; and (B) the Committee on Energy and Commerce of the House of Representatives. (2) Essential generic medicine The term essential generic medicine means a drug included on the most current list under section 319N(a). (3) Key starting material The term key starting material means an active pharmaceutical ingredient or critical input used in the manufacturing of an essential generic medicine, as well as ingredients or components that possess unique attributes essential in assessing the safety and effectiveness of such essential generic medicines, including excipients and inactive ingredients. (h) Authorization of appropriations There are authorized to be appropriated to carry out this section such sums as may be necessary. . 4. Waiver of certain FDA ANDA requirements Section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j) ) is amended by adding at the end the following: (14) Notwithstanding any other provision of this section, the holder of an approved application under this subsection that changes the source of an active pharmaceutical ingredient of the drug that is the subject of such application to a source available through the Strategic Active Pharmaceutical Ingredient Reserve established under section 319N–1 of the Public Health Service Act— (A) shall not be required to update the approved application with respect to such change before changing the source; and (B) shall inform the Secretary of the change, through an update to the approved application or other manner determined appropriate by the Secretary, prior to commercial distribution of the drug. . 5. GAO report By not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall prepare and submit a report to Congress that includes— (1) an assessment of what is known about active pharmaceutical ingredient manufacturing, including— (A) the time needed to develop and implement domestic manufacturing capabilities