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.115 [Pre-2018 and 2018 Requirement] – Preparation and documentation of IRB activities
Protection of Human Subjects: Common Rule (56 FR 28001)
OMB: 0990-0260
IC ID: 187691
OMB.report
HHS/HHSDM
OMB 0990-0260
ICR 202407-0990-001
IC 187691
( )
Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
.115 [Pre-2018 and 2018 Requirement] – Preparation and documentation of IRB activities
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Mandatory
CFR Citation:
45 CFR 46
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
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:
6,000
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits, Not-for-profit institutions
Percentage of Respondents Reporting Electronically:
25 %
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
96,000
0
0
0
0
96,000
Annual IC Time Burden (Hours)
1,152,000
0
0
0
0
1,152,000
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.