Information Collection

One time - add adverse event reporting plan to COOP

IC 198613 under ICR 201107-0910-010 · 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⚠️ Notice: This information collection may be referencing outdated material.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 Pandemic.doc	Other-guidance document

IC Title:

One time - add adverse event reporting plan to COOP

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

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 document			guidance Pandemic.doc		Yes	Yes	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: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion
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.