Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Ancillary Studies in PREDICT-HD (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

  • July 25, 2013 - See Notice NOT-NS-13-037. Discontinuation of this PAR, after the August 14, 2013 Application Due Date.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PAR-12-097

Companion FOA

NoneNone

Number of Applications

See 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 ancillary studies that will further our understanding of the unique clinical and biomarker signatures of premanifest or prodromal Huntington's disease (HD) through coordination with the NINDS-funded Neurobiological Predictors of Huntington's Disease (PREDICT-HD) study. The PREDICT-HD study is an international 32-site observational study of persons at-risk for HD, and includes clinical and biospecimen resources from 800 premanifest HD participants and 200 healthy control subjects.  Extensive clinical data including UHDRS motor examination, cognitive and neuropsychiatric assessments, and structural MRI imaging have been collected over a ten-year time frame, with a subset of these data accessible through the dbGaP website http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000222.v1.p1

This FOA encourages collaborative investigations combining expertise in imaging, proteomics, biomarker assay development, clinical trial design, phenotype/genotype modifier analysis, and motor, neuropsychological and cognitive assessments of Huntington's disease.   Among the areas of research encouraged in this initiative are innovative and informative clinical and biomarker assessments designed to improve the translation of existing knowledge towards efficient and effective clinical trials for the prevention and treatment of Huntington's disease.

Key Dates
Posted Date

February 3, 2012

Open Date (Earliest Submission Date)

February 25, 2012

Letter of Intent Due Date

One month prior to application due date.

Application Due Date(s)

April 25, 2012; August 14, 2012; December 11, 2012; April 12, 2013; August 14, 2013; December 11, 2013; April 11, 2014, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May/June 2012, October/November 2012, February/March 2013, May/June 2013, October/November 2013, February/March 2014, May/June 2014

Advisory Council Review

August 2012, January 2013, May 2013, October 2013, January 2014, May 2014, October 2014

Earliest Start Date(s)

September 30, 2012; April 1, 2013; July 1, 2013; December 1, 2013; April 1, 2014; July 1, 2014; December 1, 2014

Expiration Date

(Now Expiring August 15, 2013 per NOT-NS-13-037), Originally April 12, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

Background

PREDICT-HD is a 32-site observational study of individuals at-risk for Huntington's disease (HD).  The PREDICT-HD study has been funded since 2001 to collect imaging and clinical assessments that will help to advance our understanding of the natural history of HD.  In this regard, the PREDICT-HD study cohort and database have become international resources that offer an unprecedented opportunity to examine early HD progression and prognostic biomarkers. The goals of the PREDICT-HD study focus on laying the groundwork for future clinical trials in an at-risk HD patient population. The specific aims of the PREDICT-HD study were designed to 1) improve prediction of disease diagnosis in healthy individuals using longitudinal measures of plasma, imaging, cognitive performances, motor ratings and psychiatric measures; 2) enable identification of assessment tools for disease progression prior to clinical diagnosis and characterize the natural history of these clinical and/or biological readouts; and 3) improve the validity and reliability of disease measures upon which the power and sensitivity of multi-site trials and studies depend.

Given the significant contribution of the PREDICT-HD study to our knowledge of HD pathogenesis and correlations with other brain diseases, the availability and the dissemination of PREDICT-HD data through the NIH database for Genotypes and Phenotypes (dbGaP) is an important advancement for HD clinical and biomarker-driven research.   Extensive clinical data including the Unified Huntington's Disease Rating Scale (UHDRS) motor examination, cognitive and neuropsychiatric assessments, and structural MRI imaging have been collected over a ten-year time frame.  A subset of these data, representing over 25 clinical variables such as the UHDRS score, CAG repeat length, and Cognitive Assessment Summary (CAS) score, are accessible through the dbGaP website http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000222.v1.p1 . Longitudinal phenotypic data available through the PREDICT-HD dbGaP website has also been linked to genotyping data available for PREDICT-HD subjects genotyped in a National Institute of Neurological Disorders and Stroke (NINDS)-sponsored Huntington's disease genome-wide association study (GWAS).   Biospecimen samples including plasma, blood and urine are collected yearly and stored at the NINDS Human Genetics DNA and Cell Line Repository at the Coriell Institute for Medical Research http://ccr.coriell.org/Sections/Collections/NINDS/?SsId=10.  PREDICT-HD participants and related biospecimens are categorized based on the CAG-Age Product Scaled index or CAP(s), which is a data-derived index that reflects the time to HD diagnosis.  Under the PREDICT-HD 2.0 study protocol, for example, more than 789 PREDICT-HD participants have contributed 1,203 plasma samples (in EDTA tubes) for proteomic, ELISA and multi-variant analysis, 1,261 plasma samples (in lithium-heparin tubes) for metabolomic analysis and over 2,400 whole blood and urine samples.  These samples are distributed across all CAP groups (control, low, medium and high) and from multiple visits over the last 2 to 3 years, thereby providing the opportunity for either cross-sectional or longitudinal biomarker assessment.  A summary of biospecimens available from the PREDICT-HD study can be found at http://www.ninds.nih.gov/funding/areas/neurodegeneration/index.htm

 
Research Objectives

The goal of this FOA is to accelerate and enhance our understanding of the unique clinical and biomarker signatures of premanifest Huntington's disease through ancillary investigations coordinated with the NINDS-funded PREDICT-HD study.   During this current and final period of funding for the PREDICT-HD study, the specific goals of this FOA include:

This FOA will encourage collaborative investigations combining expertise in imaging, proteomics, biomarker assay development, clinical trial design, phenotype/genotype variant analysis, and motor, neuropsychological and cognitive assessments of Huntington's disease.   Among the areas of research encouraged in this funding announcement are innovative and informative clinical and biomarker assessments designed to improve the translation of existing knowledge towards efficient and effective clinical trials for the prevention and treatment of Huntington's disease

A. Research Scope

The purpose of this Funding Opportunity Announcement (FOA) is to encourage ancillary studies which will be reviewed independently, but in a timely fashion allowing them to be tied to the ongoing PREDICT-HD study.  All additional clinical assessments or biospecimen collection must be within the current capabilities and timeframe (completion by August 31, 2014) of the PREDICT-HD study and should not result in an unmanageable or unduly burden on PREDICT-HD participants.

For the purposes of this FOA, ancillary studies are defined as: research activities undertaken to address a scientific question relevant to the mission of PREDICT-HD and that require access to data or records from PREDICT-HD and/or involve collection of additional data, specimens, or records from participants enrolled in the PREDICT-HD study.

Depending on the scientific questions posed, ancillary studies supported under this program might involve the entire cohort participating in the ongoing PREDICT-HD observational study or selected subsets of PREDICT-HD participants. In general, all participants in the ancillary study must be participants in the PREDICT-HD study.  All applications should include a statistical plan. It is strongly recommended that a statistician from the PREDICT-HD study be part of the research team and active in the preparation of the application.

Research questions, research tools or approaches addressed by the ancillary study might include, among others, the study of:

The Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) of the proposed ancillary study must provide documentation from the PREDICT-HD Executive Committee of approval to use existing PREDICT-HD infrastructure, participants, and other data from the parent study.  For ancillary studies involving collection of additional clinical data or biospecimens, a brief description of the ancillary study proposed, the number of PREDICT-HD participants required for the study, the number of collection time points and a statistical analysis plan must be submitted to the PREDICT-HD Executive Committee for approval, using the approval form available at http://www.ninds.nih.gov/funding/areas/neurodegeneration/index.htm, prior to submission of a grant application in response to this FOA.  The PREDICT-HD Executive Committee includes NINDS program staff, the PREDICT-HD Principal Investigator, study statistician, and subject matter experts outside of the PREDICT-HD study. Ancillary studies must not interfere with the parent study or unduly burden participants. Approved procedures and policies from the parent PREDICT-HD study must be followed.

This program will use a modified application process and accelerated peer review which is expected to decrease the time from application to funding. It is expected that ancillary study applications will be able to demonstrate the time-sensitive nature of the proposal and provide a rationale for why an expedited review is essential.

B.  Milestones

The U01 application must have a section labeled "Milestones" within the 12 page Research Strategy that addresses the critical areas identified for the U01 outlined in Section 1 under Research Scope and relates to the timeframe of the current PREDICT-HD study.  Please see Section IV for additional information.

The following are key aspects of the FOA:

Ancillary studies involving additional clinical assessments or biospecimen collection must be within the current capabilities of the PREDICT-HD study and collection must be completed by August 31, 2014

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New
Resubmission

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

The U01 direct cost budget for individual applications is expected to be between $200,000 to $499,000 per year for up to 3 years for ancillary studies involving additional clinical assessments or biospecimen collection, and for up to 2 years for studies using existing PREDICT-HD data or biospecimens.

Award Project Period

The maximum award 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

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

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.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

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.

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. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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, 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.

Letter of Intent

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:

The letter of intent should be sent to:

Margaret Sutherland, PhD
Program Director, Neurodegeneration
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard
Neuroscience Center, Room 2222
Bethesda, MD 20892
Telephone: (301) 496-5680
Fax: (301) 480-1080
Email: sutherlandm@ninds.nih.gov 

Required and Optional Components

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

Page Limitations

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

PHS 398 Research Plan Component

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

For this FOA, under separate headings, a milestone plan, data and resource sharing plans, and Letters of Support must be included within the 12 page Research Strategy section.

 Letters of Support section of the Research Plan:

The Research plan should also include a section documenting the letter of support from the PREDICT-HD Executive Committee regarding the feasibility to use parent PREDICT-HD infrastructure, patient cohorts, patient samples, and/or other data from parent study for the proposed ancillary study.  This section should also describe the collaboration between the ancillary study and PREDICT-HD study investigators.   Institutional Review Board (IRB) approval from the parent PERDICT-HD study and ancillary studies, if completed should be included in this section. (Note: IRB approval for the proposed ancillary study is not required at the time of submission of the application but will be required as part of just-in-time information before award.)

Human Subjects: It is recommended that the following items be clarified under Protection of Human Subjects: (1) list of additional samples/specimens/examinations that will be collected as part of the ancillary study; (2) the right of the subjects to refuse to participate in the ancillary study and still participate in the PREDICT-HD study; and (3) absence of cost to the subject for participation in the ancillary studies. Any incentives provided to subjects to participate in the ancillary studies (if in addition to those under the PREDICT-HD study) should be clearly described and strongly justified.

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 modifications:

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, with the following modifications:

The Appendix should contain the following materials:

In regards to consent forms the following information should be addressed:

IRB approval of the informed consent form(s) is not required at the time of submission of the application. However, drafts of informed consent form(s) for the parent PREDICT-HD study and the ancillary studies, if different, must be included as part of the appendix, to ensure that the consent obtained will allow for the use of existing samples as proposed in the ancillary study. It is recommended that applications submitted under this program have clear language in the informed consent form(s) that distinguishes ancillary studies from the PREDICT-HD study with which they are linked.

3. Submission Dates and Times

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

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

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

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

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

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

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

Post Submission Materials

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

Section V. Application Review Information

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 ancillary studies for PREDICT-HD support the investigation of novel scientific ideas for the development of tools, clinical assessments or biomarkers that have the potential for significant impact on the analysis of disease progression in presymptomatic HD patients. The ancillary study grant application need not have extensive background material or preliminary information. Accordingly, for this FOA, the level of innovation, and the potential to significantly advance our knowledge or understanding of HD will be emphasized. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for the ancillary studies in PREDICT-HD; however, they may be included if available. 

Overall Impact

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).

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(s)/PI(s), 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? Will the ancillary study proposed advance the clinical assessment of progression in prodromal or presymptomatic HD?

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? In the case of ancillary studies requiring additional clinical assessment or biospecimen collection, does the parent grant acknowledge the feasibility of these add on studies within the framework of PREDICT-HD? In the case of ancillary studies that will require additional clinical assessments and/or require additional biospecimen collection, does the milestone plan specify the number of PREDICT-HD subjects required for the ancillary study, the PREDICT-HD clinical sites involved and the timeline for data/biospecimen collection, where collection of all new clinical data and biospecimens must be completed by August 31, 2014?    

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/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

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/priority score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Institute of Neurological Disorders and Stroke Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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.

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

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:

Awardees are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, reports to NINDS program staff, and other mechanisms.

Publications

The PD(s)/PI(s) will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by project investigators and supported in whole or in part under this Cooperative Agreement. The Principal Investigator and Project Leaders are requested to submit manuscripts to the NIH Project Scientist within two weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained. Publications and oral presentations of work conducted under this Cooperative Agreement are the responsibility of the PD(s)/PI(s) and appropriate Project Leaders and will require appropriate acknowledgement of NINDS support and the PREDICT-HD study. Timely publication of major findings is encouraged.

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

NINDS program staff will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination.  However, the role of NINDS Project Scientists will be to facilitate and not to direct the activities. 

The NINDS Project Scientist will:

Additionally, 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:

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.

Requirements prior to award:

Prior to award, the applicant must provide to the funding institute a memorandum of understanding signed by the applicant, an appropriate representative of the applicant institution, the principal investigator of the PREDICT-HD study and her academic institution.  This memorandum will confirm agreement among the various parties and will outline the terms and conditions of the agreement in the following areas: 1) ownership, analysis, access, and release of data from the ancillary studies; 2) method and timing of access to the data from the PREDICT-HD study that are needed to analyze the ancillary studies; 3) documentation of quality assurance procedures for both the PREDICT-HD study and the ancillary studies; 4) ownership of intellectual property developed by the ancillary studies; and 5) plan for publication of the ancillary study results.

3. Reporting

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. 

Section VII. Agency Contacts

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

Application Submission Contacts

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
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

Scientific/Research Contact(s)

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

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