HIGH IMPACT RESEARCH: FEASIBILITY STUDIES

Release Date:  April 29, 1999

PA NUMBER:  PAR-99-092

P.T.

National Institute on Deafness and Other Communication Disorders

Application Receipt Date: August 24, 1999

THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.

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: High Impact Research: Feasibility Studies, PAR-98-015 (NIH
Guide, Vol. 26, No. 39, December 5, 1997).  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 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, August 24, 1999.

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 PA 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 project.  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 subcontract/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.  The R03 program is for scientists
who are in the early stages of pursuing an independent research career, but are
not yet ready to submit a new-investigator R01 application for the project of
focus (NIH Guide, PAR-99-018, November 25, 1998).

Specific application instructions have been modified to reflect "MODULAR GRANT"
and "JUST-IN-TIME" streamlining efforts being examined by the NIH. The modular
grant concept establishes specific modules in which direct costs may be requested
as well as a maximum level for requested budgets. Only limited budgetary
information is required under this approach. The just-in-time concept allows
applicants to submit certain information only when there is a possibility for an
award. It is anticipated that these changes will reduce the administrative burden
for the applicants, reviewers and Institute staff. Complete and detailed
instructions and information on Modular Grants can be found at
http://www.nih.gov/grants/funding/modular/modular.htm.

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.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them.  This
policy applies to all initial (Type 1) applications submitted for receipt dates
after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for Grants
and Contracts, March 6, 1998, and is available at the following URL address:
http://www.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators may obtain copies from these sources or from the program staff
person listed under INQUIRIES.  Program staff may also provide additional
relevant information concerning the policy.

APPLICATION PROCEDURES

The PHS 398 (rev 4/98) is the form to be used to apply for this program.  The
form may be downloaded from the NIH Home Page at
http://www.nih.gov/grants/forms.htm.  It is also available at most institutional
offices of sponsored research, or it may be obtained from the Division of
Extramural Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, Bethesda, MD 20892-7910, telephone: 301/710-0267, email:
GrantsInfo@nih.gov.  The instructions in the PHS 398 application kit must be
adhered to, except where they have been modified by the following Supplemental
Instructions.

BUDGET INSTRUCTIONS

The total direct costs must be requested in accordance with the program
guidelines and the modifications made to the standard PHS 398 application
instructions described below:

PHS 398
o  FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments up to a maximum of $50,000) and Total Costs [Modular Total
Direct plus Facilities and Administrative (F&A) costs] for the initial budget
period. Items 8a and 8b should be completed indicating the Direct and Total Costs
for the entire proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398. It is not required and will not be accepted with the application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required and
will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page.
(See http://www.nih.gov/grants/funding/modular/modular.htm for sample pages.) At
the top of the page, enter the total direct costs requested for each year.

o  Under Personnel, List key project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should be
provided.

For Consortium/Contractual costs, provide an estimate of total costs (direct plus
facilities and administrative) for each year, each rounded to the nearest $1,000.
List the individuals/organizations with whom consortium or contractual
arrangements have been made, the percent effort of key personnel, and the role
on the project.  Indicate whether the collaborating institution is foreign or
domestic.  The total cost for a consortium/ contractual arrangement is included
in the overall requested modular direct cost amount.  Provide an additional
narrative budget justification for any variation in the number of modules
requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a specific
role in the proposed project, as well as to evaluate the overall qualifications
of the research team.  A biographical sketch is required for all key personnel,
following the instructions below.  No more than three pages may be used for each
person.  A sample biographical sketch may be viewed at: 
http://www.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- List current position(s) and then previous positions;
- List selected peer-reviewed publications, with full citations;
- Provide information, including overall goals and responsibilities, on research
projects ongoing or completed during the last three years.

o  CHECKLIST - This page should be completed and submitted with the application.
If the F&A rate agreement has been established, indicate the type of agreement
and the date. It is important to identify all exclusions that were used in the
calculation of the F&A costs for the initial budget period and all future budget
years.

o  The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information is
necessary following the initial review.

The completed original application and three copies must be submitted to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)

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 August 24, 1999; applications received after this
date will be returned to the applicant.  The earliest date of award is May 1,
2000.  This PA may be reissued.

REVIEW CONSIDERATIONS

All applications will be examined for completeness by CSR and responsiveness to
this PA by NIDCD staff.  Complete and responsive applications will then 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 children, 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.

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. Amy Donahue
Telephone:  (301) 402-3458
Email: amy_donahue@nih.gov

Dr. Lynn Luethke
Telephone:  (301) 402-3461
Email: lynn_huerta@nih.gov

Balance/Vestibular:

Dr. Daniel Sklare
Telephone:  (301) 496-1804
Email:  daniel_sklare@nih.gov

Chemical Senses:

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
Grants Management Branch
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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