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Special Protocol Assessment Guidance
Special Protocol Assessment Guidance
OMB: 0910-0470
IC ID: 6167
OMB.report
HHS/FDA
OMB 0910-0470
ICR 200708-0910-002
IC 6167
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0470 can be found here:
2020-04-27 - Revision of a currently approved collection
2017-03-15 - Extension without change of a currently approved collection
Documents and Forms
Document Name
Document Type
guidance.pdf
Other-guidance
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Special Protocol Assessment Guidance
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
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-guidance
guidance.pdf
No
No
Printable Only
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Public Health Monitoring
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
151
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
75 %
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
374
0
0
40
0
334
Annual IC Time Burden (Hours)
5,610
0
0
887
0
4,723
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.