Information Collection

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

IC 251395 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⚠️ Notice: This information collection may be referencing outdated material.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-Patient Guide
Patient Interview-Guide.docx	Other-Patient Guide
Patient Interview-Recruitment Messages-Email Forward-Patient Only.docx	Other-Recruitment Messages-Email
Patient Interview-Recruitment Messages-Email Forward-Patient Only.docx	Other-Recruitment Messages-Email
Patient Interview-Recruitment Messages-Email Forward-Patient or Caretaker.docx	Other-Recruitment Messages-Email For
Patient Interview-Recruitment Messages-Email Forward-Patient or Caretaker.docx	Other-Recruitment Messages-Email For
Patient Interview-Recruitment Messages-Email-Patient Only.docx	Other-Recruitment Messages-Email-Pat
Patient Interview-Recruitment Messages-Email-Patient Only.docx	Other-Recruitment Messages-Email-Pat
Patient Interview-Recruitment Messages-Email-Patient or Caretaker.docx	Other-Recruitment Messages-Email-Pat
Patient Interview-Recruitment Messages-Email-Patient or Caretaker.docx	Other-Recruitment Messages-Email-Pat
Patient Interview-Recruitment Messages-Rally.docx	Other-Recruitment Messages-Rally
Patient Interview-Recruitment Messages-Rally.docx	Other-Recruitment Messages-Rally
Patient Interview-Recruitment Messages-Rally-Patient Only.docx	Other-Recruitment Messages-Rally-Pat
Patient Interview-Recruitment Messages-Rally-Patient Only.docx	Other-Recruitment Messages-Rally-Pat
Patient Interview-Recruitment Messages-Rally-Patient or Caretaker.docx	Other-Recruitment Messages-Rally-Pat
Patient Interview-Recruitment Messages-Rally-Patient or Caretaker.docx	Other-Recruitment Messages-Rally-Pat
Physician Interview-Alvimopan Guide.docx	Other-Patient Interview-Alvimopan Gu
Physician Interview-Alvimopan Guide.docx	Other-Patient Interview-Alvimopan Gu
Physician Interview-Fact Sheet.docx	Other-Fact Sheet
Physician Interview-Fact Sheet.docx	Other-Fact Sheet
Physician Survey-Ambrisentan.docx	Other-Physician Survey - Ambrisentan
Physician Survey-Ambrisentan.docx	Other-Physician Survey - Ambrisentan
Physician Survey-Bosentan.docx	Other-Physician Survey-Bosentan
Physician Survey-Bosentan.docx	Other-Physician Survey-Bosentan
Physician Survey-Clozapine.docx	Other-Physician Survey-Clozapine
Physician Survey-Clozapine.docx	Other-Physician Survey-Clozapine
Physician Survey-Isotretinoin.docx	Other-Physician Survey-Isotretinoin
Physician Survey-Isotretinoin.docx	Other-Physician Survey-Isotretinoin
Physician Survey-Lenalidomide-Pomalidomide-Thalidomide.docx	Other-Physician Survey-Lenalidomide-
Physician Survey-Lenalidomide-Pomalidomide-Thalidomide.docx	Other-Physician Survey-Lenalidomide-
Physician Survey-Sodium Oxybate.docx	Other-Physician Survey-Sodium Oxybat
Physician Survey-Sodium Oxybate.docx	Other-Physician Survey-Sodium Oxybat
0847 OMB Approval Memo - REMS Surveys 2022.docx OMB Approval Memo	IC Document
0847 OMB Approval Memo - REMS Surveys 2022.docx OMB Approval Memo	IC Document

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

Risk Evaluation and Mitigation Strategy (REMS) Programs to Promote Appropriate Medication Use and Knowledge: Physician 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	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Patient Guide	Yes	No	Printable Only
Other-Recruitment Messages-Email	Yes	No	Printable Only
Other-Recruitment Messages-Email Forward-Patient and Caretaker	Yes	No	Printable Only
Other-Recruitment Messages-Email-Patient Only	Yes	No	Printable Only
Other-Recruitment Messages-Email-Patient or Caretaker	Yes	No	Printable Only
Other-Recruitment Messages-Rally	Yes	No	Printable Only
Other-Recruitment Messages-Rally-Patient Only	Yes	No	Printable Only
Other-Recruitment Messages-Rally-Patient or Caretaker	Yes	No	Printable Only
Other-Patient Interview-Alvimopan Guide	Yes	No	Printable Only
Other-Fact Sheet	Yes	No	Printable Only
Other-Physician Survey - Ambrisentan	Yes	No	Printable Only
Other-Physician Survey-Bosentan	Yes	No	Printable Only
Other-Physician Survey-Clozapine	Yes	No	Printable Only
Other-Physician Survey-Isotretinoin	Yes	No	Printable Only
Other-Physician Survey-Lenalidomide-Pomalidomide-Thalidomide	Yes	No	Printable Only
Other-Physician Survey-Sodium Oxybate	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: 1,420

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	1,420	1,420
Annual IC Time Burden (Hours)	0	0
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
OMB Approval Memo		02/01/2022

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

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