Information Collection

Interviews with Applicants and Other External Stakeholders Regarding Clarity, Understandability, and Usefulness of FDA's Benefit-Risk Framework

IC 219150 under ICR 201407-0910-016 · OMB 0910-0360.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0360 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Interview Guide BRF Applicant Questions 12-02-2015.docx	Other-Survey
Interview Guide BRF External Stakeholders Questions 12-02-2015.docx	Other-Survey
OMB Justification Memo for Generic Clearance for Customer Satisfaction Survey for BRF Related Interviews 12-2-15.doc OMB Justification Memo	IC Document
Interview Guide BRF Applicant Script 12-02-2015.docx Script - Applicant	IC Document
Interview Guide BRF External Stakeholders Script 12-02-2015.docx Script - External Stakeholders	IC Document

IC Title:

Interviews with Applicants and Other External Stakeholders Regarding Clarity, Understandability, and Usefulness of FDA's Benefit-Risk Framework

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	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Survey			Interview Guide BRF Applicant Questions 12-02-2015.docx		Yes	No	Paper Only
Other-Survey			Interview Guide BRF External Stakeholders Questions 12-02-2015.docx		Yes	No	Paper Only

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 485

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	485	485
Annual IC Time Burden (Hours)	729	729
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
OMB Justification Memo	OMB Justification Memo for Generic Clearance for Customer Satisfaction Survey for BRF Related Interviews 12-2-15.doc	12/03/2015
Script - Applicant	Interview Guide BRF Applicant Script 12-02-2015.docx	12/03/2015
Script - External Stakeholders	Interview Guide BRF External Stakeholders Script 12-02-2015.docx	12/03/2015

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