0910-AC48 200310 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 Applications for FDA Approval To Market a New Drug: Patent Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Economically Significant Previously Published in The Unified Agenda Completed Actions Yes Private Sector 21 CFR 314.52(a)(3) 21 CFR 314.53(b) 21 CFR 314.53(c)(1) 21 CFR 314.53(c)(2) 21 CFR 314.95(a)(3) 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 355a 21 USC 356 21 USC 356a 21 USC 356b 21 USC 356c 21 USC 371 21 USC 374 21 USC 379e No NPRM 10/24/2002 67 FR 65448 NPRM Comment Period End 12/23/2002 Final Rule 06/18/2003 68 FR 36676 No No None No NA Not Collected Jarilyn Dupont 0910 Food and Drug Administration FDA 301 796-4830 301 847-3541 jarilyn.dupont@fda.hhs.gov WO Building 32, Room 4245, 10903 New Hampshire Avenue, Silver Spring MD 20993