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Main Study Screener
Study of Disclosures to Health Care Providers Regarding Data that Do Not Support Unapproved Use of an Approved Prescription Drug
OMB: 0910-0900
IC ID: 248044
OMB.report
HHS/FDA
OMB 0910-0900
ICR 202106-0910-014
IC 248044
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0900 can be found here:
2022-07-29 - No material or nonsubstantive change to a currently approved collection
2022-04-18 - No material or nonsubstantive change to a currently approved collection
Documents and Forms
Document Name
Document Type
Appendix A - Informed Consent.docx
Other-Informed Consent
Appendix A - Informed Consent.docx
Other-Informed Consent
Appendix C - Recruitment Email and Screener.docx
Other-Recruitment Email and Screener
Appendix C - Recruitment Email and Screener.docx
Other-Recruitment Email and Screener
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Main Study Screener
Agency IC Tracking Number:
CDER
Is this a Common Form?
No
IC Status:
New
Obligation to Respond:
Voluntary
CFR Citation:
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Other-Informed Consent
Appendix A - Informed Consent.docx
Yes
Yes
Fillable Fileable
Other-Recruitment Email and Screener
Appendix C - Recruitment Email and Screener.docx
Yes
Yes
Fillable Fileable
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:
2,526
Number of Respondents for Small Entity:
0
Affected Public:
Individuals or Households
Percentage of Respondents Reporting Electronically:
100 %
Approved
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
2,526
0
2,526
0
0
0
Annual IC Time Burden (Hours)
202
0
202
0
0
0
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
No associated records found
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.