[Federal Register Volume 84, Number 143 (Thursday, July 25, 2019)] [Notices] [Pages 35874-35875] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2019-15790] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0370] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) 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. [[Page 35875]] DATES: Fax written comments on the collection of information by August 26, 2019. ADDRESSES: 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 protected]. 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. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]. SUPPLEMENTARY 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 (FD&C Act) (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 March 11, 2019 (84 FR 8727), 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: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Total Number of responses Total annual Average operating and Activity/FD&C Act section respondents per responses burden per Total hours maintenance respondent response costs -------------------------------------------------------------------------------------------------------------------------------------------------------- Foreign letter of approval--801(e)(2)............................. 33 1 33 3 99 $8,250 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs associated with this collection of information. We have adjusted our burden estimate by decreasing the number of respondents by 5, which has resulted in a corresponding decrease of 15 hours to the currently approved hour burden and $1,250 to the total operating and maintenance costs. This adjustment is based on a decrease in the number of submissions we received over the last few years. Dated: July 19, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019-15790 Filed 7-24-19; 8:45 am] BILLING CODE 4164-01-P