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

Customer/Partner Service Surveys

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

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

Information Collection (IC) Details

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:

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 %

	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

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.