00-20498. Cooperative Agreement for Research on the Ecology of Lyme Disease in the United States; Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2001 funds for a cooperative agreement program for research on the ecology of Lyme disease in the United States. This program addresses the “Healthy People 2010” focus area of Immunization and Infectious Diseases.

The purpose of the program is to gain an increased understanding of the ecology of Lyme disease in the United States that will lead directly to the design of new prevention strategies to limit the transmission of the etiologic agent of Lyme disease, Borrelia burgdorferi, and closely related Borrelia organisms.

B. Eligible Applicants

Applications may be submitted by public and private, nonprofit organizations and by governments and their agencies; that is, universities, colleges, research institutions, hospitals, other public and private nonprofit organizations, state and local governments, or their bona fide agents, federally recognized Indian tribal governments, Indian tribes or Indian tribal organizations.

Note:

Public Law 104-65 states that an organization described in section 501(c)(4) of the Internal Revenue Code of 1986 that engages in lobbying activities is not eligible to receive federal funds constituting an award, grant, cooperative agreement, contract, loan, or any other form.

C. Availability of Funds

Approximately $840,000 is available in FY 2001, to fund approximately five awards. It is expected that the average awards will be $210,000, ranging from $150,000 to $300,000. It is expected that the awards will begin on or about February 15, 2001, and will be made for a 12-month budget period within a project period of up to three 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.

D. 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). Applicants may apply for and receive support under one or more of the five focus areas listed in 1.a.

1. Recipient Activities

a. Define studies to address the following ecological issues:

(1) Tick population densities. Determine the biotic and abiotic factors that potentially regulate population densities of questing nymphal populations of Ixodes scapularis and Ixodes pacificus vector ticks. The influence of temperature, humidity, soil type, vegetation, and leaf litter on the density of questing nymphal ticks are examples of abiotic factors. The availability of hosts is a biotic factor.

(2) Prevalence of infection. Determine the biotic and abiotic factors that potentially regulate the prevalence of infection with Borrelia burgdorferi sensu stricto in questing populations of nymphal Ixodes scapularis and Ixodes pacificus. Factors that are subject to examination include habitat types and host species distributions. The usefulness of an Ecological Risk Index (ERI) should be included. The correlation between an ERI and human cases is subject to examination. Along the eastern United States, a cline of infection prevalence in nymphal Ixodes scapularis ticks has been observed, with high infection prevalence in northern hyperendemic regions and low infection prevalence in southern regions. Determination of what factors influence this cline of infection prevalence should examine the role of reptiles as zooprophylactic hosts diverting larval ticks from feeding on more reservoir competent hosts such as rodents, the influence of overall host diversity of infection prevalence in tick populations, and the importance of the genetic composition of vector tick populations in maintaining spirochete enzootic cycles. Also, the role of transovarial transmission and cofeeding on infection prevalence should be addressed.

(3) Spirochete diversity. Determine the diversity of spirochetes in populations of Ixodes scapularis and Ixodes pacificus and how this diversity affects the ecologic risk of transmission of pathogenic Borrelia to people. In addition to Borrelia burgdorferi sensu stricto, the genetic type associated with human Lyme disease in North America, other genetic types of spirochetes have been found to be circulating in Ixodes tick populations, including Borrelia bissettii, Borrelia andersoni, and other as yet uncharacterized variants. The degree to which these diverse genetic types of spirochetes interact in nature and influence the transmission of pathogenic Borrelia to people should be subject to examination. The affect of spirochete genetic diversity on efforts to determine the overall ecologic risk of spirochete transmission to people should be addressed. The degree to which estimates of ecologic risk should be based solely on the prevalence of Borrelia burgdorferi sensu stricto versus other genetic types of Borrelia burgdorferi and should be addressed.

(4) Borrelia lonestari. Describe the enzootic cycle of Borrelia lonestari and evaluate the risk of transmission of this spirochete to people exposed to the bites of Amblyomma americanum ticks. Borrelia lonestari has been characterized by PCR as a spirochete infecting Amblyomma americanum ticks associated with rash related illnesses in the southern United States. This spirochete has not been cultured, and the reservoir hosts for these spirochetes have not been defined. Description of methods for culturing and further characterizing these spirochetes should be pursued. In addition, the reservoir hosts that serve to maintain this spirochete in nature should be addressed. Finally, the extent to which ticks infected with B. lonestari spirochetes contact people should be subject to evaluation.

(5) Tick distribution and dispersal. Describe the factors that potentially influence the distribution and dispersal of populations of Ixodes scapularis and Ixodes pacificus. The presence or absence of these vector ticks has been determined on a county by county basis for the entire United States. This distribution is dynamic, with ticks actively dispersing to new regions. The factors associated with this dispersal should be determined, including role of habitat type and host availability. The factors determining dispersal of each stage of the tick (larval, nymphal, and adult) as well as the dispersal of Borrelia burgdorferi associated with these tick populations should be evaluated.

b. Develop the research plan. Develop a sound research plan that will determine what potential factors play an important role influencing the one, several, or all of the ecological issues (A1-A5) listed above. The research plan should clearly state the hypothesis to be tested and the plan of action for gathering the needed data to prove or disprove the specific hypothesis. The resources available to test specific ecological hypotheses should be clearly spelled out. The sequence and time frame for obtaining the field and laboratory data must be clearly described.

c. Implement the research plan. The schedule for obtaining ecological data must be followed and the scientific testing of hypotheses carried out. Specific plans for significance testing of field and laboratory data must be implemented. Data must be collected and analyzed in a timely fashion.

d. Recommendations for new intervention strategies. Once the ecological studies are conducted and the analysis is completed, new intervention strategies based on these ecological studies should be devised. The overall purpose of conducting these ecological studies is to find weak links in the enzootic cycle of Lyme disease spirochetes that can be exploited to develop new prevention strategies. Formal recommendations on exploiting ecological knowledge for the development of applied control tools should be developed and submitted to CDC.

2. CDC Activities

a. Provide technical assistance in the design of ecological studies on Lyme disease, including information on the current distribution of vector ticks and their associated spirochetes, and the distribution of human cases of Lyme disease based on national surveillance data.

b. Provide technical assistance in the design of microbiological studies to detect and characterize spirochetes in tick populations.

c. Assist in the analysis of entomologic and ecologic data.

d. Assist, as requested, in the development of recommendations based on ecologic studies for novel means of preventing transmission of Lyme disease spirochetes.

e. 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.

E. Application Content

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. The narrative should be no more than 12 double spaced pages, printed on one side, with one-inch margins, and unreduced font.

Each application should consist of: (1) An abstract; (2) a program narrative; and (3) a detailed budget.

(1) The abstract should summarize the background, needs, goals, objective and methods of the proposal on one page.

(2) The program narrative should include the following sections: Background, objectives, methods, plan of operation, and plan of evaluation. List and briefly describe specific, measurable, realistic, and time-phased objectives.

(3) A budget justification is required for all budget items and must be submitted with Standard Form 424A, “Budget Information”, as part of PHS 5161-1 (Revised 7/92). For applicants requesting funding for subcontracts, include the name of the person or organization to receive the subcontract, the method of selection, the period of performance, and a description of the subcontracted service requested.

Letters of support can be included if applicants anticipate the participation of other organizations or political subdivisions in conducting proposed activities. Specific roles and responsibilities should be delineated.

Required Format

Due to the need to reproduce copies of the applications for the reviewers, ALL pages of the application MUST be in the following format.

1. Applications should be UNSTAPLED and UNBOUND.

2. ALL pages must be clearly numbered, and a complete index to the application and its appendices must be included.

3. Begin each separate section on a new page.

4. All materials must be typewritten, single-spaced, and with a 12 point font on ONLY 81/2″ by 11″ paper.

5. Any reprints, brochures, or other enclosures should be copied (single-sided) on to 81/2″ by 11″ paper by the applicant.

6. All pages should be printed on ONE side only, with at least 1″ margins, headers, and footers.

7. The application narrative for each recipient activity component must be limited to 12 pages, excluding abstract, budget, and appendices.

8. Materials that are part of the basic plan should not be placed in the appendices.

F. Submission and Deadline

Letter of Intent

In order to assist CDC in planning for and executing the evaluation of applications submitted under this Program Announcement, all parties intending to submit an application are requested to inform CDC of their intention to do so. Your letter of intent should include the name and address of institution and name, address and phone number of a contact person. Notification can be provided by facsimile, postal mail, or Email.

On or before September 10, 2000, submit the letter of intent to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Application

Submit the original and two copies of PHS 5161-1 (OMB Number 0937-0189).

On or before October 15, 2000, submit the application to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Deadline: Applications shall be considered as meeting the deadline if they are either:

(a) Received on or before the deadline date; or (b) Sent on or before the Independent Review Group deadline date and received in time for submission to the IRG. (Applicants must request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing.)

Late Applications: Applications which do not meet the criteria in (a) or (b) above are considered late applications, will not be considered, and will be returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated individually against the following criteria by an independent review group appointed by CDC.

1. Plan (20 points)

a. The extent to which the applicant has understood the proposed activities and developed a sound research plan to address valid ecological issues relevant to the transmission of Lyme disease (10 points)

b. The extent to which the research plan is clear and concise (10 points)

2. Capacity (25 points)

a. Documented expertise in tick population biology and ecology. (15 points)

b. Demonstrated capacity in research on tick-borne disease and Lyme disease in particular (10 points)

3. Objectives (30 points)

a. Overall scientific quality of the proposed ecologic studies (15 points)

b. Likelihood that study outcome will result in the development of new intervention strategies (15 points)

4. Evaluation (20 points)

Demonstrated ability to perform outlined studies and derive conclusions from proposed activities

5. The degree to which the applicant has met the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. (5 points)

This includes:

(1) The proposed plan for the inclusion of both sexes and racial and ethnic populations for appropriate representation,

(2) the proposed justification when representation is limited or absent,

(3) a statement as to whether the design of the study is adequate to measure differences when warranted, and

(4) 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.

If these provisions are not relevant to the proposed scope of work, state this and 5 points will be credited to the application.

6. Budget (Not scored)

The extent to which the budget is reasonable, clearly justified, and consistent with the intended use of cooperative agreement funds.

7. Human Subjects (Not scored)

Does the application adequately address the requirements of Title 45 CFR Part 46 for the protection of human subjects?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. Progress reports (semiannual);

2. financial status report, no more than 90 days after the end of the budget period; and

3. final financial status and performance reports, no more than 90 days after the end of the project period.

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 I in the application kit.

AR-1 Human Subjects Requirements

AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

AR-3 Animal Subjects Requirements

AR-7 Executive Order 12372 Review

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

AR-15 Proof of Non-Profit Status

I. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under sections 301(a) and 317(k)(2) of the Public Health Service Act [42 U.S.C. 241(a)] and 247b(k)(2), as amended. The Catalog of Federal Domestic Assistance number is 93.942.

J. Where To Obtain Additional Information

This and other CDC announcements can be found on the CDC home page internet address—http://www.cdc.gov Click on “Funding” then “Grants and Cooperative Agreements.”

To receive additional written information and to request an application kit, call 1-888-GRANTS4 (1-888 472-6874). You will be asked to leave your name and address and will be instructed to identify the Announcement number of interest, [01003].

If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained from: Henry E. Eggink, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention, Room 3000, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone number: 770-488-2740, Email address: [e-mail]

For program technical assistance, contact: Joseph Piesman, D.Sc., Division of Vector-Borne Infectious Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Fort Collins, CO 80522, Telephone number: 970-221-6400 Email address: [e-mail].

Dated: August 8, 2000.

John L. Williams,

Director, Procurement and Grants Office, Center for Disease Control and Prevention (CDC).