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GFI: Medical Product Communications That Are Consistent with the FDA-Required Labeling – Questions and Answers
Medical Product Communications That Are Consistent With the Food and Drug Administration Required Labeling -Questions and Answers
OMB: 0910-0856
IC ID: 231802
OMB.report
HHS/FDA
OMB 0910-0856
ICR 202107-0910-006
IC 231802
( )
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:
GFI: Medical Product Communications That Are Consistent with the FDA-Required Labeling – Questions and Answers
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Unchanged
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
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:
324
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
0 %
Requested
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
9,720
0
0
0
0
9,720
Annual IC Time Burden (Hours)
38,880
0
0
0
0
38,880
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.