Information Collection

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

IC 249972 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⚠️ Notice: This information collection may be referencing outdated material.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
Patient Interview Guide.docx	Other-Interview Guide
Patient Interview Guide.docx	Other-Interview Guide
Consent Form.docx	Other-Consent Form
Consent Form.docx	Other-Consent Form
Recruitment Messages - Email - All Drugs - Patient Only.docx	Other-Recruitment Message-Email-All
Recruitment Messages - Email - All Drugs - Patient Only.docx	Other-Recruitment Message-Email-All
Recruitment Messages - Email - Patient Or Caretaker.docx	Other-Recruitment Message-Email-Pati
Recruitment Messages - Email - Patient Or Caretaker.docx	Other-Recruitment Message-Email-Pati
Recruitment Messages - Email Forward - Patient Only.docx	Other-Recruitment Message-Email Forw
Recruitment Messages - Email Forward - Patient Only.docx	Other-Recruitment Message-Email Forw
Recruitment Messages - Email Forward - Patient or Caretaker.docx	Other-Recruitment Message-Email Forw
Recruitment Messages - Email Forward - Patient or Caretaker.docx	Other-Recruitment Message-Email Forw
Recruitment Messages - Rally - All Drugs - Patient Only.docx	Other-Recruitment Message-Rally-All
Recruitment Messages - Rally - All Drugs - Patient Only.docx	Other-Recruitment Message-Rally-All
Recruitment Messages - Rally - C and P - Patient Only.docx	Other-Recruitment Message-Rally-C an
Recruitment Messages - Rally - C and P - Patient Only.docx	Other-Recruitment Message-Rally-C an
Recruitment Research Match - All Drugs - Patient Only.docx	Other-Recruitment Research Match-All
Recruitment Research Match - All Drugs - Patient Only.docx	Other-Recruitment Research Match-All
Recruitment Research Match - Patient or Caretaker.docx	Other-Recruitment Research Match-Pat
Recruitment Research Match - Patient or Caretaker.docx	Other-Recruitment Research Match-Pat
Drug Specific Content for Patient Interview Guide.docx	Other-Drug Specific Content
Drug Specific Content for Patient Interview Guide.docx	Other-Drug Specific Content
IRB Approval Letter.pdf	Other-IRB Letter
IRB Approval Letter.pdf	Other-IRB Letter
0847 OMB Approval Memo REMS Patient Interview 2021.docx OMB approval memo	IC Document
0847 OMB Approval Memo REMS Patient Interview 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: Patient 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-Interview Guide	Patient Interview Guide.docx	Yes	No	Printable Only
Other-Consent Form	Consent Form.docx	Yes	No	Printable Only
Other-Recruitment Message-Email-All Drugs-Patient Only	Recruitment Messages - Email - All Drugs - Patient Only.docx	Yes	No	Printable Only
Other-Recruitment Message-Email-Patient or Caretaker	Recruitment Messages - Email - Patient Or Caretaker.docx	Yes	No	Printable Only
Other-Recruitment Message-Email Forward- Patient Only	Recruitment Messages - Email Forward - Patient Only.docx	Yes	No	Printable Only
Other-Recruitment Message-Email Forward-Patient or Caretaker	Recruitment Messages - Email Forward - Patient or Caretaker.docx	Yes	No	Printable Only
Other-Recruitment Message-Rally-All Drugs-Patient Only	Recruitment Messages - Rally - All Drugs - Patient Only.docx	Yes	No	Printable Only
Other-Recruitment Message-Rally-C and P - Patient Only	Recruitment Messages - Rally - C and P - Patient Only.docx	Yes	No	Printable Only
Other-Recruitment Research Match-All Drugs - Patient Only	Recruitment Research Match - All Drugs - Patient Only.docx	Yes	No	Printable Only
Other-Recruitment Research Match-Patient or Caretaker	Recruitment Research Match - Patient or Caretaker.docx	Yes	No	Printable Only
Other-Drug Specific Content	Drug Specific Content for Patient Interview Guide.docx	Yes	No	Printable Only
Other-IRB Letter	IRB Approval Letter.pdf	Yes	No	Printable Only

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 160

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	160	160
Annual IC Time Burden (Hours)	160	160
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 Patient Interview 2021.docx	10/29/2021

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