Export of Medical Devices - Foreign Letters of Approval

ICR 201907-0910-025

OMB: 0910-0264

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-07-30
IC Document Collections
IC ID
Document
Title
Status
5838
Modified
ICR Details
0910-0264 201907-0910-025
Active 201608-0910-002
HHS/FDA CDRH
Export of Medical Devices - Foreign Letters of Approval
Extension without change of a currently approved collection   No
Regular
Approved without change 08/27/2019
Retrieve Notice of Action (NOA) 07/30/2019
  Inventory as of this Action Requested Previously Approved
08/31/2022 36 Months From Approved 09/30/2019
33 0 38
99 0 114
8,250 0 9,500

Exportation of an unapproved device may be permitted under certain circumstances if the exportation is not contrary to the public health and safety and it has the approval of the foreign country to which it is intended for export. Requesters communicate (either directly or through a business associate in the foreign country) with a representative of the foreign government to which they seek exportation, and written authorization must be obtained from the appropriate office within the foreign government approving the importation of the medical device. An alternative to obtaining written authorization from the foreign government is to accept a notarized certification from a responsible company official in the United States that the product is not in conflict with the foreign country's laws. This certification must include a statement acknowledging that the responsible company official making the certification is subject to certain statutory provisions that make it a criminal offense to knowingly and willingly make a false or fraudulent statement, or make or use a false document, in any manner within the jurisdiction of a department or agency of the United States. The respondents to this collection of information are companies that seek to export medical devices. FDA's estimate of the reporting burden is based on the experience of FDA's medical device program personnel.

US Code: 21 USC 381-801 Name of Law: FD&C - Imports and Exports
  
None

Not associated with rulemaking

  84 FR 8728 03/11/2019
84 FR 35874 07/25/2019
No

1
IC Title Form No. Form Name
Export of Medical Devices - Foreign Letters of Approval

  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 33 38 0 0 -5 0
Annual Time Burden (Hours) 99 114 0 0 -15 0
Annual Cost Burden (Dollars) 8,250 9,500 0 0 -1,250 0
No
No
We have adjusted our burden estimate by decreasing the number of respondents by 5, which has resulted in a corresponding decrease of 15 hours to the currently approved hour burden and $1,250 to the total operating and maintenance costs. This adjustment is based on a decrease in the number of submissions we received over the last few years.

$540,610
No
    Yes
    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.
07/30/2019


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