Subject: NIH GUIDE - RFA DC-92-05 - V20(33) 09/06/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Fri, 06 Sep 91 15:02 EST

Hi Paul,
  This is the first of l0 RFAs for the 9/6/9l NIH Guide.  Please post
this one to the NIH Listserver as:
     RFADC-92-05.910906
                       DSB
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA DC9205 DC-92-05 P1O1 *****************************************
 
REQUEST FOR APPLICATIONS
 
RFA:  DC-92-05
 
TRANSPORT OF SUBSTANCES IN THE OLFACTORY SYSTEM
 
P.T. 34; K.W. 0705070, 0710085
 
National Institute on Deafness and Other Communication Disorders
 
Letter of Intent Receipt Date:  October 25, 1991
Application Receipt Date:  November 27, 1991
 
PURPOSE
 
The National Institute on Deafness and Other Communication Disorders
(NIDCD) invites research project grant (R01) applications focused on the
transport of organic and inorganic substances into the peripheral and
central olfactory system and the effects of these substances on the
olfactory system.  Both basic and clinical studies of the olfactory
system are applicable to the present Request for Applications (RFA).
 
BACKGROUND
 
The olfactory receptor neurons of the olfactory neuroepithelium are in
direct contact with the external environment, and they are at risk to
potentially harmful infections or toxic agents.  It has been shown that
various organic and inorganic substances can be taken up by the
olfactory receptor neurons and transported by a vigorous axoplasmic
transport system into the olfactory bulb of the brain.  These substances
include dyes, amino acids, colloidal gold, and lectins.  Some of these
substances are transported transneuronally from the bulb into other
parts of the forebrain.  For example, recent studies have demonstrated
that a lectin conjugate (wheat germ agglutinin-horseradish peroxidase)
was transported from the olfactory nerve to the olfactory bulb and
subsequently to other areas of the forebrain.  In addition, the
olfactory neuroepithelium has been shown to be one of the portals of
entry of neurotropic viruses into the brain.  Certain arboviruses enter
the olfactory bulb through the olfactory nerve and spread to other parts
of the brain.  Herpes simplex virus type 1 has been observed in the
olfactory bulb.  Certain viruses appear to have a greater propensity to
infect the olfactory neuroepithelium than the respiratory epithelium,
whereas the reverse is true of other viruses.  According to some
investigators, the olfactory deficits expressed in the early stages of a
number of disorders may result from substances that entered the brain
through the olfactory nerve.
 
Studies of the axoplasmic transport process of the olfactory nerve also
have important implications for improved pharmacotherapy of the
olfactory system.  For example, this transport system potentially can
provide a route for administration of pharmacotherapeutics to specific
targets in the brain, avoiding the blood-brain barrier which ordinarily
prevents such access.
 
RESEARCH GOALS AND SCOPE
 
The research is to advance the understanding of olfactory mechanisms in
health and disease.  Both basic and clinical studies are applicable to
the stated purpose of this RFA.  Examples of areas of research include
but are not limited to:
 
o For any suspected toxin or pathogen, evidence of the causal
relationship to observed findings of damage to the olfactory system.
 
o Neurophysiological and histopathological studies that determine the
localization of the insults within the olfactory system.
 
o Investigations into the molecular mechanisms triggered by insults to
the olfactory system.
 
o Defense mechanisms in the olfactory system against toxins and
pathogens.
 
o Normal and abnormal prograde and retrograde axoplasmic transport in
the olfactory nerve.
 
o Active and passive mechanisms of uptake of substances into the
olfactory neuroepithelium.
 
o Comparison of effects of pathogens on olfactory and nasal trigeminal
nerves.
 
o Interactions between olfactory nerve and brain tissue.
 
o Transneuronal transport of substances from olfactory bulb to other
parts of the forebrain.
 
ELIGIBILITY
 
Any of the following organizations are eligible to apply:  non-profit
institutions of higher education; other non-profit and for-profit
organizations; state and local governments and their agencies; and
authorized Federal agencies.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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 in Section 2,
A-D of the Research Plan AND summarized in Section 2, E, 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 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
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 and 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.
 
MECHANISM FOR SUPPORT
 
This RFA will use the National Institutes of Health (NIH) individual
research project grant (R01).  Applicants will be responsible for the
planning, direction, and execution of the proposed project.  All policy
requirements that govern the grant programs of the Public Health
Services apply.
 
Up to three meritorious applications will be funded.  The earliest
possible start date for the initial award will be July 1, 1992.  Funding
for these grants beyond the initial period will be subject to
competitive renewal.
 
Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research.  In such a case, a letter of agreement from either the GCRC
program director or Principal Investigator may be included with the
application.
 
RECEIPT AND REVIEW SCHEDULE
 
The schedule for receipt and review of applications is:
 
Receipt        Initial      Advisory Council    Earliest Start
Date           Review       Review              Date
 
Nov. 29, 1991  Feb/Mar      May/June            July 1, 1992
 
Applications received after the receipt date specified above will be
returned to the applicant.
 
REVIEW PROCEDURES AND CRITERIA
 
Applications will be evaluated by Institute staff to determine
responsiveness to the RFA.  Responsive applications will be evaluated
for scientific/technical merit as stated in form PHS 398 by a review
committee convened by the Scientific Review Branch of NIDCD solely for
this purpose.  A second level review will be by the National Deafness
and Other Communication Disorders Advisory Council.
 
METHOD OF APPLYING
 
Applications must be submitted on form PHS 398 (rev. 10/88) using the
instructions included in the application kit.  These kits are available
from the NIDCD Program Administrator address cited below and from the
Division of Research Grants, National Institutes of Health, Westwood
Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441.
 
On page 1 of form PHS 398, check "yes" in item 2 and type:  DC-92-05,
Transport of Substances in the Olfactory System.
 
The RFA label available in the 10/88 revision of application form PHS
398 must be affixed to the bottom of the face page.  Failure to use this
label could result in delayed processing of the application such that it
may not reach the review comittee in time for review.
 
Send the original and four copies of the application to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
To expedite the review, send two copies of the application to:
 
Dr. Earleen Elkins
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
National Institutes of Health
Executive Plaza South, Room 400-B
6120 Executive Boulevard
Rockville, MD  20892
 
LETTER OF INTENT
 
Prospective applicants are asked to submit by October 25, 1991, a letter
of intent that includes a descriptive title of the proposed application,
the name, address, and telephone number of the Principal Investigator,
the names of other key personnel, the participating institutions, and
the number or title of this RFA.
 
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 Institute 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 Dr. Jack Pearl at the address
below.
 
IDENTIFICATION OF CONTACT POINTS
 
Investigators are encouraged to call or write:
 
Jack Pearl, Ph.D.
Program Administrator
Division of Communication Sciences and Disorders
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 446
6120 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 496-5061
FAX:  (301) 402-6251
 
For questions concerning budget and fiscal matters, contact:
 
Sharon Hunt
Grants Management Officer
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400-B
6120 Executive Blvd.
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, Research Related to Deafness and Communication Disorders.
Awards will be made under the authority of the Public Health Service
Act, Section 301 (Public Law 78-410, as amended; 42 USC 241) and
administered under PHS grants policies and Federal Regulations 42 CFR
Part 52 and 45 CFR Part 74.  The program is not subject to the
intergovernmental review requirements
of Executive Order 12372 or review by a Health Systems Agency.