Maintain Records to Identify What Reports Have Been Stored and When the Reporting Process was Restored

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⚠️ Notice: This information collection may be referencing outdated material.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
GUIDANCE 0701 12-24-14.pdf Other-Guidance

Information Collection (IC) Details

IC Title:	Maintain Records to Identify What Reports Have Been Stored and When the Reporting Process was Restored	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	Yes	Paper Only
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: 500	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	500	500
Annual IC Time Burden (Hours)	4,000	4,000
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.