CBER- Meeting Requests

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

OMB: 0910-0429

IC ID: 189762

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

View Information Collection (IC)

CBER- Meeting Requests CDER
 
No Modified
 
Voluntary
 
21 CFR 312.47 21 CFR 312.82

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance FINAL GUIDANCE 0429 10-16-2015.pdf Yes Yes Paper Only

Health Health Care Services

 

175 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 264 0 0 11 0 253
Annual IC Time Burden (Hours) 2,640 0 0 110 0 2,530
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