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 301-710-0267, 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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