[Federal Register Volume 65, Number 157 (Monday, August 14, 2000)]
[Notices]
[Pages 49579-49582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20499]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement Number 01004]


Cooperative Agreements To Prevent 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 to prevent Lyme disease in human populations exposed to endemic 
Borrelia burgdorferi transmission. CDC is committed to achieving the 
health promotion and disease prevention objectives of ``Healthy People 
2010,'' a national activity to reduce morbidity and mortality and 
improve the quality of life. This announcement is related to the focus 
area of Immunization and Infectious Diseases. For the conference copy 
of ``Healthy People 2010'', visit the internet site http://www.health.gov/healthypeople.
    The purpose of this cooperative agreement program is to: (1) 
Promote and support community and other population-based interventions 
to prevent Lyme disease, and (2) develop novel strategies for Lyme 
disease prevention that are likely to be successfully implemented in 
the near future.
    This program's overall objective is to lower the incidence of Lyme 
disease in hyperendemic states to 9.6 per 100,000 population or less by 
the year 2010. Eligible applicants may request support for the 
following two areas: interventions to reduce the incidence of human 
Lyme disease and its complications in endemic communities or high risk 
populations, and to develop and evaluate novel strategies to prevent 
Lyme disease by controlling vector tick populations or otherwise 
interrupt the transmission cycle of B. burgdorferi.
    The incidence of Lyme disease in the United States has been 
increasing and is likely to continue to increase unless affected 
communities and populations at risk develop and implement integrated 
control and prevention strategies. Principal Lyme disease interventions 
include the use of area-wide and host-targeted acaricides; habitat 
modification; avoidance of tick-infested habitat; personal protective 
measures, including tick checks and early tick removal; early disease 
detection and treatment; and vaccination. In addition, there is a need 
to explore new methods of Lyme disease prevention that may yield higher 
levels of community and individual participation than existing 
strategies.

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

    Funds will be awarded in two separate categories of prevention 
projects.
    Approximately $2,000,000 is available in FY 2001 to fund 
approximately five awards for community-based or other population-based 
interventions to prevent Lyme disease. It is expected that the awards 
will be $400,000, ranging from $200,000 to $600,000.
    Approximately $600,000 is available in FY 2001 to fund 
approximately four awards for developing and evaluating novel 
strategies to prevent Lyme disease. It is expected that the awards will 
be $150,000 ranging from $100,000 to $200,000.
    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 estimates 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.

Funding Preference

    Funding preference will be given to proposals that incorporate 
integrated strategies for population-based control of tick-borne 
diseases.

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) below:

[[Page 49580]]

1. Recipient Activities

    a. Proposals for interventions to reduce the incidence of human 
Lyme disease and its complications in endemic communities. Note: 
applicants are expected to carry out all of the following activities 
over the course of the project period.
    (1) In cooperation with community leaders, residents, and local 
organizations and agencies, implement a population-based intervention 
strategy to prevent Lyme disease. This could include integrated 
application of methods to reduce tick abundance, promotion of personal 
protective practices, education leading to early disease detection and 
treatment, and the appropriate use of Lyme disease vaccine.
    (2) Obtain data on the population's knowledge, attitudes, and 
practices related to the risk of Lyme disease, as well as factors 
influencing the adoption of prevention strategies.
    (3) Obtain population-based data on current practices to control I. 
scapularis populations, or otherwise prevent Lyme disease, and on the 
feasibility of implementing specific control strategies.
    (4) Establish active surveillance for Lyme disease in the 
intervention population, and promote active or passive surveillance for 
Lyme disease throughout the county or state of the applicant's 
jurisdiction during the project period.
    (5) Collect and analyze data on tick abundance and tick infection 
rates that affect the intervention population. A plan to gather such 
data on a comparison population as well may enhance the scientific 
validity of the proposal, but is not a requirement.
    (6) Analyze data on human cases of Lyme disease in both the 
intervention population and other populations within the same state and 
county during and after the intervention.
    (7) Develop a plan to evaluate the intervention strategies' effect 
on Lyme disease incidence and tick densities in the area.
    b. Proposals to develop and evaluate novel approaches to prevent 
Lyme disease by controlling vector tick populations or otherwise 
interrupt the transmission cycle of B. burgdorferi. Note: applicants 
are required to complete all components (1-4) for tick control 
proposals, or only component (5) for anti-tick vaccine proposals, 
during the project period.
    (1) Design innovative methods to reduce tick populations in endemic 
communities. This may include one or more of the following: improved 
delivery of existing approved area-wide or host-targeted acaricides, 
the development of alternative acaricides, habitat modifications, host 
management, or biological control of ticks.
    (2) Implement the tick control strategy in a Lyme disease endemic 
area.
    (3) Evaluate the effect of the intervention on tick densities, 
infection rates, or human incidence of Lyme disease.
    (4) Develop a plan for widespread or commercial dissemination of 
the tick control strategy.
    (5) Develop candidate anti-tick vaccines that have potential to 
block the transmission of Borrelia burgdorferi to people, including any 
or all of the following:
    (a) Utilize molecular biological and/or immunological techniques to 
identify unique candidate antigens.
    (b) Evaluate the immunogenicity of candidate molecules in terms of 
both the B and T cell responses in a suitable model of tick-transmitted 
Lyme borreliosis.
    (c) Evaluate novel methods of vaccine candidate delivery, i.e. 
plasmid DNA or sustained release vaccine technologies in a suitable 
model of tick-transmitted Lyme borreliosis.

2. CDC Activities

    a. Proposals for interventions to reduce the incidence of human 
Lyme disease and its complications in endemic communities.
    (1) Provide technical assistance, as requested, in the design of 
the intervention to prevent disease transmitted by I. scapularis.
    (2) Provide technical assistance, as requested, in the 
implementation of the population-based intervention.
    (3) Assist in the analysis of entomological, microbiological, 
population-based survey, and case surveillance data.
    (4) Assist in the development of recommendations for population-
based prevention of diseases transmitted by I. scapularis that can be 
extended to other endemic communities.
    (5) Assist in the evaluation of the outcomes of the project and of 
the applicability to other populations at risk of Lyme disease.
    (6) 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.
    b. Proposals to develop and evaluate novel approaches to prevent 
Lyme disease by controlling vector tick populations or otherwise 
interrupt the transmission cycle of B. burgdorferi.
    (1) Provide technical assistance in the design, implementation, and 
evaluation of the intervention strategies, including technical 
assistance in the evaluation of candidate anti-tick vaccine candidates.
    (2) Assist in performing selected laboratory and field procedures, 
as appropriate depending on the needs of the recipient.
    (3) Assist in the coordination of research activities among 
different recipient sites and between agencies or other groups working 
on the same project.
    (4) Assist in the analysis of research data.
    (5) Support efforts to move forward toward registration and 
dissemination of novel control methodologies.
    (6) 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.
    If the applicant is not a state or local health department, then 
the applicant should collaborate with the appropriate state or county 
health department to assure that Lyme disease surveillance will be 
carried out during the project period. The community or group of 
communities in a Lyme disease endemic area (or a population otherwise 
at high risk of Lyme disease) selected for the population-based 
intervention project should be identified in the application. Consider 
identifying non-intervention populations for comparison.
    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 10 double-spaced pages, printed on one side, 
with one-inch margins, and unreduced font.
    A table of contents should precede the narrative, and appropriate 
content headings should be clearly identified within the narrative. 
Applications which do not conform to the length requirements will be 
penalized points on review (see evaluation criteria).
    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:

[[Page 49581]]

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 8\1/2\" by 11" paper.
    5. Any reprints, brochures, or other enclosures should be copied 
(single-sided) on to 8\1/2\" 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 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). Forms are in the application kit.
    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 deadline date and received in time for 
submission to the independent review group (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 by an independent 
review group appointed by CDC.
    1. Proposals for interventions to reduce the incidence of human 
Lyme disease and its complications in endemic communities.
    a. Demonstrated high endemicity of Lyme disease in both target and 
comparison communities. (10 points)
    b. Demonstrated support for the intervention from community 
residents and organizations. (10 points)
    c. Documented expertise of the applicant in strategies to control 
populations of I. scapularis or in other methods to prevent Lyme 
disease. (10 points)
    d. Demonstrated epidemiologic expertise in measuring population-
based occurrence of disease and health outcomes. (10 points)
    e. Likelihood that any proposed tick control strategies will result 
in substantial reductions of tick abundance in the target community. 
(13 points)
    f. Likelihood that community education efforts will promote Lyme 
disease prevention within the target community. (12 points)
    g. 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. (5 
points)
    h. Likelihood that the proposed intervention will be practical and 
sustainable in the target community and can be implemented in other 
endemic communities. (10 points)
    i. 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. (10 points) 
(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.)
    j. Conformity of application narrative to stated requirements (no 
more that 10 single-spaced pages, no less than 12 point type. (5 
points)

    Note: Applications which are either more than 10 single spaced 
pages, or use less than 12 point type, or both, will receive 0 
points for this criterion.

    k. 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.
    l. Budget (Not scored) The extent to which the budget is 
reasonable, clearly justified, and consistent with the intended use of 
cooperative agreement fund.
    m. Human Subjects (Not scored) Does the application adequately 
address the requirements of Title 45 CFR Part 46 for the protection of 
human subjects?
    n. Animal Research (Not scored) If applicable, does the application 
adequately address the requirements for ethical research using animals?
    2. Proposals to develop and evaluate novel approaches to prevent 
Lyme disease by controlling vector tick populations or otherwise 
interrupt the transmission cycle of B. burgdorferi.

[[Page 49582]]

    a. Extent to which the proposed method of tick control or anti-tick 
vaccines is scientifically valid and feasible. (20 points)
    b. Scientific quality of the plan to evaluate the proposed 
prevention method (20 points)
    c. Documented expertise of the applicant in tick control research 
or tick immunology, including publication of results in peer-reviewed 
scientific journals. (30 points)
    d. 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. (20 points)
    e. Conformity of application narrative to stated requirements (no 
more that 10 single-spaced pages, no less than 12 point type. (5 
points) Note: applications which are either more than 10 single-spaced 
pages, or use less than 12 point type, or both, will receive 0 points 
for this criterion).
    f. 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.
    g. Budget (Not scored)
    The extent to which the budget is reasonable, clearly justified, 
and consistent with the intended use of cooperative agreement funds.
    h. Human Subjects (Not scored)
    Does the application adequately address the requirements of Title 
45 CFR Part 46 for the protection of human subjects?
    i. Animal Research (Not scored)
    If applicable, does the application adequately address the 
requirements for ethical research using animals?

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Semiannual progress reports;
    2. Financial Status Report, no more than 90 days after the end of 
the budget period; and
    3. Final financial report 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.
    For descriptions of the following Other Requirements, 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-9 Paperwork Reduction Act Requirements
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 [42 U.S.C. 
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, [01004].
    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: [email protected]. For 
program technical assistance, contact:
    Edward B. Hayes, M.D., Joseph Piesman, D.Sc, Kathleen Orloski, 
D.V.M., M.S. or David Dennis, M.D., MPH, 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: [email protected] or [email protected].

    Dated: August 8, 2000.
John L. Williams,
Director, Procurement and Grants Office, Center for Disease Control and 
Prevention (CDC).
[FR Doc. 00-20499 Filed 8-11-00; 8:45 am]
BILLING CODE 4163-18-P