[Federal Register Volume 65, Number 157 (Monday, August 14, 2000)]
[Notices]
[Pages 49574-49577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20498]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01003]


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

[[Page 49575]]

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

[[Page 49576]]

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 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

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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: [email protected]
    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: 
[email protected].

    Dated: August 8, 2000.
John L. Williams,
Director, Procurement and Grants Office, Center for Disease Control and 
Prevention (CDC).
[FR Doc. 00-20498 Filed 8-11-00; 8:45 am]
BILLING CODE 4163-18-P