Expanded Access Records - Initial

Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)

OMB: 0925-0586

IC ID: 239368

Information Collection (IC) Details

View Information Collection (IC)

Expanded Access Records - Initial
 
No New
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction 5 Expanded Access Record Data Element Definitions and Data Entry Form Attachment 3 - Expanded Access Record Data Element Definitions and Data Entry Forms.pdf Yes Yes Fillable Fileable

Health Health Care Services

 

213 0
   
Individuals or Households
 
   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 213 0 213 0 0 0
Annual IC Time Burden (Hours) 426 0 426 0 0 0
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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