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Application for Biosimilars - 351(l)(6)(C)
General Licensing Provisions; Section 351(k) Biosimilar Applications
OMB: 0910-0719
IC ID: 202640
OMB.report
HHS/FDA
OMB 0910-0719
ICR 201206-0910-004
IC 202640
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0719 can be found here:
2021-01-27 - No material or nonsubstantive change to a currently approved collection
2018-12-06 - 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:
Application for Biosimilars - 351(l)(6)(C)
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
New
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 601.2(a) and 601.60-601.65
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:
Illness Prevention
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:
0 %
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
2
0
0
Annual IC Time Burden (Hours)
4
0
0
4
0
0
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.