CDER - Requests for Formal Dispute Resolution

Guidance for Industry on Formal Dispute Resolutions; Appeals Above the Division Level

OMB: 0910-0430

IC ID: 6100

Documents and Forms
Document Name
Document Type
Other-Guidance
Information Collection (IC) Details

View Information Collection (IC)

CDER - Requests for Formal Dispute Resolution CDER
 
No Modified
 
Voluntary
 
21 CFR 314 21 CFR 312

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance FINAL GUIDANCE 0430 10-16-2015.pdf Yes Yes Paper Only

Health Health Care Services

 

8 0
   
Private Sector Businesses or other for-profits
 
   100 %

  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 31 0 13 0 0 18
Annual IC Time Burden (Hours) 248 0 104 0 0 144
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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