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

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Information about this document as published in the Federal Register.

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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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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 January 12, 2007.


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: 202-395-6974.

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Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

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In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Postmarket Surveillance—21 CFR Part 822 (OMB No. 0910-0449)—Extension

Section 522(a) of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 360(l)) 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 specific, clear, and flexible instructions to manufacturers so they know what information is required in a PS plan submission. FDA reviews submissions in accordance with part 822 (21 CFR part 822) in §§ 822.15 to 822.18 of the regulation, which describe the grounds for approving or disapproving a PS plan. If this information is not collected, FDA would not be able to ensure that the PS will result in the collection of useful data that could reveal unforeseen adverse events or other information necessary to protect the public health.

Respondents to this collection of information are those manufacturers who require PS of their products.

In the Federal Register of October 2, 2006 (71 FR 57973), FDA published a 60-day notice requesting public comment on the information collection provisions. 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, 822.10515120600
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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Table 2.—Estimated Annual Recordkeeping Burden1

21 CFR SectionNo. of RecordkeepersAnnual Frequency per RecordkeepingTotal Annual RecordsHours per RecordTotal Hours
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA estimates that, based on current staffing and resources and experience with five actual PS actions over the past 3 years, five PS actions will be issued for generic devices, comprised of approximately five manufacturers. Each manufacturer will be required to submit a PS plan (§§ 822.9 and 822.10) and interim and final reports on the progress of the PS (§ 822.38). FDA anticipates that, on a case-by-case basis, requests for additional information may be made from a manufacturer. FDA expects that a small number of respondents will propose changes to their PS plans (§ 822.21), request a waiver of a specific requirement of this regulation (§ 822.29), or request exemption from the requirement to conduct PS of their device (§ 822.30). FDA's experience has shown that a few respondents will go out of business (§ 822.26) or cease marketing the device subject to PS (§ 822.28) each year. In addition, manufacturers must certify transfer of records when ownership changes (§ 822.34).

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 PS plan, using three investigators. These estimates are based on FDA's knowledge and experience with limited implementation of section 522 under the Safe Medical Device Act of 1990. Therefore, FDA would expect that the recordkeeping requirements would apply to a maximum of 10 manufacturers (3 to 4 added each year) and 30 investigators (3 per PS plan). After 3 years, FDA would expect these numbers to remain level as the PS plans conducted under the earliest orders reach completion and new orders are issued.

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Dated: December 7, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E6-21167 Filed 12-12-06; 8:45 am]