[Federal Register Volume 67, Number 116 (Monday, June 17, 2002)]
[Notices]
[Pages 41239-41243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15154]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 02174]
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) 2002 funds for a cooperative agreement
for the Emerging Infections Program (EIP). This program addresses the
``Healthy People 2010'' focus area of Immunization and Infectious
Diseases.
The purpose of the program is to expand the national EIP network by
adding a tenth EIP in a state along the United States-Mexico Border.
Measurable outcomes of the program will be in alignment with one or
more of the following performance goals for the National Center for
Infectious Diseases: (1) Protect Americans from priority infectious
diseases, (2) Apply scientific findings to prevent and control
infectious diseases, and (3) Strengthen epidemiologic and laboratory
capacity to recognize, respond to, and monitor infectious diseases.
B. 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.
C. Eligible Applicants
Assistance will be provided only to the health departments of
States or their bona fide agents, along the United States-Mexico
border. No other applications are solicited.
Eligibility is limited to these states for the following reasons:
1. Infectious diseases in the border region are a high priority and
Congress has continually encouraged CDC to expand its efforts in this
area, most recently in the FY 2002 appropriations language [Senate
Report 107-84 (S.1536)].
2. The EIP model for population-based approach to infectious
diseases is perfectly suited for studying and addressing infectious
diseases along the border.
3. One of the key goals of the EIP network is to establish
individual EIPs so that the network is geographically diverse. Adding
the tenth EIP in one of the United States-Mexico border states is fully
consistent with this goal.
Note: Title 2 of the United States Code section 1611 states that
an organization described in section 501(c)(4) of the Internal
Revenue Code that engages in lobbying activities is not eligible to
receive Federal funds constituting an award, grant or loan.
D. Availability of Funds
Approximately $1,000,000 is available in FY 2002 to fund one award.
It is expected that the award will begin on or about September 1, 2002
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.
Matching funds are not required for this program.
E. Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities under 1. Recipient
Activities, and CDC will be responsible for the activities listed under
2. CDC Activities.
1. Recipient Activities
a. Establish and operate an EIP to further local, State, and
national efforts to address emerging infectious diseases:
(1) 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.
(2) Organize the EIP so that it will have the capacity to conduct
multiple concurrent projects.
(3) 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.
(4) 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
[[Page 41240]]
groups, to establish priorities, to coordinate and monitor projects,
and to assure that important emerging infections issues are well
addressed.
b. Work to obtain technical and financial assistance to complement
the basic assistance obtained from CDC.
c. 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
professionals, clinical laboratories, community-based organizations,
other Federal and State government agencies, research organizations,
medical institutions, foundations, etc.).
d. Conduct emerging infections activities in collaboration with
appropriate partner organizations. Collaborate with other EIPs, as
appropriate, to develop and conduct EIP activities.
(1) Categories of EIP activities. Activities of the EIPs generally
fall into three categories:
(a) 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.
(b) Applied epidemiologic and applied laboratory projects. Examples
of potential projects include: evaluation of illnesses often not
specifically diagnosed for which information on 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 pneumococcal and meningococcal conjugate vaccines.
(c) 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, evaluation of the impact of Group B
Streptococcus prevention activities, or evaluation of antibiotic
prescribing practices in outpatient settings.
(2) Specific EIP activities.
In the application, propose the following four activities: three
Core plus Border Infectious Disease Surveillance (BIDS). Applicants may
also include (in addition to the four required activities) other
activities of local interest or concern that are consistent with the
guiding principles of the EIP network. Applicants are encouraged to
consult with CDC programs in planning their proposed activities.
Core Activities:
(a) Active Bacterial Core surveillance (ABCs) and related
activities.
(b) Active population-based laboratory surveillance for food-borne
diseases and related activities (FoodNet).
(c) A syndrome surveillance activity, which includes a laboratory
component (e.g., surveillance for respiratory syndromes; surveillance
for meningitis and encephalitis).
Border Infectious Disease Activity: Border Infectious Disease
Surveillance (BIDS) activities.
e. As a part of certain EIP projects, provide specimens such as
disease-causing isolates or serum specimens to appropriate
organizations (which may include, but are not limited to, CDC) for
laboratory evaluation (e.g., molecular epidemiologic studies,
evaluation of diagnostic tools).
f. 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.
g. Use measures of effectiveness to evaluate and demonstrate
accomplishment of the scientific and operational objectives and purpose
of the EIP cooperative agreement. Measures should be objective and
quantitative and adequate to measure the intended outcome.
h. Incorporate training activities as an important component of the
EIP. Training activities may take one or more of these forms:
(1) Provide training opportunities for persons in professional
training, such as infectious disease fellows, laboratory fellows,
public health students.
(2) Provide training for partner organizations within the EIP area,
such as infection control practitioners or local health department
personnel.
(3) Act 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.
i. If a proposed project involves research on human participants,
ensure appropriate IRB review.
2. CDC Activities
a. Provide general coordination for the EIP network.
b. Provide consultation, scientific and technical assistance in the
operation of the EIP and in designing and conducting individual EIP
projects.
c. Participate in analysis and interpretation of data from EIP
projects. Participate in the dissemination of findings and information
stemming from EIP projects.
d. Assist in monitoring and evaluating scientific and operational
accomplishments of the EIP and progress in achieving the purpose and
overall goals of this program.
e. 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.
f. Assist in the development of a research protocol for
Institutional Review Board (IRB) review by all cooperating 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.
F. Content
Applications
The Program Announcement title and number must appear in the
application. Use the information in the Program Requirements, Other
Requirements, and Evaluation Criteria sections to develop the
application content. Your application will be evaluated on the criteria
listed, so it is important to follow them in laying out 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 four required (three core plus BIDS)
activities and at least one optional activity. CDC will fund core and
optional projects based on the application and availability of
[[Page 41241]]
resources. 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 required and optional
activities, should be clearly identified in a distinct portion of the
operational plan and should not exceed three pages. Although 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, 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.
G. Submission and Deadline
Application
Submit the original and two copies of PHS 5161-1 (OMB Number 0920-
0428). Forms are available in the application kit and at the following
Internet address: www.cdc.gov/od/pgo/forminfo.htm.
Application forms must be submitted in the following order:
Cover Letter
Table of Contents
Application
Budget Information Form
Budget Justification
Checklist
Assurances
Certifications
Disclosure Form
HIV Assurance Form (if applicable)
Human Subjects Certification (if applicable)
Indirect Cost Rate Agreement (if applicable)
Narrative
Applications may not be submitted electronically.
On or before 5 p.m. Eastern Time July 30, 2002, the application
must be received by: Technical Information Management--PA 02174,
Procurement and Grants Office, Centers for Disease Control and
Prevention, 2920 Brandywine Rd, Room 3000, Atlanta, GA 30341-4146.
Deadline: Applications shall be considered as meeting the deadline
if they are received before 5 p.m. Eastern Time on the deadline date.
Applicants sending applications by the United States Postal Service or
commercial delivery services must ensure that the carrier will be able
to guarantee delivery of the application by the closing date and time.
If an application is received after closing due to (1) carrier error,
when the carrier accepted the package with a guarantee for delivery by
the closing date and time, or (2) significant weather delays or natural
disasters, CDC will upon receipt of proper documentation, consider the
application as having been received by the deadline.
Applications which do not meet the above criteria will not be
eligible for competition and will be discarded. Applicants will be
notified of their failure to meet the submission requirements.
H. Evaluation Criteria
Each application will be evaluated individually against the
following criteria by an independent review group appointed by CDC:
1. 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 specifically on emerging infectious diseases,
including antimicrobial drug resistant, food-borne and waterborne,
currently or potentially vaccine preventable, and opportunistic
diseases. (A list of relevant papers and abstracts should be included
in an appendix.)
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., 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 multi-
state collaborative network.
2. 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 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 the 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
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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: (a) The proposed plan
for the inclusion of both sexes and racial and ethnic minority
populations for appropriate representation, (b) the proposed
justification when representation is limited or absent, (c) a statement
as to whether the design of the study is adequate to measure
differences when warranted, and (d) 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.
3. Evaluation (10 points)
a. Extent to which the application includes Measures of
Effectiveness that will be used to measure and demonstrate
accomplishment of the identified objectives of the grant. Extent to
which the measures are objective and quantitative and appear adequate
to measure the intended outcome.
b. Quality of the plan for monitoring and evaluating scientific and
operational accomplishments of the EIP and of individual EIP projects.
c. Quality of plan for monitoring and evaluating progress in
achieving the purpose and overall goals of this cooperative agreement
program.
4. 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.
5. Description of the Population Base of the EIP Area (5 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 demographically diverse.
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.
8. Human Subjects (not scored)
Does the application adequately address the requirements of Title
45 CFR Part 46 for the protection of human subjects? (Not scored;
however, an application can be disapproved if the research risks are
sufficiently serious and protection against risks is so inadequate as
to make the entire application unacceptable.)
I. Other Requirements
Technical Reporting Requirements
Provide CDC with original plus two copies of:
1. Semiannual progress reports. The progress report will include a
data requirement that demonstrates measures of effectiveness.
2. Financial status report, no more than 90 days after the end of
the budget period.
3. Final financial and performance reports, no more than 90 days
after the end of the project period.
4. Applicants are required to provide measures of effectiveness
that will demonstrate the accomplishment of the identified objectives
of the cooperative agreement. Measures of effectiveness must relate to
the performance goals stated in section ``A. Purpose'' of this
announcement.
Send all reports to the Grants Management Specialist identified in
the ``Where to Obtain Additional Information'' section of this
announcement.
The following additional requirements are applicable to this
program. For a complete description of each, see Attachment III of 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
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-15 Proof of Non-Profit Status
AR-22 Research Integrity
J. Where To Obtain Additional Information
This and other CDC announcements, the necessary applications, and
associated forms can be found on the CDC Home Page Internet address--
http://www.cdc.gov Click on ``Funding'' then ``Grants and Cooperative
Agreements.''
For business management assistance, contact:
Yolanda Sledge, Grants Management Specialist, Procurement and
Grants
[[Page 41243]]
Office, Centers for Disease Control and Prevention, 2920 Brandywine
Road, Room 3000, Atlanta, GA 30341-4146, Telephone number: (770) 488-
2787, email address: [email protected].
For program technical assistance, contact: Catherine Rebmann,
National Center for Infectious Diseases, Centers for Disease Control
and Prevention, 1600 Clifton Road, NE., Atlanta, GA 30333, Telephone
number: (404) 371-5363, email address: [email protected].
Dated: June 11, 2002.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 02-15154 Filed 6-14-02; 8:45 am]
BILLING CODE 4163-18-P