Proposed Data Collection Submitted for Public Comment and Recommendations, 57488-57490 [2018-24969]
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57488
Federal Register / Vol. 83, No. 221 / Thursday, November 15, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Number of
responses per
respondent
Total burden
(in hours)
Form name
Middle and High School Age Adolescents.
Middle and High School Age Adolescents.
Middle and High School Age Adolescents.
Parents/caregivers of adolescents ....
Parents/caregivers of adolescents ....
Youth Questionnaire ........................
20,000
1
50/60
16,667
Pre/Post youth questionnaire ...........
10,000
2
50/60
16,667
Youth interview/focus group guide ...
3,000
2
1.5
9,000
Parent/Caregiver questionnaire .......
Parent/Caregiver
interview/focus
group guide.
7,500
3,000
2
2
25/60
1.5
6,250
9,000
Total ...........................................
...........................................................
........................
........................
........................
57,584
Jeffery M. Zirger,
Acting Lead, Information Collection Review
Office, Office of Scientific Integrity, Office
of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2018–24966 Filed 11–14–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–19–0978; Docket No. CDC–2018–
0098]
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 Emerging Infections Program
(EIP). The EIP is a population-based
surveillance activity performed via
active, laboratory case finding that is
used for detecting, identifying, and
monitoring emerging pathogens.
DATES: CDC must receive written
comments on or before January 14,
2019.
SUMMARY:
khammond on DSK30JT082PROD with NOTICES
Number of
respondents
Type of respondents
You may submit comments,
identified by Docket No. CDC–2018–
0098 by any of the following methods:
ADDRESSES:
VerDate Sep<11>2014
16:53 Nov 14, 2018
Jkt 247001
• Federal eRulemaking Portal:
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–D74, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(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–
D74, Atlanta, Georgia 30329; phone:
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 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:
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
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; and
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.
5. Assess information collection costs.
Proposed Project
Emerging Infections Program OMB#
0920–0978 Exp. Date: 05/31/2021—
Revision—National Center for Emerging
and Zoonotic Infectious Diseases
(NCEZID), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Emerging Infections Programs
(EIPs) are population-based centers of
excellence established through a
network of state health departments
collaborating with academic
institutions; local health departments;
public health and clinical laboratories;
infection control professionals; and
healthcare providers. EIPs assist in
local, state, and national efforts to
prevent, control, and monitor the public
health impact of infectious diseases.
Activities of the EIPs fall into the
following general categories: (1) Active
surveillance; (2) applied public health
epidemiologic and laboratory activities;
(3) implementation and evaluation of
E:\FR\FM\15NON1.SGM
15NON1
57489
Federal Register / Vol. 83, No. 221 / Thursday, November 15, 2018 / Notices
pilot prevention/intervention projects;
and (4) flexible response to public
health emergencies. Activities of the
EIPs are designed to: (1) Address issues
that the EIP network is particularly
suited to investigate; (2) maintain
sufficient flexibility for emergency
response and new problems as they
arise; (3) develop and evaluate public
health interventions to inform public
EIP to better detect, identify, track
changes in laboratory testing
methodology, gather information about
laboratory utilization in the EIP
catchment area to ensure that all cases
are being captured, and survey EIP staff
to evaluate program quality.
The total estimated burden is 40,601
hours. There is no cost to respondents
other than their time.
health policy and treatment guidelines;
(4) incorporate training as a key
function; and (5) prioritize projects that
lead directly to the prevention of
disease.
A revision is being submitted to make
existing collection instruments clearer
and to add several new forms
specifically surveying laboratory
practices. These forms will allow the
khammond on DSK30JT082PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Form name
State Health Department
ABCs Case Report Form .....................................
ABCs Invasive Pneumococcal Disease in Children Case Report Form.
ABCs H.influenzae Neonatal Sepsis Expanded
Surveillance Form.
ABCs Severe GAS Infection Supplemental Form
ABCs Neonatal Infection Expanded Tracking
Form.
FoodNet Campylobacter ......................................
FoodNet Cyclospora ............................................
FoodNet Listeria monocytogenes ........................
FoodNet Salmonella ............................................
FoodNet Shiga toxin producing E. coli ................
FoodNet Shigella .................................................
FoodNet Vibrio .....................................................
FoodNet Yersinia .................................................
FoodNet Hemolytic Uremic Syndrome Case Report Form.
FoodNet Clinical Laboratory Practices and Testing Volume—NEW.
Influenza Hospitalization Surveillance Network
Case Report Form.
Influenza Hospitalization Surveillance Project
Vaccination Phone Script Consent Form
(English/Spanish).
Influenza Hospitalization Surveillance Project
Vaccination Phone Script (English/Spanish).
Influenza Hospitalization Surveillance Project
Provider Vaccination History Fax Form (Children/Adults).
FluSurv-NET Laboratory Survey—NEW ..............
HAIC CDI Case Report Form ..............................
HAIC CDI Annual Laboratory Survey—NEW ......
HAIC CDI Annual Surveillance Officers Survey—
NEW.
HAIC CDI LTCF Survey—NEW ...........................
HAIC Multi-site Gram-Negative Bacilli Case Report Form (MuGSI–CRE/CRAB).
HAIC Multi-site Gram-Negative Surveillance Initiative—Extended-Spectrum Beta-LactamaseProducing Enterobacteriaceae (MuGSI–ESBL).
HAIC Invasive Methicillin-resistant Staphylococcus aureus (MRSA).
HAIC Invasive Methicillin-sensitive Staphylococcus aureus (MSSA).
HAIC Invasive Staphylococcus aureus Annual
Laboratory Survey—NEW.
HAIC Invasive Staphylococcus aureus Annual
Surveillance Officers Survey—NEW.
HAIC Candidemia Case Report Form .................
HAIC Candidemia Periodic Laboratory Survey—
NEW.
10
10
809
22
20/60
10/60
2697
37
10
6
10/60
10
10
10
136
37
20/60
20/60
453
123
10
10
10
10
10
10
10
10
10
942
163
15
789
205
213
34
48
10
21/60
10/60
20/60
21/60
20/60
10/60
10/60
10/60
1
3297
272
50
2761
683
355
56
80
100
10
70
20/60
233
10
1000
25/60
4167
10
333
5/60
278
10
333
5/60
278
10
333
5/60
278
10
10
10
10
23
1650
16
1
10/60
35/60
10/60
15/60
38
9625
27
3
10
10
45
500
5/60
25/60
38
2083
10
1200
25/60
5000
10
474
25/60
1975
10
754
25/60
3142
10
11
8/60
15
10
1
10/60
2
9
9
800
15
20/60
20/60
2400
45
..............................................................................
........................
........................
........................
40,601
Total .......................
VerDate Sep<11>2014
16:53 Nov 14, 2018
Jkt 247001
PO 00000
Frm 00091
Number of
respondents
Avg. burden
per response
(in hours)
Type of
respondent
Fmt 4703
Sfmt 4703
E:\FR\FM\15NON1.SGM
15NON1
Total burden
(in hours)
57490
Federal Register / Vol. 83, No. 221 / Thursday, November 15, 2018 / Notices
Jeffrey M. Zirger,
Acting Lead, Information Collection Review
Office, Office of Scientific Integrity, Office
of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2018–24969 Filed 11–14–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10688]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
January 14, 2019.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
khammond on DSK30JT082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:53 Nov 14, 2018
Jkt 247001
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number llll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10688 Home Health (HH)
National Provider Survey
Under the 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.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Home Health
(HH) National Provider Survey; Use:
Section 1890A(a)(6) of the Social
PO 00000
Frm 00092
Fmt 4703
Sfmt 4703
Security Act (the Act) requires the
Secretary of HHS every three years to
assess the quality and efficiency effects
of the use of endorsed measures in
specific Medicare quality reporting and
incentive programs. This request is for
review and approval of a survey and
qualitative interview guide for the home
health setting, which CMS proposes to
use to address critical needs regarding
the impact of use of quality and
efficiency measures in the home health
setting, including the burden they
impose on home health agencies.
CMS plans to use the findings from
surveys and qualitative interviews for
multiple purposes. The qualitative
interviews and standardized survey will
inform CMS about the impact of
measures used to assess care in HHAs.
The surveys will help CMS understand
whether the use of performance
measures has been associated with
changes in HHA behavior—namely,
what quality improvements (QI)
investments HHAs are making and
whether adoption of QI changes is
associated with higher performance on
the measures. The survey will help CMS
identify characteristics associated with
high performance, which, if understood,
could be used to leverage improvements
in care among lower-performing HHAs.
The survey and interviews, assuming
approval by August 2019, would be
fielded from fall 2019 through spring
2020. Form Number: CMS–10688 (OMB
control number: 0938–NEW);
Frequency: Yearly; Affected Public:
Private Sector (Business or other forprofits, Not-for-Profit Institutions);
Number of Respondents: 1,040; Total
Annual Responses: 1,040; Total Annual
Hours: 1,040. (For policy questions
regarding this collection contact Noni
Bodkin at 410–786–7837.)
Dated: November 9, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–24951 Filed 11–14–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3692]
Evaluating the Pressor Effects of
Drugs; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\15NON1.SGM
Notice of public workshop.
15NON1
]]>Agencies
[Federal Register Volume 83, Number 221 (Thursday, November 15, 2018)]
[Notices]
[Pages 57488-57490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24969]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60 Day-19-0978; Docket No. CDC-2018-0098]
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 Emerging Infections Program
(EIP). The EIP is a population-based surveillance activity performed
via active, laboratory case finding that is used for detecting,
identifying, and monitoring emerging pathogens.
DATES: CDC must receive written comments on or before January 14, 2019.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0098 by any of the following methods:
Federal eRulemaking Portal: 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-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (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-D74, Atlanta, Georgia 30329; phone: 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; and
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.
5. Assess information collection costs.
Proposed Project
Emerging Infections Program OMB# 0920-0978 Exp. Date: 05/31/2021--
Revision--National Center for Emerging and Zoonotic Infectious Diseases
(NCEZID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Emerging Infections Programs (EIPs) are population-based
centers of excellence established through a network of state health
departments collaborating with academic institutions; local health
departments; public health and clinical laboratories; infection control
professionals; and healthcare providers. EIPs assist in local, state,
and national efforts to prevent, control, and monitor the public health
impact of infectious diseases.
Activities of the EIPs fall into the following general categories:
(1) Active surveillance; (2) applied public health epidemiologic and
laboratory activities; (3) implementation and evaluation of
[[Page 57489]]
pilot prevention/intervention projects; and (4) flexible response to
public health emergencies. Activities of the EIPs are designed to: (1)
Address issues that the EIP network is particularly suited to
investigate; (2) maintain sufficient flexibility for emergency response
and new problems as they arise; (3) develop and evaluate public health
interventions to inform public health policy and treatment guidelines;
(4) incorporate training as a key function; and (5) prioritize projects
that lead directly to the prevention of disease.
A revision is being submitted to make existing collection
instruments clearer and to add several new forms specifically surveying
laboratory practices. These forms will allow the EIP to better detect,
identify, track changes in laboratory testing methodology, gather
information about laboratory utilization in the EIP catchment area to
ensure that all cases are being captured, and survey EIP staff to
evaluate program quality.
The total estimated burden is 40,601 hours. There is no cost to
respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
State Health Department....... ABCs Case Report 10 809 20/60 2697
Form.
ABCs Invasive 10 22 10/60 37
Pneumococcal
Disease in
Children Case
Report Form.
ABCs 10 6 10/60 10
H.influenzae
Neonatal Sepsis
Expanded
Surveillance
Form.
ABCs Severe GAS 10 136 20/60 453
Infection
Supplemental
Form.
ABCs Neonatal 10 37 20/60 123
Infection
Expanded
Tracking Form.
FoodNet 10 942 21/60 3297
Campylobacter.
FoodNet 10 163 10/60 272
Cyclospora.
FoodNet Listeria 10 15 20/60 50
monocytogenes.
FoodNet 10 789 21/60 2761
Salmonella.
FoodNet Shiga 10 205 20/60 683
toxin producing
E. coli.
FoodNet Shigella 10 213 10/60 355
FoodNet Vibrio.. 10 34 10/60 56
FoodNet Yersinia 10 48 10/60 80
FoodNet 10 10 1 100
Hemolytic
Uremic Syndrome
Case Report
Form.
FoodNet Clinical 10 70 20/60 233
Laboratory
Practices and
Testing Volume--
NEW.
Influenza 10 1000 25/60 4167
Hospitalization
Surveillance
Network Case
Report Form.
Influenza 10 333 5/60 278
Hospitalization
Surveillance
Project
Vaccination
Phone Script
Consent Form
(English/
Spanish).
Influenza 10 333 5/60 278
Hospitalization
Surveillance
Project
Vaccination
Phone Script
(English/
Spanish).
Influenza 10 333 5/60 278
Hospitalization
Surveillance
Project
Provider
Vaccination
History Fax
Form (Children/
Adults).
FluSurv-NET 10 23 10/60 38
Laboratory
Survey--NEW.
HAIC CDI Case 10 1650 35/60 9625
Report Form.
HAIC CDI Annual 10 16 10/60 27
Laboratory
Survey--NEW.
HAIC CDI Annual 10 1 15/60 3
Surveillance
Officers
Survey--NEW.
HAIC CDI LTCF 10 45 5/60 38
Survey--NEW.
HAIC Multi-site 10 500 25/60 2083
Gram-Negative
Bacilli Case
Report Form
(MuGSI-CRE/
CRAB).
HAIC Multi-site 10 1200 25/60 5000
Gram-Negative
Surveillance
Initiative--Ext
ended-Spectrum
Beta-Lactamase-
Producing
Enterobacteriac
eae (MuGSI-
ESBL).
HAIC Invasive 10 474 25/60 1975
Methicillin-
resistant
Staphylococcus
aureus (MRSA).
HAIC Invasive 10 754 25/60 3142
Methicillin-
sensitive
Staphylococcus
aureus (MSSA).
HAIC Invasive 10 11 8/60 15
Staphylococcus
aureus Annual
Laboratory
Survey--NEW.
HAIC Invasive 10 1 10/60 2
Staphylococcus
aureus Annual
Surveillance
Officers
Survey--NEW.
HAIC Candidemia 9 800 20/60 2400
Case Report
Form.
HAIC Candidemia 9 15 20/60 45
Periodic
Laboratory
Survey--NEW.
---------------------------------------------------------------------------------
Total..................... ................ .............. .............. .............. 40,601
----------------------------------------------------------------------------------------------------------------
[[Page 57490]]
Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2018-24969 Filed 11-14-18; 8:45 am]
BILLING CODE 4163-18-P
