Supervisory Regulatory Counsel

0910-AG18 201904 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products

This rule would require electronic package inserts for human drug and biological prescription products with limited exceptions, in lieu of paper, which is currently used. These inserts contain prescribing information intended for healthcare practitioners. This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products.

]]> Other Significant Previously Published in The Unified Agenda Long-Term Actions No No Other 21 CFR 201.100 21 CFR 201.306 21 CFR 201.310 21 CFR 606.121 21 CFR 606.122 21 CFR 610.60 21 CFR 610.61 ... 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 358 21 U.S.C. 360 21 U.S.C. 360b 21 U.S.C. 360gg to 360ss 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 379e 42 U.S.C. 216 42 U.S.C. 241 42 U.S.C. 262 42 U.S.C. 264 No NPRM 12/18/2014 79 FR 75506 NPRM Comment Period Extended 03/09/2015 80 FR 12364 NPRM Comment Period End 03/18/2015 NPRM Comment Period Extended End 05/18/2015 Final Rule To Be Determined Includes Retrospective Review under E.O. 13563. Yes Businesses None No No Yes Yes Michael Bernstein Supervisory Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3478 michael.bernstein@fda.hhs.gov Center for Drug Evaluation and Research, WO Bldg. 51, Rm. 6240, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002