[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
