[Federal Register Volume 65, Number 91 (Wednesday, May 10, 2000)]
[Notices]
[Pages 30123-30125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11647]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 00063]


Interdisciplinary Evaluation of Combination Therapy for 
Uncomplicated Malaria; 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 Interdisciplinary Evaluations of Combination Therapy for 
Uncomplicated Malaria. 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 areas of 
Immunization and Infectious Diseases. The purpose of the program is to 
evaluate the effectiveness of combination antimalarial therapy at 
district or multidistrict level in sub-Saharan Africa.

B. Eligible Applicants

    Assistance will be provided only to Ifakara Health and Research 
Development Center (IHRDC), in Ifakara, United Republic of Tanzania. No 
other applications are solicited.
    The United Republic of Tanzania is the only country located in sub-
Saharan Africa where large portions of the country are located in areas 
of active, and intense, transmission of the parasite Plasmodium 
falciparum. They represent one of only a few countries where drug 
policy reform is underway because of antimalarial drug resistance and 
is actively engaged in developing and testing strategies for addressing 
the problem of antimalarial drug resistance. Antimalarial drug 
resistance to chloroquine, the traditional first-line treatment for 
uncomplicated malaria, has intensified to a point where the Ministry of 
Health has decided to switch to an alternative medicine, sulfadoxine/
pyrimethamine (SP), for first-line treatment of malaria. Because of 
concerns that this strategy will be short lived due to pre-existing 
levels of drug resistance to SP, the Ministry of Health is keenly 
interested in understanding potential future options for addressing 
this pressing public health challenge.
    The IHRDC in Ifakara, Tanzania, is a non-government organization 
that comes under the jurisdiction of the United Republic of Tanzania, 
Ministry of Health. The Ministry of Health has oversight of the IHRDC 
and must approve all actions taken on behalf of the United Republic of 
Tanzania. IHRDC is the only institution in sub-Saharan Africa that is 
located in an area of very intense malaria transmission, that is 
located in a country that: Is poised to adopt a national malaria 
treatment policy of SP while actively engaged in investigating future 
treatment options; is actively engaged in research activities that are 
directly related to the objectives listed above; and has the needed 
experience and capacity. Because of its work in malaria for more than a 
decade, IHRDC is an internationally respected research institution. 
Investigators at IHRDC have a detailed understanding of the 
epidemiologic patterns and geographic distribution of malaria infection 
and transmission in their area, are actively engaged in using state-of-
the-art techniques for evaluating antimalarial drug resistance, and 
have needed and proven expertise in socio-behavioral research related 
to malaria. In addition, the IHRDC maintains a demographic surveillance 
system (DSS) covering approximately 55,000 individuals, allowing for 
measurement of public health impact of malaria treatment policies, and, 
through its existing collaborative links to other institutions and 
projects, has the ability to access comparable data from 2 additional 
DSS data bases (covering a total population of over 300,000 
individuals). The IHRDC is the only organization that has the capacity 
to carry out large-scale community-based public health interventions, 
to conduct malaria research, and to correctly diagnose drug resistant 
malaria infections in its laboratories and field activities. They have 
the required field experience and demonstrated capacity in areas 
directly related to all 6 principal objectives of this proposed 
evaluation: (1) Using state-of-the-art methods of diagnosing 
antimalarial drug resistance, including in vivo, in vitro, and 
molecular methods; (2) monitoring for changes in gametocytemia rates; 
(3) socio-behavioral research related to malaria, malaria drug use 
practices, and malaria treatment seeking practices; (4) economics of 
malaria and malaria treatment; (5) research into the process 
development of public health policy related to malaria; and (6) 
monitoring for public health impact, including on a population level.

C. Availability of Funds

    Approximately $500,000 is available in FY 2000 to fund one award. 
It is expected that the award will begin on or about August 30, 2000, 
and will be made for a 12-month budget period within a project period 
of up to five years. The funding estimate may change.
    Continuation awards within an approved project period may 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 conducting the activities under 
1. (Recipient Activities) and CDC will be responsible for conducting 
the activities under 2. (CDC Activities).

1. Recipient Activities

    a. Identify an appropriate set of districts for the evaluation of a 
pilot policy of antimalarial combination therapy, including comparison 
areas using SP monotherapy for treatment of all cases of uncomplicated 
malaria.
    b. Design a multifaceted evaluation program to determine the 
effectiveness of antimalarial combination therapy on inhibiting 
development of drug resistance and decreasing malaria transmission, as 
well as to elucidate programmatic, behavioral, economic, or policy 
aspects of combination therapy that could either enhance or limit this 
effectiveness.
    c. Define, collect, and analyze baseline data: Collect baseline 
data so that the public health impact of the interventions can be 
evaluated (including impact on mortality rates).
    d. Carry out the evaluation activities.
    e. Measure the effect of the national treatment policy compared 
with the pilot policy of combination therapy in terms of (1) inhibiting 
the development of resistance to SP; (2) interrupting

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transmission of the parasite; and (3) describing the behavioral, 
economic, and policy determinants of the policies.
    f. Disseminate research results by appropriate methods such as 
publication in journals, presentation at meetings, conferences, etc.
    g. Develop a research protocol for Institutional Review Board (IRB) 
review by all cooperating institutions participating in the research 
project.

2. CDC Activities

    CDC will provide technical assistance in the design and conduct of 
the research as needed to possibly include:
    a. Providing assistance in the evaluation methods and analytic 
approach.
    b. Performing selected laboratory tests, as requested by IHRDC, 
including analysis of drug resistance conferring mutations in parasite 
samples by polymerase chain reaction (PCR) or gene sequencing, testing 
of biologic samples for presence of antimalarial drugs; testing of 
pharmaceutical samples for quality.
    c. Assisting in data collection, data management, analysis of 
research data, interpretation, and dissemination of research findings.
    d. Collaborating in the design of the evaluation.
    e. Providing educational and training materials, as appropriate.
    f. Assisting 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 10 double-spaced pages, 
printed on one side, with one inch margins, and unreduced font.

F. Submission and Application Deadline

    Submit the original and two copies of PHS 5161-1 (OMB Number 0937-
0189). Forms are in the application kit. On or before June 30, 2000, 
submit the application to the Grants Management Specialist identified 
in the ``Where to Obtain Additional Information'' section of this 
announcement.

G. Evaluation Criteria

    The application will be evaluated against the following criteria by 
an independent review group appointed by CDC.

1. Background and Need (10 points)

    Extent to which applicant's discussion of the background for the 
proposed project demonstrates a clear understanding of the purpose and 
objectives of this cooperative agreement program. Extent to which 
applicant illustrates and justifies the need for the proposed project 
that is consistent with the purpose and objectives of this program.

2. Capacity (30 points total)

    a. Extent to which applicant describes adequate resources and 
facilities (both technical and administrative) for conducting the 
project. This includes the capacity to conduct quality laboratory 
measurements. (15 points)
    b. Extent to which applicant documents that professional personnel 
involved in the project are qualified and have past experience and 
achievements in research and programs related to that proposed as 
evidenced by curriculum vitae, publications, etc. (10 points)
    c. Extent to which applicant includes letters of support from non-
applicant organizations, individuals, etc. Extent to which the letters 
clearly indicate the author's commitment to participate as described in 
the operational plan. (5 points)

3. Objectives and Technical Approach (60 points total)

    a. Extent to which applicant describes specific objectives of the 
proposed project which are consistent with the purpose and goals of 
this program and which are measurable and time-phased. (10 points)
    b. Extent to which the applicant identifies appropriate populations 
for study, with an adequate size to evaluate the program. Extent to 
which adequate procedures are described for the protection of human 
subjects. (10 points)
    c. Extent to which applicant presents a detailed operational plan 
for initiating and conducting the project, which clearly and 
appropriately addresses all recipient activities. Extent to which 
applicant clearly identifies specific assigned responsibilities for all 
key professional personnel. 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. The extent to which applicant describes the existence 
of or plans to establish partnerships. (30 points)
    d. Extent to which applicant provides a detailed and adequate plan 
for evaluating study results (including laboratory data and data on 
prescribing practices), as well as plans for evaluating progress toward 
achieving project objectives. (10 points)

4. Budget (not scored)

    Extent to which the proposed budget is reasonable, clearly 
justifiable, and consistent with the intended use of cooperative 
agreement funds.
    5. 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. Annual progress reports,
    2. Financial status report, no more than 90 days after the end of 
the budget period, and
    3. Final financial status 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-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 the Public Health Service Act, 
Sections

[[Page 30125]]

301(a) [42 U.S.C. 241(a)], 307 [42 U.S.C. 2421], as amended. The 
Catalog of Federal Domestic Assistance number is 93.283.

J. Where To Obtain Additional Information

    If you have any questions after reviewing the contents of all 
documents, business management technical assistance may be obtained 
from: Van Malone, 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 (770) 488-2764, Email address [email protected].
    For program technical assistance, contact: Peter B. Bloland, DVM, 
MPVM, Division of Parasitic Diseases, National Center for Infectious 
Diseases, Centers for Disease Control and Prevention, 1600 Clifton 
Road, Mailstop F-22, Atlanta, GA 30333, Telephone (770) 488-7760, Email 
address: [email protected].

    Dated: May 4, 2000.
Henry S. Cassell III,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 00-11647 Filed 5-9-00; 8:45 am]
BILLING CODE 4163-18-P