Rulemaking

(a) In general The Secretary of the Treasury shall, not later than 1 year after the date of the enactment of this Act, issue a rule to further define the parameters of the area of biotechnology, as used in paragraphs (7)(A) and (10)(A) of section 809 of the Defense Production Act of 1950, as amended by section 3. (b) Requirements When defining the parameters of the area of biotechnology pursuant to subsection (a), the Secretary of the Treasury shall— (1) consult with the Secretary of Health and Human Services, the Secretary of Defense, and the Director of National Intelligence; (2) give particular consideration to transactions involving the licensing of intellectual property, drug discovery platforms, clinical research and development capabilities, and biologics manufacturing know-how to covered foreign persons (as defined in section 809 of the Defense Production Act of 1950); (3) give particular consideration to licensing transactions, joint ventures, and equity investments involving drug discovery platforms, clinical development capabilities, and biologics manufacturing as priority categories for both the prohibited and notifiable technology tiers within the biotechnology sector; (4) consider the degree to which a transaction would transfer pharmaceutical innovation capacity, clinical development capabilities, or manufacturing know-how to entities subject to the direction or control of the People’s Republic of China; and (5) not define the biotechnology sector in a manner that includes or could be construed to include agricultural biotechnology, industrial fermentation unrelated to pharmaceutical or therapeutic production, or basic academic research with no direct pharmaceutical or therapeutic application.