[Federal Register Volume 61, Number 126 (Friday, June 28, 1996)]
[Notices]
[Pages 33748-33750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16547]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement Number 645]


Applied Research in Emerging Infections--Tickborne Diseases

Introduction

    The Centers for Disease Control and Prevention (CDC) is 
implementing a program for competitive cooperative agreements and/or 
research project grants to support applied research on emerging 
infections. CDC announces the availability of fiscal year (FY) 1996 
funds for cooperative agreements and/or research project grants to 
conduct applied research on domestic tickborne diseases (e.g., 
ehrlichiosis, babesiosis, Rocky Mountain spotted fever, tularemia, 
Colorado tick fever, etc.). 1. CDC is committed to achieving the health 
promotion and disease prevention objectives of Healthy People 2000, a 
national activity to reduce morbidity and mortality and improve the 
quality of life. This announcement is related to the priority area of 
Immunization and Infectious Diseases.

    1. Note: An existing CDC cooperative agreement program supports 
research focusing on Lyme disease caused by Borrelia burgdorferi, 
specifically. Therefore, this new program will not support research 
projects which focus substantially on classical Lyme disease caused 
by B. burgdorferi.

(For ordering a copy of Healthy People 2000, see the section Where To 
Obtain Additional Information.)

Authority

    This program is authorized under Sections 301 and 317 of the Public 
Health Service Act, as amended (42 U.S.C. 241 and 247b).

Smoke-Free Workplace

    CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the non-use of all tobacco products, and 
Public Law 103-227, the Pro-Children's Act of 1994, prohibits smoking 
in certain facilities that receive Federal funds in which education, 
library, day-care, health care and early childhood development services 
are provided to children.

Eligible Applicants

    Applications may be submitted by public and private, nonprofit and 
for-profit organizations and governments and their agencies. Thus, 
universities, colleges, research institutions, hospitals, other public 
and private organizations, including State and local governments or 
their bona fide agents, federally recognized Indian tribal governments, 
Indian tribes or Indian tribal organizations, and small, minority- and/
or women-owned businesses are eligible to apply.

Availability of Funds

    Approximately $300,000 is available in FY 1996 to fund 
approximately two to four awards. It is expected that approximately 
two-thirds of the funds will be made available for the first 
programmatic focus (epidemiologic studies focusing on ehrlichiosis) and 
one-third for the second (development of improved diagnostic tests for 
babesiosis). Awards will begin on or about September 30, 1996, and will 
be made for a 12-month budget period within a project period of up to 
three years. Funding estimates may vary and are subject to change. 
Continuation awards within an approved project period will be made on 
the basis of satisfactory progress and availability of funds.

Purpose

    The purpose of the emerging infections extramural research program 
is to provide financial and technical assistance for applied research 
projects on emerging infections in the United States. As a component of 
the emerging infections extramural research program, the purpose of 
this grant/cooperative announcement is to provide assistance for 
tickborne disease projects addressing the following two programmatic 
focus areas:
    1. Epidemiologic studies focusing on ehrlichiosis
    2. Development and evaluation of improved diagnostic tests for 
babesiosis.
    Applicants may submit separate applications for projects in one or 
both programmatic areas. See Application Content of the program 
announcement included in the application kit for detailed application 
instructions.

Program Requirements

    Applicants may apply and receive support for projects under one or 
both of the two programmatic focus areas. In conducting activities to 
achieve the purpose of this program, the recipient will be responsible 
for the activities under either A.1. or A.2., or both, below; and CDC 
will be responsible for conducting activities under B., below:

A. Recipient Activities

1. Epidemiologic Studies
    Implement an active prospective ehrlichiosis surveillance system in 
a geographic area where the disease(s) (monocytic or granulocytic) is/
are believed to be present, utilizing case finding based on a 
standardized clinical case definition. Cases should be laboratory 
confirmed, using standardized methods such as isolation or direct 
detection of the etiologic agent from clinical specimens by antigen 
detection or PCR; and/or serology. Laboratory diagnosis should be 
validated by retesting clinical specimens in a reference laboratory. A 
population based study in which incidence can be calculated and that 
simultaneously captures incident cases of babesiosis in the same 
location is most desirable.
2. Development and Evaluation of Improved Diagnostic Tests for 
Babesiosis:
    a. Develop and evaluate improved laboratory methods for the 
diagnosis of babesiosis, which may include methods for antibody or 
antigen detection, molecular techniques, and isolation of the parasite 
from clinical specimens. Consider such characteristics of the test as 
sensitivity (e.g., ability to detect subpotent infection), specificity 
(e.g., ability to distinguish Babesia infection from other infections 
and conditions, ability to distinguish persistent from remote Babesia 
infection, genus- vs. species-level specificity), and ease of 
automation.
    b. As part of certain projects and as appropriate, obtain and 
provide such

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materials as isolates; human serum, whole blood, and other fluids and 
tissues; and diagnostic test reagents to a national reference 
laboratory (e.g., for development of a reference collection of 
specimens).

B. CDC Activities

1. Research Project Grants
    A research project grant is one in which substantial programmatic 
involvement by CDC is not anticipated by the recipient during the 
project period. Applicants for grants must demonstrate an ability to 
conduct the proposed research with minimal assistance, other than 
financial support, from CDC. This would include possessing sufficient 
resources for clinical, laboratory, and data management services and a 
level of scientific expertise to achieve the objectives described in 
their research proposal without substantial technical assistance from 
CDC.
2. Cooperative Agreements
    A cooperative agreement implies that CDC will assist recipients in 
conducting the proposed research. The application should be presented 
in a manner that demonstrates the applicant's ability to address the 
research problem in a collaborative manner with CDC. In addition to the 
financial support provided, CDC will collaborate by: (a) Providing 
technical assistance in the design and conduct of the research; (b) 
performing selected laboratory tests as appropriate; (c) participate in 
data management, the analysis of research data, and the interpretation 
and presentation of research findings; and (d) provide biological 
materials (e.g., strains) as necessary for studies, etc.
3. Determination of Which Instrument to Use
    Applicants must specify the type of award for which they are 
applying, either grant or cooperative agreement. The funding agency 
will review the applications in accordance with the evaluation 
criteria. Before issuing awards, CDC will determine whether a grant or 
cooperative agreement is the appropriate instrument based upon the need 
for substantial CDC involvement in the project.

Evaluation Criteria

    The applications will be reviewed and evaluated according to the 
following criteria:
1. Background and Need (20 Points)
    Extent to which applicant's discussion of the background for the 
proposed project demonstrates a clear understanding of the purpose and 
objectives of this grant/cooperative agreement program. Extent to which 
applicant illustrates and justifies the need for the proposed project 
that is consistent with the purpose and objectives of this grant/
cooperative agreement program.
2. Capacity (40 Points Total)
    a. Extent to which applicant describes adequate resources and 
facilities (both technical and administrative) for conducting the 
project. (10 points)
    b. 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. (20 points)
    c. Extent to which applicant includes letters of support from non-
applicant organizations, individuals, etc. Extent to which the letters 
clearly indicate the author's commitment to participate as described in 
the operational plan. (10 points)
3. Objectives and Technical Approach (40 Points Total)
    a. Extent to which applicant describes objectives of the proposed 
project which are consistent with the purpose and goals of this grant/
cooperative agreement program and which are measurable and time-phased. 
(10 points)
    b. Extent to which applicant presents a detailed operational plan 
for initiating and conducting the project, which clearly and 
appropriately addresses all Recipient Activities for the specific 
programmatic focus area being addressed in the application. 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 plan is 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. (15 points)
    c. Extent to which applicant describes adequate and appropriate 
collaboration with CDC and/or others during various phases of the 
project. (10 points)
    d. Extent to which applicant provides a detailed and adequate plan 
for evaluating study results and for evaluating progress toward 
achieving project objectives. If the proposed project involves 
notifiable conditions, the degree to which applicant describes an 
adequate process for providing necessary information to appropriate 
State and/or local health departments. (5 points)
4. Budget (Not Scored)
    Extent to which the proposed budget is reasonable, clearly 
justifiable, and consistent with the intended use of grant/cooperative 
agreement funds.
5. Human Subjects (Not Scored)
    If the proposed project involves human subjects, whether or not 
exempt from the Department of Health and Human Services (DHHS) 
regulations, the extent to which adequate procedures are described for 
the protection of human subjects. Note: Objective Review Group (ORG) 
recommendations on the adequacy of protections include: (1) protections 
appear adequate and there are no comments to make or concerns to raise, 
or (2) protections appear adequate, but there are comments regarding 
the protocol, or (3) protections appear inadequate and the ORG has 
concerns related to human subjects, or (4) disapproval of the 
application is recommended because the research risks are sufficiently 
serious and protection against the risks are inadequate as to make the 
entire application unacceptable, and (5) protections appear adequate 
that women, racial and ethnic minority populations are appropriately 
represented in applications involving human research.

Executive Order 12372 Review

    This program is not subject to Executive Order 12372 Review.

Public Health System Reporting Requirements

    This program is subject to the Public Health System Reporting 
Requirements. Under these requirements, all community-based 
nongovernmental applicants must prepare and submit the items identified 
below to the head of the appropriate State and/or local health 
agency(s) in the program area(s) that may be impacted by the proposed 
project no later than the receipt date of the Federal application. The 
appropriate State and/or local health agency is determined by the 
applicant. The following information must be provided:
    a. A copy of the face page of the application (SF 424).
    b. A summary of the project that should be titled ``Public Health 
System Impact Statement'' (PHSIS), not exceed one page, and include the 
following:
    (1) A description of the population to be served;

[[Page 33750]]

    (2) A summary of the services to be provided;
    (3) A description of the coordination plans with the appropriate 
State and/or local health agencies.
    If the State and/or local health official should desire a copy of 
the entire application, it may be obtained from the State Single Point 
of Contact (SPOC) or directly from the applicant.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance Number is 93.283.

Other Requirements

Paperwork Reduction Act
    Projects that involve the collection of information from ten or 
more individuals and funded by the grant/cooperative agreement will be 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act.
Human Subjects
    If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human Services 
Regulations (45 CFR Part 46) regarding the protection of human 
subjects. Assurance must be provided to demonstrate that the project 
will be subject to initial and continuing review by an appropriate 
institutional review committee. The applicant will be responsible for 
providing evidence of this assurance in accordance with the appropriate 
guidelines and form provided in the application kit.
    In addition to other applicable committees, Indian Health Service 
(IHS) institutional review committees also must review the project if 
any component of IHS will be involved or will support the research. If 
the American Indian community is involved, its tribal government must 
also approve that portion of the project applicable to it.
Women, Racial and Ethnic Minorities
    It is the policy of the Centers for Disease Control and Prevention 
(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) 
to ensure that individuals of both sexes and the various racial and 
ethnic groups will be included in CDC/ATSDR- supported research 
projects involving human subjects, whenever feasible and appropriate. 
Racial and ethnic groups are those defined in OMB Directive No. 15 and 
include American Indian, Alaskan Native, Asian, Pacific Islander, Black 
and Hispanic. Applicants shall ensure that women, racial and ethnic 
minority populations are appropriately represented in applications for 
research involving human subjects. Where clear and compelling rationale 
exist that inclusion is inappropriate or not feasible, this situation 
must be explained as part of the application. This policy does not 
apply to research studies when the investigator cannot control the 
race, ethnicity and/or sex of subjects. Further guidance to this policy 
is contained in the Federal Register, Vol. 60, No. 179, pages 47947-
47951, dated Friday, September 15, 1995.
Animal Subjects
    If the proposed project involves research on animal subjects, the 
applicant must comply with the ``PHS Policy on Humane Care and Use of 
Laboratory Animals by Awardee Institutions.'' An applicant organization 
proposing to use vertebrate animals in PHS-supported activities must 
file an Animal Welfare Assurance with the Office for Protection from 
Research Risks at the National Institutes of Health.

Application Submission and Deadline

    The original and two copies of each application PHS Form 5161-1 
(revised 7/92, OMB Number 0937-0189) must be submitted to Sharron Orum, 
Grants Management Officer, Grants Management Branch, Procurement and 
Grants Office, Centers for Disease Control and Prevention (CDC), 255 
East Paces Ferry Road, NE., Room 300, Mailstop E-18, Atlanta, Georgia 
30305, on or before August 12, 1996.
    1. Deadline: Applications shall be considered as meeting the 
deadline if they are either:
    a. Received on or before the deadline date; or
    b. Sent on or before the deadline date and received in time for 
submission to the objective 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.)
    2. Late Applications: Applications which do not meet the criteria 
in 1. a. or 1. b. above are considered late applications. Late 
applications will not be considered in the current competition and will 
be returned to the applicant.

Where to Obtain Additional Information

    A complete program description and information on application 
procedures are contained in the application package. An application 
package and business management and technical assistance may be 
obtained from Locke Thompson, Grants Management Specialist, Grants 
Management Branch, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop 
E-18, Room 300, Atlanta, Georgia 30305, telephone (404) 842-6595, or 
through the Internet or CDC Wonder electronic mail at: 
[email protected]. Programmatic technical assistance may be 
obtained from the following persons: For epidemiologic studies, James 
G. Olson, Ph.D., National Center for Infectious Diseases, Division of 
Viral and Rickettsial Diseases, Centers for Disease Control and 
Prevention (CDC), 1600 Clifton Road, NE., Mailstop G-13, Atlanta, 
Georgia 30333, telephone (404) 639-1075. For babesia diagnostics: 
Barbara Herwaldt, M.D., Division of Parasitic Diseases, National Center 
for Infectious Diseases, Centers for Disease Control and Prevention 
(CDC), 1600 Clifton Road, NE., Mailstop F-22, Atlanta, Georgia 30333, 
telephone (770) 488-7772.
    Please refer to Announcement Number 645 when requesting information 
regarding this program.
    Potential applicants may obtain a copy of Healthy People 2000 (Full 
Report, Stock No. 017-001-00474-0) or Healthy People 2000 (Summary 
Report, Stock No. 017-001-00473-1) referenced in the Introduction 
through the Superintendent of Documents, Government Printing Office, 
Washington, DC 20402-9325, telephone (202) 512-1800.
    There may be delays in mail delivery and difficulty in reaching the 
CDC Atlanta offices during the 1996 Summer Olympics. Therefore, CDC 
suggests using the Internet, following all instructions in this 
announcement and leaving messages on the contact person voice mail for 
more timely responses to any questions.

    Dated: June 24, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 96-16547 Filed 6-27-96; 8:45 am]
BILLING CODE 4163-18-P