Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov)
National Institute of Aging (NIA) (http://www.nia.nih.gov)


Title: Centers for Neurodegeneration Science (CNS) (P01)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-ES-07-003

Catalog of Federal Domestic Assistance Number(s)
93.113

Key Dates (New Dates)
Release Date: April 5, 2007
Letters of Intent Receipt Date: August 24, 2007
Application Receipt Date: September 24, 2007
Peer Review Date(s): January-February 2008
Council Review Dates: May 2008
Earliest Anticipated Start Date(s): July 1, 2008
Expiration Date: September 25, 2007

Key Dates (Old Dates)
Release Date: April 5, 2007
Letters of Intent Receipt Date(s): June 24, 2007
Application Receipt Date(s): July 24, 2007
Peer Review Date(s): October-November 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s): May 1, 2008
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: July 25, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information  
  1. Mechanism(s) of Support
  2. Funds Available

Section III. Eligibility Information
  1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
  2.Cost Sharing or Matching
  3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
  1. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
  3. Reporting

Section VII. Agency Contact(s)
  1. Scientific/Research Contact(s)
  2. Peer Review Contact(s)
  3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The National Institute of Environmental Health Sciences (NIEHS) and the National Institute of Aging (NIA) invites qualified investigators from academic institutions or non-profit research institutions to submit an application for a Center for Neurodegeneration Science (CNS) The CNS program builds on the previous success of the NIEHS Collaborative Centers for Parkinson’s Disease Environmental Research (CCPDER), provides increased flexibility for investigators and extends the scope to include researchers who study the environmental mediation of other human neurodegenerative diseases. 

The interaction of genetic and environmental factors in neurodegenerative disease presents unique scientific challenges and opportunities.  The CNS Program is founded on the premise that the combined research efforts of clinical and basic scientists will be required to clarify the causes of neurodegenerative disease.  Interdisciplinary research approaches are needed to enable scientists to incorporate risk and protective factor clues emerging from epidemiologic investigations with results from human genetic studies, clinical trials, disease models in animals and alternative organisms, and basic cellular and molecular neurobiologic studies of vulnerable neuronal populations.  Such integration is essential for rapidly identifying the initiating and/or sustaining environmental stressors and primary biologic events that participate in the injury to the neuronal populations targeted by specific neurodegenerative diseases.  This knowledge will provide novel therapeutic targets for intervention of existing disease and prevention strategies for reducing exposure in vulnerable individuals,

Specific Objectives

The objectives of the CNS program are to 1) provide a mechanistic understanding of the role(s) of environmental factors in human neurodegenerative disease; 2) identify and pursue opportunities for translation of this knowledge to the intervention and/or prevention of neurodegenerative disease; 3) establish an interdisciplinary framework  that fosters integrative research by neurodegenerative disease researchers and environmental health scientists; 4) support the development of novel and complementary lines of investigation by non-CNS investigators; and 5) promote meaningful collaborations and sharing of data and resources with other Centers. 

Background

Neurodegenerative diseases are a heterogeneous group of disorders that include the common disorders of Parkinson’s (PD), Alzheimer’s disease (AD) and related conditions (e.g., Multiple System Atrophy (MSA), Dementia with Lewy bodies (DLB), Progressive Supranuclear Palsy (PSP), Corticobasal degeneration (CBD), as well as rarer forms such as Huntington’s disease (HD) and Amyotrophic Lateral Sclerosis (ALS).  The specific clinical presentation varies among diseases, reflecting the neuronal population or populations that are selectively targeted.  Millions of individuals are affected worldwide by neurodegenerative diseases, and suffer progressive impairments in key domains of cognition and motor control. Although available therapies may provide limited symptomatic relief, no means of curing, halting or slowing the progression of disease has been identified.  Neurodegenerative diseases are primarily age-related, and thus represent a growing concern with the increasing life span occurring in the US and other industrialized countries.

The relative importance of genetic and environmental factors in common neurodegenerative diseases has been the subject of lively debate within the scientific community.  In many cases, rare genetic forms have been identified, and these have provided important mechanistic leads to the underlying pathophysiology.  Most cases are sporadic, however, and are thought to reflect the complex actions of multiple genetic and nongenetic factors.  For example, the results of recent twin studies in PD, which demonstrate a similar disease concordance rate of monozygotic and dizygtoic twin pairs, underscores the important role of nongenetic factors in disease etiology.  Epidemiologic studies have identified several primary environmental stressors, such as pesticides and metals, as risk factors for PD, while cigarette smoking and caffeine have been shown to decrease risk. Although less evidence is available to implicate primary environmental stressors as risk factors for AD and ALS, this is an area of active inquiry.  Even in monogenic, highly penetrant neurodegenerative diseases such as HD, a role for environmental factors in determining age of onset has been suggested.  Likewise, significant variation in clinical phenotype has been noted for some familial forms of PD, and has been suggested to reflect the action of additional nongenetic factors. 

General Description of a CNS

Each CNS will assemble an interdisciplinary team of investigators to tackle a central hypothesis, or related set of hypotheses, regarding the role of environmental factors in the etiology, phenotypic expression, progression, intervention and/or prevention, of a complex human neurodegenerative disease.  Three or more closely integrated research projects will be proposed to pursue the central hypothesis(es).  Collectively, these projects will embody a full range of research approaches, from studies in humans to cellular and molecular studies in suitable model systems.  Each CNS must provide a synergistic research environment that allows each research effort to share the creative strengths of the others. By supporting interrelated projects and collaborating investigators, each CNS is expected to yield results beyond those achievable were each project pursued separately and without formal interaction among the participating investigators.  The demonstration of synergy among the projects and the interdisciplinary nature of the work are critical components of this program.   

Definition of Complex Neurodegenerative Disease and Primary and Environmental Stressors

For the purpose of this solicitation, an applicant may concentrate on any complex human neurodegenerative disorder, defined as one with a known or suspected multifactorial basis and where there exists a compelling rationale for the influence of one or more primary environmental stressors on the etiology and/or clinical features of the disease (e.g., severity, age of onset, rate of progression, treatment response).  An applicant may propose to study more than one neurodegenerative disease if the central theme of the CNS involves biologic mechanisms that may be shared among a group of neurodegenerative diseases.  The primary environmental stressor(s) proposed for study within the CNS must be ones with the potential for significant human exposure.  These can be chemical, physical or biologic agents, including exogenous endocrine active chemical(s) such as pthalates; organic solvents; pesticides and other agricultural chemicals; molds and mycotoxins; PCBs, PBDEs and other industrial byproducts; particulate matter (PMs) and other components of air pollution; metals; phytochemicals and nutritional supplements.  For the purpose of this solicitation, smoking and caffeine are considered primary environmental stressors, but all other lifestyle and social/cultural factors (e.g., diet, physical activity, social stress) are excluded from consideration as primary stressors, although applicants are encouraged to investigate these as secondary factors modifying the effects of primary stressor(s).  Likewise, infectious agents, endogenous neuroactive compounds (e.g., neurotransmitters, hormones, neurotrophic factors) and prescription or nonprescription medications can be considered as secondary modifiers, but cannot provide the sole focus for a proposal.  Proposals which focus on one or more secondary modifiers in the absence of primary stressors will be considered nonresponsive and returned to the applicant without review. 

CNS Components

Each CNS must have an identifiable organizational unit within a university, medical school, non-profit research institute, or a consortium of cooperating institutions with a university affiliation.  Partnerships may consist of investigators at a single institution or at multiple sites and may include collaborative arrangements as appropriate with organizations, domestic or foreign, public or private (such as universities, colleges, hospitals, laboratories, for-profit and non-profit, units of State and local governments, and eligible agencies of the Federal government), as necessary to conduct portions of the research.  Teams that are geographically distributed must be well-justified and steps to minimize the effects of geography should be clearly stated.  The CNS Principal Investigator (PI) and a majority of the proposed research projects must be based at a domestic institution.  Any foreign CNS components are subject to additional considerations and review criteria, as detailed in Section 3.

The CNS P01 grant mechanism fosters collaborative and integrated basic, clinical and public health research and provides funds to support personnel, stipends and tuition for trainees, equipment, supplies and services for research projects, an administrative core, research development core and, if needed, facility cores.

1.  The applicant must develop a central theme that expresses a proposed relationship between environmental stressors and complex human neurodegenerative disease. 

2.  The Director for the CNS is the designated leader and provides the leadership for the administrative, scientific and programmatic direction.  It is expected that the Director will commit a minimum of 10% effort to the administration of the Center and devote a minimum of 15% additional effort to lead one of the research projects.

3.  The research projects provide the intellectual and scientific direction for the program.  These projects should be well integrated and relate to the overall theme of the center.  A minimum of three research projects are required and must include at least one human study.  For the purposes of this solicitation, human-based studies include clinical and epidemiologic studies where there is direct interaction with living individuals, as well as studies that employ postmortem human biospecimens, provided that reliable and complete information regarding the clinical characteristics of the specimens is available.  In light of the high cost of human studies and the limited funds available for this initiative, applicants are encouraged to extend or otherwise leverage existing studies to meet the requirements for a human component for the present initiative.  Project Leaders are expected to devote at least 15% effort to these projects.

4.  A required Administrative Core oversees the organizational, budgeting and reporting aspects of the CNS, provides the environment and infrastructure to promote cross-discipline interactions among all projects and cores.  To aid the Center Director in achieving the goals of the program, the establishment of an external advisory committee is required. The composition of the external advisory committee should reflect the scientific expertise of the Center and must include two or more physician-scientists.   The Administrative Core must also propose a specific plan to ensure that the research activities supported directly by the Center provide opportunities for cross-training of investigators in neurodegenerative disease and environmental health science.  The Administrative Core must provide a framework to support participation of the Center Director and Project and Core leaders in regular joint meetings with investigators from other CNSs and in the development of collaborative inter-CNS activities. 

5.  A Research Development Core is a required component of a CNS and is aimed at supporting the initial development of novel lines of investigation by non-CNS investigators.  By targeting individuals who are not currently involved in the CNS research projects, the Research Development Core provides a means for expanding and enriching the initial CNS team.  A total amount of $75,000 should be set aside each year to fund three one-year pilot projects.  These projects should complement the central research projects underway at the CNS.  The applicant must propose a plan for soliciting and reviewing pilot proposals, for fostering continuing interactions of pilot awardees with the CNS team and for monitoring progress.  It is expected that these pilot projects will provide initial support for the submission of R21 or R01 applications to NIH.

6.  Facility/Service Cores are principally designed as a service or resource component to the research projects within the Center.  Core facilities may include clinical research support, biostatistics and/or bioinformatics support, and basic molecular/cellular capabilities. These cores serve to enhance or make more cost-effective the services, techniques or instrumentation used by the Center and also promotes interdisciplinary activities.  Facility/Service Cores are not a requirement of the CNS.  The CNS may include facility cores that serve at least two research projects if resources are not available through other Institutional infrastructure.  If included, the number of Facility/Service Cores may not exceed the total number of proposed research projects.  Applicants must include a discussion of the cost savings and other efficiencies provided by the inclusion of such core facilities.

Research Themes

Research themes that may be appropriate for a CNS include, but are not limited to, the following:

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the P01 award mechanism(s).

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

NIEHS intends to commit approximately $4 million/year for this program.  NIA intends to contribute approximately $500,000/year to fund components of successful CNS applications that are relevant to the NIA mission (i.e., projects that focus on etiology and/or clinical features of Alzheimer’s disease and other dementias).   The National Institute of Neurological Disorders and Stroke (NINDS) recognizes the importance of this topic to understanding the pathology of neurodegenerative diseases.  NINDS may provide additional funding for projects that are strongly relevant to their research priorities. Two or three awards are anticipated to fund applications submitted in response to this FOA.  Awards are anticipated to begin on May 1, 2008.  Applications received from investigators previously funded under the NIEHS CCPDER (Collaborative Centers for Parkinson’s Disease Environmental Research) Program will be considered new applications. An applicant may request a project period of up to five years and a budget for direct costs up to $1 million per year. The budget ceiling of $1 million for direct costs will remain fixed for each year of support requested through this award.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

Domestic applicants are encouraged to form multi-institute consortia to accomplish the stated goals.  Applications from foreign institutions are not allowed.  Domestic institutions may include a foreign component, however, provided that the majority of the research projects are based at the domestic institution.

1.B. Eligible Individuals

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 support.

2. Cost Sharing or Matching

Cost sharing is not required

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Applicants may submit only one application.  Applicants must develop a central theme that relates to the relationship between a primary environmental stressor and a human neurodegenerative disease.  The CNS application must include at least three highly integrated research projects that, collectively, incorporate a range of complementary research approaches from basic cellular and molecular studies to human-based studies.  An Administrative Core and Research Development Core are required.  Other Facility/Service Cores are optional. 

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Guidance for Applicants Submitting a P01 CNS Grant

All applications received for this FOA will be considered new applications; thus, applications received from investigators who currently hold NIEHS CCPDER awards will not be considered competing renewals.  

Applicants should use the following guidance, in addition to the instructions accompanying the PHS 398 form.  The CNS grant proposal consists of three general sections of information:

Section I.  This section includes PHS 398 Form Pages 1-3, PHS 398 Form Page 4 - Detailed Composite Budget for the First 12-month Period Description and Form Page 5 – Composite Budget for All Years, All Projects as well as the corresponding budgets for each individual project and core supported by the CNS application.  In addition, a table that indicates the percentage use of each facility core relative to the individual projects should be included to assist the reviewers in determining the relationship between Facility Cores and Research Projects. Biographical Sketches should be provided for all KEY investigators using the PHS 398 Biographical Sketch Format Page.  List the Center Director first followed by all other key personnel in alphabetical order.  Use duplicate copies of the Biographical Sketch Format page for each investigator. Include only one copy of each biosketch in the application.  Lastly, Section I should include Institutional Environment and Resources using the PHS 398 Resources Format Page.  Include a brief description of the environment where the overall program and other activities will be conducted. If more than one campus or location will be involved, briefly describe each setting. If unique resources are available, briefly describe these and their relevance to the proposed program.

Section II.  This section is unique to the P01 application.  The information covered in this section for the most part, is not covered in the PHS 398.  The page limit for this section is 15 pages. This section includes:

Program Introduction and Statement of Objectives

Describe the major theme of the Center, its goals and objectives, background information and the overall importance of the research to the missions of the NIEHS and the NIA.  This should include the neurodegenerative disease(s) and primary environmental stressors of study and the overall hypotheses to be tested.  The applicant must provide a compelling rationale for the environmental mediation of the neurodegenerative disease(s) of interest. The program should be viewed as a group of interrelated research projects, each of which is not only individually scientifically meritorious but is also complementary to the other projects, and related to the overall theme developed for the Center.

Describe the rationale for the total proposed program.  Explain the strategy for achieving the goals defined for the overall program and how each research project and core relates to that strategy.  Highlight how the findings of the research efforts will impact clinical and public health practice and how the CNS will facilitate this translation.

Indicate and describe any collaborative arrangements between investigators in the group and the anticipated unique advantages that would be gained by the interdisciplinary approach proposed for the research being conducted by the CNS. 

Explain how different components of the organization, including key personnel, will interact, why they are essential to accomplishing the overall goal of the research, and how combined resources create capabilities that are more than the sum of the parts.  Very clear evidence that the key personnel will collaborate effectively must be presented in the application.

Organizational and Administrative Structure

Describe in detail and by diagram the organizational structure of the program including an administrative and management plan that achieve an integrated, coordinated interdisciplinary research program. 

In broad terms describe how the administrative core supports the goals and organization of the program.  Include a discussion of the function of advisory groups (both internal and external) used in the capacity of advisors and overseers of quality control.  Identify the expertise needed but do not identify by name the external consultants serving on advisory groups. Be aware that the external advisory committee must meet at least once a year and must present a written report to the NIEHS program staff two months prior to the end of the fiscal year in order to ascertain progress to secure the next year’s funding.

Describe the role of the Director and the investigators responsible for the direction of the research projects and core units. The Director of the overall CNS is called the Principal Investigator; the leaders of the individual projects are referred to as Project Leaders.  Indicate where, in the chain of responsibility, advisory groups (internal and external consultants) would be used.

Describe how the CNS will be used to advance cross-disciplinary training in environmental health sciences and neurodegenerative disease research.  Include a description of the existing training resources and activities available through the applicant institution and the potential pool of trainees, with clear delineation of how the CNS will enrich/augment these existing resources. Indicate how the success of the CNS training environment will be monitored and adjusted as needed.

Describe the relationships between the proposed CNS and other existing research, academic, and administrative units of the applicant institution such as schools, centers, institutions, departments, and central administration.

Sections III - V.  These sections contain the research plans of the individual research projects, facility cores, and administrative core.

General Instructions for all Projects and Cores

All Projects and Cores

For the title page of individual projects/cores use the PHS 398 Continuation Page and clearly denote the project/core number, the title of the project/core, and the project/core leader.  The title must not exceed 56 characters/spaces.  DO NOT provide a face page (i.e., PHS 398 Form Page 1) for individual projects.

The "Description" of the project/core should be prepared on a duplicate copy of PHS 398 Form Page 2.  All performance sites and key personnel on the project/core should be identified.

The name of the Principal Investigator of the CNS grant application is placed in the upper right corner of each page, not the name of the Project/Core Leader.  Also note: individual projects and cores must not exceed the 25-page limitation for items a - d of the Research Plan (follow PHS 398 instructions).

Subsequent pages (following the Description, Performance, and Key Personnel, Form Page 2) should use Continuation Pages and follow PHS 398 Instructions.  If collaborative or consortium arrangements are included in the application, follow PHS 398 Instructions.  Discussion should be included as to how the collaborative arrangements will be of value in achieving the specific objectives of the project.

The following information should NOT be included in the individual projects or cores. They should be included only in Section I of the application. "Face Page"(Form Page 1); "Research Grants Table of Contents" (Form Page 3); "Detailed Budget for Initial Cost Period" (Form Page 4); "Budget for Entire Proposed Period of Support" (Form Page 5); "Biographical Sketch Format Page"

Include “Letters of Commitment” and collaborative arrangements/consultants (Research Plan item “h”) that are identified in the application.

Include "Resources Format Page" within the individual Research Projects and Core sections. Include this at the end of the Research Plan (a-i).

Applicants should carefully read and adhere to the PHS 398 instructions concerning children, gender and minority inclusion in human study populations.

Section III – Individual Research Projects

Follow the instructions in the PHS 398 for the Research Plan (a-i) for describing each research project.  Each project should clearly state its overall objective and explain its relevance to the central theme of the CNS program.  In addition, an explanation should be included describing how the project relates to and both complements and enhances the other research projects and cores of the program. Specify the overall biomedical significance of the work proposed.

The research plan (a-d; 25 page limit per project) includes:

Specific Aims – List the specific aims of the research project and indicate the priority of each aim in the overall research plan.

Background and Significance – Review the most significant previous work and describe the current status of research in this field and document with complete references.

Preliminary Studies – Refer to PHS 398 Instructions for Preliminary Studies

Research Design and Methods - Give details of the research plan, including a description of the experiment or other work proposed; present the methods and techniques to be used; note the limitations, if any, of the procedures proposed.  Describe the experiments in the sequence in which they would be conducted. (It is important to convey to the reader that the proposed effort would require the time requested for the project period.)

The instructions in the PHS 398 form should be used to complete sections e-i for the individual research projects.

Section IV – Facility Cores

Follow the instructions in the PHS 398 “Research Plan” (a-i) as is appropriate for describing a Facility Core.  A Facility Core is defined as a resource for the CNS that provides centralized services to two or more research projects.  Information that should be included is as follows:

Describe the function of the core as a resource to the program. This section must clearly present the facilities, techniques, and professional skills that the core will provide.  As justification for the core, briefly indicate the specific Research Projects that will use the resources of the core.  A Research Support Core is principally designed as a service or resource component; it would be highly unusual to include research in a core (a possible exception would be methodology development).  Please contact the NIEHS program staff if you require guidance on this issue.

Describe the role of the core as a resource to the program as a whole. Discuss ways in which these centralized services will produce an economy of effort and/or savings in overall costs compared to their inclusion as part of each project in the program.  To aid in the review of your application it is recommended that you prepare in tabular form information concerning the research projects that each facility core unit would serve and the proportion of the cost of the facility core unit associated with each research project involved.

NOTE: An Applicant is NOT required to include facility cores in their CNS.  If facility cores are not proposed as part of the Center, the applicant must provide strong justification including a discussion of available institutional resources which will be utilized to support the proposed research effort.

Section V – Administrative Core

Follow the instructions in the PHS 398 “Research Plan” (a-i) as is appropriate for describing the Administrative Core.

A successful CNS application will include a well-integrated project plan.  Within the Administrative Core, the specific administrative and organizational structure that is needed to support the research and the synergies enabled by the Center needed to be clearly articulated. CNS projects will be multidisciplinary and interdisciplinary and will draw from a variety of resources.  Thus, a well thought out and carefully described organizational structure will be required.

A narrative description should be provided that includes the planning and coordination of research activities; the integration of cross-disciplinary research; the oversight of fiscal and resource management; and the maintenance of ongoing communication with NIEHS.  Indicate who will be responsible for each of these activities.  Describe the role(s) of advisory groups and consultants.

Describe how the Administrative Core will coordinate CNS research activities with existing training resources, activities or programs at the institution.  No specific CNS funds should be used to develop new training programs or to directly support existing training programs, however.  A listing of available training resources should be provided.  A plan for tracking the impact of CNS on investigator training should be described.

Describe how the Administrative Core will coordinate meetings of CNS investigators with investigators from other CNSs.  The applicant should budget travel funds sufficient for attendance of the Center Director and Project and Core leaders at two annual meetings, including a one and one-half day meeting at the NIEHS in Research Triangle Park, NC and another two-day meeting at a location to be determined after award.

Section VI -  Research Development Core

The Research Development Core provides a mechanism for enriching the CNS team by providing support for the initial development of novel lines of investigation by non-CNS  investigators that complement the ongoing CNS research projects.  A narrative description should be provided to explain the process for soliciting, reviewing, awarding and monitoring progress of pilot projects.  Describe any eligibility criteria, in addition to the requirement of this FOA that pilot award applicants have no current affiliation with the CNS.  Estimate the size of the applicant pool and provide a basis for this estimate.  Describe the size and composition of the review committee with respect to areas of expertise and internal versus external affiliations of members.  Do not name any individuals who will be asked to serve as reviewers, however.  Describe a plan for inclusion of the pilot awardees in ongoing CNS activities to ensure meaningful integration and cross fertilization of efforts.  Indicate how the products of the pilot awards (e.g., papers, grant submissions) will be tracked. 

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s): June 24, 2007
Application Receipt Date(s): July 24, 2007
Peer Review Date(s): October-November 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s): May 1, 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Cindy P. Lawler, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
79 T.W. Alexander Drive
Building 4401, Room Number 3419
Research Triangle Park, NC 27709-2233
Telephone: (919) 316-4671
FAX: (919) 541-5074
Email: lawler@niehs.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Leroy Worth, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
79 T.W. Alexander Drive
Building 4401, Room Number 3171
Research Triangle Park, NC  27709-2233
Telephone: (919)-541-0670
FAX: (919)541-2503
Email: worth@niehs.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the National Institute of Environmental Health Sciences. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

Appendix Materials

Appendix Materials for this FOA may be submitted, subject to the limitations described in NOT-OD-07-018.  Appendix materials should be submitted in paper format, collated by Project and Core, and presented in the same order that they appear in the application.  Do not staple or bind Appendix Materials.  At the time of submission of the application, five collated sets of Appendix materials should be sent to Dr. Leroy Worth, SRA, as noted in Section 3B.   

Meetings

Applicants must budget funds for travel of the Center Director and all Project and Core leaders to attend two yearly meetings.  One of these meetings will be a one and a half-day meeting held in Research Triangle Park, NC.  The site for a second two-day yearly meeting will be determined jointly in conjunction with other CNS Center Directors and NIEHS program staff.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

2. Review and Selection Process

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 NIEHS in accordance with the review criteria stated below.

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

The initial review for scientific and technical merit of applications will emphasize two major aspects: (1) review of the CNS as an integrated research effort focused on a central theme, including the administrative core and Center Director and (2) the review of each research and facility core component independently.

Review Criteria for the Overall P01 Center

The overall Center will be evaluated based on the following criteria:

Overall Research Program

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the PD/PI(s) and other key personnel 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? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?

Center Director

The Center Director will be evaluated based on the following criteria:   

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support

Coordination and Cohesiveness

Resources and Environment

Research Projects

Review of the individual research projects is similar to the review of investigator-initiated research projects (R01).  The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria 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 an 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.

Research Projects will be assessed based on the following criteria:

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? If the study is successful, would it lead to an incremental advance, or would it provide a substantial step forward that would likely not be achieved through mechanisms other than the CNS?  If successful, will the project result in knowledge or resources that could be utilized to improve human health or disease?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is there strong synergy among the combined efforts of various investigators within the CNS? Is there evidence that environmental health sciences research is well-integrated into the research design?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?   

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Administrative Core

The Administrative Core will be assessed based on the following criteria:

Research Development Core

The Research Development Core will be assessed based on the following criteria:

Facility/Service Cores

The Facility/Service Cores will be assessed based on the following criteria:

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: 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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations  The following item will reviewed but will not be considered in the determination of scientific merit and the priority score:

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.  Prior to award, the NIEHS program staff will be responsible for conducting a separate administrative review of the proposed data sharing plan and will make recommendations for any needed changes.  

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity 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:

1. Scientific/Research Contacts:

NIEHS:

Cindy P. Lawler, PhD
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
79 T.W. Alexander Drive
Building 4401, EC-23
Research Triangle Park, NC 27709-2233
Telephone: (919) 316-4671
FAX:(919) 541-5074
Email: lawler@niehs.nih.gov

NIA:

Suzana Petanceska, PhD
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
Gateway Building, Suite 350
7201 Wisconsin Avenue
Bethesda, MD, 20892 (20814 for Express Mail)
Telephone: 301-594-7754
FAX: (301) 496-1494
E-mail: petanceskas@nia.nih.gov

2. Peer Review Contacts:

Leroy Worth, PhD.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
79 T.W. Alexander Drive
Building 4401, EC-30
Research Triangle Park, NC  27709-2233
Telephone: (919)-541-0670
FAX: 919-541-2503
Email: worth@niehs.nih.gov

3. Financial or Grants Management Contacts:

NIEHS:

Pam Clark
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
79 T.W. Alexander Drive
Building 4401, EC-22
Research Triangle Park, NC 27709-2233
Telephone: (919) 541-7629
FAX: (919) 541-2860
Email: evans3@niehs.nih.gov

NIA:

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

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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 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 funding opportunity 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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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 "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is 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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

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 (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 applications for research involving human subjects and individuals designated as key personnel. The policy is available 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://stemcells.nih.gov/index.asp 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 (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, 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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 RFA 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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