01-12982. Applied Research in Emerging Infections Investigations of West Nile Virus; Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2001 funds for a cooperative agreement program for Applied Research in Emerging Infections Investigations of West Nile Virus. This program addresses the “Healthy People 2010” focus area Immunization and Infectious Diseases.

The purpose of the program is to provide assistance to organizations in developing applied research efforts pertaining to West Nile (WN) virus and other arboviruses that occur in the United States (U.S.).

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, including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau, federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations.

Note:

Title 2 of the United States Code, Chapter 26, Section 1611 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 $2,000,000 is available in FY 2001 to fund approximately ten to twelve awards. It is expected that the average award will be $150,000, ranging from $100,000 to $300,000. It is expected that the awards will begin on or about September 30, 2001, and will be made for a 12-month budget period within a project period of up to three years. Funding estimates may change.

Continuation awards 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 the activities listed under 2. (CDC Activities).

1. Recipient Activities

Develop and implement applied research investigations on one or more of the following topics:

a. Determine the current and future geographic distribution of WN virus. Utilize longitudinal laboratory-based surveillance systems for WN virus in humans, birds, other selected animals, and mosquitoes to determine the geographic distribution of WN virus in the Western Hemisphere.

b. Determine the contribution of bird migration to WN virus dispersal. Develop laboratory and field-based systems to better understand avian dissemination of WN virus. Studies could include determining the frequency and duration of chronic avian infections that would allow the long range transport and recrudescence of viremias necessary to infect mosquitoes.

c. Characterize WN virus mosquito vector and vertebrate host relationships. Analyze the vertebrate host and mosquito vector relationships of WN virus in the U.S. and the Western Hemisphere. Target selected species involved in maintenance, epidemic/epizootic transmission cycles, or both to determine what effective prevention and control strategies will be required. It is critical that the principal species and the range of these species be determined.

d. Characterize mosquito biology, behavior, and vector competence for WN virus in the U.S. Investigate the different vector species important in WN virus transmission in each geographic or ecologic region to understand better their biology and behavior. Investigate the principal mosquito vectors involved in maintenance, bridge (from enzootic to peridomestic), and epidemic/epizootic transmission to understand and design more effective methods for prevention and control.

e. Develop and evaluate prevention strategies. These strategies can include but are not limited to better defining target areas for mosquito control in response to documented WN virus activity, derivation and implementation of new, natural compounds to repel and control mosquito-vectors of disease and determining the efficacy of public outreach materials and campaigns in reducing risk from WN virus infection.

f. Develop laboratory diagnostic tests that are more sensitive, specific and reproducible than current laboratory methods used to detect West Nile virus. Test methods may include, but are not limited to serology, culture, nucleic acid amplification or antigen detection.

g. Identify the clinical spectrum of North American WN virus disease and its long-term prognosis in humans. Determine the spectrum of illness caused by WN virus infection in humans, including the long-term consequences of acute infection of the central nervous system. In addition to the severe end of the clinical spectrum (viral encephalitis), determine the degree to which mild viral syndromes occur, whether these patients have any unique clinical presentations that may be characteristic or even pathognomonic, whether they have viremia and, if so, its magnitude and duration. Determine if effective clinical management of severe disease will require detailed clinical studies of confirmed human cases of WN virus infection.

h. Identify risk factors for WN virus exposure and disease. Data on the risk factors associated with human and animal infection with WN virus are required to develop more effective prevention strategies, particularly when educating the public to take specific prevention measures to reduce exposure to infection.

i. Characterize the genetics, pathogenesis, virulence and possible direct transmission and persistence of the North American strain of WN virus as it compares to other WN viruses in animal models and wildlife. Little is known about the pathogenesis of WN virus in humans or other animals. Investigate, to better understand, whether genetic changes in WN viruses influence their phenotypic expression (e.g., host and vector range); the possibility of persistent infections including the duration of chronic infection and reactivation in birds or other animals; the possibility and importance of direct transmission without the help of mosquitoes; and the identification of overwintering mechanisms in Culex and Aedes species mosquitoes.

2. CDC Activities

a. Provide technical assistance, as requested, in the design or evaluation of experimentation.

b. Assist in the analysis of laboratory test data, as appropriate, depending on the needs of the recipient.

c. Assist in the acquisition of appropriate samples for study, as requested.

d. Assist in the coordination of research activities among different recipient sites.

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. Content

Letter of Intent (LOI)

An LOI is optional for this program. The narrative should be no more than 3 single-spaced pages, printed on one side, with one inch margins, and unreduced font. Your letter of intent will be used to enable CDC to plan for the review, and should include the following information (1) the program announcement number 01110, (2) name and address of institution, (3) name, address, and telephone number of contact person and (4) the applied research investigation topic(s) selected for submission. Notification can be provided by facsimile, postal mail, or electronic mail (E-mail).

Applications

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 25 double-spaced pages, printed on one side, with one inch margins, and unreduced font.

1. Abstract

Provide a brief (two pages maximum) abstract of the project and specify the applied research investigation topic(s) selected for submission. Clearly identify the project period proposed.

2. Background and Need

Discuss the background and need for the proposed project. Demonstrate a clear understanding of the purpose and objectives of this program announcement. Discuss and demonstrate how the proposed project addresses an important gap which is of public health importance.

3. Capacity and Personnel

Describe applicant's past experience in conducting activities similar to that being proposed. Describe applicant's resources, facilities, and professional personnel that will be involved in conducting the project. Include in an appendix curriculum vitae for all professional personnel involved with the project. Describe plans for administration of the project and identify administrative resources/personnel that will be assigned to the project. Clearly identify specific assigned responsibilities for all key professional personnel. Provide in an appendix letters of support from all key participating non-applicant organizations, individuals, etc. (if any), which clearly indicate their commitment to participate as described in the operational plan.

4. Objectives and Technical Approach

Present specific objectives for the proposed research which are measurable and time-phased and are consistent with the Purpose and Recipient Activities of this announcement. Present a detailed operational plan for initiating and conducting the research which clearly and appropriately addresses these objectives (if proposing a multi-year project, provide a detailed description of first-year activities and a brief overview of subsequent-year activities). Include a clear description of applicant's technical approach/methods which are directly relevant to the above objectives. Describe specific study protocols or plans for the development of study protocols. Describe the nature and extent of collaboration with CDC and/or others during various phases of the research. Describe in detail a plan for evaluating progress toward achieving process and outcome project objectives. If the project will employ a particular research subject population, describe characteristics of the patient population and how research in this subject group will yield generalizable information. Describe contingency plans which acknowledge how the research will address likely obstacles and assure that the proposed task(s) can still be completed. Include sample size calculations where appropriate to assure that measurable objectives can be evaluated.

5. Budget

Provide a detailed budget as outlined in the application Errata Instruction Sheet for PHS 398.

F. Submission and Deadline

Letter of Intent (LOI)

On or before June 15, 2001, submit the LOI to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

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 available in the application kit and at the following Internet address: www.cdc.gov/​od/​pgo/​forminfo.htm

On or before July 15, 2001, 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:

1. Received on or before the deadline date; or

2. 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 which do not meet the criteria in 1. or 2. above will be returned to the applicant.

G. Evaluation Criteria

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

1. Plan (20 Points)

The extent the proposed research plan shows scientific validity and whether the plan addresses a stated purpose of this program.

2. Capacity (40 Points)

a. The extent the applicant documents and describes their general expertise in the areas relevant to their submitted application (e.g., diagnostic test development, field studies with zoonotic diseases, working with small animal models of disease).

b. The extent the applicant describes and documents their experience in research on mosquito-borne viral diseases and flaviviruses in particular.

c. The extent to which the applicant has the appropriate project personnel, organizational structure, and administrative support to assure meeting proposed objectives.

d. The extent to which the applicant has access to necessary biological materials or study populations.

3. Objectives and Prospects (15 points)

The extent the objectives along with the prospects for successfully achieving them and the likelihood that the product(s) of the investigation will result in the development of better prevention or intervention measures.

4. Evaluation (20 points)

a. The feasibility of completing the proposed studies and meeting measurable objectives within the project period.

b. The extent to which the applicant proposes appropriate methods for evaluating the projects and/or design methods that are adequate to measure differences, when warranted.

5. Inclusion of Women, Ethnic, and Racial Groups (5 points)

Applicants should meet 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 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, and (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.

6. Budget (Not scored)

The extent to which the budget is reasonable, clearly justified, and consistent with the intended use of cooperative agreement funds.

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 the PHS Policy on Humane Care and Use of Laboratory animals by Awardee Institutions?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with the original plus two copies of:

1. semiannual progress reports;

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 of the announcement.

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-9 Paperwork Reduction Act Requirements

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

AR-14 Accounting System Requirements

AR-15 Proof of Non-Profit Status

AR-22 Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under section 301(a) [42 U.S.C. 241(a)] and 317(k)(2) [42 U.S.C. 247b(k)(2) of the Public Health Service Act, 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 home page Internet address—http://www.cdc.gov Click on “Funding” then “Grants and Cooperative Agreements.”

To receive additional written information and to request an application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked to leave your name and address and will be instructed to identify the Program Announcement number of interest.

If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained from: Gladys Gissentanna, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146, Telephone number: 770-488-2753, E-mail address: [e-mail].

For program technical assistance, contact: Dr. John Roehrig, Division of Vector-Borne Infectious Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, P. O. Box 2087 (Foothills Campus), Fort Collins, CO 80522, Telephone number: 970-221-6442, E-mail address: [e-mail].

Dated: May 17, 2001.

John L. Williams,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC).