0910-AG19 200904 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs Substantive, Nonsignificant First Time Published in The Unified Agenda Final Rule Stage No No 21 CFR 314.3(b) 21 CFR 314.81(b)(2)(ii)(b) 21 USC 355(t) No NPRM 09/29/2008 73 FR 56529 NPRM Comment Period End 12/15/2008 Final Action 07/00/2009 No Federal No No No No Michelle Bernstein 0910 Food and Drug Administration FDA 301 796-3469 301 847-8440 michelle.bernstein-doses@fda.hhs.gov Center for Drug Evaluation and Research, Bldg. 51, Room 6362, 10903 New Hampshire Ave., Silver Spring MD 20993-0002