Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Funding Opportunity Title
Limited Competition: National Institute on Aging (NIA) Late Onset of Alzheimer’s Disease (LOAD) Family-Based Study (FBS) (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

Reissue of PAR-16-205

Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-AG-22-001
Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.866

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications specific to infrastructure to support the Alzheimer's Disease Sequencing Project (ADSP) and related data collection, longitudinal follow-up, ascertainment of antecedent risk factors, and the characterization of additional relatives from families multiply affected by Alzheimer's disease and related dementias (AD/ADRD) in order to expand the existing NIA Late Onset of AD (LOAD) Family Based Study (FBS) sample set.

Key Dates

Posted Date
December 14, 2020
Open Date (Earliest Submission Date)
January 17, 2021
Letter of Intent Due Date(s)

January 17, 2021

Application Due Date(s)

February 17, 2021. No late applications will be accepted for this Funding Opportunity Announcement.

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

AIDS Application Due Date(s)

Not Applicable

 

 

Scientific Merit Review

June/July 2021

Advisory Council Review

October 2021

Earliest Start Date

December 2021

Expiration Date
February 18, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

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

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

This Funding Opportunity Announcement (FOA) invites applications for the National Institute on Aging (NIA) Late Onset of Alzheimer's Disease (LOAD) Family Based Study (FBS). Analysis of families that have three or more affected members (referred to as multiply affected) by Alzheimer's disease (AD) provides distinct advantages for characterizing the impact of genetic variants on disease risk. First, multiply affected families are likely to be enriched for genetic variants associated with increased risk, providing increased statistical power to estimate the effects. Second, analysis of multiply affected families provides insight into the remaining unknown genetic influences (i.e., the "residual heritability") as well as antecedent modifying factors that interact with identified genetic variants to influence disease risk. Third, family members at risk are followed at regular intervals, facilitating prospective investigation of the effects of the genetic variants on age-at-onset as well as the modifying effects of antecedent risk and protective factors. Finally, family data can provide information regarding the influence of known variants on the rate of disease progression and the residual heritability of disease progression.

The NIA LOAD FBS began in 2003 with the collection and longitudinal follow up of large multiply affected families under individual NIA investigator awards. Funded investigators developed, refined, and circulated a procedure manual for the collection and follow up of families with AD that is still in use. In this initial phase, 1,885 samples from 422 families were collected. A cooperative agreement to continue this collection was funded in 2005 to complete the collection of 1,000 new families, recruit appropriate members in existing families, and initiate and complete follow-up in all participating families. The Center for Inherited Disease Research (CIDR) performed genome wide association study (GWAS) on the first 500 families; data were deposited into the Database of Genotypes and Phenotypes (dbGaP) for broad sharing with the genetics community. At the conclusion of the cooperative agreement, investigators had created a resource of 1,000 well-characterized families with LOAD. Sample acquisition and longitudinal follow up have continued under an R01 that was funded simultaneously with the launch (in 2012) of the Alzheimer’s Disease Sequencing Project (ADSP).

The ADSP Discovery Phase included the sequencing of 583 subjects from 111 multiply affected families drawn largely from the NIA LOAD FBS. The criteria and standards employed by the NIA LOAD FBS were adopted by the ADSP. The ADSP Discovery Extension Study (2015-2018) included whole genome sequencing (WGS) on individuals from multiply affected families provided by the NIA LOAD FBS funded under PAR 16-205. The ADSP Follow-Up Phase (2018-2023) heavily engages resources provided by the NIA LOAD FBS and will depend upon the longitudinal follow up of families and the collection of 500 additional families, in particular those from diverse populations. The characterization of additional relatives, with ascertainment of antecedent risk factors and recruitment for autopsy, will benefit the field by expanding the scientific value of the NIA LOAD FBS. Numerous investigators outside of the ADSP are also using biological materials from the NIA LOAD FBS.

NIA LOAD FBS biological materials are provided to the National Central Repository for Alzheimer's Disease and Related Dementias (NCRAD) at Indiana University, which makes the samples and phenotypic data broadly available to the research community. Clinical data are collected in a uniform fashion, as the NIA LOAD FBS developed specific criteria for the inclusion of families with LOAD and has used standardized methods to identify affected and unaffected individuals across the NIA-funded Alzheimer's Disease Centers (ADCs).

As an essential research resource for the ADSP, the NIA LOAD FBS acts as the key provider of biological materials and longitudinal clinical data on large multiply affected families from ethnically diverse populations for the ADSP, the Alzheimer Disease Genetics Consortium (ADGC), the Consortium for Alzheimer's Disease Research (CADRE), and the network of NIA-sponsored Alzheimer's Disease Centers (ADCs). The NIA LOAD FBS has ongoing collaborations with investigators engaged in all phases of the ADSP, including the Alzheimer's Disease Neuroimaging Initiative (ADNI), the Cohorts for Heart and Aging Research in Genomic Epidemiology Consortium (CHARGE), and other multiple- and single-site studies that involve the collection and storage of biological research material and phenotypic data for genetic research on AD, such as the Accelerating Medicines Partnership-Alzheimer's Disease (AMP-AD). As an integral component of the ADSP, the NIA LOAD FBS works closely with NCRAD, the NIA Genetics of Alzheimer's Disease Data Storage Site (NIAGADS), the National Alzheimer's Coordinating Center (NACC), and the ADCs. The NIA LOAD FBS has developed working relationships with all of these entities. Future success depends on maintaining these relationships.

The NIA LOAD FBS should have the ability to assess subjects from diverse populations for AD status at sites both inside and outside of the United States; to acquire new biological materials from large multiply affected families and provide these samples to NCRAD; to coordinate the receipt, processing, and storage of biological materials; to share data related to families in keeping with appropriate informed consent; and to provide phenotypic data to NIAGADS for sharing and analysis by the research community at large. Biological samples, including biological materials for GWAS and WGS; peripheral blood mononuclear cells (PBMC) for stem cell modeling; plasma for studies of metabolomics, proteomics, and biomarker research; and brain autopsy materials for bulk RNA-Seq, will be made available to the larger scientific community by the NIA LOAD FBS through NCRAD. Genetic, genomic, and related phenotypic data will be made available through NIAGADS.

The NIA LOAD FBS should continue providing overall support to the ADSP in order to be able to continue family-based studies, along with providing support for investigators outside of the ADSP. Principal Investigators (PIs) should include plans to participate in phenotypic harmonization efforts that are ongoing in the ADSP. It is anticipated that biological materials from multiply affected families in multi-ethic populations will be made available for emerging NIA initiatives, including but not exclusive to functional genomics. Investigators should devise plans for working with a wide range of stakeholders, including government, academic scientists, industry, and data-management experts.

It is expected that in the coming five-year funding period the NIA LOAD FBS will expand its scope to ensure that up to 500 new families (2,000 subjects) are available to the AD genetics community for analysis to meet the needs of genetic/genomic research on AD with an emphasis on ethnic diversity and deep endophenotypes. The NIA LOAD FBS will act as a comprehensive resource to enhance the scientific community's ability to better understand how the Alzheimer's genome can affect risk for and protection against disease. Community outreach is an important aspect of the overall activity of the NIA LOAD FBS. Sample and data sharing, effective workflow management, and protocol standardization are also expected to play a significant role in the success of these activities as an Alzheimer's community research resource to enhance rapid discovery of therapeutic targets for AD. The rationale for continued study of multiply affected families should be clearly described. Families selected for further study should be carefully chosen and selection criteria well defined.

Under this FOA, in the next five years the NIA LOAD FBS should continue to:

  1. Follow up existing families to confirm current or past diagnoses, document any changes in diagnoses, and recruit new family members within these families.
  2. Phenotype and genotype (GWAS, exon chip, or a related approach with quality control checking and quality assurance) all new family members.
  3. Recruit offspring of the proband generation for each of the existing families, and phenotype and genotype offspring. GWAS should be performed on all subjects; whole genome sequencing may be performed on the most informative family members.
  4. Recruit new multiply affected families from other ethnic groups, including but not exclusively African American, Afro-Caribbean, Hispanic American, Central and South American, and Asian populations.
  5. Collaborate with NCRAD to maintain a repository of biological resources for follow up of genetic studies in order to develop biomarkers and induced pluripotent stem (iPS) cells, peripheral blood mononuclear cells, plasma and serum, and brain autopsy.
  6. Collaborate with NCRAD to augment the repository of autopsy material for diagnostic accuracy and for follow up of genetic variants, and coordinate the deposition of samples from new individuals and their phenotype and any genotype data to NIAGADS.
  7. Facilitate the disposition of biological materials to NCRAD for use by the greater scientific community.
  8. Facilitate the discovery of genetic factors that may lead to the development of new therapies to prevent and treat the disease.
  9. Engage in community outreach to help bring new subjects into the NIA LOAD FBS.

Under this FOA, in the next five years the NIA LOAD FBS should include plans to begin to:

  1. Develop and use innovative approaches to expand phenotypically and genetically well-characterized families. Innovative approaches may include telecommunications, such as web-based approaches, to conduct initial and follow-up assessments and retain engagement of the invaluable, geographically dispersed group of racially and ethnically diverse families. Investigators should ensure adherence to HIPAA and NIH policy when obtaining subject consent, clinical assessment, family history review, risk factor interview, and neuropsychological/neurological exam when using novel telecommunications approaches.
  2. Implement novel approaches, including social media and community-based outreach, to recruit new and more ethnically diverse multiply affected LOAD families, focusing on African Americans, Hispanic Americans, and Caribbean Hispanics residing in the United States.
  3. Expand the range of blood-based biospecimens in NIA LOAD FBS families to support biomarker assays and functional genomic studies in multi-ethnic populations widely used in genetic research.
  4. Coordinate continued collection of brain tissue for neuropathology and functional genomic studies in the NIA LOAD FBS.
  5. Expand the clinical, genetic, and biospecimen resources to the research community from the NIA LOAD FBS.

In summary, this FOA addresses NIA's vital need for well-coordinated acquisition and handling of biological materials and related clinical data from large, multiply affected, ethnically diverse AD families. NIA is committed to facilitating the collection, storage, and sharing of biological materials and related data from large multiplex AD families for research in the area of AD genetics, making them broadly available to the research community. The NIA LOAD FBS is a critical facet of the NIA Alzheimer's Disease Genetics Initiative that effectively leverages the investments already made related to the etiology of AD. Applications considered for funding should effectively leverage previous investment related to investigation into the core causes of the disease. The research resource should provide a large sample set of biological materials and related phenotypic data for broad use by the research community. The research resource forms the core of the Family Based Study for the ADSP and is a central component of NIA-funded infrastructure that supports the project to inform investigators about the genetic penetrance and heritability of the disease based on the genetic variants already discovered in families multiply affected by AD.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
Renewal
Resubmission
Revision

Only awardees supported under the following FOAs are eligible to apply: PAR-12-183, RFA-AG-16-002, PAR-16-406, PAR-17-214, PAR-18-890, PAR-19-234, PAR-16-205.

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIA intends to commit $3,500,000 in FY 2022 to fund one award.

Award Budget

Application budgets are limited to $2,400,000 in annual direct costs.

Award Project Period

The maximum project period is five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Only awardees supported under the following FOAs are eligible to apply: PAR-12-183, RFA-AG-16-002, PAR-16-406, PAR-17-214, PAR-18-890, PAR-19-234, PAR-16-205.

Federal Governments

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

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 allowed. 

Required Registrations

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.
  • 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

Marilyn Miller, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Fax: 301-496-1494
Email: millerm@nia.nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

It is expected that the scientific environment in which the work will be done will contribute to the probability of success of the project and of the ADSP as a whole. Institutional support, equipment, and other physical resources available to the investigators should be adequate for the project proposed. Both the project itself and the ADSP should benefit from unique features of the scientific environment, subject populations, or collaborative arrangements. The research environment of the applicant institution(s) should have appropriate resources to accomplish the research objectives of the program. It is expected that the research resource will have the capacity to serve as a repository of autopsy material for diagnostic accuracy, for follow up of genetic variants, and to coordinate the deposition of samples from new individuals at NCRAD and their phenotype and any genotype data to NIAGADS. The use of the research environment should appropriately leverage existing resources at the applicant's institution(s) to accomplish the research objectives of the U24 program.

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

The PD(s)/PI(s) should have a deep understanding of the genetics of familial AD. It is expected that PD(s)/PI(s) and other personnel will have appropriate clinical experience and training for management of acquisition of biological samples and data related to large multiply affected families with AD. The PD(s)/PI(s) should have expertise in the handling and analysis of genetic, clinical, and endophenotypic data related to AD. The PD(s)/PI(s) should have expertise in archiving, processing, and distributing phenotypic data and samples used for genetic analysis. The PD(s)/PI(s) should be facile in curation of large data sets, including genetic/genomic and phenotypic data relevant to genetic analysis, such as clinical and neuropathology data elements, and related data provided by NIA-funded investigators. The PD(s)/PI(s) should have demonstrated accomplishment in effectively interacting with subjects from diverse populations both inside and outside the United States and have expertise in the genetics of complex diseases, population genetics, and statistics in order to discover risk and protective genetics factors for AD. The PD(s)/PI(s) should demonstrate significant experience with coordinating collaborative basic and clinical research. The PD(s)/PI(s) should have expertise in managing a large sample repository that can store DNA, brain tissue, cerebrospinal fluid (CSF), and other biological materials for genetic and biomarker analysis. The PD(s)/PI(s) should have expertise in managing a repository of biological resources for follow up of genetic studies in order to study biomarkers and should have experience in handling peripheral blood mononuclear cells, plasma and serum, CSF, and a repository of autopsy material for diagnostic accuracy and for follow up of genetic variants. The PD(s)/PI(s) should have expertise in coordinating the deposition of samples to an NIA-approved repository and phenotypes from newly recruited individuals and any related genotype data to an NIA-approved database. If the application is multi-PD/PI, investigators should have complementary and integrated expertise and skills in order to provide an appropriate leadership approach, governance, plans for conflict resolution, and organizational structure applicable to the database. The applicant should have experience overseeing selection and management of sub awards, if needed.

R&R Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required.

Specific Aims: Provide a succinct description of how the proposed work will continue to meet the overall scientific goals, the expected outcomes, and the impact of the NIA LOAD FBS should its goals be achieved. The application should describe the organization and operational procedures of the collaborative research infrastructure and how the expertise of the members will be integrated and applied to complete planning, preliminary evaluation, ascertainment, and sample collection for a number of large multiply affected families. The application should describe the processes and resources that will be used to identify and evaluate subjects to be studied over the course of the award. Please read the Funding Opportunity Description in Section I prior to formulating specific aims.

Research Strategy: The applicant(s) should present an integrated plan that will be responsive and flexible regarding the evolving needs of the scientific community especially the ADSP and other major AD genetics projects. The applicant(s) should provide a rationale for selection of families and the approach and rationale for selection of genotyping methodology (i.e. genome wide association, exome content array, or other genotyping methods) to be done in the study. Plans for documentation of key procedures should be included. The contributions of individual key personnel should be specified. Provide an overall description of the proposed organizational structure and project management plan, including any relevant flow charts, and show how the research will serve particular communities of researchers studying AD. Describe the strategy for effectively carrying out each specific aim, including the establishment of an Executive Committee comprised of lead investigators from major AD genetics studies. Show how the plan to arrange coordinated receipt, storage, genotyping, and distribution of genetic material and related data will facilitate research in AD that is supported in independent projects. Please read the Funding Opportunity Description in Section I prior to developing the Research Strategy.

Innovation: Explain how the concepts, approaches or methodologies, or interventions used in the augmentation of the NIA LOAD FBS are novel to the field of AD research. Explain how the refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed are novel to the field of AD research. Explain any novel organizational concepts, management strategies, or analytical approaches in coordinating the research projects that the NIA LOAD FBS will serve. Describe any concepts, strategies, or approaches that are novel to the genetics and genomics of AD research or that are applicable in a broad sense. Explain any refinement, improvement, or new application of organizational concepts, management strategies, or instrumentation that will be employed in the research.

Approach: The proposed study should describe a comprehensive plan to address NIA's vital need for well-coordinated acquisition and handling of DNA and related clinical data from large, multiply affected, ethnically diverse families. Describe how the proposed study will facilitate the collection, storage, and sharing of DNA and augment the repository of autopsy material and related data from large multiply affected families for research in the area of AD genetics. Explain any innovative approaches for sample and data acquisition. Explain how the NIA LOAD FBS will facilitate the mission of the ADSP. Describe how the NIA LOAD FBS will work cooperatively with the ADSP as a whole. Explain how the research plan will enable the ADSP to extend previous discoveries that may ultimately result in new directions for AD therapeutics, consistent with achieving the goals of this program. Explain why the approach is feasible, how particularly risky aspects will be managed, and how the NIA LOAD FBS will advance and augment the development of novel therapeutics for AD. Explain how potential problems will be addressed, alternative strategies carried out, and benchmarks for success reached. State plans to participate actively in sample and data exchange and to collaborate with other investigators in the ADSP and with awardee(s) of other NIA grants and cooperative agreements in order to enhance the likelihood of identifying therapeutic targets for AD. Define milestones and a time line for key events for the project.

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

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 that is consistent with the NIA Genomics of Alzheimer's Disease Sharing Policy and the goals of the NIA Genetics of Alzheimer's Disease program. It is the policy of NIA that all genomic data derived from NIA-funded studies on the genomics of late onset Alzheimer’s disease, including secondary analysis data, be deposited at NIAGADS or another NIA-approved site or both whenever possible. As a resource, more information can be found at https://www.nia.nih.gov/research/dn/alzheimers-disease-genomics-sharing-plan.
Appendix:

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

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 SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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 nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIA Referral Office by email atramesh.vemuri@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

How well will the plan coordinate receipt and distribution of genetic samples and related phenotypic data from diverse sample sets to augment the existing NIA LOAD FBS collection? How well will coordinated receipt and distribution of genetic samples and related phenotypic data from diverse sample sets facilitate or expedite AD research that would be delayed or infeasible if conducted as independent projects? What advantages will the NIA LOAD FBS bring to the AD research programs it services? How responsive is the proposed study to the need to serve as an interface between the ADSP, the AD research community, and related infrastructure such as NCRAD, NACC, the ADCs, and other ongoing ADSP collaborations? How responsive and flexible will the proposed NIA LOAD FBS be to the evolving needs of the AD research community, including its ongoing collaborations and existing interactions with stakeholders? How well will the proposed study leverage the investments already made related to investigation of the core causes of the disease? How efficiently will the research resource provide a large sample set of DNA and related phenotypic data for broad use by the research community? How well will the study develop and sustain a unique, large, well-phenotyped, and diverse sample set for the AD research community at large?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

How experienced are the PD(s)/PI(s) in handling AD genetic samples, biological samples, autopsy material, study-related genetics data, and phenotype data? How appropriate is their record of accomplishments in effectively managing large sample sets like the NIA LOAD FBS? How experienced are they in handling sample and data sets for complex diseases? Do the PD(s)/PI(s) and staff have sufficient appropriate experience and training for management of large-scale sample and phenotypic data acquisition, with expertise in curation and distribution of large sample sets, including pedigrees; genetic, genomic, and phenotypic data relevant to genetic analysis; clinical and neuropathology data elements; and related data? Do the PD(s)/PI(s) have sufficient experience and an ongoing record of accomplishments in effectively managing a sample repository in order to discover risk and protective genetics factors for AD? How successful is the plan to form an effective executive committee to oversee the work that will ensure that the AD community is well served by the NIA LOAD FBS likely to be?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

How well does the application explain any refinements, improvements, or new applications of instrumentation that will be employed in the research? Is community outreach an aspect of the proposed study and likely to be effective in bringing subjects into the NIA LOAD FBS?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Are an appropriate plan for work flow and a well-established timeline proposed? How well do the PD(s)/PI(s) describe their plans for documentation of the key procedures that they will include in the project? How well will the proposed strategy maintain the continuity of the existing family based study? How likely to be successful is the plan to arrange coordinated receipt, storage, genotyping, and distribution of genetic material and related data? How adequate are plans to augment the existing repository of autopsy material? How well will the proposed NIA LOAD FBS assist the research community and NIA in achieving the goals of the Alzheimer's disease research programs it proposes to serve? How robust is the scientific rigor that is applied to the work plan? How well is the expertise of the members integrated and applied to complete planning, ascertainment, evaluation, and sample collection for a number of large multiply affected AD families? How well do the PD(s)/PI(s) describe the processes and resources that will be used to identify and evaluate subjects to be studied? How well integrated and flexible is the plan that will be put in place relative to the evolving needs of the scientific community, especially the ADSP and other major AD genetics projects?

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 scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Will the project benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Additional Review Criteria

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan and (2)  Genomic Data Sharing Plan (GDS).

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.

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 FOA.

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 FOA. 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.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a 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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

  • Defining objectives, approaches, and analysis protocols; sample and data acquisition; and distribution.
  • Working directly with members of the NIA Alzheimer's Disease Genetics Consortium (ADGC), the National Alzheimer's Coordinating Center (NACC), the National Cell Repository for Alzheimer's Disease (NCRAD), the Genome Center for Alzheimer's Disease (GCAD), the NIA Genetics of Alzheimer's Disease Data Storage Site (NIAGADS), the Alzheimer's Disease Centers (ADCs), the Alzheimer's Disease Genetics Consortium (ADGC), the Consortium for Alzheimer's Disease Research (CADRE), the Cohorts for Heart and Aging Research in Genomic Epidemiology (CHARGE) Consortium, the Alzheimer's Disease Neuroimaging Initiative (ADNI), the Alzheimer's Disease Sequencing Project (ADSP), the National Human Genome Research Institute (NHGRI), NIA, the ADSP Discovery Phase cooperative agreement studies funded under PAR-12-183, the NIA Coordinating Center for Genetics and Genomics of Alzheimer's Disease (U54) funded under RFA-AG-16-001, and the Alzheimer's Disease Sequencing Project (ADSP) Follow-Up Phase Sequencing (U01) funded under PAR-16-406 ) and Analysis Studies (U01) funded under RFA-AG-16-002, and other NIA-funded investigators.
  • Establishing, in consultation with the NIA Project Scientist, a board of external consultants to provide guidance on sample acquisition and advances in methodology appropriate for use in this context. Consultants will be selected as individuals who are not involved in AD genetics research but who could advise the awardees with an emphasis on population diversity, sample banking, iPS cell methodology, and biomarkers for AD.
  • Establishing an Executive Committee. The PD(s)/PI(s), key NIA LOAD FBS personnel, and selected awardees of the Alzheimer's Disease Sequencing Project (ADSP) Discovery Phase and Follow-Up Phase, in consultation with the NIA Project Scientist, will be members. The Executive Committee will hold meetings and conference calls to facilitate development and implementation of common measures and practices. The Executive Committee will define the rules regarding access to, and publication of, findings from analyses of NIA LOAD FBS samples and related data.
  • Transferring samples to NCRAD for distribution to the research community at large. Samples will be distributed in keeping with Institutional Review Board approval, and subject to Government rights of access, consistent with current HHS, PHS, and NIH policies.
  • Working collaboratively with other investigators to develop the study analysis design and collect appropriate samples and data for the AD genetics community as approved by the Executive Committee in consultation with the NIA Project Scientist.
  • Administering the establishment, operation, and quality control of genotypic and phenotypic data, including the development of procedures for assuring data quality control and procedures for transfer of data.
  • Working cooperatively with study sites and sponsoring organizations and overseeing the implementation of, and adherence to, common protocols, as well as assuring quality control of the samples collected.
  • In addition to organizing and attending regular meetings, maintaining close communications with the NIA Project Scientist and, where appropriate, the Program Director(s) of the ADSP, GCAD, and NIAGADS.
  • Ensuring that ADSP data are made available immediately upon deposition into the Data Storage Site.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The designated NIA Project Scientist will have scientific involvement during conduct of this activity through technical assistance, advice, and coordination, assisting in those aspects of the award as described. The NIA Project Scientist will monitor the deposition of samples into NCRAD to ensure that NIA-funded investigators have appropriately deposited data and have properly acknowledged the use of the NIA LOAD FBS in the publication of their work. The NIA Project Scientist will review protocols for work flow and data sharing before they can be implemented. The NIA Project Scientist will be a non-voting "ex officio" member of the Executive Committee and all key subcommittees.

Additionally, an NIA Program Official will be responsible for the normal scientific and programmatic stewardship of the award, including assessing the progress toward the accomplishment of specified milestones and recommending release of additional funds to the project, and will be named in the award notice.

Areas of Joint Responsibility include:

For areas of joint responsibility, an Executive Committee including Program Director(s) of the NIA LOAD FBS; selected Program Director(s) from the ADSP, GCAD, and NIAGADS; and the NIA Project Scientist should be formed. The Executive Committee will serve as the main decision-making body for the shared aspects of the study and will devise common protocols related to data sharing among collaborators, stakeholders, and the AD research community. Appropriate NIA LOAD FBS staff may attend the Executive Committee Meetings as needed. Members of the Executive Committee for the Data Storage Site will contribute to the effort by accessing and assessing appropriate genetic and phenotype data and providing expertise in the analysis of genetics data from specific AD cohorts. The Executive Committee will meet bi-monthly, or as needed. The External Board of consultants will advise the Program Director(s) on methodological approaches; phases of the award will proceed only after review of the common protocols and approval by the Executive Committee and acceptance by NIA.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (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: support@grants.gov

Scientific/Research Contact(s)

Marilyn Miller, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: millerm@nia.nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: ramesh.vemuri@nih.gov

Financial/Grants Management Contact(s)

Robin Laney
National Institute on Aging (NIA)
Telephone: 301-496-1473
Email: laneyr@mail.nih.gov

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.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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