Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Nurse Faculty Loan Program-Program Specific Data Form, Annual Performance Report Financial Data Form and NFLP Due Diligence Form; OMB No. 0915-0314-Revision, 33148-33150 [2023-10929]
Download as PDF
<![CDATA[
33148
Federal Register / Vol. 88, No. 99 / Tuesday, May 23, 2023 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Individuals (male and female) aged 18 years and older ........
Study Screener ......................
Survey Module .......................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2023–10957 Filed 5–22–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0687]
Abbott Laboratories Pharmaceutical
Products Division; Withdrawal of
Approval of New Drug Applications for
CYLERT (Pemoline) Tablets, 18.75
Milligrams, 37.5 Milligrams, and 75
Milligrams, and CYLERT (Pemoline)
Chewable Tablets, 37.5 Milligrams
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of new drug
application (NDA) 016832 for CYCLERT
(pemoline) tablets, 18.75 milligrams
(mg), 37.5 mg, and 75 mg, as well as
NDA 017703 for CYCLERT (pemoline)
chewable tablets, 37.5 mg, held by
Abbott Laboratories Pharmaceutical
Products Division, c/o G&L Scientific,
25 Independence Blvd., 4th Floor,
Warren, NJ 07059 (Abbott). Abbott
requested that approval of these
applications be withdrawn and has
waived its opportunity for a hearing.
DATES: Approval is withdrawn as of
May 23, 2023.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Office of Regulatory
Policy, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6226, Silver Spring,
MD 20993, 301–796–3137, Kimberly.
Lehrfeld@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
January 27, 1975, FDA approved NDA
016832 for CYLERT (pemoline) tablets,
18.75 mg, 37.5 mg, and 75 mg, for use
in the treatment of Attention-Deficit/
Hyperactivity Disorder (ADHD). On
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
Number of
respondents
Type of respondents
VerDate Sep<11>2014
17:24 May 22, 2023
Jkt 259001
January 30, 1976, the Agency approved
NDA 017703 for CYLERT (pemoline)
chewable tablets, 37.5 mg, for use in the
treatment of ADHD. On October 24,
2005, FDA issued a Postmarket Drug
Safety Information for Patients and
Providers communication entitled
‘‘Information for Healthcare
Professionals: Pemoline Tablets and
Chewable Tablets (Marketed as
CYLERT)’’ which concluded the overall
liver toxicity risk of CYLERT (pemoline)
(NDAs 016832 and 017703) and generic
pemoline products outweighed the
benefits of these products (https://
wayback.archive-it.org/7993/
20171114124349/https://www.fda.gov/
Drugs/DrugSafety/Postmarket
DrugSafetyInformationforPatientsand
Providers/ucm126461.htm).
All holders of approved applications
for pemoline products, including
Abbott, ceased marketing the products
at that time. On April 12, 2021, FDA
contacted Abbott and requested the
company submit a request for FDA to
withdraw approval of NDAs 016832 and
017703 for CYLERT tablets and CYLERT
chewable tablets, respectively, pursuant
to § 314.150(d) (21 CFR 314.150(d)) due
to the risk of liver toxicity. On
September 2, 2021, Abbott requested
that FDA withdraw approval of CYLERT
(pemoline) tablets and CYLERT
(pemoline) chewable tablets, NDAs
016832 and 017703, respectively, under
§ 314.150(d) and waived its opportunity
for a hearing.
For the reasons discussed above, and
in accordance with the applicant’s
request, approval of NDAs 016832 and
017703 for CYLERT (pemoline) tablets,
18.75 mg, 37.5 mg, and 75 mg, and
CYLERT (pemoline) chewable tablets,
37.5 mg, respectively, and all
amendments and supplements thereto,
is withdrawn under § 314.150(d).
Distribution of CYLERT (pemoline)
tablets, 18.75 mg, 37.5 mg, and 75 mg,
and CYLERT (pemoline) chewable
tablets, 37.5 mg, into interstate
commerce without an approved
application is illegal and subject to
regulatory action (see sections 505(a)
and 301(d) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(a) and 331(d))).
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
30,880
5,445
Average
burden per
response
(in hours)
1
1
2/60
30/60
Dated: May 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–10924 Filed 5–22–23; 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; Nurse Faculty Loan
Program—Program Specific Data
Form, Annual Performance Report
Financial Data Form and NFLP Due
Diligence Form; OMB No. 0915–0314–
Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
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.
SUMMARY:
Comments on this ICR should be
received no later than June 22, 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
submitted to OMB for review, email
Samantha Miller, the HRSA Information
DATES:
E:\FR\FM\23MYN1.SGM
23MYN1
33149
Federal Register / Vol. 88, No. 99 / Tuesday, May 23, 2023 / Notices
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Nurse Faculty Loan Program—Program
Specific Data Form, Annual
Performance Report Financial Data
Form and NFLP Due Diligence Form
OMB No. 0915–0314–Revision
Abstract: This clearance request is for
approval of the Nurse Faculty Loan
Program (NFLP)—Program Specific Data
Form, NFLP—Annual Performance
Report (APR) Financial Data Form, and
the NFLP Due Diligence Form. The
Program Specific Data Form and the
NFLP—APR Financial Data Form are
currently approved under OMB
Approval No. 0915–0314, with the
expiration date of August 31, 2023. The
NFLP Due Diligence Form is a new
form. HRSA seeks to use the NFLP Due
Diligence Form for recipients to
formally notify HRSA of any write-off
amounts due to uncollectible debt and
loan cancellation due to death and
permanent/total disability. For program
efficiency, HRSA is adding the new
NFLP Due Diligence Form to the current
NFLP ICR under OMB No. 0915–0314.
A 60-day notice published in the
Federal Register on March 8, 2023, vol.
88, No. 45; pp. 14378–79. There were no
public comments.
Need and Proposed Use of the
Information: Section 846A of the Public
Health Service Act provides the
Secretary of HHS with the authority to
enter into agreements with accredited
schools of nursing for the establishment
and operation of student loan funds to
increase the number of qualified nurse
faculty. Under the agreements, HRSA
makes awards to accredited schools of
nursing and the schools provide loans to
students enrolled in advanced
education nursing degree programs who
are committed to becoming nurse
faculty. Following graduation from the
NFLP grant recipient school, NFLP
borrowers may receive up to 85 percent
of loan cancellation over a 4-year period
in exchange for service as full-time
faculty at a school of nursing. The NFLP
grant recipient school collects any
portion of the loan that is not cancelled
and any loans that go into repayment
and deposits these monies into the
NFLP loan fund to make additional
NFLP loans.
The NFLP—Program Specific Data
Form is a required electronic attachment
within the NFLP application materials.
The data provided in the form is
essential for the formula-based criteria
used to determine the award amount to
the applicant schools. The form collects
application related data from applicants
such as the amount requested, number
of students to be funded, tuition
information, and projected unused loan
fund balance. This data collection
assists HRSA in streamlining the
application submission process,
enabling an efficient award
determination process, and facilitating
reporting on the use of funds and
analysis of program outcomes. There
have been no changes to this form.
The NFLP—APR Financial Data Form
is an online form that exists in the
HRSA Electronic Handbooks
Performance Report module. The
NFLP—APR Financial Data Form
collects outcome and financial data to
capture the NFLP loan fund account
activity related to financial receivables,
disbursements, and borrower account
data related to employment status, loan
cancellation, loan repayment and
collections. NFLP grant recipient
schools will provide HHS with current
and cumulative information on (1)
NFLP loan funds received, (2) number
and amount of NFLP loans made, (3)
number and amount of loans cancelled,
(4) number and amount of loans in
repayment, (5) loan default rate percent,
(6) number of NFLP graduates employed
as nurse faculty, and (7) other related
loan fund costs and activities. NFLP
grant recipient schools must keep
records of all NFLP loan fund
transactions. The NFLP—APR Financial
Data Form is used to monitor grantee
performance by collecting information
related to the NFLP loan fund
operations and financial activities for a
specified reporting period (July 1
through June 30 of the academic year).
NFLP grant recipient schools are
required to complete and submit the
NFLP—APR Financial Data Form
annually. The data provided in the form
is essential for HRSA to effectively
monitor the school’s use of NFLP funds
in accordance with the statute and
program guidelines. There have been no
changes to this form.
The NFLP Due Diligence Form will be
a required form to be completed and
submitted electronically by NFLP grant
recipient schools. This form indicates
that due diligence has been exercised in
the cancellation of any remaining loan
funds for NFLP borrowers due to
permanent/total disability, death, and
uncollectible/bad debt write-offs. The
data collected on the due diligence form
will include the student borrower’s
unique ID number, reason for
cancellation, the amount of principal
loaned, the total amount of principal
loan funds and corresponding interest
canceled, and the outstanding amount
of principal/interest being canceled or
written-off. The NFLP Due Diligence
Form is essential for monitoring
performance measure outcomes and to
verify and validate accuracy of
information submitted on the NFLP
Annual Performance Reports.
Likely Respondents: NFLP grant
recipient schools and applicants to the
NFLP program.
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.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
lotter on DSK11XQN23PROD with NOTICES1
Form name
Nurse Faculty Loan Program—Program Specific Data
Form .................................................................................
Nurse Faculty Loan Program—Annual Performance Report Financial Data Form .................................................
Nurse Faculty Loan Program—Due—Diligence Form ........
VerDate Sep<11>2014
17:24 May 22, 2023
Jkt 259001
PO 00000
Frm 00070
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
90
1
90
8
720
207
20
1
1
207
20
6
1
1242
20
Fmt 4703
Sfmt 4703
E:\FR\FM\23MYN1.SGM
23MYN1
33150
Federal Register / Vol. 88, No. 99 / Tuesday, May 23, 2023 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Form name
Total Burden .................................................................
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–10929 Filed 5–22–23; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0937–0198]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before June 22, 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 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 264–0041, or PRA@HHS.GOV.
SUMMARY:
Number of
responses per
respondent
317
3
When submitting comments or
requesting information, please include
the document identifier 0937–0198–30D
and project title for reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Public Health
Service Policies on Research
Misconduct (42 CFR part 93).
Type of Collection: Extension.
OMB No.: OS–0937–0198.
Abstract: The Office of Research
Integrity is requesting an extension on a
currently approved collection. The
purpose of the Institutional Assurance
and Annual Report on Possible Research
Misconduct form PHS–6349 is to
provide data on the amount of research
misconduct activity occurring in
institutions conducting PHS-supported
research. The purpose of the Assurance
of Compliance by Sub-Award Recipients
forms PHS–6315 is to establish an
assurance of compliance for a subawardee institution. Forms PHS 6349
Average
burden per
response
(in hours)
Total
responses
317
15
Total burden
hours
1982
and PHS–6315 are also used to provide
an annual assurance that the institution
has established and will follow
administrative policies and procedures
for responding to allegations of research
misconduct that comply with the Public
Health Service (PHS) Policies on
Research Misconduct (42 CFR part 93).
Research misconduct is defined as
receipt of an allegation of research
misconduct and/or the conduct of an
inquiry and/or investigation into such
allegations. These data enable the ORI to
monitor institutional compliance with
the PHS regulation.
There were minor revisions made on
forms PHS–6349 and PHS–6315. The
revisions will not alter the data
collection.
Need and Proposed Use: The
information is needed to fulfill section
493 of the Public Health Service Act (42
U.S.C. 289b), which requires assurances
from institutions that apply for financial
assistance under the Public Health
Service Act for any project or program
that involves the conduct of biomedical
or behavioral research. In addition, the
information is also required to fulfill the
assurance and annual reporting
requirements of 42 CFR part 93. ORI
uses the information to monitor
institutional compliance with the
regulation. Lastly, the information may
be used to respond to congressional
requests for information to prevent
misuse of Federal funds and to protect
the public interest.
lotter on DSK11XQN23PROD with NOTICES1
ESTIMATED ANNUALIZED BURDEN HOUR TABLE
Number of
respondents
Number of
responses per
respondents
Average
burden per
response
Forms
(if necessary)
Respondents
(if necessary)
PHS–6349 .......
PHS–6315 .......
Awardee Institutions ...........................................................
Sub-Awardee Institutions ...................................................
5,770
156
1
1
10/60
5/60
961
13
Total .........
.............................................................................................
5,926
2
........................
974
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2023–10938 Filed 5–22–23; 8:45 am]
BILLING CODE 4150–31–P
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17:24 May 22, 2023
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Fmt 4703
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23MYN1
Total burden
hours
]]>Agencies
[Federal Register Volume 88, Number 99 (Tuesday, May 23, 2023)]
[Notices]
[Pages 33148-33150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10929]
-----------------------------------------------------------------------
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; Nurse Faculty Loan
Program--Program Specific Data Form, Annual Performance Report
Financial Data Form and NFLP Due Diligence Form; OMB No. 0915-0314-
Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 June 22,
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 submitted to OMB for review, email Samantha Miller, the HRSA
Information
[[Page 33149]]
Collection Clearance Officer, at [email protected] or call (301) 443-
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Nurse Faculty Loan Program--
Program Specific Data Form, Annual Performance Report Financial Data
Form and NFLP Due Diligence Form OMB No. 0915-0314-Revision
Abstract: This clearance request is for approval of the Nurse
Faculty Loan Program (NFLP)--Program Specific Data Form, NFLP--Annual
Performance Report (APR) Financial Data Form, and the NFLP Due
Diligence Form. The Program Specific Data Form and the NFLP--APR
Financial Data Form are currently approved under OMB Approval No. 0915-
0314, with the expiration date of August 31, 2023. The NFLP Due
Diligence Form is a new form. HRSA seeks to use the NFLP Due Diligence
Form for recipients to formally notify HRSA of any write-off amounts
due to uncollectible debt and loan cancellation due to death and
permanent/total disability. For program efficiency, HRSA is adding the
new NFLP Due Diligence Form to the current NFLP ICR under OMB No. 0915-
0314.
A 60-day notice published in the Federal Register on March 8, 2023,
vol. 88, No. 45; pp. 14378-79. There were no public comments.
Need and Proposed Use of the Information: Section 846A of the
Public Health Service Act provides the Secretary of HHS with the
authority to enter into agreements with accredited schools of nursing
for the establishment and operation of student loan funds to increase
the number of qualified nurse faculty. Under the agreements, HRSA makes
awards to accredited schools of nursing and the schools provide loans
to students enrolled in advanced education nursing degree programs who
are committed to becoming nurse faculty. Following graduation from the
NFLP grant recipient school, NFLP borrowers may receive up to 85
percent of loan cancellation over a 4-year period in exchange for
service as full-time faculty at a school of nursing. The NFLP grant
recipient school collects any portion of the loan that is not cancelled
and any loans that go into repayment and deposits these monies into the
NFLP loan fund to make additional NFLP loans.
The NFLP--Program Specific Data Form is a required electronic
attachment within the NFLP application materials. The data provided in
the form is essential for the formula-based criteria used to determine
the award amount to the applicant schools. The form collects
application related data from applicants such as the amount requested,
number of students to be funded, tuition information, and projected
unused loan fund balance. This data collection assists HRSA in
streamlining the application submission process, enabling an efficient
award determination process, and facilitating reporting on the use of
funds and analysis of program outcomes. There have been no changes to
this form.
The NFLP--APR Financial Data Form is an online form that exists in
the HRSA Electronic Handbooks Performance Report module. The NFLP--APR
Financial Data Form collects outcome and financial data to capture the
NFLP loan fund account activity related to financial receivables,
disbursements, and borrower account data related to employment status,
loan cancellation, loan repayment and collections. NFLP grant recipient
schools will provide HHS with current and cumulative information on (1)
NFLP loan funds received, (2) number and amount of NFLP loans made, (3)
number and amount of loans cancelled, (4) number and amount of loans in
repayment, (5) loan default rate percent, (6) number of NFLP graduates
employed as nurse faculty, and (7) other related loan fund costs and
activities. NFLP grant recipient schools must keep records of all NFLP
loan fund transactions. The NFLP--APR Financial Data Form is used to
monitor grantee performance by collecting information related to the
NFLP loan fund operations and financial activities for a specified
reporting period (July 1 through June 30 of the academic year). NFLP
grant recipient schools are required to complete and submit the NFLP--
APR Financial Data Form annually. The data provided in the form is
essential for HRSA to effectively monitor the school's use of NFLP
funds in accordance with the statute and program guidelines. There have
been no changes to this form.
The NFLP Due Diligence Form will be a required form to be completed
and submitted electronically by NFLP grant recipient schools. This form
indicates that due diligence has been exercised in the cancellation of
any remaining loan funds for NFLP borrowers due to permanent/total
disability, death, and uncollectible/bad debt write-offs. The data
collected on the due diligence form will include the student borrower's
unique ID number, reason for cancellation, the amount of principal
loaned, the total amount of principal loan funds and corresponding
interest canceled, and the outstanding amount of principal/interest
being canceled or written-off. The NFLP Due Diligence Form is essential
for monitoring performance measure outcomes and to verify and validate
accuracy of information submitted on the NFLP Annual Performance
Reports.
Likely Respondents: NFLP grant recipient schools and applicants to
the NFLP program.
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.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Nurse Faculty Loan Program-- 90 1 90 8 720
Program Specific Data Form.....
Nurse Faculty Loan Program-- 207 1 207 6 1242
Annual Performance Report
Financial Data Form............
Nurse Faculty Loan Program--Due-- 20 1 20 1 20
Diligence Form.................
-------------------------------------------------------------------------------
[[Page 33150]]
Total Burden................ 317 3 317 15 1982
----------------------------------------------------------------------------------------------------------------
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-10929 Filed 5-22-23; 8:45 am]
BILLING CODE 4165-15-P
