This PDF is the current document as it appeared on Public Inspection on 08/18/2016 at 08:45 am.
Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by September 19, 2016.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to email@example.com. All comments should be identified with the OMB control number 0910-0264. Also include the FDA docket number found in brackets in the heading of this document.Start Further Info
FOR FURTHER INFORMATION CONTACT:
FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.End Further Info End Preamble Start Supplemental Information
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Export of Medical Devices; Foreign Letters of Approval—OMB Control Number 0910-0264—Extension
Section 801(e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) Start Printed Page 55463(21 U.S.C. 381(e)(2)) provides for the exportation of an unapproved device 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 the provisions of 18 U.S.C. 1001. This statutory provision makes 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.
In the Federal Register of April 22, 2016 (81 FR 23720), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
FDA estimates the burden of this collection of information as follows:
|Activity/Section of FD&C Act||Number of respondents||Number of responses per respondent||Total annual responses||Average burden per response||Total hours||Total operating and maintenance costs|
|Foreign letter of approval—section 801(e)(2)||38||1||38||3||114||$9,500|
|1 There are no capital costs associated with this collection of information.|
Dated: August 15, 2016.
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2016-19807 Filed 8-18-16; 8:45 am]
BILLING CODE 4164-01-P