Risk Managers' Focus Group: Adverse Event Reporting Practices for Tissue and Cell Products

Focus Groups as Used by the Food and Drug Administration

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0497 can be found here:

Documents and Forms

Document Name Document Type
focus group script--Risk Managers.doc Other-focus group script
Final Risk Managers.doc Final Risk Managers IC Document
risk managers FR OMB memo 7-17-09.doc risk managers FR OMB memo 7-17-09 IC Document
Terms of Clearance.doc Terms of Clearance IC Document

Information Collection (IC) Details

IC Title:	Risk Managers' Focus Group: Adverse Event Reporting Practices for Tissue and Cell Products	Agency IC Tracking Number:

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-focus group script			focus group script--Risk Managers.doc		Yes	Yes	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 10	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to New Statute	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA	Previously Approved
Annual Number of Responses for this IC	10	0	0	0	0	0
Annual IC Time Burden (Hours)	20	0	0	0	0	0
Annual IC Cost Burden (Dollars)	0	0	0	0	0	0

Documents for IC

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.