Information Collection

Clinical Trial Data in Professional Prescription Drug Promotion

IC 220363 under ICR 201601-0910-001 · OMB 0910-0695.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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

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:

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			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 %

table that charts list of burden
	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

table that charts IC Documents
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.