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Requests for Tier-Two Dispute Resolution
Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
OMB: 0910-0563
IC ID: 214490
OMB.report
HHS/FDA
OMB 0910-0563
ICR 201804-0910-007
IC 214490
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0563 can be found here:
2021-04-14 - 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:
Requests for Tier-Two Dispute Resolution
Agency IC Tracking Number:
CDER
Is this a Common Form?
No
IC Status:
Unchanged
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
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:
1
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
1
0
0
0
0
1
Annual IC Time Burden (Hours)
8
0
0
0
0
8
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.