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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - 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

Background

The National Longitudinal Study of Adolescent to Adult Health (Add Health) is a nationally representative, longitudinal study of individuals primarily born between 1976 through 1982. Respondents were first interviewed as adolescents in grades 7-12 (ages 12-19) between 1994-1995 and have been followed up at ages 13-20 (1996, Wave II), 18-26 (2001-2002, Wave III), 24-32 (2008, Wave IV), and 32-42 (2016-2018, Wave V). Collection of Wave VI at ages 39-49 (2023-2025) is nearing completion. Add Health is based on a sample of high schools and middle schools throughout the United States; the complex survey design yields a sample representative of United States schools according to region, urbanicity, school size, school type, and ethnicity. Add Health includes oversamples of racial and ethnic minority groups, disabled students, and siblings of varying levels of genetic similarity (from monozygotic twins to genetically unrelated siblings living in the same household), as well as large numbers of individuals differing by immigrant generation status (i.e., generation 1, 2, 3+) and family structure (e.g., two-parent family, presence of stepparents, single-parent family), and saturated samples of all individuals within select schools. The Add Health has over 50,000 registered users. A bibliography of over 9,000 publications that cite Add Health data is available at the Add Health bibliography.

Since its inception, Add Health has collected comprehensive measures of social contexts (e.g., families, schools, friendship social networks, romantic relationships, neighborhoods, and communities), and mental and physical health (including biomarkers capturing metabolic, immune, cardiovascular, and renal function as well as inflammatory markers, genetic information, and grip strength), as well as content on family background, caregiving, educational experiences, social relationships, personality and psychological characteristics, stressors, employment, children and parenting, and cognitive function. Add Health has also incorporated administrative data linkages (e.g., high school and college transcripts, birth and death records) and is poised for harmonization across key domains, including cognitive measures and biomarkers, with other aging studies. 

As Add Health respondents age through their 40s, the dataset provides an opportunity to contribute to understanding the life course determinants of AD/ADRD. Dementia is increasingly recognized as unfolding across the life course, but most studies begin several decades into life, missing an opportunity to capture potentially modifiable social, psychological, and biological processes in childhood and midlife. Ongoing data collection (Wave VI) of the study (average age 44) includes interviews on existing topics, as well as comprehensive online and in-person measurement of cognition and collection of venous blood and selected AD biomarkers (e.g., neurofilament light chain (NfL), Total tau, and glial fibrillary acidic protein (GFAP)). In addition, stored blood samples across multiple waves provide an opportunity for assays of additional AD/ADRD biomarkers. Extensive exposure measures across all waves of the study are also being added as part of Wave VI. Combining earlier waves of the data with these new measures provides an unprecedented opportunity to examine the multidimensional factors shaping life course risk and resilience for AD/ADRD outcomes in a population-representative sample.

Purpose

This is a non-competitive funding opportunity intended to fund a single award. The NIA is announcing its intent to issue a single source cooperative agreement award to the University of North Carolina at Chapel Hill to renew Add Health for a new five-year study period. Add Health originated at the University of North Carolina at Chapel Hill in 1993 and has been hosted by this institution ever since. As a large and complex data infrastructure project, transitioning Add Health to a different institution would result in tremendous risk for this project that is valuable to NIH, in part, due to its continuity and longitudinally assessed panel. The competition is therefore limited to the University of North Carolina at Chapel Hill, the only entity with knowledge of and access to the Add Health sample frame, which are necessary to contact and collect new data from Add Health participants. The transfer of the Add Health sample frame and PII to another institution would require considerable additional time to establish appropriate processes and procedures, resulting in a delay in the continuation of the study. Potential negative impacts of a delay include compromised panel maintenance activities that could reduce respondent engagement and trust and thus participation, threatening the scientific impact of the project. The University of North Carolina at Chapel Hill has robust and specialized infrastructure and personnel with study-specific knowledge and skills that would be difficult if not impossible to reproduce at another institution. NIH has longstanding and productive relationships with the intended recipient. In addition, the intended recipient has successfully competed for competitive funding for ancillary studies to enhance Add Health in recent years. The activity to be funded is a continuation of an ongoing activity and will continue with the intended recipient. As previously mentioned, the intended recipient has developed robust infrastructure to collect, document, and disseminate the data. Metrics of success include over 50,000 unique users and over 5,000 peer-reviewed journal articles. The overarching purpose of Add Health is to collect, develop, and disseminate high quality population-representative data that can be used by the research community to understand life course factors shaping disparities in outcomes related to aging and AD/ADRD

To achieve Add Health's objective, the applicant will propose plans to complete the following Core and Enhancement activities:

The project will sustain the following Core Activities:

• Re-interview Add Health cohort members in a combination of web-based and in-person modes, including comprehensive non-response follow-up and maintenance of oversamples of race/ethnic-minority and low-socioeconomic-status individuals
• Re-visit cohort members for an in-home health exam that includes venous blood collection
• Enrich measures in domains that may elucidate mid- and later-life factors shaping disparities in aging and AD/ADRD risk and resilience (e.g., work, caregiving, stressors)
• Conduct a comprehensive assessment of cognitive, physical, and sensory function
• Generate health and AD/ADRD biomarkers from biospecimens
• Maintain and expand administrative/program data linkages
• Collaborate with other studies to promote harmonization and innovation
• Describe the review process for ancillary studies, including studies accessing biospecimens (see Resource Sharing Plan)
• Provide a multidisciplinary and collaborative organizational and management structure (see Study Governance Plan)
• Clean, document, disseminate, archive (including storage of biological specimens for future study), and promote the Wave VII data to the scientific community for aging research (see Data Management and Sharing Plan)
• Provide (1) a timeline with milestones that reflects key achievements including Core and Enhancement Activities and (2) a risk management plan that considers ways of mitigating potential problems that may arise across the project period (see Project Management Plan)

The project will further conduct one additional Enhancement Activity:

• Assay blood for an expanded set of biomarkers relevant to aging processes and those relevant to AD/ADRD risk

The applicant may propose other innovative ways of supporting the study’s mission and NIA priorities that address the 2019 NIA National Advisory Council on Aging (NACA) Review of the Division of Behavioral and Social Research (BSR) and NIA AD and ADRD Research Implementation Milestones (including, but not limited to, Milestone 1.C, Milestone 1.P).

The applicant is encouraged to justify the proposed balance among longitudinal continuity of design and methods, aging of the sample, scientific innovation, budget, and other constraints. This renewal NOFO supports activities associated with primary data collection and dissemination. Secondary data analysis in support of substantive research questions is not appropriate for this NOFO; secondary data analysis in support of measurement development, validation, and documentation to support Add Health Wave VII as a public use dataset is permitted. The applicant 1must submit a Letter of Support demonstrating that they have access to personally identifiable information (PII) about Add Health panel members from the study's inception for the purpose of re-contacting respondents for longitudinal follow up. The applicant must also include a plan for protecting PII. NIH defines PII as “information that can be used to distinguish or trace an individual's identity, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual.”

All activities should be described in a unified single application that addresses the 2019 NIA NACA) Review of BSR and NIA AD and ADRD Research Implementation Milestones (including, but not limited to, Milestone 1.C, Milestone 1.P). This single application should be submitted as a renewal of the Wave VI Core application and include a description of all Wave VII Core and Enhancement Activities as well as progress made in the prior funding period for both awards funded under RFA-AG-21-008.

Non-Responsiveness Criteria

The following types of applications will be considered non-responsive and will be withdrawn prior to review:

• Applications that do not include a Resource Sharing Plan, as described in Section IV.
• Applications that do not include a Study Governance Plan, as described in Section IV.
• Applications that do not include a Data Management and Sharing Plan, as described in Section IV.
• Applications that do not include a Project Management Plan as described in Section IV.
• Applications that do not include a plan to conduct a timely (i.e., within 90 days of NIA notice) execution of a material transfer agreement of resources should the project transition to a new Institution in the future.
• Applications from grantees who were not awarded through RFA-AG-21-008. 

Resources for Applicants  

• NIA Data Sharing Resources for Researchers provides guidance on repositories and other data sharing resources as well as specific data sharing guidance.
• 2019 NIA NACA Review of BSR
• NIA AD and ADRD Research Implementation Milestones

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

Only the following applicant is eligible to apply for this single source funding: the University of North Carolina at Chapel Hill. Please refer to Section I. Notice of Funding Opportunity Information for more details.

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• 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 registrations; 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.

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 How to Apply-Application Guide.

Only the PD/PIs associated with the award issued under RFA-AG-21-008 to the University of North Carolina at Chapel Hill are eligible to apply for this single source funding. Please refer to Section I. Notice of Funding Opportunity Information for more details.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may only submit one application.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Only a single award will be issued to the University of North Carolina at Chapel Hill under this single source funding opportunity. Please refer to Section I. Notice of Funding Opportunity Information for more details.

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 How to Apply - 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:

Amelia Karraker, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3131
Email: [email protected]

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

For this specific NOFO, the Research Strategy section is limited to 24 pages.

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- Application Guide must be followed.

R&R or Modular Budget

All instructions in the How to Apply- Application Guide must be followed.

Inflationary Increases for Future Years: Inflationary salary increases for future year commitments are not allowed for applications submitted to this NOFO. However, necessary increases for other costs (e.g., supplies, equipment, etc.) are allowable as long as the out-year increase for a specific cost is well justified in the Budget Justification. For additional information, see here.

R&R Subaward Budget

All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply- Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

Study Mission: The applicant must articulate a clear Mission Statement for the program and establish a set of specific aims (more details below) that serve to propel that Mission forward. The applicant must explain how the Specific Aims, as described in the application, best position the study to support its Mission over the project period.

Specific Aims: The application must include specific aims summarizing proposed plans to continue the following Core Activities and proposed plans to add Enhancement Activity to develop Add Health as a population-representative data resource to understand life-course factors shaping disparities in outcomes related to aging and AD/ADRD. Below are the specific elements that Core Activities and Enhancement Activity must address:

Core Activities:

Re-interview Add Health cohort members in a combination of web-based and in-person modes, including comprehensive non-response follow-up and maintenance of oversamples by doing the following:

• Maintain individual respondent longitudinal membership in web-based and in-person survey modes
• Conduct mixed-mode (i.e., web-based, in-person) interview once during next project period
• Continue and refine comprehensive strategies to maximize interview participation and completion across modes and across sample demographic characteristics
• Select individuals for intensive non-response follow-up to support population representation 
• Employ multi-faceted strategies to recruit, train, engage, and retain talented field interviewer personnel

Re-visit cohort members for an in-home health exam that includes venous blood collection by doing the following:

• Continue and refine comprehensive strategies to maximize home exam consent and completion across sample demographic characteristics
• Maintain robust field, processing, and lab protocols to ensure high-quality blood collection and storage
• Employ approaches that integrate field operations from home exam consent through blood collection lab processing

Enrich measures in domains that may clarify mid- and later-life factors shaping disparities in aging and AD/ADRD risk and resilience (e.g., work, caregiving, stressors, menopause) by doing the following:

• Balance continuity of previously collected survey measurements and innovative new measurements to optimize the examination of life course factors shaping aging and AD/ADRD-related outcomes while also considering respondent burden

Conduct a comprehensive assessment of cognitive, physical, and sensory function by doing the following:

• Consider comprehensive cognitive, physical, and sensory function measurement in conjunction with consideration of respondent and field interviewer burden and measure continuity across waves

Generate health and AD/ADRD biomarkers from biospecimens by doing the following:

• Continue assaying existing health and AD/ADRD biomarkers relevant for aging and AD/ADRD outcomes

Maintain and expand administrative/program data linkages by doing the following:

• Continue and update existing data linkages, including the National Death Index linkage

Collaborate with other studies to promote harmonization and innovation by doing the following:

• Engage in harmonization efforts with other population-representative aging studies to promote comparable and innovative measures to support aging research, including measures of cognitive functioning and AD/ADRD
• Continue collaborations with other population-representative aging studies to facilitate aging and AD/ADRD biomarker harmonization and innovation

Describe the review process for ancillary studies, including studies accessing biospecimens (Resource Sharing Plan) by doing the following:

• Maintain, update, and advertise existing policies and procedures for ancillary studies, including biospecimens and long-term biospecimen reserve
• Continue documentation of ongoing and completed ancillary studies, including biospecimens on study website
• Continue maintenance of long-term biospecimen reserve

Provide a multidisciplinary and collaborative organizational and management structure by doing the following:

• Maintain a multifaceted and multidisciplinary study team to administer the study
  •  
• Outline and adhere to a Study Governance Plan, as described below, that includes contingencies for losses of key personnel
• Continue engagement with NIA program staff and the Add Health Data Monitoring Committee (DMC) on the conduct of study aims (see Section VI: Award Adminsitration Information, Cooperative Agreement Terms and Conditions of Award)

Clean, document, disseminate, archive (including storage of biological specimens for future study), and promote the Wave VII data to the scientific community for aging research (Data Management and Sharing Plan) by doing the following:

• Maintain protocols for rapidly sharing survey, performance measure, genetic, and assay data, as well as the production of user-friendly longitudinal survey files while ensuring sufficient protections from inappropriate disclosures
• Maintain a biospecimen repository along with rules for sharing biospecimen data with researchers
• Administer and expand the Add Health website for data distribution, documentation, and bibliographic information as necessary to make the Add Health program discoverable and accessible to the public
• Continue user support services
• Maintain and develop training resources (e.g., in-person and online accessible video recordings, Users Conference) on use of complex and/or high priority data elements (e.g., genetic data, contextual data, longitudinal data, etc.)
• Advertise all data at academic conferences, professional associations, and relevant social media channels
• Share all study data in accordance with NIH Data Sharing Policies

Enhancement Activity:

Assay blood for an expanded set of biomarkers relevant to aging processes and those relevant to AD/ADRD risk by doing the following:

• Describe plans to expand assays (both new assays and longitudinal measurement of existing assays) for well-characterized AD/ADRD and aging phenotypes and share data, including the following:
  • Neurological assays including biomarkers for amyloid (A), tau (T), and neurodegeneration (N) and other AD/ADRD biomarkers for Waves V, VI, and VII biospecimens
  • DNA methylation assays for Wave VII
  • Explain how the plans are innovative within the frame of a large-scale nationally representative study to support research on aging and AD/ADRD

The applicant may propose other innovative ways of supporting the study’s mission and NIA priorities, such as the recommendations from the 2019 National Advisory Council on Aging’s review of the NIA Division of Behavioral and Social Research and the NIA AD/ADRD Research Implementation Milestones.

Research Strategy:

For both Core Activities and Enhancement Activity, the Research Strategy must describe the following:

• Significance of extending the study, including in terms of Add Health as a data resource, to understand life course factors shaping disparities in outcomes related to aging and AD/ADRD
• Survey response rates, attrition, weights, and consent rates for administrative data and blood collection for Add Health Wave VI fieldwork to date
• Significance of selected survey domains, comprehensive assessments (i.e., cognitive, physical, functional), and assays, including for disparities  in aging and AD/ADRD
• Plans for collection and storage of blood specimens
• Measures and methods of the study
• Confidentiality protections for public and restricted/sensitive data
• Collaboration with other studies

Study Governance Plan: 

Applications must include a study governance plan that describes the following:

• Organization and roles of the study team
• Contingency plans for loss of key study personnel
• General processes for interactions/collaboration among team members and study leadership, NIA Program Staff, and the DMC (see Award Administration Information, Cooperative Agreement Terms and Conditions of Award)

Applicants must submit a Letter of Support demonstrating that they have access to personally identifiable information (PII) about Add Health panel members from the study's inception for the purpose of re-contacting respondents for longitudinal follow up. Applicants must also include a plan for protecting PII.

Project Management Plan: Applications must include a comprehensive Project Management Plan that provides (1) a timeline with milestones that reflect key achievements including Core and Enhancement Activities and (2) a risk management plan that considers ways of mitigating potential problems that may arise across the project period.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

• Applicants must agree to conduct a timely (i.e., within 90 days of NIA notice) execution of a material transfer agreement of resources should the project transition to a new Institution in the future.
• Applicants must provide a Resource Sharing Plan for biospecimens that details how ancillary requests for biospecimen access will be reviewed and facilitated. This plan must demonstrate how the applicant will balance current research community needs with the potential for more advanced innovations in the future.

Applicants must describe the review process for ancillary studies, including studies accessing biospecimens by doing the following:

• Maintain, update, and advertise existing policies and procedures for ancillary studies, including biospecimens and long-term biospecimen reserve
• Continue documentation of ongoing and completed ancillary studies, including biospecimens on study website
• Continue maintenance of long-term biospecimen reserve

Other Plan(s): 

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing (DMS) Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Applicants must include the following information in the DMS Plan:

• Access:
  • Explanation for how different types of data will be made accessible
  • Explanation of tiered data access and accessibility of secure data products
• Dissemination and Use:
  • Plan to disseminate data products to the research community
  • Detail on plans for comprehensive documentation for data products
  • Time frame for data dissemination across data products
  • Information on how code and methods for data products will be shared

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

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

PHS Human Subjects and Clinical Trials Information

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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply- Application Guide must be followed.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply-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 Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply 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 How to Apply 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 the NIA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

Post Submission Materials

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

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

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

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.

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 policies and practices, 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned 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 National Advisory Council on Aging. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

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 (HHS) grant administration regulations at 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 NIH as defined below.

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

• The Principal Investigator(s) will have the primary responsibility for the design and details of the project funded from this NOFO and will retain primary responsibility for performance of the activities. The recipient(s) agree(s) to accept assistance from the designated NIH Program Official and Project Scientist(s) in aspects of the scientific and technical management of the study/studies and in coordinating with other Federal agencies.
• Principal investigator(s) will also:
  • Upon award, attend monthly calls with NIH Program Staff to provide updates on study progress and scientific direction.
  • Provide a written quarterly update to NIH Program Staff on (1) timeline progress towards key milestones identified by the application’s Project Management Plan, and (2) sample representativeness across collections.
  • Present a Study Update at DMC meetings that includes details about progress towards study aims and key milestones, as identified by the Project Management Plan (as described in Section IV). Other topics to include in the Study Update include: survey response rates, attrition, consent rates for administrative data and blood collection, release of data products, initiation/completion of field periods, and other topics identified by the DMC as being of relevance for recurring update.
  • If requested by NIA, provide relevant materials for the purpose of an NIA-coordinated evaluation or impact assessment of the program.
  • Conduct a timely (i.e., within 90 days of NIA notice) execution of a material transfer agreement of resources should the project transition to a new institution in the future.
  • Contribute to DMC planning, including by suggesting DMC candidates and agenda topics.
• 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 HHS, 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) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards to provide comment on the conduct of study aims, potential future directions, and collaboration opportunities across other NIH activities. The Project Scientist will attend monthly meetings and other meetings with study key personnel as appropriate to provide timely comment on activities to complete study aims.
• An NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award. The NIH Program Official will approve all major stages of the project and all new major additions/changes to planned activities. In addition, this individual will assist in initiating and maintaining collaborative relationships with relevant federal agencies. Prior approval is required for any replacements of key personnel or other changes in subawards. The NIH Program Official will serve as the primary programmatic/administrative liaison to the study. The NIA Program Official will also manage and make final decisions for the DMC, including by: appointing DMC members, determining meeting location, confirming the DMC charter, and selecting final topics for the meeting agenda. The NIA Program Official will organize support for the DMC via a NIA-supported contractor to schedule and organize virtual, hybrid or in-person meetings as appropriate. This support will include scheduling, organizing travel for DMC members and invited third-party experts, and running logistical aspects of meetings. If a DMC meeting occurs as part of a site visit at the study institution, the PD/PI will arrange site-specific support.

DMC: In order to ensure that Add Health achieves NIA objectives under the cooperative agreement, NIA shall establish and appoint members to a DMC comprised of independent scientific experts in areas appropriate to the multidisciplinary content areas of the Add Health. Experts, including, but not limited to, the PI, co-investigators, NIA staff, and invited independent experts, will make presentations to the DMC on scientific and administrative issues regarding the development and implementation of study aims, including the Study Update (see PD(s)/PI(s) responsibilities above). DMC operations will adhere to the DMC charter established by the Program Official (see NIH staff responsibilities above). This DMC charter will describe the selection, composition, tenure, and responsibilities of the DMC membership. The DMC will meet at least twice per year; once in-person and once virtually.

The NIA Program Official and the PIs may request the DMC’s comment on specific issues associated with the conduct of study aims or future study directions. NIA Program Official and the investigators will consider DMC comments regarding implementation of study aims as well as additions or changes to content and methods during the execution of the cooperative agreement. The DMC will report to the NIA, and it will communicate specific comments to the NIA regarding priorities via executive sessions of DMC meetings. The DMC will also, where appropriate, provide comments to the PI; these comments are not binding on the PI who retains primary responsibility for scientific direction and implementation.

Areas of Joint Responsibility include:

• None; all responsibilities are divided between recipients and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the recipient 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 HHS regulation 45 CFR Part 16.

Consistent with the 2023 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.

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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. 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 2 CFR Part 200.301.

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]

Amelia Karraker, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3131
Email: [email protected]

Elizabeth L. Neilson, PhD, MPH, MSN
Office of Disease Prevention (ODP)
Phone: 301-827-5578
Email: [email protected]  

Randy Capps, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-5423
Email: [email protected] 
 

Sarah Vidal, Ph.D.
National Institute on Drug Abuse (NIDA)
Phone: 301-827-5529
Email: [email protected]

Center for Scientific Review (CSR)

Email: [email protected]

Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: [email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Chief Grants Management Officer
National Institute of Drug Abuse (NIDA)
Email: [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 2 CFR Part 200.