Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Neurological Disorders and Stroke (NINDS)
Funding Opportunity Title	Limited Competition for Continuation of the NIH Exploratory Trials in Parkinson's Disease (NET-PD): Coordinating and Statistical Centers (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-NS-13-001
Companion FOA	RFA-NS-13-002 U10 NET-PD Clinical Sites
Number of Applications	Only one application from an institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.853
FOA Purpose	The National Institute of Neurological Disorders and Stroke (NINDS) invites applications for a limited competition Funding Opportunity Announcement (FOA) utilizing a Cooperative Agreement (U01) to provide continuing support for Clinical and Data Coordinating Centers in the NIH Exploratory Trials in Parkinson's Disease network (NET-PD). The goal of this initiative is to support completion of NET-PD's current ongoing clinical trials.

Posted Date	January 31, 2012
Open Date (Earliest Submission Date)	March 17, 2012
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	April 17, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June/July, 2012
Advisory Council Review	October, 2012
Earliest Start Date(s)	December, 2012
Expiration Date	April 18, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

PURPOSE

The National Institute of Neurological Disorders and Stroke (NINDS) requests applications for Clinical and Statistical Coordinating Centers to complete the performance of ongoing NET-PD studies. An earlier competition established the NET-PD infrastructure, comprising a Clinical Coordinating Center, a Statistical Center, and multiple clinical sites; this network has conducted multiple futility trials and is currently conducting a phase III clinical trial evaluating creatine compared with placebo in over 1700 patients. Enrollment in the creatine trial was completed in 2010, with follow-up expected to be completed in 2015, when the last patient enrolled reaches 5 years of follow-up. The objective of the current solicitation is to maintain the NET-PD network by supporting Coordinating and Statistical Centers capable of continuing all patient follow-up activities necessary for the successful completion of the creatine trial. Applications for the Clinical Sites are being sought in a separate solicitation.

BACKGROUND

Parkinson’s disease (PD) affects at least a half million Americans, a number that will increase over the coming decades as the population ages. Available pharmacotherapies are usually effective for controlling symptoms during the initial years after diagnosis; however, disease progression leads to the need for higher doses of multiple medications with increasing side-effects and decreasing benefits. Although these treatments can dramatically improve the lives of patients with Parkinson’s disease initially, current agents do not address the underlying cause of the disease or its relentless progression. Effective clinical neuroprotection would substantially reduce PD-related disability for hundreds of thousands of Americans. Therefore, NINDS initiated the NET-PD program to conduct clinical trials aimed at evaluating the neuroprotective potential of pharmacological agents designed to slow the progression of PD.

Since its initiation, the NET-PD program has successfully completed four futility trials, is currently conducting a fifth futility trial, and is in the process of completing a large Phase III randomized, double-blinded, placebo-controlled clinical trial. These activities have contributed valuable scientific advances to the PD community. Through this limited competition, the NINDS seeks to continue support of ongoing NET-PD activities through their completion.

RESEARCH OBJECTIVE

The goal of this initiative is to provide continuing Coordinating and Statistical Center support for the completion of the current ongoing clinical trials being conducted in the NET-PD network.

STUDY ORGANIZATION

The organizational structure consists of the following components:

1. The Coordinating Center develops and manages the protocol, assures compliance with regulations, supervises and encourages recruitment and retention, collects, stores, and maintains clinical and laboratory data from clinical sites including recruitment and dropout data, prepares blinded reports on adverse events, monitors study execution at clinical sites, and supplies study medications to each site. The Program Director(s)/Principal Investigator(s) of the Coordinating Center serves as chair of the Steering Committee. The Coordinating Center is blinded to treatment group during recruitment and follow-up in all trials.

2. The Statistical Center is involved in study design, and in planning and performing analysis. The Statistical Center prepares all summary reports to the Coordinating Center, Oversight Committee and NINDS-appointed Data and Safety Monitoring Board (DSMB).

3. Clinical Sites recruit and follow participants, emphasizing participant adherence and the highest standards of protocol execution. For the creatine trial, new subjects are no longer being enrolled; retention of existing participants through completion of the 5 year follow-up period is therefore critical. Enrollment and follow-up activities are continuing in the FS-ZONE futility trial. During the remaining years of NET-PD support, Clinical Sites may be deactivated or placed in a follow-up mode with budget reduction, depending on performance and protection of human subjects. Selected representatives of Clinical Sites participate on the Steering Committee on a rotating basis.

Oversight of NET-PD is provided by a Steering Committee, a Data and Safety Monitoring Board (DSMB), and NINDS program staff. The DSMB monitors study execution and safety issues, and proposes and considers interim analyses. Appointed by the NINDS, the DSMB includes a non-voting NINDS representative who will act independently of the NINDS Scientific Program Director. The Steering Committee consists of the Coordinating Center Program Director(s)/Principal Investigator(s) (who chairs the committee), the Program Director(s)Principal Investigator(s) of the Statistical Center, NINDS Scientific Program Director, and selected members drawn from the Clinical Sites. The Steering Committee supervises overall execution of the trial, generates and approves study policies, considers modifications of the protocol and operations, and plans and drafts study-related publications.

A NINDS Scientific Program Director serves as funding agency representative to the trial components primarily through participation on the scientific committees of the trial. A second NINDS representative serves as Administrative Program Director and is responsible for normal fiscal management of the cooperative agreements.

SPECIAL REQUIREMENTS

The intent of this FOA is to solicit applications from qualified investigators to lead the NET-PD Coordinating and Statistical Centers in order to complete the ongoing NET-PD trials. Since the trials are nearing completion, it would not be practical or efficient to move these Centers; thus only applications from currently active NET-PD participants will be considered.

A. Coordinating Center

1) During the remaining phases of the ongoing NET-PD trials, the Coordinating Center will implement and manage the study protocols and manuals of operation, provide overall leadership for the Clinical Sites during recruitment and follow-up; collect, store, and maintain data from the Clinical Sites; and assure quality control and blinded monitoring of data. Ongoing monitoring of performance of the Clinical Sites will be done. The Coordinating Center will work cooperatively with Clinical Sites, a separate Statistical Center, and the NINDS staff.

2) The staff of the Coordinating Center will be required to manage the logistics of all Steering Committee meetings and site activities, and will produce minutes of these. The Coordinating Center will be expected to maintain close communication with the NINDS Scientific Program Director, each Clinical Site, cooperating patient advocacy groups, and the Statistical Center.

3) The Coordinating Center will be responsible for developing procedures to assure that all participants provide appropriate consent prior to participation in any aspect of the study, to assure compliance with federal regulations at each study site, to adhere to NINDS, FDA and (if appropriate) pharmaceutical company procedures for adverse event reporting.

4) The application for the Coordinating Center should address progress and accomplishments to date in NET-PD regarding data quality, and other aspects of study management and coordination of the NET-PD trials. Plans for assuring protocol adherence and complete follow-up of all study participants, including early identification of problem Clinical Sites, should be discussed. Plans for central adjudication of eligibility and outcomes (including adverse events) and an appropriate budget for adjudicators (consulting costs, telecommunication, travel) should also be included. Plans and budget for site visits to participating Clinical Sites, for any additional training for investigators, and for study closeout activities must be included.

B. Statistical Center

1) The Statistical Center has an important role in all aspects of the project, offering creative approaches to study design, execution, and ongoing monitoring and analysis. The Statistical Center is responsible for preparing periodic reports for the DSMB (including performing the required interim analyses). It will prepare interim reports for the Coordinating Center on performance of the Clinical Sites, including recruitment, patient safety, and data quality. It will perform all analyses for publication of trial data and prepare archival records of the trial.

2) The Statistical Center will arrange central adjudication of outcomes relating to efficacy and safety (as required by the final study protocol). The Statistical Center will develop and monitor procedures for blinding of the study interventions.

3) The staff of the Statistical Center will be required to travel to NET-PD investigator meetings and to participate on the Steering Committee and other subcommittees.

4) The application for the Statistical Center should address progress and accomplishments to date in NET-PD regarding procedures for data management and maintaining data quality; preparation of routine and special data reports; and plans for final study closeout, final data analysis and preparation for publication. Approaches to data sharing should also be discussed.

Funding Instrument	Cooperative Agreement
Application Types Allowed	Renewal The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NINDS intends to fund two awards (one Coordinating Center and one Statistical Center) for a total of up to $4,000,000 total costs for fiscal year 2013. Future year amounts will depend on annual appropriations. It is anticipated that one award for the Coordinating Center will be made for up to $2,000,000 direct costs per year, and one award for the Statistical Center will be made for up to $500,000 direct costs per year.
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project.
Award Project Period	The maximum period is 4 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Only currently active NET-PD Coordinating and Statistical Centers are eligible to apply.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization 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.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Only one application per institution (Coordinating Center or Statistical Center) is allowed.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Special Instructions for Preparing Applications for a Clinical Center:

The following information must be included in the Coordinating Center or Statistical Center application as appropriate:

Specific Aims: The hypotheses and specific aims of the ongoing trials must be clearly and concisely stated and justified. The primary and secondary endpoints to be measured must be clearly defined. No new aims should be proposed. Include discussion of how the Coordinating Center or Statistical Center applicant will successfully accomplish these aims.

Research Strategy:

Significance and Biological Relevance: The significance and biological relevance of the clinical trials must be clearly stated. It is particularly important that there be a discussion of how the trials will test the hypotheses proposed and how results of the trial (positive or negative) may be explained based on the biological action of the proposed intervention. The application should state why the trials are necessary with an emphasis on the public health relevance or significance of the question and how the results will advance our knowledge or clinical practice in this disease area. A discussion of the costs and benefits of the study should be included for evaluation of the trial's significance.

Preliminary Studies:  The major findings of the pre-clinical and clinical studies that led to the proposed clinical trial should be summarized. Additional supporting data from other research should be included so that the need for continuation of the NET-PD trials and the approach chosen is clearly justified. This section must also include discussion of progress to date in the ongoing NET-PD trials, in particular data completeness and quality.

Approach: A concise summary of the proposed research plan should include the following:

• Retention plans for enrolled patients
• Descriptions of all clinical, laboratory, physiological, behavioral, or other assessments addressing the primary and secondary research questions
• Potential biases or challenges in the research protocol and how they are being addressed
• Statistical methods: The statistical section should describe sample size and power calculations, linking the calculations to the primary and secondary endpoints, the hypotheses to be tested, methods of data preparation and presentation, plan for interim and final analyses, including methods to handle missing data. Include methods for monitoring the quality and consistency of the intervention and data collection; policies and methods for ensuring blinding of study results; data confidentiality and subject privacy.
• Study Organization and Administration:

The application must include a description of the organization and management of the trial, including a description of the role of advisory committees and medical safety monitor. The oversight, responsibilities, and coordination of centers or cores must be discussed.

• The application must describe any sub-contracts or service agreements for personnel or facilities and include documentation of their commitment, co-signed by a business official and scientific director at the participating center. A letter documenting DSMB recommendation for trial continuation should also be included. A timetable for completion of the various stages of the trial must be included.

Human Subjects:

Applicants should refer to Part II of the PHS398 Application Instructions Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan. Assurances of the protection of human participants and the biohazard safety of employees (if applicable) must be provided both for the overall study and for individual clinical sites. At a minimum, the human subjects sections of data coordinating center applications must address data security measures and confidentiality.

NIH policy requires education on the protection of human research participants for all key personnel submitting applications for grants or proposals for contracts or receiving new or non-competing awards for projects involving human research participants.  Certification of this requirement will be requested during the Just-in-Time process.

Data and Safety Monitoring Plan

Applicants must include a Data and Safety Monitoring (DSM) Plan for all clinical trials that is commensurate with the risk level of the proposed clinical research. Include a general description of the monitoring plan, policies, procedures, responsible entities, and approaches to identifying, managing and reporting reportable events (adverse events and unanticipated problems), to the applicable regulatory agencies (e.g., Institutional Review Board (IRB), the NINDS/NIH, the Office of Biotechnology Activities, Office of Human Research Protections, the Food and Drug Administration, and the Data and Safety Monitoring Board.

Budget

All applications must provide detailed scientific and operational plans as well as funding needs for the remaining trial and data analysis period.

Separate itemized budgets must be prepared for each subcontract and/or for each collaborating center or core, if multiple centers or cores are proposed. Do not include clinical site budgets.

If parts of the costs of the trial are to be borne by sources other than NIH, these contributions must be presented in detail in the budget justification along with supporting letters signed by individuals who have the authority to commit the institution. These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented as part of the requested budget.

Further information concerning budget preparation may be obtained from the Office of Grants Management contact listed below.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Include in the appendix the active study protocols and approved consent forms.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NINDS Referral Office by email at nindsreview@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD(s)/PI(s) name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Do the preliminary data or the literature support the need for a clinical trial to test the proposed hypothesis or intervention? Is there adequate biologic and/or public health rationale for the study? Is the study ethically justified? Is there evidence that the trial to date has been conducted with appropriate scientific rigor to assure validity of the results?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Has the applicant demonstrated prior success in leading their NET-PD Center's activities?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Has the applicant implemented innovative approaches to designing and implementing the current trials?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Have necessary agreements with participating industry partners, if any, been established?  Is there documentation of the commitment of any subcontractor and consultants, and of service agreements for personnel and facilities? 

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NINDS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke (NANDS) Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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, 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.

The PD(s)/PI(s) will have the primary responsibility for:

• Defining research objectives and approaches;
• Providing overall scientific and administrative leadership for NET-PD;
• Overseeing all aspects of the organization and execution of the ongoing clinical trials until their completion;
• Planning, conducting, analyzing, and publishing results, interpretations, and conclusions of the studies.
• Planning, coordinating and supporting Steering Committee and all necessary investigator and site meetings.
• Carrying out all other elements of the research project as described in this FOA.

Awardees have primary and lead responsibilities for the project as a whole, including any modification of study design, conduct of the studies, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee. 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 HHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• The NINDS will assign a Scientific Program Director for the study, who will (a) Advise the Steering Committee, the Publication Committee, and other subcommittees on carrying out the trials, including quality control, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and coordination of efforts of all the project centers; and (b) Have voting membership on the Steering Committee, and as appropriate, other subcommittees of the Steering Committee including the Publications Committee. To the extent that the NINDS Scientific Program Director contributes to the scientific content of the trial, authorship may be shared in publications with other investigators in accordance with the same policies of the Publication Committee that apply to other investigators.
• The NINDS will also assign an Administrative Program Director, who will administer the cooperative agreements and be responsible for normal programmatic and fiscal management and stewardship.
• Other NINDS scientists may, as appropriate, attend meetings and serve on study committees and work with awardees on issues coming before the Steering Committee or its subcommittees. However, in all cases, the NINDS will have only a single vote on each study committee.
• The NINDS will appoint and directly support the travel and other expenses of a Data and Safety Monitoring Board.
• The NINDS reserves the right to terminate or curtail the study (or an individual award) in the event of: (a) a major breach in the protocol or substantial changes in the agreed-upon protocol with which the Institute does not agree; (b) human subject ethical issues that may dictate a premature termination; (c) failure to pursue the objectives stated in this Request for Applications; (d) substantial shortfall in retention of subjects; or (e) a recommendation to the NINDS by the DSMB to stop a pilot study or the large trial.

Areas of Joint Responsibility include:

• The PD(s)/PI(s) of the Coordinating Center, Statistical Center, and selected sites will serve on the Steering Committee along with the NINDS Scientific Program Director. As described above, the Steering Committee will supervise overall execution of the trial, generate and approve study policies, consider modifications of the protocol and operations, and plan and draft study-related publications.

Dispute Resolution:

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 Dispute Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Claudia S. Moy, PhD
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-9135
Email: moyc@mail.nih.gov

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-9223
Email: nindsreview.nih.gov@mail.nih.gov

Tijuanna DeCoster, MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-9231
Email: decostert@ninds.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 Part 52 and 45 CFR Parts 74 and 92.