[Federal Register Volume 66, Number 100 (Wednesday, May 23, 2001)]
[Notices]
[Pages 28522-28525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12982]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01110]


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

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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

[[Page 28524]]

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

[[Page 28525]]

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: 
[email protected].
    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: [email protected].

    Dated: May 17, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-12982 Filed 5-22-01; 8:45 am]
BILLING CODE 4163-18-P