What This Bill Does
This bill requires the Secretary of Health and Human Services and other federal officials to create a searchable database that shows all federal government support for biomedical research and development. The database will be available to the public on the Department of Health and Human Services website so Americans can see how taxpayer money supports medical research.
Who It Affects
Federal agencies including the Department of Health and Human Services, National Institutes of Health, Department of Defense and Department of Veterans Affairs. Companies, nonprofit organizations and academic institutions that receive federal funding for medical research and development. The general public who will have access to the database.
Key Provisions
• Multiple federal agencies must work together to compile information about all federal contracts, funding agreements, licensing arrangements and tax benefits related to biomedical research into one searchable database (Sec. 2(a))
• The database must include information such as the amount of federal financial support provided, the grant number, associated patents, product names and prices, and the full terms of all agreements related to the research (Sec. 2(c))
• The database must be searchable and filterable by the information categories listed, presented in a user-friendly format, made public within one month of the bill becoming law and updated every two weeks (Sec. 2(d) and 2(e))
• Companies and organizations receiving federal support must disclose all required information to federal officials, or face civil penalties of up to $10,000 per day for failure to disclose within two weeks of being asked (Sec. 2(f))
What Changes
If this bill becomes law, taxpayers will have public access to detailed information about federal spending on biomedical research that was previously not compiled in one searchable location. Companies and organizations receiving federal research funding will be required to share information about their projects, products and agreements with the government.
Important Definitions
"Biomedical research and development" means research and development related to drugs, biological products (living or derived from living sources), cell or gene therapy, or medical devices intended to diagnose, mitigate, prevent, treat or cure any disease or condition (Sec. 2(b)).
Effective Date
The database must be made publicly available not later than one month after the date this Act becomes law (Sec. 2(e)(1)).
II
118TH CONGRESS
1ST SESSION
S. 315
To direct the Secretary of Health and Human Services and other Federal
officials to compile into a searchable database information relating to
Federal support for biomedical research and development, and for other
purposes.
IN THE SENATE OF THE UNITED STATES
FEBRUARY 9, 2023
Mr. MERKLEY (for himself, Mr. BRAUN, Mr. SANDERS, and Ms. WARREN) in-
troduced the following bill; which was read twice and referred to the Com-
mittee on Health, Education, Labor, and Pensions
A BILL
To direct the Secretary of Health and Human Services and
other Federal officials to compile into a searchable data-
base information relating to Federal support for bio-
medical research and development, and for other pur-
poses.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Taxpayer Research
4
And Contributions Knowledge Act of 2023’’ or the
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‘‘TRACK Act of 2023’’.
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•S 315 IS
SEC. 2. DATABASE.
1
(a) IN GENERAL.—The Secretary of Health and
2
Human Services, the Director of the National Institutes
3
of Health, the Assistant Secretary for Preparedness and
4
Response of the Department of Health and Human Serv-
5
ices, the Director of the Biomedical Advanced Research
6
and Development Authority, the Secretary of Defense, the
7
Secretary of Veterans Affairs, the Director of the National
8
Institute of Allergy and Infectious Diseases, and such
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other Federal officials as the Secretary of Health and
10
Human Services determines to be relevant, acting in co-
11
ordination, shall—
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(1) compile into a searchable database informa-
13
tion relating to Federal support (before or after the
14
date of enactment of this Act) for biomedical re-
15
search and development; and
16
(2) make such database available on the public
17
website of the Department of Health and Human
18
Services.
19
(b) COVERED INFORMATION.—The information relat-
20
ing to Federal support described in subsection (a)(1) in-
21
cludes all contracts, funding agreements, licensing ar-
22
rangements, other transactions, and other arrangements
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entered into by, or on behalf of, the Federal Government
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and tax benefits provided with respect to research and de-
25
velopment, and manufacturing, of a drug (including a bio-
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•S 315 IS
logical product), cell or gene therapy, or medical device
1
intended to be manufactured, used, designed, developed,
2
modified, repurposed, licensed, or procured to diagnose,
3
mitigate, prevent, treat, or cure any disease or condition,
4
including the following:
5
(1) Licensing agreements pursuant to section
6
207 or 209 of title 35, United States Code.
7
(2) Cooperative research and development
8
agreements and licensing agreements pursuant to
9
section 12 of the Stevenson-Wydler Technology In-
10
novation Act of 1980 (15 U.S.C. 3710a).
11
(3) Funding agreements, as defined in section
12
201 of title 35, United States Code.
13
(4) Transactions, contracts, grants, cooperative
14
agreements, other agreements, and other arrange-
15
ments entered into pursuant to the following stat-
16
utes:
17
(A) The Public Health Service Act (42
18
U.S.C. 201 et seq.), including sections 301,
19
319L, 421, and 480 of such Act (42 U.S.C.
20
241, 247d–7e, 285b–3, 287a).
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(B) Section 105 of the National Institutes
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of Health Reform Act of 2006 (42 U.S.C.
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284n).
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•S 315 IS
(C) Chapter 301 of title 10, United States
1
Code, including sections 4001, 4021, 4022,
2
4026, and 4023.
3
(5) Grants, contracts, and other transactions
4
pursuant to section 4021, 4022, or 4026 of title 10,
5
United States Code.
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(6) Procurement contracts and other agree-
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ments pursuant to section 4023 of title 10, United
8
States Code.
9
(c) INFORMATION REQUIRED.—Notwithstanding any
10
other provision of law, the Federal officials described in
11
subsection (a) shall include in the database under sub-
12
section (a), with regard to each contract, funding agree-
13
ment, licensing agreement, other transaction, other ar-
14
rangement, or tax benefit described in subsection (b), at
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least the following information:
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(1) The agency, program, institute, or other
17
Federal Government entity providing the Federal
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grant, cooperative agreement, or other support.
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(2) The amount and period of Federal financial
20
support with an itemized breakdown.
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(3) Other Federal nonfinancial support, includ-
22
ing the use of Federal personnel, Federal facilities,
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and Federal equipment.
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(4) The grant number, if applicable.
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•S 315 IS
(5) Associated clinical trial data, upon trial
1
completion.
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(6) Associated patents and patent applications,
3
specifying—
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(A) any Federal ownership in such patents
5
and patent applications;
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(B) the expiration date of such patents
7
and filing dates of such patent applications; and
8
(C) the numbers of such patents and pat-
9
ent applications.
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(7) Associated periods of marketing exclusivity
11
under Federal law and the durations of such peri-
12
ods.
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(8) The corporation, nonprofit organization,
14
academic institution, person, or other entity receiv-
15
ing the Federal support.
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(9) Any products (including repurposed prod-
17
ucts) approved, authorized, or cleared for marketing,
18
or for which marketing approval, authorization, or
19
clearance is being sought, the development of which
20
was aided by Federal support, including—
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(A) the names of such products;
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(B) the prices of such products; and
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(C) the current and anticipated manufac-
24
turing capacity to produce such products.
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•S 315 IS
(10) The full terms of the contract, funding
1
agreement, licensing agreement, other transaction,
2
or other arrangement described in subsection (b).
3
(d) FORMAT OF INFORMATION.—The database under
4
subsection (a) shall be—
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(1) searchable and filterable according to the
6
categories of information described in subsection (c);
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and
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(2) presented in a user-friendly format.
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(e) TIMING.—The database under subsection (a)
10
shall be—
11
(1) made publicly available not later than 1
12
month after the date of enactment of this Act; and
13
(2) updated not less than every 2 weeks.
14
(f) DISCLOSURE.—
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(1) IN GENERAL.—Notwithstanding any other
16
provision of law, to the extent necessary for an offi-
17
cial described in subsection (a) to carry out this sec-
18
tion, such official may require entities receiving Fed-
19
eral support described in subsection (a)(1) to dis-
20
close to the official any information relating to such
21
Federal support and required to be included in the
22
database under subsection (a).
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(2) INTERMEDIARY
COOPERATION.—Any ar-
24
rangement entered into by the Federal Government
25
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•S 315 IS
with an entity providing for such entity to enter into
1
contracts, licensing agreements, grants, other trans-
2
actions, or other arrangements with third parties on
3
behalf of the Federal Government shall require such
4
entity to disclose in a timely manner any informa-
5
tion necessary for the Federal Government to fulfill
6
its duties under this Act. With respect to any such
7
arrangement in place as of the date of enactment of
8
this Act, an official described in subsection (a) may
9
require the entity to disclose to the official any infor-
10
mation required to be included in the database
11
under subsection (a).
12
(3) PENALTY FOR NONDISCLOSURE.—If an en-
13
tity that is required to disclose information pursuant
14
to paragraph (1) or (2) fails to disclose such infor-
15
mation by the date that is 2 weeks after the date on
16
which the official requests such information, or by
17
such reasonable deadline as the official may specify,
18
whichever is sooner, then such entity shall be liable
19
to the United States for a civil penalty in an amount
20
not to exceed $10,000 for each day on which such
21
failure continues.
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Æ
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