[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 vxm7@cdc.gov.
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:
cad3@cdc.gov.
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
