Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Drug Experience Reporting and Recordkeeping Biological Products, 13009-13011 [2015-05591]
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Federal Register / Vol. 80, No. 48 / Thursday, March 12, 2015 / Notices
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Enforcement Fairness Act of 1996 (Pub.
L. 104–121), as outreach activities by
government agencies to small
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Dated: March 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05513 Filed 3–11–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0253]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Postmarketing
Adverse Drug Experience Reporting
and Recordkeeping Biological
Products
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 information collection provisions of
FDA’s postmarketing adverse drug
experience reporting and recordkeeping
requirements.
DATES: Submit either electronic or
written comments on the collection of
information by May 11, 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.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
SUMMARY:
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Federal Register / Vol. 80, No. 48 / Thursday, March 12, 2015 / Notices
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.
Postmarketing Adverse Drug
Experience Reporting (OMB Control
Number 0910–0230)—(Extension)
Sections 201, 502, 505, and 701 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321, 352, 355, and 371)
require that marketed drugs be safe and
effective. In order to know whether
drugs that are not safe and effective are
on the market, FDA must be promptly
informed of adverse experiences
associated with the use of marketed
drugs. In order to help ensure this, FDA
issued regulations at §§ 310.305 and
314.80 (21 CFR 310.305 and 314.80) to
impose reporting and recordkeeping
requirements on the drug industry that
would enable FDA to take the action
necessary to protect the public health
from adverse drug experiences.
All applicants who have received
marketing approval of drug products are
required to report to FDA serious,
unexpected adverse drug experiences
(‘‘15-day Alert reports’’), as well as
follow up reports (§ 314.80(c)(1)). This
includes reports of all foreign or
domestic adverse experiences as well as
those based on information from
applicable scientific literature and
certain reports from postmarketing
studies. Section 314.80(c)(1)(iii) pertains
to such reports submitted by nonapplicants.
Under § 314.80(c)(2), applicants must
provide periodic reports of adverse drug
experiences. A periodic report includes,
for the reporting interval, reports of
serious, expected adverse drug
experiences and all nonserious adverse
drug experiences and an index of these
reports, a narrative summary and
analysis of adverse drug experiences, an
analysis of the 15-day Alert reports
submitted during the reporting interval,
and a history of actions taken because
of adverse drug experiences. Under
§ 314.80(i), applicants must keep for 10
years records of all adverse drug
experience reports known to the
applicant.
For marketed prescription drug
products without approved new drug
applications or abbreviated new drug
applications, manufacturers, packers,
and distributors are required to report to
FDA serious, unexpected adverse drug
experiences as well as follow-up reports
(§ 310.305(c)). Section 310.305(c)(5)
pertains to the submission of follow-up
reports to reports forwarded to the
manufacturers, packers, and distributors
by FDA. Under § 310.305(f), each
manufacturer, packer, and distributor
shall maintain for 10 years records of all
adverse drug experiences required to be
reported.
The primary purpose of FDA’s
adverse drug experience reporting
system is to enable identification of
signals for potentially serious safety
problems with marketed drugs.
Although premarket testing discloses a
general safety profile of a new drug’s
comparatively common adverse effects,
the larger and more diverse patient
populations exposed to the marketed
drug provide the opportunity to collect
information on rare, latent, and longterm effects. Signals are obtained from
a variety of sources, including reports
from patients, treating physicians,
foreign regulatory agencies, and clinical
investigators. Information derived from
the adverse drug experience reporting
system contributes directly to increased
public health protection because the
information enables FDA to make
important changes to the product’s
labeling (such as adding a new
warning), decisions about risk
evaluation and mitigation strategies or
the need for postmarket studies or
clinical trials, and when necessary, to
initiate removal of a drug from the
market.
Respondents to this collection of
information are manufacturers, packers,
distributors, and applicants. The
following estimates are based on FDA’s
knowledge of adverse drug experience
reporting, including the time needed to
prepare the reports, and the number of
reports submitted to the Agency.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
asabaliauskas on DSK5VPTVN1PROD with NOTICES
310.305(c)(5) .........................................
314.80(c)(1)(iii) .......................................
314.80(c)(2) ...........................................
3
5
724
1
1
19.33
3
5
13,996
1
1
60
3
5
839,760
Total ................................................
..............................
..............................
..............................
..............................
839,768
1 The
2 The
reporting burden for § 310.305(c)(1), (c)(2), and (c)(3), and § 314.80(c)(1)(i) and (c)(1)(ii) is covered under OMB Control No. 0910–0291.
capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.
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Federal Register / Vol. 80, No. 48 / Thursday, March 12, 2015 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
Number of
recordkeepers
21 CFR section
Number of records
per recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
310.305(f) ...............................................
314.80(i) .................................................
25
724
1
508
25
367,959
16
16
400
5,887,344
Total ................................................
..............................
..............................
..............................
..............................
5,887,744
1 There
2 There
are no capital costs or operating costs associated with this collection of information.
are maintenance costs of approximately $22,000 annually.
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.
[FR Doc. 2015–05591 Filed 3–11–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
ADDRESSES:
Elaine L. Baker,
Director, Management Analysis and Services
Office Centers for Disease Control and
Prevention.
Dated: March 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2015–05575 Filed 3–11–15; 8:45 am]
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): 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 a meeting for the initial
review of applications in response to
DP15–007, Effectiveness of Teen
Pregnancy Prevention Programs
Designed Specifically for Young Males.
Time and Date: 9:00 a.m.—6:00 p.m., April
7–9, 2015 (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 ‘‘Effectiveness of Teen Pregnancy
Prevention Programs Designed Specifically
for Young Males’’, DP15–007.
Contact Person for More Information: M.
Chris Langub, Ph.D., Scientific Review
Officer, CDC, 4770 Buford Highway, NE.,
Mailstop F–80, Atlanta, Georgia 30341,
Telephone: (770) 488–3585, EEO6@cdc.gov.
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–0990—New–
60D]
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, announces plans
to submit a new Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, OS seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on the ICR must be
received on or before May 11, 2015.
SUMMARY:
Submit your comments to
Information.CollectionClearance@
hhs.gov or by calling (202) 690–6162.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
When
submitting comments or requesting
information, please include the
document identifier HHS–OS–0990—
New–60D for reference.
Information Collection Request Title:
HHS Entrepreneurs-in-Residence
Program (EIR).
Abstract: The HHS IDEA Lab, in the
Immediate Office of the Secretary, is
requesting an approval by Office of
Management and Budget (OMB) on a
new information collection, which is
critical to the success of the HHS EIR
program, and identifies private sector
entrepreneurs with unique skill sets not
available in government to join HHS for
a year to work on critical initiatives. The
information collection for the HHS EIR
custom form management system
involves obtaining candidate resumes
and responses to short essay questions
specifically designed to determine
whether entrepreneurs have the
knowledge, skills and abilities to
successfully complete HHS EIR projects
in the government context and mentor
existing government staff to acquire
new, entrepreneurial skills.
Likely Respondents: The candidate
pools, targeted for the HHS EIR program
are serial private sector entrepreneurs
with no prior federal government
experience.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
HHS EIR Application .......................................................................................
150
1
1
150
Total ..........................................................................................................
150
1
1
150
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]]>Agencies
[Federal Register Volume 80, Number 48 (Thursday, March 12, 2015)]
[Notices]
[Pages 13009-13011]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05591]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0253]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Postmarketing Adverse Drug Experience Reporting and
Recordkeeping Biological Products
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 the information collection
provisions of FDA's postmarketing adverse drug experience reporting and
recordkeeping requirements.
DATES: Submit either electronic or written comments on the collection
of information by May 11, 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.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
[[Page 13010]]
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.
Postmarketing Adverse Drug Experience Reporting (OMB Control Number
0910-0230)--(Extension)
Sections 201, 502, 505, and 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 352, 355, and 371) require that marketed
drugs be safe and effective. In order to know whether drugs that are
not safe and effective are on the market, FDA must be promptly informed
of adverse experiences associated with the use of marketed drugs. In
order to help ensure this, FDA issued regulations at Sec. Sec. 310.305
and 314.80 (21 CFR 310.305 and 314.80) to impose reporting and
recordkeeping requirements on the drug industry that would enable FDA
to take the action necessary to protect the public health from adverse
drug experiences.
All applicants who have received marketing approval of drug
products are required to report to FDA serious, unexpected adverse drug
experiences (``15-day Alert reports''), as well as follow up reports
(Sec. 314.80(c)(1)). This includes reports of all foreign or domestic
adverse experiences as well as those based on information from
applicable scientific literature and certain reports from postmarketing
studies. Section 314.80(c)(1)(iii) pertains to such reports submitted
by non-applicants.
Under Sec. 314.80(c)(2), applicants must provide periodic reports
of adverse drug experiences. A periodic report includes, for the
reporting interval, reports of serious, expected adverse drug
experiences and all nonserious adverse drug experiences and an index of
these reports, a narrative summary and analysis of adverse drug
experiences, an analysis of the 15-day Alert reports submitted during
the reporting interval, and a history of actions taken because of
adverse drug experiences. Under Sec. 314.80(i), applicants must keep
for 10 years records of all adverse drug experience reports known to
the applicant.
For marketed prescription drug products without approved new drug
applications or abbreviated new drug applications, manufacturers,
packers, and distributors are required to report to FDA serious,
unexpected adverse drug experiences as well as follow-up reports (Sec.
310.305(c)). Section 310.305(c)(5) pertains to the submission of
follow-up reports to reports forwarded to the manufacturers, packers,
and distributors by FDA. Under Sec. 310.305(f), each manufacturer,
packer, and distributor shall maintain for 10 years records of all
adverse drug experiences required to be reported.
The primary purpose of FDA's adverse drug experience reporting
system is to enable identification of signals for potentially serious
safety problems with marketed drugs. Although premarket testing
discloses a general safety profile of a new drug's comparatively common
adverse effects, the larger and more diverse patient populations
exposed to the marketed drug provide the opportunity to collect
information on rare, latent, and long-term effects. Signals are
obtained from a variety of sources, including reports from patients,
treating physicians, foreign regulatory agencies, and clinical
investigators. Information derived from the adverse drug experience
reporting system contributes directly to increased public health
protection because the information enables FDA to make important
changes to the product's labeling (such as adding a new warning),
decisions about risk evaluation and mitigation strategies or the need
for postmarket studies or clinical trials, and when necessary, to
initiate removal of a drug from the market.
Respondents to this collection of information are manufacturers,
packers, distributors, and applicants. The following estimates are
based on FDA's knowledge of adverse drug experience reporting,
including the time needed to prepare the reports, and the number of
reports submitted to the Agency.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
310.305(c)(5)............................................ 3 1 3 1 3
314.80(c)(1)(iii)........................................ 5 1 5 1 5
314.80(c)(2)............................................. 724 19.33 13,996 60 839,760
----------------------------------------------------------------------------------------------
Total................................................ ................. ................. ................. ................. 839,768
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The reporting burden for Sec. 310.305(c)(1), (c)(2), and (c)(3), and Sec. 314.80(c)(1)(i) and (c)(1)(ii) is covered under OMB Control No. 0910-
0291.
\2\ The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.
>
[[Page 13011]]
Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of records Total annual Average burden
21 CFR section recordkeepers per recordkeeper records per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
310.305(f)............................................... 25 1 25 16 400
314.80(i)................................................ 724 508 367,959 16 5,887,344
----------------------------------------------------------------------------------------------
Total................................................ ................. ................. ................. ................. 5,887,744
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating costs associated with this collection of information.
\2\ There are maintenance costs of approximately $22,000 annually.
Dated: March 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05591 Filed 3-11-15; 8:45 am]
BILLING CODE 4164-01-P
