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

ICR 201703-0910-003

OMB: 0910-0748

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2017-03-15
IC Document Collections
ICR Details
0910-0748 201703-0910-003
Historical Active 201401-0910-004
HHS/FDA CDRH
Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations
Extension without change of a currently approved collection   No
Regular
Approved without change 05/18/2017
Retrieve Notice of Action (NOA) 03/15/2017
  Inventory as of this Action Requested Previously Approved
05/31/2020 36 Months From Approved 05/31/2017
745 0 738
1,760 0 1,746
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

Not associated with rulemaking

  81 FR 91181 12/16/2016
82 FR 13825 03/15/2017
No

  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 745 738 0 0 7 0
Annual Time Burden (Hours) 1,760 1,746 0 0 14 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We made a minor adjustment to the number of respondents which caused a 14-hour increase in the total burden estimate.

$10,676
No
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [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.
03/15/2017


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