Senior Regulatory Counsel

0910-AF96 201410 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 Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements

The final rule would amend FDA's postmarketing safety reporting regulations for human drug and biological products to require that mandatory safety reports submitted to the Agency be transmitted in an electronic format that FDA can process, review, and archive. The rule will allow the Agency to review safety reports more quickly, to identify emerging safety problems, and disseminate safety information more rapidly in support of FDA's public health mission. The amendments also would be a key element in harmonizing FDA's postmarketing safety reporting regulations with international and International Harmonization Standards standards for the electronic submission of safety information.

]]> Other Significant Previously Published in The Unified Agenda Completed Actions No No 21 CFR 310.305 21 CFR 314.80 21 CFR 314.98 21 CFR 329.100 (new) 21 CFR 600.2 21 CFR 600.80 21 CFR 600.81 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 to 355a 21 USC 356 to 356c 21 USC 360 21 USC 371 21 USC 374 21 USC 375 21 USC 379k-l 21 USC 379aa 21 USC 381 42 USC 241 42 USC 262 42 USC 264 ... No ANPRM 11/05/1998 63 FR 59746 ANPRM Comment Period End 02/03/1999 NPRM 08/21/2009 74 FR 42184 NPRM Comment Period End 11/19/2009 Final Action 06/10/2014 79 FR 33072 Yes Businesses None No Yes No Reena Raman Senior Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-7577 301 847-8440 reena.raman@fda.hhs.gov Center for Drug Evaluation and Research, WO Bldg. 51, Room 6284, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002