Clinical Trial Data in Professional Prescription Drug Promotion

Data to Support Drug Product Communications as Used by the Food and Drug Administration

⚠️ Notice: This information collection may be referencing outdated material.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
Participant Screener 1-25-2016.doc Other-Survey
0695 OMB Justification Memo for generic clearance for Clinical Trial Data 1-25-2016.doc OMB Justification Memo for Generic Clearance of Communication Testing for Drug Products IC Document
FDA Physician Interviews Discussion Guide 1-25-2016.docx Interview Guide IC Document
Consent Form 1-25-2016.doc Consent Form IC Document
Recruitment Emails 1-25-2016.doc Recruitment Email IC Document

Information Collection (IC) Details

IC Title:	Clinical Trial Data in Professional Prescription Drug Promotion	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			Participant Screener 1-25-2016.doc		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 372	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	372	372
Annual IC Time Burden (Hours)	96	96
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
OMB Justification Memo for Generic Clearance of Communication Testing for Drug Products	0695 OMB Justification Memo for generic clearance for Clinical Trial Data 1-25-2016.doc	03/01/2016
Interview Guide	FDA Physician Interviews Discussion Guide 1-25-2016.docx	03/01/2016
Consent Form	Consent Form 1-25-2016.doc	03/01/2016
Recruitment Email	Recruitment Emails 1-25-2016.doc	03/01/2016

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