National Institutes of Health (NIH)
Funding Opportunity Title
National NeuroAIDS Tissue Consortium (NNTC) Data Coordinating Center (DCC) (U24)
U24 Resource-Related Research Projects – Cooperative Agreements
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)
Funding Opportunity Purpose
This Funding Opportunity Announcement (FOA) issued by the National Institute of Mental Health (NIMH) and the National Institute of Neurological Disease and Stroke (NINDS) seeks applications for the Data Coordinating Center (DCC) of the National NeuroAIDS Tissue Consortium (NNTC). The DCC will function as part of the NNTC, a national resource that provides clinical and research data and biological specimens to accelerate discovery research for HIV-associated central nervous system (CNS) and peripheral nervous system (PNS) diseases. It will support the NNTC Clinical Sites that are funded via the companion FOA (RFA-MH-13-070). The DCC works cooperatively with the NNTC Clinical Sites to provide (1) management and database capabilities to ensure effective clinical and brain banking operations and (2) scientific expertise in biostatistics and HIV epidemiology to enable broad analysis of the NNTC clinical database and to aid in post award statistical analysis of recruitment and retention goals for the NNTC cohort. In this consortium, the NNTC Clinical Sites will have all patient contact which will include all clinical assessments ante-mortem. The NNTC Clinical Sites will also be responsible for the collection and housing of post mortem clinical specimens. The DCC will serve as a data repository which will include the clinical assessment data and data obtained post mortem including brain pathology reports, laboratory tests conducted on the collected specimens/fluids, a comprehensive inventory of those specimens housed at each NNTC Clinical Site, and research data, such as bioinformatics datasets.
July 5, 2012
Letter of Intent Due Date
August 4, 2012
Application Due Date(s)
AIDS Application Due Date(s)
September 4, 2012
Scientific Merit Review
Advisory Council Review
Earliest Start Date(s)
September 5, 2012
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The National NeuroAIDS Tissue Consortium (NNTC) is a resource for investigators interested in conducting NeuroAIDS research to identify the neuropathogenic mechanisms involved in HIV disease of the central nervous system (CNS) and peripheral nervous system (PNS). Currently, the consortium is composed of four NNTC Clinical Sites and one Data Coordinating Center (DCC) that work cooperatively as a research resource, providing HIV/AIDS research investigators with clinically annotated datasets obtained ante mortem and associated post mortem brain tissue and fluids.
The DCC maintains a database that contains de-identified clinical information obtained from the NNTC Clinical Sites into the NNTC clinical database which includes clinical assessment data and data associated with post mortem pathology and specimens from HIV-infected and control subjects. Initially, a contract to the NNTC National Coordinating Office (NCO) provided for the convergence of the four NNTC Clinical Site databases into the NNTC clinical database. Many of the NCO functions have been subsequently incorporated into the NNTC DCC grant award in 2007 under RFA-MH-08-020. The NCO has also created a second database which has been named the, “NNTC Bioinformatics Repository”. Data obtained from NeuroAIDS investigators who have conducted studies with NNTC-resources has been deposited into the NNTC Bioinformatics Repository and includes nucleic acid sequence data, tissue microarray and some neuroimaging data. The DCC that is supported out of this FOA will be expected to incorporate clinical data from the NNTC Clinical Sites and research data such as bioinformatics datasets derived from NNTC resources into an integrated NNTC database.
The NNTC has been successful in acquiring specimens and data from HIV-infected and uninfected subjects. Altogether, 765 subjects have undergone clinical assessments and subsequently deceased with autopsy, thus the NNTC is able to provide well-characterized, clinically annotated CNS and PNS tissues and fluids to research investigators to conduct NeuroAIDS research. Currently, the NNTC has compiled clinical specimens that are stored at local NNTC Clinical Sites and which include brain tissue, thousands of plasma and CSF samples, and additional organs and tissues of interest. Research investigators may query the available NNTC clinical specimens and data at the NNTC website.
The NNTC has served as a valuable resource to the NeuroAIDS research community and continuation of its operations are critical given the need for high quality CNS tissues and fluids, especially those which are inaccessible to biopsy during life. It is expected that investigators using these resources will be able to examine emerging research topics in the NeuroAIDS field such as: a) eradication of HIV from persistent CNS reservoirs; b) pathogenic mechanisms of HIV-associated neurocognitive disorders (HAND) in the setting of long term HAART; and c) HIV and aging.
The key consortium wide objective for this and the companion FOA, RFA-MH-13-070, is to ensure that NNTC CNS and PNS tissue/fluids and data resources are available and useful to investigators engaged in research on HIV-associated CNS and PNS diseases. Through these two FOAs, the NIH expects to continue to fund up to four NNTC Clinical Sites (RFA-MH-13-070) and one Data Coordinating Center (RFA-MH-13-071).
The intent of this FOA is to seek applications for the NNTC DCC which will participate as part of the NNTC as described previously. The DCC funded under this FOA will be directed by a PD(s)/PI(s), who will lead the NNTC Steering Committee (SC) and as such will work in collaboration with the PD(s)/PI(s) of the NNTC Clinical Sites, a NIMH Project Scientist, and Program Staff from both NIMH and NINDS. The NNTC SC will guide the functions and processes of the NNTC as described in the terms and conditions of this cooperative agreement FOA. It is expected that the DCC will be comprised of an integrated team of investigators (within a single institution or across institutions) with (1) management expertise; (2) database expertise including management of complex datasets derived from clinical assessments and research; and (3) biostatistics and HIV epidemiology statistics.
The DCC must describe a process to integrate all NNTC-related data from the NNTC Clinical Sites and research, such as bioinformatics datasets, into a common database. Designing and implementing a procedure to upload NNTC-related data are needed to ensure that the clinical and research data are available to qualified investigators for research purposes. Data that should be accessible include: the data in the current NNTC clinical database, past NNTC-related clinical data files currently held at the NNTC Clinical Sites and NNTC-associated research datasets.
The DCC is responsible for the central management of data and, in this FOA, will serve as the data repository for the NNTC Clinical Sites. Management of data by the DCC will include data quality oversight, preparing analytical datasets to share with research investigators when they request NNTC datasets for their research, and ongoing analysis of the NNTC database. The DCC should provide a detailed plan to ensure a rapid, streamlined, and quality controlled process for data acquisition from the NNTC Clinical Sites.
The DCC should also define the manner in which research datasets are to be collected into the NNTC database from investigators who have conducted NeuroAIDS research using the NNTC resources. In addition, the research data should be standardized within the database to enable complex NeuroAIDS research data associated with the NNTC resources to be available for further inquiry. NeuroAIDS research incorporates multidisciplinary research areas including virology, neuropathology, immunology, neuroscience (molecular, cellular and integrative), genetics, genetic epidemiology, and biostatistical research. The DCC should develop a database management system (DBMS) that accomodates multidisciplinary research areas and which can be made readily accessible to research investigators. The DCC is encouraged to utilize databases that have the capability for potentially integrating with other large NeuroAIDS databases. Where feasible, a federated database model is encouraged in which database systems relevant to the field of NeuroAIDS are mapped to the NNTC database, yet remain autonomous and geographically decentralized.
Governance of the NNTC
The NNTC will be governed by the NNTC Steering Committee (SC). Details on the composition and function of the Steering Committee are provided in Section VI.2. Cooperative Agreement Terms and Conditions of Award.
Application Types Allowed
The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
NIMH and NINDS intend to commit approximately $600,000 in FY 2013 to fund 1 award.
Budgets for direct costs may not exceed $600,000 per year.
Award Project Period
The total project period for an application submitted in response to this FOA may not exceed five years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
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
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 not allowed.
Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
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 least4-6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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.
Applications for the DCC Open Competition (U24) may not be submitted by the 4 institutions that represent the current 4 NNTC clinical and banking sites.
Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.
It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Dianne Rausch, Ph.D.
Division of AIDS Research
National Institute of Mental Health (NIMH)
6001 Executive Boulevard, Room 6105, MSC 9616
Rockville, MD 20892-9616
Applications must be prepared using the PHS 398 research
grant application forms and instructions for preparing a research grant
application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
At the time of submission, two additional paper copies of
the application and all copies of the Appendix files must be sent to:
Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
All page limitations described in the PHS398 Application Guide and must be followed, with the following requirements:
NNTC Clinical Site Visits
The PD(s)/PI(s) of the DCC will schedule NNTC Clinical Site visits to perform training, data audits, and data management at local sites on a yearly basis. Applicants to this FOA will include travel to the NNTC Clinical Sites in their proposed budget. (See Section VI.2 Cooperative Agreement Terms and Conditions of Award).
The PD(s)/PI(s) of the DCC will organize, attend and is(are) expected to chair an annual meeting of the NNTC Steering Committee in the Washington D.C. area, or another agreed upon locality. The meeting will also be attended by the PD(s)/PI(s) and Scientific Advisors of the NNTC Clinical Sites. Applicants to this FOA will include travel to the annual meeting in their proposed budget, which should include travel for themselves and any delegates of the DCC PD(s)/PI(s). (See Section VI.2 Cooperative Agreement Terms and Conditions of Award).
All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:
Specific Aims (Not to exceed 1 page)
The specific aims should include management strategies and processes for efficient database operations to ensure effective clinical and brain banking functions. The PD(s)/PI(s) should articulate plans to conduct ongoing biostatistical and epidemiological analysis of the NNTC database to feed back information to the NNTC Clinical Sites to guide recruitment of new subjects into the cohort and to the research community at large to inform new hypothesis driven research.
Research Strategy Section (Not to exceed 12 pages)
Responsive applications will address each of the following components (Page numbers indicated below are provided only as guidelines):
1. DCC Overview - Page 1
2. DCC Management Capabilities - 1-4 pages
3. DCC Database Capabilities - 1-4 pages
4. DCC Scientific Expertise in Biostatistics and HIV Epidemiology - 1-2 pages
5. DCC Collaboration with the Steering Committee and NNTC Clinical Sites - 1-2 pages
The Overview should include background information regarding the overall DCC approach to working cooperatively to serve as a consortium wide and national resource to the scientific community engaged in NeuroAIDS research on HIV-associated central and peripheral nervous system disease by providing (1) management expertise to ensure effective clinical and brain banking operations; (2) database expertise including management of complex datasets derived from clinical assessments and research; and (3) scientific expertise in biostatistics and HIV epidemiology for analysis of the NNTC database to aid in post award statistical analysis of recruitment and retention goals for the NNTC cohort and to inform new hypothesis driven NeuroAIDS research.
The overview should also include plans to obtain and place all past, current, and future NNTC-related data from the NNTC Clinical Sites and NeuroAIDS investigators into the public domain to ensure the clinical and research data is available to qualified investigators engaged in analysis of the natural history of HIV-associated CNS and PNS diseases.
DCC Management Capabilities
Describe plans and activities to meet and fulfill the DCC-specific activities and goals of the DCC, which include:
3. DCC Database Capabilities
Provide a description for the DCC-specific capabilities that will allow the DCC to fulfill the primary objectives, which include:
4. DCC Scientific Expertise in Biostatistics and HIV Epidemiology
Describe how the DCC will:
5. DCC Collaboration with the Steering Committee and NNTC Clinical Sites
Address plans to:
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modifications:
It is expected that applications will include information on the following aspects of data coordination, standardization, and sharing:
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.
Part I. Overview Information contains information about Key Dates.
Information on the process of receipt and determining if
your application is considered “on-time” is described in detail in the PHS398
Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be received on or before the due dates in Part I. Overview Information. If an
application is received after that date, it will not be reviewed.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
NIMH will hold a pre-application teleconference on Tuesday, July 17, 2012 from 11:00am - 12:00pm (EST) to which all prospective applicants are invited. This is a technical assistance teleconference conducted by NIMH staff involved in managing this program to explain the goals and objectives of this initiative and answer questions from the attendees. Participating in the teleconference is neither required nor necessary for a successful application. It is intended to be an opportunity to clarify the objectives of the initiative. Potential applicants are encouraged to submit their questions or comments to firstname.lastname@example.org in advance of the call. Applicants interested in participating in the technical assistance call should send a message to the mailbox above to obtain a dial-in number. A set of Questions and Answers from the teleconference will be posted after the session on a site-to-be-determined and announced.
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
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.
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? Does the DCC fulfill other roles and duties that are critical to the success of the NNTC and to the work of external collaborators?
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? Are the expertise and commitment of the PD(s)/PI(s) and other key personnel adequate for the required scope and objectives of the NNTC DCC? Have the PD(s)/PI(s) demonstrated sufficient leadership in coordinating tissue banking activities across multiple institutions? Are there key personnel in place to conduct NNTC operations ranging from biomedical statistician to managing specimens, managing websites, and transferring all NNTC-related data from the clinical sites to the DCC? Has the PD(s)/PI(s) successfully served in the capacity of a data management and analysis center in the past? Do the PD(s)/PI(s) have experience with database platforms with the capacity for being federated? Have the PD(s)/PI(s) budgeted sufficient time to ensure appropriate oversight of the NNTC DCC?
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? Do the PD(s)/PI(s) propose innovative approaches and practices in data and inventory management systems, federated database capacity, and communications in support of the clinical and banking operations?
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? Have the PD(s)/PI(s) appropriately addressed the responsibility of developing the logistics and communications that are necessary to coordinate the NNTC activities? Has the application demonstrated how appropriate training will be conducted to ensure rapid, high quality data collection, submission to the database, and query of the database? Is the approach for working with the NNTC site PD(s)/PI(s) and Steering Committee members reasonable and synergistic?
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? Does the environment in which the work will be done contribute to the probability of the success of the NNTC DCC and PD(s)/PI(s) in addressing the multifaceted responsibilities?
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.
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.
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.
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
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the participating ICs, 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:
Appeals of initial peer review will not be accepted for applications submitted response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council and the National Advisory Neurological Disorders and Stroke Council. The following will be considered in making funding 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.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The Data Coordinating Center PD(s)/PI(s) will have the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
NIMH will appoint a Project Scientist (PS). Only the NIMH PS will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond normal program stewardship for grants or cooperative agreements. The NIMH PS will be responsible for:
Areas of Joint Responsibility include:
NNTC Steering Committee (SC): NIMH PS, the PD(s)/PI(s) of each grant award, or a designated representative in the case of a multiple PI award, and one Scientific Advisor (SA) from each NNTC clinical site identified as important to the consortium wide, broad scientific priorities will be members of the SC. The Data Coordinating Center PD(s)/PI(s) (DCC PI), or a delegate of the DCC PI, will serve as Chair of the SC (SC Chair). Voting members will consist of the clinical site PD(s)/PI(s), the DCC PI or the delegate SC Chair (if different from the DCC PI), and the NIMH PS. In the case of multiple-PD(s)/PI(s), consensus should be reached on their position to cast a single vote representative of their site. Awardee members of the NNTC will be required to accept and implement policies approved by the SC. The members of the SC will be responsible for:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
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)
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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