65 FR 177 pgs. 55027-55028 - Agency Information Collection Activities; Submission for OMBReview; Comment Request; Export of Medical Devices—ForeignLetters of Approval
Type: NOTICEVolume: 65Number: 177Pages: 55027 - 55028
Docket number: [Docket No. 00N-1311]
FR document: [FR Doc. 00-23326 Filed 9-11-00; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00N-1311]
Agency Information Collection Activities; Submission for OMBReview; Comment Request; Export of Medical Devices-ForeignLetters of Approval
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) isannouncing that the proposed collection of information listedbelow has been submitted to the Office of Management and Budget(OMB) for review and clearance under the Paperwork Reduction Actof 1995.
DATES:
Submit written comments on the collection ofinformation by October 12, 2000.
ADDRESSES:
Submit written comments on the collectionof information to the Office of Information and RegulatoryAffairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm.10235, Washington, DC 20503, Attn: Wendy Taylor, Desk Officer forFDA.
FOR FURTHER INFORMATION CONTACT:
Peggy Schlosburg,Office of Information Resources Management (HFA 250), Food andDrug Administration, 5600 Fishers Lane, Rockville, MD 20857,301-827-1223.
SUPPLEMENTARY INFORMATION:
In compliance with 44U.S.C. 3507, FDA has submitted the following proposed collectionof information to OMB for review and clearance.
Export of Medical Devices-Foreign Letters of Approval-FederalFood, Drug, and Cosmetic Act-21 U.S.C. 381(e)(2) (OMB Control No.0910 0264)-Extension
Section 801(e)(2) of the Federal Food, Drug, and Cosmetic Act(the act) (21 U.S.C. 381(e)(2)) provides for the exportation ofan unapproved device under certain circumstances if theexportation is not contrary to the public health and safety andit has the approval of the foreign country to which it isintended for export.
Requesters communicate (either directly or through a businessassociate in the foreign country) with a representative of theforeign government to which they seek exportation, and writtenauthorization must be obtained from the appropriate office withinthe foreign government approving the importation of the medicaldevice. FDA uses the written authorization from the foreigncountry to determine whether the foreign country has anyobjection to the importation of the device into their country.
The respondents to this collection of information arecompanies that seek to export medical devices.
In the Federal Register of June 20, 2000 (65 FR 38288),the agency requested comments on the proposed collection ofinformation. No comments were received.
FDA estimates the burden of this collection of information asfollows:
| Statute | No. of Respondents | Annual Frequency per Response | Total Annual Responses | Hours per Response | Total Hours |
|---|---|---|---|---|---|
| Section 801(e)(2) of the Federal Food, Drug, and Cosmetic Act | 20 | 1 | 20 | 2.5 | 50 |
| Total | 50 | ||||
| 1 There are no capital costs or operating and maintenancecosts associated with this collection of information. | |||||
These estimates are based on the experience of FDA's medicaldevice program personnel, who estimate that completion of therequirements of this collection of information should takeapproximately 2.5 hours to complete. Prior to the enactment ofthe Food and Drug Export Reform and Enhancement Act of 1996, FDAreceived approximately 800 requests from U.S. firms to export medical devices under section 801(e)(2) of the act. The enactmentof the Food and Drug Export Reform and Enhancement Act of 1996has greatly reduced the number of export permit requests made tothe present estimated 20 per year.
Dated: September 5, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, andLegislation.
[FR Doc. 00-23326 Filed 9-11-00; 8:45 am]
BILLING CODE 4160-01-F