Information Collection

Six Month Periodic Drug Experience Report ( submit annually after first 2 years)- Paper Form FDA 2301

IC 191898 under ICR 201001-0910-012 · 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⚠️ Notice: This information collection may be referencing outdated material.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

Document Name Document Type
Form 2301 Six Month Periodic Drug Experience Report ( submit annually after first 2 years)- Paper Form FDA 2301 Form and Instruction
2301 Transmittal of Periodic Reports and Promotional Material Form FDA 2301.pdf Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Six Month Periodic Drug Experience Report ( submit annually after first 2 years)- Paper Form FDA 2301	Agency IC Tracking Number:

Is this a Common Form?		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 514.80(b)(4)

Information Collection 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		Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 84	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	1,428	1,428
Annual IC Time Burden (Hours)	22,848	22,848
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.