Labeling Requirements 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 Labeling Requirements 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_Change Request.docx Justification for No Material/Nonsubstantive Change
0572 Rx Labeling Requirements SSA 2021 REV.docx Supporting Statement A
Drug labeling requirements; prescription drugs
Safety Labeling Changes; Posting Approved Labeling on Application Holder's website Instruction
Safety Labeling Changes (Section 505(o)(4) of the FD&C Act)-- Rebuttal Statemen Instruction
Exemption Request from Bar Code Label Requirements
Cardiovascular Outcome Claim Supplement Submission Instruction
Submission to Docket Number FDA-2008-D-0150 Instruction
Labeling requirements; medical gas containers

202202-0910-001 Approved without change	No material or nonsubstantive change to a currently approved collection	2022-02-11
202112-0910-008 Approved without change	Revision of a currently approved collection	2021-12-23
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