Submission for OMB Review; Comment Request: New Proposed Collection, Neuropsychosocial Measures Formative Research Methodology Studies for the National Children's Study, 66724-66726 [2011-27843]
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Federal Register / Vol. 76, No. 208 / Thursday, October 27, 2011 / Notices
schedule prior to the start of
construction. Section 52b.10(g) requires
a grantee to provide daily construction
logs and monthly status reports upon
request at the job site. Section 52b.11(b)
requires applicants for a project
involving the acquisition of existing
facilities to provide the estimated cost of
the project, cost of the acquisition of
existing facilities, and cost of
remodeling, renovating, or altering
facilities to serve the purposes for which
they are acquired. In terms of
recordkeeping requirements: Section
52b.10(g) requires grantees to maintain
daily construction logs and monthly
status reports at the job site. Frequency
of Response: On occasion. Affected
Public: Non-profit organizations and
Federal agencies. Type of respondents:
Grantees. The estimated respondent
burden is as follows:
ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN
Number of
respondents
Frequency of
response
Average time per
response
Annual hour
burden
60
720
100
1
60
60
100
1
1
12
1
.50
1.0
1.0
1.0
60
260
1.0
Totals .............................................................................
wreier-aviles on DSK7SPTVN1PROD with NOTICES
Reporting:
Section 52b.9(b) ...................................................................
Section 2b.10(f) ....................................................................
Section 2b.10(g) ...................................................................
Section 2b.11(b) ...................................................................
Recordkeeping.
Section 2b.10(g) ...................................................................
281
............................
The annualized cost to the public,
based on an average of 60 active grants
in the construction phase, is estimated
at: $576,818. There are no Capital Costs
to report. There are no operating or
Maintenance Costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information and
recordkeeping are necessary for the
proper performance of the function of
the agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the
agency=s estimate of the burden of the
proposed collection of information and
recordkeeping, including the
methodology and assumptions used; (3)
Enhance the quality, utility, and clarity
of the information to be collected and
the recordkeeping information to be
maintained; and (4) Minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection and
recordkeeping techniques of other forms
of information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to (202) 395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Jerry
VerDate Mar<15>2010
14:47 Oct 26, 2011
Jkt 226001
Moore, NIH Regulations Officer, Office
of Management Assessment, Division of
Management Support, National
Institutes of Health, 6011 Executive
Boulevard, Room 601, MSC 7669,
Rockville Maryland 20852; call (301)
496–4607 (this is not a toll free number)
or email your request to jm40z@nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: October 20, 2011.
Jerry Moore,
NIH Regulations Officer, National Institutes
of Health.
[FR Doc. 2011–27850 Filed 10–26–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request: New Proposed
Collection, Neuropsychosocial
Measures Formative Research
Methodology Studies for the National
Children’s Study
Summary: Under the provisions of
Section (3507(a)(1)(D)) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health has submitted to the
Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on May 2, 2011, pages 24497–
24498, and allowed 60 days for public
comment. Two written comments and
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
..............................
.50
15,600
16,480.5
two verbal comments were received.
The verbal comments expressed support
for the broad scope of the study. The
written comments were identical and
questioned the cost and utility of the
study. The purpose of this notice is to
allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Proposed Collection: Title: Neurodevelopmental and Psycho-Social
Measures Formative Research Studies
for the National Children’s Study (NCS).
Type of Information Request: New.
Need and Use of Information Collection:
The Children’s Health Act of 2000 (Pub.
L. 106–310) states:
(a) Purpose.—It is the purpose of this
section to authorize the National
Institute of Child Health and Human
Development* to conduct a national
longitudinal study of environmental
influences (including physical,
chemical, biological, and psychosocial)
on children’s health and development.
(b) In General.—The Director of the
National Institute of Child Health and
Human Development* shall establish a
consortium of representatives from
appropriate Federal agencies (including
the Centers for Disease Control and
Prevention, the Environmental
Protection Agency) to—
(1) Plan, develop, and implement a
prospective cohort study, from birth to
adulthood, to evaluate the effects of
both chronic and intermittent exposures
on child health and human
development; and
E:\FR\FM\27OCN1.SGM
27OCN1
66725
Federal Register / Vol. 76, No. 208 / Thursday, October 27, 2011 / Notices
(2) investigate basic mechanisms of
developmental disorders and
environmental factors, both risk and
protective, that influence health and
developmental processes.
(c) Requirement.—The study under
subsection (b) shall—
(1) Incorporate behavioral, emotional,
educational, and contextual
consequences to enable a complete
assessment of the physical, chemical,
biological, and psychosocial
environmental influences on children’s
well-being;
(2) gather data on environmental
influences and outcomes on diverse
populations of children, which may
include the consideration of prenatal
exposures; and
(3) consider health disparities among
children, which may include the
consideration of prenatal exposures.
To fulfill the requirements of the
Children’s Health Act, the results of
formative research will be used to
maximize the efficiency (measured by
scientific robustness, participant and
infrastructure burden, and cost) of tools
to assess language, behavior, and
neurodevelopment, psychosocial stress,
and health literacy and thereby inform
data collection methodologies for the
National Children’s Study (NCS)
Vanguard and Main Studies. With this
submission, the NCS seeks to obtain
OMB’s generic clearance to conduct
formative research featuring neurodevelopmental and psycho-social
measures.
The results from these formative
research projects will inform the
feasibility (scientific robustness),
acceptability (burden to participants
and study logistics) and cost of NCS
Vanguard and Main Study neurodevelopmental and psycho-social
measures in a manner that minimizes
public information collection burden
compared to burden anticipated if these
projects were incorporated directly into
either the NCS Vanguard or Main Study.
Frequency of Response: Annual [As
needed on an on-going and concurrent
basis]. Affected Public: Members of the
public, researchers, practitioners, and
other health professionals. Type of
Respondents: Women of child-bearing
age, infants, children, fathers,
community leaders, members, and
organizations, health care facilities and
professionals, public health,
environmental, social and cognitive
science professional organizations and
practitioners, hospital administrators,
cultural and faith-based centers, and
schools and child care organizations.
These include both persons enrolled in
the NCS Vanguard Study and their peers
who are not participating in the NCS
Vanguard Study. Annual reporting
burden: See Table 1. The annualized
cost to respondents is estimated at:
$540,000 (based on $10 per hour). There
are no Capital Costs to report. There are
no Operating or Maintenance Costs to
report.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, NEUROPSYCHOSOCIAL MEASURES
Estimated
number of
respondents
Data collection activity
Type of respondent
Adult Psychosocial Stress ................
NCS participants ..............................
Members of NCS target population
(not NCS participants).
NCS participants ..............................
Members of NCS target population
(not NCS participants).
NCS participants ..............................
Members of NCS target population
(not NCS participants).
NCS participants ..............................
Child Developmental Measures ........
Health Disparities ..............................
Small, focused survey and instrument design and administration.
Focus groups ....................................
Cognitive interviews ..........................
wreier-aviles on DSK7SPTVN1PROD with NOTICES
Total ...........................................
14:47 Oct 26, 2011
Average
burden hours
per response
Estimated
total annual
burden hours
requested
4,000
4,000
1
1
1
1
4,000
4,000
4,000
4,000
1
1
1
1
4,000
4,000
4,000
4,000
1
1
1
1
4,000
4,000
4,000
2
1
8,000
Members of NCS target population
(not NCS participants).
Health and Social Service Providers
Community Stakeholders .................
NCS participants ..............................
Members of NCS target population
(not NCS participants).
Health and Social Service Providers
Community Stakeholders .................
NCS participants ..............................
Members of NCS target population
(not NCS participants).
4,000
2
1
8,000
2,000
2,000
2,000
2,000
1
1
1
1
1
1
1
1
2,000
2,000
2,000
2,000
2,000
2,000
500
500
1
1
1
1
1
1
2
2
2,000
2,000
1,000
1,000
...........................................................
45,000
........................
........................
54,000
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
VerDate Mar<15>2010
Estimated
number of
responses per
respondent
Jkt 226001
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information collected; and (4) Ways to
minimize the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to Office of
Management and Budget, Office of
Information and Regulatory Affairs,
Attn: NIH Desk Officer, by e-mail to
E:\FR\FM\27OCN1.SGM
27OCN1
66726
Federal Register / Vol. 76, No. 208 / Thursday, October 27, 2011 / Notices
OIRA_submission@omb.eop.gov, or by
fax to 202–395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Ms.
Jamelle E. Banks, Public Health Analyst,
Office of Science Policy, Analysis and
Communication, National Institute of
Child Health and Human Development,
31 Center Drive Room 2A18, Bethesda,
Maryland, 20892, or call a non-toll free
number (301) 496–1877 or E-mail your
request, including your address to
banksj@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: October 20, 2011.
Jamelle E. Banks,
Public Health Analyst, Office of Science
Policy, Analysis and Communications,
National Institute of Child Health and Human
Development, National Institutes of Health.
[FR Doc. 2011–27843 Filed 10–26–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
SUMMARY:
Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: (301)
496–7057; fax: (301) 402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
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ADDRESSES:
VerDate Mar<15>2010
14:47 Oct 26, 2011
Jkt 226001
New Non-HLA–A2 Restricted Human T
Cell Receptors (TCRs) That Could Be
Used To Treat a Broader Cancer Patient
Population Via TCR Adoptive
Immunity
Description of Technology: NIH
scientists have developed T cell
receptors (TCRs) that recognize
melanoma antigen family A3 (MAGE–
A3) or MAGE–A12 peptide antigens.
The TCRs recognize these antigens in
the context of major histocompatibility
complex (MHC) class I molecules, HLA–
A1 and HLA–Cw7, respectively. Since
these TCRs are not HLA–A2 restricted,
their therapeutic use would expand the
number of treatable cancer patients
using MAGE–A3 or A12-specific TCR
adoptive immunotherapy.
There are twelve MAGE–A
superfamily antigens designated A1—
A12. Their normal function is not well
defined, but in cancer cells they block
the functions of tumor suppressor
proteins to mediate tumor growth and
spreading. The MAGE–A proteins are
some of the most widely expressed
cancer testis antigens expressed on
human tumors. Other than non-MHC
expressing germ cells of the testis,
normal cells do not express these
antigens, which make them ideal targets
for cancer immunotherapies anticipated
to generate less toxic side effects than
conventional cancer treatments. These
TCRs deliver a robust immune response
against MAGE–A3 or A12 expressing
cells and could prove to be a powerful
approach for selectively attacking
tumors without generating toxicity
against healthy cells.
Potential Commercial Applications:
• Personalized immunotherapy for a
variety of cancers using human T cells
expressing these TCRs
• Component of a combination
immunotherapy regimen aimed at
targeting specific tumor-associated
antigens, including MAGE–A3 and
MAGE–A12, expressed by cancer cells.
• A research tool to investigate
signaling pathways in MAGE–A3 or
MAGE–A12 antigen expressing cancer
cells.
• An in vitro diagnostic tool to screen
for cells expressing MAGE–A3 or
MAGE–A12 antigens.
Competitive Advantages:
• Highly expressed targets: MAGE–A
proteins (especially MAGE–A3) are
some of the most highly expressed
cancer testis antigens on human tumors
• Limited side effects: MAGE–A
proteins are only expressed on tumor
cells and non-MHC expressing testis
germ cells. Infused cells expressing
these TCRs should target MAGE–A3 or
A12 expressing tumor cells with little or
no toxicity to the patient’s normal cells.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
• Not HLA–A2 restricted: Expands
patient population treatable with
MAGE–A TCRs since they recognize
antigen in the context of HLA–A1 or
HLA–Cw7.
Development Stage:
• Pre-clinical
• In vitro data available
Inventors: Steven A. Rosenberg, Paul
F. Robbins, Richard A. Morgan, Steven
A. Feldman, and Shiqui Zhu (NCI).
Publication: Chinnasamy N, et al. A
TCR targeting the HLA–A*0201restricted epitope of MAGE–A3
recognizes multiple epitopes of the
MAGE–A antigen superfamily in several
types of cancer. J Immunol. 2011 Jan
15;186(2):685–696. [PMID 21149604].
Intellectual Property: HHS Reference
No. E–266–2011/0—U.S. Patent
Application No. 61/535,086 filed 15
September 2011.
Related Technology: HHS Reference
No. E–236–2010/0—U.S.Patent
Application No. 61/405,668 filed 22
October 2010.
Licensing Contact: Samuel E. Bish,
Ph.D.; (301) 435–5282;
bishse@mail.nih.gov.
Collaborative Research Opportunity:
The Surgery Branch of the National
Cancer Institute is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize T cell receptors that
target cancer/testis antigens for use in
cancer adoptive immunotherapy. For
collaboration opportunities, please
contact John Hewes, Ph.D. at
hewesj@mail.nih.gov.
Antiandrogen Small Molecules for the
Treatment of Prostate Cancer
Description of Technology: The
present licensing opportunity is for a
new class of small molecule
compounds, and the method of using
them to treat prostate cancer. This year
it is estimated there will be over 32,000
deaths from prostate cancer showing an
unmet need for a more effective
treatment particularly for castrateresistant prostate cancer (CRPC). CRPC
is characterized by androgenindependent cancer cells that have
adapted to the depletion of hormones
and continue to grow. Abnormal
androgen receptor signaling is known to
drive advanced castrate-resistant
prostate cancer. The small molecule
compounds of the instant invention are
antiandrogens that target androgen
receptor signaling in both androgenindependent and androgen-sensitive
androgen receptor activity, and
androgen receptors that are resistant to
the current antiandrogens available.
Unlike the currently available
E:\FR\FM\27OCN1.SGM
27OCN1
]]>Agencies
[Federal Register Volume 76, Number 208 (Thursday, October 27, 2011)]
[Notices]
[Pages 66724-66726]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27843]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request: New Proposed
Collection, Neuropsychosocial Measures Formative Research Methodology
Studies for the National Children's Study
Summary: Under the provisions of Section (3507(a)(1)(D)) of the
Paperwork Reduction Act of 1995, the National Institutes of Health has
submitted to the Office of Management and Budget (OMB) a request to
review and approve the information collection listed below. This
proposed information collection was previously published in the Federal
Register on May 2, 2011, pages 24497-24498, and allowed 60 days for
public comment. Two written comments and two verbal comments were
received. The verbal comments expressed support for the broad scope of
the study. The written comments were identical and questioned the cost
and utility of the study. The purpose of this notice is to allow an
additional 30 days for public comment. The National Institutes of
Health may not conduct or sponsor, and the respondent is not required
to respond to, an information collection that has been extended,
revised, or implemented on or after October 1, 1995, unless it displays
a currently valid OMB control number.
Proposed Collection: Title: Neuro-developmental and Psycho-Social
Measures Formative Research Studies for the National Children's Study
(NCS). Type of Information Request: New. Need and Use of Information
Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states:
(a) Purpose.--It is the purpose of this section to authorize the
National Institute of Child Health and Human Development* to conduct a
national longitudinal study of environmental influences (including
physical, chemical, biological, and psychosocial) on children's health
and development.
(b) In General.--The Director of the National Institute of Child
Health and Human Development* shall establish a consortium of
representatives from appropriate Federal agencies (including the
Centers for Disease Control and Prevention, the Environmental
Protection Agency) to--
(1) Plan, develop, and implement a prospective cohort study, from
birth to adulthood, to evaluate the effects of both chronic and
intermittent exposures on child health and human development; and
[[Page 66725]]
(2) investigate basic mechanisms of developmental disorders and
environmental factors, both risk and protective, that influence health
and developmental processes.
(c) Requirement.--The study under subsection (b) shall--
(1) Incorporate behavioral, emotional, educational, and contextual
consequences to enable a complete assessment of the physical, chemical,
biological, and psychosocial environmental influences on children's
well-being;
(2) gather data on environmental influences and outcomes on diverse
populations of children, which may include the consideration of
prenatal exposures; and
(3) consider health disparities among children, which may include
the consideration of prenatal exposures.
To fulfill the requirements of the Children's Health Act, the
results of formative research will be used to maximize the efficiency
(measured by scientific robustness, participant and infrastructure
burden, and cost) of tools to assess language, behavior, and
neurodevelopment, psychosocial stress, and health literacy and thereby
inform data collection methodologies for the National Children's Study
(NCS) Vanguard and Main Studies. With this submission, the NCS seeks to
obtain OMB's generic clearance to conduct formative research featuring
neuro-developmental and psycho-social measures.
The results from these formative research projects will inform the
feasibility (scientific robustness), acceptability (burden to
participants and study logistics) and cost of NCS Vanguard and Main
Study neuro-developmental and psycho-social measures in a manner that
minimizes public information collection burden compared to burden
anticipated if these projects were incorporated directly into either
the NCS Vanguard or Main Study. Frequency of Response: Annual [As
needed on an on-going and concurrent basis]. Affected Public: Members
of the public, researchers, practitioners, and other health
professionals. Type of Respondents: Women of child-bearing age,
infants, children, fathers, community leaders, members, and
organizations, health care facilities and professionals, public health,
environmental, social and cognitive science professional organizations
and practitioners, hospital administrators, cultural and faith-based
centers, and schools and child care organizations. These include both
persons enrolled in the NCS Vanguard Study and their peers who are not
participating in the NCS Vanguard Study. Annual reporting burden: See
Table 1. The annualized cost to respondents is estimated at: $540,000
(based on $10 per hour). There are no Capital Costs to report. There
are no Operating or Maintenance Costs to report.
Table 1--Estimated Annual Reporting Burden Summary, Neuropsychosocial Measures
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Type of Estimated number of Average burden total annual
Data collection activity respondent number of responses per hours per burden hours
respondents respondent response requested
----------------------------------------------------------------------------------------------------------------
Adult Psychosocial Stress..... NCS participants 4,000 1 1 4,000
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
Child Developmental Measures.. NCS participants 4,000 1 1 4,000
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
Health Disparities............ NCS participants 4,000 1 1 4,000
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
Small, focused survey and NCS participants 4,000 2 1 8,000
instrument design and
administration.
Members of NCS 4,000 2 1 8,000
target
population (not
NCS
participants).
Health and 2,000 1 1 2,000
Social Service
Providers.
Community 2,000 1 1 2,000
Stakeholders.
Focus groups.................. NCS participants 2,000 1 1 2,000
Members of NCS 2,000 1 1 2,000
target
population (not
NCS
participants).
Health and 2,000 1 1 2,000
Social Service
Providers.
Community 2,000 1 1 2,000
Stakeholders.
Cognitive interviews.......... NCS participants 500 1 2 1,000
Members of NCS 500 1 2 1,000
target
population (not
NCS
participants).
---------------------------------------------------------------
Total..................... ................ 45,000 .............. .............. 54,000
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency'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 collected; and (4) Ways to minimize the
burden of the collection of information on those who are to respond,
including the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to Office of Management and Budget, Office of Information and
Regulatory Affairs, Attn: NIH Desk Officer, by e-mail to
[[Page 66726]]
OIRA_submission@omb.eop.gov, or by fax to 202-395-6974. To request
more information on the proposed project or to obtain a copy of the
data collection plans and instruments, contact Ms. Jamelle E. Banks,
Public Health Analyst, Office of Science Policy, Analysis and
Communication, National Institute of Child Health and Human
Development, 31 Center Drive Room 2A18, Bethesda, Maryland, 20892, or
call a non-toll free number (301) 496-1877 or E-mail your request,
including your address to banksj@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
Dated: October 20, 2011.
Jamelle E. Banks,
Public Health Analyst, Office of Science Policy, Analysis and
Communications, National Institute of Child Health and Human
Development, National Institutes of Health.
[FR Doc. 2011-27843 Filed 10-26-11; 8:45 am]
BILLING CODE 4140-01-P
