Cooperative Agreements to Conduct Studies of Illnesses Among Persian Gulf War Veterans; Notice of Availability of Funds for Fiscal Year 1997

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement 748]

Cooperative Agreements to Conduct Studies of Illnesses Among

Persian Gulf War Veterans; Notice of Availability of Funds for Fiscal

Year 1997

Introduction

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

availability of fiscal year (FY) 1997 funds for a cooperative agreement

to conduct studies of illnesses among Persian Gulf War (PGW) veterans.

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 quality of life. This

announcement is related to the priority area of Environmental Health.

(For ordering a copy of ``Healthy People 2000'' see the section WHERE

TO OBTAIN ADDITIONAL INFORMATION.)

Authority

This program is authorized under the Public Health Service Act,

section 301 (42 USC 241).

Eligible Applicants

Eligible applicants include all nonprofit and for-profit

organizations. Thus, State and local health departments, State and

local governmental agencies, universities, colleges, research

institutions, hospitals, other public and private non-profit

organizations, including small, minority and/or woman-owned businesses

are eligible to apply.

Note: An organization described in section 501(c)(4) of the

Internal Revenue Code of 1986 which engages in lobbying activities

shall not be eligible to receive Federal funds constituting an

award, grant, contract, loan, or any other form.

Applications will be considered for funding to conduct studies in

one or more programmatic interest areas. Applicants interested in

conducting more than one study must submit a separate application for

each. If a single study addresses more than one programmatic interest

area, only one should be identified as the primary interest area. The

programmatic interest area should be clearly indicated for each study.

Smoke-Free Workplace

CDC strongly encourages all grant recipients to provide a smoke-

free workplace and promote the non-use 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.

Availability of Funds

Approximately $1.2 million will be available in FY 1997 to fund up

to two cooperative agreements. It is expected that the average award

will be up to $600,000 (direct and indirect costs). It is expected the

award will begin on or about September 1, 1997, and will be made for a

12-month budget period within a project period of up to three years.

The funding estimate is subject to change based on the availability of

funds.

Applications which request more than the $600,000 per year cap will

be returned to the applicant as non-responsive.

Continuation awards within the project period will be made on the

basis of satisfactory progress and the availability of funds.

Applicants may enter into contracts, including consortia agreements

(as set forth in the PHS Grants Policy Statement) as necessary to meet

the requirements of the program and strengthen the overall application.

Use of Funds

Restrictions on Lobbying

Applicants should be aware of restrictions on the use of HHS funds

for lobbying of Federal or State legislative

[[Page 24450]]

bodies. Under the provisions of 31 USC 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 HHS 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. This new law, Section 503 of Pub. L. No. 104-208,

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.

(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.

Department of Labor, Health and Human Services, and Education, and

Related Agencies Appropriations Act, 1997, as enacted by the Omnibus

Consolidated Appropriations Act, 1997, Division A, Title I, Section

101(e), Pub. L. No. 104-208 (September 30, 1996).

Background and Definitions

Background

Between August 1990 and July 1991, approximately 697,000 U.S.

military personnel were deployed to the Persian Gulf as part of

Operations Desert Shield and Desert Storm. Shortly after returning to

the U.S., many Persian Gulf War (PGW) veterans began to report a

variety of symptoms which they suspect may be related to their military

service in the Persian Gulf. The symptoms most commonly reported among

PGW veterans have been fatigue, musculoskeletal complaints, and

cognitive dysfunction. A variety of possible etiologies for PGW

veterans' illnesses have been postulated. The possible etiologies have

included infectious agents (e.g., leishmaniasis), environmental and

ambient pollutants (e.g., sand, petroleum products, pesticides,

Chemical Agent Resistant Coating (CARC) paint, and smoke from oil-well

fires), medical prophylaxes (e.g., anthrax and botulinum toxin

vaccines, and pyridostigmine bromide), depleted uranium munitions, and

biologic and chemical warfare agents.

Much of the current knowledge on the prevalence of illnesses among

Gulf War veterans comes from self-referred registries established by

the Department of Defense (DOD) and the Department of Veterans Affairs

(VA). The DOD and VA Persian Gulf registries have added useful

information on the spectrum of health concerns among Persian Gulf War

veterans. The most recent analysis of DOD's Comprehensive Clinical

Evaluation Program (CCEP) data on 18,598 Gulf War veterans found no

evidence for a unique illness affecting Gulf War veterans. Instead CCEP

participants reported a wide variety of symptoms affecting multiple

organ systems. The most common primary diagnoses were psychological

conditions (ICD-9-CM Codes 290-319--18.4%); symptoms, signs, and ill-

defined conditions (ICD-9-CM Codes 780-700--17.9%); and musculoskeletal

system diseases (ICD-9-CM Codes 710-739--18.3%). However, these

registries are of limited value as a database for determining the

actual incidence and prevalence of illnesses because they are not

representative of the population of Persian Gulf War veterans.

In December 1994, the National Center for Environmental Health

(NCEH) initiated, through the cooperative agreement mechanism, a

population-based epidemiological study to evaluate the health

consequences of a sample of PGW veterans. The purpose of this study was

to compare the prevalence of self-reported symptoms and illnesses among

PGW veterans from Iowa with military personnel from Iowa who were not

deployed to the Persian Gulf. The study found that PGW veterans from

Iowa were more likely than those who did not serve in the Gulf War to

report symptoms suggestive of cognitive dysfunction, depression,

chronic fatigue, post-traumatic stress disorder, respiratory illness

(specifically asthma and bronchitis), fibromyalgia, alcohol abuse,

generalized anxiety disorder, and sexual discomfort. The conditions

identified in this study appear to have had a measurable impact on the

functional activity and daily lives of these Persian Gulf War veterans.

Among PGW veterans, minimal differences were observed between the

National Guard or Reserve troops and the regular military personnel,

indicating that all military personnel, regardless of type of military

service, were affected by deployment to the Persian Gulf.

Findings from this study established the need to investigate

further the causes, clinical nature, and public health implications of

the higher rates of self-reported health problems of PGW veterans. More

objective clinical measurement of the specific conditions identified in

this study should be addressed to determine the underlying illnesses,

medical conditions, or other concerns that might be related to these

self-reported conditions.

The approach used in the Iowa study of PGW veterans was to assess

the prevalence of known clinical entities. Other studies have used a

data driven approach for assessing health differences between PGW

veterans and other military populations. For example, in an

investigation of PGW veterans from a Pennsylvania Air National Guard

unit, investigators used factor analysis to develop a case definition

of illness among PGW veterans. Additional research is needed to

validate the case definition developed in the Pennsylvania study and to

determine if data driven definitions or the use of known clinical

diagnoses better characterizes illnesses among PGW veterans.

Definitions

PGW veteran: A PGW veteran is defined as any regular duty or

National Guard or reserve member who deployed to the Persian Gulf for

some period from August 1, 1990, through July 31, 1991.

PGW illnesses: PGW illnesses are defined as any adverse health

outcome that is more prevalent among military personnel who deployed to

the Persian Gulf than among non-deployed military personnel.

PGW illnesses research projects: PGW illnesses research projects

are defined as research designed to evaluate the health impact of

military service in the Persian Gulf War.

Veterans Service Organization: A congressionally chartered group of

men and women who have served their country in uniform during either

peace or war. Examples of veterans service organizations include but

are not limited to, Paralyzed Veterans of America, Disabled American

Veterans,

[[Page 24451]]

American Legion, Veterans of Foreign Wars, and American Veterans.

Purpose

The purpose of this program is to:

A. Build the scientific base for determining the nature and

etiology of illnesses among PGW veterans.

B. Evaluate the role of stress-related disorders on the current

health status of PGW veterans.

C. Determine if PGW veterans are experiencing a unique illness or

are experiencing a higher prevalence of a variety of known clinical

entities.

D. Determine the health impact of military deployment to the

Persian Gulf.

E. Assess the best approach for developing a case-definition for

illness among PGW veterans.

Program Requirements

In conducting activities to achieve the purpose of these

cooperative agreements, the recipient will need to meet the

requirements and is responsible for the activities under A. (Recipient

Activities). CDC will be responsible for the activities under B. (CDC

Activities).

A. Recipient Activities

1. Collaborate with CDC and the appropriate State or local Health

Department during the development and conduct of the study, and

dissemination of the results.

2. Obtain approval of study procedures by an appropriate

institutional review committee.

3. Develop and pilot test the study protocol and data collection

instruments.

4. Provide timelines for completing all components of the study.

5. Assure and maintain the confidentiality of all study

participants.

6. Conduct the analysis, interpretation, presentation, and

reporting of the study findings in collaboration with CDC.

7. Upon completion of the study, provide CDC an electronic version

of the final data set stripped of personal identifiers.

8. Act as the focal point for the development and dissemination of

media releases, reports and publications.

9. Establish an independent Public Advisory Committee comprised of

representatives from the State or local Health Department, local

Veterans' Service Organizations, PGW veterans, other affected parties,

and CDC.

B. CDC Activities

1. Serve as collaborators in the development, analysis, and conduct

of the study, as well as reporting and publishing of study findings.

2. Provide expert review, and comment on all study protocols, data

collection instruments, analysis plans, media releases, draft and final

reports, and publications generated by the recipient.

3. Serve as the principal point of contact with the Department of

Defense, Department of Veterans Affairs, and other Federal agencies to

secure names and locating information for the study participants.

4. Coordinate the related activities of the involved Federal

legislative bodies, agencies, and national veterans service

organizations.

5. Serve as a member on the Public Advisory Committee.

Programmatic Priorities

Applicants must propose research that enhances the understanding of

conditions and symptoms reported to be more prevalent among PGW

veterans, or adds to the scientific knowledge needed to develop a case

definition of illness among PGW veterans.

Enhance the understanding of conditions and symptoms reported to be

more prevalent among PGW veterans. Conduct research on conditions known

to be more prevalent among PGW veterans. These conditions include

cognitive dysfunction, depression, anxiety disorders, chronic fatigue,

post-traumatic stress disorder, other stress-related disorders,

respiratory illness (specifically asthma and bronchitis), fibromyalgia,

and alcohol abuse. These studies should include appropriate clinical

evaluation in order to validate the diagnosis, assessment of the course

of the illness among PGW veterans, assessment of risk factors, and

assessment of the impact of the illness on functional status.

Characterization of illnesses among PGW veterans. Conduct studies

focusing on development of a case-definition for illness among PGW

veterans. These studies should evaluate whether symptoms reported among

PGW veterans represent a unique illness or are better characterized by

existing clinical entities. This should include a comparison of data

driven case-definitions and use of known clinical diagnoses in order to

determine the best way to characterize illness among PGW. It may also

include validation of previous data driven case definitions of

illnesses among Gulf War veterans.

Reporting Requirements

An original and two copies of the Financial Status Report (FSR) are

due within 90 days after the end of each budget period. An original and

two copies of the technical semi-annual reports, using the format

below, are due 30 days after the end of each quarter to the CDC Grants

Management Officer.

The semi-annual progress report must include the following for each

program, function, or activity involved:

A. Highlights

Discuss issues and activities that had significant impact

on the program and that you wish to bring to the attention of CDC.

Discuss any changes in program personnel, especially

changes affecting those involved with the grant.

B. Objectives and Achievements

List major objectives and discuss your progress in meeting

these objectives.

Summarize your accomplishments for the period and for the

budget year.

Mention anything that either helped or hindered your

achieving these objectives.

Application Content

All applications must be developed in accordance with the

instructions that are contained in this program announcement, Form PHS

398, ERRATA sheet, and the instructions outlined in the following

section headings. Applicants must identify in a cover letter one of the

topics previously outlined under the heading Programmatic Priorities

upon which their project is focused.

The following are application requirements:

1. A principal investigator who has conducted research, published

the findings, and has specific authority and responsibility to carry

out the proposed project.

2. Demonstrate the commitment of veterans service organizations to

serve on a Public Advisory Committee by securing letters of support

from at least three veterans' service organizations, as described under

the heading, ``Definitions.''

3. The applicant must provide a one page abstract outlining the

plans, objectives, and expected outcomes of the proposed research.

Provide a succinct but informative response to each requirement.

Your response must not exceed 2 pages (letters of support may be

referenced to where they are located in the application). This response

must appear as the first 2 pages of the text of your application and be

titled ``Program Requirements.'' An affirmative response to each

question is required to qualify for further review. Those that do not

[[Page 24452]]

respond will be determined as non-responsive and will be returned to

the applicant.

Applications for these cooperative agreements should include:

A. Description of the Problem to be Addressed

1. The project's focus that justifies the research need and

describes the scientific basis for the research, the expected outcome,

and the relevance of the findings to reduce morbidity among PGW

veterans.

2. Describe the issues related to requirements, problems,

complexities, and interactions required in developing the study.

3. Discuss past experiences with similar projects.

B. Goals and Objectives

1. For each of the elements (item C below) provide specific,

measurable, and time-framed objectives that are consistent with the

applicants proposed theme, purpose, and objectives.

C. Program Plan

1. A detailed plan describing the elements of the research project

and the methods by which the objectives will be achieved, including

their sequence.

2. Discuss the administrative and scientific capacity critical to

the development and conduct of the study.

3. A description of the involvement of the State or local Health

Department, veteran service organizations, and other affected parties

to ensure they have ample input during all phases of the study. It

should include commitments of support and a clear statement of their

roles.

4. Describe the State agency linkages and support that will be used

during the development, conduct, and conclusion of the study.

D. Management and Staffing Plan

1. A description of the role and responsibilities of the project's

principal investigator. Describe research background, publications,

specific authority and responsibilities to carryout the proposed

project.

2. A description of all the project staff regardless of their

funding source. It should include their title, qualifications,

experience, percentage of time each will devote to the project, as well

as that portion of their salary to be paid by the grant.

3. A description of all key contractor staff, their role in the

study, and their resumes.

4. A description of those activities related to, but not proposed

to be supported by the grant.

E. Evaluation

Describe how progress toward meeting the study objectives will be

evaluated. A comprehensive evaluation plan is an essential component of

the application.

F. Budget

1. A detailed first year budget for the project with future annual

projections.

2. A budget projection that clearly separates and distinguishes

direct and indirect costs.

An applicant organization has the option of having specific salary

and fringe benefit amounts for individuals omitted from the copies of

the application which are made available to outside reviewing groups.

To exercise this option: on the original and five copies of the

application, the applicant must use asterisks to indicate those

individuals for whom salaries and fringe benefits are not shown; the

subtotals must still be shown. In addition, the applicant must submit

an additional copy of page four of Form PHS-398, completed in full,

with the asterisks replaced by the salaries and fringe benefits. This

budget page will be reserved for internal staff use only.

Evaluation Criteria

Upon receipt, applications will be screened by CDC staff for

completeness and responsiveness. Incomplete applications and

applications that are not responsive will be returned to the applicant

without further consideration. Applications which are complete and

responsive will be evaluated by an independent Special Emphasis Panel

(SEP) according to the following criteria:

1. Understanding the Problem (5 points).

The background of the proposal, i.e., the basis for the present

proposal, the critical evaluation of existing knowledge, and specific

identification of the knowledge gaps which the proposal is intended to

fill.

2. Measurable Objectives (10 points).

Specific, measurable, and time-framed objectives that are

consistent with the applicants proposed theme, purpose, and hypotheses

to be tested.

3. Proposed Plan (75 points).

a. The significance and originality from a scientific or technical

standpoint of the specific aims of the proposed research, including the

adequacy of the theoretical and conceptual framework for the research.

(5 points)

b. The overall match between the applicant's proposed theme and

research objectives, and the program priorities as described under the

heading ``Programmatic Priorities.'' (15 points)

c. The adequacy of the proposed research design, approaches, and

methodology to carry out the research, including quality assurance

procedures, plan for data management, and statistical analysis plans.

The degree to which the applicant has met the CDC Policy requirements

regarding the inclusion of women, ethnic, and racial groups in the

proposed research. This includes: (a) The proposed plan for the

inclusion of both sexes and racial and ethnic minority populations for

appropriate representation; (b) 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) a statement as to whether the plans for recruitment and

outreach for study participants include the process of establishing

partnerships with community(ies) and recognition of mutual benefits

will be documented. (25 points)

d. The degree of commitment and cooperation of other interested

parties as evidenced by letters of commitment detailing the nature and

extent of the involvement. (10 points)

e. Qualifications, adequacy, and appropriateness of personnel to

accomplish the proposed activities. Demonstrated experience in

conducting, evaluating, and publishing research on the health effects

of military service on the applicants project team. (10 points)

f. Adequacy of existing and proposed facilities and resources. (10

points)

4. Proposed Evaluation Plan (10 points).

The extent to which the evaluation plan will allow for the

measurement of progress toward the achievement of the stated

objectives.

5. Budget (Not Scored).

The reasonableness of the proposed budget to the proposed research.

Continuation awards within the project period will be made on the

basis of the availability of funds and the following criteria:

1. The accomplishments reflected in the progress report of the

continuation application indicate that the applicant is meeting

previously stated objectives and timelines contained in the project

proposal and satisfactory progress has been demonstrated through

monitoring work-in-progress.

2. The objectives for the new budget period are realistic,

specific, and measurable.

3. The methods described will clearly lead to achievement of these

objectives.

4. The evaluation plan will allow management to monitor whether the

methods are effective.

[[Page 24453]]

5. The budget request is clearly explained, adequately justified,

reasonable and consistent with the intended use of cooperative

agreement funds.

Executive Order 12372 Review

Applications are not subject to the review requirements of

Executive Order 12372.

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 10 or more

individuals and funded by these cooperative agreements will be subject

to 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 appropriate

institutional review committees. The applicant will be responsible for

providing assurance in accordance with the appropriate guidelines and

forms provided in the application kit.

Women and Minority Inclusion Policy

It is the policy of the CDC to ensure that women and racial and

ethnic groups will be included in CDC 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.

In conducting the review of applications for scientific merit,

review groups will evaluate proposed plans for inclusion of minorities

and both sexes as part of the scientific assessment and assigned score.

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, Friday, September 15, 1995, pages 47947-47951.

Application Submission and Deadlines

A. Pre-application Letter of Intent

Although not a prerequisite of application, a non-binding letter of

intent-to-apply is requested from potential applicants. The letter

should be submitted to the Grants Management Specialist (whose address

is reflected in section B, ``Applications''). It should be postmarked

no later than June 2, 1997. The letter should identify the announcement

number, name the principal investigator, and specify the priority area

of study the proposal addresses as outlined under the section

Programmatic Priorities. The letter of intent does not influence review

or funding decisions, but it will enable CDC to plan the review more

efficiently, and will ensure that each applicant receives timely and

relevant information prior to application submission.

B. Applications

Applicants should use Form PHS-398 (OMB No. 0925-0001 Revised 5/95)

and adhere to the ERRATA Instruction Sheet for Form PHS-398 contained

in the Grant Application Kit.

Please submit an original and five copies, on or before July 8,

1997 to: Lisa G. Tamaroff, Grants Management Specialist, Grants

Management Branch, Procurement and Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 321,

Atlanta, Georgia 30305, telephone (404) 842-6796 or internet:

lgt1.cdc.gov.

C. Deadlines

1. Applications shall be considered as meeting a deadline if they

are either:

A. Received at the above address on or before the deadline date, or

B. Sent on or before the deadline date to the above address, and

received in time for the review process. Applicants should request a

legibly dated U.S. Postal Service postmark or obtain a legibly dated

receipt from a commercial carrier or the U.S. Postal Service. Private

metered postmarks shall not be acceptable as proof of timely mailings.

2. Applications which do not meet the criteria above are considered

late applications and will be returned to the applicant.

Where to Obtain Additional Information

To receive a complete program description, information on

application procedures and application forms call (404) 332-4561. You

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

will need to refer to Announcement 748. Business management technical

information may be obtained from Lisa Tamaroff, 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-13, Atlanta, GA 30305, telephone (404) 842-6796

or internet: lgt1.cdc.gov.

Programmatic technical assistance may be obtained from Phillip M.

Talboy, Project Officer, Veterans' Health Activity, Division of

Environmental Hazards and Health Effects, National Center for

Environmental Health, Centers for Disease Control and Prevention (CDC),

Mailstop F-28, 4770 Buford Highway, NE., Atlanta, Georgia 30341-3724,

telephone (770) 488-7347, internet: pmt0.cdc.gov.

This and other CDC announcements are also available through the CDC

homepage on the Internet. The address for the CDC homepage is http://

www.cdc.gov.

CDC will not send application kits by facsimile or express mail.

Please refer to Announcement Number 748 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) through the Superintendent of

Documents, Government Printing Office, Washington, DC, 20402-9325,

telephone (202) 512-1800.

Dated: April 29, 1997.

Joseph R. Carter,

Acting Associate Director for Management and Operations, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 97-11573 Filed 5-2-97; 8:45 am]

BILLING CODE 4163-18-P