81 FR 161 pgs. 55462-55463 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval
Type: NOTICEVolume: 81Number: 161Pages: 55462 - 55463
Pages: 55462, 55463Docket number: [Docket No. FDA-2013-N-0370]
FR document: [FR Doc. 2016-19807 Filed 8-18-16; 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:
Fax written comments on the collection of information by September 19, 2016.
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 oira_submission@omb.eop.gov. 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:
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.
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 (the FD&C Act)
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.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2016-19807 Filed 8-18-16; 8:45 am]
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