Book titled CFDA. CATALOG OF FEDERAL DOMESTIC ASSISTANCE

93.942:  Research, Treatment and Education Programs on Lyme Disease in the United States

Popular Name:  Lyme Disease

Objectives:  To develop and implement practical and effective measures for the primary and secondary prevention of Lyme disease.


MAIN TOPICS:


93.942 ELIGIBILITY REQUIREMENTS:

Applicant Eligibility:  Public and nonprofit organizations able to provide services to geographical areas where Lyme disease is endemic or found to be newly emerging. Thus, universities, colleges, research institutions, State and local health departments, and private nonprofit organizations are eligible. Applications containing feasible proposals for public health education are of particular interest.

Beneficiary Eligibility:  Beneficiaries will include anyone in the general public who may be exposed to the threat of Lyme disease in certain geographical areas.

Credentials/Documentation:  Nonprofit organizations are corporations or associations no part of whose net earnings may lawfully inure to the benefit of any private shareholder or individual. Proof of nonprofit status must be submitted by private nonprofit organizations with the application or, if previously filed with PHS, the applicant must state where and when the proof was submitted.

93.942 APPLICATION AND AWARD PROCESS:

Preapplication Coordination:  This program has no preapplication requirements. This program is excluded from review under E.O. 12372.

Application Procedure:  The standard application forms, as furnished by the PHS and required by 45 CFR 92, must be used for this program. This program is subject to the provisions of 45 CFR 92 for State and local governments and OMB Circular No. A-110 for nonprofit organizations. Application kits are obtained by writing to: Ms. Mildred Garner, Grants Management Officer, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341. Phone: (770) 488-2730.

Award Procedure:  After review and approval, a notice of award is prepared and processed, along with appropriate notification to the public. Initial award provides funds for first budget period (usually 12 months) and Notice of Award (Form 5152-1) indicates support recommended for the remainder of project period, allocation of Federal funds by budget categories, and special conditions, if any.

Deadlines:  Contact Headquarters Office listed below for application deadline dates.

Range of Approval/Disapproval Time:  About 3 to 6 months.

Appeals:  None.

Renewals:  Cooperative agreements may be made for up to 3-year project periods. Subject to availability of funds, after initial awards, projects may be renewed competitively contingent upon submission and approval of applicants.

Criteria for Selecting Proposals:  Three sets of criteria are used in evaluating proposals: One set is used for applications seeking support in the Recipient Activity of Research of the Ecology of Lyme Disease; another set for Recipient Activities of Community Intervention and Novel Approaches, and a third for Recipient Activities of Research on the Laboratory Diagnosis and Pathogenesis of Lyme disease. Evaluation criteria used for the first Recipient Activity ( Ecology) are: 1.Plan: 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; b. The extent to which the research plan is clear and concise. 2.Capacity: a. Documented expertise in tick population biology and ecology; b. Demonstrated capacity in research on tick-borne disease and Lyme disease in particular 3. Objectives: a. Overall scientific quality of the proposed ecologic studies; b. Likelihood that study outcome will result in the development of new intervention strategies. 4. Evaluation: 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. 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. 6. Budget: The extent to which the budget is reasonable, clearly justified, and consistent with the intended use of cooperative agreement funds. Evaluation criteria used for the second Recipient Activities (Community Intervention/Novel approaches) are: A. Proposals for interventions to reduce the incidence of human Lyme disease and its complications in endemic communities: 1. Demonstrated high endemicity of Lyme disease in both target and comparison communities. 2. Demonstrated support for the intervention from community residents and organizations. 3. Documented expertise of the applicant in strategies to control populations of scapularis or in other methods to prevent Lyme disease. 4. Demonstrated epidemiologic expertise in measuring population-based occurrence of disease and health outcomes 5. Likelihood that any proposed tick control strategies will result in substantial reductions of tick abundance in the target community. 6. Likelihood that community education efforts will promote Lyme disease prevention within the target community. 7. Quality of the plan to use Lyme disease vaccine (according to published CDC Advisory Committee on Immunization Practices guidelines), and for monitoring vaccine use in the intervention community. 8. Likelihood that the proposed intervention will be practical and sustainable in the target community and can be implemented in other endemic communities. 9. Demonstrated capacity and intent to conduct and maintain effective Lyme Disease surveillance throughout the country or State of the applicant's jurisdiction during the project period. (Note: If the applicant is not a State or local health department, then the applicant should indicate collaboration with the appropriate State or county health department to assure that Lyme disease surveillance will be carried out during the project period.) 10. Conformity of application narrative to stated requirements. 11. Inclusion of Women, ethnic, and racial groups applicants should meet CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. 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, and (3) 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 (5 points). If these provisions are not relevant to the proposed scope of work, state this, and 5 points will be credited to the application. 12. Budget: The extent to which the budget is reasonable, clearly justified, and consistent B. Proposals to develop and evaluate novel approaches to prevent Lyme disease by controlling vector tick populations or otherwise interrupt the transmission cycle of burgdorferi: 1. Extent to which the proposed method of tick control or anti-tick vaccines is scientifically valid and feasible. 2. Scientific quality of the plan to evaluate the proposed prevention method. 3. Documented expertise of the applicant in tick control research or tick immunology, including publication of results in peer-reviewed scientific journals. 4. Likelihood that the proposal will lead to a useful and practical prevention strategy that can be widely disseminated in community-based or other campaigns to prevent and control Lyme disease. 5. Conformity of application narrative to stated requirements. 6. Inclusion of women, ethnic, and racial groups. Applicants should meet CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. 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, and (3) 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 (5 points). If these provisions are not relevant to the proposed scope of work, state this and 5 points will be credited to the application. 7. Budget: The extent to which the budget is reasonable, clearly justified, and consistent with the intended use of cooperative agreement funds. Evaluation criteria used for the third recipient activity (Diagnosis and Pathogenesis) are: 1. Plan: The scientific validity of the proposed research plan and whether the plan addresses a stated purpose of the Cooperative Agreement Announcement. 2. Capacity: a. The applicant's expertise in developing laboratory diagnostic tests or investigating pathobiologic events induced by infectious agents; b. The applicant's experience in research on tick-borne disease and Lyme disease in particular; c. The extent to which the applicant has the appropriate project personnel, organizational structure, and administrative support to assure meeting proposed objectives; d. The extent to which the applicant has access to necessary biological materials or study populations. 3. Objectives and prospects for successfully achieving them and the likelihood that the product(s) of the investigation will result in the development of better prevention or intervention measures. 4. Evaluation: a. The feasibility of completing the proposed Studies and meeting measurable objectives within the project period; b. The extent to which the applicant proposes appropriate methods for evaluating the project and/or designs methods that are adequate to measure differences, when warranted. 5.Inclusion of Women, Ethnic, and Racial Groups. Applicants should meet CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. 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: The extent to which the budget is reasonable, clearly justified, and consistent with the intended use of cooperative agreement funds.

Examples of Funded Projects:  Examples of some funded projects include: development of materials for education intervention; conducting studies in integrated pest management; conducting studies on the pathogenesis of Lyme neuroborreliosis using the monkey model; implementation of active surveillance systems; and studies to improve serologic diagnostic techniques.

Range and Average of Financial Assistance:  From $80,000 to $500,000. Average: $192,500.

93.942 RELATED PROGRAMS:

None.

93.942 PROGRAM ACCOMPLISHMENTS:

In fiscal year 2001, 20 new and competitive continuation awards were made. In fiscal year 2002, 20 non-competitive continuation awards were made. It is anticipated that about 20 non-competitive continuation awards will be made in fiscal year 2003.

93.942 FINANCIAL AND ADMINISTRATIVE INFO:

Federal Agency:  CENTERS FOR DISEASE CONTROL AND PREVENTION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (Home Page)

Type of Assistance:  Project Grants (Cooperative Agreements).

Obligations:  (Cooperative Agreements) FY 01 $3,829,740; FY 02 est $3,850,475; and FY 03 est $3,900,000.

Budget Account Number:  75-0943-0-1-550.

Authorization:  Public Health Service Act, Sections 301, 42 U.S.C. 241(a) and 317(k)(2), 42 U.S.C. 247b(k)(2), as amended.

Regulations, Guidelines, and Literature:  PHS Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000 (Rev.) April 1, 1994. Pertinent information may be obtained by contacting the Headquarters Office.

93.942 INFO CONTACTS:

Regional or Local Office:  Division of Vector-borne Infectious Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, P.O. Box 2087, Fort Collins, CO 80522. Ms. Mary Ellen Fernandez - Phone: (970) 221-6426. Dr. Duane J. Gubler - Phone: (970) 221-6428. Dr. David T. Dennis - Phone: (970) 221-6418.

Headquarters Office:  Program Contact: Ms. Mary Ellen Fernandez, National Center for Infectious Diseases, Centers for Disease Control and Prevention, P.O. Box 2087, Fort Collins, CO 80522. Phone: (970) 221-6426. FAX: (970) 221-6476. Email: meg2@cdc.gov. Grants Management Contact: Ms. Elmira Benson, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, Atlanta, GA 30341. Phone: (770) 488-2628. FAX: (770) 488-2777.

Web Site Address:  http://www.cdc.gov

(See Appendix IV for more contact info.)

93.942 ASSISTANCE CONSIDERATIONS:

Formula and Matching Requirements:  This program has no matching requirements. This program has no statutory formula.

Length and Time Phasing of Assistance:  Cooperative agreements are usually awarded for a 3-year project period. Initial awards are made for a 1-year budget period with continuation awards being made for up to an additional 2 years.

Uses and Use Restrictions:  Funds will be available to develop disease surveillance, conduct ecological and epidemiological studies, develop prevention and control activities, develop better diagnostic tests, and develop and disseminate educational materials and programs. Grants include funds for direct costs, i.e., personnel, travel, equipment, supplies, necessary to carry out an approved project as well as funds for the reimbursement of applicable indirect costs. Unallowable costs, as well as those for which prior written approval is required, are indicated in the Public Health Service (PHS) Grants Policy Statement.

93.942 POST ASSISTANCE REQUIREMENTS:

Reports:  An original and two copies of the progress report are due semi-annually and must be submitted to the Grants Management Officer within 30 days after each reporting period. Financial status reports are required no later than 90 days after the end of each budget period. Final financial status and performance reports are required 90 days after the end of the project period.

Audits:  In accordance with the provisions of OMB Circular No. A-133 (Revised, June 24, 1997), "Audits of States, Local Governments, and Nonprofit Organizations," nonfederal entities that expend financial assistance of $300,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $300,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. In addition, grants are subject to inspection and audits by DHHS and other Federal officials.

Records:  Financial records, including all documents to substantiate charges, must be maintained. Records may be destroyed 3 years after the end of the budget period if audit occurs by that time; if audit has not occurred, records must be retained until 3 years following the end of the budget period, or until audit and resolution of audit findings.


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Text updated:  June 2002