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Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products
Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products
OMB: 0910-0429
IC ID: 6097
OMB.report
HHS/FDA
OMB 0910-0429
ICR 200906-0910-004
IC 6097
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0429 can be found here:
2020-02-13 - Reinstatement with change of a previously approved collection
2015-10-21 - 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:
Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Voluntary
CFR Citation:
21 CFR 301
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:
Public Health Monitoring
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
906
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
2,211
0
0
-1,431
0
3,642
Annual IC Time Burden (Hours)
22,110
0
0
-26,894
0
49,004
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.