[Federal Register Volume 66, Number 17 (Thursday, January 25, 2001)]
[Notices]
[Pages 7766-7768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-2269]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01024]


Post-Infective Fatigue: A Model for Chronic Fatigue Syndrome; 
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 Post-Infective Fatigue: A Model for Chronic Fatigue 
Syndrome. This program addresses the ``Healthy People 2010'' focus 
areas of Disability and Secondary Conditions and Immunization and 
Infectious Diseases. Visit the internet site: http://www.health.gov/healthypeople.
    The purpose of the program is to use active surveillance systems to 
identify and enroll individuals from documented acute viral and 
rickettsial infections that result in a post-infection fatigue of >3 
months and prospectively follow those individuals to define 
pathophysiological processes of the post-infective fatigue state.

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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 $500,000 is available in FY 2001 to fund one award. 
It is expected that the award will begin on or about April 30, 2001 and 
will be made for a 12-month budget period within a project period of up 
to 3 years. The funding estimate may change.
    A continuation award 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).

1. Recipient Activities

    a. Select three specific infectious agents, which should include at 
least one RNA virus, one DNA virus and one rickettsial agent and define 
the rationale.
    b. Develop a plan that will establish three post-infection cohorts 
where the enrolled subjects in each cohort are in the acute phase of 
the illness as evidenced by IgM positive antibody response results to 
the infectious agent.
    c. To ensure sufficient numbers of cases infected with each agent 
will be recruited and enrolled and to ensure that sufficient numbers of 
cases will be enrolled to reach meaningful conclusions, the applicant 
should provide evidence of an ongoing institutional surveillance 
program by providing numbers of cases for each infectious agent 
observed over a period of time (i.e., over the past year, previous six 
months).
    d. Develop and implement self-report and interview instruments that 
are standard measures of fatigue, psychological distress and 
psychiatric morbidity in addition to more specific self-report and 
interview-based measures of prolonged fatigue.
    e. Develop and conduct clinical and laboratory assessments to 
include administration of forms identified in (d) and collection of 
clinical samples necessary for detection of microbial pathogens and 
host gene expression analysis.
    f. Develop a plan that will:
    (1) Measure and evaluate possible associations between persistence 
of microbial genetic material or antigen that may predispose subjects 
to post-infective fatigue.
    (2) Measure and evaluate possible associations between cytokine 
production and development of post-infective fatigue.
    (3) Evaluate contributions of pre-morbid and concurrent psychiatric 
disorders to the persistence of post-infective fatigue.
    g. Define the contribution of genetic risk to the development of 
post-infective fatigue and examine the relationship with immunological, 
gene expression and psychological factors.
    h. Publish and disseminate results of research.

2. CDC Activities

    a. Provide technical and laboratory expertise to measure and 
evaluate the similarities and differences of host gene expression 
between the three post-infection cohorts (e.g., RNA virus, DNA virus, 
Rickettsial infections) and compare to the gene expression patterns 
defined for Chronic Fatigue Syndrome.
    b. 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 50 double-spaced pages, 
printed on one side, with one inch margins, and unreduced font.

F. Submission and Deadline

Letter of Intent (LOI)

    Your letter of intent should include the following information: 
Identification of the organization which will submit the application; 
the Principle Investigator; a brief synopsis of the extent of 
experience in dealing with patients with Chronic Fatigue Syndrome or 
research on Chronic Fatigue; the three proposed types of infectious 
agents; ability to accrue sufficient subjects in a three year period to 
reach meaningful conclusions; and the ability to perform extensive 
clinical and laboratory assessment.
    The letter of intent must be submitted on or before February 15, 
2001, to the Grants Management Specialist identified in the ``Where to 
Obtain Additional Information'' section of this announcement.

Application

    Submit the original and five copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for 
PHS-398). Forms are available at the following Internet address: 
www.cdc.gov/. . . Forms, or in the application kit. On or before March 
15, 2001, 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. Background and Need (15 points)

    Extent to which applicant demonstrates a clear understanding of the 
background, purpose, and objectives of the focus area being addressed 
and the relevance to the disease being studied. Extent to which 
applicant demonstrates that the proposed project addresses the purpose. 
Extent to which the applicant demonstrates that the

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proposed program collaborates with and does not duplicate existing 
efforts.

2. Capacity (40 points)

    Extent to which applicant describes adequate resources and 
facilities (both technical and administrative) to implement active 
surveillance systems for the three infectious agents, to identify and 
enroll individuals infected with one of the three infectious agents, to 
collect and safely transport biological specimens, to conduct 
laboratory methods necessary for evaluation persistence of infectious 
agent and for evaluation of cellular DNA and RNA. Extent to which the 
applicant documents that professional personnel involved in the project 
are qualified and have past experience and achievements in research 
related to that proposed as evidenced by curriculum vitae, 
publications, etc. If applicable, extent to which applicant includes 
letters of support from participating non-applicant organizations, 
individuals, etc., and the extent to which such letters clearly 
indicate the author's commitment to participate as described in the 
operational plan.

3. Objectives and Technical Approach (40 points total)

    (a) Extent to which applicant describes measurable and time-phased 
objectives of the proposed project which are consistent with the 
purpose of the focus area being addressed. (10 points)
    (b) Extent to which applicant presents a detailed operational plan 
for initiating and conducting the project which clearly and 
appropriately addresses all recipient activities for the specific 
programmatic focus area being addressed. Extent to which applicant 
clearly describes applicant's technical approach/methods for conducting 
the proposed studies and extent to which the approach/methods are 
feasible, appropriate, and adequate to accomplish the objectives. 
Extent to which applicant describes specific study protocols or plans 
for the development of study protocols that are appropriate for 
achieving project objectives. Extent to which applicant clearly 
describes collaboration with others during various phases of the 
project. (25 points)
    (c) 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 minorities, (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. (5 points)

4. Evaluation

    Extent to which applicant provides a detailed and adequate plan for 
evaluating progress toward achieving project process and outcome 
objectives. (5 points)

5. Budget (not scored)

    Extent to which the line-item budget is detailed, clearly 
justified, and consistent with the purpose and objectives of this 
program.

6. Human Subjects (not scored)

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

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with an original plus two copies of the following:
    1. Progress reports (annual);
    2. financial status report, no more than 90 days after the end of 
the budget period; and
    3. final financial 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-7  Executive Order 12372 Review
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2010
AR-12  Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 301(a) and 317(k)(2) of 
the Public Health Service Act, [42 U.S.C. Sections 241(a) and 
247b(k)(2)], as amended. The Catalog of Federal Domestic Assistance 
number is 93.283.

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.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Hank 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: Dr. Suzanne Vernon, 
Division of Viral and Rickettsial Diseases, National Center for 
Infectious Diseases, Centers for Disease Control and Prevention, 
Atlanta, GA 30333, Telephone number 307-334-4096, Email address: 
[email protected].

    Dated: January 19, 2000.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-2269 Filed 1-24-01; 8:45 am]
BILLING CODE 4163-18-P