Ensuring completion of pediatric study requirements

(a) Equal accountability for pediatric study requirements Section 505B(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)) is amended— (1) in paragraph (1), by striking Beginning 270 and inserting Noncompliance letter.— Beginning 270; (2) in paragraph (2)— (A) by striking The drug or and inserting Effect of noncompliance.— The drug or; and (B) by striking (except that the drug or biological product shall not be subject to action under section 303) and inserting (except that the drug or biological product shall be subject to action under section 303 only if such person demonstrated a lack of due diligence in satisfying the applicable requirement); and (3) by adding at the end the following: (3) Limitation The Secretary shall not issue enforcement actions under section 303 for failures under this subsection in the case of a drug or biological product that is no longer marketed.. (b) Due diligence Section 505B(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)), as amended by subsection (a), is further amended by adding at the end the following: (4) Due diligence Before the Secretary may conclude that a person failed to submit or otherwise meet a requirement as described in the matter preceding paragraph (1), the Secretary shall— (A) issue a noncompliance letter pursuant to paragraph (1); (B) provide such person with a 45-day period beginning on the date of receipt of such noncompliance letter to respond in writing as set forth in such paragraph; and (C) after reviewing such written response, determine whether the person demonstrated a lack of due diligence in satisfying such requirement.. (c) Conforming amendments Section 303(f)(4)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(4)(A)) is amended by striking or 505–1 and inserting 505–1, or 505B. (d) Transition rule The Secretary of Health and Human Services may take enforcement action under section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) only for failures described in section 505B(d) of such Act (21 U.S.C. 355c(d)) that occur on or after the date that is 180 days after the date of enactment of this Act.