[Federal Register Volume 59, Number 145 (Friday, July 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18491]


[[Page Unknown]]

[Federal Register: July 29, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 479]

 

Emerging Infections Program

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1994 funds for a cooperative agreement 
program to establish two demonstration Emerging Infections Programs 
(EIPs). This cooperative agreement program will assist in local, State, 
and national efforts to conduct surveillance and applied epidemiologic 
and laboratory research in emerging infectious diseases.
    The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of ``Healthy People 
2000,'' a PHS-led national activity to reduce morbidity and mortality 
and improve the quality of life. This announcement is related to the 
priority area of Immunization and Infectious Diseases. (For ordering a 
copy of ``Healthy People 2000,'' see the section WHERE TO OBTAIN 
ADDITIONAL INFORMATION.)

Authority

    This program is authorized under Sections 301(a) [42 U.S.C. 
241(a)], 317 [42 U.S.C. 247b], and 318(c) [42 U.S.C. 247c(c)] of the 
Public Health Service Act, as amended. Applicable program regulations 
are found in 42 CFR Part 51b, Project Grants for Preventive Health 
Services, and 42 CFR Part 52, Grants for Research Projects.

Smoke-Free Workplace

    The Public Health Service strongly encourages all grant recipients 
to provide a smoke-free workplace and promote the non-use of all 
tobacco products. This is consistent with the PHS mission to protect 
and advance the physical and mental health of the American people.

Eligible Applicants

    Eligible applicants are the official public health agencies of 
States or their bona fide agents. This includes the District of 
Columbia, American Samoa, the Commonwealth of Puerto Rico, the Virgin 
Islands, the Federated States of Micronesia, Guam, the Northern Mariana 
Islands, the Republic of the Marshall Islands, the Republic of Palau, 
and federally recognized Indian tribal governments.
    Non-State public health agency applicants must provide 
certification by the State designating the institution as the State's 
official applicant.

Availability of Funds

    Approximately $900,000 is available in FY 1994 to fund two awards. 
It is expected that the average award will be $450,000, ranging from 
$400,000 to $500,000. It is expected that the awards will begin on or 
about September 30, 1994, and will be made for a 12-month budget period 
within a project period of up to 5 years. Funding estimates may vary 
and are subject to change.
    Continuation awards within the project period will be made on the 
basis of satisfactory progress and the availability of funds.

Purpose

    The purpose of this cooperative agreement is to assist State health 
departments to establish demonstration Emerging Infections Programs 
(EIPs). 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.
    Activities of the EIPs will be focused in the areas of drug-
resistant infections, foodborne and waterborne diseases, and vaccine 
preventable or potentially vaccine preventable diseases.
    The EIPs will maintain sufficient flexibility to accommodate 
changes in individual projects as required by the emergence of public 
health infectious disease problems. EIPs will be strategically located 
to offer access to diverse groups and to difficult-to-reach 
populations--e.g., underserved 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.

Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under A. 
(Recipient Activities), and CDC will be responsible for the activities 
listed under B. (CDC Activities).

A. Recipient Activities

    1. Establish and operate a demonstration 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 five 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. Although there will initially be only two 
demonstration EIPs, the goal is to eventually establish additional EIPs 
in various States or localities across the United States. EIPs will 
need to coordinate project priorities with CDC and among themselves 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 500,000 may be necessary.
    2. Work to obtain technical and financial assistance to supplement 
the core assistance from CDC, as well as programmatic collaboration 
from other ``partner organizations.'' Partner organizations may be 
academic institutions and other public and private organizations with 
an interest in addressing public health issues relating to emerging 
infectious diseases (e.g., local public health agencies, public health 
laboratories, medical examiners, university medical schools, schools of 
public health, health care providers, clinical laboratories, community-
based organizations, other Federal and State government agencies, 
research organizations, medical institutions, foundations, etc.).
    3. Propose and conduct emerging infections activities in 
collaboration with CDC and appropriate partner organizations. 
Collaborate with CDC and other EIPs to finalize protocols for EIP 
activities. For activities to be conducted at more than one EIP, 
collaborate with CDC and other EIPs to develop mutually agreed upon 
standardized protocols.
    a. Categories of EIP activities. Activities of the EIP will fall 
into three categories:
    (1) Active population-based surveillance projects. These may 
include collection of disease-causing infectious agents and submission 
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.
    (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 drug resistant infections; evaluation of the clinical 
spectrum of influenza and the efficacy of influenza vaccines in target 
populations; investigation of the relationships between infections and 
chronic diseases (e.g., respiratory infections and asthma attacks); 
behavioral surveillance projects designed to assess trends in behaviors 
(e.g., food handling practices, antibiotic use) that affect the risk 
for infectious diseases; assessment of the use and impact of newer 
diagnostic tools on the diagnosis and management of specific diseases 
(e.g., neonatal group B streptococcal disease, Lyme disease); 
evaluation of emerging infectious diseases in difficult-to-reach 
populations, such as persons who do not have access to routine medical 
care or the homeless; examination of infectious diseases in particular 
populations (e.g., studying the relationship between cervical 
papillomavirus infection and cervical carcinoma in women); evaluation 
of the economic impact of infectious diseases or cost-benefit studies 
of intervention strategies.
    (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 handwashing promotion on infectious diseases in 
child care facilities, or evaluation of antibiotic prescribing 
practices in outpatient settings.
    b. Specific EIP activities.
    (1) Propose and conduct the following core activities:
    (a) Population-based laboratory surveillance for invasive disease 
caused by emerging, vaccine preventable, and drug resistant bacterial 
diseases.
    (b) Population-based surveillance of unexplained deaths due to 
possibly infectious cause in previously healthy persons.
    (2) Propose up to 3 additional projects that could be conducted in 
the EIP. The particular projects proposed would depend upon the 
interests of the applicant and local concerns, but could include the 
following projects:
    (a) Population-based surveillance for hepatitis,
    (b) Surveillance for emerging etiologies of pneumonia in the U.S., 
and
    (c) Surveillance of bloody diarrhea.
    4. 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).
    5. Manage, analyze, and interpret data from EIP projects, and 
publish and disseminate important public health information stemming 
from EIP projects in collaboration with CDC.
    6. Provide training opportunities for providers-in-training (e.g., 
infectious disease fellows).
    7. Monitor and evaluate scientific and operational accomplishments 
of the EIP and progress in achieving the purpose and overall goals of 
this program.
    B. CDC Activities
    1. Provide consultation and 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 publication and 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.

Evaluation Criteria

    The applications will be reviewed and evaluated according to the 
following criteria:
    1. Understanding the objectives of the EIP: The extent to which the 
applicant demonstrates a clear understanding of the objectives of this 
cooperative agreement program. The extent to which the applicant 
demonstrates a clear understanding of the requirements, 
responsibilities, problems, constraints, and complexities that may be 
encountered in establishing and operating the demonstration EIP. (5 
points)
    2. Population Base:
    The extent to which the applicant defines clearly the geographic 
area and population base in which the EIP will operate. The extent to 
which the applicant defines a population base for the EIP that is 
sufficiently large and diverse to accomplish proposed EIP activities. 
The extent to which the applicant clearly describes various special 
populations in the EIP area, such as the rural or inner city poor, 
underserved women and children, the homeless, immigrants/refugees, and 
persons infected with HIV, that could be the focus of one or more EIP 
projects. (5 points)
    3. Capacity:
    a. The extent to which the applicant demonstrates its capacity and 
ability to conduct surveillance, applied epidemiologic and applied 
laboratory research, and prevention research in emerging infectious 
diseases. (20 points)
    b. The extent to which the applicant demonstrates its ability to 
develop and maintain strong cooperative relationships with various 
public and private local and regional medical, public health, academic, 
and community organizations. The extent to which applicant demonstrates 
its ability to solicit and secure financial and technical support and 
programmatic collaboration from other public and private organizations 
for conducting public health research projects. The extent to which 
applicant provides letters of support from non-applicant participating 
agencies, institutions, organizations, individuals, consultants, etc., 
indicating their willingness to participate, as represented in 
applicant's operational plan, in establishing and operating the 
demonstration center. (15 points)
    4. Operational Plan:
    a. The extent to which the applicant's proposed plan for 
establishing and operating the demonstration center is detailed and 
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 in the establishment and ongoing operation of the 
demonstration EIP and individual EIP projects. The extent to which the 
applicant's plan addresses all Recipient Activities and appears 
feasible and capable of accomplishing the purpose of this cooperative 
agreement program. (15 points)
    b. The extent to which the applicant proposes to conduct the core 
activities, as outlined in the Application Content section of the 
program announcement included in the application kit. The extent to 
which the applicant proposes potential additional appropriate projects 
that could be conducted at the EIP. The extent to which the proposed 
core and additional projects demonstrate that the applicant understands 
and is capable of conducting population-based surveillance, applied 
epidemiologic and applied laboratory studies, and pilot prevention 
programs. The quality of the proposed projects regarding consistency 
with public health needs, intent of this cooperative agreement program, 
feasibility, methodology/approach, and collaboration/participation of 
partner organizations. (10 points)
    c. The extent to which the applicant's plan clearly describes 
partnerships with appropriate organizations for establishing and 
operating the proposed demonstration EIP and for conducting individual 
EIP projects. Partner organizations may be academic institutions and 
other public and private organizations with an interest in addressing 
public health issues relating to emerging infectious diseases (e.g., 
local public health agencies, public health laboratories, medical 
examiners, university medical schools, schools of public health, health 
care providers, clinical laboratories, community-based organizations, 
other Federal and State government agencies, research organizations, 
medical institutions, foundations, etc.). The extent to which the 
applicant's plan describes possible training opportunities for 
providers-in-training (e.g., infectious disease fellows). The extent to 
which the applicant proposes a clearly detailed and viable plan for 
soliciting and securing financial and technical assistance from other 
public and private organizations to supplement the core funding from 
CDC. (15 points)
    5. Project Management and Staffing:
    The extent to which the applicant identifies its own professional 
and support staff and professional and support staff from other 
agencies, institutions, and organizations, that have the experience, 
authority, and willingness to carry out recipient activities as 
evidenced by job descriptions, curriculum vitae, organizational charts, 
etc. The extent to which the applicant describes an approach to 
maintaining sufficiently flexible EIP staffing to accommodate the 
likelihood that the requirements of EIP projects will change from time 
to time. (10 points)
    6. Evaluation:
    The extent to which applicant provides a detailed evaluation plan. 
The quality of the proposed plan for monitoring scientific and 
operational accomplishments of the demonstration EIP and of individual 
EIP projects. The quality of the proposed evaluation plan for 
monitoring progress in achieving the purpose and overall goals of this 
program. (5 points)
    7. Budget:
    The extent to which the proposed budget is reasonable, clearly 
justifiable, and consistent with the intended use of cooperative 
agreement funds. (not scored)

Executive Order 12372 Review

    Applications are subject to Intergovernmental Review of Federal 
Programs as governed by Executive Order 12372. E.O. 12372 sets up a 
system for State and local government review of proposed Federal 
assistance applications. Applicants (other than federally recognized 
Indian tribal governments) should contact their State Single Point of 
Contact (SPOC) as early as possible to alert them to the prospective 
applications and receive any necessary instructions on the State 
process. For proposed projects serving more than one State, the 
applicant is advised to contact the SPOC for each affected State. A 
current list of SPOCs is included in the application kit. Indian tribes 
are strongly encouraged to request tribal government review of the 
proposed application. If SPOCs or tribal governments have any process 
recommendations on applications submitted to CDC, they should forward 
them to Edwin L. Dixon, Grants Management Officer, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop E-18, Room 
314, Atlanta, GA 30305. The due date for State process recommendations 
is 30 days after the application deadline date for new and competing 
continuation awards. (A waiver for the 60 day requirement has been 
requested). The granting agency does not guarantee to ``accommodate or 
explain'' for State process recommendations it receives after that 
date.

Public Health System Reporting Requirements

    This program is not subject to the Public Health System Reporting 
Requirements.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance number is 93.283.

Other Requirements

Paperwork Reduction Act

    Projects that involve the collection of information from ten or 
more individuals and funded by the cooperative agreement will be 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act.

Human Subjects

    If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human Services 
Regulations 45 CFR Part 46, regarding the protection of human subjects. 
Assurance must be provided to demonstrate that the project will be 
subject to initial and continuing review by the appropriate 
institutional review committee. In addition to other applicable 
committees, Indian Health Service (IHS) institutional review committees 
also must review the project if any component of IHS will be involved 
or will support the research. If any Native American community is 
involved, its tribal government must also approve that portion of the 
project applicable to it. The applicant will be responsible for 
providing assurance in accordance with the appropriate guidelines and 
form provided in the application kit.

Application Submission and Deadline

    The Program Announcement and application kits were sent to all 
eligible applicants on July 1, 1994.

Where to Obtain Additional Information

    A complete program description and information on application 
procedures are contained in the application package. Business 
management technical assistance may be obtained from Leah D. Simpson, 
Grants Management Specialist, Grants Management Branch, Procurement and 
Grants Office, Centers for Disease Control and Prevention (CDC), 255 
East Paces Ferry Road, NE., Room 314, Mailstop E-18, Atlanta, GA 30305, 
telephone (404) 842-6803. Programmatic technical assistance may be 
obtained from Robert W. Pinner, M.D., Special Assistant for 
Surveillance, 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-
2859.
    Please refer to Announcement Number 479 when requesting information 
and submitting and application.
    Potential applicants may obtain a copy of ``Healthy People 2000'' 
(Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000'' 
(Summary Report, Stock No. 017-001-00473-1) referenced in the 
``Introduction'' through the Superintendent of Documents, Government 
Printing Office, Washington, DC 20402-9325, telephone (202) 783-3238.
    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, Atlanta, GA 30333. 
Requests may also be sent by facsimile to (404) 639-3039.

    Dated: July 22, 1994.
Joseph R. Carter,
Deputy Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 94-18491 Filed 7-28-94; 8:45 am]
BILLING CODE 4163-18-P