CDER - Information Packages

Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products

OMB: 0910-0429

IC ID: 189763

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)

CDER - Information Packages
 
No Modified
 
Voluntary
 
21 CFR 301

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Public Health Monitoring

 

756 0
   
Private Sector Businesses or other for-profits
 
   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 1,394 0 0 -311 0 1,705
Annual IC Time Burden (Hours) 25,092 0 0 -5,598 0 30,690
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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.

© 2024 OMB.report | Privacy Policy