Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Patient-Centered Outcomes Research Institute (PCORI)

Components of Participating Organizations

National Institute on Aging (NIA)
Improving Health Care Systems (IHS) program

Funding Opportunity Title

Clinical Trial of a Multifactorial Fall Injury Prevention Strategy in Older Persons (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
  • August 1, 2013 - See Notice NOT-AG-13-016. Pre-application Webinar and Teleconference scheduled for this RFA.

Funding Opportunity Announcement (FOA) Number

RFA-AG-14-009

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.866 

Funding Opportunity Purpose

This initiative invites applications for funding to conduct a randomized clinical trial of a multifactorial strategy for preventing serious fall-related injuries among non-institutionalized older persons. A multifactorial strategy should be designed for maximal potency in reducing the rate of serious fall-related injuries, which (if found to be effective in the trial) is feasible for future implementation with fidelity in practice in at least one type of care setting. The trial should test an evidence-based protocol that articulates decision rules that address: screening the population to identify individuals at high risk for falling, assessing high-risk individuals to define their specific risk factors, selecting interventions to ameliorate each person’s risk factors, implementing these interventions, coordinating the delivery of each person’s set of interventions  (including methods for coordinating decisions on possible adjustments in medication prescribing among multiple prescribers for a given patient), monitoring each person’s progress toward risk factor reduction, and implementing alternative interventions to overcome lack of progress and mitigate new risk factors. The study should incorporate patients’ and other relevant stakeholders’ priorities and perspectives in the specification of the study protocol and the outcomes to be measured. Applicants should consider adaptive study design features that facilitate "learning" from accumulating positive or negative evidence.

Key Dates
Posted Date

July 16, 2013

Open Date (Earliest Submission Date)

October 13, 2013

Letter of Intent Due Date(s)

October 13, 2013

Application Due Date(s)

November 13, 2013, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

January 2014

Advisory Council Review

February 2014

Earliest Start Date

March 2014

Expiration Date

November 14, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the 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.

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

Injuries that result from falls pose a substantial public health burden, especially among older persons with risk factors for falling. Serious injuries, including hematomas, broken bones and lacerations may be important factors that contribute to older persons’ loss of independence.  Risk factors for serious injuries resulting from falls include illness, especially among those with multiple chronic conditions, functional impairments and environmental hazards.

Clinical trials focusing on reducing the incidence of falls have found that some interventions have substantial effects and others have little or none. A major determinant of the effectiveness of a fall prevention strategy is the degree to which the intervention team has control over the implementation of the intervention; strategies in which one team recommends preventive interventions for a patient and a different team implements them have generally been ineffective.

Other obstacles to the success of strategies for preventing falls and injuries have included:

These considerations are the reasons that investigators have turned to new strategies to support and provide patient-centered care in a variety of types of organizational settings, e.g., Accountable Care Organizations (ACOs), Patient-Centered Medical Homes (PCMHs) and other primary care organizations including HMOs, assisted-living facilities (ALFs), and home health care agencies.  To the extent that organizations can overcome the obstacles and barriers noted above, such settings could provide venues for clinical trials of multifactorial fall injury prevention strategies designed to be both effective in reducing injuries from falls and (if effective) scalable across the United States. The sustainability and effectiveness of scalable, multifactorial strategies have not been assessed, however, in previous clinical trials.

In recent years, attention to multifactorial fall prevention strategies has been amplified, and tools and evidence-based practice guidelines on this topic have been issued (e.g., the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines).  There is little data regarding the degree to which these guidelines, or even individual components of them, are being implemented in different practice settings and in different populations.  This lack of data limits the ability of researchers to estimate the potential impact of a given multifactorial strategy when compared to usual care.

Data on the effects of falls prevention strategies on fall-related injuries is even more limited, although some trials have found favorable effects on these outcomes as well.  Many recent falls injury prevention studies have tested interventions aimed at reducing injuries, rather than falls. One example is the use of drugs designed to increase or preserve bone mineral density. Some of these trials have found significant effects on some types of fractures, such as hip fractures, which often result from falling. To date, adequately powered studies of the effects of multifactorial strategies designed both to reduce falls and to reduce injuries from falls have not been conducted.

Moreover, there is sparse evidence about the effects of falls prevention strategies on other outcomes that are important to patients.  Many older patients, for example, view some behavioral interventions as trade-offs between safety and functional independence. These competing concerns can influence the composition and effectiveness of preventive strategies, and the willingness of older patients to participate in such strategies.  To date, clinical trials have not accommodated or measured such patient concerns.

Scope of Research Requested

NIA in partnership with PCORI requests applications for a randomized clinical trial of a multifactorial strategy for preventing serious fall-related injuries among non-institutionalized older persons, a trial designed to overcome the obstacles noted above.  PCORI, a District of Columbia non-profit corporation, is authorized by Congress to conduct research to provide information about the best available evidence to help patients and their health care providers make more informed decisions. PCORI’s research is intended to give patients a better understanding of the prevention, treatment and care options available, and the science that supports those options.

Specifically, the proposed trial should be designed to:

In designing and implementing this clinical trial, careful attention should be paid to several critical issues, such as the ones outlined below:

Responsiveness Criteria

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.

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

PCORI intends to commit $30,000,000 in FY2014 to fund one five-year award.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

Five 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

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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 not 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.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the 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.

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:

The letter of intent should be sent to:

Sergei Romashkan, MD, PhD
Chief, Clinical Trials Branch
Division of Geriatrics and Clinical Gerontology
National Institute on Aging
Gateway Building, Suite 525A
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
(Fed Ex Packages use ZIP 20814)
Telephone: 301-435-3047
Fax: 301-480-1066
Email: romashks@nia.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirement:

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

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.

SF424(R&R) Senior/Key Person Profile

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

To achieve the study’s goals, the proposed research consortium should comprise expertise in:

R&R or Modular Budget

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

The applicants should budget for at least four face-to-face meetings of the major investigators and working groups, which would be held in Bethesda, MD, during the Protocol Development and Refinement Phase.

The application should include appropriate compensation for patients and other relevant stakeholders who must be engaged in all phases of conducting the study, including design, implementation, evaluation and reporting of results.

PHS 398 Cover Letter

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:

Organize the Research Strategy into the following sections:

These sections will be scored separately by reviewers.

Given the diverse and complex challenges involved in the design and execution of this trial, applicants are encouraged, but are not required, to create specialized working groups that will assist in developing their applications. The existence and experience of such collaborative working groups would position the successful applicant to attain the challenging goals of the trial’s initial intense protocol development and refinement phase.

Protocol Development and Refinement Phase

Applicants are expected to describe a proposed trial design in their application.  However, it is recognized that the protocol development activities needed for an optimally designed and conducted trial may require resources exceeding those available to applicants prior to funding.

The application should include a detailed description of the applicants’ plans and proposed staffing for completing the several necessary activities of the protocol development and refinement phase, including a detailed time line.

Protocol Development and Refinement Phase

The award will provide for an initial protocol development and refinement phase.  This phase is expected to last approximately one year.  During this phase, awardees may simultaneously conduct activities such as the following: 

The protocol development and refinement phase will provide the trial with a considerable degree of flexibility in finalizing its protocol.   One or more alternative study designs should be described, in the event that the evidence developed in the protocol development and refinement phase suggests that the original design would not be feasible. These alternative design options should also include an indication of the resources (including staffing and participating organizations) that would be needed to complete the trial.

Based on its completion of this protocol development and refinement phase, the awardee will recommend a final study protocol. Based on this recommended final protocol, the NIA and PCORI will decide whether to authorize funding to proceed into the implementation phase of the trial (years 2-5).

Analysis of the preventive strategy’s scalability to U.S. populations

All applicants should provide a thoughtful analysis of the obstacles and facilitators of the post-trial scalability of the strategy they will test – and how the strategy could be scaled among different populations in the U.S. For example, factors which might present obstacles to scalability include: lack of an adequately trained professional workforce, lack of processes and resources to ensure providers’ fidelity to the strategy, competing demands on clinicians’ time, lack of infrastructure for coordinating providers’ efforts, cultural/educational/socioeconomic factors, incomplete participation by patients and their family caregivers, financial disincentives, and the effects of modifying the strategy for adoption after the trial. Facilitators of scalability could include engagement with patients and other stakeholders throughout the study, which would be instrumental in helping to promote the widespread post-trial adoption of the strategy, e.g., engaging with patient advocacy organizations, professional societies, public and private insurers, residential facilities, provider organizations, and others.  The quality of this analysis will be considered in the peer review of the "Significance" of the application.

Projection of the preventive strategy’s sustainability in the study organization(s)

Although applicants are not required to provide a projection of how the preventive strategy could be incorporated into at least one of their participating organizations after the conclusion of the trial, the inclusion of such a projection is encouraged.  Applicants proposing such a plan should describe how their organizations’ staffing and organizational resources could be deployed to implement the strategy.  Many aspects of such a plan cannot be designed optimally in the absence of information that will be obtained during the trial. Hence applicants proposing such a plan are encouraged to describe how information from the trial would be used to adapt their original implementation projection. The quality of this projection, if provided, will be considered in the peer review of the application. Applications which do not provide this projection will not be penalized.

The anticipated start date for the trial is February 2014, and the total funding period will be five years.  A preliminary statistical analysis of the effects of the preventive strategy on the rate of serious fall-related injuries must be reported in March 2017. The applicant should, therefore, project a schedule for implementing preventive interventions in a sufficient number of participants by December 1, 2015.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide . In accordance with PCORI’s legislative mandate on public dissemination, the award recipient shall, not later than 90 days after the completion of the study, collaborate with NIH and PCORI in order to make the study’s findings available to clinicians, patients, and the general public. PCORI encourages openness in research and freedom of access to underlying data by persons with a serious interest in the research, and NIH promotes no-cost public access through PubMed Central. Accordingly, the awardee(s) will be encouraged to explore opportunities to use existing and emerging internet distribution models and, when appropriate, publicly-accessible repositories, journals, or similar mechanisms that result in broad access for the interested field and public.

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. 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.

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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

In order to expedite review, applicants are requested to notify the NIA Referral Office by email at vemuri@nia.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 NOT-OD-10-115.

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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? 

If the aims of the project are achieved, will improvements in clinical practice likely lead to widespread improvements in outcomes that matter to patients? How credible is the applicant’s analysis of the obstacles to and facilitators of the scalability of the preventive strategy that will be tested?

Patient-Centeredness

How important to patients (and their caregivers) are the questions to be answered by the study?  How important to patients (and their caregivers) are the primary and secondary outcomes which will be measured?  

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?

Is the research novel or innovative in its methods or approach, in the population being studied or in the intervention being evaluated, in ways that make it likely to improve care?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?

Are the objectives, methods and timetable for the protocol development and refinement phase complete, feasible and realistic for finalizing the study protocol and methods that will be implemented in years 2-5 of the project?

Are the objectives, methods and timetable for the implementation phase complete, feasible and realistic for conducting the proposed controlled trial in years 2-5 of the project?

Does the proposed consortium of participating organizations comprise components with the operational capacity that will be necessary to ensure excellence in conducting all of the project’s essential processes: conducting multi-site, multi-modal research; recruiting a large sample of older participants and caregivers; delivering scalable professional education; providing consistent, protocol-driven, preventive health care; and engaging patients and other relevant stakeholders as research partners throughout all phases of the project?

Are the proposed staff’s level of effort, expertise, roles and responsibilities sufficient to complete concurrently the multiple parallel activities that will be required in order to test and refine the preventive protocol, both during the protocol development and refinement phase and during the protocol implementation phase?

Patient and Stakeholder Engagement

Does the application demonstrate meaningful patient and stakeholder engagement by integrating patients and relevant stakeholders into the research team’s decision-making throughout the development and execution of the research plan?

Specifically:

Does the application propose an independent Data and Safety Monitoring Board and describe its composition, roles and responsibilities?

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.

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?

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?

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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) Genome Wide Association Studies (GWAS).

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, comprising scientists, patients and relevant healthcare providers, convened by the National Institute on Aging, 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:

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:

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

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

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:

NIH staff have substantial programmatic involvement that is above and beyond the normal

stewardship role in awards, as described below:

Areas of Joint Responsibility:

A Steering Committee will be formed to serve as the primary high-level decision-making body for the study. Members of the Steering Committee will include the PD/PI for the study, the PD/PI of the Data Coordinating Center, a representative of PCORI, NIA Scientific Officer, and up to three scientific content experts. Each member will have one vote.  The Steering Committee will have the overall responsibility for the development and finalization of the protocols common to all study centers. The Committee will approve the study goals and methods, monitor the study’s progress, and approve revisions to the study protocols. Awardee members of the Steering Committee will be required to accept and implement all policies governing the study conduct approved by the Steering Committee. The decision to advance the study from the protocol development and refinement phase to the implementation phase and to commit the additional funds necessary for the implementation phase will require the approval of NIA and PCORI. The Steering Committee will meet every three (3) months or more often, as needed.

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.  The Dispute Resolution Panel 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 annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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. 

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Rosaly Correa-de-Araujo, M.D., M.Sc., Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-6762
Email: Rosaly.correa-de-araujo@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Deborah Stauffer
National Institute on Aging (NIA)
Telephone: 301-496-1472
Email: stauffed@nia.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 Parts 74 and 92.

Section 937(g) of the Public Health Service Act, 42 U.S.C. § 299-b-37(g) permits NIH and PCORI to enter into this Agreement and permits NIH to accept and retain funds from PCORI for the conduct and support of comparative clinical effectiveness research. This special relationship between NIH and PCORI is further established by 42 U.S.C. § 1320e(d)(2)(B)(i)(II).


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