Export of Medical Devices - Foreign Letters of Approval

ICR 200702-0910-005

OMB: 0910-0264

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
0000-00-00
IC Document Collections
ICR Details
0910-0264 200702-0910-005
Historical Active 200308-0910-002
HHS/FDA
Export of Medical Devices - Foreign Letters of Approval
Extension without change of a currently approved collection   No
Regular
Approved without change 04/27/2007
Retrieve Notice of Action (NOA) 02/20/2007
  Inventory as of this Action Requested Previously Approved
04/30/2010 36 Months From Approved 04/30/2007
25 0 20
63 0 50
0 0 0

The FDA has the statutory authority under sections CFR Part Section 801(e)(2) or the Act requires that a determination be made 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 is it 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 into the country.

Statute at Large: 21 Stat. 381 Name of Statute: null
  
None

Not associated with rulemaking

  71 FR 55487 09/22/2006
72 FR 7046 02/14/2006
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 25 20 0 5 0 0
Annual Time Burden (Hours) 63 50 0 13 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
There was an increase in the burden hours estimate (adjustment) due to an increase in the number of respondents since the last renewal request.

$22
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman

  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.
02/20/2007


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