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:

• Universities
• Colleges
• Technical schools
• Research Institutions
• Hospitals
• Community-based organizations
• Faith-based organizations
• Federally recognized Indian tribal governments
• Indian Tribes
• Indian tribal organizations
• 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)
• 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 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:

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.