[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 315 Introduced in Senate (IS)]
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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)
introduced the following bill; which was read twice and referred to the
Committee 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 database information relating to
Federal support for biomedical research and development, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Taxpayer Research And Contributions
Knowledge Act of 2023'' or the ``TRACK Act of 2023''.
SEC. 2. DATABASE.
(a) In General.--The Secretary of Health and Human Services, the
Director of the National Institutes of Health, the Assistant Secretary
for Preparedness and Response of the Department of Health and Human
Services, the Director of the Biomedical Advanced Research and
Development Authority, the Secretary of Defense, the Secretary of
Veterans Affairs, the Director of the National Institute of Allergy and
Infectious Diseases, and such other Federal officials as the Secretary
of Health and Human Services determines to be relevant, acting in
coordination, shall--
(1) compile into a searchable database information relating
to Federal support (before or after the date of enactment of
this Act) for biomedical research and development; and
(2) make such database available on the public website of
the Department of Health and Human Services.
(b) Covered Information.--The information relating to Federal
support described in subsection (a)(1) includes all contracts, funding
agreements, licensing arrangements, other transactions, and other
arrangements entered into by, or on behalf of, the Federal Government
and tax benefits provided with respect to research and development, and
manufacturing, of a drug (including a biological product), cell or gene
therapy, or medical device intended to be manufactured, used, designed,
developed, modified, repurposed, licensed, or procured to diagnose,
mitigate, prevent, treat, or cure any disease or condition, including
the following:
(1) Licensing agreements pursuant to section 207 or 209 of
title 35, United States Code.
(2) Cooperative research and development agreements and
licensing agreements pursuant to section 12 of the Stevenson-
Wydler Technology Innovation Act of 1980 (15 U.S.C. 3710a).
(3) Funding agreements, as defined in section 201 of title
35, United States Code.
(4) Transactions, contracts, grants, cooperative
agreements, other agreements, and other arrangements entered
into pursuant to the following statutes:
(A) The Public Health Service Act (42 U.S.C. 201 et
seq.), including sections 301, 319L, 421, and 480 of
such Act (42 U.S.C. 241, 247d-7e, 285b-3, 287a).
(B) Section 105 of the National Institutes of
Health Reform Act of 2006 (42 U.S.C. 284n).
(C) Chapter 301 of title 10, United States Code,
including sections 4001, 4021, 4022, 4026, and 4023.
(5) Grants, contracts, and other transactions pursuant to
section 4021, 4022, or 4026 of title 10, United States Code.
(6) Procurement contracts and other agreements pursuant to
section 4023 of title 10, United States Code.
(c) Information Required.--Notwithstanding any other provision of
law, the Federal officials described in subsection (a) shall include in
the database under subsection (a), with regard to each contract,
funding agreement, licensing agreement, other transaction, other
arrangement, or tax benefit described in subsection (b), at least the
following information:
(1) The agency, program, institute, or other Federal
Government entity providing the Federal grant, cooperative
agreement, or other support.
(2) The amount and period of Federal financial support with
an itemized breakdown.
(3) Other Federal nonfinancial support, including the use
of Federal personnel, Federal facilities, and Federal
equipment.
(4) The grant number, if applicable.
(5) Associated clinical trial data, upon trial completion.
(6) Associated patents and patent applications,
specifying--
(A) any Federal ownership in such patents and
patent applications;
(B) the expiration date of such patents and filing
dates of such patent applications; and
(C) the numbers of such patents and patent
applications.
(7) Associated periods of marketing exclusivity under
Federal law and the durations of such periods.
(8) The corporation, nonprofit organization, academic
institution, person, or other entity receiving the Federal
support.
(9) Any products (including repurposed products) approved,
authorized, or cleared for marketing, or for which marketing
approval, authorization, or clearance is being sought, the
development of which was aided by Federal support, including--
(A) the names of such products;
(B) the prices of such products; and
(C) the current and anticipated manufacturing
capacity to produce such products.
(10) The full terms of the contract, funding agreement,
licensing agreement, other transaction, or other arrangement
described in subsection (b).
(d) Format of Information.--The database under subsection (a) shall
be--
(1) searchable and filterable according to the categories
of information described in subsection (c); and
(2) presented in a user-friendly format.
(e) Timing.--The database under subsection (a) shall be--
(1) made publicly available not later than 1 month after
the date of enactment of this Act; and
(2) updated not less than every 2 weeks.
(f) Disclosure.--
(1) In general.--Notwithstanding any other provision of
law, to the extent necessary for an official described in
subsection (a) to carry out this section, such official may
require entities receiving Federal support described in
subsection (a)(1) to disclose to the official any information
relating to such Federal support and required to be included in
the database under subsection (a).
(2) Intermediary cooperation.--Any arrangement entered into
by the Federal Government with an entity providing for such
entity to enter into contracts, licensing agreements, grants,
other transactions, or other arrangements with third parties on
behalf of the Federal Government shall require such entity to
disclose in a timely manner any information necessary for the
Federal Government to fulfill its duties under this Act. With
respect to any such arrangement in place as of the date of
enactment of this Act, an official described in subsection (a)
may require the entity to disclose to the official any
information required to be included in the database under
subsection (a).
(3) Penalty for nondisclosure.--If an entity that is
required to disclose information pursuant to paragraph (1) or
(2) fails to disclose such information by the date that is 2
weeks after the date on which the official requests such
information, or by such reasonable deadline as the official may
specify, whichever is sooner, then such entity shall be liable
to the United States for a civil penalty in an amount not to
exceed $10,000 for each day on which such failure continues.
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