[Federal Register: May 6, 2003 (Volume 68, Number 87)]
[Notices]
[Page 23989-23992]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06my03-65]
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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:
[[Page 23991]]
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: lqw5@cdc.gov. 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: mlel@cdc.gov.
[[Page 23992]]
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