Focus Groups on FDA's Accelerated Approval Process

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⚠️ Notice: This information collection may be referencing outdated material.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
FDA Accelerated Approval Focus Groups_Screener_Task1.2_122917.docx Other-Respondent Screener
FDA_AA_Moderators Guide_Task1.1_122917.doc Other-Moderator's Guide
FDA AcceleratedApproval_FocusGroups_Informed Consent_Task1.2 120517.docx Other-Informed Consent
Accelerated Approval_information chart_Task1.1_122917.pptx Other-Information Chart
OMB memo AcceleratedApproval Focus Groups.doc Accelerated Approval Focus Groups IC Document

Information Collection (IC) Details

IC Title:	Focus Groups on FDA's Accelerated Approval Process	Agency IC Tracking Number:	CDER

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Respondent Screener	FDA Accelerated Approval Focus Groups_Screener_Task1.2_122917.docx	Yes	Yes	Printable Only
Other-Moderator's Guide	FDA_AA_Moderators Guide_Task1.1_122917.doc	No		Printable Only
Other-Informed Consent	FDA AcceleratedApproval_FocusGroups_Informed Consent_Task1.2 120517.docx	No		Printable Only
Other-Information Chart	Accelerated Approval_information chart_Task1.1_122917.pptx	No		Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 472	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	472	472
Annual IC Time Burden (Hours)	104	104
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
Accelerated Approval Focus Groups	OMB memo AcceleratedApproval Focus Groups.doc	01/11/2018

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