37884 Federal Register / Vol. 63, No. 134 /Tuesday, July 14, 1998 / Notices

Highway, NE, (M/S K–10), telephone

770–488–5000 or fax 770/488–5966.

Dated: July 7, 1998.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98–18668 Filed 7–13–98; 8:45 am]

BILLING CODE 4861–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Hanford Thyroid Morbidity Study

Advisory Committee: Notice of Charter

Renewal

This gives notice under the Federal

Advisory Committee Act (Public Law

92–463) of October 6, 1972, that the

Hanford Thyroid Morbidity Study

Advisory Committee (HTMSAC) of the

Centers for Disease Control and

Prevention (CDC), Department of Health

and Human Services, has been renewed

for a 2-year period. The charter will now

expire June 13, 2000.

FOR FURTHER INFORMATION CONTACT:

Henry Falk, M.D., Executive Secretary,

HTMSAC, CDC, 4770 Buford Highway,

NE, (M/S F–28), telephone 770–488–

7300 or fax 770/488–7044.

Dated: July 7, 1998.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98–18669 Filed 7–13–98; 8:45 am]

BILLING CODE 4861–18–P

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,
Federal Register / Vol. 63, No. 134 /Tuesday, July 14, 1998 / Notices 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 executivelegislative 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 wellequipped 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 nonculture 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
37886 Federal Register / Vol. 63, No. 134 /Tuesday, July 14, 1998 / Notices

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.
Federal Register / Vol. 63, No. 134 /Tuesday, July 14, 1998 / Notices 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
37888 Federal Register / Vol. 63, No. 134 /Tuesday, July 14, 1998 / Notices

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
Federal Register / Vol. 63, No. 134 /Tuesday, July 14, 1998 / Notices 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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request

Proposed Projects

Title: Annual Statistical Report on

Children in Foster Homes and Children

in Families Receiving Payments in

Excess of the Poverty Income Level from

a State Program Funded under Part A of

Title IV of the Social Security Act.

OMB No.: 0970–0040.

Description: This information is

collected to meet the statutory

requirements of section 1124 of Title I

of the Elementary and Secondary

Education Act (as amended by PL 103–

382). It is collected by DHHS from State

public welfare agencies and turned over

to the Department of Education which

uses it to arrive at the formula for

allocating Title I grant funds to State

and Local elementary and secondary

schools for the purpose of providing

educational assistance to disadvantaged

children.

Respondents: State, Local or Tribal

Govt.

ANNUAL BURDEN ESTIMATES

Instrument Number of respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

ACF–4125 ......................................................................................................... 52 1 264 13,746