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.

Documents and Forms

Documents and forms in this information collection
Document NameDocument 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)

layout table

Information Collection Instruments:
table that charts list of instruments
Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Patient Guide Patient Interview-Guide.docx Yes No Printable Only
Other-Recruitment Messages-Email Patient Interview-Recruitment Messages-Email Forward-Patient Only.docx Yes No Printable Only
Other-Recruitment Messages-Email Forward-Patient and Caretaker Patient Interview-Recruitment Messages-Email Forward-Patient or Caretaker.docx Yes No Printable Only
Other-Recruitment Messages-Email-Patient Only Patient Interview-Recruitment Messages-Email-Patient Only.docx Yes No Printable Only
Other-Recruitment Messages-Email-Patient or Caretaker Patient Interview-Recruitment Messages-Email-Patient or Caretaker.docx Yes No Printable Only
Other-Recruitment Messages-Rally Patient Interview-Recruitment Messages-Rally.docx Yes No Printable Only
Other-Recruitment Messages-Rally-Patient Only Patient Interview-Recruitment Messages-Rally-Patient Only.docx Yes No Printable Only
Other-Recruitment Messages-Rally-Patient or Caretaker Patient Interview-Recruitment Messages-Rally-Patient or Caretaker.docx Yes No Printable Only
Other-Patient Interview-Alvimopan Guide Physician Interview-Alvimopan Guide.docx Yes No Printable Only
Other-Fact Sheet Physician Interview-Fact Sheet.docx Yes No Printable Only
Other-Physician Survey - Ambrisentan Physician Survey-Ambrisentan.docx Yes No Printable Only
Other-Physician Survey-Bosentan Physician Survey-Bosentan.docx Yes No Printable Only
Other-Physician Survey-Clozapine Physician Survey-Clozapine.docx Yes No Printable Only
Other-Physician Survey-Isotretinoin Physician Survey-Isotretinoin.docx Yes No Printable Only
Other-Physician Survey-Lenalidomide-Pomalidomide-Thalidomide Physician Survey-Lenalidomide-Pomalidomide-Thalidomide.docx Yes No Printable Only
Other-Physician Survey-Sodium Oxybate Physician Survey-Sodium Oxybate.docx Yes No Printable Only

Federal Enterprise Architecture Business Reference Module


table that charts list of burden
  Requested Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 1,420 0 0 0 0 1,420
Annual IC Time Burden (Hours) 0 0 0 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Documents for IC
table that charts IC Documents
Title Document Date Uploaded
OMB Approval Memo 0847 OMB Approval Memo - REMS Surveys 2022.docx 02/01/2022
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.