3308 
† HR 2617 EAS2 
‘‘(C) CONSIDERATIONS.—In determining the 
location of each office or facility, the Director 
shall make a fair and open consideration of— 
‘‘(i) the characteristics of the intended 
location; and 
‘‘(ii) the extent to which such location 
will facilitate advancement of the goals and 
functions specified in subsection (b). 
‘‘(i) PERSONNEL.— 
‘‘(1) IN GENERAL.—The Director may— 
‘‘(A) appoint and remove scientific, engi-
neering, medical, and professional personnel, 
which may include temporary or term-limited 
appointments as determined by the Director to 
fulfill the mission of ARPA–H, without regard to 
any provision in title 5, United States Code, 
governing appointments and removals under the 
civil service laws; 
‘‘(B) notwithstanding any other provision 
of law, including any requirement with respect 
to General Schedule pay rates under subchapter 
III of chapter 53 of title 5, United States Code, 
fix the base pay compensation of such personnel 
at a rate to be determined by the Director, up 
to the amount of annual compensation (exclud-
3309 
† HR 2617 EAS2 
ing expenses) specified in section 102 of title 3, 
United States Code; and 
‘‘(C) contract with private recruiting firms 
for assistance in identifying highly qualified 
candidates for technical positions needed to 
carry out this section. 
‘‘(2) SUPPORT STAFF.—The Director may use 
authorities in existence on the date of enactment of 
this section that are provided to the Secretary to hire 
administrative, financial, clerical, and other staff 
necessary to carry out functions that support the 
goals and functions described in subsection (b). 
‘‘(3) NUMBER
OF
PERSONNEL.—The Director 
may appoint not more than 210 personnel under this 
section. The Director shall submit a notification 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 
Representatives if the Director determines that addi-
tional personnel are required to carry out this section. 
‘‘(4) CLARIFICATION ON PREVIOUS POSITIONS.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), the Director shall ensure that 
the personnel who are appointed to staff or sup-
3310 
† HR 2617 EAS2 
port ARPA–H are individuals who, at the time 
of appointment and for 3 years prior to such ap-
pointment, were not employed by the National 
Institutes of Health. The Director may grant an 
exemption only for individuals who are uniquely 
qualified, by way of professional background and 
expertise, to advance the goals and functions 
specified in subsection (b). 
‘‘(B) NONAPPLICATION OF PROVISION.—The 
restriction provided under subparagraph (A) 
shall not apply to any individuals who are em-
ployed by ARPA–H on the date of enactment of 
this section. 
‘‘(5) ADDITIONAL
CONSIDERATIONS.—In ap-
pointing personnel under this subsection, the Direc-
tor— 
‘‘(A) may contract with private entities for 
the purposes of recruitment services; 
‘‘(B) shall make efforts to recruit a diverse 
workforce, 
including 
individuals 
underrep-
resented in science, engineering, and medicine, 
including racial and ethnic minorities, provided 
such efforts do not conflict with applicable Fed-
eral civil rights law, and individuals with a va-
3311 
† HR 2617 EAS2 
riety of professional experiences or backgrounds; 
and 
‘‘(C) shall recruit program managers with 
demonstrated expertise in a wide range of sci-
entific disciplines and management skills. 
‘‘(6) USE OF INTERGOVERNMENTAL PERSONNEL 
ACT.—To the extent needed to carry out the authori-
ties under paragraph (1) and the goals and functions 
specified in subsection (b), the Director may utilize 
hiring authorities under sections 3371 through 3376 
of title 5, United States Code. 
‘‘(7) 
AUTHORITY
TO
ACCEPT
FEDERAL 
DETAILEES.—The Director may accept officers or em-
ployees of the United States or members of the uni-
formed service on a detail from an element of the Fed-
eral Government, on a reimbursable or a nonreim-
bursable basis, as jointly agreed to by the heads of the 
receiving and detailing elements, for a period not to 
exceed 3 years. 
‘‘(j) PROGRAM MANAGERS.— 
‘‘(1) IN GENERAL.—The Director shall appoint 
program managers for 3-year terms (and may re-
appoint such program managers for 1 additional con-
secutive 3-year term) for the programs carried out by 
ARPA–H.
3312 
† HR 2617 EAS2 
‘‘(2) DUTIES.—A program manager shall— 
‘‘(A) establish, in consultation with the Di-
rector, research and development goals for pro-
grams, including timelines and milestones, and 
make such goals available to the public; 
‘‘(B) manage applications and proposals, 
through the appropriate officials, for making 
awards as described in subsection (g) for activi-
ties consistent with the goals and functions de-
scribed in subsection (b); 
‘‘(C) issue funding opportunity announce-
ments, using uniform administrative processes, 
as appropriate; 
‘‘(D) select, on the basis of merit, each of the 
projects to be supported under a program carried 
out by ARPA–H, and taking into consider-
ation— 
‘‘(i) the scientific, technical merit, and 
novelty of the proposed project; 
‘‘(ii) the ability of the applicant to 
successfully carry out the proposed project; 
‘‘(iii) the potential future commercial 
applications of the project proposed by the 
applicant, including whether such applica-
tions may have the potential to address
3313 
† HR 2617 EAS2 
areas of currently unmet need within bio-
medicine and improve health outcomes; 
‘‘(iv) the degree to which the proposed 
project has the potential to transform bio-
medicine and addresses a scientific or tech-
nical question pursuant to subsection (b); 
‘‘(v) the potential for the project to take 
an interdisciplinary approach; and 
‘‘(vi) such other criteria as established 
by the Director; 
‘‘(E) provide project oversight and manage-
ment of strategic initiatives to advance the pro-
gram, including by conducting project reviews 
not later than 18 months after the date of fund-
ing awards to identify and monitor progress of 
milestones with respect to each project and prior 
to disbursement of additional funds; 
‘‘(F) provide recommendations to the Direc-
tor with respect to advancing the goals and func-
tions specified in subsection (b); 
‘‘(G) encourage research collaborations and 
cultivate opportunities for the application or uti-
lization of successful projects, including through 
identifying and supporting applicable public-
3314 
† HR 2617 EAS2 
private partnerships or partnerships between or 
among award recipients; 
‘‘(H) provide recommendations to the Direc-
tor to establish, expand, restructure, or terminate 
partnerships or projects; and 
‘‘(I) communicate and collaborate with 
leaders and experts within the health care and 
biomedical research and development fields, in-
cluding from both the public and private sectors 
and, as necessary, through the convening of 
workshops and meetings, to identify research and 
development gaps and opportunities and solicit 
stakeholder input on programs and goals. 
‘‘(k) REPORTS AND EVALUATION.— 
‘‘(1) ANNUAL REPORT.— 
‘‘(A) IN
GENERAL.—Beginning not later 
than 1 year after the date of enactment of this 
section, as part of the annual budget request sub-
mitted for each fiscal year, the Director shall 
submit a report on the actions undertaken, and 
the results generated, by ARPA–H, including— 
‘‘(i) a description of projects supported 
by ARPA–H in the previous fiscal year and 
whether such projects are meeting the goals
3315 
† HR 2617 EAS2 
developed by the Director pursuant to sub-
section (c)(4)(A); 
‘‘(ii) a description of projects termi-
nated in the previous fiscal year, and the 
reason for such termination; 
‘‘(iii) a description of planned pro-
grams starting in the next fiscal year, pend-
ing the availability of funding; 
‘‘(iv) activities conducted in coordina-
tion with other Federal departments and 
agencies; 
‘‘(v) a description of any successes 
with, or barriers to, coordinating with other 
Federal departments and agencies to achieve 
the goals and functions under subsection 
(b); 
‘‘(vi) aggregated demographic informa-
tion, if available, of direct recipients and 
performers in funded projects and of the 
ARPA–H workforce (consistent with the re-
porting requirements under paragraph (3)); 
and 
‘‘(vii) a summary of award recipient 
compliance with section 2321 of the PRE-
VENT Pandemics Act.
3316 
† HR 2617 EAS2 
‘‘(B) SUBMISSION TO CONGRESS.—The re-
port under subparagraph (A) shall be submitted 
to— 
‘‘(i) the Committee on Energy and 
Commerce and the Committee on Appro-
priations of the House of Representatives; 
and 
‘‘(ii) the Committee on Health, Edu-
cation, Labor, and Pensions and the Com-
mittee on Appropriations of the Senate. 
‘‘(2) EVALUATION.— 
‘‘(A) IN GENERAL.—Not later than 5 years 
after the date of the enactment of this section, the 
Director shall seek to enter into an agreement 
with the National Academies under which the 
National Academies conducts an evaluation of 
whether ARPA–H is meeting the goals and func-
tions specified in subsection (b). 
‘‘(B) SUBMISSION OF RESULTS.—The agree-
ment entered into under subparagraph (A) shall 
require the National Academies to submit the 
evaluation conducted under such agreement to 
the Director, the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate, and 
the Committee on Energy and Commerce of the
3317 
† HR 2617 EAS2 
House of Representatives, and make the report 
publicly available. 
‘‘(3) REPORTING
RELATED
TO
ARPA–H
PER-
SONNEL.— 
‘‘(A) IN GENERAL.—The Director shall es-
tablish and maintain records regarding the use 
of the authority under subsection (i)(1)(A), in-
cluding— 
‘‘(i) the number of positions filled 
through such authority; 
‘‘(ii) the types of appointments of such 
positions; 
‘‘(iii) the titles, occupational series, 
and grades of such positions; 
‘‘(iv) the number of positions publicly 
noticed to be filled under such authority; 
‘‘(v) the number of qualified applicants 
who apply for such positions; 
‘‘(vi) the qualification criteria for such 
positions; and 
‘‘(vii) the demographic information of 
individuals appointed to such positions. 
‘‘(B) REPORTS
TO
CONGRESS.—Not later 
than 2 years after the date of enactment of this 
section, and annually thereafter for each fiscal
3318 
† HR 2617 EAS2 
year in which such authority is used, the Direc-
tor 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 describing 
the total number of appointments filled under 
subsection (i) within the fiscal year and how the 
positions relate to the goals and functions of 
ARPA–H. 
‘‘(C) GAO REPORT.—Not later than 2 years 
after the date of enactment of this section, the 
Comptroller General of the United States shall 
submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of 
Representatives a report on the use of the author-
ity provided under subsection (i)(1)(A). Such re-
port shall, in a manner that protects personal 
privacy, to the extent required by applicable 
Federal and State privacy law, at a minimum, 
include information on— 
‘‘(i) the number of positions publicly 
noticed and filled under the authority under 
subsection (i);
3319 
† HR 2617 EAS2 
‘‘(ii) the occupational series, grades, 
and types of appointments of such posi-
tions; 
‘‘(iii) how such positions related to ad-
vancing the goals and functions of ARPA– 
H; 
‘‘(iv) how the Director made appoint-
ment decisions under subsection (i); 
‘‘(v) a summary of sources used to 
identify candidates for filling such posi-
tions, as applicable; 
‘‘(vi) the number of individuals ap-
pointed; 
‘‘(vii) aggregated demographic infor-
mation related to individuals appointed; 
and 
‘‘(viii) any challenges, limitations, or 
gaps related to the use of the authority 
under subsection (i) and any related rec-
ommendations to address such challenges, 
limitations, or gaps. 
‘‘(l) STRATEGIC PLAN.—Not later than 1 year after 
the date of the enactment of this section, and every 3 years 
thereafter, the Director shall provide to the Committee on 
Health, Education, Labor, and Pensions and the Committee
3320 
† HR 2617 EAS2 
on Appropriations of the Senate and the Committee on En-
ergy and Commerce and the Committee on Appropriations 
of the House of Representatives a strategic plan describing 
how ARPA–H will carry out investments each fiscal year 
in the following 3-year period. The requirements regarding 
individual institute and center strategic plans under sec-
tion 402(m), including paragraph (3) of such subsection, 
shall not apply to ARPA–H. 
‘‘(m) INDEPENDENT REVIEW.—Not later than 1 year 
after the date of the enactment of this section, and every 
4 years thereafter, the Comptroller General of the United 
States shall conduct, and 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, an independent review of the biomedical 
research and development portfolio of the Department of 
Health and Human Services, including ARPA–H, the Na-
tional Institutes of Health, the Food and Drug Administra-
tion, and the Biomedical Advanced Research and Develop-
ment Authority— 
‘‘(1) to assess the degree of any potential dupli-
cation of existing Federal programs and projects; and 
‘‘(2) to make any recommendations regarding 
any potential reorganization, consolidation, or termi-
nation of such programs and projects.
3321 
† HR 2617 EAS2 
‘‘(n) PRIORITIZATION.— 
‘‘(1) IN GENERAL.—The Director shall— 
‘‘(A) prioritize awarding grants, coopera-
tive agreements, contracts, prizes, and other 
transaction awards to entities that will conduct 
funded work in the United States; 
‘‘(B) as appropriate and practicable, en-
courage nondomestic recipients of any grants, co-
operative agreements, contracts, prizes, and other 
transactions under this section to collaborate 
with a domestic entity; 
‘‘(C) not make awards under this section to 
nondomestic entities organized under the laws of 
a covered foreign country (as defined in section 
119C of the National Security Act of 1947 (50 
U.S.C. 3059)); and 
‘‘(D) in accordance with the requirements of 
chapter 33 of title 41, United States Code, and 
the Federal Acquisition Regulation, not make 
awards under this section to entities that have 
more than 3 ongoing concurrent awards under 
this section. 
‘‘(2) CLARIFICATION.—In making an award 
under this section, the Director may waive the re-
quirements of subparagraphs (A), (B), and (D) of
3322 
† HR 2617 EAS2 
paragraph (1) if such requirements cannot reasonably 
be met, and the proposed project has the potential to 
advance the goals described in subsection (b)(1). The 
Director shall provide notice to Congress not later 
than 30 days after waiving such requirements. 
‘‘(o) ADDITIONAL CONSULTATION.—In carrying out 
this section, the Director may consult with— 
‘‘(1) the President’s Council of Advisors on 
Science and Technology; 
‘‘(2) representatives of professional or scientific 
organizations, including academia and industry, with 
expertise in specific technologies under consideration 
or development by ARPA–H; 
‘‘(3) an existing advisory committee providing 
advice to the Secretary or the head of any operating 
or staff division of the Department; 
‘‘(4) the advisory committee established under 
subsection (p); and 
‘‘(5) any other entity the Director may deem ap-
propriate. 
‘‘(p) ADVISORY COMMITTEE.— 
‘‘(1) IN
GENERAL.—There is established an 
ARPA–H Interagency Advisory Committee (referred 
to in this subsection as the ‘Advisory Committee’) to 
coordinate efforts and provide advice and assistance
3323 
† HR 2617 EAS2 
on specific program or project tasks and the overall 
direction of ARPA–H. 
‘‘(2) MEMBERS.—The Advisory Committee estab-
lished under paragraph (1) shall consist of the heads 
of the following agencies or their designees: 
‘‘(A) The National Institutes of Health. 
‘‘(B) The Centers for Disease Control and 
Prevention. 
‘‘(C) The Food and Drug Administration. 
‘‘(D) The Office of the Assistant Secretary 
for Preparedness and Response. 
‘‘(E) The Office of the Assistant Secretary of 
Health. 
‘‘(F) 
The 
Defense 
Advanced 
Research 
Projects Agency. 
‘‘(G) The Office of Science of the Depart-
ment of Energy. 
‘‘(H) The National Science Foundation. 
‘‘(I) Any other agency or office with subject 
matter expertise that the Director of ARPA–H 
determines appropriate to advance programs or 
projects under this section. 
‘‘(3) NONAPPLICABILITY OF FACA.—The Federal 
Advisory Committee Act (5 U.S.C. App.) shall not 
apply to the Advisory Committee.
3324 
† HR 2617 EAS2 
‘‘(4) ADVISORY NATURE.—The functions of the 
Advisory Committee shall be advisory in nature, and 
nothing in this subsection shall be construed as grant-
ing such Committee authority over the activities au-
thorized under this section. 
‘‘(5) PERFORMANCE MEASURES FRAMEWORK.— 
‘‘(A) IN GENERAL.—The Director, in con-
sultation with the Advisory Committee, shall de-
velop a performance measures framework for 
programs or projects supported by ARPA–H in 
order to inform and facilitate the evaluation re-
quired under subsection (k)(2), including identi-
fication of any data needed to perform such eval-
uation, 
‘‘(B) 
AVAILABILITY
OF
PERFORMANCE 
MEASURES.—The Director shall provide to the 
National Academies such performance measures 
and data necessary to perform the evaluation re-
quired under subsection (k)(2). 
‘‘(q) RULE OF CONSTRUCTION.—The authorities under 
this section, with respect to the Director, are additional au-
thorities that do not supersede or modify any existing au-
thorities. 
‘‘(r) TRANSFORMATIVE HEALTH TECHNOLOGY DE-
FINED.—In this section, the term ‘transformative health
3325 
† HR 2617 EAS2 
technology’ means a novel, broadly applicable capability or 
technology— 
‘‘(1) that has potential to revolutionize the detec-
tion, diagnosis, mitigation, prevention, cure, or treat-
ment of a disease or health condition that can cause 
severe health outcomes and which is an area of cur-
rently unmet need; and 
‘‘(2) for which— 
‘‘(A) significant scientific or technical chal-
lenges exist; or 
‘‘(B) incentives in the commercial market 
are unlikely to result in the adequate or timely 
development of such capability or technology. 
‘‘(s) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there is authorized to be appropriated 
$500,000,000 for each of the fiscal years 2024 through 2028, 
to remain available until expended. 
‘‘(t) ADDITIONAL
BUDGET
CLARIFICATION.—Any 
budget request for ARPA–H shall propose a separate appro-
priation from the other accounts of the National Institutes 
of Health.’’. 
(b) GAO REPORT ON CERTAIN RESEARCH REQUIRE-
MENTS.—The Comptroller General of the United States 
shall conduct a review to assess the extent to which relevant 
research conducted or supported by the National Institutes
3326 
† HR 2617 EAS2 
of Health meets Federal animal research requirements pur-
suant of the Public Health Service Policy on Humane Care 
and Use of Laboratory Animals. Such review shall also con-
sider whether, for research conducted or supported by the 
National Institutes of Health that involves the use of ani-
mals, the processes of the National Institutes of Health for 
reviewing initial research proposals and monitoring funded 
research include a review of project protocols and methods 
to ensure that results generated by such project may be rea-
sonably anticipated to be reproducible and replicable and 
achieve similar results, as applicable, in clinical trials. Not 
later than 2 years after the date of enactment of this Act, 
the Comptroller General shall submit a report on the review 
required under this subsection to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Represent-
atives. 
Subtitle 
D—Modernizing 
and 
Strengthening the Supply Chain 
for Vital Medical Products 
SEC. 2401. WARM BASE MANUFACTURING CAPACITY FOR 
MEDICAL COUNTERMEASURES. 
(a) IN GENERAL.—Section 319L of the Public Health 
Service Act (42 U.S.C. 247d–7e) is amended— 
(1) in subsection (a)(6)(B)—
3327 
† HR 2617 EAS2 
(A) by redesignating clauses (iv) and (v) as 
clauses (v) and (vi), respectively; 
(B) by inserting after clause (iii), the fol-
lowing: 
‘‘(iv) activities to support, maintain, 
and improve domestic manufacturing surge 
capacity and capabilities, as appropriate, 
including through the utilization of ad-
vanced manufacturing and platform tech-
nologies, to increase the availability of 
products that are or may become qualified 
countermeasures or qualified pandemic or 
epidemic products;’’; and 
(C) in clause (vi) (as so redesignated), by 
inserting 
‘‘manufacturing,’’ 
after 
‘‘improve-
ment,’’; 
(2) in subsection (b)— 
(A) in the first sentence of paragraph (1), 
by inserting ‘‘support for domestic manufac-
turing surge capacity and capabilities,’’ after 
‘‘initiatives for innovation,’’; and 
(B) in paragraph (2)— 
(i) in subparagraph (B), by striking 
‘‘and’’ at the end;
3328 
† HR 2617 EAS2 
(ii) by redesignating subparagraph (C) 
as subparagraph (D); and 
(iii) by inserting after subparagraph 
(B), the following: 
‘‘(C) activities to support, maintain, and 
improve domestic manufacturing surge capacity 
and capabilities, as appropriate, including 
through the utilization of advanced manufac-
turing and platform technologies, to increase the 
availability of products that are or may become 
qualified countermeasures or qualified pandemic 
or epidemic products; and’’; 
(3) in subsection (c)— 
(A) in paragraph (2)(B), by inserting before 
the semicolon ‘‘, including through the establish-
ment and maintenance of domestic manufac-
turing surge capacity and capabilities, consistent 
with subsection (a)(6)(B)(iv)’’; 
(B) in paragraph (4)— 
(i) in subparagraph (A)— 
(I) in clause (i)— 
(aa) in subclause (I), by 
striking ‘‘and’’ at the end; and 
(bb) by adding at the end the 
following:
3329 
† HR 2617 EAS2 
‘‘(III) facilitating such commu-
nication, as appropriate, regarding 
manufacturing surge capacity and ca-
pabilities with respect to qualified 
countermeasures and qualified pan-
demic or epidemic products to prepare 
for, or respond to, a public health 
emergency or potential public health 
emergency; and 
‘‘(IV) facilitating such commu-
nication, as appropriate and in a 
manner that does not compromise na-
tional security, with respect to poten-
tial eligibility for the material threat 
medical countermeasure priority re-
view voucher program under section 
565A of the Federal Food, Drug, and 
Cosmetic Act;’’; 
(II) in clause (ii)(III), by striking 
‘‘and’’ at the end; 
(III) by redesignating clause (iii) 
as clause (iv); and 
(IV) by inserting after clause (ii), 
the following:
3330 
† HR 2617 EAS2 
‘‘(iii) communicate regularly with en-
tities in receipt of an award pursuant to 
subparagraph (B)(v), and facilitate commu-
nication between such entities and other en-
tities in receipt of an award pursuant to 
subparagraph (B)(iv), as appropriate, for 
purposes of planning and response regard-
ing the availability of countermeasures and 
the maintenance of domestic manufacturing 
surge capacity and capabilities, including 
any planned uses of such capacity and ca-
pabilities in the near- and mid-term, and 
identification of any significant challenges 
related to the long-term maintenance of 
such capacity and capabilities; and’’; 
(ii) in subparagraph (B)— 
(I) in clause (iii), by striking 
‘‘and’’ at the end; 
(II) in clause (iv), by striking the 
period and inserting ‘‘; and’’; and 
(III) by adding at the end the fol-
lowing: 
‘‘(v) award contracts, grants, and co-
operative agreements and enter into other 
transactions to support, maintain, and im-
3331 
† HR 2617 EAS2 
prove domestic manufacturing surge capac-
ity and capabilities, including through sup-
porting flexible or advanced manufacturing, 
to ensure that additional capacity is avail-
able to rapidly manufacture products that 
are or may become qualified counter-
measures or qualified pandemic or epidemic 
products in the event of a public health 
emergency declaration or significant poten-
tial for a public health emergency.’’; 
(iii) in subparagraph (C)— 
(I) in clause (i), by striking 
‘‘and’’ at the end; 
(II) in clause (ii), by striking the 
period at the end and inserting ‘‘; 
and’’; and 
(III) by adding at the end the fol-
lowing: 
‘‘(iii) consult with the Commissioner of 
Food and Drugs, pursuant to section 
565(b)(2) of the Federal Food, Drug, and 
Cosmetic Act, to ensure that facilities per-
forming manufacturing, pursuant to an 
award under subparagraph (B)(v), are in 
compliance with applicable requirements
3332 
† HR 2617 EAS2 
under such Act and this Act, as appro-
priate, including current good manufac-
turing 
practice 
pursuant 
to 
section 
501(a)(2)(B) of the Food, Drug, and Cos-
metic Act; and’’; 
(iv) in subparagraph (D)(i), by insert-
ing ‘‘, including to improve manufacturing 
capacities and capabilities for medical 
countermeasures’’ before the semicolon; 
(v) in subparagraph (E)(ix), by strik-
ing ‘‘2023’’ and inserting ‘‘2028’’; and 
(vi) by adding at the end the following: 
‘‘(G) ANNUAL REPORTS BY AWARD RECIPI-
ENTS.—As a condition of receiving an award 
under subparagraph (B)(v), a recipient shall de-
velop and submit to the Secretary annual reports 
related to the maintenance of such capacity and 
capabilities, including ensuring that such capac-
ity and capabilities are able to support the rapid 
manufacture of countermeasures as required by 
the Secretary.’’; and 
(C) in paragraph (5), by adding at the end 
the following: 
‘‘(H) SUPPORTING WARM-BASE AND SURGE 
CAPACITY AND CAPABILITIES.—Pursuant to an
3333 
† HR 2617 EAS2 
award under subparagraph (B)(v), the Secretary 
may make payments for activities necessary to 
maintain domestic manufacturing surge capac-
ity and capabilities supported under such award 
to ensure that such capacity and capabilities are 
able to support the rapid manufacture of coun-
termeasures as required by the Secretary to pre-
pare for, or respond to, an existing or potential 
public health emergency or otherwise address 
threats that pose a significant level of risk to na-
tional security. The Secretary may support the 
utilization of such capacity and capabilities 
under awards for countermeasure and product 
advanced research and development, as appro-
priate, to provide for the maintenance of such 
capacity and capabilities.’’; and 
(4) in subsection (f)— 
(A) in paragraph (1), by striking ‘‘Not later 
than 180 days after the date of enactment of this 
subsection’’ and inserting ‘‘Not later than 180 
days after the date of enactment of the PRE-
VENT Pandemics Act’’; 
(B) in paragraph (2)—
3334 
† HR 2617 EAS2 
(i) in the matter preceding subpara-
graph (A), by striking ‘‘this subsection’’ and 
inserting ‘‘the PREVENT Pandemics Act’’; 
(ii) in subparagraph (B), by striking 
‘‘and’’ at the end; and 
(iii) in subparagraph (C), by striking 
the period and inserting ‘‘; and’’; and 
(C) by adding at the end the following: 
‘‘(D) plans for the near-, mid-, and long- 
term sustainment of manufacturing activities 
carried out under this section, including such ac-
tivities pursuant to subsection (c)(5)(H), specific 
actions to regularly assess the ability of recipi-
ents of an award under subsection (c)(4)(B)(v) to 
rapidly manufacture countermeasures as re-
quired by the Secretary, and recommendations to 
address challenges, if any, related to such activi-
ties.’’. 
SEC. 2402. SUPPLY CHAIN CONSIDERATIONS FOR THE STRA-
TEGIC NATIONAL STOCKPILE. 
Subclause (II) of section 319F–2(a)(2)(B)(i) of the 
Public Health Service Act (42 U.S.C. 247d–6b(a)(2)(B)(i)) 
is amended to read as follows: 
‘‘(II) planning considerations for 
appropriate manufacturing capacity
3335 
† HR 2617 EAS2 
and capability to meet the goals of 
such additions or modifications (with-
out disclosing proprietary informa-
tion), including— 
‘‘(aa) consideration of the ef-
fect such additions or modifica-
tions may have on the availability 
of such products and ancillary 
medical supplies on the health 
care system; and 
‘‘(bb) an assessment of the 
current supply chain for such 
products, including information 
on supply chain redundancies, 
any known domestic manufac-
turing capacity for such products, 
and any related vulnerabilities;’’. 
SEC. 2403. STRATEGIC NATIONAL STOCKPILE EQUIPMENT 
MAINTENANCE. 
Section 319F–2(a)(3) of the Public Health Service Act 
(42 U.S.C. 247d–6b(a)(3)) is amended— 
(1) in subparagraph (B), by inserting ‘‘, regu-
larly reviewed, and updated’’ after ‘‘followed’’; and 
(2) by amending subparagraph (D) to read as 
follows:
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‘‘(D) review and revise, as appropriate, the 
contents of the stockpile on a regular basis to en-
sure that— 
‘‘(i) emerging threats, advanced tech-
nologies, and new countermeasures are ade-
quately considered; 
‘‘(ii) the potential depletion of counter-
measures currently in the stockpile is iden-
tified and appropriately addressed, includ-
ing through necessary replenishment; and 
‘‘(iii) such contents are in working 
condition or usable, as applicable, and are 
ready for deployment, which may include 
conducting maintenance services on such 
contents of the stockpile and disposing of 
such contents that are no longer in working 
condition, or usable, as applicable;’’. 
SEC. 2404. IMPROVING TRANSPARENCY AND PREDICT-
ABILITY OF PROCESSES OF THE STRATEGIC 
NATIONAL STOCKPILE. 
(a) GUIDANCE.—Not later than 60 days after the date 
of enactment of this Act, the Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall issue guidance describing the processes by 
which the Secretary deploys the contents of the Strategic
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(vi) a strategic plan regarding the 
maintenance, operation, and sustainment of 
such increased manufacturing capacity fol-
lowing 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, ex-
pand, upgrade, modify, or recommission a facility lo-
cated 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 in-
gredient 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 manufacturing capacity of anti-
biotic drugs pursuant to a contract under this sub-
section, including actions taken to implement the 
strategic plan required under paragraph (2)(B)(vi). 
(5) CONTRACT
TERMS.—The following shall 
apply to a contract to support increased domestic 
manufacturing capacity under this subsection:
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proval or licensure is as efficient as practicable, 
which may include holding meetings with the sponsor 
and the review team throughout the development of 
the drug; and 
‘‘(3) considering inspectional findings, including 
prior findings, related to the manufacture of a drug 
that incorporates or utilizes the designated platform 
technology. 
‘‘(f) LEVERAGING DATA FROM DESIGNATED PLAT-
FORM TECHNOLOGIES.—The Secretary shall, consistent 
with applicable standards for approval, authorization, or 
licensure under this Act and section 351(a) of the Public 
Health Service Act, allow the sponsor of an application 
under section 505(b) of this Act or section 351(a) of the 
Public Health Service Act or a request for emergency use 
authorization under section 564, in order to support ap-
proval, licensure, or authorization, to reference or rely upon 
data and information within an application or request for 
a drug or biological product that incorporates or utilizes 
the same platform technology designated under subsection 
(d), provided that— 
‘‘(1) such data and information was submitted 
by the same sponsor, pursuant to the application for 
the drug with respect to which designation of the des-