02-15154. 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 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 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 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 Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146, Telephone number: [phone], email address: [e-mail].

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: [phone], email address: [e-mail].

Dated: June 11, 2002.

Sandra R. Manning,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention.