1. Short title This Act may be cited as the Effective Screening and Testing for Tuberculosis Act . 2. Treatment of certain tests for tuberculosis as breakthrough devices The Secretary of Health and Human Services shall treat a device as a breakthrough device eligible for expedited development and priority review under section 515B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e–3 ) if it is a new and innovative donor screening test with heightened sensitivity to effectively screen human cell, tissue, and cellular and tissue-based product donors for evidence of active or latent tuberculosis infection. 3. Requiring certain establishments that perform donor screening or testing to screen or test for active and latent tuberculosis (a) In general The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall promulgate regulations revising part 1271 of title 21, Code of Federal Regulations, including sections 1271.75 and 1271.85, and any other applicable regulations, to require— (1) an establishment that performs donor screening to screen for active and latent tuberculosis; and (2) an establishment that performs donor testing to test for active and latent tuberculosis. (b) Regulations The Secretary of Health and Human Services shall— (1) not later than 1 year after the date of enactment of this Act, propose the regulations required by subsection (a); (2) not later than 3 months after the close of the comment period for such proposed regulations, promulgate such regulations as final