Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program, 36318-36320 [2014-14924]
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36318
Federal Register / Vol. 79, No. 123 / Thursday, June 26, 2014 / Notices
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Gary Johnson,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2014–14974 Filed 6–25–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
tkelley on DSK3SPTVN1PROD with NOTICES
Gary Johnson,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
16:51 Jun 25, 2014
Jkt 232001
Food and Drug Administration,
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
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 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.
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
SUMMARY:
The meeting announced below
concerns the Agricultural, Forestry and
Fishing Safety and Health Research
(U01) PAR–14–175, initial review.
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Time and Date: 12:00 p.m.–4:30 p.m.,
July 15, 2014 (Closed).
Place: Teleconference.
Status: The meeting will be closed to
the public in accordance with
provisions set forth in Section
552b(c)(4) and (6), Title 5 U.S.C., and
the Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters for Discussion: The meeting
will include the initial review,
discussion, and evaluation of
applications received in response to
‘‘Agricultural, Forestry and Fishing
Safety and Health Research (U01) PAR–
14–175.’’
Contact Person for More Information:
Joan F. Karr, Ph.D., Scientific Review
Officer, CDC/NIOSH, 1600 Clifton Road,
Mailstop E–74, Atlanta, Georgia 30333,
Telephone: (404) 498–2506.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
VerDate Mar<15>2010
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance: Medical
Device ISO 13485:2003 Voluntary Audit
Report Submission Pilot Program
HHS.
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
BILLING CODE 4163–18–P
[Docket No. FDA–2014–N–0797]
AGENCY:
Centers for Disease Control and
Prevention
[FR Doc. 2014–14976 Filed 6–25–14; 8:45 am]
Food and Drug Administration
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
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
E:\FR\FM\26JNN1.SGM
26JNN1
36319
Federal Register / Vol. 79, No. 123 / Thursday, June 26, 2014 / Notices
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
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.
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
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
Compliance decision
Number
tkelley on DSK3SPTVN1PROD 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
VerDate Mar<15>2010
16:51 Jun 25, 2014
Jkt 232001
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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
169
902
1,083
249
Approximate
percentage
7
38
45
10
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
E:\FR\FM\26JNN1.SGM
26JNN1
36320
Federal Register / Vol. 79, No. 123 / Thursday, June 26, 2014 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0809]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Requirements for
Submission of Bioequivalence Data
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
the requirement for an abbreviated new
drug application (ANDA) applicant to
submit data from all bioequivalence
(BE) studies the applicant conducts on
a drug product formulation submitted
for approval.
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 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.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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.
Requirements for Submission of In Vivo
Bioequivalence Data—21 CFR Parts 314
and 320; OMB Control Number 0910–
0630—Extension
In the Federal Register of January 16,
2009 (74 FR 2849), the Agency
published a final rule revising FDA
regulations to require applicants to
submit data on all BE studies, including
studies that do not meet passing
bioequivalence criteria, which are
performed on a drug product
formulation submitted for approval
under an ANDA, or in an amendment or
supplement to an ANDA that contains
BE studies. In the final rule, FDA
amended §§ 314.94(a)(7)(i), 314.96(a)(1),
320.21(b)(1), and 314.97 (21 CFR
314.94(a)(7)(i), 314.96(a)(1),
320.21(b)(1), and 314.97) to require an
ANDA applicant to submit information
from all BE studies, both passing and
nonpassing, conducted by the applicant
on the same drug product formulation
as that submitted for approval under an
ANDA, amendment, or supplement.
In table 1 of this document, FDA has
estimated the reporting burden
associated with each section of this
requirement. FDA believes that the
majority of additional BE studies will be
reported in ANDAs (submitted under
§ 314.94), rather than supplements
(reported in § 314.97) because it is
unlikely than an ANDA holder will
conduct BE studies with a drug after the
drug has been approved. With respect to
the reporting of additional BE studies in
amendments (submitted under
§ 314.96), this should also account for a
small number of reports because most
BE studies will be conducted on a drug
prior to the submission of the ANDA
and will be reported in the ANDA itself.
FDA estimates applicants will require
approximately 120 hours of staff time to
prepare and submit each additional
complete BE study report and
approximately 60 hours of staff time for
each additional BE summary report. The
Agency believes that a complete report
will be required approximately 20
percent of the time, while a summary
will suffice approximately 80 percent of
the time. Based on a weighted-average
calculation using the information
presented previously in this document,
the submission of each additional BE
study is expected to take 72 hours of
staff time ([120 × 0.2] + [60 × 0.8]).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
314.94(a)(7) .........................................................................
VerDate Mar<15>2010
16:51 Jun 25, 2014
Jkt 232001
PO 00000
Frm 00035
Number of
responses per
respondent
84
Fmt 4703
Sfmt 4703
Total annual
responses
1
E:\FR\FM\26JNN1.SGM
84
26JNN1
Average
burden per
response
72
Total hours
6,048
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
------------------------------------------------------------------------
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
[[Page 36320]]
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
