Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program, 78444-78445 [2014-30513]
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78444
Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden
per response
Total hours
315.4, 315.5, and 315.6 .......................................................
2
1
2
2,000
4,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 22, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–30452 Filed 12–29–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0797]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance: Medical
Device ISO 13485:2003 Voluntary Audit
Report Submission Pilot Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0700. Also
include the FDA 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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
ADDRESSES:
Notice.
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.
DATES: Fax written comments on the
collection of information by January 29,
2015.
SUMMARY:
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.
In the Federal Register of June 26,
2014 (79 FR 36318), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
Activity
(One time only burden) First year, electronic setup and verification certificate 1
(Recurring burden) Audit report submission .......................................................
1 There
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Total
operating and
maintenance
costs
1,700
1
1,700
2 42
71,400
$51,000
1,700
1
1,700
3
5,100
51,000
are no capital costs associated with this information collection.
may already have a valid WebTrader account established for other FDA electronic submissions.
mstockstill on DSK4VPTVN1PROD with NOTICES
2 Respondent
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
VerDate Sep<11>2014
21:42 Dec 29, 2014
Jkt 235001
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
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
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:
E:\FR\FM\30DEN1.SGM
30DEN1
78445
Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices
TABLE 2—COMPLIANCE DECISIONS FY 2013
Compliance decision
Number
mstockstill on DSK4VPTVN1PROD with NOTICES
Official Action Indicated ...........................................................................................................................................
Voluntary Action Indicated .......................................................................................................................................
No Action Indicated .................................................................................................................................................
Pending Final Decision ............................................................................................................................................
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
VerDate Sep<11>2014
21:42 Dec 29, 2014
Jkt 235001
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
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: December 23, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–30513 Filed 12–29–14; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Approximate
percentage
169
902
1083
249
7
38
45
10
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0672]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prominent and
Conspicuous Mark of Manufacturers
on Single-Use Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
reprocessed, single-use device labeling.
DATES: Submit either electronic or
written comments on the collection of
information by March 2, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
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.
SUMMARY:
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
SUPPLEMENTARY INFORMATION:
Frm 00065
Fmt 4703
Sfmt 4703
E:\FR\FM\30DEN1.SGM
30DEN1
Agencies
[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Notices]
[Pages 78444-78445]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30513]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0797]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance: Medical
Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program
AGENCY: Food and Drug Administration, HHS.
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.
DATES: Fax written comments on the collection of information by January
29, 2015.
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 emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0700.
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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.
In the Federal Register of June 26, 2014 (79 FR 36318), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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 burden operating and
Activity respondents responses per responses per response Total hours maintenance
respondent 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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:
[[Page 78445]]
Table 2--Compliance Decisions FY 2013
------------------------------------------------------------------------
Approximate
Compliance decision Number percentage
------------------------------------------------------------------------
Official Action Indicated............... 169 7
Voluntary Action Indicated.............. 902 38
No Action Indicated..................... 1083 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 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: December 23, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30513 Filed 12-29-14; 8:45 am]
BILLING CODE 4164-01-P