Export of Medical Devices - Foreign Letters of Approval

Forms and Documents

Document Name	Status
0910-0264 SS 3 10 2010 final.doc Supporting Statement A	2010-03-29

IC Document Collections

IC ID	Document Title	Status
5838	Export of Medical Devices - Foreign Letters of Approval	Modified

ICR Details

OMB Control No: 0910-0264	ICR Reference No: 201004-0910-005
Status: Historical Active	Previous ICR Reference No: 200702-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Export of Medical Devices - Foreign Letters of Approval
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/29/2010
	Date Received in OIRA: 04/19/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2013	36 Months From Approved	08/31/2010
Responses	38	0	25
Time Burden (Hours)	114	0	63
Cost Burden (Dollars)	6,250	0	0

---

Abstract: 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.

---

Authorizing Statute(s): US Code: 21 USC 381-801 Name of Law: FD&C - Imports and Exports
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 4086	01/25/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 19651	04/15/2010
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 1

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

---

ICR Summary of Burden

	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	25	0	0	13	0
Annual Time Burden (Hours)	114	63	0	0	51	0
Annual Cost Burden (Dollars)	6,250	0	0	0	6,250	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

---

Annual Cost to Federal Government: $22,880

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 04/19/2010

---