Pediatric Subpopulation and Patient Information

Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements

OMB: 0910-0661

IC ID: 192258

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

View Information Collection (IC)

Pediatric Subpopulation and Patient Information
No Modified
Required to Obtain or Retain Benefits

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance; Humanitarian Device Exemption (HDE) Regulation: Questions and Answers 0661_Guidance_2019.pdf Yes No Printable Only

Health Consumer Health and Safety


1 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 1 0 0 -5 0 6
Annual IC Time Burden (Hours) 100 0 0 -500 0 600
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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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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