Synthetic Biology and Active Pharmaceutical Ingredients Act

118 HR 6897 IH: Synthetic Biology and Active Pharmaceutical Ingredients Act U.S. House of Representatives 2023-12-22 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. I 118th CONGRESS 1st Session H. R. 6897 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. 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.