
[Federal Register Volume 76, Number 130 (Thursday, July 7, 2011)]
[Notices]
[Pages 39880-39882]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17051]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES



Food and Drug Administration



[Docket No. FDA-2010-D-0226]




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of Management and Budget Review; Comment Request; Draft Guidance for 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



AGENCY: Food and Drug Administration, HHS.



ACTION: Notice.



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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).



[[Page 39881]]





DATES: Fax written comments on the collection of information by August 

8, 2011.



ADDRESSES: 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title ``Draft Guidance for Industry, Third Parties and Food and Drug 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: 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: 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Draft Guidance for Industry, Third Parties and Food and Drug 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



    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

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                                                            Approximate

              Compliance decision                Number   percentage (%)

------------------------------------------------------------------------

Official Action Indicated.....................       148               8

Voluntary Action Indicated....................       775              40

No Action Indicated...........................     1,025              52

Pending Final Decision........................        17               1

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\1\ June 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.



    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



[[Page 39882]]



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

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                                                                             No. of                                                        Capital and

                                                             No. of       responses per   Total annual   Average burden                   operating and

                                                           respondents   respondent per     responses     per response     Total hours     maintenance

                                                                              year                         (in hours)                         costs

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First year.............................................           1,600               1           1,600           \1\42          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

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\1\Respondent may already have a valid WebTrader account established for other FDA electronic submissions.



    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




