[Federal Register Volume 65, Number 157 (Monday, August 14, 2000)]
[Notices]
[Pages 49577-49579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20500]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01005]


Cooperative Agreement for Research on the Laboratory Diagnosis 
and Pathogenesis 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 Laboratory Diagnosis and Pathogenesis of 
Lyme Disease in the United States. 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 the program is to develop improved and standardized 
laboratory tests to identify and characterize infection by Borrelia 
burgdorferi and related Borrelia species in humans and to better 
understand the pathogenic mechanisms of B. burgdorferi. Better 
laboratory methods can facilitate correct diagnosis and appropriate 
treatment of Lyme disease, thus preventing secondary consequences of 
infection. Better laboratory methods also can be used for improved 
surveillance and understanding of the epidemiology of Lyme disease in 
communities. Pathogenesis studies can enhance understanding of host 
responses to infection, leading to improved prevention or intervention 
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, and 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 $1,200,000 dollars is available in FY 2001, to fund 
approximately seven awards. It is expected that the average award will 
be $200,000, ranging from $100,000 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 one or more of the activities 
under 1. (Recipient Activities) and CDC will be responsible for the 
activities listed under 2. (CDC Activities).

1. Recipient Activities

    a. Develop laboratory tests that are more sensitive, specific, and 
reproducible than laboratory methods currently in use to detect 
exposure to B. burgdorferi and to determine whether a patient is 
currently infected. Test methods may include, but are not limited to, 
serology, culture, polymerase chain reaction, or antigen detection.
    b. Evaluate and standardize the performance of new testing methods 
for B. burgdorferi infection. These efforts should include both 
retrospective and prospective evaluations, including testing in 
clinical practice, and a direct comparison with the performance of two-
tiered serologic testing.
    c. Investigate aspects of the pathogenesis of infection with B. 
burgdorferi that have a direct link to developing improved methods of 
diagnosing, treating, or preventing Lyme disease.
    d. Use animal models to develop interventions to ameliorate or 
prevent pathogenic effects of borrelial infection.
    e. Determine the role of Borrelia lonestari in causing human 
illness. B. lonestari is characterized by PCR as a spirochete infecting 
Amblyomma americanum ticks and is associated with rash related illness, 
particularly in the southern United States.

2. CDC Activities

    a. Provide technical assistance, as requested, in the design or 
evaluation of laboratory tests for infection with B. burgdorferi or B. 
lonestari.
    b. Assist in the analysis of laboratory test data, as appropriate, 
depending on the needs of the recipient.
    c. Assist in the acquisition of appropriate samples for study, as 
requested.
    d. Assist in the design and evaluation of experiments using animal 
models of Lyme disease, as requested.
    e. Assist in the coordination of research activities among 
different recipient sites.
    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.

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.

[[Page 49578]]

    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 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 one-
inch 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 15, 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 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 against the 
following criteria by an independent review group appointed by CDC.
    1. Plan (20 points)
    The scientific validity of the proposed research plan and whether 
the plan addresses a stated purpose of the Cooperative Agreement 
Announcement.
    2. Capacity (40 points)
    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. (15 points)
    4. Evaluation (20 points)
    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 (5 points). 
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 (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.
    For descriptions of the following Other Requirements, see 
Attachment I. in the application kit.


[[Page 49579]]


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-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, [01005].
    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: Barbara J. B. Johnson, 
Ph.D., 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. 00-20500 Filed 8-11-00; 8:45 am]
BILLING CODE 4163-18-P