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Justification Submitted as General Correspondent and in the Annual Report
Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices
OMB: 0910-0638
IC ID: 188042
OMB.report
HHS/FDA
OMB 0910-0638
ICR 201411-0910-001
IC 188042
( )
Documents and Forms
Document Name
Document Type
GUIDANCE 11-3-14.pdf
Other-Final Guidance
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Justification Submitted as General Correspondent and in the Annual Report
Agency IC Tracking Number:
CDER
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Voluntary
CFR Citation:
21 CFR 201.57(c)(2)(i)(C)
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Other-Final Guidance
GUIDANCE 11-3-14.pdf
Yes
No
Paper Only
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Public Health Monitoring
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
2
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
2
0
0
0
0
2
Annual IC Time Burden (Hours)
32
0
0
0
0
32
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.