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

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Invitation Yes No Paper Only
Other-Consent Form Yes No Paper Only
Other-Survey - Ambrisentan Yes Yes Fillable Fileable
Other-Survey - Bosentan Yes Yes Fillable Fileable
Other-Survey - Clozapine Yes Yes Fillable Fileable
Other-Survey - Isotretinoin Yes Yes Fillable Fileable
Other-Survey - Lenalidomide-Pomalidomide-Thalidomide Yes Yes Fillable Fileable
Other-Survey - Sodium Oxybate Yes Yes Fillable Fileable
Other-Reminder Letter Yes No Printable Only
Other-IRB Letter Yes No Printable Only

Health Health Care Services

 

1,200 0
   
Individuals or Households
 
   0 %

  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 1,200 0 0 0 0 1,200
Annual IC Time Burden (Hours) 400 0 0 0 0 400
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
OMB Approval Memo 11/23/2021
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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