03-12192. Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance of Medical Devices

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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 (PS) of medical devices.

DATES:

Submit written or electronic comments on the collection of information by July 14, 2003.

ADDRESSES:

Submit electronic comments on the collection of information to http://www.accessdata.fda.gov/​scripts/​oc/​dockets/​edockethome.cfm. Submit written comments on the collection of information to the Dockets Management Branch (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.

FOR FURTHER INFORMATION CONTACT:

Peggy Robbins, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION:

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: (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 of Medical Devices—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. 360l(a)) authorizes the FDA to require manufacturers to conduct PS of any device that meets the criteria set forth in the statute.

The PS regulation in part 822 (21 CFR part 822) 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 §§ 822.15 through 822.18 (which describe the grounds for approving or disapproving a PS plan). If this information is not collected, FDA cannot ensure that the PS will result in the collection of useful data that can 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. As previously stated, the collection of data and information under these regulations is conducted on a very infrequent basis and only as necessary.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden¹

21 CFR Section	No. of Respondents	Total Annual Responses	No. of Responses	Hours per Response	Total Hours
822.9 and 822.10	5	1	5	120	600
822.21	2	1	2	40	80
822.26	1	1	1	8	8
822.27	1	1	1	40	40
822.28	1	1	1	40	40
822.29	1	1	1	120	120
822.30	1	1	1	40	40
822.34	1	1	1	20	20
822.38	23	2	46	80	3,680
Totals					4,628
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 Section	No. of Recordkeepers	Total Annual Records	No. of Records	Hours per Record	Total Hours
822.31	23	1	23	20	460
822.32	69	1	69	10	690
Totals					1,150
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA estimates, based on current staffing and resources, only one actual PS action and manufacturers' aversion to the stigma of PS over the past year. One PS action will be issued for generic devices comprising 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 surveillance (§ 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).

Section 822.25 does not constitute information collections subject to review under the PRA because “* * * they entail 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)).

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 of the act under the Safe Medical Devices Act of 1990. Therefore, FDA would expect that the recordkeeping requirements would apply to a maximum of 23 manufacturers (6 added each year) and 69 investigators (3 years 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.

Dated: May 9, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.