Surveillance for Invasive Fungal Infections in Transplant Recipients; Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2000 funds for a cooperative agreement program for surveillance for invasive fungal infections among transplant recipients. 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 Disease. For the conference copy of “Healthy People 2010,” visit the internet site: <http://www.health.gov/healthypeople>.

The purpose of the program is to conduct active, prospective surveillance to estimate the incidence and describe the epidemiology of opportunistic invasive fungal infections (OI's) in bone marrow/stem cell and solid organ transplant recipients, and to establish through this surveillance, a network of bone marrow/stem cell and solid organ transplant centers.

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 $200,000 is available in FY 2000 to fund one award. It is expected that the award will begin on or about September 30, 2000, 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 listed under 1. (Recipient Activities), and CDC will be responsible for the activities listed under 2. (CDC Activities).

1. Recipient Activities

a. Develop and implement a plan to network transplant medical centers to conduct surveillance for invasive fungal infections. This network should consist of multiple centers with large numbers of transplants performed per year (a minimum of 100 to 200 bone marrow/stem cell per center a year and a minimum of 200 solid organ transplants per year) to have adequate estimates of the incidence of various invasive fungal OIs (a total transplant population of at least 5000 per year (i.e. 10 to 20 centers)).

b. Design a network that will consider centers of various sizes and affiliations and includes centers from various U.S. regions to ensure representativeness.

c. Develop a work plan to manage surveillance activities at the different transplant centers.

d. Design a strategy for the participating medical centers to report every case of invasive fungal OI's that occurs in any of their transplant recipients, even if not hospitalized.

e. Design a data collection form for reporting each individual incident case of invasive fungal OI in a transplant recipient.

f. Develop a standardized protocol for surveillance for invasive fungal infections in stem cell/bone marrow and solid organ transplant recipients.

g. Analyze findings and publish as necessary.

2. CDC Activities

a. Provide technical assistance in the development of a data collection form.

b. Provide periodic laboratory confirmation of identified isolates, and pathology confirmation of available diagnostic tissues, as needed and appropriate.

c. Assist with data management and statistical support to analyze the surveillance data, as needed.

d. 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 30 double spaced pages printed on one side, with one inch margins and unreduced font.

F. Submission and Deadline

Letter of Intent (LOI)

In order to assist CDC in planning the evaluation of applications submitted under this Program Announcement, all parties intending to submit an application are requested to submit an LOI to inform CDC of their intention to do so. The LOI should include (1) name and address of institution and (2) name, address, and telephone number of contact person. Notification can be provided by facsimile, postal mail, or Email.

On or before July 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). Forms are available in the application kit.

On or before July 31, 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. Background and Need (10 points)

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

2. Capacity (45 points)

Extent to which applicant describes adequate resources and facilities (both technical and administrative) for conducting the project. Extent to which 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 (45 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 identifies specific assigned responsibilities of all key professional personnel. Extent to which the plan 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 CDC and/or others during various phases of the project. (25 points)

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

d. 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 minority 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. (5 points)

4. Budget (not scored)

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

5. 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. Semi-annual progress reports;

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-9 Paperwork Reduction Act Requirements

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-GRANTS (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: Gladys Gissentanna, 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: 770-488-2753; Email Address: gcg4@cdc.gov.

For program technical assistance, contact: Rana A. Hajjeh, M.D., National Center for Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., Atlanta, GA 30333, Telephone Number: 404-639-4753; E-mail Address: rfh5@cdc.gov.