Physician Interviews on FDA-Approved Labeling

Data to Support Drug Product Communications

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0695 can be found here:

Documents and Forms

Document Name Document Type
Appendix A -Phone Script and Emails.docx Other-Script and Emails
Appendix B - Screener.docx Other-Screener
Appendix C - Confirmation Email.docx Other-Confirmation Email
Appendix D - Informed Consent.docx Other-Informed Consent
Appendix E - Interview Guide.docx Other-Interview Guide
0695 OMB Approval Memo for Physician Interviews on FDA Approved Labeling 2019.doc OMB Approval Memo IC Document

Information Collection (IC) Details

IC Title:	Physician Interviews on FDA-Approved Labeling	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-Script and Emails	Appendix A -Phone Script and Emails.docx	Yes	No	Printable Only
Other-Screener	Appendix B - Screener.docx	Yes	Yes	Fillable Fileable
Other-Confirmation Email	Appendix C - Confirmation Email.docx	Yes	No	Printable Only
Other-Informed Consent	Appendix D - Informed Consent.docx	Yes	Yes	Fillable Fileable
Other-Interview Guide	Appendix E - Interview Guide.docx	Yes	No	Printable Only

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 330	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	330	330
Annual IC Time Burden (Hours)	97	97
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
OMB Approval Memo	0695 OMB Approval Memo for Physician Interviews on FDA Approved Labeling 2019.doc	11/06/2019

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