[Federal Register Volume 63, Number 144 (Tuesday, July 28, 1998)]
[Notices]
[Pages 40294-40295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20079]


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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,

[[Page 40295]]

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