R21 FAST TRACK GRANTS FOR PARKINSON"S DISEASE RESEARCH

Release Date:  May 17, 2001

RFA:  RFA-NS-02-006

The National Institute of Neurological Disorders and Stroke
The National Institute on Deafness and Other Communication Disorders
The National Institute of Environmental Health Sciences
The National Institute of Mental Health
The Michael J. Fox Foundation for Parkinson"s Research
The Parkinson’s Disease Foundation/National Parkinson’s Foundation
The Parkinson’s Alliance

Letter of Intent Receipt Date:  June 13, 2001
Application Receipt Date:       July 19, 2001

THIS RFA 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 RFA.

PURPOSE

The National Institute of Neurological Disorders and Stroke (NINDS), 
The National Institute on Deafness and Other Communication Disorders 
(NIDCD), the National Institute of Environmental Health Sciences 
(NIEHS), the National Institute of Mental Health (NIMH), the Michael J. 
Fox Foundation for Parkinson"s Research, the Parkinson’s Disease 
Foundation/National Parkinson’s Foundation, and the Parkinson’s 
Alliance invite investigator-initiated grant applications to conduct 
research relevant to the cure, cause, prevention or improved treatment 
of Parkinson’s Disease (PD) and its complications. The intent of this 
RFA is to stimulate novel, innovative, or high impact approaches to the 
field of Parkinson"s Disease research within the framework of the 
exploratory/developmental granting mechanism to enhance and escalate 
discoveries beneficial to PD.  

RESEARCH OBJECTIVES

Background

One of the highest priority goals in the mission of the National 
Institute of Neurological Disorders and Stroke (NINDS) is to encourage 
research in neurodegeneration over the entire life span from birth to 
the last years of life.  As a part of that mission, the NINDS has 
written a 5-year plan to escalate progress in the treatment, prevention 
or cure of Parkinson"s Disease (see the website: 
http://www.ninds.nih.gov/about_ninds/plans/nihparkinsons_agenda.htm). 
Parkinson"s Disease is the most common neurodegenerative movement 
disorder, and is caused by selective degeneration of the dopaminergic 
neurons of the substantia nigra, a brain area critical for purposeful 
control of movement.  When the level of striatal dopamine falls below 
20% as the result of nigrostriatal degeneration, the symptoms of the 
disease appear, including tremor, bradykinesia, gait abnormality, and 
postural instability. With progression of the disease, further 
complications can arise such as cognitive impairment or dementia, 
depression, and perturbations of the autonomic nervous system. People 
with Parkinson"s Disease often experience difficulties in communication 
abilities and swallowing function, an area which is of strong priority 
to the National Institute on Deafness and Other Communication Disorders 
(NIDCD). The burden of Parkinson"s Disease and related parkinsonisms is 
extraordinarily devastating to individuals, to families, and to the 
nation. Approximately 1 percent of the population over age 50, suffer 
from PD.

Scope

The purpose of this RFA is to invite investigator initiated 
applications focused on advancing our understanding of Parkinson"s 
Disease as relevant to its treatment, cause, prevention, or cure. 
Investigators with diverse scientific interests are invited to direct 
their expertise to both basic and applied research. The intent is to 
enhance our understanding of the genetic and environmental causes of 
PD, to develop appropriate models relevant to understanding and 
treating the disease, and to develop innovative strategies to prevent, 
limit, or reverse the pathogenesis of PD. Applications may focus on 
epidemiology, genetics, biochemistry, cell biology, physiology, or 
clinical studies. An important component of disease cure or prevention 
is the translation of basic discoveries to their eventual application 
to the patient, so studies utilizing translational or "bench-to-
bedside" approaches are encouraged. Collaborative efforts between of 
basic neurobiologists and clinicians are welcomed. 

A special area of interest for NIEHS is the role of environmental 
agents in the causation of Parkinson’s disease including the 
interactions of environmental agents with potential susceptibility 
genes and the development of novel animal models that could facilitate 
understanding environmental inputs in the etiology of the disease.  The 
NIEHS would be especially interested in applications responsive to this 
RFA focused on these areas.

A major priority in the NIDCD strategic plan is the development and 
improvement of devices, pharmacologic agents, and strategies for 
habilitation/rehabilitation of human communication disorders.   The 
NIDCD would be specifically interested in applications responsive to 
this RFA focused on the areas of dysarthria and dysphagia.

SPECIAL REQUIREMENTS

Letter of Authorization

Because the domestic applications will be co-funded by the NIH and the 
Foundations, all applicants should submit a brief letter to the NIH 
indicating that the application and the summary statements for such 
applications can be shared with the Foundations.  Letters of 
authorization should be prepared by the principal investigator and co-
signed by the official signing for the applicant organization.  This 
letter may be combined with the Letter of Intent (see below) or may be 
submitted as a cover letter accompanying the
application. 

Periodic Meetings

Upon initiation of this program, the NIH and the Foundations plan to 
sponsor periodic meetings to encourage exchange of information among 
investigators, to foster collaborative efforts among program grantees, 
and to identify resources that would enhance the productivity of 
grantees.  For this purpose, applicants should request travel funds for 
a two-day meeting each year, the location of which will be announced.  
Applicants should also include a statement in their applications 
indicating their willingness to participate in such meetings and to 
cooperate with other researchers.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) 
Exploratory/Developmental research grant (R21) award mechanism. 
Instructions for preparing the R21 grants are found at:
http://www.ninds.nih.gov/funding/r21guidelines.htm.  The R21 mechanism 
requires much less preliminary data than other funding mechanisms, and 
encourages newcomers to the field, and also high-risk, high-impact 
hypotheses.

Please note that the instructions limit the Research Plan to 15 pages.  
For the purposes of this RFA, the Research Plan is limited to 10 pages. 
Color/glossy figures are permitted when needed to show information.

FUNDS AVAILABLE

For FY 2002, the NINDS will commit $1.5 million (total costs) to fund 
new applications submitted in response to this RFA. The Fox Foundation 
will commit $500,000, and the Parkinson’s Disease Foundation/National 
Parkinson’s Foundation and the Parkinson’s Alliance will contribute 
$500,000. Pursuant to receipt of applications within their scientific 
interest, the NIDCD intends to commit approximately $400,000, NIMH 
intends to commit $500,000 and the NIEHS will commit $400,000. All 
awards will be issued by the NIH. An applicant may request a project 
period of up to 2 years and a budget for direct costs of up to $125,000 
per year. Because the nature and scope of the research proposed may 
vary, it is anticipated that the size of each award will also vary. 
Although the financial plans of the NINDS and the Foundations provide 
support for this program, awards pursuant to this RFA are contingent 
upon the availability of funds and the receipt of a sufficient number 
of applications high scientific merit. At this time, it is not known if 
this RFA will be reissued. Competitive renewals of grants awarded under 
this program will not be accepted.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and 
non-profit organizations, public and private, such as universities, 
colleges, hospitals, laboratories, units of state and local 
governments, and eligible agencies of the federal government.  
Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to 
clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Diane D. Murphy, Ph.D. 
Program Director, Neurodegeneration, NINDS
NSC Rm. 2223
6001 Executive Blvd.
Bethesda, MD  20892
Tel:  (301) 496-5680
Fax:  (301) 480-1080
Email: murphyd@ninds.nih.gov

Lana Shekim, Ph.D.
Program Director, Voice & Speech,
Scientific Programs Branch, DER
National Institute on Deafness and Other Communication Disorders, NIH
6120 Executive Blvd., EPS-400-C MSC 7180
Bethesda, MD  20892-7180
Tel:  301-496-5061
Fax: 301-402-6251
Email: shekiml@nidcd.nih.gov

Dr. Steven Zalcman
Chief, Clinical Neuroscience Research Branch
NIMH/Division of Neuroscience and Basic Behavioral Science
6001 Executive Blvd., Room 7177 MSC 9639
Bethesda, MD 20892-9639
Tel: 301-443-1692
Fax: 301-443-4822
Email: sz7f@nih.gov

Dr. Annette Kirshner 			
Health Scientist Administrator				
NIEHS												
MD EC-23 						
P.O. BOX 12233 					
RTP, NC  27709 					
Tel: (919) 541-0488					
Fax: (919) 541-5064 					
Email: kirshner@niehs.nih.gov	
		
Dr. Cindy Lawler 
Health Scientist Administrator
NIEHS
MD EC-23
P.O. BOX 12233
RTP, NC  27709
Tel: 919 316-4671
Fax: (919) 541-5064
email: lawler@niehs.nih.gov

Direct inquiries regarding review to:

Dr. Lillian Pubols
Chief, Scientific Review Branch, NINDS, NIH
Neuroscience Center, Suite 3208 MSC9529
6001 Executive Blvd.
Bethesda, MD 20892-9529
Rockville, MD 20852 (for express/courier service)
Telephone:  301/496-9223
Email: pubolsl@ninds.nih.gov

Direct inquiries regarding fiscal and administrative matters to:

Carlos Pena, Ph.D.
Program Analyst, Neurodegeneration, NINDS
Neuroscience Center
6001 Executive Blvd., Room 2228
Bethesda, MD  20892
Telephone: (301) 496-5680
Fax:  (301) 480-1080
Email:  penac@ninds.nih.gov

Kimberly Pendleton
Grants Management Specialist
Grants Management Branch, DER, NINDS
Neuroscience Center
6001 Executive Blvd., Room 3290
Bethesda, MD 20892-9537
Telephone: (301) 496-9231
FAX: 301-402-0219
EMAIL: kp33e@nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit, by June 13, 2001, a letter 
of intent that includes a descriptive title of the proposed research, 
the name, address, and telephone number of the Principal Investigator, 
the identities of other key personnel and participating institutions, 
and the number and title of the RFA in response to which the 
application may be submitted.

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 NINDS staff to estimate the potential review 
workload and avoid conflict of interest in the review.

The letter of intent should be faxed or emailed to:

Dr. Diane D. Murphy
Program Director, Neurodegeneration
Division of Extramural Activities
National Institute of Neurological Disorders and Stroke
NSC Rm. 2223
6001 Executive Blvd.
Rockville, MD 20852
Phone (301) 496-5680
Fax (301) 480-1080
Email: murphyd@ninds.nih.gov

SCHEDULE SUMMARY:

Letter of Intent Receipt Date:       June 13, 2001
Application Receipt Date:            July 19, 2001
Initial Review:                      August 2001
Second Level Review:                 September 2001
Earliest Anticipated Date of Award:  December 1, 2001

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants.  These forms are available at most 
institutional offices of sponsored research and may be obtained from 
the Division of Extramural Outreach and Information Resources, National 
Institutes of Health, 6701 Rockledge Drive, Suite 6095, Bethesda, MD 
20892-7910, telephone 301-435-0714, email: GrantsInfo@nih.gov.

All applicants should use the NINDS guidelines for the R21 mechanism at 
the url: http://www.ninds.nih.gov/funding/r21guidelines.htm.
These guidelines contain important information on the suggested format 
of applications and on review criteria.

The RFA label available in the PHS 398 (rev. 4/98) application form 
must be affixed to the bottom of the face page of the application.  
Failure to use this label could result in delayed processing of the 
application such that it may not reach the review committee in time for 
review.  In addition, the RFA title and number must be typed on line 2 
of the face page of the application form and the YES box must be 
marked.

Submit a signed, typewritten original of the application, and 3 
photocopies, including the Checklist 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)

At time of submission, 2 additional copies of the application must be 
sent to:

Dr. Lillian Pubols
Chief, Scientific Review Branch, NINDS, NIH
Neuroscience Center, Suite 3208 MSC9529
6001 Executive Blvd.
Bethesda, MD 20892-9529
Rockville, MD 20852 (for express/courier service)
Telephone:  301/496-9223
Email: pubolsl@ninds.nih.gov

Applications must be received by July 19, 2001.  If an application is 
received after that date, it will be returned to the applicant without 
review. Similarly, supplemental documents containing significant 
revision or additions will not be accepted after that date. The Center 
for Scientific Review (CSR) will not accept any application in response 
to this RFA 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 
substantial revisions of applications previously reviewed, but such 
applications must include an introduction addressing the previous 
critique.

SPECIFIC INSTRUCTIONS FOR MODUALR GRANT APPLICATIONS

Specific application instructions have been modified to reflect 
"MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined 
by the NIH.  Complete and detailed instructions and information on 
Modular Grant applications can be found at:
http://grants.nih.gov/grants/funding/modular/modular.htm.  
Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant.  The total 
project period for an application submitted in response to this RFA may 
not exceed two years and the funding for each year may not exceed 
$125,000 in direct costs. The anticipated award date is December 1, 
2001.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by NINDS.  Applications that are complete and 
responsive to the RFA will be evaluated for scientific and technical 
merit by an appropriate peer review group convened by NINDS in 
accordance with NIH peer review procedures.  As part of the initial 
merit review, all applications will receive a written critique and 
undergo a process in which only those applications deemed to have the 
highest scientific merit will be discussed, assigned a priority score, 
and receive a second level review by the National Institute of 
Neurological Disorders and Stroke 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.  Note that 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.

o  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?

o  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?

o  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? 

o  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)?

o  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?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be review with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children 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 duration in relation 
to the proposed research.

o  The adequacy of the proposed protection of humans, animals, or of 
the environment, to the extent that they may be adversely affected by 
the project proposed in the application.

The initial review group will also examine the provisions for the 
protection of human subjects and the safety of the research 
environment.

AWARD CRITERIA

The earliest anticipated date of award is December 1, 2001.  Awards 
will be based upon the following criteria:

--scientific merit as determined by peer review
--availability of funds
--programmatic priorities of the funding institute

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 sub-populations 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 
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 research involving human subjects should 
read the updated "NIH Guidelines for Inclusion of Women and Minorities 
as Subjects in Clinical Research," published in the NIH Guide for 
Grants and Contracts on  August 2, 2000, available on the Internet at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html
The revisions relate to NIH defined Phase III clinical trials and 
require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, 
and to conduct and report analyses, as appropriate, by sex/gender 
and/or racial/ethnic group differences."

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:
http://grants.nih.gov/grants/guide/notice-files/not98-024.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.  Reviewers are cautioned 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 Request for 
Applications (RFA), R21 Fast Track Grants for Parkinson"s Disease Research, 
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. 93.853 (NINDS), 93.113 (NIEHS), 93.242 (NIMH), and 93.173 (NIDCD).  
Awards are made under authorization of Sections 301 and 405 of the 
Public Health Service Act (42 USC 241 and 248) and administered under 
NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 
74 and 92.  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 contract 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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