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Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing information collection, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for Postmarket Surveillance under 21 CFR part 822.


Submit written or electronic comments on the collection of information by December 1, 2006.

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Submit electronic comments on the collection of information to​dockets/​ecomments. Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

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Denver Presley, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

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Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Postmarket Surveillance—21 CFR Part 822 (OMB Control Number 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 of any device that meets the criteria set forth in the statute.

The postmarket surveillance (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 postmarket surveillance 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 plan could result in the collection of useful data which 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 postmarket surveillance of their products.

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.

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 postmarket surveillance 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 Start Printed Page 57975shown 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 Devices 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 (three 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: September 26, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E6-16231 Filed 9-29-06; 8:45 am]