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Agenda
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ICR
View Information Collection (IC)
View Information Collection (IC)
IC Title:
.46.116(a) and (b) (Pre-2018 Requirements)/ .46.116 (b), (c) and (d) [2018 Requirements] – Elements of informed consent and broad consent
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
New
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 %
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
150,000
0
150,000
0
0
0
Annual IC Time Burden (Hours)
75,000
0
75,000
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.
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The .gov means it's official.
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