[Federal Register Volume 63, Number 115 (Tuesday, June 16, 1998)]
[Notices]
[Pages 32882-32886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15924]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 99011]


Notice of Availability of Funds; Emerging Infections Program

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1999 funds for a cooperative agreement 
program to establish an Emerging Infections Program (EIP) to join a 
national network of EIPs. This program will assist in local, State, and 
national efforts to conduct surveillance and applied epidemiologic and 
laboratory research in emerging infectious diseases and to pilot and 
evaluate prevention measures. This program addresses the ``Healthy 
People 2000'' priority area of Immunization and Infectious Diseases.
    The purpose of the program is to assist State health departments to 
establish new EIPs as part of the national network. EIPs will be 
population-based centers designed to assess the public health impact of 
emerging infections and to evaluate methods for their prevention and 
control.
    Activities of the EIPs will fall into the general categories of: 
(1) active surveillance; (2) applied epidemiologic and applied 
laboratory research; and (3) implementation and evaluation of pilot 
prevention/intervention projects.
    The EIPs will maintain sufficient flexibility to accommodate 
changes in projects as required by the emergence of public health 
infectious disease problems. EIPs will be strategically located to 
serve a variety of geographical areas, diverse groups and difficult-to-
reach populations--e.g., under-served women and children, the homeless, 
immigrants and refugees, and persons infected with HIV. They will 
enlist the participation of local health departments, academic 
institutions, and other public and private organizations with an 
interest in addressing public health issues relating to emerging 
infectious diseases, and will seek support from sources, in addition to 
CDC, to operate the EIP.

B. Eligible Applicants

    Assistance will be provided only to the health departments of 
States or their bona fide agents, including the District of Columbia, 
the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth 
of the Northern Mariana Islands, American Samoa, Guam, federally-
recognized Indian tribal governments, the Federated States of 
Micronesia, the Republic of the Marshall Islands, and the Republic of 
Palau. In consultation with States, assistance may be provided to 
political subdivisions of States.
    The following States already participating in the EIP cooperative 
agreement program should not apply to this announcement: California, 
Connecticut, Georgia, Maryland, Minnesota, New York, and Oregon.

C. Availability of Funds

    Up to $1,000,000 is available in FY 1999 to fund two awards. The 
average award will be about $500,000. This amount is for both direct 
and indirect costs. It is expected that the awards will begin on or 
about October 1, 1998, and will be made for a 12-month budget period 
within a project period of up to five years. The funding estimate may 
change.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

    Note: Per instructions in Evaluation Criteria section below, the 
application should include proposals for four projects. CDC will 
select from one to four of those projects to fund based on the 
capacity of the applicant, priorities of the EIP network, and 
availability of resources.

Funding Preferences

    EIPs are currently established in the seven following states: 
California, Connecticut, Georgia, Maryland, Minnesota, New York, and 
Oregon. To achieve appropriate geographical representation in the EIP 
network, for one of the two potential awards made under this 
announcement, funding preference may be given to approved applications 
from States in Standard Federal Regions VI, VII, and VIII.

Region VI: Arkansas, Louisiana, New Mexico, Oklahoma, Texas
Region VII: Iowa, Kansas, Missouri, Nebraska
Region VIII: Colorado, Montana, North Dakota, South Dakota, Utah, 
Wyoming

[[Page 32883]]

D. Program Requirements

Recipient Activities

    1. Establish and operate an EIP to further local, State, and 
national efforts to address emerging infectious diseases:
    a. Organize the EIP so that it will have the capacity to conduct 
approximately three concurrent projects.
    b. Organize the EIP so that it will maintain the ability to 
accommodate changes in specific projects and priorities as the public 
health system's need for information changes or new health problems 
emerge.
    c. Operate the EIP so that it can function effectively as part of a 
national network of EIPs. Collaborate with CDC and other EIP sites, 
through the EIP steering committee and otherwise, to coordinate project 
priorities and to assure that important emerging infections issues are 
addressed appropriately.
    d. Establish the EIP in a defined population, which could include 
either an entire State or a geographically defined area (or areas) 
within a State. To accomplish the objectives of certain EIP activities, 
a minimum population base of approximately 1,000,000 may be necessary.
    2. Obtain technical and financial assistance to supplement the core 
assistance from CDC.
    3. Collaborate with other public and private organizations that 
have an interest in addressing public health issues relating to 
emerging infectious diseases (e.g., local public health agencies, 
schools of public health, university medical schools, medical 
examiners, health care providers, clinical laboratories, community-
based organizations, other Federal and State government agencies, 
research organizations, medical institutions, foundations, etc.).
    4. Propose and conduct emerging infections activities in 
collaboration with appropriate partner organizations. Collaborate with 
other EIPs, as appropriate, to finalize protocols for and conduct EIP 
activities.
    a. Categories of EIP activities. Activities of the EIP will fall 
into three categories:
    (1) Active population-based surveillance projects. These may 
include collection and submission of disease-causing infectious agents 
to State, CDC, or other laboratories. For example, the surveillance 
case definition for the condition might involve detection of a positive 
culture or a drug resistant isolate in a microbiology laboratory, a 
serologic test result, a histopathologic finding, or a clinical 
syndrome, depending upon the disease or condition under surveillance; 
the specific approach to surveillance could also vary depending on the 
disease or condition under surveillance. Surveillance should be 
comprehensive (e.g., inclusion of audits to assure complete reporting), 
with active rather than passive case-finding.
    (2) Applied epidemiologic and applied laboratory projects. Examples 
of potential projects include: evaluation of illnesses often not 
specifically diagnosed for which information about trends and etiology 
are important (e.g., diarrhea, community-acquired pneumonia); 
evaluation of clinical outcomes or risk factors for drug resistant 
infections; and evaluation of the clinical spectrum of influenza and 
the efficacy of influenza vaccines in target populations.
    (3) Implementation and evaluation of pilot prevention/intervention 
projects for emerging infectious diseases. Examples might include 
assessment of efforts to promote safe food preparation in the home, 
evaluation of impact of hand-washing promotion on infectious diseases 
in child-care facilities, or evaluation of antibiotic prescribing 
practices in out-patient settings.
    b. Specific EIP activities. In the application, propose a total of 
4 projects from the following list (see Applicant Content section for 
details):
    Required (propose both):
    (1) Active population-based laboratory surveillance for foodborne 
diseases and related activities (FoodNet).
    (2) Active Bacterial Core Surveillance (ABCs) activities.
    Optional (select and propose 2 of the following):
    (3) Active surveillance for syndromes of possibly infectious 
etiology (e.g., encephalitis, fulminant hepatitis).
    (4) A collaboration with one or more managed-care organizations on 
a surveillance, risk factor, or pilot prevention project.
    (5) A project to quantify or otherwise explore linkages between 
chronic and infectious diseases.
    5. As a part of certain EIP projects, provide specimens such as 
disease-causing isolates or serum specimens to appropriate 
organizations (which may include CDC) for laboratory evaluation (e.g., 
molecular epidemiologic studies, evaluation of diagnostic tools).
    6. Manage, analyze, and interpret data from EIP projects, and 
publish and disseminate important public health information stemming 
from EIP projects in collaboration with CDC.
    7. Monitor and evaluate scientific and operational accomplishments 
and progress in achieving the purpose of this program.
    8. Provide training opportunities at the EIP site (e.g., infectious 
disease fellows, laboratory fellows, public health students) that are 
consistent with the purpose of this announcement.

CDC Activities

    1. Provide consultation, scientific, and technical assistance in 
general operation of the EIP and in designing and conducting individual 
EIP projects.
    2. Participate in analysis and interpretation of data from EIP 
projects. Participate in the dissemination of findings and information 
stemming from EIP projects.
    3. Assist in monitoring and evaluating scientific and operational 
accomplishments of the EIP and progress in achieving the purpose and 
overall goals of this program.
    4. As needed, perform laboratory evaluation of specimens or 
isolates (e.g., molecular epidemiologic studies, evaluation of 
diagnostic tools) obtained in EIP projects and integrate results with 
other data from EIP projects.

E. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application. Your application will be evaluated on the criteria listed, 
so it is important to follow them in preparing your program plan.
    Applications should address the following topics in the order 
presented:
    1. Understanding the objectives of the EIP;
    2. Description of the population base for the EIP;
    3. Description of existing capacity to assess, control, and prevent 
emerging infectious diseases;
    4. Operational plan (including 4 project proposals as described 
below);
    5. Personnel qualifications and management plan;
    6. Evaluation plan; and
    7. Budget.
    Applicants should propose a total of 4 projects from the following 
list of activities.

    Note: Two of the four projects proposed must be the FoodNet and 
ABC's projects (numbers 1 and 2 below). The other two should be 
selected from numbers 3-5 below. Each specific project proposal 
should be clearly identified in a distinct portion of the 
Operational Plan and should not exceed 3 pages. Though the 
activities described below address distinct issues and needs, they 
may be implemented in an integrated manner such that staff members 
work on more than one activity (supplies and equipment are shared, 
etc.):


[[Page 32884]]


    1. Population-based laboratory surveillance for foodborne diseases 
and related activities (FoodNet): Conduct population-based laboratory 
surveillance including completion of case reports (which include 
demographic information as well as information about the diagnosis and 
outcome) and collection of disease-causing isolates--for seven 
bacterial and two parasitic foodborne pathogens (Salmonella, E. coli 
O157, Campylobacter, Shigella, Listeria, Yersinia, Vibrio, 
Cryptosporidium and Cyclospora). Completeness of surveillance should be 
verified by periodic (at least yearly) audits of area laboratories. In 
these audits, records in each laboratory should be reviewed and case 
report form information should be completed on cases not identified 
through the routine surveillance. Since this core activity will be done 
in collaboration with other EIP sites and CDC, the project should be 
designed so that data can be integrated with data from the other EIPs. 
Additional core activities for foodborne disease surveillance: (a) 
systematic survey of physician and laboratory practices regarding 
diagnostic practices for diarrheal pathogens (similar to those done in 
other sites), (b) active hemolytic uremic syndrome (HUS) surveillance 
through pediatric nephrologists, (c) pulsed-field gel electrophoresis 
(PFGE) of all E. coli O157 from catchment area, as part of expanding 
national network, and when the method is ready to be applied, PFGE of 
Salmonella typhimurium isolates, (d) participation in national 
antimicrobial resistance surveillance, and (e) surveillance for 
outbreaks of calicivirus gastroenteritis and/or endemic calicivirus 
gastroenteritis.
    2. Active Bacterial Core Surveillance (ABCs) activities: 
Population-based laboratory surveillance for invasive disease caused by 
emerging, vaccine preventable, and drug resistant bacterial diseases. 
Conduct active population-based laboratory surveillance including 
completion of case reports (which include demographic information as 
well as information about the diagnosis and outcome) and collection of 
disease-causing isolates for invasive bacterial disease caused by 
Streptococcus pneumoniae, Haemophilus influenzae, Neisseria 
meningitidis, groups A and B streptococci, Vancomycin-resistant 
enterococcus and Listeria monocytogenes. Collect additional 
demographic, medical, and vaccination history information on all 
invasive Haemophilus influenzae cases in persons less than 15 years of 
age (very small numbers). Collect additional information in cases of 
early-onset group B streptococcus disease. Completeness of surveillance 
should be verified by periodic (semiannual) audits of area 
laboratories. In these audits, records in each laboratory should be 
reviewed and case report form information should be completed on cases 
not identified through the routine surveillance. Since this core 
activity will be done in collaboration with the other EIP sites and 
CDC, the project should be designed so that data can be integrated with 
data from the other EIPs.
    3. Active surveillance for syndromes of possibly infectious 
etiology: (For example: encephalitis, fulminant hepatitis, or 
myocarditis.) Protocols for this project should be developed together 
with CDC and the EIP sites involved in the current EIP project on 
Unexplained Deaths and Critical Illnesses Possibly Due to Infections.
    4. Collaboration with managed-care organizations. (For example, 
collaborations with one or more managed-care organizations might 
include surveillance of infectious syndromes or piloting and evaluation 
of prevention projects.) Emphasis should be on infectious diseases of 
public health importance.
    5. Linkages between chronic and infectious diseases. (For example, 
projects might seek to quantify or otherwise explore links between 
chronic diseases and infectious diseases (e.g., hepatitis C and chronic 
liver disease; infections due to Chlamydia pneumoniae and 
atherosclerosis; mycoplasma infections and asthma, human papilloma 
virus and cervical cancer, genital infections and premature birth, or 
others.)
    Funding in future years may permit implementation of projects which 
are developed and implemented by individual EIP sites. Briefly describe 
activities which the applicant would propose to implement in the EIP in 
the future if given the opportunity.
Page Limitations
    The application narrative (excluding budget, appendices, and 
required forms) must not exceed 25 single-spaced pages, printed on one 
side, with one inch margins, and unreduced font. Only the following 
information should be presented in appendices: Letters of support, 
documentation of bona fide agent status, curricula vitaes, and budget. 
All other materials or information that should be included in the 
narrative will not be accepted if placed in the appendices.
Budget Instructions
    For each line-item (as identified on the Form 424a of the 
application), show both Federal and non-Federal (e.g., State funding) 
shares of total cost for the EIP. For each staff member listed under 
the Personnel line item, indicate their specific responsibilities 
relative to each of the proposed projects. Include provisions for 
travel of the principal investigator and one EIP participant to two 
meetings at CDC in Atlanta during the first year of the program.
Bona Fide Agent Status
    If applicant is an agent of a State public health agency and not a 
State public health agency itself, documentation that applicant is 
acting as a bona fide agent of a State public health agency should be 
provided in an appendix. Applicants acting as bona fide agents of a 
State public health agency are strongly encouraged to consult with 
CDC's Grants Management Specialist (identified in Section J below) 
prior to submitting the application for guidance regarding what 
constitutes acceptable documentation.

F. Submission and Deadline

Notice of Intent To Apply

    In order to assist CDC in planning and executing the evaluation of 
applications submitted under this announcement, all parties intending 
to submit an application are requested to inform CDC of their intention 
to do so at least ten (10) days prior to the application due date. 
Notification should include: (1) name and address of institution, and 
(2) name, address, and telephone number of contact person. Notification 
should be provided by facsimile, postal mail, or E-mail, to Laura Conn, 
National Center for Infectious Diseases (NCID), Centers for Disease 
Control and Prevention (CDC), 1600 Clifton Road, NE., Mailstop C-12, 
Atlanta, GA 30333, E-mail address [email protected], Facsimile (404) 639-
4197.

Application

    Submit the original and two copies of PHS 5161-1 (OMB Number 0937-
0189). Forms are provided in the application kit. On or before July 31, 
1998, submit the application to: Oppie Byrd, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Announcement 99011, Centers for Disease Control and Prevention (CDC), 
255 East Paces Ferry Road, NE., Room 300, Mailstop E-18, Atlanta, GA 
30305-2209
    If your application does not arrive in time for submission to the 
independent review group, it will not be considered

[[Page 32885]]

in the current competition unless you can provide proof that you mailed 
it on or before the deadline (i.e., receipt from U.S. Postal Service or 
a commercial carrier; private metered postmarks are not acceptable).

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC. 
Your application should address each section in the order presented 
below:
    1. Understanding the objectives of the EIP (10 points)
    a. Demonstration of a clear understanding of the background and 
objectives of this cooperative agreement program.
    b. Demonstration of a clear understanding of the requirements, 
responsibilities, problems, constraints, and complexities that may be 
encountered in establishing and operating the EIP.
    c. Demonstration of a clear understanding of the roles and 
responsibilities of participation in the EIP network.
    2. Description of the population base of the EIP area (10 points).
    a. Clear definition of the geographic area and population base in 
which the EIP will operate. Detailed description of the demographics of 
the proposed population base.
    b. Clear description of various special populations within the 
defined population base as they relate to the proposed activities of 
the EIP, such as the rural or inner city poor, under served women and 
children, the homeless, immigrants and refugees, and persons infected 
with HIV.
    c. Extent to which the population base is diverse in terms of 
demographics and special populations.
    3. Description of existing capacity to assess, control and prevent 
emerging infectious diseases: (35 points)
    a. Description of applicant's past experience in conducting active 
surveillance, applied epidemiologic research, applied laboratory 
research, and prevention research, in general, and on emerging 
infectious diseases, including antimicrobial drug resistant, foodborne 
and waterborne, currently or potentially vaccine preventable, and 
opportunistic diseases.
    b. Demonstration of applicant's ability to develop and maintain 
strong cooperative relationships with both public and private, local 
and regional, medical, public health, laboratory, academic, and 
community organizations. Evidence of applicant's ability to solicit and 
secure programmatic collaboration, and financial and technical support 
from such organizations.
    c. Demonstration of support from non-applicant participating 
agencies, institutions, organizations, laboratories, individuals, 
consultants, etc., indicated in applicant's operational plan. Applicant 
should provide (in an appendix) letters of support which clearly 
indicate collaborators' willingness to be participants in the EIP. Do 
not include letters of support from CDC personnel.
    4. Operational plan (40 points).
    a. The extent to which the applicant's plan for establishing and 
operating the population-based EIP clearly describes the proposed 
organizational and operating structure/procedures and clearly 
identifies the roles and responsibilities of all participating 
agencies, organizations, institutions, and individuals. The extent to 
which the applicant describes plans for collaboration with CDC and 
other EIP sites in the establishment and operation of the EIP and 
individual EIP projects, including project design/development (e.g., 
protocols), management and analysis of data, and synthesis and 
dissemination of findings.
    b. Description of applicant's partnerships with necessary and 
appropriate organizations for establishing and operating the proposed 
EIP and for conducting individual EIP projects.
    c. Description of plans to provide training opportunities for 
providers-in-training (e.g., infectious disease fellows, laboratory 
fellows, public health students).
    d. Description of a plan to solicit and secure financial and 
technical assistance from other public and private organizations (e.g., 
schools of public health, university medical schools, public health 
laboratories, community-based organizations, other Federal and State 
government agencies, research organizations, foundations, etc.) to 
supplement the core funding from CDC.
    e. Quality of the proposed projects (as requested in the 
Application Content section above) regarding consistency with public 
health needs, intent of this program, feasibility, methodology/
approach, and collaboration/participation of partner organizations. The 
degree to which the applicant has met the CDC Policy requirements 
regarding the inclusion of women, ethnic, and racial groups in the 
proposed research. This includes: (1) The proposed plan for the 
inclusion of both sexes and racial and ethnic minority populations for 
appropriate representation; (2) The proposed justification when 
representation is limited or absent; (3) A statement as to whether the 
design of the study is adequate to measure differences when warranted; 
and (4) A statement as to whether the plans for recruitment and 
outreach for study participants include the process of establishing 
partnerships with community(ies) and recognition of mutual benefits.
    5. Personnel qualifications and management plan.
    a. Identification of applicant's key professional personnel to be 
assigned to the EIP and EIP projects (provide curriculum vitae for each 
in an appendix). Clear identification of their respective roles in the 
management and operation of the EIP. Descriptions of their experience 
in conducting work similar to that proposed in this announcement.
    b. Identification of key professional personnel from other 
participating or collaborating institutions, agencies, organizations 
outside of the applicant's agency that will be assigned to EIP 
activities (provide curriculum vitae for each in an appendix). Clear 
identification of their respective roles.
    c. Description of all support staff and services to be assigned to 
the EIP.
    d. Description of approach to maintaining sufficiently flexible EIP 
staffing to accommodate the likelihood that the requirements of EIP 
projects will change from time to time due to changes in the public 
health system's need for information or the emergence of new diseases.
    6. Evaluation (5 points).
    a. Quality of plan for monitoring and evaluating scientific and 
operational accomplishments of the EIP and of individual EIP projects.
    b. Quality of plan for monitoring and evaluating progress in 
achieving the purpose and overall goals of this cooperative agreement 
program.
    7. Budget (not scored).
    Extent to which the line-item budget is detailed, clearly 
justified, and consistent with the purpose and objectives of this 
program. Extent to which applicant shows both Federal and non-Federal 
(e.g., State funding) shares of total cost for the EIP.
    If requesting funds for any contracts, provide the following 
information for each proposed contract: (1) Name of proposed 
contractor, (2) breakdown and justification for estimated costs, (3) 
description and scope of activities to be performed by contractor, (4) 
period of performance, and (5) method of contractor selection (e.g., 
sole-source or competitive solicitation).
    8. Human Subjects (not scored).

[[Page 32886]]

    Does the application adequately address the requirements of Title 
45 CFR Part 46 for the protection of human subjects?
____ Yes    ____ No     Comments:__________

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Semiannual progress reports. The first semiannual report is 
required with each year's continuation application and should cover 
program activities from beginning of the current budget period to date 
of report/application preparation. The second semiannual report is due 
90 days after the end of each budget period and should cover activities 
for the entire budget period recently completed. This second report may 
simply be a ``cut/paste'' update of the first semiannual (partial 
budget period) report to add information from date of first report to 
the end of the budget period.
    2. Financial Status Report (FSR), no more than 90 days after the 
end of the budget period; and
    3. Final FSR and performance reports, no more than 90 days after 
the end of the project period. Send all reports to: Oppie Byrd, Grants 
Management Specialist, Grants Management Branch, Procurement and Grants 
Office, Centers for Disease Control and Prevention (CDC), 255 East 
Paces Ferry Rd., NE., Rm. 300, Mailstop E-18, Atlanta, GA 30305-2209.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I in the 
application kit.

AR98-1 Human Subjects Requirements
AR98-2 Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR98-7 Executive Order 12372 Review
AR98-9 Paperwork Reduction Act Requirements
AR98-10 Smoke-Free Workplace Requirements
AR98-11 Healthy People 2000
AR98-12 Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under Sections 301(a) and 317(k)(1)(2) 
of the Public Health Service Act [42 U.S.C. sections 241(a) and 
247b(k)(1)(2)], as amended. The Catalog of Federal Domestic Assistance 
number is 93.283.

J. Where To Obtain Additional Information

    To receive additional written information and to request an 
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked 
to leave your name and address and will be instructed to identify the 
Announcement number of interest.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from Oppie Byrd, Grants Management Specialist Grants Management Branch, 
Procurement and Grants Office, Announcement 99011, Centers for Disease 
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, 
Mailstop E-18, Atlanta, GA 30305-2209, Telephone (404) 842-6546, E-mail 
address: [email protected].
    For program technical assistance, contact Robert W. Pinner, M.D., 
or Pat McConnon, M.P.H., Office of the Director, National Center for 
Infectious Diseases, Centers for Disease Control and Prevention (CDC), 
Mailstop C-12, 1600 Clifton Road, NE., Atlanta, GA 30333, Telephone 
(404) 639-2603, E-mail address for Dr. Pinner: [email protected]/E-mail 
address for Mr. McConnon: [email protected].
    See also the CDC homepage on the Internet: http://www.cdc.gov
    Potential applicants may obtain a copy of ``Addressing Emerging 
Infectious Disease Threats: A Prevention Strategy for the United 
States'' through the Centers for Disease Control and Prevention (CDC), 
National Center for Infectious Diseases, Office of Planning and Health 
Communication--EP, Mailstop C-14, 1600 Clifton Road, NE., Atlanta, GA 
30333. Requests may also be sent by facsimile to (404) 639-3039.

    Dated: June 10, 1998.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 98-15924 Filed 6-15-98; 8:45 am]
BILLING CODE 4163-18-P