H. R. 2617—1316 
‘‘(1) IN
GENERAL.—In order to facilitate the enhanced 
collaboration and communication with respect to the most cur-
rent priorities of ARPA–H, the Food and Drug Administration 
may meet with ARPA–H and any other Federal partners at 
appropriate intervals to discuss the development status, and 
actions that may be taken to facilitate the development, of 
medical products and projects that are the highest priorities 
to ARPA–H. 
‘‘(2) REIMBURSEMENT.—Utilizing interagency agreements or 
other appropriate resource allocation mechanisms available, 
the Director shall reimburse, using funds made available to 
ARPA–H, the Food and Drug Administration, as appropriate, 
for activities identified by the Commissioner of Food and Drugs 
and the Director as being conducted by the Food and Drug 
Administration under the authority of this subsection. 
‘‘(g) AWARDS.— 
‘‘(1) IN GENERAL.—In carrying out this section, the Director 
may— 
‘‘(A) award grants and cooperative agreements, which 
shall include requirements to publicly report indirect facili-
ties and administrative costs, broken out by fixed capital 
costs, administrative overhead, and labor costs; 
‘‘(B) award contracts, which may include multi-year 
contracts subject to section 3903 of title 41, United States 
Code; 
‘‘(C) award cash prizes, utilizing the authorities and 
processes established under section 24 of the Stevenson- 
Wydler Technology Innovation Act of 1980; and 
‘‘(D) enter into other transactions, as defined by section 
319L(a)(3), subject to paragraph (2). 
‘‘(2) LIMITATIONS
ON
ENTERING
INTO
OTHER
TRANS-
ACTIONS.— 
‘‘(A) USE OF COMPETITIVE PROCEDURES.—To the max-
imum extent practicable, competitive procedures shall be 
used when entering into other transactions under this sec-
tion. 
‘‘(B) 
WRITTEN
DETERMINATION
REQUIRED.—The 
authority of paragraph (1)(D) may be exercised for a project 
if the program manager— 
‘‘(i) submits a request to the Director for each 
individual use of such authority before conducting or 
supporting a program, including an explanation of why 
the use of such authority is essential to promoting 
the success of the project; 
‘‘(ii) receives approval for the use of such authority 
from the Director; and 
‘‘(iii) for each year in which the program manager 
has used such authority in accordance with this para-
graph, submits a report to the Director on the activities 
of the program related to such project. 
‘‘(3) EXEMPTIONS FROM CERTAIN REQUIREMENTS.—Research 
funded by ARPA–H shall not be subject to the requirements 
of section 406(a)(3)(A)(ii) or section 492. 
‘‘(h) FACILITIES AUTHORITY.— 
‘‘(1) IN GENERAL.—The Director is authorized, for adminis-
trative purposes, to—
H. R. 2617—1317 
‘‘(A) acquire (by purchase, lease, condemnation or 
otherwise), construct, improve, repair, operate, and main-
tain such real and personal property as are necessary to 
carry out this section; and 
‘‘(B) lease an interest in property for not more than 
20 years, notwithstanding section 1341(a)(1) of title 31, 
United States Code. 
‘‘(2) LOCATIONS.— 
‘‘(A) IN
GENERAL.—ARPA–H, including its head-
quarters, shall not be located on any part of the existing 
National Institutes of Health campuses. 
‘‘(B) NUMBER
OF
LOCATIONS.—ARPA–H shall have 
offices or facilities in not less than 3 geographic areas. 
‘‘(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, engineering, med-
ical, and professional personnel, which may include tem-
porary 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 
(excluding expenses) specified in section 102 of title 3, 
United States Code; and 
‘‘(C) contract with private recruiting firms for assist-
ance 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, Edu-
cation, Labor, and Pensions and the Committee on Appropria-
tions of the Senate and the Committee on Energy and Com-
merce and the Committee on Appropriations of the House of 
Representatives if the Director determines that additional per-
sonnel 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 support ARPA–H are individuals who,
H. R. 2617—1318 
at the time of appointment and for 3 years prior to such 
appointment, 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 profes-
sional 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 employed by ARPA–H on the date 
of enactment of this section. 
‘‘(5) ADDITIONAL CONSIDERATIONS.—In appointing personnel 
under this subsection, the Director— 
‘‘(A) may contract with private entities for the purposes 
of recruitment services; 
‘‘(B) shall make efforts to recruit a diverse workforce, 
including 
individuals 
underrepresented 
in 
science, 
engineering, and medicine, including racial and ethnic 
minorities, provided such efforts do not conflict with 
applicable Federal civil rights law, and individuals with 
a variety of professional experiences or backgrounds; and 
‘‘(C) shall recruit program managers with dem-
onstrated expertise in a wide range of scientific disciplines 
and management skills. 
‘‘(6) USE OF INTERGOVERNMENTAL PERSONNEL ACT.—To the 
extent needed to carry out the authorities 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 employees of the United States 
or members of the uniformed service on a detail from an ele-
ment of the Federal Government, on a reimbursable or a nonre-
imbursable 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 man-
agers for 3-year terms (and may reappoint such program man-
agers for 1 additional consecutive 3-year term) for the programs 
carried out by ARPA–H. 
‘‘(2) DUTIES.—A program manager shall— 
‘‘(A) establish, in consultation with the Director, 
research and development goals for programs, 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 activities consistent with the goals and 
functions described in subsection (b); 
‘‘(C) issue funding opportunity announcements, 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 consideration— 
‘‘(i) the scientific, technical merit, and novelty of 
the proposed project;
H. R. 2617—1319 
‘‘(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 applications may have the potential to 
address areas of currently unmet need within biomedi-
cine and improve health outcomes; 
‘‘(iv) the degree to which the proposed project has 
the potential to transform biomedicine and addresses 
a scientific or technical question pursuant to subsection 
(b); 
‘‘(v) the potential for the project to take an inter-
disciplinary approach; and 
‘‘(vi) such other criteria as established by the 
Director; 
‘‘(E) provide project oversight and management of stra-
tegic initiatives to advance the program, including by con-
ducting project reviews not later than 18 months after 
the date of funding 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 Director with 
respect to advancing the goals and functions specified in 
subsection (b); 
‘‘(G) encourage research collaborations and cultivate 
opportunities for the application or utilization of successful 
projects, including through identifying and supporting 
applicable public-private partnerships or partnerships 
between or among award recipients; 
‘‘(H) provide recommendations to the Director to estab-
lish, 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, including from both the public 
and private sectors and, as necessary, through the con-
vening of workshops and meetings, to identify research 
and development gaps and opportunities and solicit stake-
holder 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 submitted for each fiscal year, 
the Director shall submit a report on the actions under-
taken, 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 developed by the Director pursu-
ant to subsection (c)(4)(A); 
‘‘(ii) a description of projects terminated in the 
previous fiscal year, and the reason for such termi-
nation; 
‘‘(iii) a description of planned programs starting 
in the next fiscal year, pending the availability of 
funding;
H. R. 2617—1320 
‘‘(iv) activities conducted in coordination 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 sub-
section (b); 
‘‘(vi) aggregated demographic information, if avail-
able, of direct recipients and performers in funded 
projects and of the ARPA–H workforce (consistent with 
the reporting requirements under paragraph (3)); and 
‘‘(vii) a summary of award recipient compliance 
with section 2321 of the PREVENT Pandemics Act. 
‘‘(B) SUBMISSION
TO
CONGRESS.—The report under 
subparagraph (A) shall be submitted to— 
‘‘(i) the Committee on Energy and Commerce and 
the Committee on Appropriations of the House of Rep-
resentatives; and 
‘‘(ii) the Committee on Health, Education, Labor, 
and Pensions and the Committee 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 Acad-
emies under which the National Academies conducts an 
evaluation of whether ARPA–H is meeting the goals and 
functions specified in subsection (b). 
‘‘(B) SUBMISSION OF RESULTS.—The agreement 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 Com-
mittee on Energy and Commerce of the House of Represent-
atives, and make the report publicly available. 
‘‘(3) REPORTING RELATED TO ARPA–H PERSONNEL.— 
‘‘(A) IN
GENERAL.—The Director shall establish and 
maintain records regarding the use of the authority under 
subsection (i)(1)(A), including— 
‘‘(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 year in which such authority 
is used, the Director shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House
H. R. 2617—1321 
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 Committee on Energy and Commerce of the House 
of Representatives a report on the use of the authority 
provided under subsection (i)(1)(A). Such report 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); 
‘‘(ii) the occupational series, grades, and types of 
appointments of such positions; 
‘‘(iii) how such positions related to advancing the 
goals and functions of ARPA–H; 
‘‘(iv) how the Director made appointment decisions 
under subsection (i); 
‘‘(v) a summary of sources used to identify can-
didates for filling such positions, as applicable; 
‘‘(vi) the number of individuals appointed; 
‘‘(vii) aggregated demographic information related 
to individuals appointed; and 
‘‘(viii) any challenges, limitations, or gaps related 
to the use of the authority under subsection (i) and 
any related recommendations to address such chal-
lenges, 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 on Appropriations of the 
Senate and the Committee on Energy and Commerce and the Com-
mittee 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 section 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 bio-
medical research and development portfolio of the Department of 
Health and Human Services, including ARPA–H, the National 
Institutes of Health, the Food and Drug Administration, and the 
Biomedical Advanced Research and Development Authority— 
‘‘(1) to assess the degree of any potential duplication of 
existing Federal programs and projects; and 
‘‘(2) to make any recommendations regarding any potential 
reorganization, consolidation, or termination of such programs 
and projects.
H. R. 2617—1322 
‘‘(n) PRIORITIZATION.— 
‘‘(1) IN GENERAL.—The Director shall— 
‘‘(A) prioritize awarding grants, cooperative agree-
ments, contracts, prizes, and other transaction awards to 
entities that will conduct funded work in the United States; 
‘‘(B) as appropriate and practicable, encourage non-
domestic recipients of any grants, cooperative agreements, 
contracts, prizes, and other transactions under this section 
to collaborate with a domestic entity; 
‘‘(C) not make awards under this section to non-
domestic 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 Acquisi-
tion 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 sec-
tion, the Director may waive the requirements of subparagraphs 
(A), (B), and (D) of 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 organiza-
tions, including academia and industry, with expertise in spe-
cific 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 appropriate. 
‘‘(p) ADVISORY COMMITTEE.— 
‘‘(1) IN GENERAL.—There is established an ARPA–H Inter-
agency Advisory Committee (referred to in this subsection as 
the ‘Advisory Committee’) to coordinate efforts and provide 
advice and assistance on specific program or project tasks and 
the overall direction of ARPA–H. 
‘‘(2) MEMBERS.—The Advisory Committee established 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 Prepared-
ness 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 Department of Energy. 
‘‘(H) The National Science Foundation.
H. R. 2617—1323 
‘‘(I) Any other agency or office with subject matter 
expertise that the Director of ARPA–H determines appro-
priate 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. 
‘‘(4) ADVISORY
NATURE.—The functions of the Advisory 
Committee shall be advisory in nature, and nothing in this 
subsection shall be construed as granting such Committee 
authority over the activities authorized under this section. 
‘‘(5) PERFORMANCE MEASURES FRAMEWORK.— 
‘‘(A) IN GENERAL.—The Director, in consultation with 
the Advisory Committee, shall develop a performance meas-
ures framework for programs or projects supported by 
ARPA–H in order to inform and facilitate the evaluation 
required under subsection (k)(2), including identification 
of any data needed to perform such evaluation, 
‘‘(B) AVAILABILITY OF PERFORMANCE MEASURES.—The 
Director shall provide to the National Academies such 
performance measures and data necessary to perform the 
evaluation required under subsection (k)(2). 
‘‘(q) RULE OF CONSTRUCTION.—The authorities under this sec-
tion, with respect to the Director, are additional authorities that 
do not supersede or modify any existing authorities. 
‘‘(r) TRANSFORMATIVE HEALTH TECHNOLOGY DEFINED.—In this 
section, the term ‘transformative health technology’ means a novel, 
broadly applicable capability or technology— 
‘‘(1) that has potential to revolutionize the detection, diag-
nosis, mitigation, prevention, cure, or treatment of a disease 
or health condition that can cause severe health outcomes 
and which is an area of currently unmet need; and 
‘‘(2) for which— 
‘‘(A) significant scientific or technical challenges 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 sec-
tion, 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 appropriation from the other 
accounts of the National Institutes of Health.’’. 
(b) GAO REPORT ON CERTAIN RESEARCH REQUIREMENTS.—The 
Comptroller General of the United States shall conduct a review 
to assess the extent to which relevant research conducted or sup-
ported by the National Institutes of Health meets Federal animal 
research requirements pursuant of the Public Health Service Policy 
on Humane Care and Use of Laboratory Animals. Such review 
shall also consider 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 reasonably anticipated 
to be reproducible and replicable and achieve similar results, as
H. R. 2617—1324 
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 Com-
mittee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives. 
Subtitle D—Modernizing and Strength-
ening 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)— 
(A) by redesignating clauses (iv) and (v) as clauses 
(v) and (vi), respectively; 
(B) by inserting after clause (iii), the following: 
‘‘(iv) activities to support, maintain, and improve 
domestic manufacturing surge capacity and capabili-
ties, as appropriate, including through the utilization 
of advanced manufacturing and platform technologies, 
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 ‘‘improvement,’’; 
(2) in subsection (b)— 
(A) in the first sentence of paragraph (1), by inserting 
‘‘support for domestic manufacturing surge capacity and 
capabilities,’’ after ‘‘initiatives for innovation,’’; and 
(B) in paragraph (2)— 
(i) in subparagraph (B), by striking ‘‘and’’ at the 
end; 
(ii) by redesignating subparagraph (C) as subpara-
graph (D); and 
(iii) by inserting after subparagraph (B), the fol-
lowing: 
‘‘(C) activities to support, maintain, and improve 
domestic manufacturing surge capacity and capabilities, 
as appropriate, including through the utilization of 
advanced manufacturing and platform technologies, to 
increase the availability of products that are or may become 
qualified countermeasures or qualified pandemic or epi-
demic products; and’’; 
(3) in subsection (c)— 
(A) in paragraph (2)(B), by inserting before the semi-
colon ‘‘, including through the establishment and mainte-
nance of domestic manufacturing surge capacity and 
capabilities, consistent with subsection (a)(6)(B)(iv)’’; 
(B) in paragraph (4)— 
(i) in subparagraph (A)— 
(I) in clause (i)—
H. R. 2617—1325 
(aa) in subclause (I), by striking ‘‘and’’ 
at the end; and 
(bb) by adding at the end the following: 
‘‘(III) facilitating such communication, as 
appropriate, 
regarding 
manufacturing 
surge 
capacity and capabilities with respect to qualified 
countermeasures and qualified pandemic or epi-
demic products to prepare for, or respond to, a 
public health emergency or potential public health 
emergency; and 
‘‘(IV) facilitating such communication, as 
appropriate and in a manner that does not com-
promise national security, with respect to potential 
eligibility for the material threat medical counter-
measure priority review voucher program under 
section 565A of the Federal Food, Drug, and Cos-
metic 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: 
‘‘(iii) communicate regularly with entities in receipt 
of an award pursuant to subparagraph (B)(v), and 
facilitate communication between such entities and 
other entities in receipt of an award pursuant to 
subparagraph (B)(iv), as appropriate, for purposes of 
planning and response regarding the availability of 
countermeasures and the maintenance of domestic 
manufacturing 
surge 
capacity 
and 
capabilities, 
including any planned uses of such capacity and 
capabilities in the near- and mid-term, and identifica-
tion 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 following: 
‘‘(v) award contracts, grants, and cooperative 
agreements and enter into other transactions to sup-
port, maintain, and improve domestic manufacturing 
surge capacity and capabilities, including through sup-
porting flexible or advanced manufacturing, to ensure 
that additional capacity is available to rapidly manu-
facture products that are or may become qualified 
countermeasures or qualified pandemic or epidemic 
products in the event of a public health emergency 
declaration or significant potential 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 following:
H. R. 2617—1326 
‘‘(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 
performing manufacturing, pursuant to an award 
under subparagraph (B)(v), are in compliance with 
applicable requirements under such Act and this Act, 
as appropriate, including current good manufacturing 
practice pursuant to section 501(a)(2)(B) of the Food, 
Drug, and Cosmetic Act; and’’; 
(iv) in subparagraph (D)(i), by inserting ‘‘, 
including to improve manufacturing capacities and 
capabilities for medical countermeasures’’ before the 
semicolon; 
(v) in subparagraph (E)(ix), by striking ‘‘2023’’ and 
inserting ‘‘2028’’; and 
(vi) by adding at the end the following: 
‘‘(G) ANNUAL REPORTS BY AWARD RECIPIENTS.—As a 
condition of receiving an award under subparagraph (B)(v), 
a recipient shall develop and submit to the Secretary 
annual reports related to the maintenance of such capacity 
and capabilities, including ensuring that such capacity 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 award under subparagraph 
(B)(v), the Secretary may make payments for activities 
necessary to maintain domestic manufacturing surge 
capacity and capabilities supported under such award to 
ensure that such capacity and capabilities are able to sup-
port the rapid manufacture of countermeasures as required 
by the Secretary to prepare for, or respond to, an existing 
or potential public health emergency or otherwise address 
threats that pose a significant level of risk to national 
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 enact-
ment of the PREVENT Pandemics Act’’; 
(B) in paragraph (2)— 
(i) in the matter preceding subparagraph (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 activities pursuant to sub-
section (c)(5)(H), specific actions to regularly assess the
H. R. 2617—1327 
ability of recipients of an award under subsection 
(c)(4)(B)(v) to rapidly manufacture countermeasures as 
required by the Secretary, and recommendations to address 
challenges, if any, related to such activities.’’. 
SEC. 2402. SUPPLY CHAIN CONSIDERATIONS FOR THE STRATEGIC 
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 and capability to meet the 
goals of such additions or modifications (without 
disclosing proprietary information), including— 
‘‘(aa) consideration of the effect such addi-
tions or modifications may have on the avail-
ability 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 manufacturing capacity for such 
products, and any related vulnerabilities;’’. 
SEC. 2403. STRATEGIC NATIONAL STOCKPILE EQUIPMENT MAINTE-
NANCE. 
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 ‘‘, regularly reviewed, 
and updated’’ after ‘‘followed’’; and 
(2) by amending subparagraph (D) to read as follows: 
‘‘(D) review and revise, as appropriate, the contents 
of the stockpile on a regular basis to ensure that— 
‘‘(i) emerging threats, advanced technologies, and 
new countermeasures are adequately considered; 
‘‘(ii) the potential depletion of countermeasures 
currently in the stockpile is identified and appro-
priately 
addressed, 
including 
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 PREDICTABILITY OF 
PROCESSES OF THE STRATEGIC NATIONAL STOCKPILE. 
(a) GUIDANCE.—Not later than 60 days after the date of enact-
ment of this Act, the Secretary of Health and Human Services 
(referred to in this section as the ‘‘Secretary’’) shall issue guidance 
describing the processes by which the Secretary deploys the contents 
of the Strategic 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, terri-
tories, Indian Tribes and Tribal organizations (as such terms are 
defined under section 4 of the Indian Self-Determination and Edu-
cation Assistance Act), and other applicable entities. Such guidance
H. R. 2617—1328 
shall include information related to processes by which to request 
access to the contents of the Strategic National Stockpile, factors 
considered by the Secretary when making deployment or distribu-
tion 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, relevant industries, other Federal 
agencies, and other appropriate stakeholders, in a manner 
that does not compromise national security, to coordinate 
and share information related to maintenance and use 
of the stockpile, including a description of future counter-
measure needs and additions, modifications, and replenish-
ments of the contents of the stockpile, and considerations 
related to the manufacturing and procurement of products 
consistent with the requirements of the with the require-
ments of chapter 83 of title 41, United States Code (com-
monly referred to as the ‘Buy American Act’), as appro-
priate.’’. 
SEC. 2405. IMPROVING SUPPLY CHAIN FLEXIBILITY FOR THE STRA-
TEGIC 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 required 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 para-
graphs (6) and (7), respectively; 
(C) by inserting after paragraph (4) the following: 
‘‘(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 proce-
dures under paragraph (3), the Secretary may enter into 
contracts or cooperative agreements with vendors, which 
may include manufacturers or distributors of medical prod-
ucts, with respect to medical products intended to be deliv-
ered to the ownership of the Federal Government. Each 
such contract or cooperative agreement shall be subject 
to such terms and conditions as the Secretary may specify, 
including terms and conditions with respect to— 
‘‘(i) 
procurement, 
maintenance, 
storage, 
and 
delivery of products, in alignment with inventory 
management and other applicable best practices, under 
such contract or cooperative agreement, which may
H. R. 2617—1329 
consider, as appropriate, costs of transporting and han-
dling such products; or 
‘‘(ii) maintenance of domestic manufacturing 
capacity and capabilities of such products to ensure 
additional reserved production capacity and capabili-
ties are available, and that such capacity and capabili-
ties are able to support the rapid manufacture, pur-
chase, 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 Secretary shall submit to the Com-
mittee 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 a report 
on any contracts or cooperative agreements entered into 
under subparagraph (A) for purposes of establishing and 
maintaining vendor-managed inventory or reserve manu-
facturing 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; 
‘‘(iii) the product or products covered through each 
award; and 
‘‘(iv) how the Secretary works with each recipient 
to ensure situational awareness related to the manu-
facturing capacity for, or inventory of, such products 
and coordinates the distribution and deployment of 
such products, as appropriate and applicable.’’; and 
(D) in subparagraph (A) of paragraph (6), as so redesig-
nated— 
(i) in clause (viii), by striking ‘‘; and’’ and inserting 
a semicolon; 
(ii) in clause (ix), by striking the period and 
inserting ‘‘; and’’; and 
(iii) by adding at the end the following: 
‘‘(x) with respect to reports issued in 2027 or any 
subsequent year, an assessment of selected contracts 
or cooperative agreements 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’’. 
(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 redesignated by section 
405(a)(1)(B), is amended to read as follows: 
‘‘(7) REIMBURSEMENT FOR CERTAIN SUPPLIES.—