Cooperative Agreement for the Development of New Diagnostic Methods and a Research Program To Determine the Incidence of Emerging Human Spongiform Encephalopathies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement Number 793]

Cooperative Agreement for the Development of New Diagnostic

Methods and a Research Program To Determine the Incidence of Emerging

Human Spongiform Encephalopathies

Introduction

The Centers for Disease Control and Prevention (CDC) announces the

availability of fiscal year (FY) 1997 funds to provide assistance

through a cooperative agreement for developing new diagnostic methods

and a research program to determine the incidence of emerging human

spongiform encephalopathies.

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 and 317 (42 U.S.C.

241 and 247b), of the Public Health Service Act, as amended.

Smoke-Free Workplace

CDC encourages all grant recipients to provide a smoke-free

workplace and to promote the nonuse of all tobacco products, and Pub.

L. 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 non-profit

organizations and governments and their agencies. Thus, universities,

colleges, research institutions, hospitals, other public and private

non-profit organizations are eligible to apply.

Applicant staff must have certification to practice neuropathology

(a medical field focusing on examination and study of brain tissues) in

the United States or certification to practice pathology (or neurology)

in the United States and show, in their curriculum vitae, the extent of

their experience in neuropathology.

Note: Effective January 1, 1996, Public Law 104-65 states that

an organization described in section 501(c)(4) of the Internal

Revenue Code of 1986 which engages in lobbying activities will not

be eligible for the receipt of Federal funds constituting an award,

grant, cooperative agreement, contract, loan, or any other form.

Availability of Funds

Approximately $65,000 is available in FY 1997 to fund one award. It

is expected that the award will begin on or about September 20, 1997,

and will be made for a 12-month budget period within a project period

of up to 5 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.

Use of Funds

Restrictions on Lobbying

Applicants should be aware of restrictions on the use of 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 1997 Departments of Labor, HHS, and Education,

and Related Agencies Appropriations Act, which became effective October

1, 1996, expressly prohibits the use of 1997 appropriated funds for

indirect or ``grass roots'' lobbying efforts that are designed to

support or defeat legislation pending before State legislatures.

Section 503 of this new law, as enacted by the Omnibus Consolidated

Appropriations Act, 1997, Division A, title I, Section 101(e), Pub. L.

No. 104-208 (September 30, 1996), provides as follows:

Sec. 503(a) No part of any appropriation contained in this Act

shall be used, other than for normal and recognized executive-

legislative relationships, 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, * * * except

in presentation to the Congress or any State legislative body itself.

Sec. 503(b) 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

In 1986, a newly recognized cattle disease, bovine spongiform

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encephalopathy (BSE, commonly known as ``mad cow'' disease), was

reported in Britain. As of mid-1997, more than 166,000 British cattle

have been confirmed with BSE in more than 33,900 herds. The practice of

feeding cattle rendered animal protein was shown to be responsible in

greatly amplifying the BSE outbreak. Transmission of the BSE agent to

domestic cats and other zoo animals, possibly through contaminated

feeds, raised concerns that the human population might also be

susceptible to this new disease. These concerns were heightened in

March 1996 when the Spongiform Encephalopathy Advisory Committee (SAEC)

to the government of Britain announced 10 young Creutzfeldt-Jakob

disease (CJD) patients with unusual clinical and neuropathological

features. In the absence of known recognizable risk factors for CJD or

any other plausible explanation for the clustering of these

extraordinarily young CJD patients, the British researchers concluded

that the patients may represent spread of the BSE agent to the human

population.

In addition to the young age at onset, this new variant of CJD has

been characterized by atypical clinical features with prominent

behavioral changes at the time of clinical presentation and subsequent

onset of neurologic abnormalities including ataxia within weeks or

months, dementia and myoclonus late in the illness, a duration of

illness of at least six months, and nondiagnostic

electroencephalographic changes. The specific, uniform neuropathology

includes, in both the cerebellum and cerebrum, numerous kuru-type

amyloid plaques surrounded by vacuoles and prion protein accumulation

at high concentration, indicated by immunocytochemical analysis.

As of May 6, 1997, five additional confirmed and one probable cases

of new variant CJD were identified in the United Kingdom and one

confirmed case was identified in France. Although a definitive

scientific causal association of new variant CJD with BSE has not yet

been established, the evidence for a causal link has been accumulating.

Purpose

The purpose of this cooperative agreement is to provide assistance

for the development of new diagnostic techniques and a research program

to determine the incidence of potentially emerging human spongiform

encephalopathies in the United States.

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. Test the application of novel diagnostic methods to research the

incidence of emerging human spongiform encephalopathies.

2. Develop research programs that can be used to monitor the

emergence of human spongiform encephalopathies.

3. Identify new cases of human spongiform encephalopathies.

4. Disseminate result of research findings.

B. CDC Activities

Provide assistance in the dissemination of results and other

technical assistance as required.

Technical Reporting Requirements

Narrative semiannual progress reports are required and must be

submitted no later than 30 days after each semiannual reporting period.

The semiannual progress reports must include the following for each

program, function, or activity involved: (1) A comparison of actual

accomplishments to the goal established for the period; (2) the reasons

for failure, if established goals were not met; and (3) other pertinent

information including, when appropriate, analysis and explanation of

performance costs significantly higher than expected. All manuscripts

published as a result of the work supported in part or whole by the

cooperative agreement will be submitted with the progress reports.

An annual Financial Status Report (FSR) is required no later than

90 days after the end of each budget period. A final performance report

and financial status report are due no later than 90 days after the end

of the project period.

An original and two copies of all reports should be submitted to

the Grants Management Officer, Grants Management Branch, Procurement

and Grants Office, CDC.

Required Format for Application

All applicants must develop their application in accordance with

the PHS Form 5161-1 (revised 7/92), information contained in this

cooperative agreement announcement, and the instructions outlined

below. In order to ensure an objective, impartial, and prompt review,

applications which do not conform to these instructions may be

disqualified.

1. All pages must be clearly numbered.

2. A complete index to the application and its appendixes must be

included.

3. The original and two copies of the application must be submitted

unstapled and unbound.

4. Any reprints, brochures, or other enclosures must be copied onto

8\1/2\'' by 11'' white paper by the applicant. No bound materials will

be accepted.

5. All materials must be typewritten, single spaced, and in

unreduced type (no smaller than font size 12) on 8\1/2\'' by 11'' white

paper, with at least 1'' margins, headers, and footers.

6. All pages must be printed on one side only.

Application Content

The application narrative must not exceed 10 pages (excluding

budget and appendixes). 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:

1. Background

Discuss the background and need for the proposed project.

Demonstrate a clear understanding of the purpose and objectives of this

cooperative agreement program.

2. Capacity and Personnel

Describe applicant's past experience in conducting projects/studies

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 key

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.

3. Objectives and Technical Approach

Describe specific objectives for the proposed project which are

measurable and time-phased and are consistent with the purpose and

goals of this cooperative agreement. Present a detailed operational

plan for initiating and conducting the project which clearly and

appropriately addresses all Recipient Activities (provide a detailed

description of first-year activities and a brief overview of activities

in subsequent years. Clearly state the proposed length of the project

period). Clearly identify specific assigned

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responsibilities for all key professional personnel. Include a clear

description of applicant's technical approach/methods which are

directly relevant to the study objectives to include obtaining study

samples. Describe the nature and extent of collaboration with CDC and/

or others during various phases of the project. Describe in detail a

plan for evaluating study results and for evaluating progress toward

achieving project objectives.

4. Budget

Provide in an appendix a budget and accompanying detailed

justification for the first-year of the project that is consistent with

the purpose and objectives of this program. Also, provide estimated

total budget for each subsequent year. If requesting funds for

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).

5. Human Subjects

Whether or not exempt from DHHS regulations, if the proposed

project involves human subjects, describe in an appendix 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 by

including a description of the composition of the proposed study

population (for example, addressing the inclusion of women and members

of minority groups and their sub-populations in the section that will

describe the research design). Where clear and compelling rationale

exist that inclusion is inappropriate or not feasible, this situation

must be explained as part of the application. See the Other

Requirements Section for additional information.

Evaluation Criteria

The applications will be reviewed and evaluated according to the

following criteria:

1. Background and Need (5 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 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 cooperative

agreement program.

2. Capacity (70 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 transmissible spongiform

encephalopathies, particularly in the application of CJD diagnostic

methods such as neuropathology, immunocytochemistry, Western blot

testing, and genetic analysis in determining the incidence of emerging

human spongiform encephalopathies; these qualifications have to be

evidenced by curriculum vitae, publications, etc. Applicants must

provide curriculum vitae of their program staff and relevant scientific

articles published in peer-reviewed journals within the last five

years. (40 points)

c. Extent to which applicant demonstrates the ability to

collaborate with as many neuropathologists and/or pathologists working

in human spongiform encephalopathy research to include how study

samples will be collected. (20 points)

3. Objectives and Technical Approach (25 points total)

a. Extent to which applicant describes specific objectives of the

proposed project which are consistent with the purpose and goals of

this cooperative agreement program and which are measurable and time-

phased. (5 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. Extent to which

applicant clearly identifies specific assigned responsibilities for 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. If the proposed project

involves human subjects, whether or not exempt from the 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,

(2) protections appear adequate, but there are comments regarding the

protocol, (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. The degree to which the applicant has met the

CDC policy requirements regarding the inclusion of women, ethnic, and

racial groups in proposed research. This includes: (1) The proposed

plan for the inclusion of both sexes and racial and ethnic minority

populations for appropriate representation; (2) the proposed

justification when representation is limited or absent; (3) a statement

as to whether the design of the study is adequate to measure

differences when warranted; and (4) documentation of plans for

recruitment and outreach for study participants that includes the

process of establishing partnerships with community(ies) and

recognition of mutual benefits. (15 points)

c. Extent to which applicant provides a detailed and adequate plan

for evaluating study results and for evaluating progress toward

achieving project objectives. (5 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 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

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

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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.

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.

Application Submission and Deadline

The original and two copies of the 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 305, Mailstop E-18, Atlanta, Georgia

30305, on or before August 8, 1997.

1. Deadline: Applications shall be considered as meeting the

deadline if they are either:

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

To receive additional written information, call (404) 332-4561. You

will be asked to leave your name, address, and telephone number. Please

refer to Announcement Number 793. 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 Gladys T. Gissentanna, Grant 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) 842-6801.

Programmatic technical assistance may be obtained from Lawrence B.

Schonberger, MD, National Center for Infectious Diseases, Centers for

Disease Control and Prevention (CDC), Atlanta, GA 30333, telephone:

(404) 639-3091, Email address: [email protected] You may also obtain this

announcement from one of two Internet sites on the actual publication

date: CDC's homepage at http://www.cdc.gov or the Government Printing

Office homepage (including free on-line access to the Federal Register

at http://www.access.gpo.gov). Other CDC announcements are also listed

on the Internet on the CDC homepage.

Please refer to Announcement Number 793 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.

Dated: July 1, 1997.

Joseph R. Carter,

Acting Associate Director for Management and Operations, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 97-17847 Filed 7-8-97; 8:45 am]

BILLING CODE 4163-18-P