Export of Medical Devices, Foreign Letters of Approval

ICR 199710-0910-002

OMB: 0910-0264

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
5836
Migrated
ICR Details
0910-0264 199710-0910-002
Historical Active 199305-0910-002
HHS/FDA
Export of Medical Devices, Foreign Letters of Approval
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 11/25/1997
Retrieve Notice of Action (NOA) 10/06/1997
OMB notes that FDA allowed approval of this collection to lapse while collections remained active which is a violation of the Paperwork Reduction Act of 1995. FDA shall take additional steps to ensure such lapses do not occur in the future.
  Inventory as of this Action Requested Previously Approved
11/30/2000 11/30/2000
1 0 0
20 0 0
0 0 0

The FDA has the statutory authority under CFR section 801(e)(2) or the Act to make a determination that the exportation of an unapproved medical device has the approval of the foreign country to which it is intended for export; i.e., that it is not in conflict with the laws of the country to which it is intended for export and/or has the approval of the foreign country. In order to make such a determination, the manufacturer/exporter is required to obtain a letter from the foreign government approving the importation of the medical device in question.

None
None


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 1 0 0 1 0 0
Annual Time Burden (Hours) 20 0 0 20 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
10/06/1997


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