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Biological Products: Reporting of Biological Product Deviations in Manufacturing
Biological Products: Reporting of Biological Product Deviations in Manufacturing
OMB: 0910-0458
IC ID: 6151
OMB.report
HHS/FDA
OMB 0910-0458
ICR 200401-0910-001
IC 6151
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0458 can be found here:
2023-01-24 - Extension without change of a currently approved collection
2020-01-10 - Extension without change of a currently approved collection
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:
Biological Products: Reporting of Biological Product Deviations in Manufacturing
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Migrated
Obligation to Respond:
Mandatory
CFR Citation:
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Form
3486
Yes
Yes
Federal Enterprise Architecture Business Reference Module
Line of Business:
Subfunction:
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
6,343
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
40 %
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
33,922
0
-26,829
0
0
60,751
Annual IC Time Burden (Hours)
67,844
0
-193,804
0
0
261,648
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.