Procedures for Amending an Incomplete PMA or Resubmitting a Withdrawn PMA With any Information Concerning Potential Pediatric Uses

Companion Proposed Rule: Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations

OMB: 0910-0748

IC ID: 192786

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

View Information Collection (IC)

Procedures for Amending an Incomplete PMA or Resubmitting a Withdrawn PMA With any Information Concerning Potential Pediatric Uses
 
No New
 
Mandatory
 
21 CFR 814.37(b)(2)

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

Health Consumer Health and Safety

 

10 0
   
Private Sector Businesses or other for-profits
 
   0 %

  Requested 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 10 10 0 0 0 0
Annual IC Time Burden (Hours) 40 40 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