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OTC Hearing Aids Final Rule - One Time Burden
Medical Device Labeling Requirements
OMB: 0910-0485
IC ID: 255348
OMB.report
HHS/FDA
OMB 0910-0485
ICR 202308-0910-004
IC 255348
( )
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:
OTC Hearing Aids Final Rule - One Time Burden
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Unchanged
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 800; 801; 808; 874 (To search for a specific CFR, visit the
Code of Federal Regulations.
)
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:
105
Number of Respondents for Small Entity:
100
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
95 %
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
945
0
0
0
0
945
Annual IC Time Burden (Hours)
87,570
0
0
0
0
87,570
Annual IC Cost Burden (Dollars)
10,100,000
0
0
0
0
10,100,000
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.