Reporting: Requirement for Submitting Advertisement & Promotional Material - Form FDA 2301

Records and Reports Concerning Experience with Approved New Animal Drugs

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0284 can be found here:

Documents and Forms

Document Name Document Type
0284 Screenshots.doc Other-Screenshots - Proposed Electro
2301 Transmittal of Periodic Reports and Promotional Material Form FDA_2301.pdf www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM052264.pdf Form

Information Collection (IC) Details

IC Title:	Reporting: Requirement for Submitting Advertisement & Promotional Material - Form FDA 2301	Agency IC Tracking Number:	CVM

Is this a Common Form? No		IC Status: Removed

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 514.80(b)(5)(ii)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Screenshots - Proposed Electronic Submitter System			0284 Screenshots.doc		Yes	Yes	Fillable Fileable
Form	2301	Transmittal of Periodic Reports and Promotional Material forNew Animal Drugs	Form FDA_2301.pdf	http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM052264.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: 200	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	-4,024	4,024
Annual IC Time Burden (Hours)	-8,048	8,048
Annual IC Cost Burden (Dollars)	0	0

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.