Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drug Applications and Supporting Regulations and Form FDA 356V, 27969-27971 [2013-11273]
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Federal Register / Vol. 78, No. 92 / Monday, May 13, 2013 / Notices
Alto Lee Adams, Sr., United States
Courthouse
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James F. Battin United States
Courthouse
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Billings, MT 59101
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James F. Battin U.S. Courthouse)
4. Redesignation. The former and new
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New Name
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5. Who should we contact for further
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Service (PBS), 1800 F Street NW.,
Washington, DC 20405, telephone
number: 202–501–1100.
Dan Tangherlini,
Acting Administrator of General
Services.
[FR Doc. 2013–11247 Filed 5–10–13; 8:45 am]
BILLING CODE 6820–23–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Meeting of the Community Preventive
Services Task Force (Task Force)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
The Centers for Disease
Control and Prevention (CDC)
announces the next meeting of the
Community Preventive Services Task
Force (Task Force). The Task Force is
independent and nonfederal. Its
members are nationally known leaders
in public health practice, policy, and
research, and are appointed by the CDC
Director. The Task Force was convened
in 1996 by the Department of Health
and Human Services (HHS) to assess the
effectiveness of community,
environmental, population, and
healthcare system interventions in
public health and health promotion.
During this meeting, the Task Force will
SUMMARY:
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consider the findings of systematic
reviews and issue findings and
recommendations to help inform
decision making about policy, practice,
and research in a wide range of U.S.
settings. The Task Force’s
recommendations, along with the
systematic reviews of the scientific
evidence on which they are based, are
compiled in the Guide to Community
Preventive Services (Community Guide).
DATES: The meeting will be held on
Wednesday, June 19, 2013 from 8:30
a.m. to 5:30 p.m., EDT and Thursday,
June 20, 2013 from 8:30 a.m. to 1:00
p.m. EDT.
Logistics: The Task Force Meeting will
be held at the Emory Conference Center
at 1615 Clifton Road Atlanta, GA 30329.
Information regarding logistics will be
available Wednesday, May 22, 2013 on
the Community Guide Web site
(www.thecommunityguide.org).
FOR FURTHER INFORMATION CONTACT:
Andrea Baeder, The Community Guide
Branch, Epidemiology and Analysis
Program Office, Office of Surveillance,
Epidemiology, and Laboratory Services,
Centers for Disease Control and
Prevention, 1600 Clifton Road, MS–E–
69, Atlanta, Georgia 30333, phone: (404)
498–6876, email: CPSTF@cdc.gov.
Purpose: The purpose of the meeting
is for the Task Force to consider the
findings of systematic reviews and issue
findings and recommendations to help
inform decision making about policy,
practice, and research in a wide range
of U.S. settings.
Matters to be discussed: Matters to be
discussed: cancer prevention and
control, cardiovascular disease
prevention and control, diabetes
prevention and control, motor vehiclerelated injury prevention, improving
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oral health, promoting physical activity,
promoting health equity, and reducing
tobacco use and secondhand smoke
exposure.
Meeting Accessibility: This meeting is
open to the public, limited only by
space availability.
Dated: May 6, 2013.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2013–11242 Filed 5–10–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1131]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; New Animal Drug
Applications and Supporting
Regulations and Form FDA 356V
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 12,
2013.
To ensure that comments on
the information collection are received,
OMB recommends that written
ADDRESSES:
E:\FR\FM\13MYN1.SGM
13MYN1
27970
Federal Register / Vol. 78, No. 92 / Monday, May 13, 2013 / Notices
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0032. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796,
3794,
Jonnalynn.capezzuto@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Presubmission Conferences, New
Animal Drug Applications and
Supporting Regulations and Guidance
#152, and Form FDA 356V—21 CFR
514.5, 514.1, 514.4, and 514.8 (OMB
Control Number 0910–0032)—Extension
Under section 512(b)(3) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360b(b)(3)), any
person intending to file a new animal
drug application (NADA) or
supplemental NADA or a request for an
investigational exemption under section
512(j) of the FD&C Act is entitled to one
or more conferences with FDA to reach
an agreement acceptable to FDA
establishing a submission or
investigational requirement. FDA and
industry have found that these meetings
have increased the efficiency of the drug
development and drug review
processes.
Section 514.5 of Title 21 of the Code
of Federal Regulations describes the
procedures for requesting, conducting,
and documenting presubmission
conferences. Section 514.5(b) describes
the information that must be included
in a letter submitted by a potential
applicant requesting a presubmission
conference, including a proposed
agenda and a list of expected
participants. Section 514.5(d) describes
the information that must be provided
by the potential applicant to FDA at
least 30 days prior to a presubmission
conference. This information includes a
detailed agenda, a copy of any materials
to be presented at the conference, a list
of proposed indications and, if
available, a copy of the proposed
labeling for the product under
consideration, and a copy of any
background material that provides
scientific rationale to support the
potential applicant’s position on issues
listed in the agenda for the conference.
Section 514.5(f) discusses the content of
the memorandum of conference that
will be prepared by FDA and gives the
potential applicant an opportunity to
seek correction to or clarification of the
memorandum.
Under section 512(b)(1) of the FD&C
Act, any person may file a NADA
seeking approval to legally market a
new animal drug. Section 512(b)(1) sets
forth the information required to be
submitted in a NADA. FDA allows
applicants to submit a complete NADA
or to submit information in support of
a NADA for phased review followed by
submission of an administrative NADA
when FDA finds all the applicable
technical sections are complete.
Section 514.1 of Title 21 of the Code
of Federal Regulations interprets section
512(b)(1) of the FD&C Act and further
describes the information that must be
submitted as part of a NADA and the
manner and form in which the NADA
must be assembled and submitted. The
application must include safety and
effectiveness data, proposed labeling,
product manufacturing information, and
where necessary, complete information
on food safety (including microbial food
safety) and any methods used to
determine residues of drug chemicals in
edible tissue from food producing
animals. Guidance #152 outlines a risk
assessment approach for evaluating the
microbial food safety of antimicrobial
new animal drugs. FDA requests that an
applicant accompany NADAs,
supplemental NADAs, and requests for
phased review of data to support
NADAs, with the Form FDA 356V to
ensure efficient and accurate processing
of information to support new animal
drug approval.
In the Federal Register of November
20, 2012, (77 FR 69630), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—NADAS—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR
Section/FDA form No.
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
169
169
0.41
0.07
69
12
50
212
3,450
2,544
169
2.22
375
35
13,125
169
0.06
10
71
710
169
169
169
0.72
0.08
0.01
121
14
1.7
20
1
5
2,420
14
8.5
169
169
0.15
4.37
25
739
90
5
2,250
3,695
Total ..............................................................................
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514.5(b), (d), (f) Requesting presubmission conferences ...
514.1 and 514.6 Applications and amended applications ...
514.8(b) Manufacturing changes to an approved application ....................................................................................
514.8(c)(1) Labeling and other changes to an approved
application ........................................................................
514.8(c)(2) and (3) Labeling and other changes to an approved application ............................................................
514.11 Submission of data, studies and other information
558.5(i) Requirements for liquid medicated feed ................
514.1(b)(8) and 514.8(c)(1) 2 Evidence to establish safety
and effectiveness .............................................................
Form FDA 356V ...................................................................
........................
........................
........................
........................
28,217
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as
part of the overall preapproval safety evaluation.
2 NADAs
Based on the number of sponsors
subject to animal drug user fees, FDA
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estimates that there was an average of
169 annual respondents during the 5
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fiscal years, from October 1, 2008,
through September 30, 2012, on which
E:\FR\FM\13MYN1.SGM
13MYN1
Federal Register / Vol. 78, No. 92 / Monday, May 13, 2013 / Notices
these estimates were made. We use this
estimate consistently throughout the
table and calculate the ‘‘total annual
responses’’ by multiplying the number
of responses per respondent by the
number of respondents.
Dated: May 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–11273 Filed 5–10–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–P–1000]
Determination That REV–EYES
(Dapiprazole Hydrochloride
Ophthalmic Solution), 0.5%, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that REV–EYES (dapiprazole
hydrochloride ophthalmic solution),
0.5%, was not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for dapiprazole
hydrochloride ophthalmic solution,
0.5%, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
David E. Markert, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3602.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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Jkt 229001
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products with
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
REV–EYES (dapiprazole
hydrochloride ophthalmic solution),
0.5%, is the subject of NDA 19–849,
held by Angelini Pharmaceuticals Inc.,
and initially approved on December 31,
1990. REV–EYES is indicated for the
treatment of iatrogenically induced
mydriasis produced by adrenergic
(phenylephrine) or parasympatholytic
(tropicamide) agents.
REV–EYES (dapiprazole
hydrochloride ophthalmic solution),
0.5%, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
CUSTOpharm, Inc., submitted a
citizen petition dated September 11,
2012 (Docket No. FDA–2012–P–1000),
under 21 CFR 10.30, requesting that the
Agency determine whether REV–EYES
(dapiprazole hydrochloride ophthalmic
solution), 0.5%, was withdrawn from
sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that REV–EYES (dapiprazole
hydrochloride ophthalmic solution),
0.5%, was not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that REV–EYES
(dapiprazole hydrochloride ophthalmic
solution), 0.5%, was withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
REV–EYES (dapiprazole hydrochloride
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Fmt 4703
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27971
ophthalmic solution). 0.5%. from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list REV–EYES (dapiprazole
hydrochloride ophthalmic solution),
0.5%, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to REV–EYES
(dapiprazole hydrochloride ophthalmic
solution), 0.5%, may be approved by the
Agency as long as they meet all other
legal and regulatory requirements for
the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: May 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–11285 Filed 5–10–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0677]
Dental Products Panel of the Medical
Devices Advisory Committee; Notice of
Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Dental Products
Panel of the Medical Devices Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on July 18th, 2013, from 8 a.m. to
2:30 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B and C,
620 Perry Pkwy., Gaithersburg, MD,
E:\FR\FM\13MYN1.SGM
13MYN1
]]>Agencies
[Federal Register Volume 78, Number 92 (Monday, May 13, 2013)]
[Notices]
[Pages 27969-27971]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11273]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-1131]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; New Animal Drug
Applications and Supporting Regulations and Form FDA 356V
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by June
12, 2013.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written
[[Page 27970]]
comments be faxed to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB
control number 0910-0032. Also include the FDA docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796, 3794, Jonnalynn.capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Presubmission Conferences, New Animal Drug Applications and Supporting
Regulations and Guidance 152, and Form FDA 356V--21 CFR 514.5,
514.1, 514.4, and 514.8 (OMB Control Number 0910-0032)--Extension
Under section 512(b)(3) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360b(b)(3)), any person intending to file a
new animal drug application (NADA) or supplemental NADA or a request
for an investigational exemption under section 512(j) of the FD&C Act
is entitled to one or more conferences with FDA to reach an agreement
acceptable to FDA establishing a submission or investigational
requirement. FDA and industry have found that these meetings have
increased the efficiency of the drug development and drug review
processes.
Section 514.5 of Title 21 of the Code of Federal Regulations
describes the procedures for requesting, conducting, and documenting
presubmission conferences. Section 514.5(b) describes the information
that must be included in a letter submitted by a potential applicant
requesting a presubmission conference, including a proposed agenda and
a list of expected participants. Section 514.5(d) describes the
information that must be provided by the potential applicant to FDA at
least 30 days prior to a presubmission conference. This information
includes a detailed agenda, a copy of any materials to be presented at
the conference, a list of proposed indications and, if available, a
copy of the proposed labeling for the product under consideration, and
a copy of any background material that provides scientific rationale to
support the potential applicant's position on issues listed in the
agenda for the conference. Section 514.5(f) discusses the content of
the memorandum of conference that will be prepared by FDA and gives the
potential applicant an opportunity to seek correction to or
clarification of the memorandum.
Under section 512(b)(1) of the FD&C Act, any person may file a NADA
seeking approval to legally market a new animal drug. Section 512(b)(1)
sets forth the information required to be submitted in a NADA. FDA
allows applicants to submit a complete NADA or to submit information in
support of a NADA for phased review followed by submission of an
administrative NADA when FDA finds all the applicable technical
sections are complete.
Section 514.1 of Title 21 of the Code of Federal Regulations
interprets section 512(b)(1) of the FD&C Act and further describes the
information that must be submitted as part of a NADA and the manner and
form in which the NADA must be assembled and submitted. The application
must include safety and effectiveness data, proposed labeling, product
manufacturing information, and where necessary, complete information on
food safety (including microbial food safety) and any methods used to
determine residues of drug chemicals in edible tissue from food
producing animals. Guidance 152 outlines a risk assessment
approach for evaluating the microbial food safety of antimicrobial new
animal drugs. FDA requests that an applicant accompany NADAs,
supplemental NADAs, and requests for phased review of data to support
NADAs, with the Form FDA 356V to ensure efficient and accurate
processing of information to support new animal drug approval.
In the Federal Register of November 20, 2012, (77 FR 69630), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--NADAs--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section/FDA form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
514.5(b), (d), (f) Requesting 169 0.41 69 50 3,450
presubmission conferences......
514.1 and 514.6 Applications and 169 0.07 12 212 2,544
amended applications...........
514.8(b) Manufacturing changes 169 2.22 375 35 13,125
to an approved application.....
514.8(c)(1) Labeling and other 169 0.06 10 71 710
changes to an approved
application....................
514.8(c)(2) and (3) Labeling and 169 0.72 121 20 2,420
other changes to an approved
application....................
514.11 Submission of data, 169 0.08 14 1 14
studies and other information..
558.5(i) Requirements for liquid 169 0.01 1.7 5 8.5
medicated feed.................
514.1(b)(8) and 514.8(c)(1) \2\ 169 0.15 25 90 2,250
Evidence to establish safety
and effectiveness..............
Form FDA 356V................... 169 4.37 739 5 3,695
----------------------------------------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 28,217
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing
antimicrobial concerns as part of the overall preapproval safety evaluation.
Based on the number of sponsors subject to animal drug user fees,
FDA estimates that there was an average of 169 annual respondents
during the 5 fiscal years, from October 1, 2008, through September 30,
2012, on which
[[Page 27971]]
these estimates were made. We use this estimate consistently throughout
the table and calculate the ``total annual responses'' by multiplying
the number of responses per respondent by the number of respondents.
Dated: May 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11273 Filed 5-10-13; 8:45 am]
BILLING CODE 4160-01-P
