INNOVATIVE EXPLORATORY STUDIES AND TECHNOLOGY DEVELOPMENT IN NEUROINFORMATICS 
RESEARCH (R21)

RELEASE DATE:  December 4, 2002 
PA NUMBER:  PAR-03-036 (This PAR, requesting applications for the HBP, will not 
be reissued after it expires, see NOT-MH-05-014) 
                       (see addendum NOT-NS-03-023)
                       (Updated contact info for NLM, see NOT-LM-05-002)

EXPIRATION DATE:  September 23, 2005

National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov/)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
 (http://www.nibib1.nih.gov/)
National Institute on Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD)
 (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidr.nih.gov/)
National Library of Medicine (NLM)
 (http://www.nlm.nih.gov/)
National Aeronautics and Space Administration (NASA)
 (http://www.nasa.gov/)
National Science Foundation (NSF)
 (http://www.nsf.gov/)
U.S. Department of Energy (DOE)
 (http://www.energy.gov/)

Letter of Intent Receipt Dates:  One month prior to receipt date
Application Receipt Dates:  January 21 May 21 September 22, 2003
                            January 21 May 21 September 22, 2004
                            January 21 May 20 September 22, 2005

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  Letter of Intent
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) encourages applications for a one-time grant
award to support: innovative research directions requiring preliminary testing
or development of neuroscience databases or analytical tools (neuroinformatics)
research; exploration of the use of approaches and concepts new to a particular
substantive area of neuroscience informatics (neuroinformatics) research; or
research and development of new technologies, techniques or methods in
informatics that will have a high impact upon the advancement of neuroscience
research.  Neuroinformatics combines neuroscience and informatics (information
technology/computer sciences) research to develop databases and neuroscience
knowledge management systems, and advanced tools and approaches essential for
efficient data sharing and data integration, including tools that integrate
information from different levels of organization across temporal and spatial
scales.  The proposed pilot studies are to involve technological,
methodological,or theoretical informatics approaches to a complex neuroscience
research problem that lacks sufficient preliminary data and/or a body of
peer-reviewed publications.  The successful outcome of these studies should make
a significant contribution to the neuroinformatics and neuroscience fields.

RESEARCH OBJECTIVES

Background

The Human Brain Project (HBP) is a broadly based Federal research initiative,
which is sponsored by sixteen Federal organizations from four Federal agencies
and coordinated by the National Institute of Mental Health through the
activities of the Federal Interagency Coordinating Committee of the Human Brain
Project (FICC-HBP).  The HBP seeks to encourage exploratory research pilot
studies having the potential to make a significant advancement in neuroscience
research through the creation of neuroscience databases, knowledge management
systems, and analytic tools to integrate vast, complex data and information
about the nervous system.  Tools that describe different levels of organization
are needed to model nervous system function and the effects of abnormalities on
other physiological systems.  This research should involve exploration of
scientific experimental hypotheses, linked with the development of new computer
science technologies, or vice versa.  It should represent a unique focus or
direction for the conceptualization of both neuroscience and informatics
research, with one being preliminary and innovative.  It is intended that the
additional pilot data generated by these exploratory studies, if promising, will
serve as a basis for a more extensive follow-up investigation, commonly pursued
through the submission of an investigator-initiated research project (R01) grant
application in the field of neuroinformatics.  This mechanism does not support
research that is essentially the logical progression of an ongoing research
program.

For a detailed description on the research objectives of the FICC-HBP sponsored 
Human Brain Project/Neuroinformatics Initiative, refer to this program's
homepage (http://www.nimh.nih.gov/neuroinformatics/index.cfm), and PAR-03-035,
The Human Brain Project (Neuroinformatics): Phase I & II
(https://grants.nih.gov/grants/guide/pa-files/PAR-03-035.html).

MECHANISM OF SUPPORT

This PA will use the NIH Exploratory/Developmental Grant (R21) mechanism.  As an 
applicant, you will be solely responsible for planning, directing, and executing
the proposed project.  Under this program announcement, applicants for the R21
award may request direct costs of up to $100,000 per year for up to two years to
support exploratory research where sufficient pilot data to support a regular
research grant application is lacking.  Competitive renewals of grants awarded
under this program announcement will not be accepted.

This PA uses just-in-time concepts.  It also uses the modular budgeting format
(see https://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically,
applicants submitting an application with direct costs in each year of $250,000
or less must use the modular format, thus all applicants for the R21 must submit
a modular budget.

ELIGIBLE INSTITUTIONS

You may submit an application 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

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.

It is anticipated that most applications will be submitted by investigators with 
ongoing research programs who wish to change the focus of their current research 
effort or move into a new area of research utilizing innovative electronic and 
digital neuroinformatics research capabilities (methodological strategies, 
databases, and tools), but need additional funds to complete initial pilot
studies.  This PA also encourages applications from investigators conducting
research outside of the basic and clinical neuroscience research field, whose
expertise in methodological or technological approaches to Informatics
(information technology, computers sciences, mathematics, physics, engineering)
would significantly advance progress and new knowledge in this field.  This
announcement is not intended for new investigators planning or at the early
stages of an independent research career.

SPECIAL REQUIREMENTS

Areas of science with sufficient existing preliminary data to support the
submission of a regular research grant application do not qualify under this PA.
Investigators are encouraged to consider carefully whether their research can
best be accomplished through this or other grant mechanisms, such as the
research project grant (R01) or the small grant (R03) program of the NIH.
Although the amount of pilot data that typically accompanies an R01 application
is not required as a part of this program announcement, the applicant has the
responsibility to provide sufficient pilot data to demonstrate the soundness of
the research plan.  Moreover, since the goal of this R21 grant mechanism is to
encourage a change in research from that of an ongoing research program, the
appropriate expertise of key personnel and collaborators to pursue such novel
research must be evident.

It is strongly encouraged that researchers funded under the Human Brain Project 
communicate, coordinate, and collaborate across different grants.  A list of 
investigators participating in this program is located at 
http://www.nimh.nih.gov/neuroinformatics/index.cfm and the types of data,
software, or other information that is available from or through them will be
shared among all grantees to minimize scientifically unnecessary duplication of
effort in all Phases.  Grantees are expected to participate in (1) the Annual
Spring Human Brain Project Meeting at NIH, as well as (2) an annual meeting of
Principal Investigators to be rotated among the funded sites.  These meetings
will promote communication among different groups of investigators (see Post
Award Management).

NIH is interested in ensuring that the research resources developed through this 
Program Announcement become readily available to the research community for
further research, development, and application, in the expectation that this
will lead to products and knowledge of benefit to the public.  At the same time,
NIH recognizes the rights of grantees to elect and retain title to subject
inventions developed under Federal funding under the provision of the Bayh-Dole
Act.  Indeed, for inventions developed in its intramural program, NIH does file
patent applications, in accord with a set of policies described at
http://www.nih.gov/od/ott/200po6.htm.  Grantees are encouraged to perfect
copyright protection of software produced as a result of Human Brain Project
funding https://grants.nih.gov/archive/grants/policy/nihgps_2001/nihgps_2001.pdf.
These should include prominent notification in the software and its documentation
that thesoftware is copyrighted.  Notification could consist of the following:

Copyright c [year] by [your name, the names of your colleagues, or the name of
your institution] with funding from the Human Brain Project.

This notification will identify the source of the software and help ensure that
the software can be shared freely while protecting any commercial rights in it.
In addition, grantees will be required to agree that they will provide the
primary funding organization, upon its request and at a reasonable cost, a copy
of any software produced under this Human Brain Project funding, with the
understanding that the Federal organizations directly involved with this Project
will have the right to use such software for internal research and archival
purposes only, and will not permit its distribution beyond those organizations.

Application components related to ethical, legal, and social issues pertinent to 
this initiative are encouraged.  Also encouraged are components of applications
that are designed to reach out to the public, academic, and/or commercial
sectors to help educate and inform about the available opportunities provided by
research and development in the neuroinformatics field.

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.  Representatives from each of the participating agencies, institutes and
center can be contacted for further information or clarification.

o  General programmatic inquiries regarding the Human Brain Project should be 
directed to:

Stephen H. Koslow, Ph.D.
Chair, FICC-HBP
Office on Neuroinformatics
National Institute of Mental Health
6001 Executive Boulevard, Room 6167, MSC 9613
Bethesda, MD  20892-9613
Telephone:  (301) 443-1815
FAX:  (301) 443-1867
Email:  koz@helix.nih.gov

A current list of Agency Contacts may be found at: 
http://www.nimh.nih.gov/neuroinformatics/agencycontacts.cfm

o  Questions regarding scientific/research issues related to participating ICs
may be directed to these individuals:

National Institute of Mental Health
Michael D. Hirsch, Ph.D.
Deputy Director, Office on Neuroinformatics
6001 Executive Boulevard, Room 6167, MSC 9613
Bethesda, MD  20892-9613
Telephone:  (301) 443-1815
FAX:  (301) 443-1867
Email:  mhirsch@helix.nih.gov

National Heart, Lung, and Blood Institute
Carl E. Hunt, M.D.
Director, National Center on Sleep Disorders Research
6701 Rockledge Drive, Suite 10038, MSC 7920
Bethesda, MD  20892-7920
Telephone:  (301) 435-0199
FAX:  (301) 480-3451
Email:  HuntC@nhlbi.nih.gov

National Institute on Aging
Molly V. Wagster, Ph.D.
Neuroscience and Neuropsychology of Aging Program
7201 Wisconsin Avenue, Suite 3C307, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-9350
FAX:  (301) 496-1494
Email:  wagsterm@nia.nih.gov

National Institute on Alcohol Abuse and Alcoholism
Antonio Noronha, Ph.D.
Chief, Neuroscience & Behavioral Research Branch
Division of Basic Research
6001 Executive Boulevard, Suite 402, MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-7722
FAX:  (301) 594-0673
Email:  anoronha@willco.niaaa.nih.gov

National Institute of Biomedical Imaging and Biomedical Engineering
Grace C.Y. Peng, Ph.D.
Program Director, Division of Bioengineering
6707 Democracy Boulevard, Suite 226, MSC 5469
Bethesda, MD  20892-5469
Telephone:  (301) 496-9178
FAX:  (301) 480-0679
Email:  penggr@mail.nih.gov

National Institute of Child Health and Human Development
Lisa Freund, Ph.D.
Director, Research Programs in Developmental Psychobiology and Neuroscience
Human Learning and Behavior Branch
Center for Research for Mothers and Children
6100 Executive Boulevard, Room 4B05, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6879
FAX:  (301) 480-7773
Email:  freundl@mail.nih.gov

National Institute on Drug Abuse
Thomas Aigner, Ph.D.
Division of Basic Research
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD  20892-9555
Telephone:  (301) 443-6975
FAX:  (301) 594-6043
Email:  taigner@nida.nih.gov

National Institute on Deafness and Other Communication Disorders
Barry Davis, Ph.D.
Director, Taste and Smell Program
6120 Executive Boulevard, Room 400C, MSC 7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-3464
FAX:  (301) 402-6251
Email:  barry_davis@nih.gov

National Institute on Dental and Craniofacial Research
Eleni Kousvelari, DDS, D.Sc.
Chief, Cellular and Molecular Biology, Physiology and Biotechnology Branch
Division of Basic and Translational Sciences
45 Center Drive, Room 4AN-18A, MSC 6402
Bethesda, MD  20892-6402
Telephone:  (301) 594-2427
FAX:  (301) 480-8318
Email:  kousvelari@de45.nidr.nih.gov

National Library of Medicine (Updated contact info for NLM, see NOT-LM-05-002)

Carol Bean, Ph.D.
Program Officer, Division of Extramural Programs
6705 Rockledge Drive, Suite 301, MSC 7968
Bethesda, MD  20892-7968
Bethesda, MD  20817 (for courier/express service)
Telephone:  (301) 594-4882
FAX:  (301) 402-2952
Email:  beanc@mail.nlm.nih.gov

National Aeronautics and Space Administration
Marc Shepanek, Ph.D.
300 E Street, S.W.
Washington, DC  20546
Telephone:  (202) 358-2201
FAX:  (202) 358-4168
Email:  mshepane@hq.nasa.gov

National Science Foundation
Soo-Siang Lim, Ph.D. or
Diane Witt, Ph.D.
Behavioral Neuroscience and Neuroendocrinology Program
Division of Integrative Biology and Neuroscience
4201 Wilson Boulevard, Room 685S 
Arlington, VA  22230
Telephone:  (703) 292-8423 
FAX:  (703) 292-9153
Email:  slim@nsf.gov
Email:  dwitt@nsf.gov

U.S. Department of Energy
Dean Cole, Ph.D.
Office of Biological and Environmental Research
Medical Science Division
SC-73/Germantown Building
1000 Independence Avenue, SW
Washington, DC  20585-1290
Telephone:  (301) 903-3268
FAX:  (301) 903-0567
Email:  dean.cole@science.doe.gov

o  Direct your questions about peer review issues to:

Peter M. Lyster, Ph.D.
Scientific Review Administrator
Center for Scientific Review
6701 Rockledge Drive, Rm. 5218, MSC 7850
Bethesda, MD 20892-7850
Bethesda, MD  20817 (for express/courier service)
Telephone:  (301) 435-1256
FAX:  (301) 480-2241
Email:  lysterp@mail.nih.gov

o  Direct your questions about financial or grants management matters to:

National Institute of Mental Health
Joy R. Knipple
Grants Management Branch
6001 Executive Boulevard, Room 6131, MSC 9605
Bethesda, MD  20892-9605 
Telephone:  (301) 443-8811
FAX:  (301) 443-6885
Email:  jk173r@mail.nih.gov

National Heart, Lung, and Blood Institute
Raymond L. Zimmerman
Grants Operations Branch
6701 Rockledge Drive, Room 7174, MSC 7926
Bethesda, MD  20892-7926
Telephone:  (301) 435-0171
FAX:  (301) 480-3310
Email:  ZimmermR@nhlbi.nih.gov

National Institute on Aging
Linda Whipp
Grants and Contracts Management Office
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  whippl@nia.nih.gov

National Institute on Alcohol Abuse and Alcoholism
Judy Fox
Grants Management Branch
6000 Executive Boulevard, Suite 504, MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-4704
FAX:  (301) 443-3891
Email:  jsimons@willco.niaaa.nih.gov

National Institute of Biomedical Imaging and Biomedical Engineering
Lisa Moeller
Grants Management Specialist
6707 Democracy Boulevard, Room 983, MSC 5469
Bethesda, MD  20892-5469
Telephone:  (301) 451-4793
FAX:  (301) 480-4974
Email:  lm236j@nih.gov

National Institute of Child Health and Human Development
Douglas E. Shawver
Grants Management Branch
6100 Executive Boulevard, Room 8A17F, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6999
FAX:  (301) 402-0915
Email:  shawverd@mail.nih.gov

National Institute on Drug Abuse
Gary Fleming, J.D., M.A.
Chief, Grants Management Officer
Grants Management Branch
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301)  443-6710
FAX:  (301) 594-6849
Email:  gf6s@nih.gov

National Institute on Deafness and Other Communication Disorders
Sara Stone
Grants Management Branch
6120 Executive Boulevard, Room 400-B, MSC 7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-0909
FAX:  (301) 402-1758
Email:  stones@nihcd.nih.gov

National Institute of Dental and Craniofacial Research
Bonnie Smith
Division of Extramural Research
45 Center Drive, Room 4AN-44 MSC 6402
Bethesda, MD  20892-6402
Telephone:  (301) 594-4800
FAX:  (301) 480-8301
Email:  bonnie.smith@nih.gov

National Library of Medicine
Dwight Mowery
Grants Management Branch
6705 Rockledge Drive, Suite 301, MSC 7968 
Bethesda, MD  20892-7968
Telephone:  (301) 496-4221
FAX:  (301) 402-2952
Email:  dm99n@nih.gov

LETTER OF INTENT

It is recommended that applicants contact the appropriate program official(s)
listed under INQUIRIES and submit a letter of intent that includes the following 
information:

o  Descriptive title of the proposed research
o  Name, address, and telephone number of the Principal Investigator
o  Names of other key personnel
o  Participating institutions
o  Number and title of this PA

Although a letter of intent is not required, is not binding, and does not enter
into the review of a subsequent application, the information that it contains
allows IC staff to estimate the potential review workload and plan the review.
Each letter of intent will be distributed to all of the sponsoring agencies,
institutes and center.

The letter of intent is to be submitted to Dr. Stephen H. Koslow at the address 
listed above, by the receipt dates listed in the heading of this PA.

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.

The NIH encourages applicants to access application instructions and forms, via
the Internet.  Certain forms are available electronically on the NIH Home Page 
(https://grants.nih.gov/grants/forms.htm).  Instructions for downloading
documents and electronic forms can be accessed at
https://grants.nih.gov/grants/edocs.htm.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted on the application receipt dates listed in the
heading of this PA.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications requesting
up to $250,000 per year in direct costs must be submitted in a modular grant
format.  The modular 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
https://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 https://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS:  Follow the PHS 398 instructions for "Preparing Your 
Application" with modifications and additions as described in the sections
below:

1.  Face Page of the application:  To identify the application as a response to
this Program Announcement (PA), check "Yes" on item 2, and the number and title
of the PA must be typed on line 2 of the face page of the application form.

2.  Description:  As part of the description, identify briefly how this
application relates to the purpose of the R21 mechanism as stated in this
program announcement (i.e., highly innovative research; exploration of the use
of approaches and concepts new to a particular substantive area; research and
development of new technologies, techniques or methods; or initial research and
development of a body of data upon which significant future research may be
built).

Research Plan:

The Research Plan may not exceed 10 pages.

Item a.1, SPECIFIC AIMS

The instructions for this section suggest that the applicant state "the
hypotheses to be tested."  Since some applications submitted in response to this
program announcement may also be design- or problem-driven (e.g., development of
novel technologies), or need-driven (initial research to develop a body of data
upon which future research will build).  In such instances, hypothesis testing
per se may not be the driving force in developing such a proposal and,
therefore, may not be applicable.  Thus, the application should state the
hypotheses, design, problem and/or need which will drive the proposed research.

Item a.2, JUSTIFICATION AS EXPLORATORY RESEARCH

In the introductory paragraph at the beginning of the research plan, amply
justify the designation of the application as an initial feasibility pilot study.
Explain how this project represents a change in research focus or a new research
direction for your laboratory.  Justify why the project would not be appropriate
for submission as a regular research grant at this time, and how this project,
if fruitful, would enable you to craft a research program appropriate for
submission as a full-scale research grant application.  Label this paragraph,
"Justification as Exploratory Research."  Applications that lack the
introductory justification 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 new technologies) or data-driven (e.g., database management,
mining or distribution), rather than problem-driven (e.g., testing of scientific 
hypotheses).  In the cases of design-driven or data-driven applications, 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.  It also should well articulate the integration of
neuroscience and neuroinformatics research approaches.

Item b, BACKGROUND AND SIGNIFICANCE

In this section, it is important to clearly elaborate upon how the application 
serves the purpose of this program announcement.

Item c, PRELIMINARY STUDIES/PROGRESS REPORT

Although preliminary data are not expected for an Exploratory/Developmental
Grant application, if such data exist they should be presented.

Item d, RESEARCH DESIGN AND METHODS

In many cases, an Exploratory/Developmental Grant mechanism will support novel 
research in an area or the research and development of new technologies.  Where 
appropriate, specific criteria by which to judge the feasibility of novel
approaches (including milestones that will mark progress) should be explicitly
described in this section.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of the 
application, including the checklist, and five 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)

Schedule

Letter of Intent Receipt Date:  Dec 21    Apr 21    Aug 22
Application Receipt Date:       Jan 21    May 21    Sep 22
Administrative Review:          Feb       Jun       Oct
Scientific Review:              Mar/Apr   Aug/Sep   Nov/Dec
Advisory Council Review:        Sep/Oct   Jan/Feb   May/Jun
Earliest Starting Date:         Dec       Mar       Jul

APPLICATION PROCESSING:  Applications must be received by the application
receipt dates listed in the heading of this PA.  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 application already reviewed, but such application must include
an Introduction addressing the previous critique.

PEER REVIEW PROCESS

Applications will be assigned on the basis of established PHS referral
guidelines.  A special scientific review group convened in accordance with the
standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will
evaluate applications for scientific and technical merit.

As part of the initial merit review, all applications will:

o  Receive a written critique
o  Undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, will
be discussed and assigned a priority score
o  Receive a second level review by the appropriate national advisory council or 
board

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
your application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals:

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

The scientific review group will address and consider each of these criteria in 
assigning your application's overall score, weighting them as appropriate for
each application.  Your 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, you may propose to carry out important work that
by its nature is not innovative but is essential to move a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem?  If the aims of 
your application are achieved, how do they advance scientific knowledge?  What
will be the effect of these studies on the concepts or methods that drive this
field?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the
project?  Do you acknowledge potential problem areas and consider alternative
tactics?

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

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

(5) ENVIRONMENT:  Does the scientific environment in which your 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, your application 
will also be reviewed with respect to the following:

PROTECTIONS:  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.

INCLUSION:  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.  Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria included in the section
on Federal Citations, below.)

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

OTHER REVIEW CRITERIA

(1) Does the proposed research represent a change in research focus or a new 
research direction for the laboratory that requires feasibility pilot studies,
or is the proposed research the logical continuation of ongoing research
efforts?

(2) In the case of research that is hypothesis-driven, will the successful
outcome of the proposed studies likely generate sufficient data to pursue
follow-up studies and lead to a full-scale research grant application?

(3) In the case of proposed research that is either technology-driven or design-
driven, will the project generate a body of data, a technological advance or
product that will be useful to the communication sciences community?

(4) How will the successful completion of the proposed studies impact the
concepts, methods, or technologies that drive the field?

(5) Is the integration of Neuroscience and Informatics clear and appropriate?

AWARD CRITERIA

Applications 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

POST-AWARD MANAGEMENT

The FICC-HBP committee maintains a Human Brain Project/Neuroinformatics web in
order to provide the public and scientists with the most recent activities of
this program (http://www.nimh.nih.gov/neuroinformatics/index.cfm).  Each funded
grant application will be listed and briefly described (provided by the
principal investigator), and hotlinks provided to connect interested parties
directly to the HBP grantees' web site.  The grantees' web page to which the
hotlink connects should indicate the program support from the Human Brain
Project, the individual supporting Agencies/Institutes and the Logo.  The
individual web sites of grantees are expected to contain complete and accurate
information on the activities of their funded Human Brain Project, and to be
maintained by the principal investigator to ensure that it contains the most
current information on the project, as well as the availability of new resources
or capabilities created via this mechanism.  The Human Brain Project web site
also contains a listing of all publications, software, hardware, and patents
that have resulted from this funding.  The principal investigator shall provide,
at a minimum, to the coordinating Human Brain Project Office an updated listing
of these results, electronically in cold fusion, at least two times per year.
This list should contain appropriate hot links to allow individuals to find
either the source document and/or additional directly relevant information.
Grantees are expected to participate in the Annual Spring Human Brain Project
Meetings of Agencies and Grantees and the annual Principal Investigator Meeting.
These meetings will promote communications among different groups of HBP 
investigators, who are involved in research, curricula development, and career 
development and/or other cross-training activities in neuroinformatics.  All 
publications and meeting abstracts, etc., resulting from HBP funding should give 
appropriate citation to the Human Brain Project and the funding Institutes and 
Agencies.

REQUIRED FEDERAL CITATIONS

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components
involving Phase I and II clinical trials must include provisions for assessment
of patient eligibility and status, rigorous data management, quality assurance,
and auditing procedures.  In addition, it is NIH policy that all clinical trials
require data and safety monitoring, with the method and degree of monitoring
being commensurate with the risks (NIH Policy for Data Safety and Monitoring,
NIH Guide for Grants and Contracts, June 12, 1998:
https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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 AMENDMENT "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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at 
https://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 
https://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
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS:  Criteria for federal funding of research on hESCs
can be found at https://grants.nih.gov/grants/stem_cells.htm and at 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only
research using 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 the official NIH
identifier(s)for the 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 
https://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.

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.health.gov/healthypeople.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of Federal 
Domestic Assistance Nos. 93.242 (NIMH), 93.838 (NHLBI), 93.866 (NIA), 93.273 
(NIAAA), 93.287, 93.287 (NIBIB), 93.279 (NIDA), 47.074 (NSF), 93.865 (NICHD),
93.173 (NIDCD), 93.121 (NIDCR), 93.879 (NLM), 81.049 (DOE), and 43.002 (NASA),
and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.  Awards are made under
authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and administered under NIH grants policies
described at https://grants.nih.gov/grants/policy/policy.htm and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

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


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
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Bethesda, Maryland 20892
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and Human Services (HHS)
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