Reporting-FDAAA, Section 520(m)(6)(A)(ii)- Assignment of Annual distribution Number ( ADN) for Devices Indicated For Pediatric Patients

Guidance: Humanitarian Device Exemption Regulation: Questions and Answers

OMB: 0910-0661

IC ID: 192259

Documents and Forms
Document Name
Document Type
Other-Guidance: HDE-Questions and An
Information Collection (IC) Details

View Information Collection (IC)

Reporting-FDAAA, Section 520(m)(6)(A)(ii)- Assignment of Annual distribution Number ( ADN) for Devices Indicated For Pediatric Patients
 
No New
 
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: HDE-Questions and Answers Guidance - HDE-Questions and Answers.doc Yes No Printable Only

Health Consumer Health and Safety

 

3 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 3 3 0 0 0 0
Annual IC Time Burden (Hours) 150 150 0 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
No associated records found
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

© 2024 OMB.report | Privacy Policy