TRACK Act of 2023

Bill: 118-s-315
Sponsor: full_name: Sen. Merkley, Jeff [D-OR]
Introduced: 2023-02-09
Policy area: Health
Subjects: Cardiovascular and respiratory health

Drug safety, medical device, and laboratory regulation

Drug therapy

Emergency medical services and trauma care

Genetics

Government information and archives

Health information and medical records

Health programs administration and funding

Health promotion and preventive care

Infectious and parasitic diseases

Intellectual property

Licensing and registrations

Manufacturing

Marketing and advertising

Medical research

Public contracts and procurement

Research administration and funding

Research and development
Latest action: action_date: 2023-02-09
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2023-02-09
action_desc: Introduced in Senate
text: <p><b>Taxpayer Research and Contributions Knowledge Act of 2023</b> <b>or the TRACK Act of 2023</b></p> <p>This bill requires the Department of Health and Human Services (HHS) to work with other federal entities to compile a public database of federal contracts, tax benefits, and other support for biomedical research and development. HHS must develop the database within one month and update it every two weeks.</p> <p>The bill sets out elements that must be in the database, including (1) the agency or other federal entity providing the support, (2) the entity receiving the support, (3) an itemized accounting of the support provided, (4) any associated clinical trial data, and (5) any medical products that were developed using the support and that are being brought to market.</p>

tv_txt: II 118th CONGRESS 1st Session S. 315 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.

1. Short title This Act may be cited as the Taxpayer Research And Contributions Knowledge Act of 2023 or the TRACK Act of 2023 . 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.