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Notice

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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 (the PRA).

DATES:

Fax written comments on the collection of information by May 20, 2010.

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 e-mailed to oira_submission@eop.gov. All comments should be identified with the OMB control number 0910-0449. Also include the FDA docket number found in brackets in the heading of this document.

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FOR FURTHER INFORMATION CONTACT:

Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156, email: Daniel.Gittleson@fda.hhs.gov.

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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.Start Printed Page 20605

Postmarket Surveillance—21 CFR Part 822 (OMB Control Number 0910-0449)—Extension

Section 522(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) authorizes FDA to require manufacturers to conduct postmarket surveillance (PS) of any device that meets the criteria set forth in the statute. The PS regulation establishes procedures that FDA uses to approve and disapprove PS plans. The regulation provides instructions to manufacturers so they know what information is required in a PS plan submission. FDA reviews PS plan submissions in accordance with part 822 (21 CFR part 822) in §§ 822.15 to 822.19 of the regulation, which describe the grounds for approving or disapproving a PS plan. In addition, the PS regulation provides instructions to manufacturers to submit interim and final reports in accordance with § 822.38. Respondents to this collection of information are those manufacturers who require postmarket surveillance of their products.

Explanation of Reporting Burden Estimate

The burden captured in table 1 of this document for each of these responses is based on the data available in FDA's internal tracking system for 2009. There was not an internal tracking system prior to 2009. Sections 822.26, 822.27, and 822.34 do not constitute information collection subject to review under the PRA because “it entails no burden other than that necessary to identify the respondent, the date, the respondent's address, and the nature of the instrument.” (5 CFR 1320.3(h)(1)).

Explanation of Recordkeeping Burden Estimate

FDA expects that at least some of the manufacturers will be able to satisfy the PS requirement using information or data they already have. For purposes of calculating burden, however, FDA has assumed that each PS order can only be satisfied by a 3-year clinically-based surveillance plan, using three investigators. These estimates are based on FDA's knowledge and experience with limited implementation of section 522 under the Safe Medical Devices Act. Therefore, FDA would expect that the recordkeeping requirements would apply to a maximum of 21 manufacturers (3 to 4 added each year) and 30 investigators (3 per surveillance plan). After 3 years, FDA would expect these numbers to remain level as the surveillance plans conducted under the earliest orders reach completion and new orders are issued.

In the Federal Register of February 5, 2010 (75 FR 6036), 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 Burden1

21 CFR SectionNo. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesHours per ResponseTotal Hours
822.9 and 822.10211211202,520
822.2151540200
822.28515840
822.291114040
822.301114040
822.3840140401,600
Total4,440
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2.—Estimated Annual Recordkeeping Burden1

21 CFR SectionNo. of RecordkeepersAnnual Frequency per RecordkeepingTotal Annual RecordHours per RecordsTotal Hours
822.312112120420
822.32631635315
Total735
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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Dated: April 14, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2010-8977 Filed 4-19-10; 8:45 am]

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