Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

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.

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 NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

 The flood in the quantity and complexity of data in Behavioral and Social Science Research (BSSR) presents considerable challenges in our ability to structure, mine, standardize, and integrate information within and across health domains. Currently, there are few interoperable knowledge structures in health-related BSSR, and BSSR terminology has not been optimally integrated into standard controlled vocabularies (e.g., Unified Medical Language System knowledge sources). Within and across sub-fields of BSSR, there are unique definitional challenges to overcome, including the proliferation of separate theories, constructs, and associated measures.

Rigorous and reproducible BSSR requires clear and consistent definitions of social and behavioral phenotypes, outcomes, and intervention components to allow effective communication between scientists and across scientific disciplines. It also requires a better understanding of the relationships between concepts. Further, identifying targets for behavioral interventions requires the ability to measure and describe a wide range of social and behavioral factors and outcomes across disciplines and diseases. Therefore, BSSR knowledge structures that include clear definitions and delineate a wide range of inter-relationships must be developed and enhanced. Finally, to be truly impactful, ontologies must be interoperable, usable, and widely adopted. This requires strong use cases to demonstrate an enhanced capacity to solve widespread and important problems.

Definitions

Ontology: For the purposes of this NOFO, an 'ontology' exists within an information sciences framework (rather than a philosophical framework). In this context, an ontology is defined as a formal, explicit, machine-readable specification of the shared knowledge within a field of BSSR, including relevant concepts, associated measures and their inter-relationships. Here, ontology development should be understood to encompass the processes of establishing and expanding agreed-upon controlled vocabularies and taxonomies, the computational infrastructure necessary for access and utilization, and the potential for interoperability with other relevant semantic knowledge resources.

Use Case: A specific situation in which an ontology or related vocabularies and taxonomies could potentially be used. For this funding opportunity, ontologies must fall within the general use case of health-related BSSR, including relevant concepts, associated measures, and their inter-relationships.

Construct: (Psychological) idea or theory including various conceptual and testable elements.

Purpose

This Notice of Funding Opportunity (NOFO) invites applications from multi-disciplinary teams to establish a Dissemination and Coordination Center (DCC) for the Behavioral and Social Science Ontology Development U01 Research Network Projects (FOA #). Teams must include subject matter experts in one or more fields of behavioral or social science, ontology-related informatics and computational approaches, and Team Science or the Science of Science. Tools or resources must also account for socio-behavioral cultural context in vocabulary/ontology development.

The primary responsibilities of the DCC are to: 1) Coordinate and provide logistical support to facilitate cross-project learning, discussions, and collaboration; 2) Provide ontology-related technical, computational, and informatics expertise that is grounded in BSSR and biomedical research; 3) Facilitate dissemination of resources and training to support ontology expansion, development, and use; and 4) Provide active outreach to relevant stakeholders to increase understanding and uptake of BSSR ontology-related tools and resources.

The overall goals of the U01 Research Network are to address health-related behavioral and social science problems not easily solved without improvement in semantic knowledge structures and collaborative research projects focused on ontology expansion or development, dissemination, and use. For example, a U01 might focus on ontological tools and resources to facilitate more rapid and efficient identification, merging and reuse of findings within and between scientific domains. The DCC will serve as a hub with primary responsibilities of coordinating and supporting activities across the U01 Network. The DCC should encourage cross-U01 communication, as well as technical interoperability across the U01 projects. However, neither the DCC nor the individual U01s are expected to be working toward a single or unified "truth".

Structure

The DCC must serve the following functions: Administrative, Technical, and Dissemination. It must also include a plan for enhancing diverse perspectives.

Tasks of the DCC are varied, and consequently it is expected that the team will include appropriate experience and expertise in such areas as: one or more BSSR sub-fields (see https://obssr.od.nih.gov/about/bssr-definition), biomedical informatics, knowledge representation languages and semantic web standards (such as OWL), statistics, computational modeling, team science and/or the science of science, scientific and health communications. Because ontologies should advance relevant knowledge for all populations, including those currently underrepresented in behavioral and social science research, teams should also include members with expertise in addressing socio-behavioral cultural context in vocabulary/ontology development. Because approaches and specific use cases of individual U01s are likely to vary, the DCC should be prepared to bring on additional ad hoc or full-time staff or consultants after the network is established. 

Administrative

The DCC will support a variety of logistical, and administrative functions and activities for the U01 Research Network, including but not limited to the following:

• Establish an executive committee including all DCC and U01 PIs, as well as NIH program staff.
• Coordinate communications across the U01 Network.
• Support the implementation of policies and procedures for cross-Network cooperation and resource sharing.
• Logistically support monthly virtual meetings of the executive committee, as well as 1 annual in-person scientific meeting for all DCC and all U01 PIs. The DCC will provide travel and financial support for any speakers invited from outside the U01 Network.
• Create and convene external advisory group(s) (ad hoc or standing, subject to NIH approval) such as experts in BSSR, end user groups, or other relevant experts.
• Organize and coordinate working groups to support common activities and enhance scientific collaborations across the U01 Network.
• Conduct and update landscape reviews of BSSR vocabularies and taxonomies.
• Establish, curate, and maintain a user-friendly website hub for the storage and dissemination of U01 Network information and relevant ontological resources, including code and links to both existing BSSR and biomedical knowledge structures, open science websites, and developments from the U01 Network.
• Provide timely responses to inquiries from interested researchers; facilitate access to and use of Network and DCC products by the larger BSSR research community.
• Ensure that copyrights and open source licenses allow for broad sharing of the tools, as well as the resulting data.
• Explore ways to ensure that Network products and the website hub transition to self-sustaining, internally and externally interoperable, publicly available resources.
• Provide administrative support for the Network Steering Committee, working groups, and collaborative activities as described below.
• Track, summarize, and report on Network and DCC activities in both internal and public venues. 

Technical

The DCC will provide core expertise in informatics, programming, quality control, and team science, as well as shared tools to facilitate ontology creation and maintenance. Activities will include, but not be limited to the following:

• Incorporate and apply effective team science principles for managing the research network as well as facilitating engagement with a variety of relevant audiences and end users.
• Ensure consistent application of state-of-the-art informatics and computational approaches across the Network.
• Implement common Application Programming Interfaces (APIs) to support data exchange across ontology tools and platforms.
• Develop ontology visualization tools and provide technical assistance with data visualization.
• Provide environments for interactive modeling and simulation.
• Facilitate interoperability of ontology tools and platforms both across the Network and with existing and developing ontology-related research resources outside the Network.
• Facilitate data integration, storage, management, and sharing across the Network.
• Promote rigor and reproducibility and ensure that DCC and Network products meet the FAIR principles: findable, accessible, interoperable, and reusable.
• Facilitate the implementation of data standards, exchange formats, quality assurance methods, and privacy management tools across the Network.
• Ensure expertise in terminology for BSS domains at both the individual level and at levels outside the individual, such as the group, social network, and other social determinants of health.
• Incorporate diverse perspectives and account for socio-behavioral cultural context in vocabulary/ontology development. This includes expertise in testing for bias and ensure the relevance of the ontology and related resources to diverse communities through the inclusion of subject matter experts with diverse perspectives related to terminology, definitions, measurement and meaning that may differ across cultural and demographic populations including sexual and gender minorities, and racial and ethnic groups.
• Develop evaluation metrics for success of the DCC and the Network as a whole, such as achieving milestones, documented use of network tools and resources, and effectiveness of outreach and engagement with relevant groups outside the funded network.
• Develop and disseminate technical assistance products for members of the larger BSSR community interested in the fundamentals of ontology creation and use. 

Dissemination

• The DCC will conduct broad outreach activities to disseminate information to the wider BSSR community, especially transdisciplinary and trans-disease research communities.
• As a resource, the DCC must foster communication and collaborative activities and interact with other connected national and/or international ontology resources, such as, but not limited to, the Unified Medical Language System (UMLS), NCI Vocabulary Enterprise Services, MeSH and SNOMED International.
• Potential audiences for outreach include both early career investigators and experienced investigators new to ontology development and use. Activities will include, but not be limited to the following:
• Develop a strategy for engagement with national and international scientific societies, networks, and organizations to promote further advances in BSSR-focused ontology development, to break down silos across BSSR sub-fields, and to facilitate rapid integration of new approaches in the field.
• Identify, further develop, and promulgate best practices or guidelines for ontology development and use in BSSR.
• Distribute information, web resources, ontology tools and guides through scientific publications, talks and symposia at scientific conferences, webinars etc.
• Support U01 posting of ontology tools on sites accessible to all, such as, but not limited to, the Open Biological and Biomedical Ontologies Foundry or the Bioportal.
• Conduct community outreach and engagement to raise awareness of availability of BSSR ontology tools and resources.
• Ensure relevance of ontologies and related resources to diverse communities.
• Ensure access to training resources and activities by scientists from low resourced backgrounds and institutions. 
• Develop and provide educational and training activities such as intensive summer institutes, workshops, and advanced seminars.

Plan for Enhancing Diverse Perspectives (PEDP)

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp. 

Non-Responsiveness Criteria

Potential applicants are strongly encouraged to consult with the Scientific/Research contact listed in Section VII for the appropriateness of submission to this NOFO.

Applications that will be considered non-responsive and withdrawn prior to review are those that:

• Lack a focus on and expertise in BSSR.
• Lack a focus on and expertise in ontology development.
• Lack expertise in Team Science and/or the Science of Science.
• Do not include a comprehensive Resource Sharing Plan for disseminating network resources, products, and opportunities with the field at large.
• Do not adhere to FAIR principles and the NIH Strategic Plan for Data Science.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

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.

• System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

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 NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Michael Spittel, Ph.D.
Telephone: 301-825-3990
Email: [email protected]

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

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

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

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

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

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

R&R Budget

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

PEDP implementation costs:

• Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

R&R Subaward Budget

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

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

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

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R& R) Application Guide. 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

•  All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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.

Delayed Onset Study

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.

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

Foreign Institutions

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

3. Unique Entity Identifier and System for Award Management (SAM)

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.

5. Intergovernmental Review (E.O. 12372)

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 form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applications that will be considered non-responsive and withdrawn prior to review are those that:

• Lack a focus on and expertise in BSSR.
• Lack a focus on and expertise in ontology development.
• Lack expertise in Team Science and/or the Science of Science.
• Do not include a comprehensive Resource Sharing Plan for disseminating network resources, products, and opportunities with the field at large.
• Do not adhere to FAIR principles and the NIH Strategic Plan for Data Science.

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

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed Center address the needs of the research network that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research network?

Significance

Specific to this NOFO: 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? W To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing collaborative dat analytic research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed? 

Specific to this NOFO: 

• How appropriate is the composition of subject matter experts, in one or more fields of behavioral or social science, ontology-related informatics and computational approaches, and Team Science or the Science of Science, for the Center? 
• To what extent does the Center team have expertise to address the socio-behavioral cultural context in vocabulary/ontology development?

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

Does the proposed Center have appropriate subject matter experts in one or more fields of behavioral or social science, ontology-related informatics and computational approaches, and Team Science or the Science of Science? 

Does the Center team have enough expertise to address the socio-behavioral cultural context in vocabulary/ontology development?

Innovation

Does the application propose novel management strategies in coordinating the research network the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of management strategies proposed?

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Approach

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? 

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?

Specific to this NOFO:

• Does the approach to ontology development and deployment include diverse perspectives related to terminology, definitions, measurement and meaning that occur across cultural and demographic populations including sexual and gender minorities, and racial and ethnic groups? 
• Will the approach to developing and deploying the behavioral and social science ontological resources allow for the ontology to “learn” (i.e., evolve, adapt, be refined) as new perspectives are tested and new discoveries are made? 
• Is the plan for iterative improvement and active and ongoing engagement with the intended end-users throughout the development and deployment of the resources or tools well justified and feasible? 
• Is the plan for dissemination and maintenance of the ontological resources and tools well justified and feasible? 
• Do the proposed BSSR knowledge structures build on and/or interface with existing knowledge structures and data repositories? Will the proposed approach facilitate meaningful and productive cross-project learning, discussions, and collaboration? 
• Will the proposed plan appropriately facilitate dissemination of resources and training to support ontology expansion, development, and use? 
• Will the plan for outreach to relevant end users effectively disseminate information to the wider BSSR community, especially transdisciplinary and trans-disease research communities? 
• Does the outreach plan include specifics for dissemination to low resourced researchers and institutions? 
• Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?  

Environment

Will the institutional environment in which the DCC will operate contribute to the probability of success in facilitating the research program/projects/network/consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the DCC benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling? 

To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Will the proposed resources or tools meet the following parameters?

• Will they be interoperable with or, where applicable, build upon existing health-related semantic knowledge structures within and outside of BSSR?

Promote rigor and reproducibility and ensure that any products development meet the FHIR and/or FAIR principles

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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.

Vertebrate Animals

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 Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable 

Revisions

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.

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 Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For consortia involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients 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 NOFO 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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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. 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 NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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 judgment 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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

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 2 CFR Part 200, 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 recipients 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 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
 

The PD(s)/PI(s) will have the primary responsibility for:

• Agreeing to accept close coordination, cooperation, and management of the project with NIH, including establishment of Steering Committee and Stakeholder Board.
• Providing salary support to the Chair of the Steering Committee. Budget for the Steering Committee Chair should also include reimbursement for travel expenses to all in-person Steering Committee Meetings.
• Participating in cooperative activities, including annual project update meetings.
• Planning and hosting the face-to-face or virtual annual meetings of the cooperative PIs.
• Facilitating comparability (e.g., common data elements) across the data from the network research projects, when feasible and appropriate to scientific research questions.
• Providing integrative, organizational, and logistical support for the entire program, including tracking, scheduling, facilitating work group meetings and conference calls, and preparing concise minutes or summaries of meetings for distribution.
• Coordinating the eventual release to the scientific, public health and other relevant methods, tools, data, results, and other resources.
• Providing high-quality documentation as needed, particularly of protocols or approaches that have broad applicability across the program that will be sufficient for outside users to understand and apply to their research projects with minimal assistance.
• Integrating and managing administrative or other data sets as needed. Facilitating data quality monitoring through rigorous data management and identification of data biases and errors as they arise.
• Supporting the conduct of data analyses and defining approaches, innovations, and methods related to data integration methods, metrics, and any harmonized network dataset.
• Providing expertise and leadership in addressing issues of broad scientific applicability, such as informed consent, data sharing standards, advanced analytics and methodological consultation, and dissemination of findings to NIH and research project grantees in the network related to methods, strategies and approaches within and between the projects.
• Obtaining prior written approval of the NIH Grants Management Specialist in consultation with the NIH Program Officer for a change in any of the key personnel identified in the Notice of Award.
• Award recipients should aim to make resulting publications, code, and to the extent possible, the underlying primary data immediately and broadly available to the public. See Section 8.2.3.1 of the NIH GPS.
• Award recipients 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:

NIH Project Scientist(s). Designated NIH Program Official(s) acting as Project Scientist(s) will have the following responsibilities:

• Serve as a resource for specific information on NIH's programmatic intentions and priorities, and help to foster collaborations between researchers and other relevant partners within and across other Federal agencies to increase the value of research to these participants. Similarly, the project scientist will facilitate communication involving the Coordinating Center, the network grantees and others in the network as needed.
• Play an active role in developing innovative methodological strategies to support data collection, management, and analysis.
• Identify methodology and analytic questions relevant to the network objectives based on overall network and cross-project aims. They may cooperate with recipients in development, design, and coordination of research plans and study reports emerging from the methodologies employed and data produced. In instances where significant involvement in the design of studies and/or analysis of results has occurred, the NIH Project Scientist(s) may cooperate with recipients as coauthor in preparing publications of data resulting from the research. In this regard, they will be subject to the publication/authorship policies governing all participants. In addition, publications involving NIH staff require internal clearances.

The NIH Program Official, who will not participate in the research or the preparation of publications, will be responsible for the oversight of the research project and award. The Program Official carries primary responsibility for:

(1) periodic review and monitoring and approval of the progress of the research plans in relation to their stated objectives, including consistent communication with the PI and the Coordinating Center staff as well as requests for additional reports or documentation; and,

(2) making recommendations regarding continuance of the program. The NIH Program Official will be responsible for monitoring the conduct of the project and overseeing the Coordinating Center.

The Program Official will receive all required progress reports to determine that satisfactory progress is being made and will work collaboratively with the NIH Grants Management Specialist to assure high quality business management of the program, including the most effective use of Federal financial assistance provided through this cooperative agreement.

Additional NIH staff may participate in all cooperative-related meetings and work groups, as appropriate. Participation by staff from other federal agencies may also be appropriate and advantageous to facilitate the activities of the program.

The NIH reserves the option to recommend withholding or reduction of support from activities that fail to achieve their goal or comply with the Terms and Conditions.

• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

The PD(s)/PI(s) provide, in concert with the NIH staff, support necessary to ensure that sites and investigators, and NIH and other research partners fully comply with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events, if relevant.

Recipients and NIH will jointly develop appropriate procedures for data collection, processing, storage and analysis to ensure the confidentiality of data, if needed.

All recipients and NIH will cooperate to ensure the timely and broad dissemination of lessons learned, to inform researchers and other terminology or practice systems as appropriate.

The Steering Committee is the primary governing body of the network. Recipients must participate in the Steering Committee. The Steering Committee reviews and approves the agenda for collaborative research activities, develops and monitors policies and procedures guiding the research activities, and oversees communications. Recipients agree to abide by the procedures and policies established by the Steering Committee.

The Steering Committee, with the support of the Coordinating Center, will facilitate these and other joint activities including, but not limited to: coordination of research protocols and methodology when appropriate, human subjects and other regulatory protocols when appropriate, dissemination planning, and dissemination products resulting from collaborative projects across the network.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between 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 recipient. This special dispute resolution procedure does not alter the recipient'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. 

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

Ensure that copyrights and open source licenses allow for broad sharing of the tools, as well as the resulting data.

Facilitate data integration, storage, management, and sharing across the Network.

Promote rigor and reproducibility and ensure that DCC and Network products meet the FAIR principles: findable, accessible, interoperable, and reusable.

Facilitate the implementation of data standards, exchange formats, quality assurance methods, and privacy management tools across the Network.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Recipients  will provide updates at least annually on implementation of the PEDP.

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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 2 CFR Part 200 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200– Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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: https://www.era.nih.gov/need-help (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: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Michael Spittel, Ph.D.
Office of Behavioral and Social Science Research (OBSSR)
Telephone: 301-825-3990
Email: [email protected]

Steve Tsang, PhD
Office of Data Science Strategy (ODSS)
Phone: 240-234-0702
Email: [email protected]

Janine Simmons, M.D., Ph.D.
NATIONAL INSTITUTE ON AGING (NIA) 
Division of Behavioral and Social Research (DBSR)
Phone: 301-443-6652
E-mail: [email protected]

Center for Scientific Review (CSR)

Email: [email protected]  

OBSSR does not accept assignment of applications or manage awards that are funded. Please contact an IC-based grants management professional for financial-related inquiries.

Ryan Blakeney
NATIONAL INSTITUTE ON AGING (NIA)
Phone: 301-451-9802
E-mail: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 Part 75 and 2 CFR Part 200.