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HHS/FDA

RIN: 0910-AG18

Publication ID: Spring 2013

Title: Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products
Abstract: 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.
Agency: Department of Health and Human Services(HHS)	Priority: Economically Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: Yes	Unfunded Mandates: Private Sector
CFR Citation: 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 ... (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 21 USC 352 21 USC 353 21 USC 355 21 USC 358 21 USC 360 21 USC 360b 21 USC 360gg to 360ss 21 USC 371 21 USC 374 21 USC 379e 42 USC 216 42 USC 241 42 USC 262 42 USC 264

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	10/00/2013

Additional Information: Includes Retrospective Review under E.O. 13563.
Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: None
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: No
RIN Data Printed in the FR: Yes
Agency Contact: Lauren Milner Regulatory Policy Advisor Department of Health and Human Services Food and Drug Administration Office of Good Clinical Practice, WO 32, Room 5108, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-5114 Email: lauren.milner@fda.hhs.gov