CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies

Investigational New Drug Regulations

OMB: 0910-0014

IC ID: 189332

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: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies
 
No Unchanged
 
Mandatory
 
21 CFR 312.110-312.145

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

Health Consumer Health and Safety

 

1,463 0
   
Private Sector Businesses or other for-profits
 
   99 %

  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 12,563 0 0 0 0 12,563
Annual IC Time Burden (Hours) 413,715 0 0 0 0 413,715
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