
[Federal Register Volume 79, Number 123 (Thursday, June 26, 2014)]
[Notices]
[Pages 36318-36320]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14924]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0797]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance: Medical Device ISO 13485:2003 Voluntary 
Audit Report Submission Pilot Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
associated with the Medical Device ISO 13485:2003 Voluntary Audit 
Report Submission Pilot Program.

DATES: Submit either electronic or written comments on the collection 
of information by August 25, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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 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.

Guidance: Medical Device ISO 13485:2003 Voluntary Audit Report 
Submission Pilot Program--(OMB Control Number 0910-0700)--Extension

    Under section 228 of the Food and Drug Administration Amendments 
Act of 2007 (Pub. L. 110-85), as amended by section 704(g)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)(7)), the owner 
or operator of an establishment may submit an audit report that 
assesses conformance with appropriate quality system standards set by 
the International Organization for Standardization (ISO) and identified 
by the Secretary in public notice.
    The ``Guidance for Industry, Third Parties and FDA Staff: Medical 
Device ISO 13485:2003 Voluntary Audit Report Submission Program'' 
describes 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. The collected information is used for 
setting risk-based inspectional priorities.
    The ``Guidance for Industry, Third Parties, and FDA Staff: Medical 
Device ISO 13485:2003 Voluntary Audit Report Submission Program'' 
describes how FDA's Center for Devices and

[[Page 36319]]

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

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                                             Number of       Number of     Total annual       Average                      operating and
                        Activity                            respondents    responses per     responses      burden per      Total hours     maintenance
                                                                            respondent                       response                          costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
(One time only burden) First year, electronic setup and            1,700               1           1,700          \2\ 42          71,400         $51,000
 verification certificate \1\...........................
(Recurring burden) Audit report submission..............           1,700               1           1,700               3           5,100          51,000
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\1\ There are no capital costs associated with this information collection.
\2\ Respondent may already have a valid WebTrader account established for other FDA electronic submissions.

    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 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) 2013 (October 1, 2012 to October 1, 2013) and determined that 
the total number of inspections finalized in FY 2013 for medical 
devices was 2,404. The breakdown for the 2,404 compliance decisions is 
as follows:

                  Table 2--Compliance Decisions FY 2013
------------------------------------------------------------------------
                                                            Approximate
           Compliance decision                Number        percentage
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Official Action Indicated...............             169               7
Voluntary Action Indicated..............             902              38
No Action Indicated.....................           1,083              45
Pending Final Decision..................             249              10
------------------------------------------------------------------------

    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 FY 2013 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 45 percent 
of all compliance decisions resulted in an NAI decision, FDA estimates 
that 1,546 of the facilities certified under ISO 13485:2003 by Health 
Canada (45 percent of the total 3,436 facilities) would have had an 
inspection classified as an NAI.
    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 
1,500 audit reports), the total number of audit reports FDA expects to 
receive in a year is approximately 1,700 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 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 subsequent 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.
    There are operating and maintenance costs associated with this 
information collection. The costs are $30 per year to establish and 
maintain the Electronic Submission Gateway verification certificate.
    This guidance also refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are

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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.

    Dated: June 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14924 Filed 6-25-14; 8:45 am]
BILLING CODE 4164-01-P


