NIH GUIDE, Volume 21, Number 34, September 25, 1992

PA NUMBER:  PA-92-106

P.T. 34


  Communicative Disorders, Hearing 

  Biology, Cellular 

  Biology, Molecular 

National Institute on Deafness and Other Communication Disorders


The National Institute on Deafness and Other Communication Disorders

(NIDCD) invites grant applications addressing the identification of the

mechanisms involved in the repair and regeneration of damaged sensory

epithelial cells in the auditory periphery.  Innovative research on the

molecular bases of the repair process should elucidate ways to initiate

and control the regeneration of damaged hair cells.


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 (PA), Molecular Bases of Repair and Regeneration of the

Auditory Receptor, is related to the priority areas of occupational

safety and health; and diabetes and chronic disabling conditions.

Potential applicants may obtain a copy of "Healthy People 2000" (Full

Report:  Stock No. 017-001-11474-0 or 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.


Support mechanisms for this announcement include the individual

research project grant (R01) and the First Independent Research Support

and Transition (FIRST) Award (R29).  Foreign institutions are not

eligible for the FIRST Award.



More than 17 million Americans suffer from sensorineural hearing

impairment, which is often attributed to damage to the hair cells of

the cochlea.  Until recently, damage to these hair cells in mammals was

considered to be irreversible.  One of the most exciting discoveries of

the past decade has been that the auditory sensory epithelia of birds,

amphibians, and fish are capable of repair and regeneration after

damage by noise or drugs.  Studies have shown that the regenerated

cells establish functional neural connections.  In addition, precursor

cells for the regenerated cells have been identified and these

precursor cells appear to have mammalian homologues.  Recently,

regeneration of hair cells from postnatal birds has been achieved in

vitro.  Further elucidation of these repair and regeneration processes

should lead to therapeutic advances.

Research Goals and Scope

The ultimate goal of this PA is to gain the knowledge needed to

stimulate and control the repair processes involved in hair cell

regeneration so that sensorineural hearing loss due to hair cell damage

might be prevented or reversed.  Investigation of the molecular and

cellular mechanisms involved in the initiation and control of this

repair process is amenable to methods of modern biotechnology.

Innovative, multidisciplinary, state-of-the-art studies are encouraged

to determine the factors that initiate and control sensory cell

replacement and recovery of hearing.

Studies may include, but are not limited to, the topics listed below:

o  improved models of hair cell damage such that the resulting auditory

impairment is less variable, and therefore easier to control and study;

o  more specific identification of the cellular precursors of the

replacement hair cells and supporting cells;

o  identification of the factors that trigger the regeneration response

in the hair cell epithelia;

o  definition of the role of known mitotic growth factors and other

chemical agents (for example, retinoic acid) that may control and/or

trigger progenitor cell division;

o  development of pharmacologic agents for inducing and controlling

cell replacement and auditory recovery;

o  investigation of the molecular and cellular bases for hair cell

regeneration in the mammalian ear;

o  assessment of the contribution of other potential repair processes

in the ear, including repair of damaged subcellular components of hair

cells and repair of damaged links between sensory cells and the

overlying tectorial membrane;

o  evaluation of the role and extent of the re-establishment of

neuronal connections in the sensory organ for their contribution to the

recovery of hearing; and

o  correlation of structural changes with measures of functional

changes during the course of regeneration.





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 1-4

of the Research Plan AND summarized in Section 5, Human Subjects.

Applicants/offerors are urged to assess carefully the feasibility of

including the broadest possible representation of minority groups.

However, the 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 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 reflected in assigning

the priority score to the application.

All applications for clinical research submitted to the NIH are

required to address these policies.  NIH funding components will not

award grants or cooperative agreements that do not comply with these



Applications are to be submitted on the grant application form PHS 398

(rev. 9/91) and will be accepted at the standard application deadlines

as indicated in the application kit.  The receipt dates for

applications for AIDS-related research are found in the PHS 398


Application kits are available at most institutional business offices

and may be obtained from the Office of Grants Inquiries, Division of

Research Grants, National Institutes of Health, Westwood Building, Room

449,  Bethesda, MD 20892, telephone 301-496-7441.  The title and number

of the announcement must be typed in Section 2a on the face page of the


The completed original application and five exact copies must be sent

or delivered to:

Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**


Applications will be reviewed for scientific and technical merit by

study sections of the Division of Research Grants, NIH, in accordance

with the standard NIH peer review procedures.  Following

scientific-technical review, the applications will receive a

second-level review by the appropriate national advisory council.


Applications will compete for available funds with all other approved

applications.  The following will be considered as funding decisions

are made:

o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Program balance among research areas of the announcement


Written and telephone inquiries concerning this PA are encouraged.  The

opportunity to clarify any issues or questions from potential

applicants is welcome.

Direct inquiries regarding programmatic issues to:

Amy Donahue, Ph.D.

Chief, Hearing Program

Division of Communication Sciences and Disorders

National Institute on Deafness and Other Communication Disorders

Executive Plaza South, Suite 400-B

Rockville, MD  20892

Telephone:  (301) 402-3458

FAX:  (301) 402-6251

Direct inquiries regarding fiscal matters to:

Sharon Hunt

Grants Management Officer

Division of Extramural Activities

National Institute on Deafness and Other Communication Disorders

Executive Plaza South, Suite 400-B

Rockville, MD  20892

Telephone:  (301) 402-0909


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.


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