Full Text DC-93-01


NIH GUIDE, Volume 21, Number 26, July 17, 1992

RFA:  DC-93-01

P.T. 34

  Sensory System 

National Institute on Deafness and Other Communication Disorders

Letter of Intent Receipt Date:  October 26, 1992

Application Receipt Date:  November 30, 1992


The National Institute on Deafness and Other Communication Disorders
(NIDCD) invites research grant (R01) applications focused on the
application of olfactory evoked potentials to address basic and
clinical research issues in the area of olfaction.  The scope of
studies applicable to the present Request for Applications (RFA)
includes the identification of the cortical generators of the
potentials, differentiation and control of olfactory and chemosensory
trigeminal stimulation, and anatomic diagnosis of chemosensory


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,
Olfactory Evoked Potentials, is related to several priority areas,
including nutrition, environmental health, maternal and infant health,
and cancer, as they relate to dysfunctions of the sense of smell.
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).


Applications may be submitted by domestic and foreign 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.


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.
The total project period for applications submitted in response to the
present RFA may not exceed five years.
This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all investigator-initiated
applications and be reviewed according to the customary peer review

The NIDCD appreciates the value of complementary funding from other
public and private sources, including foundations and industrial
concerns, for activities that will complement and expand those
supported by the NIDCD.


It is expected that $725,000 will be available for the first year of
support (direct and indirect costs) for the entire program and that
from two to four applications will be funded.  The level of support is
dependent on the scientific merit and scope of the applications and the
availability of funds.



Intensive research on visual, auditory, and somatosensory evoked
potentials has provided a large body of valuable information on how
various parts of the nervous system respond to a presented stimulus.
For example, auditory evoked potentials have proved useful for
differentiating sensory and neural hearing loss, for detecting tumors
and other disease states affecting central auditory pathways, and for
noninvasively detecting hearing loss in newborns and infants.  In
addition, development of new stimulus delivery systems and recording
electrodes now permits the use of auditory brainstem responses for
intraoperative monitoring of patients with head injuries.

In comparison to visual, auditory, and somatosensory evoked potentials,
olfactory evoked potentials have received much less attention, and
their development and application has progressed much more slowly.
Investigators have often experienced considerable difficulties in
controlling olfactory stimulation and have found it necessary to employ
special olfactometers and procedures to present identical stimuli with
steep rise and fall times, that is, stimulus delivery that produces
approximate square waves.  Precise delivery of the chemical stimulus
must be achieved without altering the mechanical or thermal conditions
at the stimulated mucosa.  Some unwanted non-chemosensory events,
notably neuromuscular events, can be eliminated by the use of a
procedure in which the stimulus is delivered intranasally and closure
of the soft palate isolates the nasal cavity from the oral cavity.
Cognitive events related to voluntary sniffing are also eliminated by
this procedure.

To date, only late near-field olfactory evoked potentials have been
recorded in humans.  Although the site of the cortical generators of
olfactory evoked potentials has not been identified, studies suggest
that the generators originate from a neocortical olfactory projection
area in the orbitofrontal cortex.  Evoked magnetic field recordings
indicate that responses to chemosensory trigeminal stimuli are
generated in the secondary somatosensory cortex.

The topographical distribution of chemosensory evoked potentials
appears to be useful in differentiating chemosensory trigeminal from
olfactory activity.  For example, after stimulation with ammonia,
maximum amplitudes were recorded contralateral to the stimulated
nostril; after stimulation with vanillin, little difference in
amplitudes was seen between hemispheres. Measurements of latency and
waveform complexity may also provide useful topographical information.
Additional investigations of the topographical distribution of
chemosensory evoked potentials could prove helpful in the
interpretation of the psychophysical interactions between the
trigeminal and olfactory systems and in the differentiation of
olfactory and chemosensory trigeminal disorders.

At present, psychophysical techniques do not provide an anatomic
diagnosis of chemosensory disorders.  Hope for progress in this area of
differential anatomic diagnosis has led to renewed interest in the
clinical application of olfactory evoked potentials.  Additional
research is needed to determine the degree to which olfactory evoked
potentials will attain fundamental research importance and clinical
usefulness comparable to visual, auditory, and somatosensory evoked


This RFA is aimed at stimulating investigators to utilize olfactory
evoked potentials to advance fundamental research and clinical research
progress in the area of olfaction.  Applicants must address specific
hypotheses or research questions related to olfaction.

A wide spectrum of research topics is acceptable for this RFA. Studies
may include those below.  Investigators are encouraged to consider
other topics relevant to this program.

o  Identify the cortical generators of olfactory evoked potentials and
other chemosensory evoked potentials.

o  Differentiate olfactory disorders from chemosensory trigeminal

o  Identify the sites of anatomic damage in patients with olfactory

o  Investigate individual differences in the rate of adaptation as
measured by olfactory evoked potentials.

o  Investigate the usefulness of olfactory evoked potentials for the
diagnosis of dysosmia, hyperosmia, hyposmia, and anosmia.

o  Determine the effects of different odor qualities on olfactory
evoked potentials.

o  Identify chemicals that differentially stimulate the various
chemoreceptive systems in the nose.

o  Develop a measure of the olfactory epithelial potential analogous to
the electroretinogram.

Close interactions are encouraged among investigators in and outside
the field of  olfaction and among those in various disciplines,
including neurophysiology, psychophysics, otolaryngology, and other
medical disciplines.



NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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 2,
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.

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

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.


Prospective applicants are asked to submit, by October 26, 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 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:

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


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 under

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 2 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

Applications must be received by November 30, 1992.  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 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.

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.


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 contact the
applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications at the next review cycle.

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

Review criteria for this RFA is generally the same as those for
unsolicited research 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 aea of the proposed

o  availability of resources necessary to perform the research; and

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


The anticipated date of award is July 1993.

Awards will be made on the basis of the quality of the proposed project
as determined by peer review, program balance among research areas, and
level of funding set aside for this RFA.


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:

Jack Pearl, 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) 402-3464
FAX:  (301) 402-6251

Direct inquiries regarding fiscal matters to:

Sharon Hunt
Division of Extramural Activities
Grants Management Branch
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) 402-6251


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.


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