Full Text PAR-96-073
 
EXPLORATORY/DEVELOPMENTAL GRANTS FOR HIGH RISK/HIGH IMPACT RESEARCH
 
NIH GUIDE, Volume 25, Number 31, September 20, 1996
 
PA NUMBER:  PAR-96-073
 
P.T.


Keywords: 

 
National Institute on Deafness and Other Communication Disorders
 
Application Receipt Date:  November 20, 1996
 
PURPOSE
 
The National Institute on Deafness and Other Communication Disorders
(NIDCD) invites grant applications from basic and clinical
investigators who are interested in pursuing high risk/high impact
(HR/HI) research focused on hearing, balance, smell, taste, voice,
speech, or language related to the specific mission of the NIDCD.
This HR/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 HR/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 research
projects.  This Program Announcement is a solicitation for a single
receipt date, November 20, 1996.
 
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 Program
Announcement (PA), Exploratory/Developmental Grants for High
Risk/High Impact Research, 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. 017-001-00474-0 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, 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 these 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.  These pilot/feasibility projects provide support for
HR/HI activities that lack a traditional historical basis or
preliminary data.  Indeed, 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 as HR/HI 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.
 
This initiative provides nonrenewable, one-year awards of up to
$50,000 in direct costs; indirect 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.  It is
expected that the preliminary data generated by these grants will
serve as a basis for more extensive research projects.
 
Investigators are encouraged to consider carefully whether their
research can best be accomplished through this or other grant
mechanisms, such as the R01, the broad program of Small Grants for
Innovative Technology of the National Center for Research Resources
(NCRR) (NIH Guide, Vol. 20, No. 31, August 16, 1991), or the Small
Grant Program of the NIDCD for scientists who are in the early stages
of pursuing an independent research career (NIH Guide, Vol. 34, No.
38, October 27, 1995).
 
Investigators who have questions about the appropriateness of their
research plan to this initiative should contact one of the program
officials listed under INQUIRIES.
 
RESEARCH OBJECTIVES
 
The purpose of this PA is to encourage the submission of applications
from basic and clinical investigators who are interested in pursuing
HR/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 payoff
potential 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, or 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 is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines For 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
and errors in the earlier publication, and reprinted in the NIH GUIDE
FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.
 
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
 
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 Grants Information
Office, Office of Extramural Outreach and Information Resources,
National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301/710-0267, email:
ASKNIH@odrockm1.od.nih.gov.
The title and number of the program announcement must be typed in
Section 2 on the face page of the application.
 
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  Indirect costs will be calculated at the time of the award using
the institution's actual indirect cost rate.  Applicants will be
asked to identify the indirect cost exclusions prior to award.
 
o  If consortium/contractual costs are requested, provide the
percentage of the subcontract total costs (direct and indirect)
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:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817-7710 (EXPRESS MAIL)
 
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
Executive Plaza South, Room 400-C
6120 Executive Boulevard  MSC 7180
Bethesda, MD  20892-7180
 
Schedule
 
The application receipt date is November 20, , 1996.  Applications
received after this date will be returned to the applicant.  The
earliest date of award is July, 1997.  This program announcement may
be reissued.
 
REVIEW CONSIDERATIONS
 
Applications will be assigned on the basis of established PHS
referral guidelines.  Applications whose specific aims are not
relevant to the mission of NIDCD will not be accepted for review
under this Program Announcement.  Applications 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 and
undergo a process in which only 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 NDCD Advisory Council.
 
Review Criteria
 
o  potential scientific, technical, or medical significance of the
proposed pilot/feasibility studies, including the potential to lead
to a major conceptual breakthrough or to remove a major obstacle to
progress;
 
o  originality of proposed exploratory/developmental research;
 
o  appropriateness and adequacy of the experimental approach and
methodology, including a demonstrably sound research plan designed to
assess the feasibility of these pilot projects;
 
o  qualifications and research experience of the Principal
Investigator and staff in the areas of the proposed research,
particularly those demanding unusual technical sophistication;
 
o  availability of the resources necessary to perform the research;
 
o  availability of special opportunities for furthering research
programs through the use of unusual talent resources, populations, or
environmental conditions;
 
o  appropriateness of the budget and timeline for 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.
 
The initial review group will also examine the provisions for the
protection of human subjects and animal welfare and the safety of the
research environment.
 
REPORTING REQUIREMENTS
 
If an award is made in response to a R21 application, a Final
Progress Report, an Invention Statement, and a Financial Status
Report must be submitted within ninety days after the termination of
the award.  This reporting requirement is the same as that of other
types of research grants and is in accord with 42 CFR 52 and 45 CFR
74.  This information will be of assistance to the NIDCD in
evaluating the usefulness of this R21 mechanism.  If an R21 leads to
the submission of another research grant, a statement to that effect
would also be much appreciated; the applicant is not required to
submit this statement.
 
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 to:
 
Hearing:
Dr. Chyren Hunter
Telephone: (301) 402-3458
E-Mail:  Chyren_Hunter@nih.gov
 
Balance/Vestibular:
Dr. Daniel Sklare
Telephone: (301) 496-1804
E-Mail:  Daniel_Sklare@nih.go
 
Smell/Taste:
Dr. Jack Pearl
Telephone: (301) 402-3464
E-Mail:  Jack_Pearl@nih.gov
 
Dr. Rochelle Small
Telephone: (301) 402-3464
E-Mail:  Rochelle_Small@nih.gov
 
Voice/Speech:
Dr. Beth Ansel
Telephone: (301) 402-3461
E-Mail:  Beth_Ansel@nih.gov
 
Language:
 
Dr. Judith Cooper
Telephone: (301) 496-5061
E-Mail:  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
Executive Plaza South, Room 400-C
6120 Executive Boulevard 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
Executive Plaza South, Room 400-B
6120 Executive Boulevard, 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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