Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Behavioral and Social Sciences Research (OBSSR)
New
None
93.866; 93.350; 93.213; 93.865; 93.279; 93.121
This Funding Opportunity Announcement (FOA) invites applications to continue support for a Resource and Coordinating Center (RCC) for the NIH Science of Behavior Change (SOBC) program, which was supported for the past ten years by the NIH Common Fund. The goal of the RCC will be to lead, participate in, and support activities that will maximize the creativity, productivity, scientific rigor, and dissemination of SOBC products and approaches to meaningfully impact health behaviors.
Applicants should propose activities that include the following:
June 27, 2019
September 23, 2019
October 23, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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.
Background
In 2009, the trans-NIH Science of Behavior Change (SOBC) Common Fund Program was launched to capitalize on emerging basic science and the success of existing evidence-based behavior change interventions to accelerate investigation of common mechanisms of behavior change applicable across a broad range of health behaviors. Mechanisms of behavior change relevant to SOBC include processes at any level of measurement (e.g., behavioral, social, neurobiological) whose engagement by manipulation or intervention play a causal role in driving behavior change.
The primary goals for the SOBC program throughout its ten years of Common Fund support were:
SOBC seeks to break down silos between basic science, which provides mechanistic insights about malleable behavioral and biobehavioral processes and mechanisms, and clinical science, which seeks to modify those processes to affect behavioral and clinical endpoints. A central SOBC principle is that tests of mechanistic hypotheses are essential to understanding how and why an intervention works to produce initiation or maintenance of behavior over time. Much of existing behavior change research has proceeded without testing mechanistic hypotheses and in a disease- or condition-specific way, thus reducing the potential for impact beyond a narrow application area or for elucidating fundamental processes of change that may be relevant to other diseases, conditions, or health behaviors. To remedy this situation, the SOBC program promoted two main approaches in behavior change science: (1) use-oriented basic research and (2) the experimental medicine approach to behavior change intervention design.
Support for use-oriented basic research grows out of the need to bridge the gap between basic research and clinical practice. SOBC promotes studies of mechanisms of change in basic research and continued examination of mechanisms as intervention research progresses across the translational continuum. If, in the context of an experiment or subsequent trial, the researcher can learn something about how and why behavior change worked or did not, they have a chance of advancing basic understanding of the mechanisms of change as well as accelerating the translation of basic science to applied settings.
Support for the experimental medicine approach to behavior change intervention research aligns with other efforts in the field that require testing hypotheses about mechanisms of change in the context of interventions (e.g., NIAAA mechanisms of behavior change, NIMH Experimental Therapeutic Approach, NIH Stage Model for Behavioral Intervention Development, ORBIT model). Foundational to much social and behavioral science, this approach has become de-emphasized in the last few decades, contributing to the growing gap between basic science and specific clinical areas. Among many potential intervention targets (mechanisms/mediators), the SOBC program has, to date, focused on three broad behavioral domains that were identified as being especially relevant because they contain multiple putative behavior change targets with a variety of existing measures (assays): self-regulation, stress reactivity and stress resilience, and interpersonal and social processes.
In 2014, SOBC funded a network of projects designed to identify, develop, and validate measures of targets in these three target domains, as well as a Resource and Coordinating Center (RCC)(https://scienceofbehaviorchange.org/) to provide national leadership for the coordinated efforts of SOBC's projects and initiatives. The RCC serves as the central resource for the organization of meetings and other activities of the SOBC program, and it maintains a publicly available repository of assays developed by research network projects that can be used to measure the activity of specific targets within the three selected target domains. The RCC engages in dissemination activities related to the SOBC approach, such as publications, presentations at scientific meetings, and the development of training materials and workshops. The RCC conducts systematic reviews of the extant literature on behavior change and adherence to medical regimens to identify and classify other putative targets that may inform the development of future research programs, especially in the area of medical regimen adherence.
SOBC Resource and Coordinating Center Research Objectives
The overall goal of the continuation of the SOBC RCC is for it to serve as a resource for the scientific community by providing national leadership in mechanisms-focused behavior change research; by drawing on basic and applied expertise across diseases and behaviors to promote and facilitate adoption of use-oriented basic research and mechanisms-focused experimental medicine (and related) approaches to behavior change research; by providing tools, outreach and dissemination, and technical assistance; by working to improve controlled vocabularies and measures harmonization; and by conducting or supporting systematic reviews.
Applications should propose activities that address the following six objectives:
The RCC should have expertise to support the above activities, as well as expertise in the following:
It is expected that the RCC will engage nationally and internationally with other organizations and projects working in similar areas and help lead the integration of emerging basic and clinical science into mechanisms-focused behavior change research. This could include other NIH-funded projects, as well as other federal- or privately supported efforts and entities within the academic community. Additional required activities, already supported by the current RCC, include the following:
Applications are encouraged to be creative and flexible in their approach to achieving the six objectives for the RCC outlined above.
Expansion of the SOBC Measures Repository
Applicants should propose plans to maintain, update, and curate the current SOBC Measures Repository of putative targets of behavior change and experimental manipulations, as well as other types of measures of behavior change outcomes; maintain and facilitate connection of measures to related Open Science Framework webpages; and promote and implement open science practices to promote rigor, reproducibility, and transparency. Proposed plans should include attention to capacity for ensuring a user-friendly and intuitive interface to facilitate ease of access by the research community and for expanding and improving the SOBC Measures Repository with input from the behavior change research community. Applications should include plans for making the repository self-sustaining at the end of the 5 years of NIH support. Plans should support knowledge representation and ontology development, including the development of clearly defined vocabularies and taxonomies, elucidation of relationships across constructs and between constructs and measures, and integration of knowledge into existing interoperable and sharable behavioral measures or ontology frameworks.
Support for Integration of Basic and Applied Research on Mechanisms of Change
To facilitate continued advances in use-oriented basic science and identification and refinement of potential new behavior change targets, the applicant should propose plans to support meetings, pilot projects, ontology refinement and development, and systematic reviews of putative mechanisms of change in the domains of self-regulation, stress reactivity and stress resilience, and interpersonal and social processes; refine these domains through development of ontologies; identify new, emerging target domains or subdomains that merit development; and foster activities to promote their inclusion in SOBC activities.
Outreach, Dissemination, and Technical Assistance around Best Practices
Applicants should propose plans to provide national leadership and conduct broad outreach to disseminate use-oriented basic research, the experimental medicine approach, and other mechanisms-focused approaches to behavior change science, as well as assisting researchers in accessing and implementing measures and tools. The RCC will also provide technical assistance to researchers studying mechanisms of change at all levels, stages, and phases and develop best practices for the mechanisms-focused approach to behavior change research. Applicants should include proposed plans to implement a multi-faceted outreach and dissemination plan, including, for example, symposia and pre-conference workshops at scientific conferences, publications, scientific meetings, expansion/improvement of the public-facing website, and engagement with national and international behavior change organizations to promote mechanisms-focused behavior change science.
Applicants should also propose plans to:
Potential audiences for outreach and technical assistance include early career investigators, as well as more experienced investigators new to the approach. The approach and tools promoted by the SOBC program span basic, clinical, and intervention development research, and the outreach, dissemination, and technical assistance plans should reflect efforts to reach transdisciplinary and trans-disease research communities.
Collaboration and Integration of the Mechanistic Approach of SOBC with Allied Initiatives
The RCC will support collaboration and integration of the mechanistic approach of SOBC with other related and important basic and translational efforts in the behavior change field. These include, but are not limited to, the following:
The RCC will engage in a systematic effort to find, document, and further explicate the relationship between the mechanistic approach of SOBC and both previous and current efforts in the behavior change field.
Systematic Reviews and Meta-Analyses
The RCC will support and/or conduct systematic reviews and meta-analyses of behavior change and measurement research to support the development of clearly defined vocabularies and taxonomies; to elucidate relationships across constructs and between constructs and measures; and to generate testable hypotheses concerning potential putative intervention targets, differential response of individuals to treatment, and estimates of intervention efficacy and effectiveness. Applicants should address their capacity to conduct systematic reviews and assist members of the research community interested in conducting systematic reviews for this purpose.
Engagement with National and International Behavior Change Organizations
The RCC will partner with national and international scientific societies, networks, and organizations engaged in basic and applied behavior change research to promote further advances in mechanisms-focused behavior change science and facilitate rapid integration of new approaches in the field. This includes continued efforts to break down silos between organizations supporting basic research, where mechanistic targets are identified, and those supporting clinical research, where interventions to manipulate those targets to change behavior are developed and tested.
The application funded under this FOA will be a cooperative agreement (see Section VI.2 Cooperative Agreement Terms and Conditions of Award). Close interaction with the NIH will be required to accomplish the goals of this program.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
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NIA and partner components intend to commit an estimated total of $1,250,000 to fund approximately one award.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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
For-Profit Organizations
Governments
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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:
Lisbeth Nielsen, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Fax: 301-402-0051
Email: [email protected]
The RCC Director must devote at least 20 percent of his/her effort (2.4 person-months) to this program. In cases for which multiple PDs/PIs serve as co-Directors of the RCC, the Directors must devote a combined effort of at least 2.4 person-months.
All instructions in the SF424 (R&R) Application Guide must be followed.
Research Strategy
Describe plans for accomplishing the following six objectives of the RCC:
The RCC is expected to have significant experience and knowledge in the following areas:
The application should highlight the depth of relevant experience in the above areas and how it will be provided by the proposed team and structure.
It is also expected that the RCC will engage nationally and internationally with other organizations and projects working in similar areas and stay abreast of emerging basic and clinical science that could be integrated into the other projects supported by the SOBC program. This could include other NIH-funded projects (e.g., PCAR, the NIH Health Systems Collaboratory, and CTSAs) as well as other federal- or privately-supported efforts and entities within the academic community.
Applicants should describe their plans for providing administrative support to meet the objectives of the RCC, including, but not limited to, the following:
Resource and Coordinating Center Transition Plan
The application should describe a plan for the transition of the materials produced to address each specific objective of the SOBC program to a potential successor at the end of the 5-year project period, including transition of the repository to a self-sustaining, publicly available source. This should include ongoing documentation of required software, hardware, and licenses, as well as ongoing maintenance of standard operating procedures, best practices, and other documentation for management of the RCC. Inclusion of approaches and activities that will facilitate the transition of the activities and infrastructure of the RCC, including content of the public website, at the end of the award period is required.
Timeline for Achieving Objectives
As noted above, applications are encouraged to be creative and flexible in their approach to achieving the six objectives for the RCC outlined above but should include a timeline that describes when and how the PD(s)/PI(s) will complete the activities proposed to achieve the RCC objectives. Applicants should also keep in mind that actual activities and completion dates may change following consultation with NIH staff.
The following modifications also apply:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant, and/or nonresponsive will not be reviewed.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
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? Is the prior research that serves as the key support for the proposed project rigorous? 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?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Will the proposed investigative team be able to facilitate cooperation between basic and clinical scientists? Does the investigative team have the relevant experience and expertise in project management required to continue support for the RCC? Does the investigative team have relevant expertise in the conduct of systematic reviews, the development of technical guidelines and best practices, and the dissemination of research results and materials? Does the investigative team have sufficient expertise in basic behavioral and biobehavioral research, behavioral intervention development, study design, and statistics relevant to the goals of the SOBC program?
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?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Will the plan described for the management and coordination of the SOBC network and for the development, adaptation, and dissemination of project-related materials enhance their usability by the larger research community? Does the proposed center have a detailed plan for meeting the objectives in a timely fashion? The six objectives are:
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
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?
For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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.
Not Applicable
For Renewals, the committee will consider the progress made in the last funding period.
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Not A?p?p?l?icable
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).
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) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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 Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
Information regarding the disposition of applications is available 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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
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 Part 75, 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.
Definitions
SOBC Resource and Coordinating Center (RCC): The awardee of RFA-AG-20-024
NIH SOBC Implementation Team: The trans-NIH committee of NIH staff members that remain involved in SOBC efforts, including representatives from Institutes, Centers, and Offices contributing funds to this announcement.
The RCC PD(s)/PI(s) will have the primary responsibility for:
Defining the details for the U24 project within the guidelines of this FOA and for performing the scientific activities. The PD(s)/PI(s) will agree to accept close coordination, cooperation, and participation of NIH program staff in those aspects of scientific and technical management of the project described under "NIH Program Staff Responsibilities." For institutions/organizations proposing multiple PD/PI projects, all PD(s)/PI(s) will share the rights and responsibilities of an individual award as described by the NIH Multiple Program Director/Principal Investigator Policy.
The RCC PD(s)/PI(s) will:
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The NIH Project Scientist(s) assigned to the RCC will have substantial scientific and programmatic involvement that is above and beyond the normal stewardship role in awards through technical assistance, advice, and coordination, as described below. However, the role of NIH Project Scientist(s) will be to facilitate, not direct, the activities. It is anticipated that decisions in all activities will be reached by consensus and the Project Scientist(s) will be given the opportunity to offer input to this process.The Project Scientist(s) is/are not required to be from the administering Institute, Center, or Office.
The NIH Project Scientists will:
Additionally, a Program Official from the administering IC will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. A single individual may not serve the roles of both Program Official and Project Scientist.
Areas of Joint Responsibility include:
The RCC and relevant NIH staff will, throughout the award:
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 arbitration. An Arbitration Panel will be convened, composed of three members: a designee of the RCC, one NIH designee, and a third designee from the extramural research community with a history of NIH funding and with expertise in the relevant area who is chosen by the other two. The first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise able to be appealed in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
A final RPPR, 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.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Lisbeth Nielsen, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]
Maribeth Champoux
Center for Scientific Review (CSR)
Telephone: 301-594-3163
Email: [email protected]
Amy Gipson
National Institute on Aging (NIA)
Telephone: 301-827-8198
Email: [email protected]
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.