[Federal Register Volume 65, Number 85 (Tuesday, May 2, 2000)]
[Notices]
[Pages 25490-25491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-10878]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement Number 00056]


Development and Testing of New Antimalarial Drugs; 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 the Development and Testing of New Antimalarial Drugs. 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. For the conference copy of ``Healthy People 
2010'', visit the internet site http://www.health.gov/healthypeople.
    The purpose of this program is to support research projects to 
develop and test new antimalarial drugs. Projects may include, but not 
be limited to a range of activities such as identifying promising 
agents, purifying or creating them, optimizing them for clinical use, 
and testing them in in vitro and in vivo systems. Applications may 
include components to develop national centers of excellence that would 
serve as national repositories of expertise and experience. For 
example, an application to establish a national center of excellence 
for computer-assisted drug design for malaria and for screening 
potential candidate drugs could be considered. This might include high 
throughput testing of potential antimalarial compounds. Second and 
third year plans may include clinical trials.

B. Eligible Applicants

    Assistance will be provided only to the University of Mississippi. 
No other applications are solicited.
    The FY 2000 United States Senate Labor-Health and Human Services 
Appropriations Report: Report 106-166 (S 1650), recognized the unique 
qualifications of the consortium of the University of Mississippi 
Laboratory for Applied Drug Design and Synthesis and the Tulane 
University Center for Infectious Diseases for carrying out the 
activities specified in this cooperative agreement.

    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 $5,000,000 is available in FY 2000 to fund one award. 
It is expected 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 three 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 under 1. 
(Recipient Activities) and CDC will be responsible for conducting 
activities under 2. (CDC Activities):

1. Recipient Activities

    a. Develop and implement strategies for acquiring or developing new 
antimalarial compounds. This may include the use of natural products, 
computer-aided drug design, and development of analogs of known drugs.
    b. Develop and implement a rational approach to selecting promising 
drug candidates.
    c. Develop strategies and capacity to produce adequate quantities 
of compound, for example, by using an automated organic synthesizer or 
other technology.
    d. Develop and implement a systematic approach to in vitro testing 
of drug candidates. Develop and evaluate in vitro systems for drug 
testing where results allow prediction of the risk of development of in 
vivo resistance and the rate at which resistance is likely to develop.
    e. Conduct in vivo testing of promising candidates, including the 
use of primate models.
    f. Develop a plan for enhancing commercial interest in promising 
drugs.
    g. Disseminate results of research.

2. CDC Activities

    a. Provide technical assistance in the design and conduct of the 
research.
    b. Provide selected laboratory tests, as necessary or appropriate.
    c. Provide biological materials (e.g., strains, reagents, etc.) as 
necessary or appropriate.
    d. Upon request, assist in the development of assays for evaluating 
pharmacokinetics of new antimalarial drugs.
    e. Upon request, provide in vitro testing for P. vivax, as well as 
in vivo testing for malaria parasites.
    f. 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 10 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 
PHS 398). Forms are in the application kit.
    On or before June 1, 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.

[[Page 25491]]

1. Background and Need (10 points)

    Extent to which applicant demonstrates a clear understanding of the 
background, purpose, and objectives of the focus area being addressed. 
Extent to which applicant demonstrates that the proposed project 
addresses the purpose. Extent to which the applicant demonstrates that 
the proposed program collaborates with and does not duplicate existing 
rational development efforts.

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 (a) the proposed plan 
for the inclusion of both sexes and racial and ethnic minority 
populations for appropriate representation, (b) the proposed 
justification when representation is limited or absent, (c) a statement 
as to whether the design of the study is adequate to measure 
differences when warranted and (d) 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?

6. Animal Subjects (not scored)

    Does the application adequately address the requirements of PHS 
Policy on Humane Care and Use of Laboratory Animals by Awardee 
Institutions?

H. Other Requirements

Technical Reporting Requirements
    Provide CDC with original plus two copies of
    1. progress reports (semiannual);
    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 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-3  Animal Subjects 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)(1)(2) of 
the Public Health Service Act, [42 U.S.C. sections 241(a) and 
247b(k)(1)(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 Homepage 
Internet address-http://www.cdc.gov. Click on ``Funding'' then ``Grants 
and Cooperative Agreements''.
    To obtain additional information, contact: Gladys T. 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: John W. Barnwell, 
Division of Parasitic Diseases, National Center for Infectious 
Diseases, Centers for Disease Control and Prevention, 4770 Buford 
Highway, N.E., Atlanta, GA 30333, Telephone number 770-488-4528, Email 
address [email protected]

    Dated: April 26, 2000.
Henry S. Cassell, III,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 00-10878 Filed 5-1-00; 8:45 am]
BILLING CODE 4163-18-P