Full Text AI-94-020

CHRONIC FATIGUE SYNDROME COOPERATIVE RESEARCH CENTERS

NIH GUIDE, Volume 23, Number 16, April 29, 1994

RFA:  AI-94-020

P.T. 04

Keywords: 
  Chronic Fatigue 
  Biomedical Research, Multidiscipl 


National Institute of Allergy and Infectious Diseases

Letter of Intent Receipt Date:  September 15, 1994
Application Receipt Date:  October 25, 1994

PURPOSE

The Virology Branch (VB) of the Division of Microbiology and
Infectious Diseases (DMID) of the National Institute of Allergy and
Infectious Diseases (NIAID) invites applications for the continuation
and/or establishment of high-quality Chronic Fatigue Syndrome
Cooperative Research Centers (CFS CRCs) that provide a multi-
disciplinary, systematic, sustained approach to the study of CFS.  A
nucleus of CFS CRCs dedicated to use of standardized methodologies
and collaborative efforts was established in 1991. This is a
recompetition to identify centers with capabilities to build on the
initial effort in order to facilitate progress in this difficult
research area.

HEALTHY PEOPLE 2000

The Public Health Service is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Applications (RFA), Chronic Fatigue Syndrome Cooperative Research
Centers, is related to the priority area of chronic disabling
diseases.  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 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State or local government, and
eligible agencies of the Federal government.  Foreign organizations
are not eligible to apply.  Domestic applications may not include
international components.  Applications from minority individuals and
women are encouraged.

MECHANISM OF SUPPORT

The administrative and funding mechanism to be used to undertake this
program will be the Cooperative Agreement (U01, U19), an "assistance"
mechanism, rather than an "acquisition" mechanism, in which
substantial NIH scientific and/or programmatic involvement with the
awardee is anticipated during the performance of the activity.  The
U19 is the multiproject funding mechanism that will be used for
applications comprised of three or more projects; the U01 mechanism
will be used for applications with two projects.  Under the
cooperative agreement, the NIH purpose is to support and/or stimulate
the recipient's activity by involvement in and otherwise working
jointly with the award recipient in a partner role, but it is not to
assume direction, prime responsibility, or a dominant role in the
activity.  Details of the responsibilities, relationships, and
governance of a study funded under cooperative agreement(s) are
discussed later in this document under the section "Terms and
Conditions of Award."

The entire project period for each application submitted in response
to this RFA may not exceed five years.  At present, the NIAID is
administratively limiting the duration of cooperative agreements
(U01, U19) to four years; this administrative limitation may change
in the future.  The NIAID has not yet determined whether and how this
solicitation will be continued beyond the present RFA, but
anticipates that there will be a renewed competition after four years
contingent upon the continued availability of funds for this purpose.

FUNDS AVAILABLE

The NIAID plans to make at least three competing continuation and/or
new awards under this RFA.  The funds (direct and indirect costs) set
aside for the first year of support will be $1.6 million.  This level
of support is dependent on the receipt of a sufficient number of
applications of high scientific merit.  The size of individual awards
(estimated range, $350,000 to $650,000 total costs) will vary
depending on the number of participating institutions and the
complexity of the application.  The usual PHS policies governing
grants administration and management will apply.  Although this
program is provided for in the financial plans of the NIAID, awards
pursuant to this RFA are contingent upon the availability of funds
for this purpose.

RESEARCH OBJECTIVES

Background

Chronic fatigue syndrome (CFS) is a multisystem syndrome thought to
be triggered by viral infection and characterized by months of
debilitating fatigue frequently associated with myalgia, headache,
sore throat, low grade fever, gastrointestinal symptoms, and tender
lymph nodes.  There have been reports of immunologic and, more
recently, neuroendocrine parameters in CFS patients that on a group
basis are different from those in healthy controls, but no single
immunologic or neuroendocrine marker can be used to diagnose the
syndrome.  The cause and pathogenic mechanisms of the illness are
unknown.

Objectives and Scope

The purpose of this RFA is to support a network of clinical centers
of research excellence that use standardized methods for patient
enrollment and data collection to pursue multidisciplinary
coordinated projects to study etiology, natural history and/or
pathogenesis of CFS.  Expertise in fields of medicine, immunology,
virology, physiology, psychology, clinical anthropology or clinical
epidemiology may be helpful in furthering our understanding of CFS.
It is not expected that expertise in all these areas be available at
a single institution.  Input from the NIAID Scientific Coordinator
will facilitate technology transfer, assist in the identification of
expert consultants, collaborators and resources, enhance
communication among awardees and help to ensure that pilot studies
funded through the CFS CRC program will complement and not
unnecessarily duplicate existing or planned research endeavors.

Well-designed studies with adequate sample sizes are needed to test
biologically rational hypotheses concerning etiology or pathogenesis
that will lead to improved diagnosis and effective interventions.
Originality in concept and approach are encouraged.  Examples of
observations reported in the literature that merit further study to
determine their biologic and/or epidemiologic basis and role in
illness manifestation include, but are not limited to:

o  lymphocyte patterns suggestive of immune activation
o  low levels of cortisol and corticotropin-releasing hormone
o  low tolerance to physical exertion
o  demographic risk factors (gender, age, race, socioeconomic class)
o  reactivation of latent viruses
o  familial risk factors--including immunogenetic, behavioral and
environmental factors
o  increased frequency of atopy
o  higher than normal frequency of brain scan abnormalities

The development, standardization and evaluation of outcome measures
for use in monitoring clinical status in natural history and
therapeutic studies comprise another potential area for study.
Medically and statistically sound therapeutic studies may be
appropriate for testing certain hypotheses regarding pathogenesis,
but it is not the intent of this RFA to support large-scale clinical
trials.

Budget and Related Issues

In addition to support for personnel, supplies, travel to an annual
CFS CRC workshop for CRC Director and Project Leaders (see "SPECIAL
REQUIREMENTS") and other necessary costs justified in the application
for conducting CRC research projects, award funds may be utilized to
support the following research-related activities:

o  SHARED ADMINISTRATIVE, CLINICAL AND RESEARCH RESOURCES (CORES,
pages 17-18 of brochure cited above):  CFS CRCs may include funds for
administration, equipment, supplies and  services to expand and/or
maintain clinical, laboratory, biostatistical, and data management
facilities that are shared by research staff from at least two CRC
research projects.  Costs associated with patient and control
recruitment, enrollment, follow-up and data entry would be
appropriate for a core budget.  Any research-related cost  for
patient and control subject enrollment that is not eligible for
third-party payment should be included in the budget as PATIENT CARE
COSTS.

The amounts requested for Core support should be well justified and
in keeping with the overall complexity and size of the budget.  In
any case, such costs may not duplicate or replace costs included in
the institution's indirect cost base.  Since the program cannot
provide funds for new construction, adequate physical facilities must
be available to meet the primary needs of the CRC.  Please read pages
17-18 of the NIAID booklet on Program Project Grants and Multiproject
Cooperative Agreements.

o  BIOSTATISTICAL SUPPORT:  The budget must include adequate
biostatistical support to ensure sound study design, data  collection
and data analysis procedures.

o  OTHER BUDGETABLE ITEMS:  Budget requests may also include limited
investigator travel and costs for publication.

o  DEVELOPMENTAL FUND FOR PILOT STUDIES:  Applicants may request that
$40,000 in direct costs be made available annually in a Developmental
Fund for pilot studies.  This Developmental Fund would be set aside
and restricted solely to cover salaries and other research costs for
small pilot studies to follow-up on new observations and novel
hypotheses.  It is envisioned that availability of funds for pilot
studies would increase flexibility and responsiveness to important
new scientific observations and medical reports.

Pilot studies need not be restricted to the awardee institution.  IT
IS EMPHASIZED THAT INDIVIDUAL CRC RESEARCH PROJECTS ARE DISTINCT FROM
PILOT STUDIES AWARDED FROM THE DEVELOPMENTAL FUND.

The direct costs may not exceed $40,000 for any single pilot study.
The duration of support for each study typically would be one year,
but may be up to three years, unless the study is independently
funded through a traditional research project grant (R01) or a FIRST
(R29) award prior to the end of the three-year period.  In these
instances, the support of the pilot study from the Developmental Fund
must be terminated, and unexpended funds must be returned to the
Developmental Fund.  Funds reserved for pilot projects may not be
rebudgeted into other budget categories except in unusual
circumstances and following approval from the Grants Management
Specialist and the Scientific Coordinator.  The  CRC must maintain
detailed records of disbursements and expenditures of the
Developmental Fund.

Procedures for soliciting and selection of pilot studies should be
described, if developmental funds are requested.  It is anticipated
that pilot studies and their budgets recommended by the CFS CRC
Director will be reviewed and selected by a local review committee.
Studies involving Human Subjects will require prior approval by the
Institutional Review Board like all other NIH supported projects.

PILOT STUDIES PER SE, UNLIKE THE INDIVIDUAL CRC RESEARCH PROJECTS,
SHOULD NOT BE DESCRIBED IN THE CRC APPLICATION.  Only the
solicitation process and selection method (institutional review
process) and review criteria to be used need be described.  Examples
of criteria are scientific merit of the proposal, medical relevance
and need for data to advance the research objectives of the CRC.

The $40,000 annual direct costs should be entered in the OTHER
category in the Consolidated Budget (see pages 15 and 21 in the
accompanying brochure).

SPECIAL REQUIREMENTS

A.  Study Organization

The Cooperative Research Center Program requires cooperation between
CRC Directors and the Scientific Coordinator to ensure that basic
patient enrollment data under this program will be collected in a
standardized manner and can be pooled in a computerized CRC database.
Reports based on this pooled database are co-authored by CRC
Directors.  Patients are enrolled according to carefully specified
criteria set forth by each CRC Director, but at a minimum all CRC CFS
patients enrolled must meet inclusion and exclusion criteria
comparable to those specified by CDC and NIH so that studies at
different CRCs can be compared (Holmes, et al., Annals of Internal
Medicine: 108, 387-389, 1988; Schluederberg, et al., Annals of
Internal Medicine: 117, 325-331, 1992) (See also "Collaborative
Responsibilities" under "Terms and Conditions of Award" below, and
"SPECIAL REQUIREMENTS: Minimum Requirements for Application.")

WORKSHOP PARTICIPATION:  Successful applicants will be expected to
participate in regularly scheduled workshops.  These workshops will
be held once a year in Bethesda, MD to provide the setting in which
to share CFS research advances and to discuss CFS research needs and
opportunities with the CRC Directors and other CRC principal
investigators as well as with other investigators active in CFS
research or working in relevant related areas.  SUPPORT FOR TRAVEL TO
THE WORKSHOP MUST BE INCLUDED IN THE CRC BUDGET REQUEST.

B.  Terms and Conditions of Award

The following terms and conditions will be incorporated into the
award statement and provided to the Principal Investigator as well as
the institutional official at the time of award.  These special Terms
of Award are in addition to, and not in lieu of, otherwise applicable
OMB administrative guidelines, HHS Grant Administration Regulations
at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant
Administration policy statements.

The administrative and funding instrument used for this program is
the cooperative agreement (U01, U19), an "assistance" mechanism
(rather than an "acquisition" mechanism), in which substantial NIH
scientific and/or programmatic involvement with the awardee is
anticipated during the performance of the activity.  Under the
cooperative agreement, the NIH purpose is to support and/or stimulate
the recipient's activity by involvement in and otherwise working
jointly with the award recipient in a partner role, but it is not to
assume  direction, prime responsibility, or a dominant role in the
activity.  Consistent with this concept, the dominant role and prime
responsibility for the activity resides with the awardees for the
project as a whole, although specific tasks and activities in
carrying out the study will be shared among the awardees and the
NIAID scientific coordinator.

1.  Awardee Rights and Responsibilities

Awardees will have primary responsibility for defining the details
for the project within the guidelines of the RFA and for performing
the scientific activity, and agree to accept close coordination,
cooperation, and participation of the NIAID Scientific Coordinator in
those aspects of scientific and technical management of the project
specified in 2 below. Specifically, awardees have primary
responsibilities as described below.

The CRC Director (the Principal Investigator for the CRC) will have
ultimate responsibility for the coordination of efforts within the
CRC and ensuring that the results obtained are analyzed appropriately
and published in a timely manner. However, it will be the
responsibility of each CRC Project Leader (the Principal Investigator
for an individual research project within the CRC) to plan and
conduct the research stipulated in the project proposal.  NIAID may
periodically review and generate internal reports from data and
progress reports developed under this cooperative agreement.  The
data obtained will, however, be the property of the awardee.
Awardees will retain custody of and have primary rights to the data
developed under these awards, subject to Government rights of access
consistent with current HHS, PHS and NIH policies.

The multi-disciplinary and cooperative nature of the CFS CRCs creates
an extraordinary opportunity for information exchange and scientific
advancement in high quality CFS research.  It is expected that
Awardees will take advantage of this opportunity by participating in
both formal events established expressly for this purpose and
informal investigator-initiated dialogues.

2.  NIAID Staff Responsibilities

The NIAID Scientific Coordinator will be the Program Officer
designated to administer the CFS CRC program, currently chief of the
Virology Branch, DMID.  During the award period, the NIAID Scientific
Coordinator will work closely with the CRC Director TO FACILITATE,
BUT NOT DIRECT, THE ACTIVITIES OF THE CRC.  It is anticipated that
decisions about cooperative CRC activities outlined within this RFA
will be reached by consensus of the CRC Directors and the NIAID
Scientific Coordinator.

NIAID will facilitate research at CFS CRCs through the following:

o  assistance in overall research planning, data analysis and
reporting;
o  facilitation of information exchange between CFS CRCs and other
CFS grantees and investigators;
o  reduction of duplication of efforts by CFS CRCs and other NIAID
awardees;
o  assistance in development of standardization procedures applicable
to current and future CFS CRCs and to other grantees with regard to
case definition, laboratory procedures, selection of reagents, etc;
o  facilitation of access to new research reagents and technologies;
o  assistance in review and selection of pilot studies
o  identification of experts and other important resources not
otherwise available to the CFS CRCs;
o  assistance in locating potential replacements for key personnel
vacancies including Principal Investigators, Project Leaders and Co-
Investigators.

3.  Collaborative Responsibilities

The CRC Directors, Project Leaders, and NIAID Scientific Coordinator
will communicate regularly by teleconference or at CFS related
conferences, to review progress, plan, and design research
activities, and establish CFS CRC priorities.  As stated under "Study
Organization," at a minimum, all CRC CFS patients enrolled must meet
criteria comparable to those specified by CDC and NIH consensus
reports so that studies at different CRCs can be compared and core
data agreed upon by the CRC Directors can be entered into a common
database.  In addition, each year, NIAID staff will coordinate one
workshop at the NIH in Bethesda, Maryland (or at a site designated by
the NIAID).  This workshop will provide a forum for CRC and other CFS
research grant awardees to share research advances; to discuss CFS
research needs and opportunities; and to develop collaborations.
Funds for travel to these meetings must be included in the budget.

4.  Release of Developmental Funds for Pilot Projects

Release of funds for a pilot study may not occur until a written
request is sent to the NIAID Scientific Coordinator with a copy to
the Grants Management Specialist.  A description of the proposed
project, a summary of the deliberations of the local review
committee, a committee roster and a budget countersigned by the
institutional financial officer should accompany the letter of
request.  Funds may not be released until approved.

5.  Arbitration

Any disagreement that may arise on scientific/programmatic matters
(within the scope of the award) between award recipients and the
NIAID may be brought to arbitration.  An arbitration panel will be
composed of three members -- one selected by the CRC Directors or by
the individual awardee in the event of an individual disagreement, a
second member selected by the NIAID, and the third member selected by
the two prior members.  This special arbitration procedure in no way
affects the awardee's rights to appeal an adverse action that is
otherwise appealable in accordance with the PHS regulations at 42 CFR
part 50, subpart D and HHS regulation at 45 CFR part 16.

6.  Therapeutic studies

In the event that research supported by the Cooperative Agreement
results in development of a therapeutic or other medical
intervention, NIAID will retain the option to cross-file or
independently file an application for an Investigational New Drug
Application (INDA) to the United States Food and Drug Administration.
Reports of data generated by the CRC or any of its members which are
required for inclusion in INDAs and Clinical Brochures, and for
cross-filing purposes will be submitted by the CRC Director to the
Scientific Coordinator upon request.  Such reports will be in final
draft form and include background information, methods, results, and
conclusions.  They will be subject to approval and revision by NIAID
and may be augmented with test results from other Government
sponsored projects prior to submission to the appropriate regulatory
agency.

STUDY POPULATIONS

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some new
provisions that are substantially different from the 1990 policies.
All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research", which have been published in the
Federal Register of March 9, 1994 (FR 59 11146-11151), and reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume
23, Number 11.

Investigators may obtain copies from these sources or from Dr.
Schluederberg (listed in INQUIRIES below) who may also provide
additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by September 15, 1994, a
letter of intent that includes a descriptive title of the overall
proposed research, the name, address and telephone number of the
Principal Investigator, the number and title of this RFA, and a list
of the key investigators and their institution(s).  Although the
letter of intent is not required, is not binding, does not commit the
sender to submit an application, and does not enter into the review
of subsequent applications, the information that it contains allows
NIAID staff to estimate the potential review workload and to avoid
conflict of interest in the review.  The letter of intent is to be
sent to Dr. Olivia Preble at the address listed under INQUIRIES.

APPLICATION PROCEDURES

Applications are to be submitted on the standard research grant
application form PHS 398 (rev. 9/91).  These application forms may be
obtained from the institution's office of sponsored research or its
equivalent and from the Office of Grants Information, Division of
Research Grants, National Institutes of Health, 5333 Westbard Avenue,
Room 449, Bethesda, MD 20892, telephone (301) 435-0714.  For purposes
of identification and processing, item 2a on the face page of the
application must be marked "YES" and the RFA number and the words
"CFS COOPERATIVE RESEARCH CENTERS" must be typed in.

Before preparing the application, the applicant should carefully read
the information brochure, "NIAID Program Projects and Multiproject
Cooperative Agreements."  Instructions outlined in the brochure for
the formatting of the application must be followed carefully.
Failure to follow the instructions may result in unnecessary delays
in the review process.  Investigators are urged to contact NIAID
staff early in the development of the application (See program
contact listed under INQUIRIES).

Minimum Requirements for Application

Particular attention should be given to the following areas when
responding to the application instructions found in the brochure:

o  In describing the clinical and laboratory facilities available to
the CRC, specific information should be included on the institution's
present CFS patient load and projections for patients' willingness to
participate in clinical investigations.  A detailed account of case
and control ascertainment procedures must be provided along with the
inclusion and exclusion criteria to be used for enrollment.

o  A minimum of two projects must be proposed.  The detailed
description of each research project should demonstrate that it
contributes to the attainment of the CRC's overall objectives.
Preliminary results and evidence of feasibility should be provided if
available.

o  Previously funded CRCs must submit a comprehensive progress report
and carefully justify any plans for expansion.

o  In addressing the Organization and Administrative Structure of the
CRC, the mutually reinforcing inter-relationships among the members
of the CFS CRC and the contribution of each to fulfillment of CFS CRC
objectives should be clearly described.  This section must include an
organizational chart showing the name, the organization, and the
scientific discipline of the Program Director, the Project Leaders
(principal investigators of individual research projects), and other
key personnel for the projects.

o  The application must include a signed letter of agreement from
each collaborator and/or consultant to the program indicating (1)
willingness to participate in the program, and (2) the exact nature
of the participation.

o  Also required is a plan to ensure the maintenance of close
coordination and effective communication among members of the CFS CRC
and between CRC members and the NIAID Scientific Coordinator.  This
plan should be co-signed by the CFS CRC Director and all Project
Leaders to indicate acceptance of the participation of the NIAID
Coordinator and to show commitment to the protocols of the proposed
studies.

o  A written commitment by the sponsoring institution that explicitly
defines the institution's willingness and preparedness to commit
resources to ensure development, function, and maintenance of the
proposed CFS CRC must be included in the application.  This letter
should be co-signed by the relevant departmental chairperson(s) and
dean of the institution.

Applications must be received by October 25, 1994.  All components,
subparts and sections of the application must be collated into the
application, and the packages sent to the DRG and to the NIAID must
each be complete in themselves. Applications that are not received by
the receipt date or that do not conform to the instructions contained
in PHS 398 (rev. 9/91) application kit, will be judged non-responsive
and will be returned to the applicant.

The RFA label in the application form PHS 398 must be affixed to the
bottom of the face page.  Failure to use this label could result in
delayed processing of the application such that it may not reach the
review committee in time for review.

Submit a signed, typewritten original of the application, including
the checklist, and three signed, exact, single-spaced photocopies, in
one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional exact copies of the grant
application and all five sets of any appendix material must also be
sent to Dr. Olivia Preble at the address listed under INQUIRIES.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research.  If so, a letter of agreement from either the
GCRC program director or Principal Investigator could be included
with the application.

The Division of Research Grants (DRG) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application.  The DRG will not accept any application that is
essentially the same as one already reviewed.  This does not preclude
the submission of a substantial revision of an application already
reviewed, but such applications must include an introduction
addressing the previous critique.

REVIEW CONSIDERATIONS

Review Method

Upon receipt, applications will be reviewed for completeness by the
NIH Division of Research Grants (DRG) and for responsiveness by NIAID
staff.  Incomplete applications will be returned to the applicant
without further consideration.  If the application is not responsive
to the RFA, it will be returned without further consideration.

Those applications that are complete and responsive may be subjected
to a triage by a peer review group to determine their scientific
merit relative to other applications received in response to this
RFA.  The NIAID will withdraw from competition those applications
judged to be non-competitive for award and will notify the Principal
Investigators and institutional business officials.  For applications
found to be non-competitive, summary statements will be very brief
and will generally contain a one paragraph resume, based on
reviewers' comments, indicating the major reason(s) for the findings.

Those applications judged by the reviewers to be competitive for
award will be further reviewed for scientific and technical merit by
a review committee convened by the Division of Extramural Activities,
NIAID.  The second level of review will be provided by the National
Advisory Allergy and Infectious Diseases Council.

Review Criteria

The review criteria for this RFA are the same as those for
unsolicited research project grant applications:

o  scientific, technical, or medical significance and originality of
proposed research;
o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
o  qualifications and research experience of the Principal
Investigator and staff, particularly but not exclusively in the area
of the proposed research;
o  availability of resources necessary to perform the research;
o  appropriateness of the proposed budget and duration in relation to
the proposed research;

In addition, applicants are expected to address the issues identified
under "SPECIAL REQUIREMENTS," as well as criteria specific to the
objectives of this RFA.  These criteria include:

o  CFS CRCs must offer a strong clinical facility with accessible
patient populations that are appropriate for answering CFS research
questions and are available for follow-up.

o  The value of studies of patients or their specimens will be
directly related to the care exercised in selection and initial
characterization of cases and controls.  A detailed description of
case recruitment procedures, the criteria to be used for case
definition and the manner in which the criteria are to be applied
must be included.  Similar care should be given to descriptions of
enrollment of comparison groups.

o  The CRC research program must focus on one or more aspects of CFS
related to etiology, natural history or pathogenesis and involve the
multidisciplinary expertise necessary to obtain meaningful results.

o  Each individual research project proposal must demonstrate the
investigator's awareness of the requirements for hypothesis
development and testing, and for sound data collection, management
and analysis procedures.

o  The application must include evidence that the CRC Director and
project directors have sufficient experience and expertise to make a
significant contribution to the establishment of standardized
procedures for studying CFS.

AWARD CRITERIA

Funding decisions will be made on the basis of scientific and
technical merit as determined by peer review, program priorities and
balance, and the availability of funds.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues to:

Ann Schluederberg, Sc.D.
Division of Microbiology & Infectious Diseases
National Institute of Allergy and Infectious Diseases
Solar Building, Room 3A16
6003 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-7453
FAX:  (301) 496-8030

Direct inquiries regarding review issues, address the letter of
intent to, and mail two copies of the application and all five sets
of appendices to:

Olivia Preble, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C20
6003 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-8208
FAX:  (301) 402-2638

Direct inquiries regarding fiscal matters to:

Ms. Victoria Putprush
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4B28
6003 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-7075
FAX:  (301) 480-3780

Schedule

Letter of Intent Receipt Date:  September 15, 1994
Application Receipt Date:       October 25, 1994
Scientific Review Date:         February 1995
Advisory Council Date:          June 1995
Earliest Award Date:            September 1995

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.856, Microbiology and Infectious Diseases Research.
Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158,
42 USC 241 and 285) and administered under PHS grants policies and
Federal Regulations 42 CFR 52 and 45 CFR Part 74.  This program is
not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.

The Public Health Service strongly encourages all grant recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

.

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9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


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