What This Bill Does
This bill directs federal health officials to create a searchable online database showing how the government has funded biomedical (medical and biological science) research and development. The database will be available to the public on the Department of Health and Human Services website and will include information about contracts, grants, licensing deals and tax benefits related to drug, therapy and medical device development. (Sec. 2(a))
Who It Affects
* Federal officials at the Department of Health and Human Services
* The National Institutes of Health
* The Department of Defense
* The Department of Veterans Affairs
* Companies, nonprofits and academic institutions that receive federal support for biomedical research
* American taxpayers and members of the public who access the database
Key Provisions
* Federal officials must compile a searchable database showing all federal contracts, funding agreements, licensing arrangements and tax benefits related to biomedical research and make it available on the Department of Health and Human Services public website. (Sec. 2(a))
* The database must include the amount of federal funding, the entity receiving the support, any products developed with federal help and their prices, associated patents, and the full terms of agreements. (Sec. 2(c))
* The database must be searchable by different categories and presented in a user-friendly format. (Sec. 2(d))
* The database must be made publicly available within one month of the law taking effect and updated at least every two weeks. (Sec. 2(e))
* Entities receiving federal support must disclose information needed for the database or face penalties up to $10,000 per day for failing to provide information within two weeks of a request. (Sec. 2(f))
What Changes
If this becomes law, the federal government will create and maintain a public database that shows taxpayers where their money goes in biomedical research. Currently, this information exists across many different federal agencies without a single searchable location. This database will allow anyone to search for details about specific drugs, devices, companies or research projects that received federal funding.
Important Definitions
* Biomedical research and development: Research and development involving drugs (including biological products), cell or gene therapies, or medical devices designed to diagnose, treat, prevent, cure or reduce the effects of diseases or conditions. (Sec. 2(b))
* Biological product: Not explicitly defined in the bill text.
* Tax benefits: Not explicitly defined in the bill text.
Effective Date
The database must be made publicly available no later than one month after the law takes effect. (Sec. 2(e))
I
118TH CONGRESS
1ST SESSION
H. R. 885
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 HOUSE OF REPRESENTATIVES
FEBRUARY 9, 2023
Mr. DOGGETT (for himself, Ms. BARRAGA´N, Mr. BEYER, Mr. BISHOP of Geor-
gia, Mr. BLUMENAUER, Mr. BOWMAN, Ms. CHU, Mr. CICILLINE, Mr.
CLEAVER, Mr. COHEN, Mr. COURTNEY, Ms. DEGETTE, Ms. DELAURO,
Mr. DESAULNIER, Mrs. DINGELL, Mr. ESPAILLAT, Mr. EVANS, Mr.
GREEN of Texas, Mr. GRIJALVA, Mrs. HAYES, Ms. JAYAPAL, Ms. KAP-
TUR, Mr. KHANNA, Ms. LEE of California, Ms. MENG, Mr. NADLER, Mrs.
NAPOLITANO, Mr. NEGUSE, Ms. NORTON, Ms. PINGREE, Mr. POCAN, Ms.
PORTER, Mr. RASKIN, Ms. SCANLON, Ms. SCHAKOWSKY, Mr. TAKANO,
Mr. THOMPSON of California, Ms. TITUS, Ms. TLAIB, Mr. TONKO, Mr.
TRONE, Mr. VARGAS, Ms. VELA´ZQUEZ, Ms. WILD, Ms. WILLIAMS of
Georgia, Mr. KILDEE, and Ms. LEGER FERNANDEZ) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committees on Armed Services, Veterans’
Affairs, the Judiciary, Ways and Means, and Science, Space, and Tech-
nology, for a period to be subsequently determined by the Speaker, in
each case for consideration of such provisions as fall within the jurisdic-
tion of the committee concerned
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.
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•HR 885 IH
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
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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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SEC. 2. DATABASE.
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(a) IN GENERAL.—The Secretary of Health and
8
Human Services, the Director of the National Institutes
9
of Health, the Assistant Secretary for Preparedness and
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Response of the Department of Health and Human Serv-
11
ices, the Director of the Biomedical Advanced Research
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and Development Authority, the Secretary of Defense, the
13
Secretary of Veterans Affairs, the Director of the National
14
Institute of Allergy and Infectious Diseases, and such
15
other Federal officials as the Secretary of Health and
16
Human Services determines to be relevant, acting in co-
17
ordination, shall—
18
(1) compile into a searchable database informa-
19
tion relating to Federal support (before or after the
20
date of enactment of this Act) for biomedical re-
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search and development; and
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(2) make such database available on the public
23
website of the Department of Health and Human
24
Services.
25
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•HR 885 IH
(b) COVERED INFORMATION.—The information relat-
1
ing to Federal support described in subsection (a)(1) in-
2
cludes all contracts, funding agreements, licensing ar-
3
rangements, other transactions, and other arrangements
4
entered into by, or on behalf of, the Federal Government
5
and tax benefits provided with respect to research and de-
6
velopment, and manufacturing, of a drug (including a bio-
7
logical product), cell or gene therapy, or medical device
8
intended to be manufactured, used, designed, developed,
9
modified, repurposed, licensed, or procured to diagnose,
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mitigate, prevent, treat, or cure any disease or condition,
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including the following:
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(1) Licensing agreements pursuant to section
13
207 or 209 of title 35, United States Code.
14
(2) Cooperative research and development
15
agreements and licensing agreements pursuant to
16
section 12 of the Stevenson-Wydler Technology In-
17
novation Act of 1980 (15 U.S.C. 3710a).
18
(3) Funding agreements, as defined in section
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201 of title 35, United States Code.
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(4) Transactions, contracts, grants, cooperative
21
agreements, other agreements, and other arrange-
22
ments entered into pursuant to the following stat-
23
utes:
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•HR 885 IH
(A) The Public Health Service Act (42
1
U.S.C. 201 et seq.), including sections 301,
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319L, 421, and 480 of such Act (42 U.S.C.
3
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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(C) Chapter 301 of title 10, United States
8
Code, including sections 4001, 4021, 4022,
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4026, and 4023.
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(5) Grants, contracts, and other transactions
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pursuant to section 4021, 4022, or 4026 of title 10,
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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
15
States Code.
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(c) INFORMATION REQUIRED.—Notwithstanding any
17
other provision of law, the Federal officials described in
18
subsection (a) shall include in the database under sub-
19
section (a), with regard to each contract, funding agree-
20
ment, licensing agreement, other transaction, other ar-
21
rangement, or tax benefit described in subsection (b), at
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least the following information:
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•HR 885 IH
(1) The agency, program, institute, or other
1
Federal Government entity providing the Federal
2
grant, cooperative agreement, or other support.
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(2) The amount and period of Federal financial
4
support with an itemized breakdown.
5
(3) Other Federal nonfinancial support, includ-
6
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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(5) Associated clinical trial data, upon trial
10
completion.
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(6) Associated patents and patent applications,
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specifying—
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(A) any Federal ownership in such patents
14
and patent applications;
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(B) the expiration date of such patents
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and filing dates of such patent applications; and
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(C) the numbers of such patents and pat-
18
ent applications.
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(7) Associated periods of marketing exclusivity
20
under Federal law and the durations of such peri-
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ods.
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(8) The corporation, nonprofit organization,
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academic institution, person, or other entity receiv-
24
ing the Federal support.
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•HR 885 IH
(9) Any products (including repurposed prod-
1
ucts) approved, authorized, or cleared for marketing,
2
or for which marketing approval, authorization, or
3
clearance is being sought, the development of which
4
was aided by Federal support, including—
5
(A) the names of such products;
6
(B) the prices of such products; and
7
(C) the current and anticipated manufac-
8
turing capacity to produce such products.
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(10) The full terms of the contract, funding
10
agreement, licensing agreement, other transaction,
11
or other arrangement described in subsection (b).
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(d) FORMAT OF INFORMATION.—The database under
13
subsection (a) shall be—
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(1) searchable and filterable according to the
15
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)
19
shall be—
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(1) made publicly available not later than 1
21
month after the date of enactment of this Act; and
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(2) updated not less than every 2 weeks.
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(f) DISCLOSURE.—
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•HR 885 IH
(1) IN GENERAL.—Notwithstanding any other
1
provision of law, to the extent necessary for an offi-
2
cial described in subsection (a) to carry out this sec-
3
tion, such official may require entities receiving Fed-
4
eral support described in subsection (a)(1) to dis-
5
close to the official any information relating to such
6
Federal support and required to be included in the
7
database under subsection (a).
8
(2) INTERMEDIARY
COOPERATION.—Any ar-
9
rangement entered into by the Federal Government
10
with an entity providing for such entity to enter into
11
contracts, licensing agreements, grants, other trans-
12
actions, or other arrangements with third parties on
13
behalf of the Federal Government shall require such
14
entity to disclose in a timely manner any informa-
15
tion necessary for the Federal Government to fulfill
16
its duties under this Act. With respect to any such
17
arrangement in place as of the date of enactment of
18
this Act, an official described in subsection (a) may
19
require the entity to disclose to the official any infor-
20
mation required to be included in the database
21
under subsection (a).
22
(3) PENALTY FOR NONDISCLOSURE.—If an en-
23
tity that is required to disclose information pursuant
24
to paragraph (1) or (2) fails to disclose such infor-
25
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•HR 885 IH
mation by the date that is 2 weeks after the date on
1
which the official requests such information, or by
2
such reasonable deadline as the official may specify,
3
whichever is sooner, then such entity shall be liable
4
to the United States for a civil penalty in an amount
5
not to exceed $10,000 for each day on which such
6
failure continues.
7
Æ
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