[Federal Register Volume 68, Number 87 (Tuesday, May 6, 2003)]
[Notices]
[Pages 23989-23992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11139]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03056]


Development and Testing of New Medications for Treatment of 
Emerging Infectious Diseases; Notice of Availability of Funds

    Application Deadline: June 15, 2003.

A. 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. section 241(a) and 
247(k)(2)), as amended. The Catalog of Federal Domestic Assistance 
number is 93.283.

B. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2003 funds for a cooperative agreement 
program for Development and Testing of New Medications for Treatment of 
Emerging Infectious Diseases. This program addresses the ``Healthy 
People 2010'' focus area(s) Immunization and Infectious Diseases.
    The purpose of the program is to develop and test 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.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the National Center for Infectious 
Diseases (NCID): Protect Americans from infectious diseases.

C. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and and by governments and their agencies, that is:

[sbull] Universities
[sbull] Colleges
[sbull] Technical schools
[sbull] Research Institutions
[sbull] Hospitals
[sbull] Community-based organizations
[sbull] Faith-based organizations
[sbull] Federally recognized Indian tribal governments
[sbull] Indian Tribes
[sbull] Indian tribal organizations
[sbull] State and local governments or their bona fide agents (this 
includes the District of Columbia, the Commonwealth of Puerto Rico, the 
Virgin Islands, the Commonwealth of the Northern Marianna Islands, 
American Samoa, Guam, the Federated States of Micronesia, the Republic 
of the Marshall Islands, and the Republic of Palau)
[sbull] Political subdivisions of States (in consultation with States)

    Note: Title 2 of the United States Code section 1611 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant or loan.

D. Funding

Availability of Funds

    Approximately $1,500,000 is available in FY 2003 to fund one award. 
It is

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expected that the award will begin on or about September 15, 2003, 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.

Recipient Financial Participation

    Matching funds are not required for this program.

Funding Preferences

    Applications for new studies are encouraged. Funding preference may 
be given to the competing continuation application over applications 
for programs not already receiving support under the existing program. 
The current awardee has implemented strategies and begun developing and 
testing for treatment of infectious diseases using natural products. 
This research requires continued support to become fully developed and 
to realize the benefits of continued product development.

E. 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 strategies for selection of emerging 
infectious disease(s) that affect humans, and for 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 and disseminate the research results.

2. CDC Activities

    a. Assist in the design and conduct of the research through 
consultations and meetings between CDC experts and the Recipient.
    b. Perform selected in vivo and ex vivo laboratory tests available 
at CDC for drug activity and efficacy on parasitic protozoan parasites. 
These assays will be performed on promising compounds that have 
undergone initial basic in vitro biochemical and computer modeling 
screens by the Awardee.
    c. Provide biological materials from the CDC repository in the form 
of various parasitic protozoan species with strains of variable 
geographical origin, genetic background and phenotypic differences and 
are necessary to analyze the full range of drug efficacy of promising 
chemotherapeutic compounds to be developed.
    d. Assist in the development of assays for evaluating 
pharmacokinetics of new drugs.
    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.

F. Content

Applications

    The Program Announcement title and number must appear in the 
application. 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 pages, double-spaced, 
printed on one side, with one-inch margins, and unreduced 12-point 
font.
    The narrative should consist of capacity, objectives and technical 
approach, background and need, evaluation plan, measures of 
effectiveness and budget.

G. Submission and Deadline

Application Forms

    Submit the signed original and two copies of PHS 398 (OMB Number 
0925-0001). Adhere to the instructions on the Errata Instruction Sheet 
(posted on the CDC web site) for PHS 398. Forms are available at the 
following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm. If 
you do not have access to the Internet, or if you have difficulty 
accessing the forms on-line, you may contact the CDC Procurement and 
Grants Office Technical Information Management Section (PGO-TIM) at: 
770-488-2700. Application forms can be mailed to you.

Submission Date, Time, and Address

    The application must be received by 4 p.m. Eastern Time June 15, 
2003. Submit the application to: Technical Information Management-
PA03056, CDC Procurement and Grants Office, 2920 Brandywine Road, 
Atlanta, GA 30341-4146. Applications may not be submitted 
electronically.

CDC Acknowledgment of Application Receipt

    A postcard will be mailed by PGO-TIM, notifying you that CDC has 
received your application.

Deadline

    Applications shall be considered as meeting the deadline if they 
are received before 4 p.m. Eastern Time on the deadline date. Any 
applicant who sends their application by the United States Postal 
Service or commercial delivery services must ensure that the carrier 
will be able to guarantee delivery of the application by the closing 
date and time. If an application is received after closing due to (1) 
carrier error, when the carrier accepted the package with a guarantee 
for delivery by the closing date and time, or (2) significant weather 
delays or natural disasters, CDC will upon receipt of proper 
documentation, consider the application as having been received by the 
deadline.
    Any application that does not meet the above criteria will not be 
eligible for competition, and will be discarded. The applicant will be 
notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Application

    Applicants are required to provide measures of effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the cooperative agreement. Measures of effectiveness must 
relate to the performance goals stated in the purpose section of this 
announcement. Measures must be objective and quantitative and must 
measure the intended outcome. These measures of effectiveness must be 
submitted with the application and will be an element of evaluation.
    An independent review group appointed by CDC will evaluate each 
application against the following criteria:

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1. 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.
2. Objective and Technical Approach (40 points total)
    a. Extent to which applicant presents a detailed operational plan 
for initiating and conducting the project. The plan must clearly and 
appropriately address 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)
    b. 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)
    c. Does the application adequately address 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.
    (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)
3. 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 
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.
4. Evaluation (5 Points)
    Extent to which applicant provides a detailed and adequate plan for 
evaluating progress toward achieving project process and outcome 
objectives.
5. Measures of Effectiveness (5 points)
    Does the applicant provide measures of effectiveness that will 
demonstrate the accomplishment of the various identified objectives of 
the cooperative agreement? Are the measures objective/quantitative and 
do they adequately measure the intended outcome?
6. Budget (not scored)
    Extent to which the line-item budget is detailed, clearly 
justified, and consistent with the purpose and objectives of this 
program.
7. Human Subjects (not scored)
    Does the application adequately address the requirements of Title 
45 CFR part 46 for the protection of human subjects? Not scored: 
however, an application can be disapproved if the research risks are 
sufficiently serious and protection against risks is so inadequate as 
to make the entire application unacceptable.
8. Animal Subjects (not scored)
    Does the application adequately address the requirements of PHS 
Policy on Humane Care and Use of Laboratory Animals?

I. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Interim progress report, no less than 90 days before the end of 
the budget period. The progress report will serve as your non-competing 
continuation application, and must contain the following elements:
    a. Current Budget Period Activity Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Detailed Line-Item Budget and Justification.
    e. Additional Requested Information.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    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.

Additional Requirements

    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I of the 
program announcement, as posted on the CDC Web site.

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
AR-10--Smoke-Free Workplace Requirements
AR-11--Healthy People 2010
AR-12--Lobbying Restrictions

J. Where To Obtain Additional Information

    This and other CDC announcements, the necessary applications, and 
associated forms can be found on the CDC Web site, Internet address: 
http://www.cdc.gov. Click on ``Funding'' then ``Grants and Cooperative 
Agreements.''
    For general questions about this announcement, contact: Technical 
Information Management, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.
    For business management and budget assistance, contact: Lynn 
Walling, Contract Specialist, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2612, E-
mail Address: [email protected].
    For program technical assistance, contact: Mark L. Eberhard, Ph.D., 
Division of Parasitic Diseases, CDC, National Center for Infectious 
Diseases, 4770 Bufford Highway, NE., Atlanta, GA 30333, Telephone: 770-
488-7791, E-mail Address: [email protected].


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    Dated: April 30, 2003.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 03-11139 Filed 5-5-03; 8:45 am]
BILLING CODE 4163-18-P