[Federal Register Volume 65, Number 121 (Thursday, June 22, 2000)]
[Notices]
[Pages 38833-38835]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15769]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 00055]


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.

[[Page 38834]]

    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

[[Page 38835]]

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: 
[email protected].
    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: [email protected].

    Dated: June 16, 2000.
Henry S. Cassell, III,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 00-15769 Filed 6-21-00; 8:45 am]
BILLING CODE 4163-18-P