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Safety Labeling Changes (Section 505(o)(4) of the FD&C Act)-- Rebuttal Statemen
Labeling Requirements for Human Prescription Drug and Biological Products
OMB: 0910-0572
IC ID: 251544
OMB.report
HHS/FDA
OMB 0910-0572
ICR 202202-0910-001
IC 251544
( )
Documents and Forms
Document Name
Document Type
GFI_Safety Labeling Changes —Implementation of Section 505(o)(4) of the FD&C Act.pdf
www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-labeling-changes-implementation-section-505o4-fe
Instruction
GFI_Safety Labeling Changes —Implementation of Section 505(o)(4) of the FD&C Act.pdf
www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-labeling-changes-implementation-section-505o4-fe
Instruction
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Safety Labeling Changes (Section 505(o)(4) of the FD&C Act)-- Rebuttal Statemen
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
New
Obligation to Respond:
Voluntary
CFR Citation:
21 CFR 601
21 CFR 314
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Instruction
GFI_Safety Labeling Changes —Implementation of Section 505(o)(4) of the FD&C Act.pdf
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-labeling-changes-implementation-section-505o4-federal-food-drug-and-cosmetic-act
Yes
Yes
Printable 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:
36
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
36
0
0
36
0
0
Annual IC Time Burden (Hours)
216
0
0
216
0
0
Annual IC Cost Burden (Dollars)
16,200
0
0
16,200
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.
