Full Text DC-96-001

DYSOSMIA AND DYSGEUSIA: MECHANISMS, ASSESSMENT, AND TREATMENT

NIH GUIDE, Volume 24, Number 13, April 7, 1995

RFA:  DC-96-001

P.T. 34

Keywords: 
  0765050 
  Treatment, Medical+ 


National Institute on Deafness and Other Communication Disorders

Letter of Intent Receipt Date:  June 1, 1995
Application Receipt Date:  July 11, 1995

PURPOSE

The National Institute on Deafness and Other Communication Disorders
(NIDCD) is soliciting research applications for basic and clinical
studies focused on the causes, diagnosis, and treatment of dysosmia
and dysgeusia (i.e., distortions of olfaction and gustation or
spontaneous chemosensation without identifiable chemosensory
stimuli).  Support for these studies will be through the
Exploratory/Developmental Grant mechanism (R21).  These pilot
project/feasibility studies provide flexibility for developing highly
creative research approaches for which substantial preliminary data
are not yet available.

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 Request
for Applications (RFA), Dysosmia and Dysgeusia: Mechanisms,
Assessment, and Treatment, is related to the priority area of
nutrition.  Potential applicants may obtain a copy of "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 for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of state or local governments, and
eligible agencies of the Federal government.  Applications from
minority individuals, women, and individuals with disabilities are
encouraged.  Applications from foreign institutions will not be
accepted.  However, subcontracts to foreign institutions are
allowable, with sufficient justification.

MECHANISM OF SUPPORT

Support for this program will be through the National Institutes of
Health (NIH) Exploratory/Developmental Grant mechanism (R21).  This
pilot project/feasibility study mechanism provides flexibility for
developing highly creative research approaches for which substantial
preliminary data are not yet available.  Although preliminary data as
evidence of feasibility are not a requirement, the applicant bears
the responsibility for developing a sound research plan.  Support
will be limited to a maximum of two years.  The R21 grants are not
renewable, but future project continuation is possible through other
grant mechanisms, such as the individual research project (R01) and
program project (P01).

Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  Awards will
be administered under PHS grants policy as stated in the Public
Health Service Grants Policy Statement.

This RFA is a one-time solicitation, with an anticipated award date
of December 1, 1995.  The levels and time frames for support of R21
awards indicated here are specific to this solicitation.

FUNDS AVAILABLE

It is anticipated that approximately $350,000 (direct plus indirect
costs) per year will be available beginning in fiscal year 1996 for
the support of meritorious applications submitted in response to this
solicitation.  This level of funding should permit the support of two
or three applications, depending on their cost.

RESEARCH OBJECTIVES

Dysosmia is a distortion of olfaction (e.g., a normally pleasant
odorant is perceived as unpleasant) or the perception of an odor for
which there is no chemosensory stimulus.  Dysgeusia is a distortion
of gustation (e.g., a normally pleasant tastant is perceived as
unpleasant) or the spontaneous perception of a taste for which there
is no chemosensory stimulus.  Dysosmia and dysgeusia occur commonly
and may or may not be associated with a loss of chemosensory
sensitivity.  Dysosmia and dysgeusia may occur spontaneously or only
be evoked by chemosensory stimuli in the environment.

Dysosmia and dysgeusia can impair food intake and, consequently,
nutritional status.  Dysosmia and dysgeusia have been attributed to a
diversity of medical conditions, agents, and events, including upper
respiratory infection, nasal and paranasal sinus disease, head
trauma, psychiatric conditions, toxic chemicals, medications, and
dental procedures.  Idiopathic dysgeusia has frequently been
associated with another disorder of oral sensation, burning mouth
syndrome.

Few studies have been reported on the systematic assessment and
treatment of dysosmia and dysgeusia, and difficulties in determining
their causal mechanisms have hindered etiologic and anatomic
diagnosis, prognosis, and treatment.  Although a number of approaches
to treatment of these dysfunctions have been suggested, none are as
yet widely accepted and used.

This initiative encourages research designed to contribute to the
understanding of the etiology and mechanisms of dysosmia and
dysgeusia and to the development of approaches to etiologic and
anatomic diagnosis, prognosis, treatment, and other therapeutic
interventions.  A broad range of research extending from the
molecular to the behavioral levels of basic and clinical research is
applicable to this program.  Examples of possible research approaches
are listed below and are in no way considered all inclusive.

o  Use of contemporary imaging techniques in studies of chemosensory
dysfunction; application of biochemical and molecular probes in
studies of biopsy material, secretions, and body fluids.

o  Refinement of psychophysical tests, such as tests of taste
function for specific regions of the tongue, and development of taste
tests for identifying quality-specific dysgeusias, such as salty
taste.

o  Development of experimental models of dysosmia and dysgeusia,
including the induction of these dysfunctions under controlled
conditions.

o  Use of topical anesthetics and quality-specific taste modifiers to
identify the origin of dysgeusias within the nervous system; use of
these agents as potential treatments for dysgeusia.

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
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 was reprinted in the Federal
Register of March 28, 1994 (FR 59 14508-14513) to correct typesetting
and errors in the earlier publication, and reprinted in the NIH GUIDE
FOR GRANTS AND CONTRACTS of March 18, 1994. Volume 23, Number 11,
March 18, 1994.

Investigators also may obtain copies of the policy from the program
staff listed  under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by June 1, 1995, a letter
of intent that includes a descriptive title of the proposed research,
the name, address, and telephone number of the Principal
Investigator, 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:

Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400-B
6120 Executive Boulevard  MSC 7180
Rockville, MD  20892-7180

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 offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892-7180,
telephone 301/710-0267; and from the NIH program administrator listed
under INQUIRIES.

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.

Send a signed, typewritten original of the application, including the
Checklist, and three exact single-sided copies, in one package to:

Division of Research Grants
National Institutes of Health
6701 Rockledge Drive, Room 1040 MSC-7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express or courier service)

At the time of submission, two additional copies of the application
and all five copies of the appendices must also be sent to the Chief,
Scientific Review Branch, at the address listed under LETTER OF
INTENT.

Applications must be received by July 11, 1995.  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 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 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 DRG staff for
completeness and by NIDCD for responsiveness.  Incomplete and/or non-
responsive applications will be returned to the applicant without
further consideration.

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.  The
second level of review will be provided by the National Deafness and
Other Communication Disorders Advisory Council.

As part of the initial merit review, a process (triage) will be used
by the initial review group in which applications will be determined
to be competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be competitive will be discussed and be
assigned a priority score.  Applications determined to be
non-competitive will be withdrawn from further consideration and the
Principal Investigator and the official signing for the applicant
organization will be notified.

Review criteria for this RFA are:

o  Scientific or technical merit and originality of proposed
research;

o  Appropriateness and adequacy of the experimental approaches and
methodologies proposed to carry out the research;

o  Availability of resources necessary to perform the research;

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

o  Adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects ill also be
evaluated.

AWARD CRITERIA

The following will be considered in making funding decisions:

o  Quality of the proposed project as determined by peer review;
o  Availability of funds.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Jack Pearl, Ph.D.
Division of Human Communication
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400-C
6120 Executive Boulevard MSC 7180
Bethesda MD  20892-7180
Telephone:  (301) 402-3464
FAX:  (301) 402-6251
Email:  Jack_Pearl@nih.gov

Direct inquiries regarding fiscal matters to:

Sharon Hunt
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400-B
6120 Executive Boulevard MSC 7180
Bethesda MD  20892-7180
Telephone:  (301) 402-0909
FAX:  (301) 402-1758

Schedule

Letter of Intent Receipt Date:  June 1, 1995
Application Receipt Date:       July 11, 1995
Scientific Review Date:         August 1995
Advisory Council Date:          September/October 1995
Earliest Award Date:            December 1, 1995

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 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 PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routing education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the phs
mission to protect and advance the physical and mental health of the
american people.

.

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