Reporting: FDAAA Section 520(m)(6)(A)(iii)- Immediate Notification to The Agency by HDE Holders if ADN Number is Exceed During the calendar Year.

Guidance: Humanitarian Device Exemption Regulation: Questions and Answers

OMB: 0910-0661

IC ID: 192260

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Other-Buidance: HDE Holders- Questio
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Reporting: FDAAA Section 520(m)(6)(A)(iii)- Immediate Notification to The Agency by HDE Holders if ADN Number is Exceed During the calendar Year.
 
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Required to Obtain or Retain Benefits
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Buidance: HDE Holders- Questions and Answers Guidance - HDE-Questions and Answers.doc Yes No Printable Only

Health Consumer Health and Safety

 

1 0
   
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   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 0 0 1
Annual IC Time Burden (Hours) 100 0 0 0 0 100
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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