Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minor Use and Minor Species, 42080-42082 [2023-13853]
Download as PDF
<![CDATA[
42080
Federal Register / Vol. 88, No. 124 / Thursday, June 29, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR part 14
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Subpart E—Members of Advisory Committees
Advisory Committee Membership Nominations ..................
308
1
308
Member Submission of Updated Information ......................
452
1
452
Total ..............................................................................
........................
........................
........................
1 There
Dated: June 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–13863 Filed 6–28–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2016–N–2474]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; New Animal Drugs
for Minor Use and Minor Species
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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: Submit written comments
(including recommendations) on the
collection of information by July 31,
2023.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0605. Also include
the FDA docket number found in
brackets in the heading of this
document.
lotter on DSK11XQN23PROD with NOTICES1
ADDRESSES:
VerDate Sep<11>2014
17:21 Jun 28, 2023
Jkt 259001
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
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.
New Animal Drugs for Minor Use and
Minor Species
Food and Drug Administration
ACTION:
........................
77
113
190
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
AGENCY:
0.25 (15 minutes).
0.25 (15 minutes).
OMB Control Number 0910–0605—
Revision
This information collection supports
FDA regulations that implement
sections 572 and 573 of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360ccc–1 and 21 U.S.C.
360ccc–2) which establish an index of
legally marketed unapproved new
animal drugs for minor species and
requirements for the designation of
minor use or minor species new animal
drugs, respectively. Agency regulations
are codified in part 516 (21 CFR part
516) and include recordkeeping and
reporting requirements. The purpose of
these regulations is to encourage the
development of these new animal drugs,
while still ensuring appropriate
safeguards for animal and human
health. The general provisions in part
516, subpart A, set forth its purpose,
scope, and applicable definitions.
Our regulations in part 516, subpart B,
provide for designation status for Minor
Use and Minor Species (MUMS) drugs
prior to their approval or conditional
approval. MUMS-drug designation
makes the sponsor eligible for
incentives to support the approval or
conditional approval of the designated
use and is completely optional for drug
sponsors. The regulations describe how
to apply for designation, what needs to
be submitted, and other information
pertaining to this option. Sponsors of
designated new animal drugs are
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
required to demonstrate due diligence
toward approval or conditional approval
through submission of annual reports
documenting their progress for each
designated use. We use this information
to allow for determining eligibility for
designation and the associated
incentives and benefits, including a
7-year period of exclusive marketing
rights, as provided by section 573 of the
FD&C Act. It enables us to process
requests for MUMS-drug designation,
requests to amend MUMS-drug
designation, changes in sponsorship,
termination of MUMS-drug designation,
requirements for annual reports from
sponsors, and provisions for insufficient
quantities of MUMS-designated drugs.
Regulations in part 516, subpart C, are
intended to make more medications
legally available to veterinarians and
animal owners for the treatment of
minor animal species. In some cases, a
minor species drug is intended for use
in species that are too rare or too varied
to be the subject of adequate and wellcontrolled studies in support of a drug
approval. In such cases, FDA may add
the drug to the public index listing of
legally marketed unapproved new
animal drugs for minor species animals
(Index), as provided for by section 572
of the FD&C Act. Within limitations
established by the statute, such indexing
provides a basis for legally marketing an
unapproved new animal drug intended
for use in a minor species. Our
regulations in part 516, subpart C,
specify, among other things, the criteria
and procedures for requesting eligibility
for indexing and for requesting addition
to the Index, as well as the annual
reporting requirements for holders of an
index listing. The administrative
procedures and criteria for indexing a
new animal drug for use in a minor
species, as well as modifications and
removal of a drug from the Index are
also set forth. FDA uses the information
for the activities described above.
In the Federal Register of August 1,
2022 (87 FR 46961), FDA published a
60-day notice requesting public
E:\FR\FM\29JNN1.SGM
29JNN1
42081
Federal Register / Vol. 88, No. 124 / Thursday, June 29, 2023 / Notices
comment on the information collection
requirements related to designation
status for MUMS drugs. No comments
were received. We are revising the
information collection to add the
information collection requirements
companies that sponsor new animal
drugs for designation or requesters
wishing to add a new animal drug to the
Index.
FDA estimates the burden of this
collection of information as follows:
associated with the index listing of
legally marketed unapproved new
animal drugs for minor species, for
efficiency of Agency operations.
Description of Respondents: The
respondents to this information
collection are pharmaceutical
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section; activity
Number of
responses per
respondent
Total annual
responses 2
Average
burden per
response
(hours)
Total hours 3
Designated New Animal Drugs for Minor Use and Minor Species, Part 516, Subpart B
516.20, 516.26, 516.27, 516.29, 516.30, and 516.36; Reporting burden associated with drug designation requests and termination of designation .............................
∼2.65
26
69
4
276
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, Part 516, Subpart C
516.119, 516.121, 516.123, 516.125, 516.141, 516.143,
516.145; 516.161, 516.163, and 516.165; Reporting burden associated with requests for index listing and modifying indexed drugs ..........................................................
30
∼10.33
310
∼16.954
5,256
Total ..............................................................................
........................
........................
........................
........................
5,532
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
rounded.
up.
2 Decimal
3 Rounded
Burden we attribute to reporting
activities is assumed to be distributed
among the individual elements and
averaged among respondents. Our
estimate of the burden per disclosure (4
and 16.954 hours, respectively) reflect
what we believe is the average burden
based on the reporting required by the
information collection.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section, activity
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Designated New Animal Drugs for Minor Use and Minor Species, Part 516, Subpart B
One-time recordkeeping burden associated with reading
and understanding the rule 2.
474
1
474
0.68 (∼41 minutes) 3.
323
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, Part 516, Subpart C
516.141 and 516.165; recordkeeping associated with
panel deliberations and the information pertinent to the
safety and effectiveness from foreign sources.
40
2
80
Total ..............................................................................
........................
........................
........................
0.625 (37.5
minutes).
........................
50
373
1 There
lotter on DSK11XQN23PROD with NOTICES1
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Direct Final Rule, ‘‘Defining ‘Small Number of Animals’ for Minor Use Determination; Periodic Reassessment’’ (September 15, 2022; 87 FR
56583). Preliminary Regulatory Impact Analysis (https://www.regulations.gov/document/FDA-2022-N-1128-0007).
3 Rounded up.
Burden we attribute to recordkeeping
activities for the indexing provisions is
assumed to be distributed among the
individual elements and averaged
among respondents. Our estimate of the
burden per record (0.625 hours) reflects
what we believe is the average burden
based on the recordkeeping required by
the information collection.
For efficiency of Agency operations,
we are consolidating the related
information collection activities
VerDate Sep<11>2014
17:21 Jun 28, 2023
Jkt 259001
currently approved in OMB control
numbers 0910–0605 and 0910–0620 into
a single collection request. The burden
estimates reflect our current experience
with the information collection and
requests received by respondents over
the past 3 years. We also include burden
that may be attributable to rulemaking
(RIN 0910–A146), which became
effective on December 14, 2022.
Although the rulemaking revised the
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
definition of ‘‘small number of
animals,’’ for purposes of determining
whether a particular intended use of a
drug in a major species qualifies as a
minor use, we believe only nominal
adjustments in burden associated with
designation status for MUMS drugs may
result, other than a one-time
recordkeeping burden. In addition,
upon review of the previous information
collection submission related to
E:\FR\FM\29JNN1.SGM
29JNN1
42082
Federal Register / Vol. 88, No. 124 / Thursday, June 29, 2023 / Notices
indexing, we include burden associated
with recordkeeping to address a dataentry error in the RISC/ORIA Combined
Information System (ROCIS system).
Cumulatively, these changes and
adjustments reflect an overall increase
of 5,905 hours and a corresponding
increase of 864 responses, annually, to
the information collection.
Dated: June 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–13853 Filed 6–28–23; 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; Rural Communities Opioid
Response Program Performance
Measures—OMB No. 0906–0044—
Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA 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. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
DATES: Comments on this ICR should be
received no later than July 31, 2023.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:21 Jun 28, 2023
Jkt 259001
submitted to OMB for review, email
paperwork@hrsa.gov or call Samantha
Miller, the HRSA Information Collection
Clearance Officer, at (301) 443–3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Rural Communities Opioid Response
Program Performance Measures—OMB
No. 0906–0044—Revision.
Abstract: HRSA administers the Rural
Communities Opioid Response Program
(RCORP), which is authorized by
section 711(b)(5) of the Social Security
Act (42 U.S.C. 912(b)(5)) and is a multiinitiative program that aims to: (1)
support treatment for and prevention of
substance use disorder (SUD), including
opioid use disorder (OUD); and (2)
reduce morbidity and mortality
associated with SUD, to include OUD,
by improving access to and delivering
prevention, treatment, and recovery
support services to high-risk rural
communities. To support this purpose,
RCORP grant initiatives include:
• RCORP—Implementation grants to
fund established networks and consortia
to deliver SUD/OUD prevention,
treatment, and recovery activities in
high-risk rural communities;
• RCORP—Neonatal Abstinence
Syndrome grants to reduce the
incidence and impact of Neonatal
Abstinence Syndrome in rural
communities by improving systems of
care, family supports, and social
determinants of health;
• RCORP—Psychostimulant Support
grants to strengthen and expand
prevention, treatment, and recovery
services for individuals in rural areas
who misuse psychostimulants; to
enhance their ability to access treatment
and move toward recovery;
• RCORP—Medication Assisted
Treatment (MAT) Access grants aim to
establish new access points in rural
facilities where none currently exist;
and
• RCORP—Behavioral Health Care
support grants aim to expand access to
and quality of behavioral health care
services at the individual-, provider-,
and community-levels.
• Note that additional grant
initiatives may be added pending fiscal
year 2024 and future fiscal year
appropriations.
HRSA currently collects information
about RCORP grants using approved
performance measures. HRSA
developed separate performance
measures for RCORP’s new MAT Access
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
and Behavioral Health Care Support
grants and seeks OMB approval for the
new collection.
A 60-day notice published in the
Federal Register on April 23, 2023, vol.
88, No. 63; pp. 19651–52. There were no
public comments.
Need and Proposed Use of the
Information: Due to the growth in the
number of grant initiatives included
within RCORP, as well as emerging SUD
and other behavioral health trends in
rural communities, HRSA is submitting
a revised ICR that includes measures for
RCORP’s new MAT Access and
Behavioral Health Care Support grants.
For this program, performance measures
were developed to provide data on each
RCORP initiative and enable HRSA to
provide aggregate program data required
by Congress under the Government
Performance and Results Act of 1993.
These measures cover the principal
topic areas of interest to the Federal
Office of Rural Health Policy, including:
(a) provision of, and referral to, rural
behavioral health care services,
including SUD prevention, treatment
and recovery support services; (b)
behavioral health care, including SUD
prevention, treatment, and recovery,
process and outcomes; (c) education of
health care providers and community
members; (d) emerging trends in rural
behavioral health care needs and areas
of concern; and (e) consortium strength
and sustainability. All measures will
speak to the Federal Office of Rural
Health Policy’s progress toward meeting
the goals set.
Likely Respondents: The respondents
will be recipients of the RCORP grants.
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 ICR are
summarized in the table below.
E:\FR\FM\29JNN1.SGM
29JNN1
]]>Agencies
[Federal Register Volume 88, Number 124 (Thursday, June 29, 2023)]
[Notices]
[Pages 42080-42082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13853]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2474]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; New Animal Drugs for
Minor Use and Minor Species
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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: Submit written comments (including recommendations) on the
collection of information by July 31, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0605. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[email protected].
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.
New Animal Drugs for Minor Use and Minor Species
OMB Control Number 0910-0605--Revision
This information collection supports FDA regulations that implement
sections 572 and 573 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360ccc-1 and 21 U.S.C. 360ccc-2) which establish an
index of legally marketed unapproved new animal drugs for minor species
and requirements for the designation of minor use or minor species new
animal drugs, respectively. Agency regulations are codified in part 516
(21 CFR part 516) and include recordkeeping and reporting requirements.
The purpose of these regulations is to encourage the development of
these new animal drugs, while still ensuring appropriate safeguards for
animal and human health. The general provisions in part 516, subpart A,
set forth its purpose, scope, and applicable definitions.
Our regulations in part 516, subpart B, provide for designation
status for Minor Use and Minor Species (MUMS) drugs prior to their
approval or conditional approval. MUMS-drug designation makes the
sponsor eligible for incentives to support the approval or conditional
approval of the designated use and is completely optional for drug
sponsors. The regulations describe how to apply for designation, what
needs to be submitted, and other information pertaining to this option.
Sponsors of designated new animal drugs are required to demonstrate due
diligence toward approval or conditional approval through submission of
annual reports documenting their progress for each designated use. We
use this information to allow for determining eligibility for
designation and the associated incentives and benefits, including a 7-
year period of exclusive marketing rights, as provided by section 573
of the FD&C Act. It enables us to process requests for MUMS-drug
designation, requests to amend MUMS-drug designation, changes in
sponsorship, termination of MUMS-drug designation, requirements for
annual reports from sponsors, and provisions for insufficient
quantities of MUMS-designated drugs.
Regulations in part 516, subpart C, are intended to make more
medications legally available to veterinarians and animal owners for
the treatment of minor animal species. In some cases, a minor species
drug is intended for use in species that are too rare or too varied to
be the subject of adequate and well-controlled studies in support of a
drug approval. In such cases, FDA may add the drug to the public index
listing of legally marketed unapproved new animal drugs for minor
species animals (Index), as provided for by section 572 of the FD&C
Act. Within limitations established by the statute, such indexing
provides a basis for legally marketing an unapproved new animal drug
intended for use in a minor species. Our regulations in part 516,
subpart C, specify, among other things, the criteria and procedures for
requesting eligibility for indexing and for requesting addition to the
Index, as well as the annual reporting requirements for holders of an
index listing. The administrative procedures and criteria for indexing
a new animal drug for use in a minor species, as well as modifications
and removal of a drug from the Index are also set forth. FDA uses the
information for the activities described above.
In the Federal Register of August 1, 2022 (87 FR 46961), FDA
published a 60-day notice requesting public
[[Page 42081]]
comment on the information collection requirements related to
designation status for MUMS drugs. No comments were received. We are
revising the information collection to add the information collection
requirements associated with the index listing of legally marketed
unapproved new animal drugs for minor species, for efficiency of Agency
operations.
Description of Respondents: The respondents to this information
collection are pharmaceutical companies that sponsor new animal drugs
for designation or requesters wishing to add a new animal drug to the
Index.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section; activity Number of responses per Total annual per response Total hours
respondents respondent responses \2\ (hours) \3\
----------------------------------------------------------------------------------------------------------------
Designated New Animal Drugs for Minor Use and Minor Species, Part 516, Subpart B
----------------------------------------------------------------------------------------------------------------
516.20, 516.26, 516.27, 516.29, 26 ~2.65 69 4 276
516.30, and 516.36; Reporting
burden associated with drug
designation requests and
termination of designation.....
----------------------------------------------------------------------------------------------------------------
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, Part 516, Subpart C
----------------------------------------------------------------------------------------------------------------
516.119, 516.121, 516.123, 30 ~10.33 310 ~16.954 5,256
516.125, 516.141, 516.143,
516.145; 516.161, 516.163, and
516.165; Reporting burden
associated with requests for
index listing and modifying
indexed drugs..................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 5,532
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Decimal rounded.
\3\ Rounded up.
Burden we attribute to reporting activities is assumed to be
distributed among the individual elements and averaged among
respondents. Our estimate of the burden per disclosure (4 and 16.954
hours, respectively) reflect what we believe is the average burden
based on the reporting required by the information collection.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section, activity Number of records per Total annual Average burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Designated New Animal Drugs for Minor Use and Minor Species, Part 516, Subpart B
----------------------------------------------------------------------------------------------------------------
One-time recordkeeping 474 1 474 0.68 (~41 minutes) 323
burden associated with \3\.
reading and understanding
the rule \2\.
----------------------------------------------------------------------------------------------------------------
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, Part 516, Subpart C
----------------------------------------------------------------------------------------------------------------
516.141 and 516.165; 40 2 80 0.625 (37.5 50
recordkeeping associated minutes).
with panel deliberations
and the information
pertinent to the safety and
effectiveness from foreign
sources.
-----------------------------------------------------------------------------------
Total................... .............. .............. .............. .................. 373
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Direct Final Rule, ``Defining `Small Number of Animals' for Minor Use Determination; Periodic Reassessment''
(September 15, 2022; 87 FR 56583). Preliminary Regulatory Impact Analysis (https://www.regulations.gov/document/FDA-2022-N-1128-0007).
\3\ Rounded up.
Burden we attribute to recordkeeping activities for the indexing
provisions is assumed to be distributed among the individual elements
and averaged among respondents. Our estimate of the burden per record
(0.625 hours) reflects what we believe is the average burden based on
the recordkeeping required by the information collection.
For efficiency of Agency operations, we are consolidating the
related information collection activities currently approved in OMB
control numbers 0910-0605 and 0910-0620 into a single collection
request. The burden estimates reflect our current experience with the
information collection and requests received by respondents over the
past 3 years. We also include burden that may be attributable to
rulemaking (RIN 0910-A146), which became effective on December 14,
2022. Although the rulemaking revised the definition of ``small number
of animals,'' for purposes of determining whether a particular intended
use of a drug in a major species qualifies as a minor use, we believe
only nominal adjustments in burden associated with designation status
for MUMS drugs may result, other than a one-time recordkeeping burden.
In addition, upon review of the previous information collection
submission related to
[[Page 42082]]
indexing, we include burden associated with recordkeeping to address a
data-entry error in the RISC/ORIA Combined Information System (ROCIS
system). Cumulatively, these changes and adjustments reflect an overall
increase of 5,905 hours and a corresponding increase of 864 responses,
annually, to the information collection.
Dated: June 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13853 Filed 6-28-23; 8:45 am]
BILLING CODE 4164-01-P
