Proposed Data Collection Submitted for Public Comment and Recommendations, 77160-77162 [2024-21570]
Download as PDF
77160
Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Notices
Proposed Project
Institutional Review Board
Authorization Agreement for Human
Research—New—Office of Science (OS),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The CDC Human Research Protection
Office (HRPO) often receives requests
from outside institutions seeking to rely
on the CDC Institutional Review Board
(IRB) for review of a research study.
This arrangement also allows multiple
institutions to use, or rely on, the CDC
IRB for centralized review and approval
of research studies instead of review by
the site-specific IRBs, which helps
reduce duplication of effort, delays, and
expenses. To meet regulatory
requirements, institutions that elect to
rely on the CDC IRB are required to
complete a CDC IRB Authorization
Agreement for Human Research and a
Local Context Survey. The goal is to use
the agreement and survey to provide
regulatory oversight for human subjects
research, to maintain records, and to
track those institutions that have elected
to rely on the CDC IRB for review.
CDC requests OMB approval for an
estimated 450 annual burden hours.
There is no cost to respondents other
than their time to participate.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Hospital/Academic Institutions/IRB
Administrators.
Hospital/Academic Institutions/IRB
Administrators.
CDC IRB Authorization Agreement for Human Research (for review, completion, and submission to
CDC).
Local context survey (for completion and submission
to CDC).
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. 2024–21571 Filed 9–19–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–24–1365; Docket No. CDC–2024–
0069]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled Program Evaluation of CDC’s Core
State Injury Prevention Program. This
project allows CDC to collect
information from awardees funded
under the Core State Injury Prevention
Program.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:43 Sep 19, 2024
Number
of respondents
Form name
Jkt 262001
CDC must receive written
comments on or before November 19,
2024.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2024–
0069 by either of the following methods:
• Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
www.regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(www.regulations.gov) or by U.S. mail to
the address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H21–8, Atlanta, Georgia 30329;
Telephone: 404–639–7570; Email: omb@
cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires federal agencies to provide a
60-day notice in the Federal Register
DATES:
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
Number
responses per
respondent
Avg. burden
per response
(in hrs.)
150
1
1
150
1
2
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions 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,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Proposed Project
Program Evaluation of CDC’s Core
State Injury Prevention Program (OMB
Control No. 0920–1365, Exp. 7/31/
2025)—Revision—National Center for
Injury Prevention and Control (NCIPC),
E:\FR\FM\20SEN1.SGM
20SEN1
77161
Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Notices
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC is submitting a Revision request
for the currently approved Program
Evaluation of CDC’s Core State Injury
Prevention Program (OMB Control No.
0920–1365, Expiration Date 7/31/2025).
Approval is requested for an additional
three years to continue collecting
information from awardees funded
under the Core State Injury Prevention
Program cooperative agreement (CE21–
2101), hereafter known as Core SIPP.
CDC requests to continue collecting
several types of information from
recipients over the course of the funding
cycle. The Core SIPP Program added
three new recipients to the program and
is requesting a revision to allow for data
collection of these three new recipients.
This Revision is requested to
incorporate data collection and analysis
of three new funded recipients who
were added. Data collected up until this
point has been used to inform technical
assistance (TA) to recipients and
programmatic decision-making. CDC
has used this data to develop reports to
show program impact on recipient
capacity, public health actions, and
continuous quality improvement. This
information will continue to be used to:
(1) Evaluate and track outcomes at the
recipient- and program-levels as they
relate to injury prevention-focused
infrastructure development,
surveillance system development and
use, and partnerships to prevent
Adverse Childhood Experiences (ACEs),
Traumatic Brain Injury (TBI), and
transportation-related injuries.
Recipient-and program-level
identification of disproportionately
affected populations and subsequent
public health actions taken to address
injury-related health disparities will
also be assessed.
(2) Identify TA needs of individual
recipients and the recipient cohort, so
that the CDC team can appropriately
deploy resources to support recipients.
(3) Identify practice-based evidence
for injury prevention public health
actions to advance the field through
future partnerships, program design,
and publications.
(4) Inform continuous quality
improvement activities over the course
of the funding period, to include
quarterly and annual strategic planning
for current and later iterations of this
program under future funding.
Information is collected by CDC
through the following modes to address
the purposes identified above:
(1) The Core SIPP Implementation
Capacity Development Rubric was
implemented once at the start of
program funding (baseline collection),
and subsequently during the middle of
each reporting year. Recipients selfadminister the rubric via CDC’s Partner
Portal, where they self-score their state
injury prevention programs according to
their current level of capacity for
components of interest. These scores are
used to identify recipient strengths,
areas for improvement, and additional
needs for CDC TA support. Measuring
recipient improvements in
implementing public health actions in
this standard way greatly increases the
ability for CDC to measure the impact of
the program investment. CDC aggregates
these scores across recipients to identify
larger program needs and to inform
internal Continuous Quality
Improvement (CQI) activities. This
information is shared back with
recipients individually during annual
technical review calls, as well as in
aggregate at annual partnership
meetings. Additionally, increased
capacity will increase the likelihood of
sustainability beyond the funding cycle.
(2) Recipient-level Group Interviews
will take place at the end of Program
Years 3, 4, and 5. The purpose of these
interviews is to evaluate progress and
challenges in implementing the Core
SIPP program within the individual
recipient-level context to inform
tailored supports from CDC and
partners. The tailored support is an
effort to facilitate solutions to
programmatic barriers, adjust recipient
strategies as needed, and ensure the
quality of data reported annually to
CDC.
(3) Economic Indicators are collected
to better understand the cost of IVP
implementation by strategy as well as
how recipients have leveraged funds
and resources to increased sustainability
for injury and violence prevention work.
(4) Injury Indicator Spreadsheets and
Special Emphasis Reports are collected
annually to track state level injury and
violence morbidity and mortality data.
This allows CDC to measure trends over
time within a state, across states, and
against the national average to identify
changes during the Core SIPP funding
period. Completion of the spreadsheets
and reports ensures recipient
surveillance capacity and reporting is in
alignment with best practices.
CDC requests OMB approval for an
estimated 764 annual burden hours.
There is no cost to respondents other
than their time to participate.
ddrumheller on DSK120RN23PROD with NOTICES1
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Implementation Capacity Rubric ......................
Economic Indicators .........................................
Recipient-level Group Interviews .....................
Injury Indicators Spreadsheet ..........................
Emergency Department Injury Indicators
Spreadsheet.
Hospital Discharge Injury Indicators Spreadsheet.
Special Emphasis Reports ...............................
26
23
26
26
26
1
1
1
1
1
2
1
1.5
5
5
52
23
39
130
130
26
1
5
130
26
1
10
260
..........................................................................
....................
........................
..................
764
Type of respondents
Form name
Core SIPP Program Awardees .........
Total ...........................................
VerDate Sep<11>2014
16:44 Sep 19, 2024
Jkt 262001
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
E:\FR\FM\20SEN1.SGM
20SEN1
Total
burden
(in hours)
77162
Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Notices
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. 2024–21570 Filed 9–19–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Announcing the Intent To Award a Sole
Source Supplement to the National
Association of Councils on
Developmental Disabilities (NACDD)
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) is announcing
the award of a sole-source supplement
for the Bridging Aging and Disability
Networks cooperative agreement. ACL’s
Office of Supportive and Caregiver
Services (OSCS), Administration on
Aging (AoA) is collaborating with the
Projects of National Significance, the
Administration on Disabilities (AoD) to
provide a $180,478 supplement to the
Bridging Aging and Disability grant.
This grant is awarded to the NACDD,
who is partnering with the Institute on
Disability and Human Development at
the University of Illinois-Chicago, the
Lurie Institute for Disability Policy at
Brandeis University, The Arc, and US
Aging—the national association
representing and supporting the
network of Area Agencies on Aging
(AAAs) and Title VI Native American
Aging Programs. The goal of the grant is
to strengthen the collaboration between
aging and disability networks to better
support individuals with intellectual
and developmental disabilities (I/DD)
and their family caregivers in future
planning as they age. The supplemental
funding will be used to additionally
support aging caregivers of adults with
I/DD and will enhance the work of the
17 State Consortia teams to more
directly build capacity of AAAs to serve
adults with I/DD as they age and their
aging caregivers. The administrative
supplement for FY 2024 will be in the
amount of $180,478, bringing the total
award for FY 2024 to $600,000.00.
FOR FURTHER INFORMATION CONTACT: For
further information or comments
regarding this program supplement,
contact Larissa Crossen, U.S.
Department of Health and Human
Services, Administration for
Community Living, telephone (202)
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
16:44 Sep 19, 2024
Jkt 262001
795–7333; email Larissa.crossen@
acl.hhs.gov
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The
purpose of the supplemental funding is
to additionally support aging caregivers
of adults with I/DD and will enhance
the work of the 17 State Consortia
teams. A portion of the funding
(estimated 50%) will be used to pay for
existing workplan activities of the
grantee, particularly where there is
overlap in the existing work to bridge
the aging and disability networks to
support aging caregivers of adults with
I/DD. The remainder of the funding
(estimated to be 50%) will be used to
enhance the work of the 17 State
Consortia teams to more directly build
capacity of AAAs to serve adults with
I/DD as they age and their aging
caregivers.
Program Name: Bridging Aging and
Disabilities Networks.
Recipient: NACDD.
Period of Performance: The
supplement award will be issued for the
fourth year of a five-year project period,
September 30, 2024, through September
29, 2025.
Award Amount: $180,478.
Award Type: Cooperative Agreement.
Statutory Authority: This program is
authorized under the Developmental
Disabilities Assistance and Bill of Rights
Act of 2000, Title I, Subtitle E.
CFDA Number: 93.631 Discretionary
Projects.
Basis for Award: NACDD is currently
funded to carry out the objectives of this
project, Bridging Aging and Disability
Networks, and has completed three
years of work. ACL believes it is in the
best interest of the Federal Government
to supplement the current grantee’s
existing project. Establishing a new
grant project at this time would be
potentially disruptive to the current
work already well under way. Further,
it could create unintended duplication
of effort and missed opportunities for
greater coordination between the aging
and disability networks.
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
Dated: September 16, 2024.
Alison Barkoff,
Principal Deputy Administrator for the
Administration for Community Living,
performing the delegable duties of the
Administrator and the Assistant Secretary for
Aging.
[FR Doc. 2024–21498 Filed 9–19–24; 8:45 am]
BILLING CODE 4154–01–P
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
[Docket No. FDA–2024–D–4165]
Chemical Analysis for Biocompatibility
Assessment of Medical Devices; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Chemical Analysis
for Biocompatibility Assessment of
Medical Devices.’’ FDA is issuing this
draft guidance to describe
recommended methodological
approaches for chemical analysis for
biocompatibility assessment of medical
devices. The biocompatibility of
medical devices is evaluated based on
the duration of exposure and nature of
contact with the body. Chemical
characterization is one approach that
manufacturers can consider when
developing a strategy for the overall
biocompatibility assessment of a device.
This draft guidance is not final nor is it
for implementation at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by November 19, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
E:\FR\FM\20SEN1.SGM
20SEN1
Agencies
[Federal Register Volume 89, Number 183 (Friday, September 20, 2024)]
[Notices]
[Pages 77160-77162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21570]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-24-1365; Docket No. CDC-2024-0069]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled Program Evaluation of CDC's Core
State Injury Prevention Program. This project allows CDC to collect
information from awardees funded under the Core State Injury Prevention
Program.
DATES: CDC must receive written comments on or before November 19,
2024.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0069 by either of the following methods:
Federal eRulemaking Portal: www.regulations.gov. Follow
the instructions for submitting comments.
Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to www.regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (www.regulations.gov) or by U.S. mail to the address listed
above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570;
Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions 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, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected;
4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submissions of responses; and
5. Assess information collection costs.
Proposed Project
Program Evaluation of CDC's Core State Injury Prevention Program
(OMB Control No. 0920-1365, Exp. 7/31/2025)--Revision--National Center
for Injury Prevention and Control (NCIPC),
[[Page 77161]]
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
CDC is submitting a Revision request for the currently approved
Program Evaluation of CDC's Core State Injury Prevention Program (OMB
Control No. 0920-1365, Expiration Date 7/31/2025). Approval is
requested for an additional three years to continue collecting
information from awardees funded under the Core State Injury Prevention
Program cooperative agreement (CE21-2101), hereafter known as Core
SIPP.
CDC requests to continue collecting several types of information
from recipients over the course of the funding cycle. The Core SIPP
Program added three new recipients to the program and is requesting a
revision to allow for data collection of these three new recipients.
This Revision is requested to incorporate data collection and analysis
of three new funded recipients who were added. Data collected up until
this point has been used to inform technical assistance (TA) to
recipients and programmatic decision-making. CDC has used this data to
develop reports to show program impact on recipient capacity, public
health actions, and continuous quality improvement. This information
will continue to be used to:
(1) Evaluate and track outcomes at the recipient- and program-
levels as they relate to injury prevention-focused infrastructure
development, surveillance system development and use, and partnerships
to prevent Adverse Childhood Experiences (ACEs), Traumatic Brain Injury
(TBI), and transportation-related injuries. Recipient-and program-level
identification of disproportionately affected populations and
subsequent public health actions taken to address injury-related health
disparities will also be assessed.
(2) Identify TA needs of individual recipients and the recipient
cohort, so that the CDC team can appropriately deploy resources to
support recipients.
(3) Identify practice-based evidence for injury prevention public
health actions to advance the field through future partnerships,
program design, and publications.
(4) Inform continuous quality improvement activities over the
course of the funding period, to include quarterly and annual strategic
planning for current and later iterations of this program under future
funding.
Information is collected by CDC through the following modes to
address the purposes identified above:
(1) The Core SIPP Implementation Capacity Development Rubric was
implemented once at the start of program funding (baseline collection),
and subsequently during the middle of each reporting year. Recipients
self-administer the rubric via CDC's Partner Portal, where they self-
score their state injury prevention programs according to their current
level of capacity for components of interest. These scores are used to
identify recipient strengths, areas for improvement, and additional
needs for CDC TA support. Measuring recipient improvements in
implementing public health actions in this standard way greatly
increases the ability for CDC to measure the impact of the program
investment. CDC aggregates these scores across recipients to identify
larger program needs and to inform internal Continuous Quality
Improvement (CQI) activities. This information is shared back with
recipients individually during annual technical review calls, as well
as in aggregate at annual partnership meetings. Additionally, increased
capacity will increase the likelihood of sustainability beyond the
funding cycle.
(2) Recipient-level Group Interviews will take place at the end of
Program Years 3, 4, and 5. The purpose of these interviews is to
evaluate progress and challenges in implementing the Core SIPP program
within the individual recipient-level context to inform tailored
supports from CDC and partners. The tailored support is an effort to
facilitate solutions to programmatic barriers, adjust recipient
strategies as needed, and ensure the quality of data reported annually
to CDC.
(3) Economic Indicators are collected to better understand the cost
of IVP implementation by strategy as well as how recipients have
leveraged funds and resources to increased sustainability for injury
and violence prevention work.
(4) Injury Indicator Spreadsheets and Special Emphasis Reports are
collected annually to track state level injury and violence morbidity
and mortality data. This allows CDC to measure trends over time within
a state, across states, and against the national average to identify
changes during the Core SIPP funding period. Completion of the
spreadsheets and reports ensures recipient surveillance capacity and
reporting is in alignment with best practices.
CDC requests OMB approval for an estimated 764 annual burden hours.
There is no cost to respondents other than their time to participate.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total
Type of respondents Form name respondents responses per response burden (in
respondent (in hours) hours)
----------------------------------------------------------------------------------------------------------------
Core SIPP Program Awardees......... Implementation 26 1 2 52
Capacity Rubric.
Economic Indicators... 23 1 1 23
Recipient-level Group 26 1 1.5 39
Interviews.
Injury Indicators 26 1 5 130
Spreadsheet.
Emergency Department 26 1 5 130
Injury Indicators
Spreadsheet.
Hospital Discharge 26 1 5 130
Injury Indicators
Spreadsheet.
Special Emphasis 26 1 10 260
Reports.
----------------------------------------------------
Total.......................... ...................... ........... .............. .......... 764
----------------------------------------------------------------------------------------------------------------
[[Page 77162]]
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. 2024-21570 Filed 9-19-24; 8:45 am]
BILLING CODE 4163-18-P