and Human Services (HHS)
EXPIRED
NIDCD SMALL GRANT (R03) PROGRAM
RELEASE DATE: February 13, 2004
PA NUMBER: PAR-04-062
March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov
using the electronic SF424 (R&R) application. Accordingly, the portion of this
funding opportunity relating to these mechanisms expires on the date indicated
below. A Replacement R03 (PAR-06-263) funding opportunity announcement has been
issued for the submission date of June 1, 2006 and submission dates thereafter.
Other Related Notices: NOT-DC-06-002 and NOT-DC-05-003
EXPIRATION DATE: March 16, 2006
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute on Deafness and Other Communication Disorders (NIDCD)
(http://www.nidcd.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.173
APPLICATION RECEIPT DATES: 2004 April 22 July 15 Nov. 15
2005 March 15 July 15 Nov. 15
2006 March 15 July 14 Nov. 15
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
This Program Announcement (PA) supersedes all previous announcements of the
National Institute on Deafness and Other Communication Disorders (NIDCD) Small
Grant (R03) Program for support of pilot research that is likely to lead to a
subsequent individual research project grant (R01) application. The research
must be focused on one or more of the areas within the biomedical and behavioral
scientific mission of the NIDCD: hearing, balance, smell, taste, voice, speech,
or language.
The NIDCD Small Grant (R03) Program is designed to support basic and clinical
research of scientists who are in the early stages of establishing an
independent research career. The Small Grant (R03) Program may be used to
support individuals transitioning from postdoctoral status to their first
independent research position. In addition, the Program may be used by
early-stage clinician-scientists planning to make future application for an
NIDCD mentored research career development award (K-award) to demonstrate the
feasibility of the research to be proposed in their K-award application.
RESEARCH OBJECTIVES
The Small Grant (R03) Program supports the research of scientists who are in the
early stages of establishing an independent research career in the basic and
clinical sciences of human communication, including individuals transitioning
from postdoctoral status to their first independent research position.
Applicants are typically within ten years of obtaining a terminal professional
degree (e.g., M.A., Ph.D. or M.D.), excluding years spent in clinical training.
Allowances are made for the years spent in clinical service delivery and heavy
teaching responsibilities. Applicants are not required to have their own
independent research space or equipment. It is intended that an R03 grant will
enable such individuals to obtain the amount of preliminary data that is likely
to lead to a subsequent individual research project grant (R01) application.
The NIDCD encourages early-stage clinician-scientists planning to make future
application for an NIDCD mentored research career development award (K-award),
such as the Mentored Clinical Scientist Development Awards (K08) or Mentored
Patient-Oriented Research Career Development Awards (K23), to consider applying
for one year of support through an NIDCD R03 award, if needed, to demonstrate
the feasibility of the research to be proposed in their K08 or K23 application.
In addition, recipients of a NIDCD mentored K-award may hold an R03 concurrently
if additional research development support is needed to transition to
independence. During the last two years of a mentored K-award, awardees may
adjust their effort on the K-award in order to obtain salary support, as
Principal Investigator, from a NIH research project grant, including an R03
grant, as per a recently adopted NIH policy
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html).
Additional details on these provisions and the availability of other types of
research support to the K-awardee can be obtained from the NIDCD web site
(http://www.nidcd.nih.gov/funding/types/careerdevt.asp).
MECHANISM OF SUPPORT
This PA will use the NIH R03 award mechanism. As an applicant, you will be
solely responsible for planning, directing, and executing the proposed project.
This PA uses just-in-time concepts. It also uses the modular budgeting format. (See
http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are
submitting an application with direct costs in each year of $250,000 or less, use the
modular budget format. This program does not require cost sharing as defined in the
current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
Applications may be submitted for up to 2 modules of $25,000 each ($50,000 Direct Costs
per year), for up to three years of support. The total cost (Direct plus Facilities and
Administrative costs (F & A costs)) for any consortium/contractual arrangement must be
included within the overall requested direct cost amount for the application, which
cannot exceed $50,000.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals, and
laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic institutions/organizations
o Faith-based or community-based institutions
o Foreign institutions are not eligible to apply
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry out the
proposed research is invited to work with their institution to develop an application
for support. Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH programs.
Former recipients of Federally-funded National Research Service Award (NRSA)
fellowships and traineeships or mentored career development awards are eligible for
this R03 Program. Individuals who have served as Principal Investigators on any NIH
research grant (including subprojects of program project and center grants) or other
Federally-funded research grants (e.g., NSF) are not eligible for the NIDCD Small Grant
(R03) Program.
Other questions about eligibility may be directed to one of the program
officials listed under INQUIRIES.
SPECIAL REQUIREMENTS
The specific R03 guidelines listed below (e.g., page limitations, number of copies,
application dates) supersede the PHS 398 instructions.
New and amended applications submitted in response to this PA have the same receipt
date. If a prior submission in response to the previous NIDCD R03 Small Grant PA,
PA-01-126, was not funded and the investigator wishes to resubmit an application on
the same topic in response to this PA, it is to be submitted as an amended (-A1)
application using the current guidelines. An NIDCD R03 Small Grant is not renewable.
Only one Small Grant application may be submitted by a Principal Investigator per
receipt date. Applicants may not submit an R01 application on the same topic
concurrently (i.e., to be considered within the same review cycle) with the submission
of a Small Grant application.
The research plan should not exceed ten pages. Information regarding
specific aims, background and significance, preliminary studies/progress
report, and research design and methods are all included in this ten-page limit.
For revised/amended applications, an Introduction (not to exceed one page) in addition
to the Research Plan is required. This Introduction, which is not included in the ten-
page limit, must include responses to the criticisms and issues raised in the summary
statement. The changes in the Research Plan must be clearly marked by appropriate
bracketing, indenting or changing of typography, unless the changes include most of the
text. Changes should be highlighted in the Introduction.
Up to five publications, submitted manuscripts, or abstracts may also be included as
Appendix material. (Please refer to PHS 398 application for additional Appendix
guidelines.) Letters of reference are not required.
Applications that exceed the page limit indicated above or requirements for type/font
size and margins (refer to PHS 398 for details) may be returned to the investigator
without review.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to answer
questions from potential applicants. Inquiries may fall into three areas:
scientific/research, peer review, and financial or grants management issues:
o Direct your questions about scientific/research issues to:
Hearing:
Dr. Amy Donahue
Telephone: (301) 402-3458
Email: [email protected]
Dr. Nancy Freeman
Telephone: (301) 402-3458
Email: [email protected]
Dr. Lynn Luethke
Telephone: (301) 402-3458
Email: [email protected]
Dr. Bracie Watson
Telephone: (301) 402-3458
Email: [email protected]
Vestibular/Balance:
Dr. Christopher Platt
Telephone: (301) 402-3458
Email: [email protected]
Taste/Smell:
Dr. Barry Davis
Telephone: (301) 402-3464
Email: [email protected]
Voice and Speech:
Dr. Lana Shekim
Telephone: (301) 496-5061
Email: [email protected]
Language:
Dr. Judith Cooper
Telephone: (301) 496-5061
Email: [email protected]
Research Training:
Dr. Daniel Sklare
Telephone: (301) 496-1804
Email: [email protected]
The address and FAX number for the above-named persons are:
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS Room 400C, MSC-7180
Bethesda, MD 20892-7180
FAX: (301) 402-6251
o Direct your questions about peer review issues to:
Melissa J. Stick, Ph.D., MPH
Chief, Scientific Review Branch
Division of Extramural Activities
National Institute on Deafness and Other
Communication Disorders
6120 Executive Blvd., Rm 400C
Bethesda, Maryland, 20892-7180
Telephone: (301) 496-8683
FAX: (301) 402-6250
Email: [email protected]
o Direct your questions about financial or grants management matters to:
Sara Stone
Chief, Grants Management Office
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS Room 400B, MSC-7180
Bethesda, MD 20892-7180
Telephone: (301)402-0909
FAX: (301) 4021758
Email: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application instructions
and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data
Universal Numbering System (DUNS) number as the Universal Identifier when applying for
Federal grants or cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS
number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398
is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an
interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: [email protected].
The title and number of this program announcement must be typed on line 2 of the face
page of the application and the YES box must be checked.
SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting
up to $250,000 per year in direct costs must be submitted in a modular budget grant
format. The modular budget grant format simplifies the preparation of the budget in
these applications by limiting the level of budgetary detail. Applicants request
direct costs in $25,000 modules. Section C of the research grant application
instructions for the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance
for preparing modular grants. Additional information on modular grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the
application (less the Appendix), including the checklist, and three signed photocopies
in one package 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)
Please send an additional two copies 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, EPS Room 400-C, MSC 7180
Bethesda, MD 20892-7180
Rockville, MD 20852 (for express/courier service)
APPLICATION PROCESSING: Applications must be received by the date listed on the first
page. The CSR will not accept any application in response to this PA that is
essentially the same as one currently pending initial review unless the applicant
withdraws the pending application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude the submission of
a substantial revision of an unfunded version of an application already reviewed, but
such application must include an Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an application,
applicants are generally notified of the review and funding assignment within 8 weeks.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIDCD. Incomplete applications will not be reviewed.
Applications that are complete and responsive to the PA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by the
NIDCD in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
o Undergo a selection process in which only those applications deemed to have the
highest scientific merit, generally the top half of applications under review, will be
discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the NDCD 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 evaluate application in order to judge the likelihood that
the proposed research will have a substantial impact on the pursuit of these goals.
The scientific review group will address and consider each of the following criteria in
assigning the application’s overall score, weighting them as appropriate for each
application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
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. For example, an
investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.
SIGNIFICANCE: Does this 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?
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?
INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims
original and innovative? Does the project challenge existing paradigms or develop new
methodologies or technologies?
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)?
ENVIRONMENT: Does the scientific environment in which the work will be done contribute
to the probability of success? Do the proposed experiments take advantage of unique
features of the scientific environment or employ useful collaborative arrangements? Is
there evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items
will be considered in the determination of scientific merit and the priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and
protections from research risk relating to their participation in the proposed research
will be assessed. (See criteria included in the section on Federal Citations, below).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and subgroups), and
children as appropriate for the scientific goals of the research will be assessed.
Plans for the recruitment and retention of subjects will also be evaluated. (See
Inclusion Criteria in the sections on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in
the project, the five items described under Section f of the PHS 398 research grant
application instructions (rev. 5/2001) will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested period of support
in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds with all
other recommended applications. The following will be considered in making funding
decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
The submission, review, and award schedule for the Small Grant Program through 2006 is:
APPLICATION RECEIPT DATES: April 22, 2004 July 15, 2004 Nov 15, 2004
March 15, 2005 July 15, 2005 Nov 15, 2005
March 15, 2006 July 14, 2006 Nov 15, 2006
NIDCD Initial Review Panel: June/July Oct/Nov Feb/March
Council Review: Sept Jan May
Earliest Start Date: December April July
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and
proposals involving human subjects must be evaluated with reference to the risks to the
subjects, the adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained or to
be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH
that women and members of minority groups and their sub-populations must be included in
all NIH-supported clinical research projects unless a clear and compelling
justification is provided indicating 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 clinical research should read the "NIH Guidelines for
Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October,
2001," published in the NIH Guide for Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The
amended policy incorporates: the use of an NIH definition of clinical research; updated
racial and ethnic categories in compliance with the new OMB standards; clarification of
language governing NIH-defined Phase III clinical trials consistent with the new PHS
Form 398; and updated roles and responsibilities of NIH staff and the extramural
community. The policy continues to require for all NIH-defined Phase III clinical
trials that: a) all applications or proposals and/or protocols must provide a
description of plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH
maintains a policy 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 is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires
education on the protection of human subject participants for all investigators
submitting NIH proposals for research involving human subjects. You will find this
policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June
5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs
can be found at http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research
using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is
the responsibility of the applicant to provide, in the project description and
elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC
line(s)to be used in the proposed research. Applications that do not provide this
information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide public access to
research data through the Freedom of Information Act (FOIA) under some circumstances.
Data that are (1) first produced in a project that is supported in whole or in part
with Federal funds and (2) cited publicly and officially by a Federal agency in support
of an action that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope of this
amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public archive, which
can provide protections for the data and manage the distribution for an indefinite
period of time. If so, the application should include a description of the archiving
plan in the study design and include information about this in the budget justification
section of the application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the potential for
wider use of data collected under this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department
of Health and Human Services (DHHS) issued final modification to the Standards for
Privacy of Individually Identifiable Health Information , the Privacy Rule, on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection of
individually identifiable health information, and is administered and enforced by the
DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule
(classified under the Rule as covered entities ) must do so by April 14, 2003 (with
the exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside with the
researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and a set of
decision tools on Am I a covered entity? Information on the impact of the HIPAA
Privacy Rule on NIH processes involving the review, funding, and progress monitoring of
grants, cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH
funding must be self-contained within specified page limitations. Unless otherwise
specified in an NIH solicitation, Internet addresses (URLs) should not be used to
provide information necessary to the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
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 priority areas. This PA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic
Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review. Awards are made
under the authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts
74 and 92. All awards are subject to the terms and conditions, cost principles, and
other considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and
discourage the 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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