[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,

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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

[[Page 37886]]

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 
<a href="/cdn-cgi/l/email-protection#c9aba8bafc89aaadaae7aea6bf"><span class="__cf_email__" data-cfemail="d9bbb8aaec99babdbaf7beb6af">[email protected]</span></a>.
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 
<a href="/cdn-cgi/l/email-protection#e18e9983d2a1828582cf868e97"><span class="__cf_email__" data-cfemail="98f7e0faabd8fbfcfbb6fff7ee">[email protected]</span></a>.
    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 
<a href="/cdn-cgi/l/email-protection#2547445610654641460b424a53"><span class="__cf_email__" data-cfemail="88eae9fbbdc8ebeceba6efe7fe">[email protected]</span></a>.
    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


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