Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products

OMB 0910-0572

The information collection supports agency regulations governing the content and format of labeling for human prescription drug and biological products. Respondents to the collection are sponsors of new drug and biological product applications.

The latest form for Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products expires 2022-01-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0572 Rx labeling for drugs and biologics SSA 2018 Ext.pdf Supporting Statement A
Labeling Requirements

All Historical Document Collections

201810-0910-004 Approved without change	Extension without change of a currently approved collection	2018-12-06
201506-0910-012 Approved without change	Extension without change of a currently approved collection	2015-06-23
201204-0910-001 Approved with change	Revision of a currently approved collection	2012-04-04
200901-0910-004 Approved with change	Extension without change of a currently approved collection	2009-01-16
200509-0910-002 Approved without change	New collection (Request for a new OMB Control Number)	2005-09-15