Research
Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

The Michael J. Fox Foundation (MJFF)
Harvard Biomarker Study

National Brain and Tissue Resource for Parkinson's Disease and Related Disorders, Banner Sun Health Research Institute

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Request to Access Parkinson's Disease Related-Biospecimens (X01)

Activity Code

X01 Resource Access Award

Announcement Type

New

Related Notices

  • August 2, 2016 - Notice of Discontinuation of PAR-14-340. See Notice NOT-NS-16-040.
  • April 14, 2016 - Updated Application Forms (FORMS-D) Available for PAR-14-340. See Notice NOT-NS-16-015.
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
  • November 3, 2015 - Notice Announcing the Creation of a Dedicated NINDS Biomarkers Repository for Biospecimen Banking for NINDS Biomarkers Projects . See Notice NOT-NS-15-046.
  • May 13, 2015 - Notice of Informational Webinar on Biosample Access and Funding Opportunities for Parkinson's Disease Biomarker Discovery. See Notice NOT-NS-15-028.

Funding Opportunity Announcement (FOA) Number

PAR-14-340

Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.853  

Funding Opportunity Purpose

The National Institute of Neurological Disorders and Stroke (NINDS) Parkinson's Disease Biomarkers Program (PDBP), The Michael J. Fox Foundation (MJFF) Parkinson's Disease cohorts and biosample collections, the NINDS-sponsored National Brain and Tissue Resource for Parkinson's Disease and Related Disorders at the Banner Sun Health Research Institute and the Harvard Biomarker Study Biospecimen Repository offer unique biospecimen resources and corresponding clinical data for Parkinson's Disease biomarker discovery, optimization and replication studies.  This FOA allows an investigator to apply for access to non-renewable biosamples from one or more of these biosample collections. 

Key Dates
Posted Date

September 10, 2014

Open Date (Earliest Submission Date)

October 13, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Applications are accepted by continuous receipt, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on

Council Round: May
Receipt Window: November 13 - March 12

Council Round: October
Receipt Window: March 13 - July 12

Council Round: January
Receipt Window: July 13 - November 12

Expiration Date

New Date: August 12, 2016 per NOT-NS-16-040 . (Original Expiration Date: November 13, 2017)

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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.

Table of Contents

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

This FOA allows investigators to apply for access to Parkinson's Disease (PD) data and biosample and tissue resources available for PD biomarker discovery, optimization and replication studies.  The resources and associated data include the following programs: 1) the NINDS Parkinson's Disease Biomarkers Program (PDBP); 2) The Michael J. Fox Foundation (MJFF) supported cohorts (BioFIND, DATATOP, LRRK2 Cohort, 24-hour Biofluid Sampling) and biospecimen collections (DATATOP); 3) the Harvard Biomarker Study; and 4) National Brain and Tissue Resource for Parkinson's Disease and Related Disorders, Banner Health Research Institute.  Information about the biosamples or tissue available from each of these collections can be found at the following websites: NINDS Parkinson's Disease Biomarkers Program; MJFF Parkinson's disease cohorts and biosample collections; the Harvard Biomarker Study Biospecimen Resource and the NINDS National Brain and Tissue Repository for Parkinson's Disease and related disorders at the Banner Sun Health Research Institute. It is recommended that investigators visit these websites to learn more about the data and biospecimens available; the Material Transfer Agreements and Data Use Agreements associated with each collection; and any tissue processing or other fees associated with the biospecimens and tissue.   

Specific Areas of Research Interest

Recently, there has been considerable progress in our understanding of the biology of PD.  However, the limited ability to detect early-stage PD prior to the onset of motor signs, inadequate measures of processes or pathways related to disease pathogenesis, and the lack of biomarkers that define disease progression all currently impede therapy development and effective clinical trial design.  This FOA seeks projects that show promise of identifying PD biomarkers that will enable early diagnosis, stratification of a patient population for clinical trials or measurement of Parkinson's disease progression.  Projects may focus on biomarker discovery, optimization of assays and/or replication of prior results.  Appropriate biomarker platforms may include but are not limited to: transcriptomics, whole exome or whole genome sequencing, epigenomics, proteomics, lipidomics, and metabolomics. 

Section II. Award Information
Funding Instrument

Other: A mechanism that is not a grant or cooperative agreement. Examples include access to research resources or pre-application.

Application Types Allowed

New
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon scientific merit and availability of biosample resources.  No funds are associated with this award mechanism.

Award Budget

Not applicable, as funds are not awarded via this X01.

Award Project Period

One year

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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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 - including the NIH Intramural Program
  • 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 Institutions)
Foreign Institutions

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.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.
Section IV. Application and Submission Information
1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

  • For this specific FOA, the Research Strategy section is limited to 6 pages.
Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

Total Federal Funds Requested:  Enter $0.

Total Federal & Non-Federal Funds:  $0.

Estimated Program Income:  Enter $0.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. 

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

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

Research Strategy:

Rationale: Briefly describe the studies proposed and the rationale for these analyses.

Biosamples/Tissue/Data Requested: In a table, briefly outline the number, type, and amount of biospecimens/tissue requested, including subject type (e.g. PD, control, any specific clinical parameters), visit number (if applicable) and the cohort or biorepository through which the biosamples are currently available. For applicants requesting access to data outside of the PDBP DMR (with funding for analyses), briefly outline what data is required and how the data will be used.

For Fluid Biosamples

Name of Cohort Sample and Data Set

()

Number of Samples

Biosample Type

Volume or concentration requested

Any other criteria to be considered e.g. quality control data

Longitudinal samples, visit types and number of samples per visit

PDBP -PD cases (specify criteria e.g. UPDRS score, if any)

100

Plasma

200 microliters

Hemoglobin < 0.2

Visit 1 -50 samples

Visit 2 - 50 samples

PDBP- Controls (specify criteria  e.g. age and gender matched, if any

100

Plasma

200 microliters

Hemoglobin < 0.2

Visit 1 -50 samples

Visit 2 - 50 samples

For Tissue Specimens

Name of Cohort Sample and Data Set

(PD tissue, Control tissue, Dementia with Lewy Tissue)

Number of Samples

Biosample Type

Fixed (sample format e.g. formalin-fixed: wet tissue block; paraffin blocks; paraffin sections; free floating sections )

Frozen (sample format e.g. blocks 0.5 or 1.0 grams; or cryostat sections )

Any other criteria to be considered e.g. quality control data

Banner Sun Health Research Institute PD cases (specify criteria e.g. UPDRS score, if any)

50

Brain and/or body tissue

Fixed

Free floating sections

Frozen

0.5 gram block

Time to autopsy

Banner Sun Health Research InstituteControls (specify criteria  e.g. age and gender matched, if any

50

Brain and/or body tissue

Fixed

Free floating sections

Frozen

0.5 gram block

Time to autopsy

A. Background: Provide the relevant background to justify the request. Be sure to include:

  • Importance of the project, including the significance of both the study question and of the specific project.
  • Justification for requesting these specific samples, and why other sources of similar samples are not appropriate. This section should explain how the proposed use relates to the design and outcomes of the study that produced the requested samples. The question being posed by the investigator must be appropriate to the source of the biospecimens, how they were collected, prepared, analyzed and stored; their age; and the phenotypic and other accompanying data.
  • Relevant preliminary data demonstrating the applicant’s experience with the assay or technique that will be used with the requested samples
  • B. Sample Information:
  • Include detailed information about what samples are requested. If you will be combining the results from the proposed study with those obtained from other samples, be sure to explain how the requested samples will fit in with your overall study design (e.g. from which study and stage of the study the specimens are requested, whether random samples or specific selection of those with subjects with or without specified clinical events and laboratory or imaging findings are sought, etc.).
  • Include a clear justification for the amount of sample being requested. In all cases, applicants should only request the minimum volume needed for the study.
  • C. Project Details:
  • Hypothesis: There should be at least one important hypothesis that can be tested using the proposed methods and non-renewable samples provided by the repository, or a strong justification for carrying out discovery research.
  • Methodology: Describe how the requested samples will be used, including a description of the specific procedures by which the samples will be tested and analyzed and the quality control and robustness of the assay. Is this a discovery, optimization or replication study?
  • Power and effect size: Describe the power of the project and the anticipated size of a detectable effect.
  • Data analysis: Provide a detailed plan for data analysis. Include a brief summary of the team’s expertise and experience and evidence that they can handle the analysis proposed.
  • Sample management: Explicitly address how the samples will be held, managed, and processed. For example, who will have the main responsibility for storing and testing the samples?
  • Plans for the next phase: Describe plans for follow up studies and, if relevant, further biomarker or assay development. If collaborations have been established for follow up, include these letters of collaboration.

D. Project Support:

  • Describe whether there is current NIH funding to support the research project and if so, provide the grant number(s). If there is no NIH funding, briefly describe the source of funding to support the proposed project or the plan to apply for funding. If the applicant proposes to apply for funding subsequent to approval of this X01 application, approval of access to samples will be conditional on successfully obtaining funding. Conditional approvals will be valid for a period of up to 15 months.

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, with the following modification:

  • All applications should address a Data Sharing Plan.

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.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

Not Applicable.  No funds are involved with this Resource Access Award.  

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (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 SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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 System for Award Management. 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, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

1. Criteria

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.

For this particular announcement, note the following:

The X01 Resource Access Program invites applications from investigators interested in Parkinson's Disease Biomarker Discovery and who seek access to NINDS research resources, MJFF cohort data and related biospecimen resources, biosamples available through the Harvard Biomarker Study, and/or autopsy tissue and associated clinical data available through the NINDS National Brain and Tissue Resource for PD and related disorders (Banner Sun Health Research Institute), which are specified in this X01 FOA.  Important factors in the peer review of X01 applications are the need for, and potential benefit of, gaining access to the resource; specifications for any assays proposed; time lines for completion; and plans for follow-on studies.

Overall Impact

Reviewers will provide an overall impact 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).

Scored Review Criteria

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(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/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 human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion 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?   

Additional Review Criteria

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 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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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 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.

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

  • Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete with all other recommended applications. Applications will be reviewed by the Biospecimen Resource Access Committee. The following will be considered in making resource access decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information
1. Award Notices

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  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

Not Applicable

3. Reporting

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

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

Scientific/Research Contact(s)

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

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

Catherine Kopil
The Michael J. Fox Foundation
Telephone: 212-509-0995
Email: ckopil@michaeljfox.org

Clemens Scherzer
Harvard Medical School
Telephone: 617-768-8427
Email: cscherzer@rics.bwh.harvard.edu

Thomas Beach
Banner Sun Health Research Institute
Telephone: 623-876-5643
Email: Thomas.Beach@bannerhealth.com

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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.

Authority and Regulations

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.

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