[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4757 Introduced in House (IH)]

<DOC>






117th CONGRESS
  1st Session
                                H. R. 4757

     To authorize the use of certain drugs, vaccines, and medical 
 technologies to expand military and civilian access to such products, 
                        and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 28, 2021

  Mr. Doggett (for himself and Ms. DeLauro) introduced the following 
  bill; which was referred to the Committee on Armed Services, and in 
    addition to the Committee on the Judiciary, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL


 
     To authorize the use of certain drugs, vaccines, and medical 
 technologies to expand military and civilian access to such products, 
                        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 ``Make Taxpayer-Funded Department of 
Defense Medical Interventions Affordable Act''.

SEC. 2. AUTHORIZATION OF USE OF DRUGS, VACCINES, AND MEDICAL 
              TECHNOLOGIES TO EXPAND MILITARY AND CIVILIAN ACCESS TO 
              SUCH PRODUCTS.

    (a) Report and Identification of Products.--Not later than one year 
after the date of the enactment of this Act, the Secretary of Defense 
shall submit to the Committees on Armed Services of the Senate and the 
House of Representatives a report on the efforts of the Secretary to 
comply with the paragraph titled ``Licensing of Federally owned medical 
interventions'', included on page 173 of the report of the Committee on 
Armed Services of the Senate accompanying S. 1519 of the 115th Congress 
(S. Rept. 115-125), which shall include the following information:
            (1) A description of what steps, if any, the Secretary has 
        taken to comply with such paragraph.
            (2) A complete list of the drugs, vaccines, and medical 
        technologies that, as of the date of the enactment of this Act, 
        meet the requirements outlined in such paragraph.
            (3) For each drug, vaccine, or medical technology 
        identified under paragraph (2), a discussion of the plans of 
        the Secretary to utilize the authorities of the Secretary under 
        section 203 or 209(d)(1) of title 35, United States Code, to 
        authorize a third party or Federal agency to use the drug, 
        vaccine, or medical technology.
    (b) Authorization of Use.--Not later than one year after the date 
of the enactment of this Act, the Secretary, pursuant to section 203 or 
209(d)(1) of title 35, United States Code, shall authorize third 
parties or Federal agencies to use not fewer than 10 drugs, vaccines, 
or medical technologies identified under subsection (a)(2) for the 
purpose of expanding military and civilian access to such drugs, 
vaccines, or technologies.

SEC. 3. DEPARTMENT OF DEFENSE DATABASE ON SUPPORT FOR BIOMEDICAL 
              RESEARCH AND DEVELOPMENT.

    (a) Database.--The Secretary of Defense shall--
            (1) compile into a searchable database information relating 
        to any support provided before or after the date of enactment 
        of this Act by the Department of Defense, or an entity acting 
        on its behalf, for biomedical research and development, 
        including with respect to drugs, vaccines, and medical 
        technologies; and
            (2) make such database available on a public website of the 
        Department.
    (b) Covered Information.--The information relating to support 
described in subsection (a)(1) shall include all contracts, funding 
agreements, licensing arrangements, other transactions, and other 
arrangements entered into by, or on behalf of, the Department of 
Defense with respect to the research and development, or the 
manufacturing and distribution, of a drug (including a biological 
product), cell or gene therapy, or medical device or other medical 
technology, 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 entered into pursuant to section 12 of the 
        Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C. 
        3710a).
            (3) Funding agreements, as defined under 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 authorities:
                    (A) Section 2358 of title 10, United States Code.
                    (B) Section 2371 of such title.
                    (C) Section 2371a of such title.
                    (D) Section 2371b of such title.
                    (E) Section 2373 of such title.
    (c) Information Required.--Notwithstanding any other provision of 
law, the Secretary shall include in the database under subsection (a) 
at a minimum, with regard to each contract, funding agreement, 
licensing agreement, other transaction, or other arrangement, described 
in subsection (b), the following information:
            (1) The element of the Department of Defense providing the 
        grant, cooperative agreement, or other support.
            (2) The amount and period of financial support provided by 
        the Department, with an itemized breakdown.
            (3) Other nonfinancial support provided by the Department, 
        including the use of personnel, facilities, or equipment of the 
        Department.
            (4) The grant number, if applicable.
            (5) Associated clinical trial data, upon trial completion.
            (6) Associated patents and patent applications, 
        specifying--
                    (A) any Department 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 support 
        provided by the Department.
            (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 support provided by the 
        Department, 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.
    (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 30 days after 
        the date of enactment of this Act; and
            (2) updated not less frequently than once every two weeks.
    (f) Disclosure.--
            (1) In general.--Notwithstanding any other provision of 
        law, to the extent necessary for the Secretary to carry out 
        this section, the Secretary may require entities receiving 
        support as described in subsection (a)(1) to disclose to the 
        Secretary any information relating to such support and required 
        to be included in the database under subsection (a).
            (2) Intermediary cooperation.--Any arrangement entered into 
        by the Department of Defense 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 Department shall require such entity to disclose 
        in a timely manner any information necessary for the Secretary 
        of Defense to fulfill the duties of the Secretary under this 
        Act. With respect to any such arrangement in place as of the 
        date of enactment of this Act, the Secretary may require the 
        entity to disclose to the Secretary 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 two 
        weeks after the date on which the Secretary requests such 
        information, or by such reasonable deadline as the Secretary 
        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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