MORRIS K. UDALL PARKINSON'S DISEASE RESEARCH CENTERS OF EXCELLENCE

RELEASE DATE:  October 7, 2002 (This PAR has been reissued, see PAR-06-058)
                               (see NOT-NS-03-021 and NOT-NS-03-020)

PA NUMBER:  PAR-03-004

EXPIRATION DATE:  2 November 2005, unless reissued
 
National Institute of Neurological Disorders and Stroke (NINDS) 
 (http://www.ninds.nih.gov)
National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this PA
o Research Objectives
o Research Scope
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations:

PURPOSE OF THIS PA 

In response to continuing research progress and opportunity, and in 
recognition of continuing Congressional interest to intensify and to 
expand basic and clinical research in Parkinson's disease, The National 
Institute of Neurological Disorders and Stroke (NINDS) and the National 
Institute of Environmental Health Sciences (NIEHS) invite qualified 
investigators to submit grant applications for the establishment of 
Morris K. Udall Parkinson's Disease Research Centers of Excellence.  
The purpose of this Program Announcement (PA) is to encourage 
additional research opportunities and discoveries that will lead to 
improved diagnosis and treatment of patients with Parkinson's Disease 
and related neurodegenerative disorders, based on a better 
understanding of the fundamental cause(s) of the disease.  It is 
expected that these Centers will form a consortium of investigators 
that will foster an environment that will enhance research 
effectiveness in a multi-disciplinary setting, utilizing specialized 
methods relevant to the study of these disorders.  There were two 
previous requests 
(http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-98-001.html and 
http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-99-004.html. 

RESEARCH OBJECTIVES

The overall purpose of this initiative is to continue to support and 
develop outstanding Parkinson's disease research centers of excellence.  
Each center may contain either basic or clinical research or 
proportions of each that are appropriate for the research objectives.  
Emphasis is placed on multi-disciplinary and collaborative studies that 
can best be carried out in a Center setting.  The organizational 
structure of the Center should be flexible to allow the expeditious 
translation of new scientific findings and new technological 
developments to clinical research.  Studies might include, but are not 
limited to, the epidemiology, natural history, pathogenesis or 
treatment of PD and related disorders.  To generate new ideas, develop 
young investigators, and enhance the national PD research 
infrastructure each center should have a research-training component 
identifying opportunities for either basic or clinical inter-
institutional research collaborations.  This component is to allow 
young investigators to work for a time at the center or allow center 
investigators to travel between Centers to learn new techniques.  
Centers are expected to be characterized by a broad but thematically 
coherent set of investigations bearing on the etiology, pathogenesis 
and treatment of PD.  To the extent that they inform and/or expand 
research on Parkinson's disease, investigations on related 
neurodegenerative disorders may be included.  It is anticipated that 
the ensemble of individual Centers will constitute a comprehensive and 
systematic pursuit of the needs and opportunities in PD research. Each 
single center will focus on a select subset of topics according to its 
individual strengths while continuing to expand the PD research 
enterprise through collaborations.  To facilitate interaction and 
collaboration between the Centers a consortium will be established.  

RESEARCH SCOPE

New research techniques have created extraordinary opportunities for 
further exploration into the etiology, pathogenesis, diagnosis and 
treatment of Parkinson's disease and related neurodegenerative 
disorders.  Topics of investigation within a center might include, but 
are not limited to:

o Clinical studies of Parkinson's disease, parkinsonism, and related 
disorders.

o The natural history of PD and related disorders including prospective 
clinical assessment, neuropathological analysis, and banking of brain 
tissue from individuals with Parkinson's disease who agree to 
participate in an autopsy program.

o Studies to address the non-motor aspects of Parkinson's disease.

o Development of therapeutic technology related to Parkinson's disease.

o Epidemiological and genetic studies to identify risk and 
susceptibility factors.

o Studies on gene-environment interactions as risk factors for
Parkinson's disease.

o Translational research.

o Cellular and molecular mechanisms of cell injury and death in 
Parkinson's disease and related neurodegenerative disorders.

o Studies of the structure, function, composition, role, and possible 
interrelationship of proteins and inclusion bodies implicated in the 
pathogenesis of Parkinson's disease and related disorders.

o Development of animal models and their use for investigation of 
pathophysiology and efficacy of therapeutic intervention.

o Development and function of the neural circuitry involved in PD and 
related disorders, including those functions affected by the disease 
process or treatment. 

o Molecular and cell biology of the dopaminergic systems and other 
relevant neurotransmitters and neuromodulators and their function in 
the brain.

o Exploration of trophic factors and their receptors that promote the 
survival of dopamine neurons in the adult brain.

o Neuronal reconstruction using engineered cell lines that are relevant 
to Parkinson's disease.

o Markers of PD onset, progression and response to therapy.

MECHANISM OF SUPPORT

The mechanism of support for the Morris K. Udall Parkinson's Disease 
Research Centers of Excellence is the Research Center Grant (P50).  
Responsibility for planning, direction, and execution of the proposed 
research centers will rest solely with the applicant.  Because the 
nature and scope of the research proposed in response to this PA may 
vary, it is anticipated that the size of the award may also vary.  It 
is expected that grants will not exceed one million dollars per year 
direct costs for five years.  At this time, it is not known if this PA 
will be reissued. Any future unsolicited competing continuation 
applications based on this project will compete with all NIH 
investigator-initiated applications and be reviewed according to the 
customary peer review procedures.

Investigators seeking to carry out pilot studies of therapies in 
preparation for a clinical trial should apply under the auspices of the 
NINDS Pilot clinical trial grant program announcement PAR-01-119.  This 
announcement can be found at 
http://grants.nih.gov/grants/guide/pa-files/PAR-01-119.html).  Since such 
applications must conform to the intent of both program announcements, 
including the additional review criteria of PAR-01-119, potential 
applicants are strongly encouraged to contact NINDS program staff for 
guidance.  Close collaboration and integration between research center 
activities and clinical trials is encouraged.

FUNDS AVAILABLE 

Applications based on this PA will compete with all NIH investigator-
initiated applications and be reviewed according to the customary peer 
review procedures.  Awards pursuant to this PA are contingent upon the 
availability of funds and the receipt of applications that address a 
sufficient number of the topics identified in the "RESEARCH SCOPE".

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your institution has any of the 
following characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges,  
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government 
o Domestic institutions or organizations
o Faith-based or community based organizations 

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

Consortium and Annual Meeting:  Investigators who participate in this 
PA will collaborate with other investigators in the existing 
consortium. Synthesis of the individual Center's research projects into 
an integrated research effort to understand and treat Parkinson's 
disease will require multidisciplinary collaboration, communication of 
research results and ideas, and sharing of research resources.  To 
facilitate such interactions, the NINDS will coordinate an annual 
meeting.  The PI and other representatives from each Center will attend 
this meeting. As appropriate, this meeting will also be open to 
interested members of the research community and representatives of 
health research voluntary agencies.

Collaborative Studies: The consortium structure is put in place to 
facilitate collaboration among participating investigators. As 
discussed in the "RESEARCH OBJECTIVES", a mission of the consortium is 
to foster interdisciplinary efforts among members.  Examples of 
interdisciplinary efforts may consist of the sharing of ideas, results, 
reagents, resources, and the exchange of post-doctoral students, etc.  
The cost of attendance at the annual meeting and of participating in 
collaborative studies should be built into the proposed budget.

WHERE TO SEND INQUIRIES

We encourage 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:

Direct your questions about scientific/research issues to:

Eugene J. Oliver, Ph.D.
Program Director
Neurodegeneration Cluster
National Institute of Neurological Disorders and Stroke
Neuroscience Center, RM 2203
6001 Executive Blvd MSC 9525
Bethesda, MD  20892-9525
Phone: 301-496-5680
FAX: 301-480-1080
Email: eo11c@nih.gov 

Annette Kirshner, Ph.D.
Program Administrator
National Institute of Environmental Health Sciences
Box 12233 MD EC-23
RTP, NC 27709
Phone: 919-541-0488
FAX: 919-541-5064
Email: kirshner@niehs.nih.gov

Cindy Lawler, Ph.D.
Program Administrator
National Institute of Environmental Health Sciences
Box 12233 MD EC-23
RTP, NC 27709
Phone: 919-316-4671
FAX: 919-541-5064
Email: lawler@niehs.nih.gov

Direct your questions about peer review issues to:

Alan Willard, Ph.D.
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Neuroscience Center, RM 3208
6001 Executive Blvd MSC 9529
Bethesda, MD 20892-9529
Phone: 301-496-9223
FAX: 301-402-0182
Email: alanw@ninds.nih.gov

Direct your questions about financial or grants management matters to:

King P. Bond Jr.
Grants Management Officer
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Suite 3254
6001 Executive Blvd MSC 9537
Bethesda, MD  20892-9537
Phone: 301-496-3813
FAX: 301-402-0219
Email: kb33s@nih.gov

Lerlita Garcia
Grants Management Specialist
National Institute of Environmental Health Sciences
Box 12233 MD EC-22
RTP, NC 27709
Phone: 919-316-4638
FAX: 919-541-2860
Email: garcia1@niehs.nih.gov

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 Grants Info, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this 
program announcement 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.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER 
YEAR: 

Applications requesting $500,000 or more in direct costs for any year 
must include a cover letter identifying the NIH staff member within one 
of NIH institutes or centers who has agreed to accept assignment of the 
application.   

Applicants requesting more than $500,000 must carry out the following 
steps:
        
1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff 
member and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any amended 
or revised version of these grant application types. Additional 
information on this policy is available in the NIH Guide for Grants and 
Contracts, October 19, 2001 at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and three signed, 
photocopies, in one package to:

Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

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

Eugene J. Oliver, Ph.D.
Program Director
Neurodegeneration Cluster
National Institute of Neurological Disorders and Stroke
Neuroscience Center, RM 2203
6001 Executive Blvd MSC 9525
Bethesda, MD  20892-9525
Phone: 301-496-5680
FAX: 301-480-1080
Email: e011c@nih.gov

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.

The NINDS Guidelines for the development of Program Project and Center 
Applications should be followed when preparing the application.  They 
are available on the NINDS home page at: 
http://www.ninds.nih.gov/index.htm. 

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

PEER REVIEW PROCESS  

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review 
group convened by NINDS 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 selection 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 National Advisory Council of the 
relevant participating IC 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:

o INTEGRATION AND COLLABORATION:  The adequacy of the proposed Center 
to integrate across research projects and collaborate across 
laboratories including basic and clinical approaches (for applications 
that propose basic and clinical research).  Activities in each project 
should inform and advance the others and the proposed collaborative 
activities should provide synergy to the proposed Center.

o 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.

o 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)

o DATA SHARING:  The adequacy of the proposed plan to share data, 
resources, and tools. 

o 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 

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: 
http://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 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates: the use of an NIH definition 
of clinical research; updated racial and ethnic categories in 
compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of NIH staff and 
the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or 
proposals and/or protocols must provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) 
investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS:  The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 
1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the inclusion of children as 
participants in research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for 
research involving human subjects.  You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of 
research on hESCs can be found at 
http://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 93.113, 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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