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Notice

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program

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 (PRA).

 

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DATES: Back to Top

Fax written comments on the collection of information by August 8, 2011.

ADDRESSES: Back to Top

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@omb.eop.gov. All comments should be identified with the OMB control number 0910-NEW and title “Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program”. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Back to Top

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

SUPPLEMENTARY INFORMATION: Back to Top

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

Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program—(OMB Control Number 0910)-NEW Back to Top

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 before submitting the collection to OMB for approval. To comply with this requirement, in the Federal Register of May 20, 2010 (75 FR 28257), FDA published a notice of availability of the draft guidance document providing a 60-day public comment period on the proposed collection of information provisions.

Title: Draft Guidance for Industry, Third Parties and FDA Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program.

Description: Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), amended section 704(g)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)(7)) to add the following provision: “(F) For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality system standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice. If the owner or operator of an establishment elects to submit audit reports under this subparagraph, the owner or operator shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.”

The “Draft Guidance for Industry, Third Parties and FDA Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program” will describe how FDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research are implementing this provision of the law and providing public notice as required. The proposed collections of information are necessary to satisfy the previously mentioned statutory requirements for implementing this voluntary submission program.

Based on FDA's experience with the founding regulatory members of the Global Harmonization Task Force (GHTF), FDA expects that the vast majority of manufacturers who will participate in the Voluntary Audit Report Submission Program will be manufacturers who are certified by Health Canada under ISO 13485:2003. In 2008, approximately 2,650 manufacturers or manufacturing sites had been certified by Health Canada. The majority of these manufacturers are also certified under ISO 13485:2003 by the European Union Notified Body accreditation system.

In addition, FDA only expects firms that do not have major deficiencies or observations in their ISO 13485:2003 audits to be willing to submit their audit reports to FDA under the Voluntary Audit Report Submission Program. FDA analyzed its inspection data from Fiscal Year (FY) 2008 (October 1, 2007 to October 1, 2008) and determined that the total number of inspections finalized in FY2008 for medical devices was 1,965. The breakdown for the 1,965 compliance decisions is as follows:

Table 1—Compliance Decision Breakdown Back to Top
Compliance decision Number Approximate percentage (%)
1June 15, 2006, Compliance Program 7382.845 Inspection of Medical Device Manufacturers Part V http://www.fda.gov/cdrh/comp/guidance/7382.845.html#p5p5.pdf.
Official Action Indicated 148 8
Voluntary Action Indicated 775 40
No Action Indicated 1,025 52
Pending Final Decision 17 1

Because FDA only expects firms who do not have major deficiencies or observations to be willing to submit their audit reports to FDA under the Voluntary Audit Report Submission Program, FDA only expects to receive audit reports that would have been classified by FDA as No Action Indicated (NAI).

Assuming that the percentage breakdown of compliance decisions for all inspections conducted in FY2008 can be extrapolated and applied to audits of manufacturers certified under ISO 13485:2003 by Health Canada, FDA can estimate the number of Canadian establishments that would have had an inspection classified as an NAI. Because 52 percent of all compliance decisions resulted in an NAI decision, FDA estimates that 1,378 of the facilities certified under ISO 13485:2003 by Health Canada (52 percent of the total 2,650 facilities) would have had an inspection classified as an NAI. Because FDA only expects to receive audit reports that would have been classified by FDA as NAI, FDA expects 1,378, or approximately 1,400, audit reports to be submitted.

Because FDA expects that the vast majority of manufacturers who will participate in the Voluntary Audit Report Submission Program will be manufacturers certified by Health Canada under ISO 13485:2003, FDA expects the number of reports to be submitted from manufacturers certified by regulatory systems established by other founding GHTF members to be minimal. For purposes of calculating the reporting burden, FDA estimates that approximately 10 percent of total audit reports submitted under this program will be from these other manufacturers. Because 90 percent of the audit reports are expected to be submitted by manufacturers certified by Health Canada (approximately 1,400 audit reports as calculated previously in this document), the total number of audit reports FDA expects to receive in a year is 1,556, or approximately 1,600 audit reports.

FDA estimates from past experience with the Electronic Submission Gateway system, WebTrader, that the first year to set up the account and to receive the verification certificate takes approximately 40 hours. This burden may be minimized if the Respondent already has an established account in WebTrader for other electronic submissions to FDA but FDA is assuming that all respondents to this new pilot program will be setting up a WebTrader account for the first time in the first year. For subsequent years, the estimate burden hours are estimated at 1 hour to renew the yearly required verification certification.

FDA further estimates that the gathering, scanning, and submission of the audit reports, certificates, and related correspondence would take approximately 2 hours utilizing the eSubmitter system.

Therefore, the first year will include 40 hours for the WebTrader system plus 2 hours for the eSubmitter submission process, resulting in 42 hours per response for the first year. For both the second and third years, it is estimated that only 1 hour will be necessary for the WebTrader system plus the 2 hours for the eSubmitter submission process, resulting in 3 hours per response each year thereafter.

The draft guidance also refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073 and the collections of information for the Inspection by Accredited Persons Program have been approved under OMB control number 0910-0569.

In the Federal Register of May 20, 2010 (75 FR 28257), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment which was related to the PRA reporting burden.

The comment stated that the reporting burden hours may be too low for the first submission and may take less time for subsequent submissions. In addition, this comment stated that the number of reports anticipated to be submitted may be a high estimate by a factor of 10. FDA appreciates the consideration of burden hours by the comment. The comment, however, did not provide any data to assist FDA to adjust the burden hours for the submission. Absent baseline information at this time, FDA will review the submissions during the pilot period and modify the burden to respondents accordingly.

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

Table 2—Estimated Annual Reporting Burden Back to Top
No. of respondents No. of responses per respondent per year Total annual responses Average burden per response (in hours) Total hours Capital and operating and maintenance costs
1Respondent may already have a valid WebTrader account established for other FDA electronic submissions.
First year 1,600 1 1,600 142 67,200 2,016,000
Second year (recurring) 1,600 1 1,600 3 4,800 48,000
Third year (recurring) 1,600 1 1,600 3 4,800 48,000
Totals 76,800 2,112,000

There are capital, start-up, operating, or maintenance cost associated with this information collection. The costs are $30 per year to establish and maintain the Electronic Submission Gateway verification certificate.

Dated: July 1, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2011-17051 Filed 7-6-11; 8:45 am]

BILLING CODE 4160-01-P

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