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BE Supplements/Amendments - ODG
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
OMB: 0910-0616
IC ID: 214358
OMB.report
HHS/FDA
OMB 0910-0616
ICR 202011-0910-004
IC 214358
( )
Documents and Forms
Document Name
Document Type
Guidance.pdf
Other-Guidance
Guidance.pdf
Other-Guidance
FDA 3674 Certification of Compliance
Form_3674.pdf
Form
FDA 3674 Certification of Compliance
Form_3674.pdf
Form
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
BE Supplements/Amendments - ODG
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Removed
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
FDA 3674
Certification of Compliance
Form_3674.pdf
Yes
Yes
Fillable Fileable Signable
Other-Guidance
Guidance.pdf
Yes
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:
698
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits, Not-for-profit institutions
Percentage of Respondents Reporting Electronically:
70 %
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
0
0
-698
0
0
698
Annual IC Time Burden (Hours)
0
0
-524
0
0
524
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.