NOTIFICATION OF FDA INTENT TO REGULATE LABORATORY-DEVELOPED TESTS.

SEC. 1143. [21 U.S.C. 371 note] NOTIFICATION OF FDA INTENT TO REGULATE LABORATORY-DEVELOPED TESTS. (a) In General.—The Food and Drug Administration may not issue any draft or final guidance on the regulation of laboratory-developed tests under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) without, at least 60 days prior to such issuance— (1) notifying the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate of the Administration’s intent to take such action; and (2) including in such notification the anticipated details of such action. (b) Sunset.—Subsection (a) shall cease to have force or effect on the date that is 5 years after the date of enactment of this Act.