Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations

ICR 201401-0910-004

OMB: 0910-0748

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-01-07
IC Document Collections
ICR Details
0910-0748 201401-0910-004
Historical Active 201308-0910-002
HHS/FDA 21287
Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 03/12/2014
Retrieve Notice of Action (NOA) 01/14/2014
  Inventory as of this Action Requested Previously Approved
03/31/2017 36 Months From Approved
738 0 0
1,746 0 0
0 0 0

This ICR collects information from medical device manufacturers who wish to obtain market clearance for a device. Respondents must submit, as part of their premarket approval application (PMA) or product development protocol (PDP), PMA amendment, PMA supplement, or humanitarian device exemption (HDE), readily available information providing a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and the number of affected pediatric patients.

US Code: 21 USC 360e Name of Law: FFDCA
  
None

0910-AG29 Final or interim final rulemaking 79 FR 1735 01/10/2014

Yes

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 738 0 0 738 0 0
Annual Time Burden (Hours) 1,746 0 0 1,746 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Changing Regulations
No
This is a new information collection.

$8,325
No
No
No
No
No
Uncollected
JonnaLynn Capezzuto 301 827-4659 [email protected]

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
01/14/2014


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