‘‘(1) Plans for commercialization of technologies 
developed under the award, including business plans, 
technology-to market plans, market studies, and cost 
and performance models. 
‘‘(2) Investments provided to an awardee from 
third parties (such as venture capital firms, hedge 
funds, and private equity firms), including amounts 
and the percentage of ownership of the awardee pro-
vided in return for the investments. 
‘‘(3) Additional financial support that the 
awardee— 
‘‘(A) plans to invest or has invested in the 
technology developed under the award; or 
‘‘(B) is seeking from third parties. 
‘‘(4) Revenue from the licensing or sale of new 
products or services resulting from research conducted 
under the award. 
‘‘(f) SHARING INFORMATION WITH THE CENTERS FOR 
MEDICARE & MEDICAID SERVICES.—The Director shall 
timely share relevant information with the Administrator 
of the Centers for Medicare & Medicaid Services that may 
help to expedite determinations of coverage of trans-
formative health technologies developed by ARPA–H. 
VerDate Sep 11 2014 
01:08 Jun 14, 2022
Jkt 029200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6203
E:\BILLS\H5585.RH
H5585
kjohnson on DSK79L0C42PROD with BILLS
‘‘(g) EXPEDITING BREAKTHROUGHS THROUGH CO-
OPERATION WITH
THE FOOD
AND DRUG ADMINISTRA-
TION.— 
‘‘(1) 
IN
GENERAL.—The 
Secretary, 
acting 
through the Commissioner of Food and Drugs and in 
consultation with the Director, may take actions to 
facilitate translation of transformative health tech-
nology into tangible solutions for patients and to ex-
pedite development of drugs, devices, and biological 
products, including through— 
‘‘(A) helping to ensure that drug, device, or 
biological product development programs, in as 
efficient a manner as possible, gather the non-
clinical and clinical data necessary to advancing 
the development of such products and to obtain-
ing their approval, licensure, or clearance, as 
applicable, by the Food and Drug Administra-
tion under sections 505, 510(k), and 515 of the 
Federal Food, Drug, and Cosmetic Act and sec-
tion 351 of this Act; 
‘‘(B) expediting review of investigational 
new drug applications under section 505(i) of 
the Federal Food, Drug, and Cosmetic Act, re-
view of investigational device exemptions under 
section 520(g) of such Act, and review of appli-
VerDate Sep 11 2014 
01:08 Jun 14, 2022
Jkt 029200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6203
E:\BILLS\H5585.RH
H5585
kjohnson on DSK79L0C42PROD with BILLS
cations for approval, licensure, and clearance of 
drugs, devices, or biological products under sec-
tions 505, 510(k), and 515 of such Act, and sec-
tion 351 of this Act; and 
‘‘(C) meeting at appropriate intervals with 
the Director and any member of the ARPA–H 
Interagency Research Council to discuss the de-
velopment status of drugs, devices, or biological 
products and projects that are the highest prior-
ities to ARPA–H, unless the Director and the 
Commissioner of Food and Drugs determine that 
any such meetings are not necessary. 
‘‘(2) RELATION TO OTHERWISE AUTHORIZED AC-
TIVITIES OF THE FDA.—The authority specified in 
paragraph (1) shall not be construed as limiting the 
authority of the Secretary, acting through the Com-
missioner of Food and Drugs, with respect to the re-
view and approval, clearance, authorization for emer-
gency use, or licensure of drugs, devices, or biological 
products under the Federal Food, Drug, and Cosmetic 
Act or section 351 of this Act. 
‘‘(3) REIMBURSEMENT.—The Director, using 
funds made available to ARPA–H, may reimburse the 
Food and Drug Administration for expenditures 
made by the Food and Drug Administration for ac-
VerDate Sep 11 2014 
01:08 Jun 14, 2022
Jkt 029200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6203
E:\BILLS\H5585.RH
H5585
kjohnson on DSK79L0C42PROD with BILLS
tivities carried out under this section that have been 
identified by the Commissioner of Food and Drugs 
and the Director as being carried out by the Food and 
Drug Administration. 
‘‘(h) AWARDS.— 
‘‘(1) IN GENERAL.—In carrying out this section, 
the Director may make awards including— 
‘‘(A) grants and cooperative agreements, 
which shall— 
‘‘(i) be subject to the uniform adminis-
trative requirements, cost principles, and 
audit requirements for Federal awards con-
tained in part 200 of title 2, Code of Fed-
eral Regulations (or successor regulations); 
and 
‘‘(ii) include the total line-item and 
itemized indirect facilities and administra-
tive costs that shall be made publicly avail-
able and published in a machine-readable 
format; 
‘‘(B) contracts subject to the Federal Acqui-
sition Regulation; 
‘‘(C) multi-year contracts under section 
3903 of title 41, United States Code; 
‘‘(D) prizes; and 
VerDate Sep 11 2014 
01:08 Jun 14, 2022
Jkt 029200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6203
E:\BILLS\H5585.RH
H5585
kjohnson on DSK79L0C42PROD with BILLS
‘‘(E) other transactions. 
‘‘(2) 
EXEMPTIONS
FOR
CERTAIN
REQUIRE-
MENTS.—Research funded by ARPA–H shall not be 
subject to the requirements of section 406(a)(3)(A)(ii) 
or section 492. 
‘‘(i) FACILITIES AUTHORITY.— 
‘‘(1) IN GENERAL.—The Director may acquire 
(by purchase, lease, condemnation, or otherwise), con-
struct, improve, repair, operate, and maintain such 
real and personal property as may be necessary to 
carry out this section. 
‘‘(2) LEASE OF NONEXCESS PROPERTY.—The Di-
rector may enter into a lease under this section with 
any person or entity (including another department 
or agency of the Federal Government or an entity of 
a State or local government) with regard to any non-
excess real property and related personal property 
under the jurisdiction of the Director. 
‘‘(3) UTILIZATION OF LEASE FUNDS.— 
‘‘(A) IN GENERAL.—The Director may uti-
lize, without further appropriation, amounts of 
cash consideration received for a lease entered 
into under this subsection to cover the full costs 
to ARPA–H in connection with the lease. Funds 
VerDate Sep 11 2014 
01:08 Jun 14, 2022
Jkt 029200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6203
E:\BILLS\H5585.RH
H5585
kjohnson on DSK79L0C42PROD with BILLS
received as such cash consideration shall remain 
available until expended. 
‘‘(B) CAPITAL
REVITALIZATION
AND
IM-
PROVEMENTS.—Of any amounts of cash consid-
eration received under this subsection that are 
not utilized in accordance with subparagraph 
(A), without further appropriation— 
‘‘(i) 35 percent shall— 
‘‘(I) be deposited in a capital 
asset account to be established by the 
Director; 
‘‘(II) be available for mainte-
nance, capital revitalization, and im-
provements of the real property assets 
and related personal property under 
the jurisdiction of the Director; and 
‘‘(III) remain available until ex-
pended; and 
‘‘(ii) the remaining 65 percent shall be 
available to the respective center or facility 
of ARPA–H engaged in the lease of non-
excess real property, and shall remain 
available until expended for maintenance, 
capital revitalization, and improvements of 
the real property assets and related personal 
VerDate Sep 11 2014 
01:08 Jun 14, 2022
Jkt 029200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6203
E:\BILLS\H5585.RH
H5585
kjohnson on DSK79L0C42PROD with BILLS
property at the respective center or facility 
subject to the concurrence of the Director. 
‘‘(C) NO
UTILIZATION
FOR
DAILY
OPER-
ATING COSTS.—Amounts utilized under subpara-
graph (B) may not be utilized for daily oper-
ating costs. 
‘‘(4) LOCATIONS.— 
‘‘(A) IN GENERAL.—ARPA–H, including its 
headquarters, shall not be located on any part of 
the existing National Institutes of Health cam-
puses. 
‘‘(B) 
CONSIDERATIONS.—In 
determining 
the location of facilities, 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 
methods specified in subsection (b). 
‘‘(j) PERSONNEL.— 
‘‘(1) IN GENERAL.—The Director may— 
‘‘(A) make and rescind appointments of sci-
entific, engineering, medical, and professional 
personnel, which may include temporary or 
time-limited appointments as determined by the 
VerDate Sep 11 2014 
01:08 Jun 14, 2022
Jkt 029200
PO 00000
Frm 00016
Fmt 6652
Sfmt 6203
E:\BILLS\H5585.RH
H5585
kjohnson on DSK79L0C42PROD with BILLS
Director to fulfill the mission of ARPA–H, with-
out regard to any provision in title 5, United 
States Code, governing appointments and remov-
als under the civil service laws, and 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 
‘‘(B) contract with private recruiting firms 
for the hiring of qualified staff referenced in sub-
paragraph (A). 
‘‘(2) ADDITIONAL STAFF.—The Director may use, 
to the same extent and in the same manner as the 
Secretary, all authorities in existence on the date of 
the enactment of this section that are provided to the 
Secretary to hire administrative, financial, contracts, 
legislative affairs, information technology, ethics, and 
communications staff, and such other staff as may be 
identified by the Director as necessary to carry out 
this section. 
‘‘(3) ADDITIONAL
CONSIDERATIONS.—In ap-
pointing personnel under this subsection, the Direc-
tor— 
‘‘(A) may contract with private entities; 
VerDate Sep 11 2014 
01:08 Jun 14, 2022
Jkt 029200
PO 00000
Frm 00017
Fmt 6652
Sfmt 6203
E:\BILLS\H5585.RH
H5585
kjohnson on DSK79L0C42PROD with BILLS
‘‘(B) shall make efforts to recruit and retain 
a diverse workforce, including individuals under-
represented in science and medicine and racial 
and ethnic minorities (as long as such efforts 
comply with applicable Federal civil rights law); 
and 
‘‘(C) shall recruit program managers with 
expertise in a wide range of relevant disciplines, 
including life sciences, the physical sciences, en-
gineering, and the computational sciences. 
‘‘(4) ADDITIONAL HIRING AUTHORITY.—To the 
extent needed to carry out the authorities vested by 
paragraph (1), the Director may utilize hiring au-
thorities under sections 3371 through 3376 of title 5, 
United States Code, to staff ARPA–H with employees 
from other Federal agencies, State and local govern-
ments, Indian Tribes and Tribal organizations, insti-
tutions of higher education, and other organizations, 
as described in such sections. 
‘‘(5) EXISTING
AUTHORITIES.—The authorities 
granted by this section are— 
‘‘(A) in addition to existing authorities 
granted to the Secretary; and 
‘‘(B) are not intended to supersede or mod-
ify any existing authorities. 
VerDate Sep 11 2014 
01:08 Jun 14, 2022
Jkt 029200
PO 00000
Frm 00018
Fmt 6652
Sfmt 6203
E:\BILLS\H5585.RH
H5585
kjohnson on DSK79L0C42PROD with BILLS
‘‘(6) 
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 nonreimburs-
able basis, as jointly agreed to by the heads of the re-
ceiving and detailing elements, for a period not to ex-
ceed 3 years. 
‘‘(k) PROGRAM MANAGERS.— 
‘‘(1) IN GENERAL.—The Director shall appoint 
program managers for 3-year terms (and may re-
appoint such program managers for 1 consecutive 3- 
year term) for the programs carried out by ARPA– 
H. 
‘‘(2) DUTIES.—A program manager shall— 
‘‘(A) establish, in consultation with the Di-
rector or Deputy Director, research and develop-
ment goals for programs, including timelines 
and milestones, and make such goals available to 
the public; 
‘‘(B) collaborate with experts from the Na-
tional Institutes of Health and other Federal 
agencies and experts in relevant scientific fields 
to identify research and development gaps and 
opportunities; 
VerDate Sep 11 2014 
01:08 Jun 14, 2022
Jkt 029200
PO 00000
Frm 00019
Fmt 6652
Sfmt 6203
E:\BILLS\H5585.RH
H5585
kjohnson on DSK79L0C42PROD with BILLS
‘‘(C) convene workshops and meetings, as 
needed, with entities such as patients, patient 
advocacy groups, practitioners, professional soci-
eties, and other stakeholders to solicit input on 
programs and goals; 
‘‘(D) manage applications and proposals, 
through the appropriate officials for making 
grants, cooperative agreements, contracts, prizes, 
and other transaction awards for advanced re-
search that may show particular promise, espe-
cially in areas in which the private sector and 
the Federal Government have not undertaken 
sufficient research; 
‘‘(E) issue funding opportunity announce-
ments, using uniform administrative processes, 
as appropriate; 
‘‘(F) 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 and technical merit 
of the proposed project; 
‘‘(ii) the capabilities of the applicants 
to successfully carry out the proposed 
project; 
VerDate Sep 11 2014 
01:08 Jun 14, 2022
Jkt 029200
PO 00000
Frm 00020
Fmt 6652
Sfmt 6203
E:\BILLS\H5585.RH
H5585
kjohnson on DSK79L0C42PROD with BILLS