Emerging Infections Program; Notice of Availability of Funds

[Federal Register Volume 64, Number 132 (Monday, July 12, 1999)]
[Notices]
[Pages 37540-37544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17556]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 00011]


Emerging Infections Program; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2000 funds for a cooperative agreement 
program to support the national network of Emerging Infections Programs 
(EIP). 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 
support established EIPs (California, Connecticut, Georgia, Maryland, 
Minnesota, New York, Oregon, and Tennessee) or to develop 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. The EIP network 
has developed these guiding principles:
    1. The EIP network aims to be a national resource for surveillance, 
prevention, and control of emerging infectious diseases. EIP activities 
are intended to go beyond the routine functions of health departments 
in ways that allow important public health questions to be answered.
    2. EIP activities address important issues in infectious diseases 
and are selected with regard to what is appropriate, in particular, for 
the EIP network.
    3. The EIP network maintains sufficient flexibility for emergency 
response and to address new problems as they arise.
    4. Training is a key function of the EIPs.
    5. The EIP network develops and evaluates public health practices 
and transfers what is learned to the public health community.
    6. The EIP network gives high priority to activities that lead 
directly to prevention of disease.
    Activities of the EIPs 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 and diverse groups of people. 
They may 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. EIPs will work as part of a collaborative 
network.

B. Eligible Applicants

    Assistance will be provided only to the health departments of 
States or their bona fide agents, the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of 
the Northern Mariana Islands, American Samoa, Guam, the Federated 
States of Micronesia, the Republic of the Marshall Islands, and the 
Republic of Palau. In addition, official public health agencies of city 
governments with jurisdictional populations greater than 2,500,000 
(based on 1990 census data) or county governments with jurisdictional 
populations greater than 8,000,000 (based on 1990 census data) are 
eligible to apply. Specifically, the three eligible local jurisdictions 
are New York City; Los Angeles County, California; and Chicago.

C. Availability of Funds

    Approximately $9,000,000 is available in FY 2000 to fund up to 
eight awards. Although only eight awards are expected at this time, CDC 
may make additional awards to approved applications received and 
evaluated under this announcement. It is expected that the awards will 
range from approximately $500,000 (for a new award) to approximately 
$1,200,000 (for a competing continuation) depending on the activities 
funded per site. This amount is for both direct and indirect costs. It 
is expected that the awards will begin on or about December 30, 1999, 
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 and the availability of funds.

    Note: Per instructions in Evaluation Criteria section below, the 
application should include proposals for the core activities and at 
least one optional project. CDC will fund core and optional projects 
based on the application and availability of resources.

Funding Preferences

    To achieve appropriate geographic representation in the EIP 
network, funding preference may be given to approved applications that 
would enhance the geographic diversity of the network.
    Funding preference may be given to competing continuation 
applications over applications for programs not already receiving 
support under the EIP cooperative agreement.

D. Program Requirements

Recipient Activities

    1. Establish and operate an EIP to further local, State, and 
national efforts to address emerging infectious diseases:
    a. 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 1,500,000 may be necessary.
    b. Organize the EIP so that it will have the capacity to conduct 
multiple concurrent projects.
    c. Organize the EIP so that it will maintain the ability to 
accommodate changes in specific activities and priorities as the public 
health system's need for information changes or new health problems 
emerge.
    d. 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 group and other EIP working groups, to 
establish priorities, to coordinate and monitor projects, and to assure 
that important emerging infections issues are well addressed.
    2. Work to obtain technical and financial assistance to complement 
the basic assistance obtained from CDC.
    3. Develop the EIP as a partnership between the health department 
and 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, health care providers, infection control 
practitioners, clinical laboratories, community-based organizations, 
other Federal and State government agencies, research organizations, 
medical institutions, foundations, etc.).
    4. Conduct emerging infections activities in collaboration with 
appropriate partner organizations.

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Collaborate with other EIPs, as appropriate, to develop and conduct EIP 
activities.
    a. Categories of EIP activities. Activities of the EIPs 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., may include audits to assure complete reporting) 
with active 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, encephalitis); evaluation of clinical 
outcomes or risk factors for drug resistant infections; and evaluation 
of the efficacy of upcoming pneumococcal and meningococcal conjugate 
vaccines.
    (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 the core activities and at least one 
optional activity. (Note: Approximately 80-90% of resources will go for 
core and multisite activities.) See Appendix for details about 
activities. Applicants are encouraged to consult with CDC programs in 
planning their proposed activities. Core Activities (propose all):
    (1) Active Bacterial Core surveillance (ABCs) and related 
activities.
    (2) Active population-based laboratory surveillance for foodborne 
diseases and related activities (FoodNet).
    (3) Unexplained Deaths and Critical Illnesses Project, OR Active 
surveillance for syndromes of possibly infectious etiology (e.g., 
encephalitis, fulminant hepatitis).
    Optional (applicant may propose activities from the list below or 
other projects of local interest or concern that are in keeping with 
the guiding principles of the EIP network):
    (1) Sentinel Surveillance for chronic liver disease.
    (2) Sentinel Counties Study for Acute Viral Hepatitis.
    (3) Population-based laboratory surveillance for invasive disease 
caused by community acquired methicillin-resistant Staphylococcus 
aureus.
    (4) Surveillance of antimicrobial-resistant isolates from clinical 
microbiology laboratories by aggregating cumulative susceptibility 
data, i.e., antibiograms and correlation with antimicrobial usage 
practices.
    (5) Facilitating electronic reporting from clinical laboratories to 
public health (Electronic Laboratory-based Reporting, ELR).
    (6) Enhanced case ascertainment for culture negative meningococcal 
disease.
    (7) Active laboratory-based surveillance for Bordetella pertussis.
    5. As a part of certain EIP projects, provide specimens such as 
disease-causing isolates or serum specimens to appropriate 
organizations (which may include, but is not limited to, 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 and the EIP network.
    7. Monitor and evaluate scientific and operational accomplishments 
and progress in achieving the purpose of this program.
    8. Incorporate training activities as an important component of the 
EIP. Training activities may take one or more of these forms:
    (1) Providing training opportunities for persons in professional 
training, such as infectious disease fellows, laboratory fellows, 
public health students.
    (2) Providing training for partner organizations within the EIP 
area, such as infection control practitioners or local health 
department personnel.
    (3) Acting as a resource for states that are not participating in 
the EIP network, for example by providing information, training, or 
recommendations about emerging public health issues and evolving public 
health practices.
    9. If a proposed project involves research on human participants, 
ensure appropriate IRB review.

CDC Activities

    1. Provide general coordination for the EIP network.
    2. Provide consultation, scientific and technical assistance in the 
operation of the EIP and in designing and conducting individual EIP 
projects.
    3. Participate in analysis and interpretation of data from EIP 
projects. Participate in the dissemination of findings and information 
stemming from EIP projects.
    4. Assist in monitoring and evaluating scientific and operational 
accomplishments of the EIP and progress in achieving the purpose and 
overall goals of this program.
    5. If 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.
    6. If during the project period research involving human subjects 
should be conducted and CDC scientists will be co-investigators in that 
research, assist in the development of a research protocol for IRB 
review by all institutions participating in the research project. The 
CDC IRB will review and approve the protocol initially and on, at 
least, an annual basis until the research project is completed.

E. Application Content

    Use the information in the Program Requirements and Evaluation 
Criteria sections to develop the application. Applications 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
5. Evaluation plan
6. Budget

    Applicants should propose the core activities and at least one 
optional activity. Optional activities may be chosen from the list 
provided or initiated by the applicant based on local interest, 
concern, or expertise that are in keeping with the guiding principles 
of the EIP. Each activity proposal, including both core and optional 
activities, should be clearly identified in a distinct portion of the 
Operational Plan and should not exceed 3 pages. Although the activities 
described below

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address distinct issues and needs, they may be implemented in an 
integrated manner such that staff members work on more than one 
activity, or supplies and equipment are shared.

Page Limitations

    The application narrative (excluding budget, budget narrative, 
appendices, and required forms) must not exceed 25 single-spaced pages, 
printed on one side, with one inch margins, and a font size no smaller 
than 10. The following information should be presented in appendices: 
Letters of support, documentation of bona fide agent status, curricula 
vitaes, and budget. In addition, documentation of relevant 
accomplishments, such as abstracts, manuscripts, or bibliographies may 
be included in appendices. Materials or information that should be 
included in the narrative will not be reviewed 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. All other line-items should 
also be clearly justified. In addition to the budget justification, 
provide an estimate of the budget for each separate activity or project 
(e.g., FoodNet, ABCs, etc.).

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 thirty (30) 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: Catherine 
Spruill, 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 cas5@cdc.gov. Facsimile (404) 
639-4197.

Application Submission and Deadline

    Submit the original and two copies of PHS 5161-1 (OMB Number 0937-
0189). Forms are provided in the application kit. On or before 
September 1, 1999, submit the application to: Andrea Wooddall, Grants 
Management Specialist, Grants Management Branch, Procurement and Grants 
Office, Announcement 00011, Centers for Disease Control and Prevention 
(CDC), 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146.
    1. Deadline: Applications shall be considered as meeting the 
deadline if they are either:
    (a) Received on or before the deadline date; or
    (b) Sent on or before the deadline date and received in time for 
submission to the objective review group. (Applicants must request a 
legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or U.S. Postal Service. Private 
metered postmarks shall not be acceptable as proof of timely mailing.)
    2. Late Applications: Applications which do not meet the criteria 
in 1.(a) or 1.(b) above are considered late applications. Late 
applications will not be considered in the current competition and will 
be returned to the applicant.

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 (5 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, underserved women and 
children, the homeless, immigrants and refugees, and persons infected 
with HIV.
    c. Extent to which the population base is demographically diverse.
    3. Description of existing capacity to assess, control and prevent 
emerging infectious diseases (40 points).
    a. Description of applicant's past experience and documentation of 
accomplishments 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. (A list of 
relevant papers and abstracts should be included in an appendix.) 
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., included in the operational plan. Applicant should 
provide (in an appendix) letters of support which clearly indicate 
collaborators' willingness to participate in the EIP and define their 
roles. Do not include letters of support from CDC personnel.
    d. Demonstration of applicant's ability to participate in a 
multistate collaborative network.
    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.
    b. The extent to which the applicant describes plans for 
collaboration with CDC and other EIP sites in the

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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.
    c. Description and quality of applicant's partnerships with 
necessary and appropriate organizations for establishing and operating 
the proposed EIP and for conducting individual EIP projects.
    d. Description and quality of plans to provide training 
opportunities in one or more of these areas: (1) Providing training 
opportunities for persons in professional training, such as infectious 
disease fellows, laboratory fellows, public health students; (2) 
Providing training for partner organizations within the EIP area, such 
as infection control practitioners or local health department 
personnel; (3) Acting as a resource for states that are not 
participating in the EIP network, for example by providing information, 
training, or recommendations about emerging public health issues and 
evolving public health practices.
    e. 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.
    f. Quality of the proposed projects (as requested in the 
Application Content section above) regarding consistency with EIP 
guiding principles, public health needs, intent of this program, 
feasibility, methodology/approach, and collaboration/ participation of 
partner organizations.
    g. Identification of applicant's key professional personnel to be 
assigned to the EIP and EIP projects as well as key professional 
personnel from other participating or collaborating institutions, 
agencies, and 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 participants' respective roles in 
the management and operation of the EIP. Descriptions of participants' 
experience in conducting work similar to that proposed in this 
announcement.
    h. Description of all support staff and services to be assigned to 
the EIP.
    i. The extent to which the applicant clearly describes how the EIP 
or its design for the EIP is flexible and able to swiftly address new 
public health challenges in infectious diseases.
    j. The degree to which the applicant has met the CDC Policy 
requirements regarding the inclusion of women, ethnic, and racial 
groups in any 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.
    (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. 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.
    6. 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).
    Does the application adequately address the requirements of Title 
45 CFR Part 46 for the protection of human subjects?

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.
    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: Andrea Wooddall, Grants Management Specialist, 
Grants Management Branch, Procurement and Grants Office, Announcement 
00011, Centers for Disease Control and Prevention (CDC), 2920 
Brandywine Road, Room 3000, Atlanta, GA 30341-4146.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I in the 
application kit.

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

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under Sections 301(a), 317(k)(1) and 
317(k)(2) of the Public Health Service Act [42 U.S.C. sections 241(a), 
247b(k)(1) and 247b(k)(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 assistance may be obtained from: Andrea 
Wooddall, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Announcement 00011, Centers for Disease 
Control and Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, 
GA 30341-4146, Telephone: (770) 488-2751. E-mail address: ayw3@cdc.gov.
    For program technical assistance, contact: Catherine Spruill, 
National Center for Infectious Diseases (NCID), Centers for Disease 
Control and Prevention (CDC), 1600 Clifton Road, NE., Mailstop C-12, 
Atlanta, GA 30333,

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Telephone (404) 639-2603. E-mail address: cas5@cdc.gov.
    See also the CDC homepage on the Internet for a copy of this 
announcement, application and forms: http://www.cdc.gov.
    Potential applicants may obtain a copy of ``Preventing Emerging 
Infectious Diseases: A Strategy for the 21st Century'' 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 or on the CDC 
webpage.

    Dated: July 6, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 99-17556 Filed 7-9-99; 8:45 am]
BILLING CODE 4163-18-P