0910-AB33 200110 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Antibiotic Drug Approval and Exclusivity The final rule would implement the incorporation of antibiotics, which were formerly regulated under authority of section 507 of the Federal Food, Drug, and Cosmetic Act, into the new drug regulatory scheme under section 505 of the Act. The regulation will describe which antibiotics are excepted under section 125(d) of the Food and Drug Administration Modernization Act of 1997 from certain provisions in section 505, including the exclusivity provisions under sections 505(c) and 505(j) of the Act. Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No Undetermined 21 CFR 314 PL 105-115, sec 125 No NPRM 01/24/2000 65 FR 3623 NPRM Comment Period End 04/24/2000 Final Action 04/00/2002 No None No NA Not Collected Paul Varki C. 0910 Food and Drug Administration FDA 301 594-2041 varkip@cder.fda.gov Suite 3037, (HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, Rockville MD 20852 Not Procurement Related Revising Text to Reduce Burden or Duplication, or Streamline Requirements