HIGH IMPACT RESEARCH:  FEASIBILITY STUDIES

NIH GUIDE, Volume 26, Number 39, December 5, 1997

PA NUMBER:  PAR-98-015

P.T.

National Institute on Deafness and Other Communication Disorders

Application Receipt Date:  March 12, 1998

PURPOSE

The National Institute on Deafness and Other Communication Disorders (NIDCD)
invites grant applications from basic and clinical investigators who are
interested in pursuing feasibility studies of high impact (HI) research focused
on hearing, balance, smell, taste, voice, speech, or language related to the
specific mission of the NIDCD.  This Program Announcement (PA) supersedes a
previous NIDCD PA:  Exploratory/Developmental Grants for High Risk/High Impact
Research, PAR-96-073 (NIH Guide, Vol. 25, No. 31, September 20, 1996).  HI
research involves pilot/feasibility studies in which the technological,
methodological, or theoretical approach to the problem lacks a traditional
historical basis or pilot data, but which could have a major impact on a
scientific area or field.  Descriptions for the characteristics of this /HI
research have included "groundbreaking," "revolutionary," and "paradigm shifting"
(High Risk/Innovative Research Identification in NIH Peer Review Notes, Division
of Research Grants, June 1993).  This research program will be supported through
Exploratory/Developmental (R21) Grants restricted in level of support and in
time.  These grants provide support for the development of a basis for more
extensive traditional research projects.  This PA is a solicitation for a single
receipt date, March 12, 1998.

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 PA, High Impact Research: Feasibility
Studies, is related to the priority areas of diabetes and chronic disabling
conditions and special population objectives.  Potential applicants may obtain
a copy of "Healthy People 2000" (Full Report:  Stock No. 017-001-11474-0 or
Summary Report:  Stock No. 017-001-00473-1) 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, 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.  Foreign organizations or
organizations in foreign countries are not eligible; subcontracts to foreign
organizations are allowable, with sufficient justification.

Submission of an application under this Program Announcement precludes concurrent
submission of any other application containing substantially the same research
proposal. In addition, these R21 awards may not be used to supplement research
projects currently supported by Federal or non-Federal funds, or to provide
interim support of projects under review by the Department of Health and Human
Services.

MECHANISM OF SUPPORT

Support for this program will be provided through the National Institutes of
Health (NIH) Exploratory/Developmental Grants (R21) mechanism.  The mechanism
offers support for HI research that lacks a traditional historical basis or
preliminary data.  Areas of science in which there is a sufficient historical
basis or sufficient preliminary data to support the submission of a regular
research project grant application do not qualify under this Program
Announcement.  However, the applicant does have the responsibility for developing
a demonstrably sound research plan designed to assess the feasibility of the
proposed pilot projects.  It is expected that the preliminary data generated by
these grants will serve as a basis for more extensive research projects.

This initiative provides nonrenewable awards for up to two years of support and
up to $50,000 in direct costs per year; Facilities and Administration (F&A) costs
applicable to sub-contract/consortium activity must be included under the direct
cost ceiling levels. The grants may be extended in time, but not amount, at the
discretion of the applicant organization.

Investigators are encouraged to consider carefully whether their research can
best be accomplished through this or other grant mechanisms, such as the R01 or
the small grant (R03) program of the NIDCD for scientists who are in the early
stages of pursuing an independent research career (NIH Guide, Vol. 25, No. 41,
November 29, 1996).

RESEARCH OBJECTIVES

The purpose of this PA is to encourage the submission of feasibility studies by
basic and clinical investigators who are interested in pursuing HI research that
has the potential for leading to a technological, methodological, or conceptual
breakthrough or major contribution in biomedical or behavioral research. Studies
that enhance the significance and innovativeness of the research by bridging one
line of investigation with another are encouraged.  The research must be focused
on one or more areas within the scientific mission of the NIDCD:  hearing,
balance, smell, taste, voice, speech, and language.

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 are provided that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the research.  This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43).

All investigators proposing research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11,
March 18, 1994.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95). Applications kits are available at most institutional offices of sponsored
research and may be obtained from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda, MD 20892-7910, telephone 301/435-710-0267, email:
ASKNIH@od.nih.gov.  The title and number of the program announcement must be
typed in Section 2 on the face page of the application.

Justify the designation of the application as a feasibility study for HI research
in an introductory paragraph at the beginning of the research plan.  Justify why
the project requires additional data and why it would not be appropriate for a
traditional research grant.

o  Do not exceed a total of 10 pages for the research plan, sections a-d.  This
limitation includes tables and figures but not sections e-i.

o  Appendix may not be used to circumvent the page limitations.

Applications that lack the introductory justification or exceed the page
limitation will not be reviewed and will be returned to the investigator.

The following modifications regarding the budget are to be used in conjunction
with the information accompanying application form PHS-398 (rev. 5/95).

Detailed Budget for Initial Budget Period (page 4).  Do not submit this page.
Certain details of the budget may be requested prior to any award.

Budget for Entire Proposed Period of Support (page 5).  Enter total direct costs
requested in the box at the bottom of the table.

Justification (page 5)

o  List the name, role on project and percent effort for all project personnel
(salaried or unsalaried) and provide a narrative justification for each person
based on his/her role on the project and proposed level of effort.

o  Identify all consultants by name and organizational affiliation and describe
the services to be performed.

o  Provide a narrative justification for any major budget items, other than
personnel, that are requested for the conduct of the project that would be
considered unusual for the scope of research.  No specific costs for items or
categories should be shown.

o  F&A costs will be calculated at the time of the award using the institution's
actual F and A cost rate.  Applicants will be asked to identify the F&A base
exclusions prior to award.

o If consortium/contractual costs are requested, provide the percentage of the
subcontract total costs (direct and F&A) relative to the total direct costs of
the overall project.  The subcontract budget justification should be prepared
following the instructions provided above.

The completed original application and three legible copies must be sent or
delivered to:

CENTER FOR SCIENTIFIC REVIEW (formerly Division of Research Grants)
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817-7710 (for express/courier service)

At the time of submission, send two additional copies of the application to:

Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-C, MSC 7180
Bethesda, MD  20892-7180

The application receipt date is March 12, 1998, applications received after this
date will be returned to the applicant.  The earliest date of award is December
1, 1998.  This program announcement may be reissued.

REVIEW CONSIDERATIONS

Applications that are judged as complete and responsive to this PA by NIDCD staff
will be reviewed for scientific and technical merit in accordance with the
standard NIH procedures by a review group convened by the NIDCD.  As part of the
initial review, all applications will receive a written critique; those
applications deemed to have the highest merit, generally the top half of
applications under review, will be discussed, assigned a priority score, and
receive a second level of review by the NIDCD Advisory Council.

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  In the
written comments reviewers will be asked to discuss the following aspects of the
application in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals.  Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application.  The application does not need to be strong in
all categories to be judged likely to have major scientific impact and thus
deserve a high priority score.

(1) Significance:  Does this feasibility study address an important problem?  If
the aims of the application are achieved, how will scientific knowledge be
advanced?  What will be the effect of these studies on the concepts or methods
that drive this field and other fields?  Does the successful completion of the
study have the potential to be groundbreaking, revolutionary, or paradigm
shifting, and to lead directly to more extensive studies that would likely
achieve these goals?

(2) Approach:  Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?  Does the application contain a demonstrably sound plan
designed to assess the feasibility of the pilot project?

(3) Innovation:  Does the project employ novel concepts, approaches or method?
Are the aims original and innovative?  Does the project challenge existing
paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the investigator appropriately trained and well suited to
carry out this work?  Is the work proposed appropriate to the experience level
of the principal investigator and other researchers (if any)?

(5) Environment:  Does the scientific environment in which the work will be
conducted contribute to the probability of success?  Is there evidence of
institutional support for feasibility studies and traditional NIH research?  Are
there special opportunities available for furthering research programs through
the use of unusual talent resources, populations, or environmental conditions? 
Do the proposed experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, 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.

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

o  The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project proposed
in the application.

AWARD CRITERIA

Applications will compete for available funds with all other favorably
recommended applications.  Funding decisions will be based on the quality of the
proposed project as determined by peer review, relevance to the mission of the
NIDCD, program priorities, and availability of funds.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions
from potential applicants is encouraged.

Direct inquiries regarding programmatic issues, including eligibility and
responsiveness, to:

Hearing:
Dr. Chyren Hunter
Telephone:  (301) 402-3461
Email:  Chyren_Hunter@nih.gov

Balance/Vestibular:
Dr. Daniel Sklare
Telephone:  (301) 496-1804
Email:  Daniel_Sklare@nih.gov

Chemical Senses:
Dr. Jack Pearl
Telephone:  (301) 402-3464
Email:  Jack_Pearl@nih.gov

Dr. Rochelle Small
Telephone:  (301) 402-3464
Email:  Rochelle_Small@nih.gov

Voice/Speech:
Dr. Beth Ansel
Telephone:  (301) 402-3461
Email:  Beth_Ansel@nih.gov

Language:
Dr. Judith Cooper
Telephone:  (301) 496-5061
Email:  Judith_Cooper@nih.gov

The address and FAX number for the above named persons are:

Division of Human Communication
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-C, MSC-7180
Bethesda, MD  20892-7180
FAX: (301) 402-6251

Direct inquiries regarding fiscal matters to:

Sharon Hunt, Chief
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-B, MSC  7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-0909
FAX:  (301) 402-1758
Email:  SH79F@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 and 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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