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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6897 Introduced in House (IH)]

<DOC>

118th CONGRESS
  1st Session
                                H. R. 6897

  To require the Secretary of Defense to establish a pilot program to 
evaluate novel pharmaceutical manufacturing technologies to reduce the 
    reliance of the Department on foreign manufacturers for active 
         pharmaceutical ingredients and key starting materials.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                           December 22, 2023

 Ms. Slotkin (for herself and Mr. Gallagher) introduced the following 
      bill; which was referred to the Committee on Armed Services

_______________________________________________________________________

                                 A BILL

 
  To require the Secretary of Defense to establish a pilot program to 
evaluate novel pharmaceutical manufacturing technologies to reduce the 
    reliance of the Department on foreign manufacturers for active 
         pharmaceutical ingredients and key starting materials.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. DOMESTIC SYNTHETIC BIOLOGY PHARMACEUTICAL MANUFACTURING 
              PILOT PROGRAM.

    (a) Short Title.--This Act may be cited as the ``Synthetic Biology 
and Active Pharmaceutical Ingredients Act''.
    (b) In General.--Not later than January 1, 2025, the Secretary of 
Defense shall establish a pilot program to evaluate the use of novel 
technologies using synthetic biology to expand domestic manufacturing 
of covered active pharmaceutical ingredients and covered key starting 
materials to reduce the reliance of the Department of Defense on 
foreign countries for such covered active pharmaceutical ingredients 
and covered key starting materials.
    (c) Sunset.--The pilot program established under subsection (a) 
shall terminate on the date that is three years after the date of the 
enactment of this Act.
    (d) Definitions.--
            (1) Active pharmaceutical ingredient.--The term ``active 
        pharmaceutical ingredient'' has the meaning given such term in 
        section 744A of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 379j-41).
            (2) Covered active pharmaceutical ingredient.--The term 
        ``covered active pharmaceutical ingredient'' means an active 
        pharmaceutical ingredient of which a sufficient quantity or 
        quality is not available from domestic manufacturers to meet 
        the needs of the Department and which the Secretary determines 
        to be of strategic importance to the United States.
            (3) Covered key starting material.--The term ``covered key 
        starting material'' means a key starting material of which a 
        sufficient quantity or quality is not available from domestic 
        manufacturers to meet the needs of the Department and which the 
        Secretary determines to be of strategic importance to the 
        United States.
            (4) Key starting material.--The term ``key starting 
        material'' means any material that is--
                    (A) used in the manufacture of an active 
                pharmaceutical ingredient; and
                    (B) incorporated as an integral part of the active 
                pharmaceutical ingredient.
                                 <all>
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