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 201910-0910-010 · 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⚠️ Notice: This information collection may be referencing outdated material.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 Message - Professional Society.docx	Other-Recruitment Message - Professi
Consent Form.docx	Other-Consent
Interview Guide - Alemtuzumab.docx	Other-Interview Guide - Alemtuzumab
Interview Guide - Alvimopan.docx	Other-Alvimopan
Interview Guide - Pegvaliase.docx	Other-Interview Guide - Pegvaliase
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

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: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Recruitment Message - Physicians	Yes	No	Printable Only
Other-Recruitment Message - Professional Society	Yes	No	Printable Only
Other-Consent	Yes	No	Printable Only
Other-Interview Guide - Alemtuzumab	Yes	No	Printable Only
Other-Alvimopan	Yes	No	Printable Only
Other-Interview Guide - Pegvaliase	Yes	No	Printable Only
Other-IRB Letter	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
	Approved	Program Change Due to Agency Discretion
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		12/15/2021

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

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