OMB
.report
Search
Annual Report for Custom Devices
Annual Reporting for Custom Device Exemption
OMB: 0910-0767
IC ID: 211453
OMB.report
HHS/FDA
OMB 0910-0767
ICR 202008-0910-011
IC 211453
( )
Documents and Forms
Document Name
Document Type
0767_custom device exemption guidance_2017.pdf
Other-Guidance document
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Annual Report for Custom Devices
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Voluntary
CFR Citation:
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Other-Guidance document
0767_custom device exemption guidance_2017.pdf
Yes
Yes
Fillable Fileable
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:
34
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
34
0
0
1
0
33
Annual IC Time Burden (Hours)
1,360
0
0
40
0
1,320
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.