Full Text DC-96-003
 
PHYSIOLOGIC AND MOLECULAR BASES OF TINNITUS
 
NIH GUIDE, Volume 25, Number 10, March 29, 1996
 
RFA:  DC-96-003
 
P.T. 34

Keywords: 
  Communicative Disorders, Hearing 
  Hearing 

 
National Institute on Deafness and Other Communication Disorders
 
Letter of Intent Receipt Date:  April 22, 1996
Application Receipt Date:  May 22, 1996
 
PURPOSE
 
The National Institute on Deafness and Other Communication Disorders
(NIDCD) invites applications for the support of exploratory research
addressing the physiologic and molecular bases of tinnitus.  The goal
of this Request For Applications (RFA) is to stimulate research on
pathologic processes in the auditory system that produce tinnitus.
 
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 area.  This
RFA, Physiologic and Molecular Bases of Tinnitus, is related to the
priority area of diabetes and chronic disabling diseases.  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 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic for-profit and non-profit
organizations, such as universities, colleges, hospitals,
laboratories, units of state and local governments, and eligible
agencies of the Federal government.  Foreign institutions or
institutions located in foreign countries are ineligible.
Applications from minority individuals, women, and persons with
disabilities are encouraged.
 
MECHANISM OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH)
exploratory/developmental (R21) grant mechanism.  This mechanism is
designed to encourage the development of new research activities for
which substantial preliminary data are not yet available.  Although
preliminary data as evidence of feasibility are not required, the
applicant bears the responsibility for developing a sound research
plan.  The total project period for an application submitted in
response to this RFA may not exceed two years.  The R21 grant is not
renewable, but future project continuation is possible through other
grant mechanisms, such as the research project grant (R01), First
Independent Research Support and Transition (FIRST) Award (R29) and
the program project (P01).  Continuations will compete with all
investigator-initiated applications and be reviewed according to the
customary peer review procedures.  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, with an anticipated award date
of December 1, 1996.   The maximum funding levels and time frames of
project support for the R21 awards indicated here are specific to
this solicitation.
 
FUNDS AVAILABLE
 
The total funds available (direct and indirect costs) for the first
year of support for successful responses to this RFA is $750,000,
with maximum direct costs per grant per year of $100,000.  The NIDCD
anticipates making three to five awards under this solicitation.
However, awards pursuant to this RFA are contingent upon the
availability of funds for this purpose.
 
RESEARCH OBJECTIVES
 
Background
 
Tinnitus, the subjective perception of sound in the absence of
acoustic stimulation, is a condition that affects at least 18.5
million people in the United States.  Tinnitus is an important
national health problem, affecting many people to the point that
normal occupational and social activities are precluded.  It usually
results from a disease of the auditory system that also produces
hearing impairment.  Tinnitus is a symptom that can result from
pathologic conditions affecting various parts of the auditory system.
Although the initial insult that produces tinnitus may be known,
there is little, if any, evidence implicating specific physiologic or
molecular mechanisms in the pathogenic process.  Without information
on specific pathophysiologic mechanisms, rational therapeutic
strategies cannot be formulated.
 
An NIDCD-sponsored workshop to define future directions for tinnitus
research was held in March, 1995.  Copies of the workshop report may
be obtained by contacting the program officer listed under INQUIRIES.
 
Recent advances in the physiology and molecular biology of the
auditory system have provided insights into the function of the inner
ear and the auditory portion of the central nervous system.  For
example, the characterization of the membrane properties of the
sensory and neural elements within the organ of Corti has begun to
provide an understanding of the molecular bases of auditory function.
Molecular techniques have been used to identify specific cellular ion
transport processes that contribute to auditory function, as well as
many of the neurotransmitters at specific synapses throughout the
auditory neural axis.  There has been greater clarification of the
relationship between the perception of stimulus variables and the
neural codes for  intensity, frequency, and temporal characteristics
of sound.  Working models of auditory perception have been produced
which link contemporary psychoacoustic and physiologic research.
Thus, progress in auditory system research has advanced this field to
the point that concerted study of the problem of tinnitus is now
possible.
 
Research Goals and Scope
 
There is a need to apply the results of recent research in the
physiology and molecular biology of the auditory system to explore
pathologic mechanisms that may induce tinnitus.  Areas of research on
the physiologic and molecular mechanisms of tinnitus that would be
responsive to this RFA include, but are not limited to:
 
o  animal models of specific pathophysiologic conditions known to
induce tinnitus;
 
o  genetic predisposition as a factor in differential responses to
insults that produce tinnitus or tinnitus-like abnormal neural
activity;
 
o  neural plasticity, or the ability of neuronal fields to alter
their sensory input characteristics in response to insults or stress,
as it relates to stimuli (e.g. noise) or lesions known to induce
tinnitus or abnormal electrical activity in the auditory system;
 
o  the effects of aging on the auditory system as a factor that may
predispose the development of tinnitus;
 
o  animal models of the physiologic basis for electrical stimulation
to reduce tinnitus in cochlear implant patients;
 
o  the effects of tinnitus-inducing stimuli or lesions on the
expression of neurotransmitters and their receptors in the auditory
nervous system;
 
o  the mechanisms involved in noise-induced and ototoxicity-induced
alterations in auditory function, including basilar membrane
mechanics, effects on inner and outer hair cells, cochlear afferent
and efferent neural activity, and the release of potentially
neuromodulatory substances; and
 
o  the role of cochlear blood flow and cellular ion transport
mechanisms, related to their effects on the generation or maintenance
of tinnitus.
 
SPECIAL REQUIREMENTS
 
Principal Investigators of grants awarded under this RFA will be
expected to attend an annual meeting to report their research
progress.  This meeting will be held on the NIH campus, Bethesda, MD,
and funds should be included in the budget to cover the costs of
attendance at this meeting for the Principal Investigator.
 
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
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492 B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women and Minorities in Study
Populations, and Concerning the Inclusion of Minorities in Study
Populations) which have been in effect since 1990.  The new policy
contains some new provisions that are substantially different from
the 1990 policies.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines on the 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
errors in the earlier publication, and reprinted in the NIH GUIDE FOR
GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.
 
Investigators may obtain copies from these sources or from the
program staff or contact person listed under INQUIRIES.  Program
staff may also provide additional relevant information concerning the
policy.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by April 22, 1996, 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 application, the information that it contains allows
NIDCD staff to estimate the potential review workload and avoid
conflict of interest in the review.
 
The letter of intent is to be sent to:
 
Marilyn Semmes, Ph.D.
Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Suite-400C - MSC-7180
Bethesda, MD  20892-7180
Telephone:  (301) 496-8683
FAX:  (301) 402-6250
Email:  Marilyn_Semmes@nih.gov
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  Applications kits are available at
most institutional offices of sponsored research and may be obtained
from the Grants Information Office, Office of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714,
email:  ASKNIH@odrockm1.od.nih.gov.
 
The RFA label available in the PHS 398 (rev. 5/95) application kit
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
6701 ROCKLEDGE DRIVE, ROOM 1040 -MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for courier/overnight service)
 
At the time of submission, two additional copies of the application
must be sent to:
 
Marilyn Semmes, Ph.D.
Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Suite 400C - MSC-7180
Bethesda, MD  20892-7180
Telephone:  (301) 496-8683
 
Applications must be received by May 22, 1996.  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 RFA that is essentially
the same as one currently pending initial review, unless the
applicant withdraws the pending application, nor will DRG 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 for completeness by the
DRG and for responsiveness by NIDCD staff.  Incomplete and/or
nonresponsive applications will be returned to the applicant without
further consideration.
 
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIDCD, in accordance with NIH peer
review procedures.  As part of the initial merit review, all accepted
applications will receive a written critique and may undergo a
process in which only those applications deemed to have the highest
scientific merit, generally the top half of all applications under
review, will be discussed, assigned a priority score, and receive a
second level review by the National Deafness and Other Communication
Disorders Advisory Council.
 
Review Criteria
 
A direct relevance to the elucidation of specific pathologic
mechanisms that may produce tinnitus is mandatory for an application
to be considered responsive to this announcement.  However,
preliminary data are not required.
 
Additional review criteria include:
 
o  scientific, technical, or medical significance and originality of
proposed research;
 
o  characterization as an innovative or high risk pilot project;
 
o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
 
o  probability the study will provide a basis for more extended
research in the relevant area;
 
o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
 
o  availability of the resources necessary to perform the research;
 
o  appropriateness of the proposed budget and duration in relation to
the proposed research; and
 
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 will also be
evaluated.
 
The initial review groups will also examine the provisions for the
protection of human and animal subjects, and safety of the research
environment.
 
Note:  Because of the high risk feasibility-testing nature of the
applications support of salaries for student employees working on a
dissertation is discouraged.
 
AWARD CRITERIA
 
The following will be considered as funding decisions are made:  the
scientific and technical merit reflected in the priority score
assigned by the peer review group; programmatic priorities; and
availability of funds.
 
INQUIRIES
 
Written, telephone, and email inquiries concerning this RFA are
encouraged.  The opportunity to clarify any issues or questions from
potential applicants is welcomed.
 
Direct inquiries regarding scientific and programmatic issues to:
 
Kenneth A. Gruber, Ph.D.
Division of Human Communication
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Suite 400C - MSC-7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-3458
FAX:  (301) 402-6251
Email:  Kenneth_Gruber@nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Sharon Hunt
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Suite 400B - MSC-7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-0909
FAX:  (301) 402-1758
Email:  Sharon_Hunt@nih.gov
 
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 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 routine 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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