[Federal Register Volume 65, Number 96 (Wednesday, May 17, 2000)]
[Notices]
[Pages 31330-31332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12343]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement Number 00111]


Development and Testing of New Medications for Treatment of 
Emerging Infectious Diseases; 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 medications for emerging 
infectious diseases. 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 for the development and testing of 
new anti-infectious agents developed from natural products primarily 
for use in humans. Of particular, but not exclusive interest are anti-
infective agents for parasitic diseases. Projects may include, but are 
not limited to a range of activities such as identifying promising 
agents, purifying or creating them, optimizing them for clinical use, 
and testing them.

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

[[Page 31331]]

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 $1,500,000 is available in FY 2000 to fund one award. 
It is expected the award will begin on or about September 1, 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 selection of emerging 
infectious disease(s) that affect humans and or acquiring or developing 
new medications for treatment of those diseases using natural products. 
This includes studying the pharmacologic and biologic characteristics 
of natural product structures and analogs and designing molecules using 
computer methods for known biochemical targets.
    b. Use combinatorial methods to optimize anti-infectives resulting 
from these approaches.
    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.
    e. Conduct in vivo testing of promising candidates if appropriate.
    f. Develop a plan for enhancing commercial interest in promising 
drugs.
    g. Publish or disseminate results of research.

2. CDC Activities

    a. Provide technical assistance in the design and conduct of the 
research, as needed.
    b. Perform selected laboratory tests, as requested.
    c. Provide biological materials (e.g., strains, reagents, etc.) as 
necessary or appropriate.
    d. Assist in the development of assays for evaluating 
pharmacokinetics of new drugs as necessary or appropriate.
    e. 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 two copies of PHS 5161-1 (OMB Number 0937-
0189). Forms are in the application kit.
    On or before July 1, 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

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

1. Background and Need (15 Points)

    Extent to which applicant demonstrates a clear understanding of the 
background, purpose, and objectives of the focus area being addressed 
and the relevance of disease(s) to be studied. 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 (40 Points)

    Extent to which applicant describes adequate resources and 
facilities (both technical and administrative) to use natural products, 
computer-aided drug design, and development of analogs of known drugs 
to develop strategies for producing adequate quantities of compound, 
for example, by using automated organic synthesis or other technologies 
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 others during various phases of the project. (25 
points)
    c. 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

[[Page 31332]]

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. Evaluation

    Extent to which applicant provides a detailed and adequate plan for 
evaluating progress toward achieving project process and outcome 
objectives. (5 points)

5. Budget (Not Scored)

    Extent to which the line-item budget is detailed, clearly 
justified, and consistent with the purpose and objectives of this 
program.

6. Human Subjects (Not Scored)

    Does the application adequately address the requirements of Title 
45 CFR Part 46 for the protection of human subjects?

7. Animal Subjects (Not Scored)

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

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-7  Executive Order 12372 Review
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

    To obtain additional information, contact: Andrea Wooddall, 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 770-488-2749, 
Email address [email protected]
    For program technical assistance, contact: Sue Binder, M.D., 
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 770-488-7793, Email 
address [email protected]

    Dated: May 11, 2000.
Henry S. Cassell, III,
Acting, Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 00-12343 Filed 5-16-00; 8:45 am]
BILLING CODE 4163-18-P