[Federal Register Volume 79, Number 123 (Thursday, June 26, 2014)]
[Notices]
[Pages 36318-36320]
From the Federal Register Online via the Government Publishing 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, [email protected].
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\
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Total
Number of Number of Total annual Average operating and
Activity respondents responses per responses burden per Total hours maintenance
respondent response costs
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(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
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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
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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]
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