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Investigational Device Exemptions Reports and Records - 21 CFR 812
Investigational Device Exemptions Reports and Records - 21 CFR 812
OMB: 0910-0078
IC ID: 5717
OMB.report
HHS/FDA
OMB 0910-0078
ICR 200007-0910-001
IC 5717
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0078 can be found here:
2022-11-22 - Revision of a currently approved collection
2021-05-19 - No material or nonsubstantive change to a currently approved collection
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:
Investigational Device Exemptions Reports and Records - 21 CFR 812
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Migrated
Obligation to Respond:
Mandatory
CFR Citation:
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:
Subfunction:
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
600
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
0 %
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
4,527
0
0
882
0
3,645
Annual IC Time Burden (Hours)
61,021
0
0
14,750
0
46,271
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.