[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