OMB
.report
Search
Reporting and Recordkeeping
Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices
OMB: 0910-0741
IC ID: 206693
OMB.report
HHS/FDA
OMB 0910-0741
ICR 201803-0910-006
IC 206693
( )
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:
Reporting and Recordkeeping
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 807.87(j)
21 CFR 812.27(b)(4)
21 CFR 812.28(c)
21 CFR 812.28(b)
21 CFR 814.20
21 CFR 814.104
21 CFR 812.28(d)
21 CFR 812.140
21 CFR 812.28(a)(1)
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:
2,010
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
50 %
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
2,010
0
0
2,010
0
0
Annual IC Time Burden (Hours)
17,780
0
0
17,780
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.