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HHS/FDA RIN: 0910-AH33 Publication ID: Spring 2016 
Title: ●Patient Medication Information 

The proposed rule would amend FDA medication guide regulations to require a new form of patient labeling, Patient Medication Information, for submission to and review by the FDA for human prescription drug products used, dispensed, or administered on an outpatient basis. The proposed rule would include requirements for Patient Medication Information development, consumer testing, and distribution. The proposed rule would require clear and concise written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 208    21 CFR 310.501 and 310.515    21 CFR 201.57(a)(18)    21 CFR 201.809(f)(2)    21 CFR 314.70(b)(2)(v)(B)    21 CFR 610.60(a)(7)   
Legal Authority: 21 U.S.C. 321 et seq.    42 U.S.C. 262    42 U.S.C. 264    21 U.S.C. 371   
Legal Deadline:  None
Action Date FR Cite
NPRM  12/00/2016 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Elisabeth Walther
Health Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Building 50 Room 6312, 10903 New Hampshire Ave,
Silver Spring, MD 20993
Phone:301 796-3913
Fax:301 847-3529