87 FR 164 pgs. 52388-52389 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval
Type: NOTICEVolume: 87Number: 164Pages: 52388 - 52389
Pages: 52388, 52389Docket number: [Docket No. FDA-2013-N-0370]
FR document: [FR Doc. 2022-18326 Filed 8-24-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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) 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.
DATES:
Submit written comments (including recommendations) on the collection of information by September 26, 2022.
ADDRESSES:
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting "Currently under Review-Open for Public Comments" or by using the search function. The OMB control number for this information collection is 0910-0264. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov.
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
[top] 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
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. Respondents to this collection of information are companies that seek to export medical devices.
In the Federal Register of January 28, 2022 (87 FR 4609) we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
We estimate the burden of the collection of information as follows:
| Activity and FD&C Act section | 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-801(e)(2) | 36 | 1 | 36 | 2 | 72 | $8,250 |
| 1 ?There are no capital costs associated with this collection of information. | ||||||
Our estimate of the reporting burden is based on our experience with the information collection and reflects an overall decrease of 27 hours and a corresponding increase of three responses. We attribute this adjustment to an increase in the number of submissions received.
Dated: August 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18326 Filed 8-24-22; 8:45 am]
BILLING CODE 4164-01-P