Information Collection

Risk Evaluation and Mitigation Strategy Programs to Promote Appropriate Medication Use and Knowledge: Physician Interviews on Experiences with REMS Programs (CDER)

IC 250770 under ICR 202205-0910-005 · OMB 0910-0847.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0847 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Recruitment Messages - Physician.docx	Other-Recruitment Message - Physicia
Recruitment Messages - Physician.docx	Other-Recruitment Message - Physicia
Recruitment Message - Professional Society.docx	Other-Recruitment Message - Professi
Recruitment Message - Professional Society.docx	Other-Recruitment Message - Professi
Consent Form.docx	Other-Consent
Consent Form.docx	Other-Consent
Interview Guide - Alemtuzumab.docx	Other-Interview Guide - Alemtuzumab
Interview Guide - Alemtuzumab.docx	Other-Interview Guide - Alemtuzumab
Interview Guide - Alvimopan.docx	Other-Alvimopan
Interview Guide - Alvimopan.docx	Other-Alvimopan
Interview Guide - Pegvaliase.docx	Other-Interview Guide - Pegvaliase
Interview Guide - Pegvaliase.docx	Other-Interview Guide - Pegvaliase
IRB Letter 2021P002615.pdf	Other-IRB Letter
IRB Letter 2021P002615.pdf	Other-IRB Letter
0847 OMB Approval Memo - REMS Physician Experience Interviews (3 Covered Drugs) 2021.docx OMB Approval Memo	IC Document
0847 OMB Approval Memo - REMS Physician Experience Interviews (3 Covered Drugs) 2021.docx OMB Approval Memo	IC Document

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

Risk Evaluation and Mitigation Strategy Programs to Promote Appropriate Medication Use and Knowledge: Physician Interviews on Experiences with REMS Programs (CDER)

Agency IC Tracking Number:

CDER

IC Status: Unchanged

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Recruitment Message - Physicians	Recruitment Messages - Physician.docx	Yes	No	Printable Only
Other-Recruitment Message - Professional Society	Recruitment Message - Professional Society.docx	Yes	No	Printable Only
Other-Consent	Consent Form.docx	Yes	No	Printable Only
Other-Interview Guide - Alemtuzumab	Interview Guide - Alemtuzumab.docx	Yes	No	Printable Only
Other-Alvimopan	Interview Guide - Alvimopan.docx	Yes	No	Printable Only
Other-Interview Guide - Pegvaliase	Interview Guide - Pegvaliase.docx	Yes	No	Printable Only
Other-IRB Letter	IRB Letter 2021P002615.pdf	Yes	No	Printable Only

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 60

Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Requested	Previously Approved
Annual Number of Responses for this IC	60	60
Annual IC Time Burden (Hours)	60	60
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
OMB Approval Memo	0847 OMB Approval Memo - REMS Physician Experience Interviews (3 Covered Drugs) 2021.docx	12/15/2021

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