Information Collection

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

IC 250492 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⚠️ Notice: This information collection may be referencing outdated material.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
Invitation Letter.docx	Other-Invitation
Invitation Letter.docx	Other-Invitation
Consent Form.docx	Other-Consent Form
Consent Form.docx	Other-Consent Form
Physician Survey - Ambrisentan.docx	Other-Survey - Ambrisentan
Physician Survey - Ambrisentan.docx	Other-Survey - Ambrisentan
Physician Survey - Bosentan.docx	Other-Survey - Bosentan
Physician Survey - Bosentan.docx	Other-Survey - Bosentan
Physician Survey - Clozapine.docx	Other-Survey - Clozapine
Physician Survey - Clozapine.docx	Other-Survey - Clozapine
Physician Survey - Isotretinoin.docx	Other-Survey - Isotretinoin
Physician Survey - Isotretinoin.docx	Other-Survey - Isotretinoin
Physician Survey - Lenalidomide-Pomalidomide-Thalidomide.docx	Other-Survey - Lenalidomide-Pomalido
Physician Survey - Lenalidomide-Pomalidomide-Thalidomide.docx	Other-Survey - Lenalidomide-Pomalido
Physician Survey - Sodium Oxybate.docx	Other-Survey - Sodium Oxybate
Physician Survey - Sodium Oxybate.docx	Other-Survey - Sodium Oxybate
Reminder Letter.docx	Other-Reminder Letter
Reminder Letter.docx	Other-Reminder Letter
IRB Approval Letter 2021P002109.pdf	Other-IRB Letter
IRB Approval Letter 2021P002109.pdf	Other-IRB Letter
0847 OMB Approval Memo - REMS Physician Experience Surveys 2021.docx OMB Approval Memo	IC Document
0847 OMB Approval Memo - REMS Physician Experience Surveys 2021.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	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Invitation	Invitation Letter.docx	Yes	No	Paper Only
Other-Consent Form	Consent Form.docx	Yes	No	Paper Only
Other-Survey - Ambrisentan	Physician Survey - Ambrisentan.docx	Yes	Yes	Fillable Fileable
Other-Survey - Bosentan	Physician Survey - Bosentan.docx	Yes	Yes	Fillable Fileable
Other-Survey - Clozapine	Physician Survey - Clozapine.docx	Yes	Yes	Fillable Fileable
Other-Survey - Isotretinoin	Physician Survey - Isotretinoin.docx	Yes	Yes	Fillable Fileable
Other-Survey - Lenalidomide-Pomalidomide-Thalidomide	Physician Survey - Lenalidomide-Pomalidomide-Thalidomide.docx	Yes	Yes	Fillable Fileable
Other-Survey - Sodium Oxybate	Physician Survey - Sodium Oxybate.docx	Yes	Yes	Fillable Fileable
Other-Reminder Letter	Reminder Letter.docx	Yes	No	Printable Only
Other-IRB Letter	IRB Approval Letter 2021P002109.pdf	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: 1,200

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	1,200	1,200
Annual IC Time Burden (Hours)	400	400
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 Physician Experience Surveys 2021.docx	11/23/2021

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