Part I Overview Information

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Department of Health and Human Services

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

Components of Participating Organizations
NIH Blueprint for Neuroscience Research (http://neuroscienceblueprint.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM), (http://www.nccam.nih.gov/)
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov/)
National Eye Institute (NEI), (http://www.nei.nih.gov/)
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR), (http://ninr.nih.gov/ninr/)
Office of Behavioral and Social Sciences Research (OBSSR), (http://obssr.od.nih.gov/)

Title: Centers for Evaluation of Neurodevelopmental Antibodies (CENA, U24)

Announcement Type
New

Request For Applications (RFA) Number: RFA-NS-08-005

Catalog of Federal Domestic Assistance Number(s)
93.213, 93.389, 93.867, 93.866, 93.273, 93.286, 93.865, 93.173, 93.121, 93.279, 93.894, 93.859, 93.242, 93.853, 93.361   

Key Dates
Release Date:  December 13, 2007
Letters of Intent Receipt Date: January 15, 2008
Application Receipt Date: February 15, 2008
Peer Review Date(s): April/May 2008
Council Review Date(s): August 2008
Earliest Anticipated Start Date: September 30, 2008
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: February 16, 2008

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

• Purpose: The goal of this initiative is to create a center (or centers) to 1) evaluate new monoclonal antibodies (mABs) to neurodevelopmental antigens using multiple model systems and 2) provide detailed information for use of these reagents to the research community. Some of the most powerful tools in understanding nervous system development are antibodies that monitor the expression of key developmental proteins. Accordingly, one of the most compelling needs within the community is greater access to well-validated mABs. As an initial step to address this need, the NIH Blueprint for Neuroscience Research (subsequently referred to as the Blueprint) is currently funding the targeted creation and distribution of a large number of high quality monoclonal antibodies via the Blueprint Resource Antibodies Initiative for Neurodevelopment (BRAINdev) in partnership with the UC Davis/NINDS/NIMH NeuroMab Facility (www.neuromab.org). An important component of the overall Blueprint mAB plan is to provide detailed information on the performance of the antibodies across model systems common to neurodevelopmental research. While BRAINdev antibodies will initially be assayed in a limited number of model organisms via NeuroMab, their utility in a broad range model systems will be evaluated by a associated, but distinct center(s) to be called the Center(s) for Neurodevelopmental Antibodies (CENA). All of the BRAINdev antibodies, and all of the evaluation data produced by the centers, will be made available to the research community. To fulfill the evaluation portion of this plan, this Funding Opportunity Announcement (FOA) solicits applications directed toward the creation of a center (or centers) to perform further examination of mABs immunoreactivity in the developing central and peripheral nervous systems of multiple model systems. This announcement specifically requests the creation of antibody evaluation centers which will, in total, determine the ability of antibodies to recognize their corresponding antigen during development in the following organisms: fruit fly (D. melanogaster), nematode (C. elegans), zebrafish (D. rerio), mouse (M. musculus), chick (G. gallus), frog (X. laevis and X. tropicalis), rat (R. norvegicus), rhesus monkey (M. mulatta) and human (H. sapiens).  Individual centers will establish experimental conditions for antibody use during development, including immunoblotting, and immunohistochemistry in at least five species, as well as provide these data to the neurodevelopment community.
• Mechanism of Support. This FOA uses the Resource-Related Research Projects-Cooperative Agreement (U24) award mechanism
• Funds Available and Anticipated Number of Awards.  The Blueprint is a framework to enhance cooperative activities among the NIH Office of the Director and 15 NIH Institutes and Centers (ICs) that support research on the central and peripheral nervous systems.  In fiscal year 2008, the Blueprint is emphasizing neural development.  The participating Blueprint organizations intend to commit $1,200,000 over a two-year period to fund 1 to 3 applications in response to this FOA. Additional meritorious applications may be funded by individual NIH Institutes.  Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
• Budget and Project Period. The total project period for an application submitted in response to this funding opportunity may not exceed two years. Direct costs are limited to $600,000 per year for a two-year period.
• Eligible Institutions/Organizations. Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Small Business; For-Profit Organization (Other than Small Business); State Government; U.S. Territory or Possession; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organization; Non-domestic (non-U.S.) Entity (Foreign Organization); Hispanic-serving Institution; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Regional Organization; Eligible agencies of the Federal government.
• Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are 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.
• Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.
• Renewals and Resubmissions. Neither renewals or resubmissions will be accepted for this FOA.
• Number of PDs/PIs. More than one PD/PI, or multiple PDs/PIs, may be designated on the application. 
• Application Materials. See Section IV.1 for application materials.
• Hearing Impaired. Telecommunications for the hearing impaired is available at: TTY 301-451-5936.
• Initial merit review will be convened by NINDS
• Special Receipt Date: February 15, 2008

Table of Contents

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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
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
  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

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Section I. Funding Opportunity Description

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1. Research Objectives

Background

Neuroscience research is a unifying theme across many NIH ICs. The Blueprint was launched in 2004 with 15 participating ICs to provide a framework for coordinating research, and developing tools and resources that are broadly useful for advancing neuroscience research (http://neuroscienceblueprint.nih.gov/). To this end, the Blueprint is generating a series of focused initiatives designed to catalyze research in areas of shared interest.

In 2008, the Blueprint will focus on providing tools and resources to advance the field of neurodevelopment. The NIH ICs that participate in the Blueprint share an interest in understanding normal neural developmental processes as well as how alterations in these processes lead to specific neurological disorders and diseases. Establishing tools and resources, which catalyze our understanding of both normal neuronal development and related disorders, are priorities of the Blueprint.

This Funding Opportunity Announcement (FOA) reflects a major priority identified by the neurodevelopment research community, both through responses solicited by a Request for Information and by participants at the NIH Neuroscience Blueprint Workshop on Neurodevelopment (November 13-15, 2006). The Blueprint workshop convened researchers from diverse areas of investigation in order to identify the current challenges in neurodevelopmental research that can be addressed by the Blueprint. Participants identified a need for enhanced tools and/or resources to rapidly advance understanding of developmental processes.  In both cases, researchers noted that antibodies against key developmental antigens are among the most useful tools for studying neurodevelopment across species, and that open access to high-quality, affordable, and validated monoclonal antibodies would significantly advance the field.

To that end, the Blueprint will support the creation, validation, and distribution of a number of monoclonal antibodies specifically for use in the study of neurodevelopment over the next three years   through the Blueprint Resources Antibody Initiative for Neurodevelopment (BRAINdev).  BRAINdev funds have been provided to the NeuroMab Facility (www.neuromab.org) at the University of California, Davis for the creation and initial validation of these neurodevelopmental antibodies.  In order to address the issue of developmental and cross-species utilities, each of these newly created monoclonal antibodies will be analyzed in multiple species by a distinct center(s), the Center(s) for the Evaluation of Neurodevelopmental Antibodies (CENA) - funded through this Funding Opportunity Announcement (FOA).

Purpose and Objectives Beginning in September 2007, the Blueprint will establish a pipeline for the creation, validation and distribution of mABs raised against key neurodevelopmental antigens.  As an important aspect of this process, the research community is encouraged to suggest specific antibodies via an associated RFI (NOT-NS-08-001).  Suggestions received from the community will be prioritized by the Blueprint ICs and an associated scientific advisory group. Antibodies will be generated by the NeuroMab Facility (www.neuromab.org), an established monoclonal antibody (mAB) production facility. Ultimately, the NeuroMab Facility will distribute approximately 150 high-quality mABs directed against selected developmental antigens under the direction of the Blueprint Resource Antibody Initiative for Neurodevelopment (BRAINdev). The expectation is that these mABs will be useful in a number of model systems, but the initial characterization will be limited to validation in a subset of adult organisms.

The goal of this FOA is to further characterize the activity of these mABs in multiple animal species, in multiple developmental stages and to release that information to the scientific community.  To accomplish this, the Blueprint plans to create at least one CENA, and possibly more. Regardless of the number of CENAs supported, all of the activities will be coordinated both internally, and with the NeuroMab production facility. The NIH will work with the Center Director(s) of each CENA, via a cooperative agreement (U24) mechanism, which is designed to support research projects contributing to improvement of the capability of resources to serve biomedical research. After consultation with scientists in the field and the BRAINdev Advisory Board, the NIH will provide the list of antibodies for creation and distribution via the NeuroMab Facility and cross-species evaluation by CENA. The NeuroMab Facility and CENA will work with the NIH and BRAINdev Advisory Board to oversee the validation of each antibody and the dissemination of this information to the community.

Key Components of the Evaluation Center

The Blueprint goal is to provide a large number of useful, well validated mABs to the research community via a two stage, integrated process.  First, the NeuroMab Facility using BRAINdev funds will create a series of high quality mABs.  These mABs may be able recognize their targets in a variety of species but this level of analysis will not initially be done by the NeuroMab Facility. The mABs created with BRAINdev funds will be transferred to the CENAs to determine developmental efficacy and cross-species reactivity in multiple species.

To that end, CENA’s role is to further evaluate mAB binding during the development of a variety of model organisms with the goal of enhancing the value of these newly created mABs As such, any CENA proposal should have a detailed plan for evaluating the specificity of each mAB during development, in multiple species, in immunoblots, as well as a means to detect this epitope in cultured cells and in situ. Responsive Center applications must have demonstrated the ability to work successfully with antibody evaluation in at least five species and are encouraged to work with more. If a center proposes to use tissue from a species beyond one of those mentioned, then it must include a clear justification for doing so.

Applicants are urged to keep in mind the importance of translating experimental findings across species. To that end, an evaluation center should have a means of performing antibody evaluation in a variety of neural tissues and in a number of developmental model systems.  While the planned antibody evaluation could be performed by a single geographic center, a consortium of researchers from different institutions could provide the strongest center application.  Investigators are therefore strongly encouraged to establish creative, working collaborations within or between institutions.  In addition, applicants should recognize the essential importance of wide dissemination of results and protocols developed in response to this announcement (see Section V - 2.D. Sharing Research Resources).  The presentation of this information to the Blueprint and the neuroscience community should be well described.

Each Center must have a Director, an Administrative Coordinator, and a series of Cores for the evaluation of antibody specificity in at least five developmental model species.  For example, cores could include an immunoblotting core, an immunohistochemistry core, and cores for each animal species.  Cores could be at the home institution or at collaborating institutions. The application must include a timeline and define the work flow for the evaluation period.

The following components must be clearly presented in all submitted applications:

1. The research plan must show Center expertise in detecting protein expression in at least five of the following developmental model systems: fruit fly, (D. melanogaster), nematode (C elegans), zebrafish (D. rerio), frog (X. laevis and/or X. tropicalis), chick (G. gallus), mouse (M. musculus rat (R. norvegicus), Rhesus macaque (M. mulatta) and/or human (H. sapiens). While detection may, by necessity, be limited to a single developmental stage, in general applicants should provide details regarding the extent to which tissue can be provided from multiple developmental stages for each chosen organism. The limitations on developmental stages, and quantities of tissue samples available should be clear.

2. The organization of a CENA must be clearly presented. A center can function in the same facility or exist as a more extended collaborative team across institutions. In either case, the person acting as the primary coordinator to oversee operations must be clearly identified as the Center director.

3. A work flow diagram should be presented to demonstrate how the facility will evaluate the mABs.  A timeline should be present as well. Both administrative and evaluation cores should be well described. How this data will be processed and ultimately presented to the community must be described.

4. The proposal must adequately describe plans for the creation and implementation of all proposed cores. This will likely include: Western blot detection, immunohistochemistry, data coordination, and data dissemination.

5.  The application must provide plans for coordination of efforts with the BRAINdev Scientific Advisory Board.

6. There must be a plan for establishing the optimal assay conditions in each model system tested.

7.  Plans for dissemination to the research community of evaluation results and methods.  At a minimum, this information could be disseminated as pdf files8.  The maximum number of mABs that the center can evaluate with the available funds. It must have the capacity to process at least 150 mABs in two years and include a plan for evaluating an additional 300 mABs.  The ability to process more than the minimum number of mABs will be viewed favorably. If the additional 300 mABs will require additional funds, this should be made clear in the proposal.

Issues to be detailed in the application. 

In addition to the components of the evaluation pipeline outlined above, there are a number of other issues important to a successful project that must be discussed separately in the application:

1) Quality control.  The applicant should describe measures that will ensure the quality of, or otherwise validity of, the results that will be generated (e.g., how background immunoreactivity will be reduced). Evidence of the effectiveness of such quality assessment programs should be included. The applicant should address the quantitative aspect of this component, (e.g. the extent to which tissue will be available to provide adequate quality assessment) and the anticipated costs, on average, associated with evaluating antibodies in each model system.

2) Cost per mAB evaluated: The applicant should describe the cost of assaying the efficacy of 150 mABs. The calculated costs must take into account all of the expenses associated with each activity.   In addition, the portion of costs attributable to informatics infrastructure, quality control, management, and data release should be included in the total cost, but recorded in such a way as to be identifiable.  The cost accounting should be done in such a way that the sum of the identifiable cost elements is equal to the unit cost calculated as dollars per evaluation.

3). Ability to increase production. The proposal should discuss the feasibility and increase in costs incurred if any additional mABs were to be assayedThe maximum number of mABs that can be assayed with available funds must be stated, as well as the maximum number of mABs that could be assays if additional funds were available.

4)  Management Plan.  The effective management of the CENA requires a significant commitment by the Principal Investigator (P.I.).  The application should describe the management plan for the proposed project, and how it will support the achievement of the proposed goals.

5)  Data and materials release.  Applicants should be familiar with the NIH statements regarding sharing of resources developed with Federal funds (http://www.ott.nih.gov/policy/rt_guide_final.html).   Responses to this RFA should propose a specific and comprehensive plan for the rapid release of data and materials resulting from this effort.  The quality of this plan will be an important criterion in the review of the application, and the submission of an appropriate plan for release of data and materials will be made a condition of the awards made as a result of this FOA. 

Awardees will be free to patent any inventions developed under this award consistent with the Bayh-Dole Act and NIH policies, but funding of an award will be dependent upon an acceptable plan to ensure that the materials generated under this award will be available for non-commercial research purposes in a manner consistent with the goals of this funding opportunity. 

Summary

Monoclonal Antibodies (mABs) are powerful tools to study developmental neurobiology. The Blueprint will support the creation and distribution of a panel of antibodies directed against key molecules involved in neurodevelopmental processes via BRAINdev. These antibodies will be tested for immunoreactivity in a number of model systems via the CENA(s).The purpose of this announcement is to establish a vital evaluation center, CENA, for all of the antibodies created with funds from the Blueprint. The center will systematically test the antibodies in multiple model systems, and establish the optimal conditions for working with each mAB. These validated antibodies and their associated expression data will be made readily available to the research community. These efforts are intended to catalyze neurodevelopmental research by providing critical tools and resources.

Section II. Award Information

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1. Mechanism(s) of Support

This funding opportunity will use the U24 award mechanism.

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 https://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. 

The NIH U24 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award". 

Plans beyond the current funding opportunity are indefinite.

2. Funds Available

The Blueprint intends to commit approximately $1.2 million dollars (direct costs) in FY 2008 to fund 1 to 3 meritorious applications. An applicant may request a project period of up to two years and a budget for direct costs up to $600,000 dollars per year. The anticipated start date for the awards is September 30, 2008. 

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

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1. Eligible Applicants

1.A. Eligible Institutions

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

• Public/State Controlled Institution of Higher Education
• Private Institution of Higher Education
• Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
• Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
• Small Business
• For-Profit Organization (Other than Small Business)
• State Government
• U.S. Territory or Possession
• Indian/Native American Tribal Government (Federally Recognized)
• Indian/Native American Tribal Government (Other than Federally Recognized)
• Indian/Native American Tribally Designated Organization
• Non-domestic (non-U.S.) Entity (Foreign Organization)
• Hispanic-serving Institution
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Regional Organization
• Eligible agencies of the Federal government

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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at https://grants.nih.gov/grants/multi_pi. 

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information

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1. Address to Request Application Information

The PHS 398 application instructions are available at https://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) 710-0267, 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.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

• Request budgets in U.S. dollars.
• Prepare detailed budgets for all applications (that is, complete the Research & Related Budget component of the SF424 (R&R) application forms – not the PHS398 Modular Budget component). See NOT-OD-06-096, August 23, 2006.
• Charge back of customs and import fees is not allowed.
• U.S. Government grants cannot pay taxes in foreign countries, including VAT tax.  
• Format: Every effort should be made to comply with the format specifications, which are based upon a standard U.S. paper size of 8.5” x 11” within each PDF.
• Funds for up to 8% administrative costs (excluding equipment) may be requested. See NOT-OD-01-028, March 29, 2001.                        
• Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.
• Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI.2., “Administrative and National Policy Requirements.”

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS  

Applications with Multiple PDs/PIs

Multiple PD/PI Leadership Plan: For applications designating multiple PD/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” (Section I of the Research Plan in the PHS 398), must be included. A rationale for choosing a multiple PD/PI approach should be described.  The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PD/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PD/PIs must be delineated in the Leadership Plan.  In the event of an award, the requested allocation may be reflected in a footnote on the NOGA.

When all PDs/PIs are within a single institution, follow the instructions contained in the SF398 (R&R) Application Guide.

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form.

Integration of projects

The proposed research must be significantly reactive such that its functions can be closely integrated within the goals and objectives of the overall Blueprint mAB plan. In particular, a CENA must have a means of working with the NeuroMab Facility as well as any and all members of the CENA network. Integration across projects of successful applications will be demonstrated not only by distinct approaches to a common scientific goal by individual projects but also by evidence of collaboration within and across projects and cores comprising individual CENAs.

Multiple sites

A CENA may consist of investigators at a single institution or at multiple institutions.  Collaborations between highly active laboratories using state-of-the-art methods are encouraged, even if this means that the investigators are geographically distributed.  Plans for mitigating the effects of geographic separation should be clearly stated.

Scientific Advisory Board

CENAs will be expected to have a Scientific Advisory Board (SAB), drawn from experts outside the project. These advisors will be selected in conjunction with NINDS staff and will meet annually to review and provide guidance on all CENA(s) activities.  While a description of the Board's activities should be included in the application, potential members of the Board should not be contacted, named, or selected until an award has been made.  This stipulation will allow a wider pool of potential reviewers of the application.  Costs for activities of the Board should be included in the budget.

Operational Plan for the Overall Center (not to exceed 10 pages)

This section should not exceed 10 pages and should describe the working administrative and logistical arrangements, as well as the resource support necessary to implement the research.  When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements should be included (documentation of these arrangements should be included in the “Letters of Support” section).

The PI is responsible for ensuring that scientific goals are met and for developing and managing a decision-making structure and process that will allow resources to be allocated (and reallocated, as necessary) to meet those goals. It is anticipated that the success of a CENA will require considerable scientific and managerial oversight by the Center PI. Therefore, the PI will be required to devote at least 20% effort to the Center (10% effort for managerial oversight, 10% effort to each individual project).

Milestones and Timeline

The operational plan must include a section listing expected milestones as well as a timeline.  This section should detail specific milestones expected to be achieved with each model system and by the Center as a whole for each year.  The written narrative should be accompanied by a graphic representation (timeline).   The reasonableness of the proposed milestones and timeline will be evaluated during review and will be used in the future to assist the NIH staff and their advisors in evaluating progress toward the project's goals. Applicants should present explicit, quantitative milestones.  Cost sharing or institutional support, if any, should be described in this section.

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: January 15, 2008
Application Receipt Date: February 15, 2008
Peer Review Date(s): April/May, 2008
Council Review Date: August 2008
Earliest Anticipated Start Date: September 30, 2008

3.A.1. Letter of Intent

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

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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:

Robert Riddle, Ph.D.
Neurogenetics Cluster
National Institute on Neurological Disorders and Stroke
6001 Executive Blvd.
NSC, Room 2156
Bethesda, MD 20892
Telephone: (301) 496-5745
FAX: (301) 402-1501
Email: riddler@ninds.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 https://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:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Boulevard
Bethesda, MD 20892-9529
(Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-9223
Fax: (301) 402-0182
E-mail: nindsreview.nih.gov@mail.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: https://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 NINDS. 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 https://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 https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

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 https://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 https://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and https://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, https://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

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1. Criteria

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

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of program priorities

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 NINDS in accordance with the review criteria stated below.

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

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique.
• Receive a second level of review by the appropriate national advisory council or board advising a Blueprint IC. 

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.

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?  For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

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 or methodologies, tools, or technologies for this area?

Investigators: Are the PD/PIs and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the PD/PIs and investigative team bring complementary and integrated expertise to the project (if applicable)?

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(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? 

Special Review Criteria 

• The likelihood that the proposed project can effectively evaluate at least 150 mABs in a two year period. This evaluation will be based on past experience and the detailed research plan. Important points for evaluation include expected levels of throughput, quality, and cost.
• The potential of the plan to increase throughput while lowering cost/antibody ratios.
• The quality of the plan for optimizing conditions for each mAB at different developmental time points, in each model system utilized. These will include managing databases, infrastructure/laboratory information management, organization/publication of antibody protocols (i.e. Western blots, immunohistochemistry for each species at different ages).
• The ability to present information to the neuroscience research community in a manageable, useful format (e.g. PDF files showing expression data for each antibody examined).
• The quality of the plan for the timely release of data, including evidence that the systems are in place to support data release, and the plans for release or distribution of the information generated under this award (see sec. 2D Sharing Research Resources below).
• The quality of the plan and ability to work as a coordinated network with the BRAINdev Advisory Board, Neuromab Facility and NIH program staff to achieve the goals of this FOA. 
• The record of the Principal Investigator and other key personnel in assessing mABs in multiple model systems during key neurodevelopmental time periods.
• The reasonableness of the proposed timelines and goals in relation to the proposed project.

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:

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

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.

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

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 https://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

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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 (https://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 (https://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 (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (U24), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator (P.I.) will have the primary authority and responsibility for defining the details of the project effort within the guidelines of this RFA-NS-08-005 and for performing the scientific activities.  She/he will assume responsibility and accountability to the applicant organization and to the Blueprint for performance and proper conduct of all supported research in accordance with the Terms and Conditions of Award. The P.I. will agree to accept close coordination, cooperation, and participation of NIH staff and advisors in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities."

The P.I. of the project will:

• Determine experimental approaches, design protocols, propose project milestones and conduct experiments;
• Endeavor to meet or exceed stated milestones;
• Ensure that the products of the production effort meet the quality standards and costs agreed upon at the time of award;
• Ensure that the data are available for distribution in the appropriate Blueprint database (e.g., PDF files for each antibody assayed, as agreed upon by the SAB) and that results are presented in a timely manner; and standard nomenclature is used.
• Adhere to NIH policies regarding intellectual property, data release and other policies that might be established during the course of this activity;
• Submit data for quality assessment in any manner specified by SAB or NIH Program Staff;
• Submit periodic progress reports in a standard format, as agreed upon by the SAB;
• Accept and implement any other common guidelines and procedures approved by the SAB;
• Accept and participate in the CENA Network by contributing cooperatively to the project;
• Coordinate and collaborate with other U.S. and international groups producing relevant mABs;
• Inform the NIH Program Director of all major interactions with members of the Steering Committee;
• Attend Steering Committee meetings

A Research Project Leader is a senior scientist with proven independent research capabilities who serves as director of one of the scientific Research Project components for the group and is responsible for the scientific conduct of that program. The Principal Investigator may be a Project Leader. Foreign scientists and NIH intramural scientists may be Project Leaders. 

Principal Investigators and Research Project Leaders will be expected to attend an annual meeting to review progress and share information among awardees.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

Blueprint Program Staff will have access to data generated under this cooperative agreement and may periodically review the data consistent with current DHHS, PHS, and NIH policies. Timely publication of findings by the Group members is encouraged. Publication or oral presentation of work done under this cooperative agreement will require appropriate acknowledgment of Blueprint support, including the assigned cooperative agreement award number.  The Awardee must submit an intellectual property and research resource sharing plan to Blueprint Program Staff for review to ensure consistency with NIH policy.

2.A.2. NIH Responsibilities

NIH Blueprint Project Coordinator. During performance of the award, a scientist from the extramural program staff representing the Neuroscience Blueprint will serve as the NIH Project Coordinator, with substantial involvement above and beyond the normal program stewardship role of the NIH Program Official, as described below.

The Primary Blueprint Project Coordinator interacts scientifically with the Principal Investigator(s) and Research Project Leaders and, using recommendations from the Blueprint Working Group, facilitates the role of the NIH Neuroscience Blueprint as a partner in the research.  A second NIH scientist maybe appointed as an Alternate Blueprint Project Coordinator who can attend meetings when the Primary Coordinator is unavailable to ensure adequate NIH representation.  The NIH Coordinator(s) will be appointed after award by NINDS in consultation with the Blueprint Working Group and will have one vote on the Steering Committee even when more than one Blueprint Project Coordinator (Primary and Alternate) is designated and present.  It is anticipated that decisions in all activities of the BRAINdev and CENA(s) will be reached by consensus of the Steering Committee and that Blueprint Program Staff (through the participation of the Blueprint Working Group and the Blueprint Project Coordinator(s)) will be given the opportunity to offer input to this process.  The NINDS Blueprint Project Coordinator(s) interacts scientifically with the group and may provide appropriate assistance, including assisting in research planning, recommending spatial/temporal expression targets for antibody assays, presenting experimental findings to the group from published sources or from relevant contract projects, participating in the design of experiments agreed to by the group, participating in the analysis of results, and advising in management and technical performance and helping to ensure that duplication is avoided. The Blueprint Project Coordinator(s) will be a voting member of the Steering Committee, and offering a single vote. Additional NIH Program Staff may attend Steering Committee meetings as non-voting participants. In all cases, the role of Blueprint Project Coordinator(s) will be to assist and facilitate and not to direct activities.

The Blueprint Project Coordinator(s) will:

• Participate with the other Steering Committee members in the group process of setting research priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted. The Blueprint Project Coordinator(s) will assist and facilitate the group process and not direct it;
• Negotiate throughput, quality, and cost goals with the awardees of the CENA(s) as necessary;
• Serve as a liaison between the awardees and the Blueprint Working Group as well as the larger community in helping the awardee(s) select useful antibodies;
• Coordinate the efforts of the Awardees with other participants, including other awardees under this RFA, the NeuroMab Facility, with other U.S. efforts, with the international community; as well as with the larger biological community;
• Attend all Steering Committee meetings as a voting member (single vote) and assist in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action.
• Periodically report progress to the Blueprint Working Group and the Directors of the NIH ICs supporting this initiative through the Neuroscience Blueprint;
• Lend relevant expertise and overall knowledge of NIH-sponsored research to facilitate the selection of scientists not affiliated with the awardee institutions who are to serve as external scientific advisors on the Steering Committee;
• Serve as liaison between the CENA(s), their SAB, the NeuroMab Facility and the Blueprint Working Group;
• Serve on subcommittees of the SAB as appropriate;
• Provide advice in the management and technical performance of the investigation;
• Assist in promoting the availability of antibodies and related tissues developed in the course of this project to the scientific community at large; 
• Participate in data analyses, interpretations, and where warranted, co-authorship of the publication of results of studies conducted through this initiative;
• Assist awardees in the development, if needed, of policies for dealing with situations that require coordinated action;
• Retain the option to recommend, with the advice of the Blueprint Working Group and external scientific advisors, the withholding or reduction of support from any cooperative agreement that substantially fails to achieve its goals according to the milestones agreed to at the time of award, or fails to comply with the Terms and Conditions of the award.

A Blueprint Working Group, whose primary role is to ensure that the mABs generated represent the diverse interests of the participating Blueprint ICs, will advise on antibody selection and analysis relevant to their individual Institute/Center mission, monitor overall progress, attend Steering Committee meetings as required, and report back to their Institute/Center.  The Blueprint Working Group will be composed of Program Officials and should include the Blueprint Project Coordinator(s) from participating Blueprint ICs. The Blueprint Project Coordinator(s) will chair the Blueprint Working Group, and communicate their opinions and recommendations to the Steering Committee.

Additionally, an NINDS Program Official will be responsible for the normal scientific and programmatic stewardship and guidance for the overall project within the Blueprint and will ensure that the design, generation, and characterization of mABs are relevant to the diverse research community represented in the Neuroscience Blueprint.  The Program Official will be responsible for ensuring that the milestones are being achieved and goals are being met.  In addition, the NINDS Program Official is responsible for monitoring and implementing the Data Sharing Plan (https://grants.nih.gov/grants/policy/data_sharing/index.htm) and NIH Policy for Sharing Model Organisms (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-066.html).  The NINDS Program Official may attend Steering Committee meetings as a non-voting participant. The NINDS Program Official will be named in the award notice.

2.A.3. Collaborative Responsibilities

CENA SAB. A governing steering committee, composed of the P.I.s, Research Project Leaders, Core Directors, Blueprint Project Coordinator(s) and external scientific advisors (experts to be named after award) will be established to help monitor progress, encourage improvements, and coordinate the efforts of the CENA(s). In the event of multiple CENAs, a single SAB will be formed. The members will meet periodically to plan and design activities, review and discuss progress, and establish priorities and Network policies. A chair will be designated from the external scientific advisors (not a PI) on a rotating 1 year basis.  Each PI, Project Leader, Core Director, and external scientific advisor will have one vote each and the NIH will have one vote through the participation of the Blueprint Project Coordinator(s).  The frequency of meetings, not fewer than one per year,  will be determined by the Chair who will be responsible for scheduling the time and place and for preparing concise proceedings or minutes (two or three pages) which will be delivered to the Steering Committee members within 30 days of the meeting.  Each full member will have one vote including the NIH represented by the Blueprint Coordinator(s) on the SAB.  Awardee members of the SAB will be required to accept and implement policies approved by the SAB and Steering Committee.

The Steering Committee will:

• Discuss progress in meeting the research community's need for specific analysis of mAB immunoreactivity during development, in each model system.
• Help to develop uniform procedures and policies for data quality measures and assessment, nomenclature and annotation conventions for data depositions, and so forth. Awardee members of the steering committee will be required to accept and implement the common guidelines and procedures approved by the Steering Committee.
• Serve as a venue for coordination on improving mAB analysis, for example by reporting progress, disseminating best practices and collectively evaluating new procedures, resources, and technologies.
• Serve, in appropriate subgroups, as a coordinating body so that the BRAINdev and CENA projects can collaborate closely on selection and generation of appropriate assay conditions.  In these cases, for example, common policies and data exchange will be critical to the success of the effort and will eliminate duplication/overlap.
• Be composed of members agreed upon by the Blueprint.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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

Section VII. Agency Contacts

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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:

Robert Riddle, Ph.D.
Program Director for Neurogenetics
National Institute on Neurological Disorders and Stroke
National Institutes of Health
Neuroscience Center/Room 2156
6001 Executive Blvd.
Bethesda, MD 20892
Phone: (301) 496-5745
E-mail: riddler@ninds.nih.gov

Randall R. Stewart, Ph.D.
Program Director for Channels, Synapses and Circuits
National Institute on Neurological Disorders and Stroke
National Institutes of Health
Neuroscience Center/Room 2135
6001 Executive Blvd.
Bethesda, MD 20892
Phone: (301) 496-1917
E-mail: stewartr@ninds.nih.gov

2. Peer Review Contacts:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Boulevard
Bethesda, MD 20892-9529 (use Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-9223
Fax: (301) 402-0182
Email: nindsreview.nih.gov@mail.nih.gov

3. Financial or Grants Management Contacts:

Ms. Tijuanna DeCoster, MPA
National Institute of Neurological Disorders and Stroke
Grants Management Officer
Division of Extramural Research
Neuroscience Center
6001 Executive Blvd., Room 3258
Bethesda, MD  20892
Telephone: 301-496-9531
Fax: 301-402-0219
Email: Tijuanna.DeCoster@ninds.nih.gov

Section VIII. Other Information

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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 (https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (https://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.

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 (https://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 https://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 https://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 https://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.

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 https://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 https://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.