Information Collection

Reporting: Requirement for Submission of Special Drug Experience Report More Frequently - Form FDA 2301

IC 197281 under ICR 201412-0910-009 · 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⚠️ Notice: This information collection may be referencing outdated material.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 Reporting: Requirement for Submission of Special Drug Experience Report More Frequently - Form FDA 2301	Form and Instruction
2301 Transmittal of Periodic Reports and Promotional Material Form FDA 2301.pdf	Form and Instruction

IC Title:

Reporting: Requirement for Submission of Special Drug Experience Report More Frequently - Form FDA 2301

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

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

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

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 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	114	88	26
Annual IC Time Burden (Hours)	228	176	52
Annual IC Cost Burden (Dollars)	0	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.