33528 Federal Register / Vol. 61, No. 125 / Thursday, June 27, 1996 / Notices

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 the appropriate institutional review

committee. 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

any American Indian community is

involved, its tribal government must

also approve that portion of the project

applicable to it. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and form provided in the

application kit.

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 the

application PHS Form 5161–1 (Revised

7/92, OMB Control Number 0937–0189)

must be submitted to Sharron P. 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 314,

Mailstop E–18, Atlanta, GA 30305,

Attention: Marsha Driggans, on or before

August 23, 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. Business management

technical assistance may be obtained

from Marsha Driggans, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 314,

Mailstop E–18, Atlanta, GA 30305,

telephone (404) 842–6523, facsimile

(404) 842–6513, E-mail

mdd2@opspgo1.em.cdc.gov or CDC

WONDER.

Programmatic technical assistance

may be obtained from Robert Pinner,

M.D., or Pat McConnon, M.P.H., Office

of the Director, National Center for

Infectious Diseases, Centers for Disease

Control and Prevention (CDC), Mailstop

C–12, 1600 Clifton Road, NE., Atlanta,

GA 30333, telephone (404) 639–2603.

E-mail address for Dr. Pinner:

rwp1@cidod1.em.cdc.gov or CDC

WONDER. E-mail address for Mr.

McConnon: pjm2@cidod1.em.cdc.gov or

CDC WONDER.

Please refer to Announcement

Number 655 when requesting

information and submitting and

application.

Important Notice: Atlanta, GA, will be the

host of the 1996 Summer Olympics Games,

July 19 through August 4, 1996. As a result

of this event, it is likely that the Procurement

and Grants Office (PGO), CDC, may

experience delays in the receipt of both

regular and overnight mail deliveries.

Contacting PGO employees during this time

frame may also be hindered due to the

possible telephone disruptions. To the extent

authorized, please consider the use of voice

mail, E-mail, and facsimile transmission to

the maximum extent practicable. However,

do not fax lengthy documents or grant

applications.

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.

Potential applicants may obtain a

copy of ‘‘Addressing Emerging

Infectious Disease Threats: A Prevention

Strategy for the United States’’ through

the Centers for Disease Control and

Prevention (CDC), National Center for

Infectious Diseases, Office of Planning

and Health Communication—EP,

Mailstop C–14, 1600 Clifton Road,

Atlanta, GA 30333. Requests may also

be sent by facsimile to (404) 639–3039.

Dated: June 21, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–16389 Filed 6–26–96; 8:45 am]

BILLING CODE 4163–18–P

[Announcement Number 664]

Primate Model for Studying the

Pathogenesis of Measles Infections

and for Development of Improved

Measles Vaccines

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds for a cooperative agreement
Federal Register / Vol. 61, No. 125 / Thursday, June 27, 1996 / Notices 33529

program to support research into the

pathogenesis of measles virus in a

primate model. The goal of this program

is to assist researchers in defining the

mechanism of immune protection from

measles virus and to use this

information to develop improved

vaccines for worldwide measles control

efforts.

The 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.

(To order 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)(1) [42 U.S.C.

241(a) and 247b(k)(1)] of the Public

Health Service Act, as amended.

Smoke-Free Workplace

CDC strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the nonuse of

all tobacco products, and Public Law

103–227, the Pro-Children 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 $200,000 is available

in FY 1996 to fund one award. It is

expected that the award 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 3 years.

Funding estimates may vary and are

subject to change. Continuation awards

within the approved project period will

be made on the basis of satisfactory

progress and availability of funds.

Purpose

The purpose of this cooperative

agreement is to assist the recipient in

developing a primate model for measles

infection and in conducting studies to:

(1) improve the infection model, (2)

characterize the immune response to

natural disease and vaccination, (3)

develop and test experimental measles

vaccines, and (4) investigate the

pathogenesis and epidemiology of

measles infections.

More specifically, the purpose of the

program is to achieve the following

research goals:

1. Characterization of the immune

response to natural disease and

vaccination. Studies should attempt to

measure differences between the

immune response in animals receiving

measles vaccination to those

experiencing infection with a virulent

strain. Efforts should be aimed at

providing a complete description of the

humoral and cellular immune responses

and should also attempt to measure

mucosal immunity.

2. Development of a vaccine that will

protect in the presence of maternal

antibody. The goal of these studies

should be to develop a vaccine that will

protect newborns from measles

infection during the first year of life and

not interfere with subsequent

vaccination using standard vaccines.

3. Evaluation of immune response to

individual measles virus antigens.

Research should be designed to measure

the immune response generated by

experimental measles vaccines and the

degree of protection provided. Measures

of mucosal and cellular immunity as

well as immune memory will be

particularly important.

Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

shall be responsible for the activities

under A., below, and CDC shall be

responsible for conducting activities

under B., below.

A. Recipient Activities

1. Develop study design to

accomplish the research goals described

above.

2. Perform all inoculations of animals.

Maintain records of clinical

observations and obtain samples for

laboratory analysis.

3. Perform laboratory analysis of

samples obtained from study animals.

4. Provide routine veterinary care,

housing and other support for rhesus

macaques to be used in experiments.

Comply fully with PHS policies

regarding research on animal subjects.

5. Maintain sufficient numbers of

seronegative animals so that

experiments can be completed within

an appropriate amount of time.

6. Develop experimental measles

vaccines and evaluate them in the

animal model.

7. Analyze data and prepare

manuscripts describing results of

research investigations.

B. CDC Activities

1. Provide technical assistance and

advice for design and conduct of the

research.

2. Provide assistance in development

of various preparations of measles virus

antigens for use as experimental

vaccines. This material may consist of

vaccines derived of recombinant DNA

technology.

3. Provide specialty reagents such as

monoclonal and polyclonal antiserum

and PCR primers as necessary.

4. Assist in conducting specialized

analysis of samples obtained from test

animals. These may include special

serological or immunologic assays, as

well as assays to detect and measure

measles virus or measles virus RNA in

various tissue samples. Perform genetic

characterization of viruses used in the

study.

5. Assist in data analysis.

Notice of Intent To Apply

In order to assist CDC in planning for

and executing the evaluation of

applications submitted under this

announcement, all parties intending to

submit an application are requested to

inform CDC of their intention to do so

at their earliest convenience prior to the

application due date. Notification

should include: (1) name and address of

institution, and (2) name, address, and

telephone number of contact person.

Notification should be provided by

facsimile, postal mail, or E-mail to Paul

Rota, Ph.D., National Center for

Infectious Diseases, Centers for Disease

Control and Prevention (CDC), 1600

Clifton Road, NE., Mailstop G–17,

Atlanta, GA 30333, E-mail

par1@ciddvd1.em.cdc.gov, facsimile

(404) 639–1307.

Evaluation Criteria

All applications will be reviewed and

evaluated according to the following

criteria (100 total points):

1. Background and Need (10 total

points)

Extent to which applicant

demonstrates a clear understanding of

the purpose and objectives of this

proposed cooperative agreement.
33530 Federal Register / Vol. 61, No. 125 / Thursday, June 27, 1996 / Notices

2. Capacity (55 total points)

a. Extent to which applicant describes

adequate resources and facilities for

conducting the project. Extent to which

facilities for the safe handling of

infectious agents are available. (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 in

this cooperative agreement as evidenced

by curriculum vitae, publications, etc.

Extent to which the applicant

demonstrates experience with virology,

particularly the virology of measles

virus. (10 points)

c. Extent to which applicant

demonstrates experience with viral

pathogenesis/immunology in rhesus

macaques or other primate system.

Extent to which the applicant can

demonstrate previous or ongoing

experience with measles infections of

primates. Extent to which the applicant

can produce a measles infection that is

similar to measles infections in humans

in rhesus macaques following intranasal

inoculation. (35 points)

3. Objectives and Technical Approach

(35 total points)

a. Extent to which applicant describes

objectives of the proposed project which

are consistent with the purpose and

program requirements of this

cooperative agreement and which are

measurable and time-phased. (5 points)

b. Extent to which the plan clearly

describes applicant’s technical

approach/methods for conducting the

proposed studies. Extent to which

applicant describes specific study

protocols or plans for the development

of study protocols that are appropriate

for achieving project objectives. (10

points)

c. Extent to which applicant describes

appropriate collaboration with CDC

during various phases of the project. (10

points)

d. Extent to which applicant provides

a detailed plan for evaluating study

results and for evaluating progress

towards achieving project objectives. (10

points)

4. Budget (Not Scored)

Extent to which the proposed budget

is reasonable, clearly justifiable, and

consistent with the intended use of

cooperative agreement funds.

Executive Order 12372

Applications are not subject to review

under Executive Order 12372,

Intergovernmental Review of Federal

Programs.

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

Animal Subjects

This proposed project involves

research on animal subjects; therefore,

the applicant must comply with the

‘‘PHS Policy on Humane Care and Use

of Laboratory Animals by Awardee

Institutions.’’ An applicant organization

using vertebrate animals in PHSsupported activities must file an Animal

Welfare Assurance with the Office for

Protection from Research Risks at the

National Institutes of Health, Bethesda,

Maryland.

Application Submission and Deadline

The original and two copies of

application PHS Form 398 (Revised 5/

95, OMB Number 0925–0001) must be

submitted to Sharron P. 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 314,

Mailstop E–18, Atlanta, GA 30305,

Attention: Marsha Driggans, 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 independent review group.

(Applicants should 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 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 shall not

be considered in the current

competition for funding 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 Marsha

Driggans, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

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

Room 314, Mailstop E–18, Atlanta, GA

30305, telephone (404) 842–6523, Email mdd2@opspgo1.em.cdc.gov,

facsimile (404) 842–6513.

Programmatic technical assistance

may be obtained from Paul Rota, Ph.D.,

Supervisory Research Microbiologist,

Measles Section, Division of Viral and

Rickettsial Diseases, National Center for

Infectious Diseases, Centers for Disease

Control and Prevention (CDC), 1600

Clifton Road, NE., Mailstop G–17,

Atlanta, GA 30333, telephone (404)

639–3308, E-mail

par1@ciddvd1.em.cdc.gov, facsimile

(404) 639–1307.

Please refer to Announcement

Number 664 when requesting

information regarding this program.

Important Notice: Atlanta, GA, will be the

host of the 1996 Summer Olympics Games,

July 19 through August 4, 1996. As a result

of this event, it is likely that the Procurement

and Grants Office (PGO), CDC, may

experience delays in the receipt of both

regular and overnight mail deliveries.

Contacting PGO employees during this time

frame may also be hindered due to the

possible telephone disruptions. To the extent

authorized, please consider the use of voice

mail, E-mail, and facsimile transmission to

the maximum extent practicable. However,

do not fax lengthy documents or grant

applications.

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: June 21, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–16386 Filed 6–26–96; 8:45 am]

BILLING CODE 4163–18–P