Notice of Availability of Funds; Applied Research Program in Emerging Infections Novel Diagnostic Tests for Infections of Public Health Significance

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

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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

[email protected].

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

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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

[email protected].

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

[email protected].

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