[Federal Register Volume 62, Number 86 (Monday, May 5, 1997)]
[Notices]
[Pages 24449-24453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11573]
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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
