and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Neurological Disorders and Stroke (NINDS) |
|
Funding Opportunity Title |
NeuroNEXT Infrastructure Resource Access (X01) |
Activity Code |
X01 Resource Access Award |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PAR-11-344 |
Companion FOA |
PAR-11-343, NeuroNEXT Clinical Trials (U01); PAR-11-345, NeuroNEXT Small Business Innovation in Clinical Trials (U44); NOT-NS-11-025. |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.853 |
FOA Purpose |
This FOA encourages proposals for biomarker validation trials or exploratory clinical trials of drugs, biologics, surgical therapies or devices that may contribute to the justification for and provide the data required to design a future trial to confirm efficacy (i.e., a Phase III trial) in the treatment of neurologic disease. Proposals for drugs or biologics should provide compelling scientific evidence that the investigational agent proposed for study will reach/act upon the designated target or that its mechanism of action is such that it will be of benefit in ameliorating a specific aspect of the disease. Diseases chosen for study should be based on the NINDS' strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. |
Posted Date |
September 21, 2011 |
Open Date (Earliest Submission Date) |
October 21, 2011 |
Letter of Intent Due Date |
Not Applicable |
Application Due Date(s) |
Applications are accepted by continuous receipt, as described in NOT-NS-11-025. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
We expect to review applications six times a year, with one meeting in each of the following windows: December 2011-January 2012; February-March 2012; April-May 2012; June-July 2012; August-September 2012; October-November 2012; December 2012-January 2013; February-March 2013; April-May 2013; June-July 2013; August-September 2013; October-November 2013; December 2013-January 2014; February-March 2014; April-May 2014; June-July 2014; August-September 2014; October-November 2014. |
Advisory Council Review |
Standard dates apply |
Earliest Start Date(s) |
February 15, 2012; April 15, 2012; June 15, 2012; August 15, 2012; October 15, 2012; December 15, 2012; February 15, 2013; April 15, 2013; June 15, 2013; August 15, 2013; October 15, 2013; December 15, 2013; February 15, 2014; April 15, 2014; June 15, 2014; August 15, 2014; October 15, 2014; December 15, 2014. |
Expiration Date |
(Extended to December 31, 2014 per NOT-NS-14-011), Originally October 22, 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.
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
This FOA uses the X01 mechanism to provide access to the NeuroNEXT infrastructure resource to both For-profit and Non-for profit organizations. Small businesses may wish to consider applying through PAR-11-345: NeuroNEXT Small Business Innovation in Clinical Trials (U44) (PAR-11-345). Others may wish to consider applying through PAR-11-343: NeuroNEXT Clinical Trials (U01) (PAR-11-343).
In December 2010, FOAs (RFA-NS-11-009, RFA-NS-11-010, RFA-NS-11-008) were released for a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC) and a group of clinical sites, which combined will form the Neurology Network of Excellence in Clinical Trials (NeuroNEXT, www.ninds.nih.gov/NeuroNEXT). NINDS has embarked upon this initiative to facilitate the cooperation and partnering of public and private funding organizations, universities, academic medical centers, research institutes, contract research organizations, biotechnology companies, and pharmaceutical companies.
This FOA encourages proposals for biomarker validation trials or exploratory clinical trials of drugs, biologics, surgical therapies or devices that may contribute to the justification for and provide the data required to design a future trial to confirm efficacy (i.e., a Phase III trial). Proposals for drugs or biologics should provide compelling scientific evidence that the investigational agent proposed for study will reach/act upon the designated target or that its mechanism of action is such that it will be of benefit in ameliorating a specific aspect of the disease. Neurologic diseases chosen for study must fall within the primary responsibility of NINDS (www.ninds.nih.gov/funding/areas/index.htm).
Working with NeuroNEXT is a cooperative venture between NINDS, the NeuroNEXT network and the applicant. NINDS will provide guidance to potential applicants with input from the Office of Clinical Research, the applicable NINDS Extramural group and the NeuroNEXT Steering Committee Working Group. Potential applicants are strongly encouraged to contact NINDS OCR (see Agency Contacts, Section VIII) in order to discuss the feasibility of conducting the proposed trial through the NeuroNEXT infrastructure before submitting an application. Pre-application consultation may include an introductory teleconference (at least 3 months prior to submission), followed by a conference call or in-person meeting with NINDS staff, if needed.
Successful applicants will be given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with applicants to finalize the protocol and to efficiently implement the proposed study, including securing of all site subcontracts. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.
Applicants should make note of the following:
(1) The applicant must hold intellectual property rights (IP) to the investigational agent/device proposed for study.
(2) All trials proposing use of an investigational agent/device must have an active IND/IDE.
(3) Access will be contingent on the issuance of an appropriate technology transfer agreement, possibly a Cooperative Research and Development Agreement (CRADA), between NINDS and Applicant.
(4) The applicant will be expected to make a financial contribution to clinical trial costs above the NINDS-covered infrastructure costs.
There is increasing awareness among neurological disease communities that to assess the predictive value of preclinical research, sufficient information must be available about study design, execution, analysis, and interpretation. Examples of the critical elements of a well-designed study are summarized on the NINDS website (http://www.ninds.nih.gov/funding/transparency_in_reporting_guidance.pdf). NINDS urges applicants to consider these elements when describing supporting data and designing the proposed studies.
Funding Instrument |
Not applicable-This is an infrastructure access award, not a grant |
Application Types Allowed |
New Renewals will only be considered for certain long-term
projects. For renewals, the progress made in the last funding period will be
considered by reviewers to determine whether continued resource access is
appropriate. 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 number of meritorious applications. |
Award Budget |
Not applicable, XO1 funds are not awarded via this X01 |
Award Project Period |
Maximum period of 5 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.
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
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)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 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 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.
It is not necessary that the designated study PD(s)/PI(s) be part of the NeuroNEXT infrastructure in order to be eligible to respond to this FOA. Access to NeuroNEXT will be contingent on the issuance of an appropriate technology transfer agreement, possibly a Cooperative Research and Development Agreement (CRADA), between NINDS and Applicant.
This FOA does 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. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide must be followed, with the following exceptions or additional requirements:
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Introduction section (required for a resubmission or revision application) is limited to 1 page.
Specific Aims:
Applicants should describe the potential impact of the proposed research. The hypotheses and specific aims of the trial must be clearly and concisely stated. The primary endpoints must be clearly defined. The inclusion of secondary endpoints should be justified by stating the need for the supportive or explanatory data they are likely to yield.
Research Strategy:
Significance and Biological Relevance
Applicants are encouraged to state concisely the need, rationale, and scientific relevance of the proposed research. It is particularly important that there be a discussion of how the trial will test the hypothesis proposed and how results of the trial (positive or negative) may be explained based on the presumed biological action of the proposed intervention. The application must present an overview of the state of the science, current status of therapeutics for the disease, and relevance of the trial for treatment of the disease.
Prior Studies and Rationale for Development
The major findings of the pre-clinical and clinical studies that led to the proposed clinical trial should provide a compelling rationale for the belief that the proposed intervention is expected to be effective. Data from pre-clinical and pilot studies demonstrating the need for and the feasibility of the trial should also be presented. There is increasing awareness among neurological disease communities that to assess the predictive value of preclinical research, sufficient information must be available about study design, execution, analysis, and interpretation. Examples of the critical elements of a well-designed study are summarized on the NINDS website (http://www.ninds.nih.gov/funding/transparency_in_reporting_guidance.pdf). NINDS urges applicants to the program to consider these elements when describing supporting data and designing the proposed studies.
Information for the Use of NINDS Common Data Elements: The NINDS expects that applications will use the NINDS Common Data Elements resource when constructing data collection forms. The Common Data Element website (see: http://www.nindscommondataelements.org/) serves as a repository and dissemination tool for all NINDS CDEs for Investigators to utilize.
Human Subjects:
Applicants should refer to Part II of the PHS398 Application Instructions Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan.
Data and Safety Monitoring Plan:
NIH requires the establishment of Data and Safety Monitoring Boards (DSMBs) for multi-site clinical trials involving interventions that entail potential risk to participants (http://grants.nih.gov/grants/guide/notice-files/not98-084.html). The purpose of this board is to provide independent advice to NINDS concerning scientific issues pertaining to subject safety, data quality, study conduct and study continuation. In monitoring safety in the trial, the board also may recommend termination in the event of early significance of findings or futility, or the determination of unacceptable adverse effects. The DSMB is appointed by the NINDS and consists of individuals who are not associated with the institutions participating in the trial (http://www.ninds.nih.gov/research/clinical_research/policies/data_safety_monitoring.htm). Potential members of this board should NOT be named in the application, although the areas of expertise needed for the board should be indicated.
Clinical Protocol
The proposed clinical protocol should be uploaded as an "other attachment" (item 12 of 4.4 'Other Project Information Component')
The proposed clinical trial protocol must include:
If investigators choose to incorporate patient reported outcomes in the study, it is suggested that they review the following FDA guidance to assist in their planning: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf.
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R) Application Guide.
Appendix
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Foreign (non-US) institutions will have to work with the U.S.-based NeuroNEXT infrastructure and must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
Not Applicable.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the
Credential field of the Senior/Key Person Profile Component of the SF
424(R&R) Application Package. Failure to register in the Commons and
to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, 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 [email protected] when the application has been submitted. Please include the PAR number and title, PD(s)/PI(s) name, and title of the application.
The applicant should provide a brief statement that they expect to have sufficient drug to complete the proposed trial, to have a method of distributing the drug to the clinical trial sites and to have sufficient resources to cover the clinical trial costs above the NINDS-funded infrastructure as well as overhead costs.
If the industry partner will require a higher level of patient monitoring than that which is usually provided by the network, those costs would be covered by the applicant.
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(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?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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
Not Applicable.
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
Renewals will only be considered for certain long-term projects. For renewals, the committee will consider the progress made in the last funding period to determine whether continued resource access is appropriate.
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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
Not Applicable.
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 to NINDS for administrative management. 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 resource access award decisions:
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.
Not applicable.
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.
Not Applicable.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
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: [email protected]
D. Elizabeth McNeil, MD MSc
National Institute of Neurological Disorders & Stroke
Telephone: (301) 496-9135
Email: [email protected]
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-9223
Email: [email protected]
Not applicable.
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.
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