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Time and Extent Application; Reporting Activities
Time and Extent Applications for Nonprescription Drug Products
OMB: 0910-0688
IC ID: 197086
OMB.report
HHS/FDA
OMB 0910-0688
ICR 202305-0910-005
IC 197086
( )
Documents and Forms
Document Name
Document Type
GUIDANCE TEA 3-3-14.pdf
Other-Guidance
GUIDANCE TEA 3-3-14.pdf
Other-Guidance
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Time and Extent Application; Reporting Activities
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 330.14
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Other-Guidance
GUIDANCE TEA 3-3-14.pdf
No
Paper Only
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:
1
Number of Respondents for Small Entity:
0
Affected Public:
Individuals or Households
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
1
-8
0
0
0
9
Annual IC Time Burden (Hours)
862
-6,894
0
0
0
7,756
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.