From: kristoff@NET.BIO.NET (Dave Kristofferson)
Newsgroups: bionet.sci-resources
Subject: NIH Guide, vol. 21, no. 37, pt. 2, 16 October 1992
Date: 16 Oct 92 19:03:51 GMT
Distribution: bionet


$$XID NIHGUIDE 19921016 V21N37 P2O2 ************************************
Assistance No. 93.837, 93,838, and 93.839. 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.

$$P3 END ************************************************************

$$P4 BEGIN PA-93-009 ************************************************

NEURAL, ENDOCRINE, IMMUNE, AND VIRAL INTERACTIONS, BEHAVIOR, AND
MENTAL HEALTH

NIH GUIDE, Volume 21, Number 37, October 16, 1992

PA NUMBER:  PA-93-009

P.T. 34; K.W. 1002030, 0710070, 0705030, 1002045

National Institute of Mental Health
National Institute of Neurological Disorders and Stroke

PURPOSE

The National Institute of Mental Health (NIMH) and the National
Institute of Neurological Disorders and Stroke (NINDS) invite
research grant applications for studies of neuro-endocrine-immune
interactions, neuroimmunomodulation, psychoneuroimmunology, and the
effects of viral and other infectious challenges on such
interactions.  Applications are also invited for studies of the
health and treatment implications of such interactions.  The goal of
this program announcement is to promote research which will advance
understanding of how the brain influences, and is influenced by, the
various systems that maintain homeostasis and defend/repair the
body's tissues.  This research will increase knowledge of the
interrelationships between psychological states and physical health.
Research is encouraged to improve behavioral and medical outcomes by
the application of knowledge about neuro-endocrine-immune
interactions.
HEALTHY PEOPLE 2000

The Public Health Service (PHS) 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 Program
Announcement, Neural, Endocrine, Immune, and Viral Interactions,
Behavior, and Mental Health, is related to the priority areas of
mental health and mental disorders, HIV infection, and immunization
and infectious 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 202-783-3228).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, public and private, non-
profit and for-profit organizations such as universities, colleges,
hospitals, laboratories, research institutions, units of State and
local governments, and eligible agencies of the Federal Government.
Foreign organizations may apply for traditional research (R01) and
small (R03) grants only.  Women and minority investigators are
encouraged to apply.

MECHANISMS OF SUPPORT

Applications are requested under the following mechanisms:
traditional research grants (R01), First Independent Research Support
and Transition (FIRST) awards (R29), small grants (R03) program
projects (P01), career development awards (K-series), institutional
training grants (T32), and individual fellowships (F-series).

RESEARCH OBJECTIVES

Proposed research can be directed at any level of biological
organization from molecular to organismic.  However, at whatever
level studies are directed, applications must contain well-developed
research plans addressing questions of clear and direct biological
relevance.  Specifically, proposed in vitro experiments should
ideally seek mechanistic explanations for well-documented in vivo
phenomena or should be carried out in conjunction with in vivo
experiments.  Applications solely based on the use of cell lines
should be justified by inability to realize research objectives in
vivo or by using primary cell or organ cultures.

Support is also provided for studies aimed at improving available
methods for investigating the areas covered by this announcement.
The following are examples of broad research topics that would be of
interest.  This list is not intended to be comprehensive, nor are the
examples meant to be exclusive.

o  Mechanisms mediating functional interactions among the nervous,
endocrine, and immune systems

o  Innervation of immune and endocrine organs and the functions
accomplished by the innervating cell

o  Mechanisms involved in the conditioning of immune responses

o  Temporal and spatial distribution of immunocytes in brains of
normal and ill individuals

o  Effects of cytokines and other products of immunocytes on neural
cell function; expression and function of cytokines in the nervous
system

o  Impact of immune deficiencies on function of the central nervous
system and susceptibility to mental illness

o  Central neural circuitry and mechanisms of secretion of hormones
which cooperate in the regulation of the immune response

o  Identification and characterization of molecules coordinating
regulation of neuroendocrine and immune systems

o  Characterization of pathways of viral entry into the central
nervous system and roles of neural and non-neural cells in this
process

o  Roles of the blood-brain-barrier in impeding/facilitating
brain-immunocyte-virus interactions

o  Mechanisms of viral neuropathogenesis; regional specificity;
tropism for neural cells; replication and latency of slow-acting
viruses such as HIV and other lentiviruses; effects on neuronal
function and their mechanisms

o  Characterization of viral effects on psycho-neuro-endocrine-immune
interactions

o  Use of transgenic, immunodeficient, and other mutant animals to
investigate neuro-endocrine-immune interactions

o  Applications of novel techniques, such as in situ polymerase chain
reaction and homologous recombination, to investigate immune and
viral bases of mental disorders

o  Characterization of the effects of various mental states (e.g.,
stress and coping, sleep, intellectual activity, meditation) on
endocrine and immune function and on health outcomes

o  Characterization of immune effects on psychological states and
behavior

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are required to include minorities and women
in study populations so that research findings can be of benefit to
all persons at risk of the disease, disorder or condition under
study; special emphasis must be placed on the need for inclusion of
minorities and women in studies of diseases, disorders and conditions
which disproportionately affects them.  This policy is intended to
apply to males and females of all ages.  If women or minorities are
excluded or inadequately represented in clinical research,
particularly in proposed population-based studies, a clear compelling
rationale must be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In  addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information must be included in the form PHS 398 in
Sections 1-4 of the Research Plan AND summarized in Section 5, Human
Subjects.  Applicants are urged to  assess carefully the feasibility
of including the broadest possible representation of minority groups.
However, NIH recognizes that it may not be feasible or appropriate in
all research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans (including American Indians or Alaskan natives),
Asian/Pacific Islanders, Blacks, Hispanics).  The rationale for
studies on single minority population groups must provided.

For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
diseases, disorders or conditions, including but not limited to
clinical trials.

The usual NIH polices concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy  on inclusion of women applies fully;
since the definition of minority differs in other countries, the
application must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.

If the required information is not contained within the application,
the review will be deferred until the information is provided.

Peer reviewers will address specifically whether the research plan in
the application conforms to these polices.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants or cooperative agreements that do not comply with these
policies.

APPLICATION PROCEDURES

Application submission should follow the PHS review and award
schedule as published in the current version of Instructions for
Grant Application Form PHS 398 (rev. 9/91).

Dates for the submission of new research applications (R01, R29, R03,
P01, and K-series) and review cycles are as follows:

Receipt           IRG         Council     Earliest
Dates             Review      Review      Award Dates

Feb 1/Mar 1*      May/June    Sep/Oct     Dec 1
Jun 1/Jul 1*      Oct/Nov     Jan/Feb     Apr 1
Oct 1/Nov 1*      Feb/Mar     May/Jun     Jul 1

*Amended research applications, supplemental applications and
competing renewals are to be submitted on the latter dates.

Applications received after the above receipt dates are subject to
assignment to the next review cycle or may be returned to the
applicant.

Because institutional training grants (T32) and individual fellowship
applications (F-series) have different deadlines and application
procedures, applicants should contact program staff listed under
INQUIRIES and obtain necessary documentation pertaining to those
mechanisms.

Applicants are to use the grant application form PHS 398 (rev. 9/91)
for all grants except the F-series for which form PHS 416-1 (rev.
10/91) is to be used.  The number and title of the program
announcement, "PA-93-009: Neural, Endocrine, Immune, and Viral
Interactions, Behavior, and Mental Health," must be typed in item
number 2a on the face page of the PHS 398 application form.

Application kits containing the necessary forms and instructions for
regular research grants may be obtained from business offices or
offices of sponsored research at most universities, colleges, medical
schools, and other major research facilities.  If such a source is
not available, the program officials listed under INQUIRIES may be
contacted for the necessary application material.

The signed original and five legible copies of the completed
application form PHS 398 or two copies of the form PHS 416-1 (rev.
10/91) must be sent to:

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

REVIEW PROCEDURES

The Division of Research Grants (DRG), NIH, serves as a central point
of receipt of applications for most discretionary PHS grant programs.
Interest areas indicated in this announcement overlap with those of
other Institutes, so applications received under this announcement
will be assigned to an initial review group (IRG) in accordance with
established PHS Referral Guidelines.

The IRGs, consisting primarily of non-Federal scientific and
technical experts, will review the applications for scientific and
technical merit.  Notification of the review recommendations will be
sent to the applicant after the initial review.  Applications will
receive a second-level review by the appropriate Advisory Council
whose review may be based on policy considerations as well as
scientific merit.  Only applications recommended for approval by the
Council may be considered for funding.

AWARD CRITERIA

Criteria for scientific/technical merit review of applications will
include the following: significance and originality, from a
scientific or technical standpoint, of the goals for the proposed
research; evidence of familiarity with relevant research literature;
adequacy of the conceptual and theoretical framework for the
research; adequacy of the methodology proposed to carry out the
research; feasibility of the proposed research; qualifications and
research experience of the principal investigator and other key
research personnel; availability of adequate facilities, other
resources, and collaborative arrangements necessary for the research;
appropriateness of budget estimates for the proposed research
activities; adequacy of plans to include women and minorities in
study populations; and adequacy of provisions for the protection of
human subjects and the welfare of animal subjects, as applicable.

Applications recommended for approval by the appropriate National
Advisory Council will be considered for funding on the basis of
overall scientific and technical merit of the research as determined
by peer review, Institute program needs and balance, and availability
of funds.

Grant funds may be used for expenses clearly related and necessary to
conduct research projects, including both direct costs which can be
specifically identified with the project and allowable indirect costs
of the institution.  Funds may not be used to establish, add a
component to, or operate a treatment, rehabilitation, or prevention
intervention service program.  Support for research-related
treatment, rehabilitation, or prevention services and programs may be
requested only for costs required by the research.  These costs must
be justified in terms of research objectives, methods, and designs
which promise to yield generalizable knowledge and/or make a
significant contribution to theoretical concepts.

Grants must be administered in accordance with the PHS Grants Policy
Statement (rev. 10/90), which should be available from an office of
sponsored research.  Federal regulations at 42 CFR Part 52, Grants
for Research Projects, and Title 45 CFR Parts 74 and 92, generic
requirements concerning the administration of grants, are applicable
to these awards.

Support may be requested for a period of up to five years. The small
grants (R03) are for up to two years and are non-renewable.  The
period of individual fellowships may not exceed five years in the
aggregate for pre-doctoral training and three years in the aggregate
for post-doctoral training.  Annual awards will be made subject to
continued availability of funds and progress achieved.  A competing
supplemental application may be submitted during an approved period
of support to expand the scope or protocol of a project during the
approved period.  A competing continuation (i.e., renewal)
application may be submitted before the end of an approved period of
support to continue a project.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Ljubisa Vitkovic, Ph.D.
Chief, Neuroimmunology/Neurovirology Program
Division of Neuroscience and Behavioral Science
National Institute of Mental Health
5600 Fishers Lane, Room 11C-05
Rockville, MD  20857
Telephone:  (301) 443-5288
FAX:  (301) 443-4822
BITNET:  LV5@NIHCU

N. Herbert Spector, Ph.D.
Division of Fundamental Neurosciences
National Institute of Neurological Disorders and Stroke
Federal Building, Room 916
7550 Wisconsin Avenue
Bethesda, MD  20892
Telephone:  (301) 496-5745
FAX:  (301) 402-1501

For further information on grants management issues, applicants may
contact:

Diana Trunnell
Assistant Chief, Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 7C-23
Rockville, MD  20857
Telephone:  (301) 443-3065

Mary Whitehead
Chief, Grants Management Branch
National Institute of Neurological Disorders and Stroke
Federal Building, Room 1004
Bethesda, MD  20892
Telephone:  (301) 496-9231

AUTHORITY AND REGULATION

This program is described in the Catalog of Federal Domestic
Assistance No. 93.242 and 93.853.  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
385) 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.

$$P4 END ************************************************************


$$XID RFA NR9301 NR-93-01 P1O1 *****************************************

RESEARCH ON CLINICAL CARE IN NURSING HOMES

NIH GUIDE, Volume 21, Number 37, October 16, 1992

RFA:  NR-93-01

P.T. 34; K.W. 0785130, 0730050

National Center for Nursing Research

Letter of Intent Receipt Date:  November 24, 1992
Application Receipt Date:  January 26, 1993

PURPOSE

The National Center for Nursing Research (NCNR) invites research
applications to study the impact of contextual factors in nursing
homes on the quality of care that is provided, and to examine those
and other factors influencing the effectiveness of clinical
interventions for older persons residing in nursing homes.

The goal of this Request for Applications (RFA) is to enhance quality
of care and quality of life of nursing home residents by increasing
understanding of the influences of contextual factors and by
determining clinical strategies that increase independence and self
management among residents, maintain family participation in care,
and encourage discharge to home whenever possible.

Contextual factors include structural and organizational factors,
such as rehabilitation resources, staff to resident ratios, safety
measures, and methods of care delivery.  The clinical focus is on
intervention strategies to ameliorate clinical problems, such as
incontinence or sleep difficulties, to maintain or improve functional
abilities, to avoid the onset of further disabilities, and to
increase health-related quality of life.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) 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 RFA,
Research on Clinical Care in Nursing Homes, is related to the
priority areas of older persons as a targeted group and to
chronically disabling conditions.  Potential applicants may obtain a
copy of the "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0 or 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 and foreign, for-profit and
nonprofit, public and private, organizations such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal Government.
Applications from minority individuals and women are encouraged.
Applicants must demonstrate access to nursing homes appropriate to
the study proposed.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) individual
research grant (R01).  Responsibility for the planning, direction,
and execution of the proposed project will be solely that of the
applicant.  This RFA is a one-time solicitation.  Future unsolicited
competing continuation applications will compete with all
investigator-initiated applications and be reviewed according to
customary peer review procedures.  The total project period for
applications submitted in response to the present RFA may not exceed
four years.  Because the nature and scope of the research proposed in
response to the RFA may vary, it is anticipated that the size of an
award will vary also.  The anticipated average direct cost of an
award is $150,000.  The anticipated award date will be July 1, 1993.

FUNDS AVAILABLE

It is estimated that up to $1.0 million will be available to fund the
first-year total costs of applications submitted in response to this
RFA.  It is anticipated that four to five applications will be
funded.  This level of support is dependent on the receipt of a
sufficient number of applications of high scientific merit.  Although
this program is provided for in the financial plans of the NCNR, the
award of grants pursuant to this RFA is also contingent upon the
availability of funds for this purpose.

RESEARCH OBJECTIVES

1.  Determine the influence of structural and organizational factors
on the effectiveness of clinical interventions.

2.  Examine the effectiveness of specific clinical interventions for
older persons in nursing homes in terms of clinical quality (e.g.,
related to changes in functional status and quality of life) and
related fiscal (e.g., related to changes in costs) outcomes.

3.  Identify linkages among clinical assessments conducted in nursing
homes, clinical interventions, and anticipated clinical and fiscal
outcomes.

Applications must address objective one and either two or three.

Background

This initiative builds directly on the work of a panel of scientific
experts on long-term care convened as part of the development of the
National Nursing Research Agenda. Publication of the report of the
panel's work is anticipated in the latter part of 1992.

With the increasing longevity of our population, the number of older
persons is steadily increasing.  This is also true of the oldest old,
those 85 years and older who are more frequent residents of nursing
homes than younger older persons.  These individuals may have
disabilities due to chronic illness or acute medical problems that
require hospitalization with recovery in a nursing home.  The reasons
for admission to a nursing home for older persons are many but
frequently are related to previous hospitalization, a chronic
disability with a precipitating event such as the onset of urinary
incontinence, caregiver fatigue or disability, or absence of a
caregiver in the home.  Admission to a nursing home can often be
perceived as a terminal event for many older persons, rather than as
a useful health care setting for those who need subacute
institutional care for a period of time.  The time after admission
may be a unique time period for nursing home residents that needs to
taken into consideration in planning clinical interventions and in
examining effectiveness of clinical care.

Individualized care that avoids induced dependency and immobility
while incorporating an individual's daily habits as much as possible
has been described as important in preventing decline after admission
to a nursing home.  Interest has focused on residents in nursing
homes being able to achieve or maintain functional independence and
self management, independent choice about their care, satisfactory
quality of life, and active participation with their family.  How
best to assess and plan clinical interventions to meet individual
requirements of nursing home residents needs to be addressed.
Appropriate regularly occurring assessments, such as the use of the
Long Term Care Minimum Data Set and other clinical assessment
instruments, have been recognized as important in identifying
functional and life status factors that indicate status changes which
may require targeted interventions.  The relationship of assessment
strategies to clinical interventions and outcomes requires further
investigation.

Clinical interventions may be similar or different for short stay and
for longer stay nursing home residents. Investigations that include
examination of the differences among those with varying anticipated
lengths of stay are needed.  Also, examinations are needed of
clinical intervention strategies for residents who have the potential
for discharge home or improvement in their health status, as well as
those who are not expected to survive.  A number of clinical problems
have been identified as occurring among older adults requiring
long-term care at home or in nursing homes.  Among these are
confusion, behavior changes such as with dementias, changes in
mobility and agility, skin integrity, urinary incontinence, and sleep
disturbances.  Studies of the effectiveness of clinical interventions
for each of these clinical problems are needed.  It is important that
applicants carefully and clearly define clinical interventions in
terms of their purpose, composition, means of implementation, and
anticipated effect.

Structural and organizational factors may have a direct influence on
nursing home residents and on effectiveness of clinical intervention
strategies that are implemented.  It is important that the natural
clinical setting be examined for these influences on the
effectiveness of intervention strategies.  These factors can have
marked influence on clinical and fiscal outcomes, and identifying
clinical strategies that overcome them should lead to improved
clinical care.

Resources available in nursing homes can vary, as can clinical
management processes.  The professional staff are usually nurses,
physical and occupational therapists, social workers, and
nutritionists.  Physicians and other professional staff may also be
involved.  The extent to which there is collaboration among these
personnel and its influence on clinical care needs exploration.
Clinical staffing of nursing homes varies but generally nursing home
aides provide most of the direct daily care with registered nurses
providing leadership.  Exploration of clinical management strategies
to achieve staff adherence to plans of care may be important to
successful implementation of clinical interventions.  Findings from
some clinical studies in nursing homes have indicated considerable
differential between staff actions during a study and their actions
after the study was completed.  For example, a research team
conducting a clinical intervention study found staff compliance with
the intervention protocol during the study returned to baseline after
withdrawal of the team from the nursing home.

The milieu of nursing homes may directly influence the quality and
effectiveness of clinical care.  Clinical interventions that take the
resident milieu into consideration continue to require study.
Special care units in nursing homes have been proposed for the care
of those with particular clinical conditions, such as urinary
incontinence.  The effectiveness of these units still needs to be
demonstrated.

It is anticipated that the studies proposed will be prospective and
use primary data, build on existing scientific information, and that
the team of investigators will have access to nursing homes of
appropriate quality with appropriate resident populations.
Investigators are encouraged to provide specific information about
the status of the nursing homes proposed for inclusion in the study,
including Federal certification status, state licensure, ownership,
and current staffing ratios.  A multi-disciplinary approach is
encouraged.

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements will be required to include minorities and
women in study populations so that research findings can be of
benefit to all persons at risk of the disease, disorder or condition
under study; special emphasis should be placed on the need for
inclusion of minorities and women in studies of diseases, disorders
and conditions which disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information should be included in the form PHS 398
(rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in
Section 5, Human Subjects.  Applicants are urged to assess carefully
the feasibility of including the broadest possible representation of
minority groups.  However, NIH recognizes that it may not be feasible
or appropriate in all research projects to include representation of
the full array of United States racial/ethnic minority populations
[i.e., Native Americans (including American Indians or Alaskan
Natives), Asian/Pacific Islanders, Blacks, Hispanics].

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
disease, disorders or conditions, including, but not limited to,
clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies, If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants or cooperative agreements that do not comply with these
policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by November 24, 1992, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the names of other key personnel and consultants, the
participating institution(s), and the number and title of the RFA in
response to which an application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is extremely helpful in planning for the review of
applications.  It allows NCNR staff to estimate the potential review
workload and to avoid possible conflict of interest in the review.

The letter of intent is to be sent to:

Ethel Jackson, D.D.S.
Chief, Office of Review
National Center for Nursing Research
Building 31, Room 5B25
9000 Rockville Pike
Bethesda, MD  20892

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
to apply for these grants.  These forms are available at most
institutional business offices and from the Office of Grants
Inquiries, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone
301-496-7441.

The RFA label available in the application form PHS 398 must be
affixed to the bottom of the face page. Failure to use this label
could delay processing of the application.  In addition, on line 2a
on the face page of the application, enter "Research on Clinical Care
in Nursing Homes, NR-93-01" in the provided space and the YES box
must be marked.

Submit a signed original of the application, including the Checklist,
and three signed, exact 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 copies of the application
must also be sent to:

Ethel Jackson, D.D.S.
Chief, Office of Review
National Center for Nursing Research
Building 31, Room 5B25
9000 Rockville Pike
Bethesda, MD  20892

Applications must be received by January 26, 1993.  If an application
is received after that date, it will be returned to the applicant
without review.

The Division of Research Grants (DRG) will not accept any application
in response to this announcement that is essentially the same as one
currently pending 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 substantial revisions of applications already
reviewed, but such applications must include an introduction
addressing the previous critique.

REVIEW CONSIDERATIONS

Applications submitted to the NIH will be reviewed according to
normal NIH peer review procedures.

Review Procedure.  Upon receipt, applications will be reviewed by
NCNR for completeness and responsiveness. Incomplete applications
will be returned to the applicant without further consideration.  If
the application is not responsive to the scientific intent identified
in the RFA or to the time frame and budget guidelines, NCNR will
return it to the applicant.

Applications may be subjected to triage by a peer review group to
determine their scientific merit relative to other applications
received in response to this RFA.  Criteria for triage will be the
same as the review criteria listed below.  The NIH will
administratively withdraw from competition those applications judged
to be noncompetitive and notify the applicant and institutional
official.

Those applications judged to be complete, responsive, and competitive
will be further evaluated in accordance with the criteria stated
below for scientific/technical merit by an appropriate peer review
group convened by the NCNR.  The second level of review will be
provided by the National Advisory Council for Nursing Research.

Review Criteria.  Applications will be reviewed in accord with the
usual NIH peer review criteria:

o  scientific and technical 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  appropriateness of the nursing home settings for the conduct of
the study;

o  availability of resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research; and

o  where an application involves activities that could have an
adverse effect upon humans, animals, or the environment, the adequacy
of the proposed means for protecting against or minimizing such
effects.

AWARD CRITERIA

The anticipated date of award is July 1, 1993.  Decisions to make
awards are based on the scientific merit of the application reflected
in the priority score, availability of funds with NCNR for this
purpose, and NCNR research program priorities.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged
and may be directed to either of the following individuals.  The
program staff welcome the opportunity to clarify any issues or
questions from potential applicants.

Patricia Moritz, Ph.D., R.N.
Nursing Systems Branch
National Center for Nursing Research
Westwood Building, Room 754
Bethesda, MD  20892
Telephone:  (301) 496-0523 (for copies of the RFA)
Telephone:  (303) 844-6163 (for discussion of scientific matters)

Direct inquiries regarding fiscal matters to:

Sally Nichols
Grants Management Officer
National Center for Nursing Research
Westwood Building, Room 748
Bethesda, MD  20892
Telephone:  (301) 496-0237

SCHEDULE

Letter of Intent:          November 24, 1992
Application Receipt Date:  January 26, 1993
Initial Review:            February/March 1993
Secondary Review:          May/June 1993
Anticipated Award Date:    July 1, 1993

Other institutes and agencies are also interested in research dealing
with long-term care, including:

The National Institute on Aging; the program contacts are Marcia G.
Ory, PhD, and Katrina Johnson, PhD, Behavioral and Social Research
Program, NIA, Gateway Building, Room 2C-234, NIH, Bethesda, MD 20892,
phone (301) 496-3136.

The Agency for Health Care Policy and Research; the program contacts
are Linda Siegenthaler, PhD, and Anne Bavier, MSN, Center for General
Extramural Health Services Research, Suite 502, 2101 East Jefferson
Street, Rockville, MD, 20852, telephone (301) 227-8352.

This RFA is in addition to the ongoing program announcement on Home
Health Care and Supportive Services for Older Adults, published in
the NIH Guide for Grants and Contracts, Vol. 21, No. 18, May 15,
1992, sponsored by the National Institute on Aging, National Center
for Nursing Research, and the Agency for Health Care Policy and
Research.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.331, Nursing 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.


$$XID RFA DC93003 DC-93-003 P1O1 ***************************************

NIDCD-NASA CENTER FOR VESTIBULAR RESEARCH

NIH GUIDE, Volume 21, Number 37, October 16, 1992

RFA:  DC-93-003

P.T. 34; K.W. 0785005, 1002061

National Institute on Deafness and Other Communication Disorders

Letter of Intent Receipt Date:  November 15, 1992
Application Receipt Date:  December 22, 1992

PURPOSE

The National Institute on Deafness and Other Communication Disorders
(NIDCD) of the National Institutes of Health (NIH), in collaboration
with the Life Sciences Division of the Office of Space Science and
Applications, National Aeronautics and Space Administration (NASA),
invites applications for the support of a ground-based research
center to carry out research applicable to vestibular issues
associated with space flight, and fundamental knowledge about the
vestibular system.  In addition to research, the Center will include
a research training component.  The Center will conduct a number of
research projects in humans and/or animals integrated into a program
and centered around the vestibular control of balance and posture and
the regulation of locomotion and other volitional movements.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) 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 RFA,
NIDCD-NASA Center for Vestibular Research, is related to the priority
areas of physical activity fitness, educational and community-based
programs, unintentional injuries, occupational safety and health,
diabetes and chronic disabling diseases, and clinical prevention
services.  Potential applicants may obtain a copy of "Healthy People
2000" (Full Report:  Stock No. 017-001-11474-0) or "Healthy People
2000" (Summary Report:  Stock No. 017-001-11473-1) 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 and local governments, and
eligible agencies of the Federal government.  Applications from
minority individuals and women are encouraged.

MECHANISMS OF SUPPORT

This RFA will use the NIH Comprehensive Center (P60) grant mechanism.
The Application Guidelines for Program Project and Clinical Research
Center Grants issued by the NIDCD (rev. Nov. 1991) applies to this
solicitation and should be consulted by the applicant.  In addition,
certain provisions in the announcement on National Research Service
Awards for Institutional Training Grants issued in the NIH Guide for
Grants and Contracts (Vol. 21, No. 11, March 20, 1992) also apply to
this solicitation.  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the
applicant.

The total project period for applications submitted in response to
the present RFA must be five years.  The anticipated award date will
be July 1, 1993.

This RFA is a one-time solicitation.  At present, the NIDCD and NASA
have made no commitment to continue support for the Center beyond
five years.
 Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources (NCRR) may wish to identify the GCRC as a resource for
conducting the proposed research.  In such a case, a letter of
agreement from either the GCRC program director or Principal
Investigator may be included with the application.

FUNDS AVAILABLE

One Center will be supported jointly by NIDCD and NASA at a level of
up to $1 million total (direct plus indirect) costs per annum for a
project period of five years.  Budget increments after the first year
will be limited to necessary cost-of-living increases.  Although
funds for stipends for research trainees will be provided from funds
for the center, the stipend levels should be set at the level of the
NIH National Research Service Award (NRSA) program.  Although this
Center is provided for in the financial plans of the NIDCD and NASA,
awards pursuant to this RFA are contingent upon the availability of
funds for this purpose.

RESEARCH OBJECTIVES

Background

The importance of vestibular function in the motor performance of
humans in both the terrestrial and aerospace environments has long
been recognized.  Vestibular-deficient individuals, including
astronauts during flight and the early postflight period, show
abnormalities in trunk and head coordination. Indeed, acute
vestibulogenic changes, the effects of a lesion or the functional
unloading of the otolithic gravity receptors in space result in
dramatic symptoms of imbalance and disorientation, including reduced
muscle tone, gait and postural ataxia, and illusory self-orientation
and self-motion sensations.  Typically, these symptoms abate as
central nervous system motor programs for the reinterpretation of
sensory inputs and coordination of muscle actions undergo adaptation.

Postural control results from the integration of vestibular signals
with input from the visual and somatosensory receptors and other
motor control systems.  These integrated inputs, in turn, generate
complex activation patterns of arm, leg, trunk, and neck muscles
resulting in stabilizing movements.  To date, there has been little
systematic study of the contributions of the vestibular system to
balance control.  Early studies have underscored the primacy of
proprioceptive afferent signals from the lower leg muscles in
postural control.  Only when experimental manipulations render
proprioception inaccurate will vestibular inputs acquire greater
importance.  It has, therefore, been suggested that stabilizing
reactions may be triggered or gated by proprioceptive inputs and then
amplitude-modulated by vestibulo-spinal inputs.  Somatosensory input
from the limbs may be of greater importance to terrestrial balance
control than vision.  In the weightlessness of space, however,
vision is of primary importance in maintaining a spatial reference
for self-orientation.

Several lines of evidence support the contemporary view that both the
vestibular and somatosensory systems play a direct and prominent role
in terrestrial balance control, although the specific role of each in
triggering and coordinating postural corrections in response to
mechanical perturbations of the support surface, the head and the
trunk, remain to be elucidated.  There is convincing anatomic and
physiologic evidence of the convergence and interaction of the
vestibular and somatosensory systems at multiple levels throughout
the neuroaxis, at both the sensory input and motor output stages.
Furthermore, there is experimental evidence of a sensory substitution
process following the loss of either vestibular or somatosensory
inputs.  Both visual and vestibular inputs have been implicated in
the control of head stabilizing mechanisms during natural motion.
The otolithic organ-dependent response of the lower extremity
postural reflexes have been shown to be reduced in humans during
parabolic flight and space orbit in response to sudden "falls."  In
addition, patients with vestibular loss have been shown to exhibit
alterations in the magnitude, timing and adaptation of stabilizing
reactions to mechanical support surface perturbations.

Scope

The challenge of this initiative is to define the contributions of
the vestibular system to the control of balance and posture and the
regulation of locomotion and other volitional movements.  Such
knowledge will provide a solid empirical basis for the improved
rehabilitation of patients with balance disorders and for management
of the sensorimotor and perceptual difficulties associated with space
travel.  Our understanding of postural adaptation to microgravity is
limited, but clearly predicated on an understanding of normal
function in the terrestrial gravito-inertial environment.  Hence the
need for ground-based studies.

While the neural pathways subserving the gaze-stabilizing reflexes
are well-understood, we have a very rudimentary understanding of the
neuronal substrates of the postural reflexes.  Mathematical modeling
of reflex behavior has proven to be an important method for relating
reflex behavior to its neural substrates.  To date, the dynamic
three-dimensional spatial transformations associated with the
vestibulo-ocular and vestibulo-collic reflexes have been modeled.

The major research objective of this RFA is to characterize the
relative roles of the semicircular canal, otolithic organ and
canal-otolithic organ interactive inputs to the vestibulo-spinal
reflexes and the balance motor control systems.  A requisite
component of this research effort includes the development of a
computational model of the sensory-to-motor transformation relating
the vestibular balance control system to its neural substrates.  This
model should be driven and validated by experimental data generated
by this project.  The Center is intended to support a team of
investigators pursuing basic and applied studies at the systems and
neuronal substrate levels to conduct an integrated, multidisciplinary
inquiry into the vestibular bases of balance control.

The purpose of the research training component of the Center is to
develop opportunities for training individuals to conduct research in
the vestibular sciences.  The research training program will provide
multidisciplinary training for physicians, predoctoral trainees and
postdoctoral trainees in the areas of vestibular science that are
encompassed by the application.  The research training component of
the Center must provide opportunities for individuals with varying
levels of research experience.  Program directors are expected to
select postdoctoral trainees who are genuinely interested in a career
in research.  Plans for recruitment of underrepresented minorities,
women, and persons with disabilities must be included within this
component of the application (see the announcement in the NIH Guide
for Grants and Contracts, Vol. 18, No. 20, June 9, 1989).

The Center will be established exclusively for ground-based research
and analysis; budgets of the approved center will not support space
flight experiments.  Center investigators wishing to propose space
experiments should submit appropriate applications in response to
formal NASA solicitations open for general competition.

It is required that a description of the institution's plan to
provide instruction on the responsible conduct of research be
included in the application (see the announcement in the NIH Guide
for Grants and Contracts, Vol. 19, No. 30, August 17, 1990).

SPECIAL REQUIREMENTS

The program director and one additional investigator of the Center
will meet annually in the Washington, DC area with the scientific
program staffs of the Division of Communication Sciences and
Disorders, NIDCD, and the Life Sciences Division, NASA, to review the
progress of the Center in the areas of research and research
training.

Budget requests for travel must reflect the costs associated with
this meeting.  In addition, applicants should state their willingness
to participate in this meeting.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are required to include minorities and women
in study populations so that research findings can be of benefit to
all persons at risk of the disease, disorder or condition under
study; special emphasis must be placed on the need for inclusion of
minorities and women in studies of diseases, disorders and conditions
which disproportionately affect them.  This policy is intended to
apply to males and females of all ages.  If women or minorities are
excluded or inadequately represented in clinical research,
particularly in proposed population-based studies, a clear compelling
rationale must be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information must be included in the form PHS 398 in
Sections 1-4 of the Research Plan AND summarized in Section 5, Human
Subjects.  Applicants are urged to assess carefully the feasibility
of including the broadest possible representation of minority groups.
However, NIH recognizes that it may not be feasible or appropriate in
all research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans [including American Indians or Alaskan Natives],
Asian/Pacific Islanders, Blacks, Hispanics).  The rationale for
studies on single minority population groups should be provided.

For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
diseases, disorders or conditions, including but not limited to
clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific questions(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and reflected
in assigning the priority score to the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants or cooperative agreements that do not comply with these
policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by November 15, 1992, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Center
director, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is helpful in planning for the review of
applications.  It allows NIDCD 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:

Earleen Elkins, Ph.D.
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
Room 400-B, Executive Plaza South
6120 Executive Boulevard
Rockville, MD  20892

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional business offices; from the Office of Grants Inquiries,
Division of Research Grants, National Institutes of Health, 5333
Westbard Avenue, Room 449, Bethesda, Maryland 20892, telephone
301/496-7441; and from the NIH program administrator named below.

The RFA label available in the PHS 398 application form must be
affixed to the bottom of the face page of the application.  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.  In addition, the RFA title and number must be typed on
line 2a of the face page of the application form and the YES box must
be marked.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed 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 copies of the application
must also be sent to Dr. Earleen Elkins at the address listed under
LETTER OF INTENT.

Applications must be received by December 15, 1992.  If an
application is received after that date, it will be returned to the
applicant.  The Division of Research Grants (DRG) will not accept any
application in response to this announcement 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 substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by NIH staff for
completeness and responsiveness.  Incomplete applications will be
returned to the applicant without further consideration.  If the
application is not responsive to the RFA, NIDCD staff will return the
application to the applicant.

If the number of applications is large, the NIDCD may conduct a
preliminary scientific peer review to eliminate those applications
that are clearly not competitive.  The NIDCD will withdraw from
further competition those applications judged to be noncompetitive
and notify the applicant and institutional official.

Those applications judged to be competitive will undergo further
scientific merit review and a site visit or applicant interview in
the Washington, DC area.  Those applications that are complete and
responsive will be evaluated in accordance with the criteria stated
below for scientific/technical merit by an appropriate peer review
group convened by the NIDCD and NASA.  The second level of review
will be provided by the National Deafness and Other Communication
Disorders Advisory Council and the NASA Life Sciences Division.

The Special Review Committee will use the following criteria in
evaluating applications:

a.  The criteria for reviewing the Center as an integrated effort
are:

o  the integration of the multidisciplinary enterprise with adequate
plans for interaction and communication of information among the
collaborating investigators;

o  the coordination and interrelationship among the individual
research projects and cores and the relationship of the project
objectives to the common theme;

o  leadership ability and scientific stature of the Center director
and his/her commitment of sufficient time and effort for effective
leadership;

o  participation of a suitable number of responsible, experienced
investigators;

o  an organizational and administrative structure appropriate for
effective attainment of program objectives;

o  arrangements for internal quality control of ongoing research, the
allocation of funds, day-to-day management, collaborative
arrangements with other institutions, if any;

o  the adequacy of facilities to support the components of the
Center;

o  institutional commitment to the requirements of the Center;

o  appropriateness of the overall budget for the proposed program;
and

o  the technical merit and justification of each core unit; the
appropriateness of each research project's use of core services; and
the cost effectiveness and quality control of core units.

b.  The criteria for reviewing individual research components are:

o  approach and adherence to the scientific requirements of the RFA;

o  the scientific merit of each project;

o  qualifications, experience, and commitment of the investigators
and their ability to devote the required time and effort to the
program;

o  the appropriateness of the budget for each research project;

o  adequacy of the means proposed for protecting against risks to
human subjects, animals and the environment; and

o  the inclusion of minorities and women in study populations,
whenever feasible and appropriate.

c.  The criteria for reviewing the research training component are:

o  the proposed research training objectives and program design;

o  qualifications and research experience of the participating
faculty in the proposed areas of research training;

o  adequacy of the training environment, including laboratory and
clinical facilities;

o  the previous training record of the research program; and

o  the plan to provide instruction to trainees on ethics and
scientific integrity in research.

In addition, the research training component must include an
affirmative plan for the recruitment of underrepresented minorities,
women, and disabled individuals.

AWARD CRITERIA

The anticipated date of award is July 1993.

Selection will be made jointly by the NIDCD and NASA on the basis of
assessment of the applications by peer review, considerations of
programmatic balance, and the appropriation of allocated funds for
this RFA.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Daniel A. Sklare, Ph.D.
Division of Communication Sciences and Disorders
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400-B
6120 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 402-3461
FAX:  (301) 402-6251

Direct inquiries regarding fiscal matters to:

Sharon Hunt
Grants Management Branch
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400-B
6120 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 402-0909
FAX:    (301) 402-1758

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.173 .  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 42CFR 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.