OMB
.report
Search
Biowaiver request: powder oral dosage form, using same API/solubility approach
Abbreviated New Animal Drug Applications
OMB: 0910-0669
IC ID: 237370
OMB.report
HHS/FDA
OMB 0910-0669
ICR 202202-0910-008
IC 237370
( )
Documents and Forms
Document Name
Document Type
GFI171.pdf
Other-Guidance
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Biowaiver request: powder oral dosage form, using same API/solubility approach
Agency IC Tracking Number:
CVM
Is this a Common Form?
No
IC Status:
Modified
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
Other-Guidance
GFI171.pdf
Yes
No
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:
5
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
100 %
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
5
0
0
0
0
5
Annual IC Time Burden (Hours)
50
0
0
0
0
50
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.