Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Drug Abuse (NIDA)
National Institute of Nursing Research (NINR)
National Center for Complementary and Alternative Medicine (NCCAM)

Funding Opportunity Title

Low-Cost, Pragmatic, Patient-Centered Randomized Controlled Intervention Trials (UH2/UH3)

Activity Code

UH2/UH3 Phase Innovation Awards Cooperative Agreement
 

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HL-14-019

Companion Funding Opportunity

RFA-HL-14-020, R01Research Project

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.837, 93838, 93.839, 93.233, 93.213, 93.279, 93.866, 93.173, 93.361  

Funding Opportunity Purpose

This NIH Funding Opportunity Announcement (FOA) invites applications to plan and conduct low-cost, pragmatic randomized controlled trials (RCTs).  Pragmatic RCTs seek to determine the effectiveness of an intervention in a real world setting.   Trials proposed under this FOA should answer questions that are high impact to patients or health care providers, and must leverage existing clinical practice settings and/or existing electronic resources such as registries for the conduct of clinical trials.   Trials must include features such as randomization at the point of patient care; data collection integrated into or obtained from routine clinical records or similar existing electronic resources; minimal eligibility criteria, and interventions delivered as part of routine clinical care.

Funds from the NIH will be made available through the UH2/UH3 cooperative agreement award mechanism.  The initial one-year UH2 phase will support the refinement of  electronic and other existing resources, further development of study partnerships, and finalization of the trial protocol and manual. UH3 awards will be made after administrative review of UH2 awards that have met agreed upon milestones.  The four-year UH3 phase will support the conduct of the planned clinical trial.

Key Dates
Posted Date

November 7, 2013

Open Date (Earliest Submission Date)

December 23, 2013

Letter of Intent Due Date(s)

December 23, 2013

Application Due Date(s)

January 23, 2014, 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

June 2014

Advisory Council Review

August 2014

Earliest Start Date

September 2014

Expiration Date

January 24, 2014

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

Despite the rapid pace of discovery in health care, only a small part of routine medical therapy provided to individual patients is based on the highest level of evidence, the phase 3 patient-centered RCT.  An even smaller amount of high-quality evidence supports systems of health care delivery.   The underlying reasons for this include research studies with highly restrictive inclusion and exclusion criteria, limited testing of health care delivery strategies, and the high cost of RCTs as they are currently conducted.   There is increasing demand for high-quality evidence to determine the most effective treatment, diagnostic strategy and health care delivery system.  Comparative effectiveness studies are in high demand and new initiatives targeted at translating evidence-based practices into routine clinical care are being enacted.  The Million Hearts, a collaboration across several federal agencies, is one such initiative with the goal of preventing one million heart attacks and strokes over five years by translating the evidence base in cardiovascular prevention (aspirin, blood pressure control, cholesterol management, and smoking cessation) to the greater population. To meet this increasing demand for high-quality evidence in the health care arena, efficient, low-cost strategies for the conduct of large-scale, high-impact RCTs are needed.

The advancing electronic resources of the health care delivery system, the development of private-sector high-quality mega-registries, and the increasingly integrated health care environment offer such an opportunity.  The Federal Government’s mandate for physician practices to adopt electronic medical records, the use of patient registries, and the growth of personal health records has resulted in comprehensive data systems that could be utilized for the recruitment and conduct of RCTs.  Health care payers are also embracing studies to increase the evidence base for models of care delivery (e.g., innovative teams or referral patterns), treatment models (e.g., intensive titration of therapy), and incentive strategies (e.g., pay for performance).  Patient advocacy groups have initiated databases of volunteers willing to enroll in clinical studies. The development of inexpensive mobile and web technologies to collect data from individuals may also expand the opportunity for less expensive trials.   The intersection of these movements has provided an opportune time to develop and implement more streamlined RCTs.

Purpose

The purpose of this FOA is to encourage investigators to use existing resources to conduct low-cost pragmatic patient-centered randomized controlled trials of interventions targeted at patients, families healthcare providers, communities or health care systems through the integration of RCTs into existing clinical practice settings.  While key features of high-quality clinical trials must be maintained (standardized inclusion and exclusion criteria, randomization, study protocol with standardization where appropriate, masking to treatment assignment to the degree possible, and objective assessment of outcomes), separate research infrastructure and staff should be minimized.  

To be responsive to this FOA, applicants must:

Applications that do not propose to use existing electronic resources, conduct the trial in a real-world setting with minimal inclusion and exclusion criteria, utilize endpoints that are relevant to patients and clinicians, and minimize separate infrastructure will be considered non-responsive.

Milestones and UH2/UH3 transition

Applicants must plan for both a UH2 and a UH3 phase The UH2 section must include a description of the milestones that will be reached at the end of the UH2 phase.   To successfully transition to the UH3 phase, the project must reach the following milestones in addition to any trial specific ones outlined in the application:

Each applicant should submit additional milestones that are specific to their proposed clinical trial.  These should be quantifiable and the metrics to measure success fully explained in the application.  Additional milestones may be negotiated after funding decisions have been made. 

Additional Information
Specific Areas of Research Interest

NHLBI

Examples of studies that would be of interest to NHLBI include, but are not limited to, the following:

NIA

Examples of research topic areas that may be relevant to this FOA include, but are not limited to:

NIDA

Examples of studies that would be of interest to NIDA  include, but are not limited to, the following:

NIDCD

Examples of research topic areas that may be relevant to this FOA include, but are not limited to:

NINR

NINR solicits applications designed to enhance the evidence base for care of individual patients, families, and communities to increase knowledge of the most effective methods for health care delivery and to advance self-management and health promotion and integrate these more rapidly, and cost effectively into practice. 

Examples of research topic areas that may be relevant to this FOA include, but are not limited to:

NCCAM

Examples of studies that would be of interest to NCCAM include, but are not limited to, the following:

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

The following NIH components intend to commit the following amounts (total cost) in FY 2014:

National Heart, Lung, and Blood Institute, $3,000,000, 6 awards

National Institute on Aging, $1,000,000, 2 awards

National Institute on Deafness and Other Communication Disorders, $500,000, 1 award

National Institute on Drug Abuse, $500,000, 1 award

National Institute of Nursing Research, $500,000, 1 award

National Center for Complementary and Alternative Medicine, $500,000, 1 award

Award Budget

Application budgets are limited to $350,000 in direct costs for the UH2 phase and $500,000 in direct costs for each year of the UH3 phase

Award Project Period

The UH2 phase will be one year in length and the UH3 phase may be up to 4 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:

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
Telephone: 301-435-0270
Fax: 301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Page Limitations

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

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.

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.

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.

Applicants should budget for travel to an annual investigators meeting to be held in the Washington, DC area.

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:

Specific Aims:  Applicants should include separate specific aims for each phase of the application (UH2 and UH3), but must not exceed the designated page limit.

Research Strategy: UH2 and UH3 research strategies must both be described. The UH2 is a one-year planning period. Planning period work may include protocol development and development of collaborations. Applicants may conduct small pilot studies testing recruitment strategies, outcomes ascertainment and integration of forms into existing electronic resources during the UH2 phase. The UH3 should be devoted to the conduct of the clinical trial.

Milestones and UH2/UH3 transition

Applicants must include their research strategy for both the UH2 and the UH3 phase. The UH2 section must include a description of the milestones that will be reached at the end of the UH2 phase. To successfully transition to the UH3 phase, the project must achieve the following milestones in addition to any trial-specific ones outlined in the application:

•   Develop and document all collaboration and partnerships necessary for conduct of the clinical trial.  These may include selection of clinical sites, selection of study champions in relevant delivery locations, and execution of data use agreements.

•   Finalize protocol, manual (s) of procedure, and data collection forms.  If data collection forms are to be integrated into an existing electronic record, demonstrate the integration. If data will be collected from existing electronic sources, demonstrate validated methods to collect such data.

•   Obtain all necessary human subject protection approvals and procedures including IRB approval, review and approval of final informed consent documents or waiver of informed consent, and selection of medical monitors/data safety monitoring boards.  Applicants must comply with IC specific safety monitoring such as use of IC established DSMBs.

•   Document a potential study population adequate to meet the sample size of the trial.  Demonstrate ability to recruit potential participants to enroll in the clinical trials.

Each applicant must submit additional milestones that are specific to their proposed clinical trial.  These should be quantifiable and the metrics to measure success fully explained in the application.  Additional milestones may be negotiated after funding decisions have been made.   

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, with the following modification:

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.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report 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.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030,

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 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?  Is the proposed pragmatic trial addressing a major public health issue? Will the completion of the proposed pragmatic trial change the concepts, methods and technologies used in large scale community-based clinical research?

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?  Do the PD(s)/PI(s) and key personnel have the necessary expertise in design and implementation of a large-scale pragmatic trial such as using electronic health records for recruitment and outcomes assessment? Do the PD(s)/PI(s) have extensive experience in performing proposed Planning Phase activities, and do they have a track record of successful investigative collaborations or partnerships with (within) health delivery organizations proposed in the application?   

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? Does the application challenge and seek to impact current conventional approaches to clinical trials by utilizing novel approaches or methodologies for a pragmatic trial? Is a refinement, improvement or new strategy of approaches proposed? Does the application include mechanisms for leveraging novel collaboration and study oversight strategies?  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? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  Is the proposed trial utilizing existing electronic resources for study activities such as identification of study participants, ascertainment of outcomes and monitoring of study conduct?  Will the trial be conducted in a real-world setting with broad inclusion and exclusion criteria?  Are the study outcomes meaningful to patients and clinicians?  Is infrastructure developed solely for the purpose of the conduct of the trial minimized?  Is the study intervention being delivered in the context of routine clinical care?  Will proposed planning activities (including plans for identifying a sufficiently large target patient population), and proposed milestones, allow for implementing the clinical trial?   

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? Are there sufficient infrastructure and expertise (e.g., clinical investigators, informaticists) to implement the proposed pragmatic trial within the proposed setting?   

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.

Milestones

Are the steps and milestones clearly defined? Are the milestones feasible, well developed and quantifiable with regard to specific goals and accomplishments? Are adequate criteria provided for the UH2 phase that will be utilized in determining milestone completion before proceeding to the next phase of the project?  

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 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 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 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(s), 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 on the basis of established PHS referral guidelines 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 for the assigned institute. 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 include:

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 investigator chosen without NIH staff voting from among the PI of the FOA, 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)
Phone: 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 Phone: 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)

Denise Bonds, MD, MPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone:301-435-0379
Email: bondsde@nhlbi.nih.gov

Sergei Romashkan, MD, PhD
National Institute of Aging (NIA)
Telephone: 301-435-3047
Email: romashks@nia.nih.gov

Gordon B. Hughes, MD
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-4085
Email: hughesg@nidcd.nih.gov

Sarah Q. Duffy, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6504
Email: duffys@nida.nih.gov

Karen Huss, PhD, RN, ANP-BC, FAAN, FAAAAI, FAHA
National Institute of Nursing Research (NINR)
Telephone: 301-594-5970
Email: hussk@mail.nih.gov

Partap S. Khalsa, DC, PhD, DABCO
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-3462
Email: partap.khalsa@nih.gov

Peer Review Contact(s)

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: chiefreviewbranch@nhlbi.nih.gov

Financial/Grants Management Contact(s)

Tammi Simpson
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0166
Email: simpsontl@nhlbi.nih.gov

Deborah Stauffer
National Institute of Aging (NIA)
Telephone: 301-496-1472
Email: stauffed@nia.nih.gov

Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email: myersc@mail.nih.gov

Edith Davis
National Institute on Drug Abuse (NIDA)
Telephone: 410-360-4734
Email: edavis1@nida.nih.gov

George Tucker, MBA
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-9102
Email: gt35v@nih.gov

Lawrence Haller
National Institute of Nursing Research (NINR)
Telephone: 301-402-1878
Email: HALLERL@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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