General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions

ICR 202212-0910-002

OMB: 0910-0340

Federal Form Document

Forms and Documents

Document Name	Status
Form FDA 5009 OTC User Fee Program Form	Unchanged
0340 OTC Drug Labeling SSA 2022 REV.docx Supporting Statement A	2022-12-19

IC Document Collections

IC ID	Document Title	Status
5943	Format & content for new OTC drug products (included FDA recommendations on statutory requirements) Other-Statutory Authority	Modified
250630	Domestic Address or Phone Number Labeling Requirement (21 U.S.C. 352(x)) and Recommendation to Clarify its Purpose Other-Guidance	Removed
244708	OTC User Fee Program Form	Unchanged
209796	Format and Content Requirements; exemptions and deferrals	Unchanged