Export of Medical Devices - Foreign Letters of Approval

ICR 201608-0910-002

OMB: 0910-0264

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-08-19
IC Document Collections
IC ID
Document
Title
Status
5838
Modified
ICR Details
0910-0264 201608-0910-002
Historical Active 201307-0910-002
HHS/FDA CDRH
Export of Medical Devices - Foreign Letters of Approval
Extension without change of a currently approved collection   No
Regular
Approved without change 09/30/2016
Retrieve Notice of Action (NOA) 08/22/2016
  Inventory as of this Action Requested Previously Approved
09/30/2019 36 Months From Approved 09/30/2016
38 0 38
114 0 114
9,500 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

  81 FR 23720 04/22/2016
81 FR 55462 08/19/2016
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 38 38 0 0 0 0
Annual Time Burden (Hours) 114 114 0 0 0 0
Annual Cost Burden (Dollars) 9,500 9,500 0 0 0 0
No
No

$56,697
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.
08/22/2016


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