[Federal Register Volume 63, Number 134 (Tuesday, July 14, 1998)]
[Notices]
[Pages 37884-37889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18667]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 99012]
Notice of Availability of Funds; Applied Research Program in
Emerging Infections Novel Diagnostic Tests for Infections of Public
Health Significance
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1999 funds for competitive grants and/
or cooperative agreements to support applied research on emerging
infections. This announcement addresses the development of novel
diagnostic tests for infections of public health significance.
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. (For ordering a copy of Healthy People 2000, see
the section WHERE TO OBTAIN ADDITIONAL INFORMATION.)
Authority
This program is authorized under Sections 301(a) and 317(k)(2) of
the Public Health Service Act, as amended [42 U.S.C. 241(a) and
247b(k)(2)].
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
Pub. L. 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
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.
Only one application will be accepted from any single applicant,
organization, government, or agency in each focus area.
Availability of Funds
Approximately $500,000 is available in FY 1999 to fund two to three
awards, ranging from $160,000 to $250,000. It is expected the awards
will begin on or about February 1, 1999, and will be made for a 12-
month budget period within a project period of up to three years. (The
funding amounts listed above are for the first 12-month budget period
and include both direct and indirect costs.) The funding estimate is
subject to change.
Continuation awards within an approved project period will be made
on the basis of satisfactory progress and availability of funds.
Specifically, applications are solicited for projects addressing
any of the following three areas:
1. Diagnostic Tests of High Sensitivity and Specificity for Use in
Clinical Settings
The objective is to encourage the development of highly sensitive
and specific diagnostic tests for infectious disease agents of high
public health significance for which such tests are not currently
available.
2. Development and Evaluation of Improved Tests for Malaria Diagnosis
in the U.S.
The objective is to develop and evaluate a malaria diagnostic test
that does not require microscopic examination of blood smears and: (a)
is at least as sensitive as microscopy (4 parasites per ul. of blood);
(b) can detect all 4 known species of human malaria parasites; (c) has
a specificity of at least 95 percent; (d) is simple to perform; and (e)
can provide results in less than 1 hour.
3. Diagnostic Tests for Field Use
The objective is to encourage the development of field tests for
infectious disease agents of high public health significance.
Attributes sought in these field tests are: low cost; use with
noninvasive or easy to collect specimens; short time-to-result; stable
reagents; minimum risks to technicians; sensitivity and specificity
appropriate for setting.
Applicants may submit separate applications for projects in one or
more of the three focus areas. (See Application Process Section,
Application Content area, for detailed instructions.)
Determination of Which Instrument to Use
Applicants must specify the type of award for which they are
applying, either grant or cooperative agreement. CDC 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. To assist applicants in making a
determination as to which type of award to apply for, the following
information is provided:
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,
[[Page 37885]]
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.
Use of Funds
Restrictions on Lobbying
Applicants should be aware of restrictions on the use of the
Department of Health and Human Services (HHS) funds for lobbying of
Federal or State legislative bodies. Under the provisions of 31 U.S.C.
Section 1352 (which has been in effect since December 23, 1989),
recipients (and their subtier contractors) are prohibited from using
appropriated Federal funds (other than profits from a Federal contract)
for lobbying congress or any Federal agency in connection with the
award of a particular contract, grant, cooperative agreement, or loan.
This includes grants/cooperative agreements that, in whole or in part,
involve conferences for which Federal funds cannot be used directly or
indirectly to encourage participants to lobby or to instruct
participants on how to lobby.
In addition, the FY 1998 ``Department of Labor, Health and Human
Services, and Education, and Related Agencies Appropriations Act''
(Public Law 105-78) states in Section 503 (a) and (b) that no part of
any appropriation contained in this Act shall be used, other than for
normal and recognized executive-legislative relations, for publicity or
propaganda purposes, for the preparation, distribution, or use of any
kit, pamphlet, booklet, publication, radio, television, or video
presentation designed to support or defeat legislation pending before
the Congress or any State legislature, except in presentation to the
Congress or any State legislature itself. No part of any appropriation
contained in this Act shall be used to pay the salary or expenses of
any grant or contract recipient, or agent acting for such recipient,
related to any activity designed to influence legislation or
appropriations pending before the Congress or any State legislature.
Background
Once expected to be eliminated as a public health problem,
infectious diseases remain the leading cause of death worldwide. In the
United States (U.S.) and elsewhere, infectious diseases increasingly
threaten public health and contribute significantly to the escalating
costs of health care.
In 1992, the Institute of Medicine of the National Academy of
Sciences published a report entitled Emerging Infections, Microbial
Threats to Health in the United States highlighting the threat of
emerging infections and making specific recommendations to address the
threat. This report emphasized a critical leadership role for CDC in a
national effort to detect and control infectious disease threats.
In partnership with other Federal agencies, State and local health
departments, academic institutions, and others, CDC has developed a
plan for revitalizing the nation's ability to identify, contain, and
prevent illness from emerging infectious diseases. The plan,
``Addressing Emerging Infectious Disease Threats; A Prevention Strategy
for the United States,'' includes applied research as a major
objective, stressing the importance of integrating laboratory science
and epidemiology to optimize public health practice in the United
States (U.S.). CDC has developed an Extramural Applied Research Program
in Emerging Infections (EARP) designed to fill gaps in existing support
for research in emerging infectious disease surveillance, epidemiology,
and prevention. This announcement specifically addresses novel
diagnostic methods for infections of public health significance.
Proposals sought under this announcement may span the range from
highly sophisticated, sensitive and specific tests that require a well-
equipped laboratory and highly trained personnel to robust field tests
that are simple, rapid, and can be performed without equipment by
minimally trained persons yet provide reliable results. Examples of
infections and issues of public health significance to be addressed
include, but are not limited to, tuberculosis, malaria, dengue,
enterohemorrhagic Escherichia coli other than E. coli O157:H7,
antimicrobial resistance (e.g., detecting vancomycin resistance genes
in enterococci), and prion disease (e.g., Bovine Spongiform
Encephalitis). This announcement focuses on three specific areas:
1. Diagnostic Tests of High Sensitivity and Specificity for Use in
Clinical Settings
Despite the recent advances in molecular biology and its
applications to diagnostics, significant gaps still remain in
infectious disease diagnostics. Commercial companies tend to focus in
areas of diagnostics that have a potential for high-volume sales of
diagnostic kits. Many published methods have not been adequately
validated. Sample preparation procedures tend to be complex and time-
consuming; many of the proposed simple sample preparation methods do
not yield consistent results. Applications are encouraged that address
these and similar issues and target those infectious agents for which
there is clear need for better and more rapid diagnostic methods.
Polymerase Chain Reaction (PCR) amplification is being used to
detect and identify unculturable organisms directly in human clinical
specimens, such as blood, urine, cerebrospinal fluid, and tissues
obtained by biopsy or at autopsy. Unfortunately, the success rate of
this method is quite low when identification is attempted directly from
clinical samples. This is due to the presence of PCR inhibitors in
blood and other clinical samples and also, in part, to the often low
number of organisms in the samples. For PCR amplification tests to
become a valuable rapid identification method for uncultured bacteria,
the inhibitors must be identified and removed or overcome, and the
sensitivity of the method for a wide variety of human pathogenic
bacteria in various clinical samples must be determined.
For many infectious agents, new non-culture methods have been
developed that facilitate rapid detection of the pathogen in clinical
specimens without its isolation. Because many local, State and Federal
surveillance programs depend on the continued availability of
pathogenic microorganisms isolated by culture, the Council of State and
Territorial Epidemiologists (CSTE) has recently developed a new
position statement on this topic. In its position statement, CSTE
recommends the Food and Drug Administration require each manufacturer
of non-culture tests for infectious agents of public health importance
and for which routine characterization (speciation, subtyping or
antimicrobial susceptibility testing) provides essential information
for public health surveillance or investigation, include in their
product insert a statement that positive results must be confirmed by
culture. Almost all currently available non-culture
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diagnostic tests require the laboratorian to go back to the original
specimen or an enrichment culture to attempt to isolate the pathogen.
Public health programs will greatly benefit from rapid non-culture
diagnostic methods that have built-in algorithms that facilitate the
isolation of the pathogen without having to go back to the specimen or
an enrichment broth. Such approaches are feasible in techniques that
involve selective removal or immobilization of the target pathogen from
the specimen without causing its inactivation.
2. Improved Tests for Malaria Diagnosis in the U.S.
Every year, approximately 1,000 cases of malaria are reported in
the U.S. Nineteen deaths due to malaria were recorded in the U.S.
during the period 1992-1994. Of particular concern, cases of locally-
transmitted malaria have been reported on practically an annual basis
in densely populated areas (New York City, Houston, and Palm Beach
County, Florida). The substantial U.S. public health impact of malaria
is very likely to increase in the future due to increased international
travel combined with a worldwide resurgence of malaria. Available
information indicates that malaria diagnosis is not optimally performed
in the U.S. In a recent survey of samples sent to CDC's National
Malaria Reference Laboratory (NMRL) by various health institutions
(including State health departments, hospitals, and commercial
laboratories), the diagnosis made by the NMRL differed from that made
at the health institution in 21 percent of the samples. This is due
mainly to the fact that the internationally accepted method for
diagnosing malaria (the microscopic examination of a Giemsa-stained
blood smear) requires a degree of microscopy experience that most
clinical laboratorians in the U.S. lack due to their infrequent contact
with malaria samples.
One solution to this problem would be a diagnostic test that
depends, not on the experience and skills of a microscopist, but on
more objective, quantifiable criteria. Several malaria diagnostic tests
that follow this approach are currently on the market or in various
development phases. Such tests identify malaria parasites by nucleic
acid fluorescence or by detecting parasite-specific antigens or
enzymes. However, none of these tests satisfy all desirable criteria
for a malaria diagnostic tool applicable to clinical laboratory
practice in the U.S. Such criteria include: (a) sensitivity at least
equal to that of microscopy (4) parasites per ul. of blood); (b)
detection of all 4 known species of human malaria parasites; (c)
specificity above 95 percent; (d) simplicity of performance; and (e)
rapidity of execution (results available in less than 1 hour). In
addition, none of these tests have been adequately evaluated under
strictly controlled conditions in U.S. health facilities.
3. Diagnostic Tests for Field Use
For many infectious agents, there is a critical need for rapid,
simple tests that can be performed in the field without access to a
sophisticated laboratory and for which minimal sample preparation is
required. In the past, many of these tests have been configured on the
basis of specific antigen-antibody interactions (e.g., latex
agglutination tests, dipstick immunoassays, immunoprecipitation tests)
using polyclonal or monoclonal antibodies. However, for the purpose of
this announcement, any tests that meet the following criteria will be
considered: low cost; use with noninvasive or easy to collect
specimens; short time-to-result; stable reagents; minimum risks to
technicians; sensitivity and specificity appropriate for setting, and
demonstrated need for such tests for the proposed target pathogen.
Purpose
The purpose of the EARP is to provide financial and technical
assistance for applied research projects on emerging infections in the
U.S. As a component of EARP, the purpose of this grant/cooperative
agreement announcement is to provide assistance for projects addressing
novel methods for identification of emerging infections.
Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities under A.
(Recipient Activities) and CDC will be responsible for conducting
activities under B. (CDC Activities) for cooperative agreements only:
A. Recipient Activities
1. Diagnostic Tests of High Sensitivity and Specificity for use in
Clinical Settings
a. Develop diagnostic tests for use in clinical settings for one or
more infectious diseases of high public health significance for which
such tests do not currently exist or significantly improve an existing
test; OR
b. Develop rapid diagnostic tests for use in clinical settings for
one or more infectious diseases of high public health significance.
Design the test in such a manner that the etiologic agent may be
directly isolated from the matrix that is used for rapid detection of
the etiologic agent; OR
c. Systematically develop optimal conditions for the detection of
uncultured bacteria from blood, serum, and other clinical specimens,
specifically addressing the problem of inhibition of the polymerase
chain reaction by sample components. Complete Phase I evaluation of the
diagnostic test in a clinical setting and compare against a method
which has been previously validated. Demonstrate that the sensitivity
and specificity of the test are significantly better than the current
benchmark tests. For a.2. and a.3., demonstrate that the target
pathogen can be consistently isolated from clinical specimens.
d. Organize independently or collaborate with CDC (for cooperative
agreements) to organize more extensive Phase II evaluation of the test
in multiple laboratories.
e. Publish and/or otherwise disseminate findings.
2. Development and Evaluation of Improved Tests for Malaria Diagnosis
in the U.S.
a. Develop a new diagnostic test or improve currently available
test(s) that does not require microscopic examination of blood smears
and is:
(1) At least as sensitive as microscopy (4) parasites per ul. of
blood).
(2) Can detect all 4 known species of human malaria parasites.
(3) Has a specificity of at least 95 percent.
(4) Is simple to perform.
(5) Can provide results in less than 1 hour.
b. Conduct a first phase of evaluation of the new or improved
test(s). This should involve testing clinical samples for malaria under
blinded conditions and should use mainly samples collected from non-
human primates experimentally infected with human malaria parasites and
malaria-infected human blood samples, both of which can be made
available by CDC.
c. Collaborate with CDC (for cooperative agreements) to conduct
field evaluations of the test(s) in endemic countries (e.g. a large-
scale assessment in a short time period where n > = 500) and in U.S.
facilities. (The actual U.S. field testing will likely require a longer
time period due to low frequency of malaria and should involve
collaboration with State health departments, hospitals, and commercial
laboratories.)
d. Publish and/or otherwise disseminate results.
[[Page 37887]]
3. Diagnostic Tests for Field Use
a. Develop diagnostic tests for use under field conditions for one
or more infectious diseases of high public health significance for
which such tests are needed but do not currently exist or significantly
improve an existing test.
b. Complete limited evaluation of the diagnostic test under field
conditions and compare against a method which has been previously
validated. Demonstrate that the sensitivity and specificity of the test
are acceptable and appropriate for use in field settings.
c. Organize independently or collaborate with CDC (cooperative
agreements) to organize more extensive Phase II evaluation of the test.
d. Publish and/or otherwise disseminate findings.
B. CDC Activities (for Cooperative Agreements)
1. Provide technical assistance in the design and conduct of the
research.
2. Perform selected laboratory tests, as appropriate and necessary.
3. Participate in data management, the analysis of research data,
and the interpretation and presentation of research findings.
4. Provide biological materials (e.g., strains, reagents, etc.) as
necessary for studies.
Technical Reporting Requirements
Narrative progress reports are required semiannually. The first
semiannual report is required with each year's noncompeting
continuation application and should cover program activities from date
of the previous report (or date of award for reporting in the first
year of the project). The second semiannual report is due along with
the Financial Status Report (FSR) (see next paragraph) 90 days after
the end of each budget period and should cover activities from the date
of previous report. Progress reports should address the status of
progress toward specific project objectives and should include copies
of any publications resulting from the project.
An original and two copies of the FSR are required no later than 90
days after the end of each budget period. A final performance report
and FSR are due no later than 90 days after the end of the project
period.
Application Process
1. Pre-Application Letter of Intent
In order to assist CDC in planning and executing the evaluation of
applications submitted under this Program Announcement, all parties
intending to submit application(s) are encouraged to inform CDC of
their intention to do so as soon as possible but not later than 10
business days prior to the application due date. Notification should
include: (1) name and address of institution; (2) name, address, and
phone number of contact person; and (3) which focus area(s)
application(s) will be submitted under. Notification can be provided by
facsimile, postal mail, or electronic mail (E-mail) to Bala
Swaminathan, Ph.D., National Center for Infectious Diseases, Centers
for Disease Control and Prevention (CDC), 1600 Clifton Road, N.E.,
Mailstop C-7, Atlanta, GA 30333, Facsimile (404) 639-3333, Internet
bas5@cdc.gov.
2. Application Content
Applicants may apply for assistance for projects in one or more of
the three separate focus areas identified under PURPOSE and PROGRAM
REQUIREMENTS sections. IF APPLICANT IS APPLYING FOR ASSISTANCE FOR MORE
THAN ONE FOCUS AREA, A SEPARATE AND COMPLETE APPLICATION MUST BE
SUBMITTED FOR EACH FOCUS AREA AND INDICATE WHETHER APPLYING FOR A GRANT
OR COOPERATIVE AGREEMENT.
All applicants must develop their application(s) in accordance with
PHS Form 398, information contained in this grant/cooperative agreement
announcement, AND the attached errata sheet instructions. In order to
ensure an objective, impartial, and prompt review, applications must
conform to these instructions:
a. General Instructions
1. The original and five (5) complete copies of the application
must be UNSTAPLED and UNBOUND.
2. ALL pages must be clearly numbered, and a complete index to the
application and its appendices must be included.
3. All typewritten materials must be single-spaced, using a font no
smaller than size 12. All supplemental pages of the application (i.e.,
in addition to the PHS 398 form) must be on the 8 \1/2\'' by 11'' white
paper.
4. All pages must be printed on ONE side only, with at least 1''
margins, headers, and footers.
b. Special Instructions
The application narrative must not exceed 10 pages (excluding
budget and appendices). Unless indicated otherwise, all information
requested below must appear in the narrative. Materials or information
that should be part of the narrative will not be accepted if placed in
the appendices. The application narrative must contain the following
sections in the order presented below. (REMINDER: IF PROPOSING PROJECTS
UNDER MULTIPLE FOCUS AREAS, SUBMIT A SEPARATE AND COMPLETE APPLICATION
FOR EACH PROJECT AND INDICATE WHETHER APPLYING FOR GRANT OR COOPERATIVE
AGREEMENT):
3. Abstract
a. Provide a brief (two pages maximum) abstract of the project.
Clearly identify:
1. The specific focus area being addressed;
2. The project period proposed (not to exceed three years as
indicated in AVAILABILITY OF FUNDS section); and
3. The type of award that is being applied for, grant or
cooperative agreement.
4. Background and Need
Discuss the background and need for the proposed project.
Demonstrate a clear understanding of the background, purpose, and
objectives of the focus area.
5. 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. 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. Do not
include letters of support from CDC personnel. Letters of support from
CDC will not be accepted. Award of a cooperative agreement implies CDC
participation as outlined in the PROGRAM REQUIREMENTS section of this
announcement.
6. Objectives and Technical Approach
Present specific objectives for the proposed project which are
measurable and time-phased and are consistent with the Background,
Purpose, and Recipient Activities for the specific focus area. Present
a detailed operational plan for initiating and conducting the project
which clearly and appropriately addresses these objectives (if
proposing
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a multi-year project, provide a detailed description of first-year
activities and a brief overview of subsequent-year activities). Clearly
identify specific assigned responsibilities for all key professional
personnel. 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 (if
proposing a cooperative agreement) and/or others during various phases
of the project. Describe in detail a plan for evaluating progress
toward achieving process and outcome project objectives.
7. Budget
Provide a line-item budget and accompanying detailed, line-by-line
justification for the first year of the project that demonstrates the
request is consistent with the purpose and objectives of this program.
If requesting a multi-year project, provide estimated total budget
(direct plus indirect) for subsequent years. If requesting funds for
any contracts, provide the following information for each proposed
contract: (1) Name of proposed contractor; (2) breakdown and
justification for estimated costs; (3) description and scope of
activities to be performed by contractor; (4) period of performance;
and (5) method of contractor selection (e.g., sole-source or
competitive solicitation).
8. Human Subjects
Whether or not exempt from DHHS regulations, if the proposed
project involves human subjects, describe adequate procedures for the
protection of human subjects. Also, ensure that women, racial and
ethnic minority populations are appropriately represented in
applications for research involving human subjects.
Evaluation Criteria
The applications will be reviewed and evaluated according to the
following criteria:
1. 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.
Extent to which applicant demonstrates that the proposed project
addresses an emerging infectious disease issue of public health
importance.
2. Capacity (45 Points)
Extent to which applicant describes adequate resources and
facilities (both technical and administrative) 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. If requesting a grant (versus a
cooperative agreement), the extent to which applicant demonstrates that
they can accomplish the project without substantial technical
assistance from CDC.
3. Objectives and Technical Approach (45 Points Total)
a. 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)
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. 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 CDC (if proposing a cooperative agreement) and/or
others during various phases of the project. 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. (30 points)
c. Extent to which applicant provides a detailed and adequate plan
for evaluating progress toward achieving project process and outcome
objectives. (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.
Executive Order 12372 Review
This program is not subject to Executive Order 12372 Review.
Public Health System Reporting Requirements
This program is not subject to the Public Health System Reporting
Requirements.
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 and approval 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
[[Page 37889]]
component of IHS will be involved or will support the research. If the
Native American 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 or Alaska Native, Asian, Black or African American,
Hispanic or Latino, Native Hawaiian or Other Pacific Islander.
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,
and 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 five copies of each application PHS Form 398 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, N.E., Room
300, Mailstop E-18, Atlanta, GA 30305, on or before October 1, 1998.
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 and will be returned to the
applicant.
Where to Obtain Additional Information
To receive additional written information and to request an
application kit, call 1-888-GRANTS (1-888 472-6874). You will be asked
to leave your name and address and will be instructed to identify the
Announcement number of interest. (Please refer to Announcement Number
99012.) You will receive a complete program description, information on
application procedures and application forms. If you have questions
after reviewing the contents of all the documents, business management
technical assistance may be obtained from Oppie M. Byrd, Grants
Management Specialist, Grants Management Branch, Procurement and Grants
Office, Centers for Disease Control and Prevention (CDC), 255 East
Paces Ferry Road, N.E., Room 314, Mailstop E-18, Atlanta, GA 30305,
telephone (404) 842-6546, Facsimile (404) 842-6513, Internet
oxb3@cdc.gov.
Programmatic technical assistance may be obtained from Bala
Swaminathan, Ph.D., National Center for Infectious Diseases, Division
of Bacterial and Mycotic Diseases, Centers for Disease Control and
Prevention (CDC), 1600 Clifton Road, N.E., Mailstop C-07, Atlanta, GA
30333, Telephone (404) 639-3669, Facsimile (404) 639-3333, Internet
bas5@cdc.gov.
Please refer to Announcement Number 99012 when requesting
information regarding this program.
You may obtain this announcement from one of two Internet sites on
the actual publication date: CDC's homepage at http://www.cdc.gov or at
the Government Printing Office homepage (including free on-line access
to the Federal Register at http://www.access.gpo.gov).
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.
Dated: July 8, 1998.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention (CDC).
[FR Doc. 98-18667 Filed 7-13-98; 8:45 am]
BILLING CODE 4163-18-P
