Part 1. Overview Information

Key Dates

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

The Artificial Intelligence and Technology Collaboratories for Aging Research Coordinating Center (AITCC) is intended to support the Artificial Intelligence and Technology Collaboratories for Aging Research (AITC) program by facilitating and coordinating trans-AITC activities and generally serving as a hub for the AITC program. The AITCC will work closely with the NIA Program Officer and, in coordination with all AITC sites, will be responsive to requests generated by key AITC site personnel, NIA, NIH, the scientific community, and the general public.

The AITCC will provide logistical support to the individual AITCs by performing the following necessary functions:

• Organize a yearly AITC progress meeting, where scientific and commercial advances are shared. In coordination with AITC PDs/PIsand NIA program staff, the AITCC will create the agenda and chair the meeting. The AITCC will set aside a portion of its funds to support the AITC progress meeting.
• Develop infrastructure for accepting and reviewing pilot applications from national competitions conducted by each AITC.
• Maintain a centralized database through which the AITCs can track pilot/preliminary study progress, including recruitment and retention.
• Foster communication and cooperative arrangements between AITCs and other NIA research centers (i.e., Edward R. Roybal Centers for Translational Research in the Behavioral and Social Sciences of Aging, Centers on the Demography and Economics of Aging, Resource Centers for Minority Aging Research (RCMARs), Alzheimer's Disease Research Centers (ADRCs), Nathan Shock Centers, Claude D. Pepper Centers).
• Arrange and host regular conference calls with AITC PDs/PIs.
• Support centralized infrastructure, resources, and sharing of best practices in the following areas: (1) setting ethical research standards involving older Americans and cognitively impaired older Americans who will be exposed to technology and artificial intelligence methods; (2) providing assistance through the preparation of background instructions and submission templates to ensure compliance with laws and FDA regulations and facilitate approval of technology and products associated with artificial intelligence; (3) preparing background instructions and submission templates to assist AITC pilot investigators with reimbursement of technology through insurers; (4) assisting pilot recipients with scaling, dissemination, and commercialization of artificial intelligence and technology products derived from AITCs or other NIA-funded grants (Program Officer approval needed); and (5) disseminating AITC scientific and product advances to the broader lay audience, scientific community, and commercial market.

The AITCC will create mechanisms for maintaining active involvement of all sites in all aspects of the program. Example mechanisms include:

• Link and foster joint activities between various AITC sites, based upon available funds. This may include supporting pilot funding, workshops, or other collaborative efforts serving the broader AITC program.
• Answer queries from the scientific, commercial, and lay communities about the program.
• Link other NIA-supported research activities and Centers to the unique expertise (artificial intelligence and technology) of the AITC program.
• Actively demonstrate to a broad and diverse audience the AITC program’s impact on the health of mid-life and older Americans.
• Coordinate and facilitate communication and activity among the AITCs.

The AITCC will be proactive in establishing a mechanism for informing and making visible the scientific and commercial advances of AITC scientists to the research community, policymakers, and other relevant stakeholders. The AITCC will:

• Highlight AITC research and commercial advances in research areas relevant to NIA, including those identified by the Program Officer, the National Advisory Council on Aging, the Alzheimer’s disease and related dementias (AD/ADRD) Research Implementation Milestones, etc.
• Keep all AITCs apprised of each participating Collaboratory’s scientific activities in order to avoid overlap. Efforts in this regard should involve other NIA-funded Centers and major research projects, as well as the broader research community, at relevant national and international scientific meetings.
• Highlight AITC research and commercial portfolios in aging.
• Coordinate network events for pilot awardees in conjunction with AITCs.
• Maintain an active AITC program website with links to each AITC site and resources generated by NIA and each AITC. The website will serve as the source of information for scientific and lay audiences and will be accessible and readily identifiable.

Additional activities or functions may be proposed to promote collaboration among AITC sites, encourage interactions between the AITC program and other NIA- and NIH-supported resources (e.g., NIA Office of Small Business Research), and enhance the value and visibility of the AITC program as a whole.

Goals and Evaluation of Outcomes

Section II. Award Information

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)

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

• 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) are not eligible to apply.

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• 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.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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.

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

3. Additional Information on Eligibility

Number of Applications

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 NOT-OD-11-101)

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

2. Content and Form of Application Submission

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:

Partha Bhattacharyya, PhD
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]

The PD/PI must be the lead Director of the AITCC and is the person responsible for the overall management of the AITCC; if there are multiple PDs/PIs of the AITCC, they will serve as co-Directors. The relationship between the AITCC and the AITC sites should be one of equal and substantial partners in all joint activities.

The AITCC team is expected to have significant experience and knowledge in multiple scientific domains (technology, management and coordination, law, ethics, geriatrics, etc.).

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

Research Strategy: Describe plans for accomplishing the following four objectives of the AITCC:

1) Working in collaboration with approximately 2-3 AITCs in order to facilitate and coordinate trans-AITC activities, including: providing logistical support to the AITCs and the NIA Program Officer to arrange a yearly AITC progress meeting; developing and maintaining a database for collecting information from AITC research activities (e.g., reports from stakeholder engagement, research advances from pilot projects, and other activities); fostering communication and collaborative arrangements between AITC sites and other NIA-funded Centers; and arranging for and hosting regular PD/PI conference calls, and arranging for similar calls and support for the various AITC Cores, as needed.

2) Creating mechanisms for maintaining active involvement of all AITC sites in all aspects of the program.

3) Establishing a mechanism for making visible the scientific and commercial advances of AITC projects (pilots and other activities) to the industry, research community, policymakers, and other relevant stakeholders.

4) Maintaining an active AITC website with links to NIA and each AITC site.

Applicants should describe how the AITCC will function as the AITC program's point-of-contact for linking the AITCs with one another, other NIA-funded Centers, and the broader scientific community around priority areas highlighted in RFA-AG-21-009Artificial Intelligence and Technology Collaboratories (P30).

Applicants should describe how they will support AITC program research and advances in both AD/ADRD and non-AD/ADRD priority areas. The application should highlight how the relevant expertise of the team will support activities highlighted in RFA-AG-21-009Artificial Intelligence and Technology Collaboratories (P30), such as:

1) Establish infrastructure for accepting and reviewing pilot applications from national competitions conducted by each AITC;

2) Set ethical research standards involving older Americans and cognitively impaired older Americans who will be exposed to technology and artificial intelligence methods;

3) Provide assistance through the preparation of background instructions and submission templates to ensure compliance with laws and FDA regulations and facilitate approval of technology and products associated with artificial intelligence;

4) Prepare background instructions and submission templates to assist AITC pilot investigators with reimbursement of technology through insurers;

5) Assist pilot recipients with scaling, dissemination, and commercialization of artificial intelligence and technology products derived from AITCs or other NIA-funded grants (Program Officer approval needed); and

6) Disseminate AITC scientific and product advances to the broader lay audience, scientific community, and commercial market.

Applicants should describe their organizational plan and management structure for providing administrative support for the activities of the AITC program.

Evaluation Plan: Applications must include a clear description of their objectives and a plan for evaluating the AITCC, including all activities supported by the AITCC, in line with the broader AITC program goals. The application must specify baseline metrics of AITCC activities (e.g., numbers and characteristics of workshop participants, scientific dissemination, databases, networking opportunities with other funders, users of resources, etc.), as well as clearly defined milestones with metrics to gauge the short- or long-term success of the AITCC in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements. The AITCC evaluation plan should focus on the activities of the AITCC, not the entire AITC program. NIH will evaluate the entire AITC program and AITCC in five years, including the role of the AITCC in fostering the success of the program. Based on the review, NIA will evaluate the effectiveness of the program, and determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program after sunset and review period.

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• The AITCC is required to share all resources generated through core activities (e.g., background materials, such as guidelines associated with facilitating FDA approval of a a technology device for diagnosis).
• The AITCC is required to facilitate the sharing of resources produced by the AITC program.

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.

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

4. Submission Dates and Times

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.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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 non-responsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIA Referral Office by email at[email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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.

Significance

Does the proposed Center address the needs of the research program 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 program?

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 artificial intelligence research? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical 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?

Does the investigative team have the relevant experience and expertise in project management and coordination required for this AITCC? Will the investigative team proposed by the AITCC be able to facilitate cooperation between AITC sites across a wide range of technology and artificial intelligence fields? Is there strong evidence of the availability of sufficient scientific expertise and of the ability to work with scientists across multiple fields as point-of-contact for a broad scientific community?

Do the investigators have the adequate expertise in ethics and legal approval processes necessary to obtain approval from the FDA or insurers?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research program 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 organizational concepts, management strategies or instrumentation proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research program the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the program, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the program? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects

Are the proposed procedures for communication and cooperation with AITC sites adequate? Are there appropriate plans to coordinate interaction between the AITC program and other NIA-funded Center programs?

How extensive is the experience of the team, and how reasonable is it to expect further success, in providing diverse sites with logistic support in arranging annual meetings, preparing pre- and post-meeting materials, and coordinating AITC program activities (e.g., preparation of presentations at professional meetings)? To what extent is there evidence that the AITCC will be able to foster or has fostered interaction between sites for sharing developments and findings such as new research tools or approvals (e.g., FDA or CMS), facilitating collaboration in the artificial intelligence/technological development arena, etc.? How strong is the evidence that the AITCC can coordinate and maintain on-time progress reporting through a database for cumulative progress reports or other documents?

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?

Environment

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of thecategories 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 Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

The AITCC program requires sharing of resources, with broad availability of policies, practices, materials, protocols, and tools to facilitate collaboration across multiple centers as well as reuse and replication by a range of researchers and private entities. Applicants are encouraged to provide an overarching data and resource sharing plan. The NIA expects awardees to implement a Resources and Data Sharing Plan consistent with achieving these program goals. The final Resources and Data Sharing Plan is expected to be developed in conjunction with AITC sites post award.

The AITCC must address how it will preserve utility of resources for the future. Resources produced, coordinated, and shared through the AITCC should be transferable, such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Authentication of Key Biological and/or Chemical Resources:

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.

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 NIA, 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.

• 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.
• Will receive a written critique.

• 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

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

Section VI. Award Administration Information

1. Award Notices

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.

Institutional Review Board or Independent Ethics Committee Approval: Grantee 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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

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.htmlor 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.

3. Reporting

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 agreementsare 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.

Section VII. Agency Contacts

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]

Partha Bhattacharyya, PhD
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: [email protected]

Megan Hancock
National Institute on Aging (NIA)
Telephone: 301-827-6335
Email: [email protected]

Section VIII. Other Information