TRACK Act of 2023

Subjects: Health, 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

Summary:  <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>

<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 315 Introduced in Senate (IS)]

&lt;DOC&gt;






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.
                                 &lt;all&gt;
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