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Post-Infective Fatigue: A Model for Chronic Fatigue Syndrome; Notice of Availability of Funds

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Information about this document as published in the Federal Register.

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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. Start Printed Page 7767

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 Start Printed Page 7768proposed 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: hbe7@cdc.gov.

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: sdv2@cdc.gov.

Start Signature

Dated: January 19, 2000.

John L. Williams,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC).

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[FR Doc. 01-2269 Filed 1-24-01; 8:45 am]

BILLING CODE 4163-18-P