HIGH IMPACT RESEARCH: FEASIBILITY STUDIES

Release Date:  March 6, 2000

PA NUMBER:  PAR-00-075

National Institute on Deafness and Other Communication Disorders

Application Receipt Date:  July 21, 2000

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 applications for feasibility studies of high impact (HI) research 
focused on hearing, balance, smell, taste, voice, speech, and language, the 
scientific mission areas of the NIDCD.  This Program Announcement (PA) 
supersedes a previous NIDCD PA: High Impact Research: Feasibility Studies, 
PAR-99-092 (NIH Guide, April 29, 1999).  HI research involves 
pilot/feasibility studies in which the technological, methodological, or 
theoretical approach to a problem lacks a historical precedent or sufficient  
preliminary/baseline data, but whose successful outcome would have a major 
impact on a scientific area or field. HI research has been described as 
"groundbreaking" and "paradigm shifting" (High Risk/Innovative Research 
Identification in NIH Peer Review Notes, Division of Research Grants, June 
1993).

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting focus areas.  This PA is related to one or 
more of the focus areas.  Potential applicants may obtain a copy of "Healthy 
People 2010" at http://www.health.gov/healthypeople.

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.  This 
mechanism offers support for HI research that lacks a historical precedent or 
sufficient 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, if promising, will serve as a 
basis for a more extensive follow-up investigation, typically pursued through 
the submission of an R01 grant application.  This initiative provides 
nonrenewable awards for up to two years of support and up to $50,000 in 
direct costs per year.  However, an application whose direct cost budget 
includes Facilities and Administration (F&A) costs associated with 
subcontract/consortium activity may exceed the $50,000 ceiling by the amount 
of one module ($25,000).  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.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" 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. 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 
https://grants.nih.gov/grants/funding/modular/modular.htm.


RESEARCH OBJECTIVES

The purpose of this PA is to encourage the submission of feasibility studies 
for HI research that have the potential for leading to a technological, 
methodological, or conceptual breakthrough or major contribution in the basic 
and clinical biomedical and behavioral sciences of human communication. This 
research may involve: 1) pilot testing of novel scientific experimental 
hypotheses, 2) the development of new or novel techniques or technologies, 
and/or 3) the acquisition of a body of data that is potentially high-impact 
for the scientific enterprise.  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: https://grants.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 
https://grants.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.

RESEARCH PLAN:

Do not exceed a total of 10 pages for the research plan, Sections a-d.  This 
limitation includes the introductory paragraph described below, tables and 
figures, but not Sections e-i.  Do not use the appendix to circumvent the 10-
page limit by including tables or figures in the appendix that should appear 
in the research plan.

Amply 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 would not be appropriate for submission as a 
traditional research grant and how this project, if fruitful, would enable 
the applicant to craft a research program appropriate for submission as a 
full-scale research grant application.  Label this paragraph, “Justification 
as High Impact Research.” Applications that lack the introductory 
justification or exceed the page limitation will not be reviewed and will be 
returned to the applicant.

Some applications submitted in response to this PA may be design-driven 
(e.g., development of novel or new technologies) or data-driven rather than 
problem-driven (e.g., testing of scientific hypotheses).  In the first two  
cases, the Specific Aims should state the technique/technology development 
needs or the data acquisition needs driving the research rather than the 
experimental hypotheses to be tested.

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 or $75,000, the latter in 
the case of consortia for contractual activity) 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 https://grants.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.

o  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 
direct cost amount for the application. Under these circumstances, the latter 
may exceed $50,000 by one module ($25,000). Provide an additional narrative 
budget justification for any variation in the number of modules or direct 
cost amount requested across a two-year grant period.

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: https://grants.nih.gov/grants/funding/modular/modular.htm

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

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.

Submission Instructions

The title and number of this PA must be typed on line 2 of the face page of 
the application form and the YES box must be marked.

The completed original application and three copies (less appendices) 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 and five sets of appendices to:

Chief, Scientific Review Branch
Division of Extramural Research
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 July 21, 2000; applications received after 
this date will be returned to the applicant.  The earliest date of award is 
May 1, 2001.  This PA may be reissued in the future.

REVIEW CONSIDERATIONS

All applications will be examined for completeness by the Center for 
Scientific Review 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 have the potential to 
significantly impact the scientific enterprise, and if so, to what degree?  
If the aims of the application are achieved, how will scientific knowledge be
advanced? Will a successful outcome from this feasibility study lead directly 
to more extensive follow-up studies that would likely achieve the long-term 
goals of this application?

(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?  Does the 
project generate a body of data that provides a foundation for important new 
research directions?

(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 the research? 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 the project’s duration in 
relation to the proposed research.

o  The adequacy of the measures proposed for protection of humans, animals 
and/or the environment, to the extent they may be adversely affected by the 
research 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, program priorities, and 
availability of funds.

INQUIRIES

NIDCD staff welcome the opportunity to clarify any issues or questions about  
this initiative from potential applicants. Direct inquiries regarding 
programmatic issues, including eligibility and responsiveness, to:

Hearing:

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

Dr. Nancy Freeman
Telephone: (301) 402-3458 
Email: nancy_freeman@nih.gov

Dr. Thomas Johnson
Telephone: (301) 402-3461
Email: thomas_johnson@nih.gov

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

Balance:

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

Smell:

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

Taste:

Dr. Barry Davis
Telephone: (301) 402-3464
Email: barry_davis@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 all of the above named persons are:

Division of Extramural Research
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:

Castilla McNamara, M.S.
Grants Management Branch
Division of Extramural Research
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: CM249E@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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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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