Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How To Submit Information in Electronic Format to the Center for Veterinary Medicine Using the Food and Drug Administration Electronic Submission Gateway, 20647-20649 [2016-08075]
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Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
ACF Certifying Officer.
[FR Doc. 2016–08018 Filed 4–7–16; 8:45 am]
BILLING CODE 4184–01–P
report. The AFI PPR will collect data on
project activities and attributes similar
to the reports that it is replacing. The
Office of Community Services (OCS) in
the Administration for Children and
Families (ACF) will use the data
collected in the AFI PPR to prepare the
annual AFI Report to Congress, to
evaluate and monitor the performance
of the AFI program overall and of
individual projects, and to inform and
support technical assistance efforts. The
AFI PPR would fulfill AFI Act reporting
requirements and program purposes.
The AFI PPR will be submitted
quarterly: three times per year using an
abbreviated short form and one time
using a long form. Both draft data
collection instruments are available for
review online at https://
idaresources.acf.hhs.gov/AFIPPR.
Respondents: Assets for
Independence (AFI) program grantees.
Annual Burden Estimates:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Assets for Independence
Program Performance Progress Report.
OMB No.: New.
Description: The Assets for
Independence (AFI) Act (Title IV of the
Community Opportunities,
Accountability, and Training and
Educational Services Act of 1998, Pub.
L. 105–285, [42 U.S.C. 604 note])
requires that organizations operating
AFI projects submit annual progress
reports.
This request is to create an AFI
program specific Performance Progress
Report (PPR) to replace the semiannual
standard form performance progress
report (SF–PPR) and the annual data
Form name
Number of
responses
Number of
responses per
respondent
Average
burden hours
per response
AFI PPR Short Form .......................................................................................
AFI PPR Long Form ........................................................................................
Estimated Annual Burden Hours .....................................................................
300
300
........................
3
1
........................
0.5
3.8
........................
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016–08090 Filed 4–7–16; 8:45 am]
BILLING CODE 4184–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0519]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on How To Submit
Information in Electronic Format to the
Center for Veterinary Medicine Using
the Food and Drug Administration
Electronic Submission Gateway
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, we) 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 extending Office
SUMMARY:
PO 00000
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20647
Total burden
hours
450
1,140
1,590
of Management and Budget (OMB)
approval on the existing reporting
requirements relating to how one may
submit information electronically to the
Center for Veterinary Medicine (CVM)
using the FDA Electronic Submissions
Gateway (ESG).
DATES: Submit either electronic or
written comments on the collection of
information by June 7, 2016.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
E:\FR\FM\08APN1.SGM
08APN1
20648
Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–N–0519 for ‘‘Guidance for
Industry on How To Submit Information
in Electronic Format to the Center for
Veterinary Medicine Using the Food
and Drug Administration Electronic
Submission Gateway.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
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 for Industry on How To
Submit Information in Electronic
Format to the Center for Veterinary
Medicine Using the Food and Drug
Administration Electronic Submission
Gateway—21 CFR 11.2 OMB Control
Number 0910–0454—Extension
We accept certain types of
submissions electronically with no
requirement for a paper copy. These
types of documents are listed in public
docket 97S–0251 as required by 21 CFR
11.2. Our ability to receive and process
information submitted electronically is
limited by our current information
technology capabilities and the
requirements of the Electronic Records;
Electronic Signatures final regulation.
Our guidance entitled ‘‘Guidance for
Industry #108: How to Submit
Information in Electronic Format to
CVM Using the FDA Electronic
Submission Gateway’’ outlines general
standards to be used for the submission
of any electronic information to CVM
using the FDA ESG. The likely
respondents are sponsors for new
animal drug applications.
FDA estimates the burden of this
collection of information as follows:
mstockstill on DSK4VPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
11.2 .....................................
1 There
FDA form No.
Number of
respondents
3538
Number of
responses per
respondent
29
1.3
Total annual
responses
38
Average burden per
response
.08 (5 minutes) ...................
are no capital costs or operating and maintenance costs associated with this collection of information.
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3.0
Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices
We base our estimates on our
experience with the submission of
electronic information to us using the
FDA ESG and the number of electronic
registration or change requests received
between January 1, 2014, and December
31, 2014.
Dated: April 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–08075 Filed 4–7–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than May 9, 2016.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Enrollment and Re-Certification of
Entities in the 340B Drug Pricing
Program and Collection of Manufacturer
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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Data to Verify 340B Drug Pricing
Program Ceiling Price Calculations.
OMB No. 0915–0327—Revision
Abstract: Section 602 of Public Law
102–585, the Veterans Health Care Act
of 1992, enacted as Section 340B of the
Public Health Service Act (PHS Act;
‘‘Limitation on Prices of Drugs
Purchased by Covered Entities’’),
provides that the Secretary of Health
and Human Services will enter into a
Pharmaceutical Pricing Agreement
(PPA) with each manufacturer of
covered outpatient drugs in which the
manufacturer agrees to charge a price for
covered outpatient drugs that will not
exceed the average manufacturer price
decreased by a rebate percentage. Under
this PPA, a manufacturer agrees not to
charge a price for covered outpatient
drugs that exceeds an amount
determined under a statutory formula
(ceiling price). A manufacturer subject
to a PPA must offer all covered
outpatient drugs at no more than the
ceiling price to a covered entity listed in
the 340B Program database if such drug
is made available to any other purchaser
at any price. The manufacturer shall
rely on the information in the 340B
database to determine if the covered
entity is participating in the 340B
Program or for any notifications of
changes to eligibility that may occur
within a quarter. By signing the PPA,
the manufacturer agrees to comply with
all applicable statutory and regulatory
requirements. In response to comments
submitted during the first public review
of this ICR, the language has been
revised in this notice and in the draft
instruments in order to align with the
applicable statutory language regarding
the obligation to sign the PPA, the
circumstances under which
participating manufacturers must offer
covered outpatient drugs to covered
entities, and the description of the
ceiling price data required to be
provided.
The purpose of this revision is to
include an addendum to the PPA to
incorporate the administrative
requirement for manufacturer integrity
provisions directly addressed in the
Affordable Care Act.
Need and Proposed Use of the
Information: HRSA is proposing
revisions to the current PPA to include
an addendum in response to
manufacturer integrity provisions
implemented in the Affordable Care
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20649
Act. Section 7102(b) of the Affordable
Care Act amends section 340B(a)(1) of
the Public Health Service Act (PHSA) to
add two new requirements for inclusion
in the PPA with manufacturers of
covered outpatient drugs:
I. ‘‘Each such agreement shall require
that the manufacturer furnish the
Secretary with reports, on a quarterly
basis, of the price for each covered
outpatient drug subject to the agreement
that, according to the manufacturer,
represents the maximum price that
covered entities may permissibly be
required to pay for the drug . . .’’ and
II. ‘‘. . . shall require that the
manufacturer offer each covered entity
covered outpatient drugs for purchase at
or below the applicable ceiling price if
such drug is made available to any other
purchaser at any price.’’
These requirements shall be included
in the PPA addendum to be signed by
manufacturers participating in the 340B
Program to ensure that the provisions of
the 340B statute requiring inclusion in
the PPA are satisfied. The execution of
the addendum by manufacturers will
fulfill the administrative requirement of
the statute that these provisions be
included in the PPA. The burden
imposed on manufacturers by the
proposed requirement of the PPA is
minimal because the addendum does
not impose requirements beyond review
and a signature by the manufacturer.
Likely Respondents: Drug
Manufacturers.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
Total Estimated Annualized Burden
Hours:
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]]>Agencies
[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)]
[Notices]
[Pages 20647-20649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08075]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0519]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on How To Submit Information in
Electronic Format to the Center for Veterinary Medicine Using the Food
and Drug Administration Electronic Submission Gateway
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we) 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 extending Office of Management
and Budget (OMB) approval on the existing reporting requirements
relating to how one may submit information electronically to the Center
for Veterinary Medicine (CVM) using the FDA Electronic Submissions
Gateway (ESG).
DATES: Submit either electronic or written comments on the collection
of information by June 7, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that
[[Page 20648]]
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-0519 for ``Guidance for Industry on How To Submit
Information in Electronic Format to the Center for Veterinary Medicine
Using the Food and Drug Administration Electronic Submission Gateway.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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 for Industry on How To Submit Information in Electronic Format
to the Center for Veterinary Medicine Using the Food and Drug
Administration Electronic Submission Gateway--21 CFR 11.2 OMB Control
Number 0910-0454--Extension
We accept certain types of submissions electronically with no
requirement for a paper copy. These types of documents are listed in
public docket 97S-0251 as required by 21 CFR 11.2. Our ability to
receive and process information submitted electronically is limited by
our current information technology capabilities and the requirements of
the Electronic Records; Electronic Signatures final regulation. Our
guidance entitled ``Guidance for Industry #108: How to Submit
Information in Electronic Format to CVM Using the FDA Electronic
Submission Gateway'' outlines general standards to be used for the
submission of any electronic information to CVM using the FDA ESG. The
likely respondents are sponsors for new animal drug applications.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section FDA form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
11.2...................................... 3538 29 1.3 38 .08 (5 minutes)............. 3.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 20649]]
We base our estimates on our experience with the submission of
electronic information to us using the FDA ESG and the number of
electronic registration or change requests received between January 1,
2014, and December 31, 2014.
Dated: April 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08075 Filed 4-7-16; 8:45 am]
BILLING CODE 4164-01-P
