CBER: Records under 312.62(b) (individual case histories)

Investigational New Drug Regulations

OMB: 0910-0014

IC ID: 215567

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CBER: Records under 312.62(b) (individual case histories)
 
No Unchanged
 
Mandatory
 
21 CFR 312.62(b)

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

Health Public Health Monitoring

 

453 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 453 0 0 0 0 453
Annual IC Time Burden (Hours) 18,120 0 0 0 0 18,120
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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