Information Collection

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

IC 5943 under ICR 202310-0910-006 · OMB 0910-0340.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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

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: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 201 21 CFR 201.66

Information Collection Instruments:

table that charts list of 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 %

table that charts list of burden
	Requested	Previously Approved
Annual Number of Responses for this IC	29,116	29,116
Annual IC Time Burden (Hours)	133,525	133,525
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
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.