Healthcare Professional Interviews: Risk Processing for Newly Promoted Prescription Drugs (CDER)

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⚠️ Notice: This information collection may be referencing outdated material.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
Screener.docx Other-Screener
Informed Consent Form - nonMedStar.docx Other-Informed Consent - nonMedStar
Informed Consent Form - NP and PA.docx Other-Informed Consent Form - NP and
Informed Consent Form - PCP.docx Other-Informed Consent Form - PCP
Informed Consent Form - Specialist.docx Other-Informed Consent Form - Specia
Recruitment Flyer - MedStar.docx Other-Recruitment Flyer - MedStar
Recruitment Flyer nonMedStar.docx Other-Recruitment Flyer - nonMedStar
0695 OMB Approval Memo 2020.docx OMB approval memo IC Document

Information Collection (IC) Details

IC Title:	Healthcare Professional Interviews: Risk Processing for Newly Promoted Prescription Drugs (CDER)	Agency IC Tracking Number:	CDER

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Instrument File	Available Electronically?	Electronic Capability
Other-Screener	Screener.docx	No	Paper Only
Other-Informed Consent - nonMedStar	Informed Consent Form - nonMedStar.docx	No	Paper Only
Other-Informed Consent Form - NP and PA	Informed Consent Form - NP and PA.docx	No	Paper Only
Other-Informed Consent Form - PCP	Informed Consent Form - PCP.docx	No	Paper Only
Other-Informed Consent Form - Specialist	Informed Consent Form - Specialist.docx	No	Paper Only
Other-Recruitment Flyer - MedStar	Recruitment Flyer - MedStar.docx	No	Paper Only
Other-Recruitment Flyer - nonMedStar	Recruitment Flyer nonMedStar.docx	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 225	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	225	225
Annual IC Time Burden (Hours)	0	0
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
OMB approval memo	0695 OMB Approval Memo 2020.docx	01/23/2020

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