Information Collection

Focus Groups on FDA's Accelerated Approval Process

IC 229723 under ICR 201707-0910-018 · OMB 0910-0497.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.