Information Collection

Drug experience reports; advertisements and promotional labeling; distributor statements

IC 197280 under ICR 202306-0910-009 · OMB 0910-0284.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 2301 Drug experience reports; advertisements and promotional labeling; distributor statements	Form and Instruction
0284 Screenshots.doc	Other-Screenshots - Proposed Electro
0284 Screenshots.doc	Other-Screenshots - Proposed Electro
2301 Transmittal of Periodic Reports and Promotional Material Form FDA 2301.pdf	Form and Instruction
2301 Transmittal of Periodic Reports and Promotional Material Form FDA 2301.pdf	Form and Instruction

IC Title:

Drug experience reports; advertisements and promotional labeling; distributor statements

Agency IC Tracking Number:

CVM

Is this a Common Form? No

IC Status: Removed

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 514.80

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
Form and Instruction	2301	Transmittal of Periodic Reports and Promotional Material	Form FDA 2301.pdf		No	No	Paper Only
Other-Screenshots - Proposed Electronic Submitter System			0284 Screenshots.doc		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: 100 %

table that charts list of burden
	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	-5,779	5,779
Annual IC Time Burden (Hours)	-34,266	34,266
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.