence, molecular struc-
ture, mechanism of action, delivery method, vector, or