Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Neurological Disorders and Stroke (NINDS)
Funding Opportunity Title	Clinical and Data Coordinating Center(s) for Parkinson s Disease Biomarkers Identification Network (PD-BIN) (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	November 24, 2010 - See Notice NOT-NS-11-003 The National Institute of Neurological Disorders and Stroke (NINDS) will hold a pre-application meeting. November 10, 2010 - See Notice NOT-NS-11-001 Notice of Intent to Publish a Request for Applications for Core Cohort Discovery or Validation Studies in the Parkinson's Disease Biomarkers Identification Network (PD-BIN) (U01).
Funding Opportunity Announcement (FOA) Number	RFA-NS-11-005
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestics Assistance (CFDA) Number(s)	93.853
FOA Purpose	The NINDS intends to fund a multi-site, multi-project network (Parkinson’s Disease Biomarker Identification Network, or PD-BIN) devoted to identifying biological markers for PD risk, onset, and/or progression, in order to facilitate development of disease-modifying treatments. The purpose of this FOA is to solicit linked cooperative agreement (U01) applications for the establishment of a Clinical Coordinating Center (CCC) and a Data Coordinating Center (DCC). The PIs for the DCC and CCC must coordinate their submissions. The CCC will be responsible for the oversight of all aspects of subject recruitment and specimen acquisition, including the management of multiple clinical sites (to be identified by the CCC applicant), enrollment of a core cohort of newly diagnosed patients with PD and matched controls, and accurate collection of all clinical and biological data. The DCC will provide all data management aspects for standardized acquisition, quality control, dissemination and public accessibility. The CCC and DCC must be flexible enough to accommodate and support a wide range of future add-on research projects seeking to utilize and augment the core PD-BIN data. Individual hypothesis-driven studies are not a component of this FOA. It is anticipated that all data and biospecimens acquired will be used to create a publicly available resource for biomarker validation and discovery. The CCC and the DCC will be expected to advance the general scientific goal of identifying and validating useful PD biomarkers.

Posted Date	September 24, 2010
Open Date (Earliest Submission Date)	December 18, 2010
Letter of Intent Due Date	December 18, 2010
Application Due Date(s)	January 18, 2011 , by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	March 2011
Advisory Council Review	May 2011
Earliest Start Date(s)	July 2011
Expiration Date	January 19, 2011
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

Background

Parkinson’s disease (PD) is a neurodegenerative condition characterized by tremor, rigidity, bradykinesia, gait imbalance, and other associated motor, autonomic, sleep, neuropsychiatric, and cognitive symptoms. The disease is believed to affect about 1 million individuals in the United States, and is likely to become more prevalent as the population ages. While therapies to alleviate the symptoms of PD exist, none slow or prevent disease onset or progression. Efforts to develop such treatments have been hampered at least in part by the lack of reliable biologically-based identifiers for PD risk, onset, or progression. The National Institute of Neurological Disorders and Stroke (NINDS) convened a workshop in May of 2010 (see http://www.ninds.nih.gov/research/parkinsonsweb/PD_meeting_schedule.htm) to discuss the current state of biomarker development in PD and how development and validation of biomarkers could most effectively be fostered. Given the insights and recommendations provided at the workshop, this initiative was developed as part of the NINDS response to the critical need for biomarker development in PD.

Purpose

The NINDS intends to fund a multi-site, multi-project network (Parkinson’s Disease Biomarker Identification Network, or PD-BIN) devoted to identifying biological markers for PD risk, onset, and/or progression, in order to facilitate development of disease-modifying treatments. The purpose of this FOA is to solicit linked cooperative agreement (U01) applications for the establishment of a Clinical Coordinating Center (CCC) and a Data Coordinating Center (DCC). The PIs for the DCC and CCC must coordinate their submissions. Core clinical sites will be proposed under the CCC and must be capable of establishing a longitudinal cohort of individuals with de novo Parkinson’s disease and matched controls. For this purpose de novo is defined as recently diagnosed subjects who are not currently on dopamine replacement therapy: it is anticipated that subjects will require treatment during the course of the study following baseline assessments and baseline biospecimen collection. Enrollment of this core cohort is to be completed within two years. Each individual subject will have a minimum follow-up of 3 years. Cohort data may include but are not limited to cognitive, motor, gait, olfactory, autonomic, and/or imaging studies. Core biospecimens (e.g. serum, plasma, CSF, whole blood, DNA, and urine, and possibly, fibroblasts) will be collected. A biorepository identified by NINDS will be utilized for biospecimen banking. The CCC will also facilitate standardization and integration of future discovery and validation projects. The DCC will provide all data management aspects for the extended network. Data and biospecimens generated will be used to create a publicly available resource for biomarker validation and discovery, and must be accessible to qualified investigators within and outside PD-BIN. It will be important that the CCC and DCC can rapidly accommodate future peer-reviewed projects funded to study promising biomarkers based upon a wide variety of technologies. These add-on studies might include new grants or supplements to existing grants. Individual hypothesis-driven studies are not a component of this FOA. However, the successful applicant to this FOA would be eligible to apply for future discovery and validation studies utilizing this and other PD-BIN resources. The CCC and the DCC will be expected to work with existing NINDS-sponsored data-coordinating efforts, biospecimen repositories, and relevant oversight committees.

Responsibilities of the Clinical Coordinating Center include:

Cohort Clinical Sites:

• Identification of clinical sites capable of recruiting up to 200-400 affected subjects and 50-100 control subjects for longitudinal evaluation starting within six months of award. All subjects are expected to have completed enrollment within two years if not sooner, and each subject should be followed for a minimum of three years. Sites should also be capable of collecting cognitive, motor, gait, olfactory, autonomic, and imaging data. Core biospecimens (e.g. serum, plasma, CSF, whole blood, DNA, and urine, and possibly, fibroblasts) will be collected.
• Evaluations should be proposed by the applicant at intervals to be specified. Plan on a minimum of two to four evaluations per year. Note that assessment may be more frequent between the time of transition from de novo to medicated in order to capture key differences biologically between these epochs.
• The CCC should have experienced coordinator(s) who will perform the following functions: participate in PD-BIN-wide communications, training, protocol review: work with the core cohort: provide training, QC, and other assessments and support to add-on cohorts.

Biospecimen Collection:

• Implementation of best practices that will facilitate banking of all biological resources in a centralized resource.
• Develop standardized protocols for biospecimen collection.
• Work with the biospecimen repository identified by NINDS for this project to ensure receipt and storage of high quality biological specimens.
• Core biospecimens (e.g. serum, plasma, CSF, whole blood, DNA, and urine, and possibly, fibroblasts) will be collected.

Administrative:

• The PI of the CCC will co-chair the Steering committee (with the PI of the DCC).
• Provide leadership and expertise in the design of common protocols for patient enrollment, follow-up/tracking, and data confidentiality. Use of NINDS Common Data Elements (http://www.nindscommondataelements.org/default.aspx) is strongly encouraged, but not to the exclusion of other standardized data collection tools. An iterative approach may be needed to refine protocols especially as discovery and validation projects are integrated.
• Develop a Manual of Operating Procedures for quality control, training and certification, and regulatory compliance (e.g., adverse event reporting).
• Establish and execute a safety monitoring plan.
• Provide design and infrastructure support as needed to future discovery and validation projects.
• Assist individual PD-BIN sites with regulatory approvals.
• The use of a central IRB of record is encouraged.
• Manage and distribute funds to individual subcontract Core Cohort sites.
• Monitor PD-BIN site performance and work with the NINDS to intervene when indicated. Non-performing sites may be eliminated if deemed non-performing by the NINDS.
• Provide reports to NINDS and relevant oversight committees on all issues related to patient enrollment and safety, specimen collection and processing, and individual site performance.
• Schedule and provide logistical support for site meetings and teleconferences. The CCC should plan to organize an in-person meeting of the Steering Committee approximately 2-4 times per year and of an Oversight Board at least 2-4 times per year. An all-site meeting should occur at least once a year. A steering committee conference call should occur at a minimum twice a month and should be a component of the CCC operations. The CCC should provide minutes of all calls and meetings to the NINDS.
• Provide support, with the DCC, for preparing and submitting collaborative presentations and manuscripts.
• Participation in a cooperative and interactive manner with all other Clinical Sites, the CCC and the DCC in all aspects of the network.

Responsibilities of the DCC will include:

• Develop an interoperable, user-friendly, expandable, flexible database for PD-BIN efforts.
• Develop an innovative, flexible, and user friendly web-based data entry system to facilitate the design, implementation, and harmonization of PD-BIN projects. Data submission must be possible 23 hours per day, seven days per week.
• Provide secure, password-protected web access for the submission and use of the data by PD-BIN and other NINDS approved users. This system must allow all investigators and NINDS staff associated with the project to review data in real-time.
• Provide help-desk support (email or web-based) which will provide a turn-around time of no more than 24 hours for a given query.
• Have the ability to flexibly integrate data from multiple sources including clinical sites, discovery and validation projects, and the biospecimen repository.
• Provide an open architecture to facilitate data mining.
• Work with the CCC and other PD-BIN projects to assure standardized data acquisition, storage, cleaning, and distribution.
• With the CCC, create data dictionaries.
• Assure that all subject data possess a unique, confidential and standard subject identifier which is HIPAA compliant and which links individual subjects to both new and existing corresponding data and materials.
• Coordinate with biorepositor(ies) to track use and availability of biospecimen resources and to associate biospecimens with clinical data. The DCC will be expected to manage all data associated with biospecimens across the network. It will be the DCC responsibility to rapidly inform the CCC, and NINDS of sample quantity, use, QC, distribution and other details based on data provided by the biorepository and clinical sites.
• Provide data analytic support as needed to future discovery and validation projects. These may include imaging, clinical, and laboratory based studies.
• Using data produced under PD-BIN, provide an unbiased analysis of candidate biomarkers for further validation.
• Track publications from the project and assist in data analysis for and preparation of manuscripts and progress reports.
• Provide data analysis and summary reports to steering and other oversight committees and the NINDS.

In addition to having demonstrable expertise in the above activities, it is expected that the most competitive applicants will have a thorough proficiency in both clinical and scientific issues related to PD (CCC) and/or significant experience in providing data coordinating center services to large multi-site clinical or biomarker projects (DCC). For this reason, applicants should emphasize in their submission, including in the personal statement of the biosketch, any expertise they have in PD genetics, neuroimaging, neurophysiology, clinical research data management, or any other area that might be considered an asset for PD biomarker development efforts.

Under the direction of NINDS, an Oversight board will be established in order to advance the general scientific goal of identifying and validating useful PD biomarkers. The CCC and DCC will remain flexible to add to the above activities as specified by an Oversight Board to be appointed by the NINDS. The CCC and DCC will provide expertise regarding the feasibility of rapidly integrating projects into PD-BIN. The CCC and DCC will also provide assistance in the development and/or adjustment of add-on study protocols under PD-BIN. The CCC and DCC will also provide assistance regarding the development and/or adjustment of add-on study protocols under PD-BIN. PIs of the CCC and DCC will co-chair a steering committee that will oversee their daily functioning. A biospecimen distribution committee, established by NINDS, will be utilized to adjudicate distribution of limited resource biospecimens.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NINDS intends to commit the following amounts in FY 2011: $4M Direct costs per award, up to two linked awards, or if only one award with both components, up to $8M for a single award.
Award Budget	Application budgets are not limited, but need to reflect actual needs of proposed project.
Award Project Period	Five 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.

Higher Education Institutions:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American tribal organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)

Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

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 be renewed at least annually
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) 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 four (4) 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 Project Director/Principal Investigator (PD/PI) 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 PDs/PIs, visit the Multiple Program Director/Principal Investigator 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.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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:

Katrina Gwinn MD
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd Room 2143
Bethesda MD 20892
Telephone: (301) 496-5745
Fax: 301-502-1501
Email: gwinnk@ninds.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
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

• 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:

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, with the following modifications:

The following may be included in the application as deemed appropriate by the applicant:

• Clinical or specimen collection protocols
• Non-referenced or non-published, non-standardized clinical assessments and data collection tools
• A table very briefly summarizing capabilities of core clinical sites including: the expected number of subjects: very brief summaries of imaging capabilities: a brief description of on-site biological sample preparation capabilities. This should not be redundant with information included in the Budget Justification and Resource pages.
• A flow chart of suggested core clinical measures and the timing of their application during the project may be included.

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations 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.

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 be returned to the applicant without review.

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?

Investigator(s)

Are the PD/PIs, 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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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?

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?

Is there integration of the linked CCC and DCC components including a feasible management plan?

Are the proposed plan and experience relating to subject recruitment and retention, staff training, data collection, and multi-site management adequate?

Is a timeline presented which will enable subject recruitment, biospecimen, and data collection to commence within six months of award?

Is there an adequate data management plan for harmonization of data elements across datasets in order to facilitate comparisons across new and existing datasets/studies?

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?

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

Not applicable

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 NINDS. (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will:

• 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.
• Receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and 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 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.
• The adequacy of the data and biospecimen sharing plan.

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.

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 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.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NGA. 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:

• The overall function of PD-BIN as described under "Purpose". This includes the prompt and efficient acquisition and management of the network s core cohort, seamless integration of additional discovery projects, and consistent emphasis on collaborative interactions between all PD-BIN investigators, advisory and steering committees, and NINDS representatives. The PIs will be responsible for disbursement of manuals of operations and training materials, certification and supervision of all enrolling sites, contract execution, protocol finalization and distribution, and other requirements delineated responsibilities in Section III.6. 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.

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

• The NINDS Project Scientist and staff will work closely with the Oversight Board, the Steering Committee, Clinical Coordinating Center PI, and Data Coordinating Center PI in order to ensure proper conduct of the Network. The NINDS Project Scientist will be responsible for: (1) overseeing the activities of the Network, along with the other entities delineated above, to ensure that studies are properly conducted and completed in a timely fashion; (2) providing advice and guidance to ensure that the Network runs in accordance with NINDS policies and procedures, and is consistent with the mission of the NINDS to improve public health; and (3) serving as a point of contact for investigators with the NINDS (4) disseminating information from the Institute and communicating with Institute leadership to ensure that the Network operates smoothly.
• The NINDS will appoint an Oversight Board for the entire PD-BIN including the CDCC and future projects. It is expected that this Board will include representatives from academia, industry, other government agencies, and non-profit organizations. The role of this oversight board will include discussion of direction of projects, including vision for integration of studies and how they can best serve the overall goals of the project and stakeholders.
• An agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• In collaboration with the NINDS Project Director, the PIs will be responsible for outreach to researchers and organizations to promote and enhance broad data sharing and PD-BIN resource usage across the PD research community.

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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

For Questions Regarding the Clinical Coordinating Center:

Katrina Gwinn, M.D.
(National Institute of Neurological Disorders and Stroke (NINDS))
Telephone: 301-496-5745
Email: gwinnk@ninds.nih.gov

For Questions Regarding the Data Coordinating Center:

Margaret Sutherland, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5680
Email: sutherlandm@ninds.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.