NINDS EXPLORATORY/DEVELOPMENTAL PROJECTS IN TRANSLATIONAL RESEARCH

RELEASE DATE:  July 26, 2002

PA NUMBER: PAR-02-138 (This PAR has been reissued, see PAR-05-157)

EXPIRATION DATE: July 31, 2005, unless reissued.

National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov)

THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators (PIs)
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

NINDS encourages translational research projects that focus on neurological 
disorders.  This PA requests applications for exploratory/developmental 
projects intended to discover potential targets for therapeutic intervention, 
to identify candidate therapeutics, or to develop assays, animal models, 
devices, or technologies for screening or developing therapeutics.  Such 
projects, if successful, should lead directly to a therapy development 
project for a particular neurological disorder.

This PA is one of three coordinated programs being released by NINDS to 
promote translational research, including "NINDS Cooperative Program in 
Translational Research" 
(http://grants.nih.gov/grants/guide/pa-files/PAR-02-139.html) and 
"NINDS Mentored Research Scientist Development Awards in Translational 
Research" 
(http://grants.nih.gov/grants/guide/pa-files/PAR-02-140.html).

RESEARCH OBJECTIVES

Definition of Translational Research:

Translational research is the process of applying ideas, insights, and 
discoveries generated through basic scientific inquiry to the treatment or 
prevention of human disease.

Background:

Remarkable insights have been made recently into the molecular, genetic, and 
cellular bases of neurological disease.  In many cases, developmental work 
must be completed before the basic research results can be translated into 
effective therapies.  A key requirement for successful therapeutic 
development is the characterization of new assays, models, tools, and 
technologies that provide for reliable discovery and testing of therapeutic 
approaches.

Scope of the Program:

This PA is intended to encourage projects that provide tools and resources 
for therapy development.  Proposed projects should relate directly to a 
disorder affecting the nervous system, and have a rational basis with regard 
to disease mechanisms, or potential therapeutics that have previously been 
shown to have efficacy.

Possible goals of such projects include, but are not limited to:

o Identification of targets for therapeutic intervention.  Examples of 
methods for target identification include genetic, protein interaction, and 
cell viability screens.

o Development of assays that permit the preliminary screening of candidate 
therapeutics.  These include biochemical and cellular assays, modified model 
organisms, and electrophysiological or behavioral recording devices.  Assays 
that can be used for high throughput screening are particularly encouraged.

o Development of animal models that permit further evaluation of candidate 
therapeutics and/or toxicology studies.  Examples include animals that have 
been modified genetically, chemically, or through any intervention that 
recapitulates critical features of a specific neurological disorder.  Animal 
model development is appropriate only if it will lead directly to therapy 
development efforts, and is not appropriate if the models will be used to 
study disease mechanisms.  

o Development of tools and technologies that can be directly used for therapy 
development.  Examples include novel gene therapy vectors, genetically-
modified cells, in-dwelling drug delivery devices, microstimulators, and 
microelectronic recording devices.  These tools or technologies should 
overcome existing obstacles to treatment and be capable of being directly 
applied to, or adapted for, delivery of potential therapeutics.
 
o Preliminary identification of candidate therapeutics that can be evaluated 
through further preclinical testing.  Such identification can be achieved 
using any of the assays or animal models described above.

MECHANISM OF SUPPORT 

This PA will use the NIH Exploratory/Developmental Grants R21 award 
mechanism.  As an applicant, you will be solely responsible for planning, 
directing, and executing the proposed project.  Applications in response to 
this PA are limited to $125,000 per year direct costs, and a maximum of two 
years.  The awards are not renewable.

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format.  (see http://grants.nih.gov/grants/funding/modular/modular.htm).

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 or foreign

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.

SPECIAL REQUIREMENTS
 
Plan for Future Preclinical Testing:

NINDS intends that each project, if successful, will initiate a process of 
therapy development.  Therefore, it is essential that applicants describe how 
future steps in this process will be taken.  For example, if the goal of a 
project is to identify a potential therapeutic or assay, the applicant should 
provide a plan describing how that therapeutic or assay will be used in 
subsequent preclinical testing.  The plan should include, when appropriate, a 
list of collaborators who will participate in this process.  Since 
translational research is intrinsically interdisciplinary, this plan will 
often involve cooperation among basic researchers and clinicians, and may 
include the participation of private-sector companies and voluntary 
organizations.  

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:

Thomas Miller, Ph.D.
Technology Development
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2139
Bethesda, MD 20892
Telephone: 301-496-1779
FAX: 301-402-1501
Email: [email protected]

o Direct your questions about peer review issues to:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3208
Bethesda, MD 20892
Telephone: 301-496-5980
FAX: 301-402-0182

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

Rebecca Claycamp
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3290
Bethesda, MD 20892
Telephone: 301-496-9231
Fax: 301-402-0219
Email: [email protected]  

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 
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].

APPLICATION PAGE LIMITS AND APPENDICES: Applications submitted in response to 
this PA are limited to 15 pages for sections A through D of PHS 398, and 
appendices are not permitted.

APPLICATION RECEIPT DATES: Applications submitted in response to this PA will 
be accepted at the standard application deadlines, which are available at 
http://grants.nih.gov/grants/dates.htm.  Application deadlines are also 
indicated in the PHS 398 application kit.

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

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: 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 
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, including the checklist, and four 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)

In order to facilitate the review of applications, the applicant should, at 
the same time, mail or deliver one copy of the application to:
 
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3208
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)

APPLICATION PROCESSING: Applications must be received by or mailed on or 
before the receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  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

Upon receipt, applications will be reviewed for completeness by the CSR.  
Incomplete applications will be returned to the applicant without further 
consideration.  Applications that are complete will be evaluated for 
scientific and technical merit by an appropriate scientific review group 
convened by NINDS in accordance with the review criteria stated below.

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

o Receive a written critique
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 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 
PI 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?

OTHER REVIEW CRITERIA:

o The likelihood that completion of the exploratory/developmental research 
objectives will assist with translation of basic observations into one or 
more therapies for the neurological disorder under study.

o The adequacy of the plan for how the project, if successful, will be used 
to initiate a process of therapy development, including, when appropriate, 
the adequacy of proposed interdisciplinary collaborations.

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.

RESOURCE SHARING: A sharing plan for the distribution of unique research 
resources developed through NINDS Exploratory/Developmental Projects in 
Translational Research should be included in the application.  The sharing 
plan should preserve research freedom and publication rights, while ensuring 
appropriate implementation of the Bayh-Dole Act (35 U.S.C. 200 et seq.) and 
dissemination of research resources.  A Federal Register Notice published on 
December 23, 1999, titled "Principles and Guidelines for Recipients of NIH 
Research Grants and Contracts on Obtaining and Disseminating Biomedical 
Research Resources: Final Notice," provides further information, and is 
available at http://www.ott.nih.gov/policy/rt_guide_final.html.  The 
application should include a request for the funds necessary to implement the 
sharing plan.

DATA SHARING:  The adequacy of the proposed plan to share data.

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

REQUIRED FEDERAL CITATIONS 

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm 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 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.

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 No. 93.853, 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 
http://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.

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