[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]


-----------------------------------------------------------------------

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

[[Page 41242]]

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