Transfer of a Premarket Notification Clearance

ICR 201803-0910-002

OMB: 0910-0852

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2018-03-02
ICR Details
0910-0852 201803-0910-002
Active
HHS/FDA CDRH
Transfer of a Premarket Notification Clearance
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 05/15/2018
Retrieve Notice of Action (NOA) 03/14/2018
  Inventory as of this Action Requested Previously Approved
05/31/2021 36 Months From Approved
6,113 0 0
9,152 0 0
0 0 0

This ICR collects information from premarket notification (510(k)) clearance holders and parties claiming to be 510(k) holders who wish to voluntarily report a transfer of 510(k) clearance on FDA’s Unified Registration and Listing System (FURLS), outside of the required listing reporting and the annual listing reporting requirement, or who submit 510(k) transfer documentation when more than one party lists the same 510(k). The information notifies FDA of the transfer of a premarket notification clearance from one holder to another and helps to ensure that the public information in FDA’s databases about the current 510(k) holder for a specific device(s) is accurate and up-to-date.

None
None

Not associated with rulemaking

  79 FR 76331 12/22/2014
83 FR 10862 03/13/2018
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 6,113 0 0 6,113 0 0
Annual Time Burden (Hours) 9,152 0 0 9,152 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
New collection

$306,800
No
    No
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

  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.
03/14/2018


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