Information Collection

Small Group Discussions with Applicants and Other External Stakeholders Regarding Clarity, Understandability, and Usefulness of FDA's Benefit-Risk Framework (BRF)

IC 251530 under ICR 202206-0910-016 · OMB 0910-0697.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0697 can be found here:

2023-11-28 - Extension without change of a currently approved collection

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
BRF_External Discussion Informed Consent.docx	Other-External Discussion Informed C
BRF_External Discussion Informed Consent.docx	Other-External Discussion Informed C
BRF_External Small Group Discussion Email Invitation.docx	Other-External Small Group Discussio
BRF_External Small Group Discussion Email Invitation.docx	Other-External Small Group Discussio
BRF_Small Group Discussion Moderator Script_Applicant and External Stakeholder.docx	Other-Small Group Discussion Moderat
BRF_Small Group Discussion Moderator Script_Applicant and External Stakeholder.docx	Other-Small Group Discussion Moderat
BRF_Small Group Discussion Questions.docx	Other-Small Group Discussion Questio
BRF_Small Group Discussion Questions.docx	Other-Small Group Discussion Questio
0697 OMB Memo Benefit-Risk Framework Small Group Discussions.docx Memo Benefit-Risk Framework Small Group Discussions	IC Document
0697 OMB Memo Benefit-Risk Framework Small Group Discussions.docx Memo Benefit-Risk Framework Small Group Discussions	IC Document

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

Small Group Discussions with Applicants and Other External Stakeholders Regarding Clarity, Understandability, and Usefulness of FDA's Benefit-Risk Framework (BRF)

Agency IC Tracking Number:

CDER

IC Status: Unchanged

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-External Discussion Informed Consent	BRF_External Discussion Informed Consent.docx	Yes	Yes	Fillable Printable
Other-External Small Group Discussion Email Invitation	BRF_External Small Group Discussion Email Invitation.docx	Yes	Yes	Fillable Printable
Other-Small Group Discussion Moderator Script_Applicant and External Stakeholder	BRF_Small Group Discussion Moderator Script_Applicant and External Stakeholder.docx	No		Printable Only
Other-Small Group Discussion Questions	BRF_Small Group Discussion Questions.docx	Yes	No	Printable Only

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 325

Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	Previously Approved
Annual Number of Responses for this IC	325	325
Annual IC Time Burden (Hours)	488	488
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
Memo Benefit-Risk Framework Small Group Discussions	0697 OMB Memo Benefit-Risk Framework Small Group Discussions.docx	02/11/2022

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