CHANGES TO REGULATIONS.

SEC. 1112. [21 U.S.C. 360ddd note] CHANGES TO REGULATIONS. (a) Report.—Not later than 18 months after the date of the enactment of this Act, the Secretary, after obtaining input from medical gas manufacturers and any other interested members of the public, shall— (1) determine whether any changes to the Federal drug regulations are necessary for medical gases; and (2) submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report regarding any such changes. (b) Regulations.—If the Secretary determines under subsection (a) that changes to the Federal drug regulations are necessary for medical gases, the Secretary shall issue final regulations revising the Federal drug regulations with respect to medical gases not later than 48 months after the date of the enactment of this Act. (c) Definitions.—In this section: (1) The term “Federal drug regulations” means regulations in title 21 of the Code of Federal Regulations pertaining to drugs. (2) The term “medical gas” has the meaning given to such term in section 575 of the Federal Food, Drug, and Cosmetic Act, as added by section 1111 of this Act. (3) The term “Secretary” means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs.