The Epidemiology of Opportunistic Infections in Bone Marrow Transplant Recipients; Notice of Availability of Funds

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 98092]

The Epidemiology of Opportunistic Infections in Bone Marrow

Transplant Recipients; Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the

availability of fiscal year (FY) 1998 funds for a cooperative agreement

program for The Epidemiology of Opportunistic Infections in Bone Marrow

Transplant Recipients. This program addresses the ``Healthy People

2000'' priority area of Immunization and Infectious Diseases. The

purpose of the program is to provide assistance for a study to assess

the epidemiology of opportunistic infections (OIs) in bone marrow

transplant (BMT) recipients in the mid-1990s. For this study, a BMT is

defined as any hematopoietic cell transplant of any type (autologous,

syngeneic, or allogeneic), with transplanted cells collected from

either the donor's bone marrow or peripheral blood. An OI is defined as

any infection which occurs with increased frequency or severity in BMT

recipients. The goals of this study are: (a) to identify the important

OIs in inpatients and outpatients, both pediatric and adult, and

autologous and allogeneic BMT recipients who have received stem cells

harvested from donor bone marrow or blood, and (b) to describe recent

trends in BMT OI epidemiology to help set priorities for BMT OI

prevention strategies.

B. Eligible Applicants

Maximum Competition

Applications may be submitted by public and private nonprofit

organizations whose functions include collecting and disseminating

national BMT data and coordinating information about OIs in BMT

recipients. Eligible applicants must perform or collect OI data on

100 new BMTs per year in order to maximize the number of

BMT recipients under surveillance, and therefore increase the power of

the study.

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 $140,000 is available in FY 1998 to fund

approximately 1-2 awards. It is expected that the average award will be

$70,000 ranging from $50,000-140,000. It is expected that the awards

will begin on or about September 30, 1998 and will be made for a 12-

month budget period within a project period of one (1) year. Funding

estimates may change.

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. Develop a plan to identify the important OIs, including new and

emerging ones, which have occurred during the mid-1990s in a

retrospective cohort of BMT recipients. Previously, important BMT OIs

have included cytomegalovirus, influenza A and B, respiratory syncytial

virus, S. pneumoniae, Haemophilus influenzae type b, Toxoplasma gondii,

Pneumocystis carinii, and invasive Candida spp. and Aspergillus spp.

Important OIs in the mid-1990s may include some or all of these agents.

b. Develop case definitions for specific BMT OIs.

c. Design a study to determine the epidemiology of OIs in BMT

recipients in the mid-1990s. This should include methods to determine

risk factors and incidence rates of important Ois.

d. Develop a plan for quality assurance to ensure completeness and

accuracy of data.

e. Interpret, publish, and disseminate findings.

2. CDC Activities

a. Collaborate on planning and designing the study. Assist with the

development of OI case definitions.

b. Provide assistance as requested by recipient(s).

c. Collaborate in data management, and in quality assurance.

d. Perform Statistical analysis as requested.

e. In collaboration with recipient(s), assist with interpretation

of data.

f. Facilitate dissemination of findings.

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 15 double-spaced pages,

printed on one side, with one inch margins, and unreduced font.

F. Submission and Deadline

Application

Submit the original and five copies of PHS 398 (OMB Number 0925-

0001)(adhere to the instructions on the Errata Instruction Sheet for

PHS398). Forms are in the application kit. On or before August 30,

1998, submit the application to: Van Malone, Grants Management

Specialist, Grants Management Branch, Procurement and Grants Office,

Announcement 98092, Centers for Disease Control and Prevention, Room

300, 255 East Paces Ferry Road, NE., M/S E18, Atlanta, Georgia 30305-

2209.

If your application does not arrive in time for submission to the

independent review group, it will not be considered in the current

competition unless you can provide proof that you mailed it on or

before the deadline (i.e., receipt from U.S. Postal Service or a

commercial carrier; private metered postmarks are not acceptable).

G. Evaluation Criteria

Each application will be evaluated individually against the

following criteria by an independent review group appointed by CDC.

Plan (10 points)

Extent to which applicant presents a detailed operational plan for

initiating and conducting the project, which clearly and appropriately

addresses all Recipient Activities.

Objectives (15 points)

Extent to which applicant describes specific objectives of the

proposed project which are consistent with the purpose and goals of

this cooperative agreement program and which are measurable and time-

phased.

Methods (30 points)

Extent to which applicant describes specific study protocols or

plans for the development of study protocols that are appropriate for

achieving project objectives. The extent the proposed plan includes the

inclusion of women,

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ethnic, and racial groups in the proposed research to include (1) 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 the community and recognition of mutual benefits will

be documented.

Extent to which applicant clearly identifies specific assigned

responsibilities for all key professional personnel.

Extent to which the plan clearly describes applicant's technical

approach/methods for conducting the proposed studies and to accomplish

the study objectives.

Extent to which the applicant evaluates completeness and accuracy

of reported data.

Capacity (35 Points)

Extent to which applicant documents past experience and achievement

in successfully completing the types of activities outlined in the

Recipient Activities section of this announcement.

Extent to which the applicant has collected OI data on a large

number of BMT recipients, including >100 new BMTs performed/year in the

mid-1990s.

Extent to which the applicant demonstrates its expertise in

infectious diseases, bone marrow transplantation, epidemiology and

laboratory practice to diagnose all important OIs, including new and

emerging ones in BMT recipients in the mid-1990s.

Extent to which the applicant demonstrates it has collected data on

the likely important OIs, as well as possible new and emerging OIs such

as Streptococcus variationist spp., coagulase-negative Staphylococcus

spp., etc. Extent to which the applicant demonstrates the ability to

determine whether previously reported OIs, such as cytomegalovirus,

influenza A and B, respiratory syncytial virus, S. pneumoniae,

Haemophilus influenzae type b, Toxoplasma gondii, Pneumocystis carinii,

invasive Candida spp. and Aspergillus spp. cytomegalovirus, are still

important OIs in the 1990s.

Evaluation (10 Points)

Extent to which applicant provides a detailed and adequate plan for

evaluating study results and for evaluating progress toward achieving

project objectives.

Budget (Reviewed, but not Scored)

Extent to which the proposed budget is reasonable, clearly

justifiable, and consistent with the intended use of cooperative

agreement funds.

Does the application adequately address the requirements of 45 CAR

Part 46 for the protection of human subjects?

____YES ____No

Comments:--------------------------------------------------------------

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. Progress reports (quarterly). Progress results should address

progress toward overall objectives as represented in the Purpose and

Recipient Activities sections of this announcement and include

summaries of research results.

2. Financial status report, no more than 90 days after the end of

the budget period.

3. Final financial status and performance reports, no more than 90

days after the end of the project period.

Send all reports to: Van Malone, Grants Management Specialist,

Grants Management Branch, Procurement and Grants Office, Centers for

Disease Control and Prevention, Room 300, 255 East Paces Ferry Road.,

NE, M/S [E18], Atlanta, GA 30305-2209

The following additional requirements are applicable to this

program. For a complete description of each, see Attachment 1 in the

application kit.

AR98-1 Human Subjects Requirements

AR98-2 Requirements for Inclusion of Women and Racial and Ethnic

Minorities in Research

AR98-9 Paperwork Reduction Act Requirements

AR98-10 Smoke-Free Workplace Requirements

AR98-11 Healthy People 2000

AR98-12 Lobbying Restrictions

AR98-15 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. section 241(a) and

247b(k)(2)], as amended. The Catalog of Federal Domestic Assistance

number is 93.283.

J. Where To Obtain Additional Information

To receive additional written information call 1-888-GRANTS4. You

will be asked to leave your name, address, and phone number and will

need to refer to Announcement 98092. You will receive a complete

program description, information on application procedures, and

application forms. CDC will not send application kits by facsimile or

express mail. Please refer to Announcement Number 98092 when requesting

information and submitting an application.

If you have questions after reviewing the contents of all the

documents, business management technical assistance may be obtained by

contacting: Van Malone, Grants Management Specialist, Grants Management

Branch, Procurement and Grants Office, Announcement 98092, Centers for

Disease Control and Prevention (CDC), Room 300, 255 East Paces Ferry

Road, NE., M/S E18, Atlanta, GA 30305-2209 telephone (404) 842-6872,

Email address [email protected].

See also the CDC home page on the Internet: http://www.cdc.gov.

For program technical assistance contact: Clare A. Decocts, M.D.,

M.P.H., CDC, Mailstop A12, 600 Clifton Rd., NE, Atlanta, GA 30333,

Telephone (404) 639-4932, FAX (404) 639-4664, Email address:

[email protected].

Dated: July 22, 1998.

John L. Williams,

Director, Procurement and Grants Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98-20079 Filed 7-27-98; 8:45 am]

BILLING CODE 4163-18-P