Source: https://www.federalregister.gov/documents/2006/10/02/E6-16231/agency-information-collection-activities-proposed-collection-comment-request-postmarket-surveillance
Timestamp: 2017-10-17 14:07:48
Document Index: 182200887

Matched Legal Cases: ['art 822', 'art 822', 'art 822', '§\u2009822', '§\u2009822', '§\u2009822', '§\u2009822', '§\u2009822', '§\u2009822', '§\u2009822', '§\u2009822', '§\u2009822']

Federal Register :: Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance
Submit written or electronic comments on the collection of information by December 1, 2006.
57973-57975 (3 pages)
Docket No. 2006N-0382
https://www.federalregister.gov/d/E6-16231 https://www.federalregister.gov/d/E6-16231
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.
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.
822.9, 822.10 5 1 5 120 600
822.21 3 1 3 40 120
822.38 10 2 20 120 2,400
822.31 10 1 10 20 200
822.32 30 1 30 10 300
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.
[FR Doc. E6-16231 Filed 9-29-06; 8:45 am]