Format & content for new OTC drug products (included FDA recommendations on statutory requirements)

General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0340 can be found here:

Documents and Forms

Document Name Document Type
FFDCA Sec 502 - 21 USC 352.pdf Other-Statutory Authority
FFDCA Sec 502 - 21 USC 352.pdf Other-Statutory Authority
Labeling of nonRx drugs under NDCPA GFI Sept 2009.pdf Other-Agency Guidance
Labeling of nonRx drugs under NDCPA GFI Sept 2009.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Format & content for new OTC drug products (included FDA recommendations on statutory requirements)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 201 21 CFR 201.66

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Statutory Authority			FFDCA Sec 502 - 21 USC 352.pdf		Yes	Yes	Fillable Fileable
Other-Agency Guidance			Labeling of nonRx drugs under NDCPA GFI Sept 2009.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 875	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	29,116	21,258	7,858
Annual IC Time Burden (Hours)	133,525	39,229	94,296
Annual IC Cost Burden (Dollars)	0	-1,950,000	1,950,000

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.