(CDER) Submissions related to expanded access and treatment of an intermediate-size patient population

Expanded Access to Investigational Drugs for Treatment Use

OMB: 0910-0814

IC ID: 253119

Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details

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(CDER) Submissions related to expanded access and treatment of an intermediate-size patient population
 
No Removed
 
Required to Obtain or Retain Benefits
 
21 CFR 312

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

Health Consumer Health and Safety

 

88 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 0 0 0 -317 0 317
Annual IC Time Burden (Hours) 0 0 0 -38,040 0 38,040
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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