Add Adverse Event Reporting Plan to COOP

Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0701 can be found here:

Documents and Forms

Document Name Document Type
GUIDANCE 0701 12-24-14.pdf Other-Guidance

Information Collection (IC) Details

IC Title:	Add Adverse Event Reporting Plan to COOP	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 379aa (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			GUIDANCE 0701 12-24-14.pdf		Yes	No	Paper Only

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 5,000	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 80 %

	Approved	Previously Approved
Annual Number of Responses for this IC	5,000	5,000
Annual IC Time Burden (Hours)	250,000	250,000
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.