General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions

OMB 0910-0340

The information collection supports agency regulations at 21 CFR 201.66. Respondents to the collection of information are producers or manufacturers of drug products requiring over-the-counter (OTC) labeling subject to these regulatory requirements.

The latest form for General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions expires 2022-12-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form FDA 5009 OTC User Fee Program Form
0340 OTC Drug Labeling SSA 2022 REV.docx Supporting Statement A
Format & content for new OTC drug products (included FDA recommendations on statutory requirements) Other-Statutory Authority
Domestic Address or Phone Number Labeling Requirement (21 U.S.C. 352(x)) and Recommendation to Clarify its Purpose Other-Guidance
OTC User Fee Program Form
Format and Content Requirements; exemptions and deferrals

All Historical Document Collections

202212-0910-002 Approved without change	Revision of a currently approved collection	2022-12-19
202112-0910-002 Approved without change	No material or nonsubstantive change to a currently approved collection	2021-12-17
202011-0910-003 Approved without change	No material or nonsubstantive change to a currently approved collection	2020-12-01
201911-0910-009 Approved without change	Extension without change of a currently approved collection	2019-12-05
201612-0910-009 Approved without change	Extension without change of a currently approved collection	2016-12-22
201312-0910-009 Approved without change	Extension without change of a currently approved collection	2013-12-20
201008-0910-009 Approved with change	Reinstatement with change of a previously approved collection	2010-08-26
200504-0910-004 Approved without change	Extension without change of a currently approved collection	2005-04-22
200203-0910-001 Approved without change	Extension without change of a currently approved collection	2002-03-14
199903-0910-005 Approved without change	Revision of a currently approved collection	1999-03-25

OMB Details

Format and Content Requirements for Over--the-Counter Drug Product Labeling; new OTC drug products (including sunscreen products)

Federal Enterprise Architecture: Health - Consumer Health and Safety