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IDE Recordkeeping
Investigational Device Exemptions
OMB: 0910-0078
IC ID: 205260
OMB.report
HHS/FDA
OMB 0910-0078
ICR 202210-0910-013
IC 205260
( )
Documents and Forms
Document Name
Document Type
GFI Consent IVD human specimens April 2006.pdf
Other-Agency Guidance
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
IDE Recordkeeping
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 812
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Other-Agency Guidance
GFI Consent IVD human specimens April 2006.pdf
Yes
Yes
Fillable Fileable
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Immunization Management
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
1,200
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
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
6,065
0
0
-2,608
0
8,673
Annual IC Time Burden (Hours)
12,006
0
0
2,800
0
9,206
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.
