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): Clinical Sites (U10)
Activity Code	U10 Cooperative Clinical Research Cooperative Agreements
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-NS-13-002
Companion FOA	RFA-NS-13-001, U01 Coordinating and Statistical Centers
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 (U10) to provide continuing support for Clinical Sites 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
Letter of Intent Due Date	March 17, 2012
Application Due Date(s)	April 17, 2012
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 PHS398 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. While some links are provided, 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 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 Sites 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 Clinical Sites capable of continuing all patient follow-up activities necessary for the successful completion of the creatine trial. Applications for the Coordinating and Statistical Centers 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 Clinical Site 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.

SPECIAL REQUIREMENTS

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

1) A Clinical Site is an institution that is actively involved with the evaluation, treatment and follow-up of study participants. It will consist of a team of researchers with experience in collaborative clinical studies and with the neurological skills to deliver medical care to PD patients. It may have agreements to form a local network with other nearby institutions to treat and retain patients for in NET-PD.

2) Each Clinical Site will collaborate with other Clinical Sites and with the Coordinating Center, Statistical Center, and NINDS Scientific Program Director, to follow the protocol for each participating patient. Accurate and complete data reporting are paramount. Complete follow-up in a large longitudinal trial will require innovative methodology to maintain prolonged patient contact. Cooperation with patient advocacy groups is encouraged as a means of encouraging patient compliance and commitment to the trial.

3) Clinical Sites will attempt to follow-up all participants according to NET-PD study protocols using standardized data collection procedures.

4) It is critical to the success of this project that each Clinical Site maintain contact with all recruited patients and carry out complete, accurate data collection and timely transmission of the data to the Coordinating Center. To assure the overall quality of the trial, Clinical Sites must cooperate with data audits and other quality control procedures established by the protocol, Steering Committee, and Data and Safety Monitoring Board.

5) A Clinical Site investigator may participate on the Steering Committee and Publications Committee, according to the charter of the Steering Committee.

6) Each Clinical Site must agree to publish data collected from their site only in accordance with guidelines established by the Publications Committee.

7) Clinical Sites are required to take all appropriate measures to protect human subjects and ensure adequate representation of genders and racial/ethnic minorities.

Funding Instrument	Cooperative Agreement
Application Types Allowed	Renewal The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NINDS intends to make up to 45 awards and to commit approximately $3,750,000 in total costs in fiscal year 2013.
Award Budget	Application budgets must follow the guidelines in Section 5 and must reflect actual needs of the proposed project.
Award Project Period	The maximum period is 3 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 Clinical Sites are eligible to apply.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations must complete the following registrations as described in the PHS398 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
• 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 PHS398 Application Guide.

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

Only one application per institution 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 are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 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.

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.

By the date listed in Part 1. Overview Information, 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 PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Claudia S. Moy, PhD
National Institute of Neurological Disorders and Stroke
National Institutes of Health
Office of Clinical Research
Neuroscience Center, Room 2214
6001 Executive Blvd.
Bethesda, MD 20892-9520
(for courier delivery: Rockville, MD 20852)
Telephone: 301-496-9135
Email: moyc@mail.nih.gov

Applications must be prepared using the PHS 398 research grant application forms and 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)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

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

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

The following issues should be covered in the Research Plan component of the application:

Clinical Sites should document a history of successful follow-up and retention of the NET-PD participants previously enrolled at their site. Provide details of special efforts to follow and retain subjects who are members of ethnic, racial or other disadvantaged populations. Additionally, measures implemented to ensure the safety of study participants should be described.

Applicants should describe the clinic environment where the study visits are conducted, including the availability and clinical research experience of the Clinical Site staff.

If the Clinical Site is a consortium of local sites, applicants should describe the history of the consortium and how it ensures uniform patient care and compliance with the protocols. Additionally, describe the advantages of the collaboration in terms of cost and recruitment capabilities.

Clinical Sites should describe existing and/or planned interactions with PD patient advocates in their local areas designed to facilitate follow-up of study participants.

Applicants should document proficiency with accurate and timely completion of data collection forms and protocols (including obtaining IRB approvals) to date. An explicit statement of willingness to continue cooperating with the other NET-PD centers (including the Coordinating and Statistical Centers) towards the goal of successfully completing the current NET-PD trials should be included.

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 PHS398 Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Foreign (non-US) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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.

CLINICAL SITE BUDGET

Applicants should budget based on the number of LS-1 patient visits to take place through study completion. These annual visit-specific costs should be allocated to personnel and other categories as appropriate. The visit costs are based on the following rates:

Month 24 (V05): $950

Month 30 (T01): $360

Month 36 (V06): $950

Month 42 (T02): $360

Month 48 (V07): $950

Month 54 (T03): $360

Month 60 (V08): $1,195

Month 66 (T04): $360

Month 72 (V09): $950

Month 78 (T05): $360

Final visit (V10): $950

A table showing the number of each type of visit expected for each remaining year of LS-1 must be included in the budget justification. In addition to the visit costs, up to $5,000 per year for other costs may be included if adequately justified.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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.

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? Has this Clinical Site made significant contributions in the conduct of the NET-PD clinical trial efforts? Does the applicant provide data supporting their ability to successfully follow and retain acceptable rates of previously-enrolled NET-PD participants thus far? Is there evidence of successful retention of Parkinson patients in previous trials?

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 consistent implementation of study protocols in a timely and accurate fashion? Is there evidence for timely and accurate completion of data collection forms and reporting of adverse events?

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 ensuring successful patient recruitment and retention efforts?

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? 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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 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.

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:

• Carrying out efficient and comprehensive patient follow-up;
• Willingly adhering to all common study protocols;
• Carrying out complete and accurate data collection and timely data transmission to the Coordinating Center;
• Suggesting approaches to the analyses of data and participating in writing manuscripts of the interim and final results of the trial and pilot studies;
• Ensuring that women and racial/ethnic minority subjects are retained in a representative fashion;
• Taking all appropriate measures to protect human subjects as required by DHHS regulations and NIH policy;
• Attending all training meetings and annual investigators meeting as outlined in the protocol;
• Agreeing to publish data collected as part of the trial according to guidelines established by the Steering/Publications Committee;
• Carrying out all other elements of the research project as described in this FOA

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 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.

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.