Information Collection

Add Adverse Event Reporting Plan to COOP

IC 198613 under ICR 201412-0910-017 · OMB 0910-0701.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
GUIDANCE 0701 12-24-14.pdf	Other-Guidance

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:

table that charts list of 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 %

table that charts list of burden
	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

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.