33748 Federal Register / Vol. 61, No. 126 / Friday, June 28, 1996 / Notices

by Internet or CDC WONDER electronic

mail at <ldc2@ccddn1.em.cdc.gov.

Please refer to Announcement 652

when requesting information and

submitting an application.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report; Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report; Stock No. 017–001–00473–1)

referenced in the ‘‘Introduction’’

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325;

telephone (202) 512–1800.

There may be delays in mail delivery

and difficulty in reaching the cdc

atlanta offices during the 1996 summer

olympics. therefore, CDC suggests using

internet, following all instructions in

this announcement and leaving

messages on the contact person’s voice

mail for more timely responses to any

questions.

Dated: June 24, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–16546 Filed 6–27–96; 8:45 am]

BILLING CODE 4163–18–P

[Announcement Number 645]

Applied Research in Emerging

Infections—Tickborne Diseases

Introduction

The Centers for Disease Control and

Prevention (CDC) is implementing a

program for competitive cooperative

agreements and/or research project

grants to support applied research on

emerging infections. CDC announces the

availability of fiscal year (FY) 1996

funds for cooperative agreements and/or

research project grants to conduct

applied research on domestic tickborne

diseases (e.g., ehrlichiosis, babesiosis,

Rocky Mountain spotted fever,

tularemia, Colorado tick fever, etc.). 1.

CDC is committed to achieving the

health promotion and disease

prevention objectives of Healthy People

2000, a national activity to reduce

morbidity and mortality and improve

the quality of life. This announcement

is related to the priority area of

Immunization and Infectious Diseases.

1. Note: An existing CDC cooperative

agreement program supports research

focusing on Lyme disease caused by Borrelia

burgdorferi, specifically. Therefore, this new

program will not support research projects

which focus substantially on classical Lyme

disease caused by B. burgdorferi.

(For ordering a copy of Healthy People

2000, see the section Where To Obtain

Additional Information.)

Authority

This program is authorized under

Sections 301 and 317 of the Public

Health Service Act, as amended (42

U.S.C. 241 and 247b).

Smoke-Free Workplace

CDC strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the non-use

of all tobacco products, and Public Law

103–227, the Pro-Children’s Act of 1994,

prohibits smoking in certain facilities

that receive Federal funds in which

education, library, day-care, health care

and early childhood development

services are provided to children.

Eligible Applicants

Applications may be submitted by

public and private, nonprofit and forprofit organizations and governments

and their agencies. Thus, universities,

colleges, research institutions, hospitals,

other public and private organizations,

including State and local governments

or their bona fide agents, federally

recognized Indian tribal governments,

Indian tribes or Indian tribal

organizations, and small, minority- and/

or women-owned businesses are eligible

to apply.

Availability of Funds

Approximately $300,000 is available

in FY 1996 to fund approximately two

to four awards. It is expected that

approximately two-thirds of the funds

will be made available for the first

programmatic focus (epidemiologic

studies focusing on ehrlichiosis) and

one-third for the second (development

of improved diagnostic tests for

babesiosis). Awards will begin on or

about September 30, 1996, and will be

made for a 12-month budget period

within a project period of up to three

years. Funding estimates may vary and

are subject to change. Continuation

awards within an approved project

period will be made on the basis of

satisfactory progress and availability of

funds.

Purpose

The purpose of the emerging

infections extramural research program

is to provide financial and technical

assistance for applied research projects

on emerging infections in the United

States. As a component of the emerging

infections extramural research program,

the purpose of this grant/cooperative

announcement is to provide assistance

for tickborne disease projects addressing

the following two programmatic focus

areas:

1. Epidemiologic studies focusing on

ehrlichiosis

2. Development and evaluation of

improved diagnostic tests for babesiosis.

Applicants may submit separate

applications for projects in one or both

programmatic areas. See Application

Content of the program announcement

included in the application kit for

detailed application instructions.

Program Requirements

Applicants may apply and receive

support for projects under one or both

of the two programmatic focus areas. In

conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under either A.1. or A.2., or both, below;

and CDC will be responsible for

conducting activities under B., below:

A. Recipient Activities

1. Epidemiologic Studies

Implement an active prospective

ehrlichiosis surveillance system in a

geographic area where the disease(s)

(monocytic or granulocytic) is/are

believed to be present, utilizing case

finding based on a standardized clinical

case definition. Cases should be

laboratory confirmed, using

standardized methods such as isolation

or direct detection of the etiologic agent

from clinical specimens by antigen

detection or PCR; and/or serology.

Laboratory diagnosis should be

validated by retesting clinical

specimens in a reference laboratory. A

population based study in which

incidence can be calculated and that

simultaneously captures incident cases

of babesiosis in the same location is

most desirable.

2. Development and Evaluation of

Improved Diagnostic Tests for

Babesiosis:

a. Develop and evaluate improved

laboratory methods for the diagnosis of

babesiosis, which may include methods

for antibody or antigen detection,

molecular techniques, and isolation of

the parasite from clinical specimens.

Consider such characteristics of the test

as sensitivity (e.g., ability to detect

subpotent infection), specificity (e.g.,

ability to distinguish Babesia infection

from other infections and conditions,

ability to distinguish persistent from

remote Babesia infection, genus- vs.

species-level specificity), and ease of

automation.

b. As part of certain projects and as

appropriate, obtain and provide such
Federal Register / Vol. 61, No. 126 / Friday, June 28, 1996 / Notices 33749

materials as isolates; human serum,

whole blood, and other fluids and

tissues; and diagnostic test reagents to a

national reference laboratory (e.g., for

development of a reference collection of

specimens).

B. CDC Activities

1. Research Project Grants

A research project grant is one in

which substantial programmatic

involvement by CDC is not anticipated

by the recipient during the project

period. Applicants for grants must

demonstrate an ability to conduct the

proposed research with minimal

assistance, other than financial support,

from CDC. This would include

possessing sufficient resources for

clinical, laboratory, and data

management services and a level of

scientific expertise to achieve the

objectives described in their research

proposal without substantial technical

assistance from CDC.

2. Cooperative Agreements

A cooperative agreement implies that

CDC will assist recipients in conducting

the proposed research. The application

should be presented in a manner that

demonstrates the applicant’s ability to

address the research problem in a

collaborative manner with CDC. In

addition to the financial support

provided, CDC will collaborate by: (a)

Providing technical assistance in the

design and conduct of the research; (b)

performing selected laboratory tests as

appropriate; (c) participate in data

management, the analysis of research

data, and the interpretation and

presentation of research findings; and

(d) provide biological materials (e.g.,

strains) as necessary for studies, etc.

3. Determination of Which Instrument

to Use

Applicants must specify the type of

award for which they are applying,

either grant or cooperative agreement.

The funding agency will review the

applications in accordance with the

evaluation criteria. Before issuing

awards, CDC will determine whether a

grant or cooperative agreement is the

appropriate instrument based upon the

need for substantial CDC involvement in

the project.

Evaluation Criteria

The applications will be reviewed and

evaluated according to the following

criteria:

1. Background and Need (20 Points)

Extent to which applicant’s

discussion of the background for the

proposed project demonstrates a clear

understanding of the purpose and

objectives of this grant/cooperative

agreement program. Extent to which

applicant illustrates and justifies the

need for the proposed project that is

consistent with the purpose and

objectives of this grant/cooperative

agreement program.

2. Capacity (40 Points Total)

a. Extent to which applicant describes

adequate resources and facilities (both

technical and administrative) for

conducting the project. (10 points)

b. Extent to which applicant

documents that professional personnel

involved in the project are qualified and

have past experience and achievements

in research related to that proposed as

evidenced by curriculum vitae,

publications, etc. (20 points)

c. Extent to which applicant includes

letters of support from non-applicant

organizations, individuals, etc. Extent to

which the letters clearly indicate the

author’s commitment to participate as

described in the operational plan. (10

points)

3. Objectives and Technical Approach

(40 Points Total)

a. Extent to which applicant describes

objectives of the proposed project which

are consistent with the purpose and

goals of this grant/cooperative

agreement program and which are

measurable and time-phased. (10 points)

b. Extent to which applicant presents

a detailed operational plan for initiating

and conducting the project, which

clearly and appropriately addresses all

Recipient Activities for the specific

programmatic focus area being

addressed in the application. Extent to

which applicant clearly identifies

specific assigned responsibilities of all

key professional personnel. Extent to

which the plan clearly describes

applicant’s technical approach/methods

for conducting the proposed studies and

extent to which the plan is adequate to

accomplish the objectives. Extent to

which applicant describes specific

study protocols or plans for the

development of study protocols that are

appropriate for achieving project

objectives. (15 points)

c. Extent to which applicant describes

adequate and appropriate collaboration

with CDC and/or others during various

phases of the project. (10 points)

d. Extent to which applicant provides

a detailed and adequate plan for

evaluating study results and for

evaluating progress toward achieving

project objectives. If the proposed

project involves notifiable conditions,

the degree to which applicant describes

an adequate process for providing

necessary information to appropriate

State and/or local health departments.

(5 points)

4. Budget (Not Scored)

Extent to which the proposed budget

is reasonable, clearly justifiable, and

consistent with the intended use of

grant/cooperative agreement funds.

5. Human Subjects (Not Scored)

If the proposed project involves

human subjects, whether or not exempt

from the Department of Health and

Human Services (DHHS) regulations,

the extent to which adequate procedures

are described for the protection of

human subjects. Note: Objective Review

Group (ORG) recommendations on the

adequacy of protections include: (1)

protections appear adequate and there

are no comments to make or concerns to

raise, or (2) protections appear adequate,

but there are comments regarding the

protocol, or (3) protections appear

inadequate and the ORG has concerns

related to human subjects, or (4)

disapproval of the application is

recommended because the research

risks are sufficiently serious and

protection against the risks are

inadequate as to make the entire

application unacceptable, and (5)

protections appear adequate that

women, racial and ethnic minority

populations are appropriately

represented in applications involving

human research.

Executive Order 12372 Review

This program is not subject to

Executive Order 12372 Review.

Public Health System Reporting

Requirements

This program is subject to the Public

Health System Reporting Requirements.

Under these requirements, all

community-based nongovernmental

applicants must prepare and submit the

items identified below to the head of the

appropriate State and/or local health

agency(s) in the program area(s) that

may be impacted by the proposed

project no later than the receipt date of

the Federal application. The appropriate

State and/or local health agency is

determined by the applicant. The

following information must be

provided:

a. A copy of the face page of the

application (SF 424).

b. A summary of the project that

should be titled ‘‘Public Health System

Impact Statement’’ (PHSIS), not exceed

one page, and include the following:

(1) A description of the population to

be served;
33750 Federal Register / Vol. 61, No. 126 / Friday, June 28, 1996 / Notices

(2) A summary of the services to be

provided;

(3) A description of the coordination

plans with the appropriate State and/or

local health agencies.

If the State and/or local health official

should desire a copy of the entire

application, it may be obtained from the

State Single Point of Contact (SPOC) or

directly from the applicant.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance Number is 93.283.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of

information from ten or more

individuals and funded by the grant/

cooperative agreement will be subject to

review by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act.

Human Subjects

If the proposed project involves

research on human subjects, the

applicant must comply with the

Department of Health and Human

Services Regulations (45 CFR Part 46)

regarding the protection of human

subjects. Assurance must be provided to

demonstrate that the project will be

subject to initial and continuing review

by an appropriate institutional review

committee. The applicant will be

responsible for providing evidence of

this assurance in accordance with the

appropriate guidelines and form

provided in the application kit.

In addition to other applicable

committees, Indian Health Service (IHS)

institutional review committees also

must review the project if any

component of IHS will be involved or

will support the research. If the

American Indian community is

involved, its tribal government must

also approve that portion of the project

applicable to it.

Women, Racial and Ethnic Minorities

It is the policy of the Centers for

Disease Control and Prevention (CDC)

and the Agency for Toxic Substances

and Disease Registry (ATSDR) to ensure

that individuals of both sexes and the

various racial and ethnic groups will be

included in CDC/ATSDR- supported

research projects involving human

subjects, whenever feasible and

appropriate. Racial and ethnic groups

are those defined in OMB Directive No.

15 and include American Indian,

Alaskan Native, Asian, Pacific Islander,

Black and Hispanic. Applicants shall

ensure that women, racial and ethnic

minority populations are appropriately

represented in applications for research

involving human subjects. Where clear

and compelling rationale exist that

inclusion is inappropriate or not

feasible, this situation must be

explained as part of the application.

This policy does not apply to research

studies when the investigator cannot

control the race, ethnicity and/or sex of

subjects. Further guidance to this policy

is contained in the Federal Register,

Vol. 60, No. 179, pages 47947–47951,

dated Friday, September 15, 1995.

Animal Subjects

If the proposed project involves

research on animal subjects, the

applicant must comply with the ‘‘PHS

Policy on Humane Care and Use of

Laboratory Animals by Awardee

Institutions.’’ An applicant organization

proposing to use vertebrate animals in

PHS-supported activities must file an

Animal Welfare Assurance with the

Office for Protection from Research

Risks at the National Institutes of

Health.

Application Submission and Deadline

The original and two copies of each

application PHS Form 5161–1 (revised

7/92, OMB Number 0937–0189) must be

submitted to Sharron Orum, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–18, Atlanta, Georgia 30305,

on or before August 12, 1996.

1. Deadline: Applications shall be

considered as meeting the deadline if

they are either:

a. Received on or before the deadline

date; or

b. Sent on or before the deadline date

and received in time for submission to

the objective review group. (Applicants

must request a legibly dated U.S. Postal

Service postmark or obtain a legibly

dated receipt from a commercial carrier

or U.S. Postal Service. Private metered

postmarks shall not be acceptable as

proof of timely mailing.)

2. Late Applications: Applications

which do not meet the criteria in 1. a.

or 1. b. above are considered late

applications. Late applications will not

be considered in the current

competition and will be returned to the

applicant.

Where to Obtain Additional Information

A complete program description and

information on application procedures

are contained in the application

package. An application package and

business management and technical

assistance may be obtained from Locke

Thompson, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Mailstop E–18, Room 300, Atlanta,

Georgia 30305, telephone (404) 842–

6595, or through the Internet or CDC

Wonder electronic mail at:

lxt1@opspgo1.em.cdc.gov.

Programmatic technical assistance may

be obtained from the following persons:

For epidemiologic studies, James G.

Olson, Ph.D., National Center for

Infectious Diseases, Division of Viral

and Rickettsial Diseases, Centers for

Disease Control and Prevention (CDC),

1600 Clifton Road, NE., Mailstop G–13,

Atlanta, Georgia 30333, telephone (404)

639–1075. For babesia diagnostics:

Barbara Herwaldt, M.D., Division of

Parasitic Diseases, National Center for

Infectious Diseases, Centers for Disease

Control and Prevention (CDC), 1600

Clifton Road, NE., Mailstop F–22,

Atlanta, Georgia 30333, telephone (770)

488–7772.

Please refer to Announcement

Number 645 when requesting

information regarding this program.

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report, Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report,

Stock No. 017–001–00473–1) referenced

in the Introduction through the

Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone

(202) 512–1800.

There may be delays in mail delivery

and difficulty in reaching the CDC

Atlanta offices during the 1996 Summer

Olympics. Therefore, CDC suggests

using the Internet, following all

instructions in this announcement and

leaving messages on the contact person

voice mail for more timely responses to

any questions.

Dated: June 24, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–16547 Filed 6–27–96; 8:45 am]

BILLING CODE 4163–18–P

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request

Proposed Projects

Title: State JOBS plan (ACF–106).

OMB No.: 0970–0108.