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: Data Coordinating Center for the Accelerating Medicines Partnership Target Discovery and Preclinical Validation Consortium AMP-AD DCC (U24- Clinical Trial Not Allowed )

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AG-18-014

Companion Funding Opportunity

RFA-AG-18-013, U01 Research Project – Cooperative Agreements

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

93.866

Funding Opportunity Purpose

The goal of this funding opportunity announcement is to solicit applications focused on 1) providing data enablement for the open-science, systems-biology enterprise of the AMP-AD Target Discovery and Preclinical Validation Consortium supported through the companion FOA (RFA-AG-18-013) and 2) sustaining and expanding the big-data infrastructure of the AMP-AD Knowledge Portal as a collaborative research platform through which members of the Consortium, researchers at large, and citizen scientists can engage in rapid translational learning and contribute to the development of predictive models of AD and AD-related dementias.  

Key Dates
Posted Date

September 27, 2017

Open Date (Earliest Submission Date)

January 20, 2018

Letter of Intent Due Date(s)

January 20, 2018

Application Due Date(s)

February 20, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

No late applications will be accepted for this funding opportunity announcement.

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 2018

Advisory Council Review

August 2018

Earliest Start Date

September 2018

Expiration Date

February 21, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow 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 the 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.


IMPORTANT: Per NOT-OD-17-062 updated application forms (FORMS-E) will be used for this opportunity. The updated forms are not yet available and will be posted no later than November 10, 2017. Once posted, you will be able to access the forms using one of the following submission options:

  1. NIH ASSIST
  2. An institutional system-to-system (S2S) solution
  3. Grants.gov Workspace
Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Background

The Accelerating Medicines Partnership-Alzheimer’s Disease (AMP-AD) Target Discovery and Preclinical Validation Project is a component of the Accelerating Medicines Partnership for AD (AMP-AD), a precompetitive collaboration harnessing the capabilities and resources across government, industry, and non-profit sectors to improve therapeutic development efforts for Alzheimer's disease (AD). The project’s central goal is to shorten the time between the discovery of potential drug targets and the development of new drugs for AD treatment and prevention by integrating the analyses of large-scale molecular data from human brain samples with network modeling approaches and experimental validation. The project is a consortium of six multi-institutional, multidisciplinary cooperative agreements and research grants. The grant awardees are applying cutting-edge systems and network biology approaches to integrate multidimensional human “omics” data (genomic, proteomic, metabolomic) from more than 2,000 human brain samples and over 1,000 blood samples from individuals at all stages of the disease with clinical and pathological data to: i) discover novel therapeutic targets for AD; ii) gain a systems-level understanding of the gene, protein, and metabolic networks within which these novel targets operate; and iii) evaluate the druggability of these targets in multiple model organisms.

A major goal of the Consortium is to create standardized open-source data structures and formats that will improve the accessibility and ease of analysis of biological data in a manner not currently practiced in the AD field. In order to achieve the strategic goal of AMP-AD, academic grant awardees are expected to engage in joint analyses and broad sharing of biological data, analytical methodology, and disease models prior to publication.

The sharing of data, network models, and analytical tools and the data integration activities for the AMP-AD Target Discovery and Preclinical Validation Consortium is provided through the AMP-AD Knowledge Portal, an NIA-designated repository for broad sharing of high-dimensional human omics data and associated clinico-pathologic data, as well as data from animal and cell-based research models. The Knowledge Portal is hosted on the Sage Bionetworks informatics platform Synapse, an IRB-approved environment where data can be stored/accessed and collaboratively analyzed. The Portal serves as the designated repository for two other NIA programs: the M2OVE-AD (Molecular Mechanisms of the Vascular Etiology of AD) Consortium and the MODEL-AD (Model Development and Evaluation for Late-Onset AD) Center.

Data are made available via open or controlled access depending on the data type and data source and as determined by the informed consent documents for each study guided by the local IRB. There is no publication embargo imposed on the use of data after they have been made available through the Knowledge Portal.

In the first iteration of the AMP-AD Target Discovery and Preclinical Validation Project, the Consortium achieved several key milestones. These achievements include: i) the development of the AMP-AD Knowledge Portal as a centralized repository for housing high-dimensional human and animal model ‘omics’ data and analytical results, making the data and analytical results rapidly and broadly available; ii) developing the first set of network models for AD largely based on RNAseq data; and iii) nominating the first set of novel therapeutic targets and initiating their preclinical validation in an array of cell-based and animal models. 

The AMP-AD Target Discovery and Preclinical Validation Consortium was established based on individual grant awards supported through NIA’s funding initiatives described in RFA-AG-13-013. In the initial funding period, data enablement and data coordination were provided via administrative support to the parent awards. Given the extensive and expansive nature of the data coordination required to support the Consortium members and the Consortium's interaction with the larger research community, it is becoming apparent that a stand-alone data coordinating center is needed for the next iteration of this program.

Research Objectives

The purpose of using independent funding to support a stand-alone Data Coordinating Center (DCC) for the AMP-AD Target Discovery and Preclinical Validation Consortium is to ensure sustained data enablement of the open-science, systems-biology enterprise of the Consortium supported through the companion FOA (RFA-AG-18-013) and to maintain and expand the big-data infrastructure of the AMP-AD Knowledge Portal as a collaborative research platform through which members of the Consortium, researchers at large, and citizen scientists can engage in rapid translational learning and contribute to the development of predictive models of AD and AD-related dementias.

Activities appropriate for the AMP-AD DCC include, but are not limited to, the following examples:

  • Maintain and continue the development of a collaborative space for centralized storage of data analysis methods and results within the Consortium. Data types include high-dimensional human omics data, clinical and pathologic data, and data from cell-based and animal models. 
  • Maintain and continue the development of the AMP-AD Knowledge Portal as a public portal for the broad sharing of data, network models and analytical tools.
  • Develop appropriate data governance for the various data types and data sources to enable sharing of data among Consortium partners and more broadly.
  • Coordinate timely deposition and release of newly generated datasets contributed by Consortium members.
  • Coordinate and provide adequate annotation and curation of datasets and analytical results to enable data integration and harmonization and to maximize data usability.
  • Develop a process for facile data and analytical results contribution from researchers external to the Consortium, and improve their ability to discover data and projects featured in the AMP-AD Knowledge Portal.
  • Facilitate Consortium-wide analyses that will leverage combined resources across partners to more effectively answer pressing scientific questions.
  • Develop web-based data visualization interfaces and tools to support data-driven target prioritization and to enable data scientists, biologists and clinicians to query and interact with the rich datasets and network models being developed by the AMP-AD Target Discovery and Preclinical Validation Consortium.
  • Provide advanced, reproducible analytical pipelines and cloud computing support for Consortium-wide collaborative projects.
  • Develop infrastructure to support a series of big-data challenges for AD to accelerate the development of analytical methods and translational learning.

Applicants are strongly encouraged to consult with NIA Scientific/Research staff early in the pre-submission process to ensure that the application is responsive to the programmatic goals of this FOA.

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

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

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

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NIA intends to commit $1.5 million in FY 2018 to fund 1 award.

Award Budget

Annual direct costs are capped at $750,000.

Award Project Period

The maximum project period is 5 years.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

 Only institutions that have previously received a sub-award for data enablement of the AMP-AD Target Discovery and Preclinical Validation Project and for development of the AMP-AD Knowledge Portal (RFA-AG-13-013) are eligible to submit an application in response to this FOA.   

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) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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

Buttons to access the online ASSIST system or to download application forms 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 Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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:

Suzana Petanceska, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: petanceskas@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.  

SF424(R&R) Other Project Information

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

Facilities & Other Resources: Describe the scientific environment that supports the electronic information handling.

Describe the integrating activities of the DCC into the AMP-AD Target Discovery and Preclinical Validation Consortium.  Describe the logistical and administrative assistance as well as operational support, including but not limited to website maintenance, meeting support, maintenance of Consortium documents and email listservs, and coordination of site visits for audits.  Describe how the proposed resources can accommodate growth of the Consortium.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

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: 

Research Strategy: In addition to the strategy for achieving the scientific goals of the DCC, please address the following:

  • Delineate a plan for interaction with the awardees of the AMP-AD Target Discovery and Preclinical Validation Consortium.
  • Delineate a strategy to engage the broader research community to reuse the Consortium data and to contribute data, analyses and insights.
  • Delineate annual milestones and deliverables for all aspects of the research plan.

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, with the following modification:

  • The resource sharing plan should cover all the activities of the AMP-AD DCC. Program staff may negotiate modifications to these plans prior to funding.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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.

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. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the proposed Center address the needs of the research program and resource that it will coordinate and manage? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research program and resource?  Does this application provide a significant contribution to the support of the AMP-AD Target Discovery and Preclinical Validation Consortium?  If the aims of the application are achieved, how will the activities of the Centers be advanced? What will be the effect of these efforts on the methods, technologies, or services provided to the Centers?   

Investigator(s)

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

Innovation

Does the application propose novel organizational concepts or management strategies in coordinating the research collaborations and resource the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?    Does the application develop or employ novel concepts, approaches, methodologies, tools, or technologies to facilitate data collection, storage, and management from data scientists, basic and clinical researchers working on many different aspects of the AMP-AD Target Discovery and Preclinical Validation Consortium in geographically disparate locations, including those that result in significant cost savings for clinical site audits and reduce the burden of rising costs of software? Are there novel methods for recruitment and outreach to health professionals, researchers, and community or patient organizations?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research within the AMP-AD Target Discovery and Preclinical Validation Consortium? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the projects and resources, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program and resource are in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the program and resource? Are an appropriate plan for work-flow and a well-established timeline proposed?  Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects? Are the designs, methods, and analyses adequately developed, well integrated, well-reasoned, and appropriate to support the AMP-AD Target Discovery and Preclinical Validation Consortium and other relevant research communities? Does the proposed approach provide for a secure, customizable, scalable coordinated data management system that allows integration of high-dimensional omic data with various types of clinical data, including genetic, imaging, pathologic, and laboratory? Does the proposed plan adequately address the informational tools necessary to support a cooperative research network, such as: the development of a portal and tools for data mining; plans for web-based data visualization tools and interfaces; and the development of a user-friendly resource site for the public, research scientists and clinicians? 

Will this approach include developing and/or adapting new technologies and technological advances for distributed computing and federated databases? Does the applicant adequately address privacy and confidentiality issues? Does the applicant acknowledge potential problem areas and consider alternative tactics?  Is the structure of the program sufficiently multidisciplinary in order to meet the needs of the AMP-AD Target Discovery and Preclinical Validation Consortium and related research communities?  

Environment

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

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 six 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 six 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 Children 

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 children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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; (2) Sharing Model Organisms; and (3)  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.

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.

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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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:

The Program Director(s)/Principal Investigator(s) will have the primary responsibility for defining the details for the projects within the guidelines of this FOA. The PD/PI will agree to accept the close coordination, cooperation, and participation of the NIH staff (Project Scientists) in those aspects of scientific and technical management of the projects as described below. Specifically, the PD/PI(s) supported by this NIA Data Coordinating Center will:

  • Retain the primary authority and responsibility for the project as a whole and development of the methods, procedures to accomplish the aims and objectives of the FOA, and preparation of publications.
  • Provide, in addition to standard annual progress reports (see Section VI.3. Reporting), other relevant information to the NIH Project Scientist(s) or Program Officer, and coordinate and cooperate with NIH staff and other members of appropriate collaborating NIH programs.
  • Work directly with the NIH Project Scientist(s) on the coordination of intra-program activities and the integration of individual projects within the AMP-AD Target Discovery and Preclinical Validation Consortium as well as with other relevant NIH programs.
  • Join the AMP-AD Target Discovery and Preclinical Validation Consortium, participate in person, and budget for travel to joint meetings held once annually, along with other critical staff.
  • Participate in the appropriate coordinating meetings and/or working groups, and/or teleconferences as needed.
  • Agree not to disclose confidential information obtained from other members of the AMP-AD Target Discovery and Preclinical Validation Consortium and extended research network.
  • 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:

One or more designated NIH Program Staff members, acting as Project Scientists, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The role of the Project Scientist(s) will be to facilitate and not to direct. This includes facilitating the partnership relationship between NIH, the AMP-AD Target Discovery and Preclinical Validation Consortium and the AMP-AD Consortium Data Coordinating Center. The Project Scientist(s)' role includes helping to maintain the overall balance in the program commensurate with the functions and scope of the DCC activities, facilitating communication and coordination between the DCC and the data science training and workforce development community, and ensuring that the activities of the awardees are consistent with the mission of the NIA. Specifically, the NIH Project Scientist will:

  • Provide technical assistance and advice to the DCC awardee as appropriate to achieve the aims of the cooperative agreement.
  • Work directly with the awardee to facilitate their interactions with the AMP-AD Target Discovery and Preclinical Validation Consortium.
  • Promote and help coordinate collaborative efforts that involve interactions with other members of the AD translational research community, as well as with other NIH-sponsored programs, projects, and centers where appropriate.
  • Assist in the interaction between the awardee and investigators at other institutions, as appropriate for the program.
  • Assist in avoiding unwarranted duplication of effort.

To help carry out these duties, Project Scientists may consult with non-NIH experts in the field.

The NIH Project Scientist(s) will perform the initial analysis of awardee milestones and will work with the Program Officer on any milestone renegotiations.

Additionally, an NIH Program Officer will be responsible for the normal scientific and programmatic stewardship of the awards and will be named in the award notice. In addition, the NIH Program Officer will:

  • Have the option to recommend, following consultation with the NIH Project Scientist(s), the withholding or reduction of support from any project that substantially fails to achieve its goals according to the milestones agreed to at the time of the award.

NIH reserves the right to withhold funding or curtail an award in the event of:

  • Substantive changes in the project, or failure to make sufficient progress toward the work scope with which NIH concurred, or
  • Ethical or conflict of interest issues.

Areas of Joint Responsibility include:

  • The NIH Project Scientist(s) and the PDs/PIs of the AMP-AD DCC will be jointly responsible for the coordination of intra-program activities and the integration of individual projects with other appropriate NIA and NIH programs. Joint responsibilities include:
  • Developing working groups and/or coordinating committees and trans-project efforts as needed.
  • Organizing and conducting regular meetings to share progress and foster collaborations of members of the AMP-AD Target Discovery and Preclinical Validation Consortium, either by teleconference, videoconference, or face-to-face, as needed.
  • Organizing workshops to promote outreach.
  • Convene to assess progress, discuss data resources, establish priorities, consider policy recommendations, propose publication guidelines and discuss strategies.
  • Meet in person, virtually, or by teleconference, with additional project staff and/or NIH staff, on a schedule to be determined.
  • The NIH Project Scientist(s) may additionally form an External Scientific Panel (ESP) composed of senior non-federal scientists who are not directly involved in the activities of the AMP-AD Target Discovery and Preclinical Validation Consortium. The ESP would advise NIH on the progress of the Consortium milestone deliverables, on the contributions of individual projects and/or project collaborations within the consortium, and on the progress and effectiveness of the consortium as a whole.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Scientific/Research Contact(s)

Suzana Petanceska, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: petanceskas@nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: ramesh.vemuri@nih.gov

Financial/Grants Management Contact(s)

Jillian Morris
National Institute on Aging (NIA)
Telephone: 301-496-8986
Email: morrisjil@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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