; or (B) a disease or condition with potentially fatal outcomes, where the end point of clinical trial analysis is survival. (3) Chronic condition The term chronic condition means a disease or condition that— (A) usually lasts for 3 months or longer; and (B) (i) requires ongoing medical attention; or (ii) limits activities of daily living. . (b) Regulations and guidance Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue final regulations and guidance for carrying out section 524B of the Federal Food, Drug, and Cosmetic Act. (c) Conforming amendment Section 505(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(a) ) is amended by inserting , or there is in effect a conditional approval under section 524B with respect to such drug before the period.