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.

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

This announcement is part of the Science of Behavior Change (SOBC) Program supported by the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress. The overall goal of SOBC is to implement a mechanisms-focused, experimental medicine approach to behavior change research and to develop the tools required to implement such an approach. Simply described, an experimental medicine approach involves identifying an intervention target, developing assays (measures) to permit verification of target engagement, engaging the target through experimentation or intervention, and testing the degree to which target engagement produces the desired behavior change. For the purposes of this announcement, putative intervention targets represent mechanisms or processes that are hypothesized to be malleable and to play a causal role producing behavior change. Behavior change, as defined here, includes the initiation, cessation, modification, maintenance, and/or adherence to health behaviors (e.g., diet, exercise, substance use, behavioral regimens, treatment regimens) that have broad health implications across a wide range of clinical endpoints.

Work supported by the initial SOBC program (http://commonfund.nih.gov/behaviorchange/index) identified three behavioral domains as promising behavior change targets, given strong evidence for their central role in health behaviors relevant to multiple clinical endpoints. Each of these broad domains contains multiple putative intervention targets with a variety of existing assays (measures).

These three behavioral domains are:

1. Self-regulation,

2. Stress reactivity and stress resilience, and

3. Interpersonal and social processes.

Research supported by this funding opportunity announcement (FOA) is meant to support the Resource and Coordinating Center (RCC). Companion FOAs will fund UH2/UH3 Target Validation Projects in the areas of interpersonal and social processes (RFA-RM-14-018), stress reactivity and stress resilience (RFA-RM-14-019), and self-regulation (RFA-RM-14-020).

The overall goal of the RCC will be to provide national leadership to coordinate the projects and initiatives of SOBC. Initially, the RCC will be collaborating with between five and eight UH2/UH3 awardees whose goal is to develop and validate specific targets for behavior change interventions. The RCC will 1) Establish and curate, a registry of validated assays and experimental methods for inducing and measuring specified behavior change targets; 2) Develop, adapt, and adopt technical guidelines and best practices for the validation of assays of behavior change targets that can be incorporated into behavior change trials to make them more informative; 3) Maintain a SOBC registry (e.g., of assays, interventions or manipulations that engage targets, best practices, guidelines, and data) publicly available to the research community for advancing SOBC research; 4) Conduct systematic reviews of the behavior change literature and specifically the medical adherence literature in order to identify additional potential targets for future validation or research; and 5) Help coordinate activities between multiple awardees working on a single target class and ensure that results produced will be suitable for the RCC’s first three objectives. The RCC will also serve as the central resource for the organization of the meetings and other activities of the SOBC program, including the support of its Steering Committee and External Scientific Panel, and any SOBC subcommittees that are established.

The foremost responsibility of the RCC will be the coordination and support of the awards made to the three companion FOAs focusing on the behavior domains mentioned above: RFA-RM-14-018, RFA-RM-14-019, and RFA-RM-14-020. The supported UH2/UH3 cooperative agreements, hereafter referred to as Target Validation Projects, are phased awards that will validate specific classes of targets by:

In the UH2 phase:

• Identify a set of putative targets within the target behavioral domain that are: a) promising as drivers of change in multiple health behaviors, one of which must be medical regimen adherence; b) hypothesized to be related to multiple health outcomes; c) and are likely to be malleable.
• Develop or adapt and test a suite of behavioral and biological assays to permit verification of target engagement.
• Use, refine, or develop an experimental manipulation and/or a targeted, focused intervention to try to engage a target.
• Demonstrate that the target(s) is/are malleable, and that the assays measure target engagement, through experimental manipulations/interventions.

In the UH3 phase:

• Test the degree to which engaging identified targets produces a desired change in medical regimen adherence and at least one other health behavior hypothesized to be related to at least two clinical endpoints or disease conditions;
• Refine at least two manipulation/intervention approaches, aiming for optimal target engagement.
• Refine assays that optimize measurement of target engagement;
• Work in collaboration with the RCC to share refined assays, experimental/intervention protocols, and other tools developed with support from the SOBC Research Network; and
• Work with the RCC PD(s)/PI(s) to facilitate the integrative analysis of data.

Success in these areas will lay the foundation for establishing a more unified science of behavior change by implementing an experimental medicine approach.

The RCC will provide leadership to support collaboration and coordination between Target Validation Projects. It is expected there will be at least two UH2/UH3 projects awarded in each target class, and the RCC will provide domain expertise to facilitate work being performed within that target class and coordinate parallel activities performed across target domains. Each application should propose a set of subcommittees that would be made up of staff from the RCC and members of each of the Target Validation Projects. There will initially be one subcommittee corresponding to each behavioral domain, and the RCC should propose in the application other subcommittees deemed necessary for the successful attainment of the SOBC project. After award, the Steering Committee may create additional subcommittees as needed. The RCC will also establish, curate, and maintain a publically available registry of successful assays and experimental manipulations for specific behavior change targets developed by the Target Validation Projects or identified by the Steering Committee. NIH anticipates funding approximately six of these Target Validation Projects in FY2015, with the UH2 phase expected to last three years and the UH3 phase to last two years. All projects will be milestone-driven; successful transition from the UH2 to the UH3 phase will be based on achievement of milestones and availability of NIH funds to support all the projects.

The RCC will develop, adapt, and establish technical guidelines and best practices for the validation of assays of behavior change targets that can be incorporated into behavior change trials. The RCC may collaborate with personnel from Target Validation Projects in this endeavor (and may in fact wish to propose a subcommittee for this purpose).

The RCC will maintain a registry and archive of SOBC-produced assays, interventions or manipulations that engage targets, and practices, and provide public access to the data and other data products produced over the course of the program. The RCC may also engage in dissemination activities related to registry that could include, but are not limited to, publication in peer-reviewed journals, presentations at scientific meetings, development of training modules and/or curricula, and partnerships with professional organizations or other institutions to further establish the experimental medicine approach.

Finally, the RCC will conduct systematic reviews of the extant behavior change and adherence to medical regimens literatures in order to identify and classify other putative targets that may inform the development of future research programs, especially in the area of medical regimen adherence. Pending successful progress of SOBC and the availability of funds, SOBC intends to launch two additional initiatives that will seek to build on the findings both of the RCC’s systematic review and the products of the Target Validation Projects by introducing the assays, interventions or manipulations that engage targets, and general experimental medicine approach to behavior change into ongoing clinical research.

The awards funded under this FOA and the companion FOAs will be cooperative agreements (see Section VI.2 Cooperative Agreement Terms and Conditions of Award). Close interaction with the NIH and with the Target Validation Project awardees will be required to accomplish the goals of this program.

An SOBC Research Network Steering Committee will be established to address issues that span all Target Validation Projects, including providing input into the policies and processes of SOBC, and assisting in dissemination of all of the deliverables named above. At a minimum, the Steering Committee will be composed of one investigator from each of the Target Validation Projects, the NIH Project Scientist for each Target Validation Project, the Director (contact PD/PI) of the RCC, the NIH Project Scientist for the RCC and other representatives from various NIH Institutes and Centers, as necessary. All members are expected to actively participate in all Steering Committee activities. The combined vote of NIH membership will count as a maximum of one-third of the total number of votes. Note: The PD/PI of the U24 RCC will serve as chair of the Steering Committee, for the first award year. Thereafter, members may serve as chair on a rotating basis, as agreed by the Steering Committee.

SOBC Program External Scientific Panel

An External Scientific Panel (ESP) will be established to review the progress of all components of the program and provide recommendations to the NIH. The members with relevant expertise will be selected and invited by the NIH. The ESP is expected to have 6-8 permanent members; however, the membership may be enlarged permanently or on an ad hoc basis as needed. The ESP will meet once a year in conjunction with the annual in-person Steering Committee meeting coordinated by the RCC. Following these meetings, the ESP will make recommendations in writing regarding progress of the program to NIH, including changes, if any, which would benefit the program.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government, including the NIH Intramural Program
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the 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.

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.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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.

It is critical that applicants follow the 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.

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:

Jonathan W. King, PhD
National Institute on Aging (NIA)
Telephone: 301- 402-4156
Fax: 301-402-0051
Email: [email protected]

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

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.

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

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

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

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

The contact PD/PI of the SOBC RCC will be the lead Director of the center and is the person responsible for the overall management of the RCC; if there are multiple PDs/PIs of the RCC, they will serve as co-directors. The relationship between the RCC and the Target Validation Projects should be one of equal and substantial partners in all joint activities.

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

The RCC Director must devote at least 20 percent (2.4 person months) to this program. In cases for which Multiple PDs/PIs serve as co-Directors of the RCC, the Directors must devote a combined effort of at least 2.4 person-monthsThe RCC application budget should include funds for RCC PD(s)/PI(s) and key personnel to travel to a kick-off meeting for the SOBC Research Network that will be organized by NIH staff and held in the Washington, DC area within 2 months of the RCC and Target Validation Project awards.

The RCC will be responsible for organizing and attending several face-to-face meetings. These meetings are meant to facilitate coordination among Target Validation Teams and the subcommittees in which they participate. The RCC application budget should include funds for organizing and traveling the RCC PD(s)/PI(s) and key personnel to the following:

• Annual 1.5-day SOBC Steering Committee meetings in the Washington, DC area (Note: Target Validation Project PD(s)/PI(s) will budget for their own travel.);
• Annual 1-day meeting of the ESP held in conjunction with the annual Steering Committee meetings, in the Washington, DC metro area, including funds for traveling the ESP members;
• One annual 1-day meeting for each of the three target domain subcommittees (i.e., the Self-regulation Target Validation Subcommittee, the Stress Reactivity and Resilience Target Validation Subcommittee, and the Interpersonal and Social Processes Target Validation Subcommittee, held separately from the annual Steering Committee meeting at a location to be determined by the RCC and the subcommittees. Note: Target Validation Project PD(s)/PI(s) will budget for their own travel.)

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

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

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

Research Strategy

Describe plans for accomplishing the following five objectives of the RCC:

1) Work in collaboration with approximately six Target Validation Projects in order to establish and curate and a registry of successful assays and experimental manipulations for specific behavior change targets developed by the UH2/UH3 projects;

2) Develop, adapt, and adopt technical guidelines and best practices for the validation of assays of behavior change targets that can be incorporated into behavior change trials to make them more informative;

3) Maintain a SOBC registry (e.g., of assays, interventions, best practices, guidelines, data) publicly available to the research community for advancing SOBC research;

4) Conduct systematic reviews of the behavior change literature and specifically, the adherence to medical regimens literature, in order to identify additional potential targets for future validation or research; and

5) Help coordinate activities between multiple awardees working on a single target class and ensure that results produced will be suitable for the RCC’s first three objectives.

In addition to the above, the application should also describe specific plans for the organization of the meetings and other activities of the SOBC program detailed above.

The RCC is expected to have significant experience and knowledge in the following areas; the application should highlight the depth of relevant experience and how it will be provided by the proposed team and structure.

• Conducting systematic reviews and meta-analyses of existing clinical trial reports and archived data sets, and using these sources to generate testable hypotheses concerning potential putative intervention targets, differential response of individuals to treatment, and estimates of intervention efficacy and effectiveness.
• All aspects of behavior change research and NIH-approved Good Clinical Practices (see http://www.nhlbi.nih.gov/research/funding/research-support/crg/management/comply-gcp.htm for more information) as well as ethical issues related to clinical research.
• Facilitating cooperation between basic and clinical scientists and in behavioral intervention development.
• Helping to take research questions from hypothesis to implementation and the ability to document these processes.
• Study design and statistics, particularly with novel designs and methods that could enhance the efficiency of validation studies and behavioral trial designs.
• Creativity and innovation in solving technical and project challenges, as well as coordinating efforts among disparate research communities.
• The three target domains (self-regulation; stress reactivity and stress resilience; interpersonal and social processes) sufficient to participate as a member of the subcommittee for that target domain and ensure that products produced by target domain subcommittees will be suitable for the first three objectives of the RCC.

It is also expected that the RCC will engage nationally with other organizations and projects working in similar areas and stay abreast of emerging basic and clinical science that could be integrated into the other projects supported by the SOBC Program. This could include other NIH-funded projects (e.g., PCAR, the NIH Health Systems Collaboratory, and CTSAs) as well as other federal or privately supported efforts and the academic community.

The exact boundaries of the activities of the RCC, the Target Validation Projects, and NIH are not possible to predict at this time, and will depend in large part on the capacities and experience of the Target Validation Project teams awarded. Some of these responsibilities will, therefore, need to be negotiated once the program is funded and started. Applicants should describe their willingness to be flexible in determining areas of responsibility in this collaborative program. The RCC will not be responsible for data coordination within the Target Validation Projects. Each Target Validation Project will have its own data collection, data quality control, and biostatistical staff. However, RCC applicants should describe how they envision facilitating interactions between the various Target Validation Project teams.

Applicants should describe their plans for providing administrative support for the activities of the SOBC Program, including but not limited to:

• Provision of a public website for communication and sharing of activities, events, and resources of the program.
• Organizational and logistical support for facilitating the activities of the subcommittees of the SOBC Steering Committee, as well as the External Scientific Panel (ESP; see below).
• Supporting standards and mechanisms for publically sharing data, resources, code, and documentation developed and used by the SOBC Target Validation Projects and by the RCC itself, as appropriate and consistent with achieving the goals of the program.
• Organizing and supporting the logistics of one face-to-face meeting of the SOBC Steering Committee in the Washington, DC area of approximately 1.5 days in each year of the award as well as one additional in-person meeting for each of the three Target Validation subcommittees assigned to a specific target domain areas (i.e., the Self-regulation Target Validation subcommittee, the Stress Reactivity and Resilience Target Validation subcommittee, and the Interpersonal and Social Processes Target Validation Subcommittee).
• Determining a schedule and organizing interim teleconferences with the Steering Committee, its subcommittees, and the ESP as appropriate.

Note that the contact PD/PI of the U24 RCC will serve as chair of the Steering Committee, for the first award year. Thereafter, other Steering Committee members may serve as chair on a rotating basis, as agreed by the Steering Committee.

Resource and Coordinating Center Transition Plan

The application should describe a plan for the transition of the materials produced to address each specific objective of the SOBC Program to a potential successor at the end of the 5-year project period. This should include ongoing documentation of required software, hardware, and licenses, as well as ongoing maintenance of standard operating procedures, best practices, and other documentation for management of the RCC. Inclusion of approaches and activities that will facilitate the transition of the activities and infrastructure of the RCC, including content of the public website, at the end of the award period is required. Continuation of the RCC beyond 5 years will not be supported by the Common Fund, but might be supported by other means.

Timeline for Achieving Objectives

As noted above, applications are encouraged to be creative and flexible in the approach to achieving the five objectives for the RCC outlined above, but should include a timeline that describes when and how the PD(s)/PI(s) will complete the activities proposed to achieve the RCC objectives. Applicants should also keep in mind that actual activities and completion dates may change following consultation with NIH staff and the SOBC Steering Committee.

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:

• All applications submitted for the January 25, 2015 due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.
• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• The SOBC Program encourages sharing of resources with broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication, both in other SOBC-supported projects and by other behavior change researchers. In addition, the SOBC Program expects the sharing of study data from both the RCC and the Target Validation Projects in a timely manner, and with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Thus, the SOBC Program expects awardees to implement a Resources and Data Sharing Plan consistent with achieving these program goals.
• In addition, the SOBC Program encourages sharing of software and code that are developed or modified to accomplish aims of this program. This may include, but is not limited to, software, tools, or protocols for stimulus generation, interventions or manipulations that engage targets, data analysis, and scoring. The goals of software sharing under this program include 1) broad availability to biobehavioral and biomedical researchers, research institutions, and government health care systems; 2) terms that permit the dissemination and/or commercialization of enhanced or customized versions of the software, or incorporation of the software or components of it into other software packages; and 3) terms of software availability that include the ability of individuals outside the applicant institution and its collaborating organizations to modify the source code and to share modifications with others. If software is developed with support from this program, awardees and their sub-contractors are expected to implement software sharing plans consistent with achieving the goals of this program.
• The application is expected to describe plans for
• Ensuring that data accumulated at the RCC are distributed to other relevant informatics resources in a standard data format; and
• Ensuring that the data accumulated under the RCC are made publicly available and can be retrieved from the RCC through multiple methods of querying, including simple web interfaces for common standard queries and tools to allow the downloading of large datasets.

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.

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

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

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.

This initiative is not subject to intergovernmental review.

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.

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.

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.

The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PD(s)/PI(s) in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above. The intramural project should be added as a separate component to the parent application.

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

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.

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).

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.

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?

Overall, does the application present a research strategy that will meet the five specific objectives: 1) Work in collaboration with approximately six Target Validation Projects in order to establish and curate a registry of successful assays and experimental manipulations for specific behavior change targets developed by the UH2/UH3 projects; 2) Develop, adapt, and adopt technical guidelines and best practices for the validation of assays of behavior change targets that can be incorporated into behavior change trials to make them more informative; 3) Maintain a SOBC registry (e.g., of assays, interventions, best practices, guidelines, and data) that is made publicly available to the research community for advancing SOBC research; 4) Conduct systematic reviews of the behavior change literature and specifically the adherence to medical regimens literature in order to identify additional potential targets for future validation or research; and 5) Help coordinate activities between multiple awardees working on a single target class and ensure that results produced will be suitable for the RCC’s first three objectives?

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?

Will the investigative team proposed by the RCC be able to facilitate cooperation between basic and clinical scientists? Does the investigative team have relevant experience and expertise in project management required for this RCC? Does the investigative team have relevant expertise in the conduct of systematic reviews, the development of technical guidelines and best practices, and the dissemination of research results and materials? Does the investigative team have sufficient expertise in the three target class domains being addressed by the Target Validation teams (self-regulation; stress resilience and stress reactivity; and interpersonal and social processes)?

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?

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?

Will the plan described for the management and coordination of the SOBC network enhance the efficacy of the Target Validation Projects being coordinated? Will the plan for the development, adaptation, and dissemination of project-related materials enhance their usability by other members of the SOBC network and the larger research community? Does the proposed center have a detailed plan for meeting the objectives in a timely fashion? The five objectives are: 1) Work in collaboration with approximately six Target Validation Projects in order to establish and curate a registry of successful assays and experimental manipulations for specific behavior change targets developed by the UH2/UH3 projects; 2) Develop, adapt, and adopt technical guidelines and best practices for the validation of assays of behavior change targets that can be incorporated into behavior change trials to make them more informative; 3)Maintain a SOBC registry (e.g., of assays, interventions, best practices, guidelines, and data) that is made publicly available to the research community for advancing SOBC research; 4) Conduct systematic reviews of the behavior change literature and specifically the adherence to medical regimens literature in order to identify additional potential targets for future validation or research; and 5) Help coordinate activities between multiple awardees working on a single target class and ensure that results produced will be suitable for the RCC’s first three objectives.

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?

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.

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.

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.

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.

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.

Not Applicable

Not Applicable

Not Applicable

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.

Not Applicable

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).

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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• 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 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 appropriate National Advisory Council or Board. 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.

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.

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 awardee'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.

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.

SOBC Research Network: The total collection of projects, committees, and staff that encompass the four companion FOAs: RFA-RM-14-017, RFA-RM-14-018, RFA-RM-14-019, and RFA-RM-14-020.

SOBC Resource and Coordinating Center (RCC): The awardee of RFA-RM-14-017 that will be responsible for coordinating activities across the network and other tasks as detailed below.

External Scientific Panel (ESP): A panel of four to six senior scientists with relevant expertise who are not PD(s)/PI(s) of a project involved in the SOBC Research Network that will provide recommendations to the SOBC Working Group about continued support of the components of the SOBC Research Network

SOBC Research Network Steering Committee: The main governing board of the SOBC Research Network comprised of PDs/PIs and NIH Project Scientists from each UH2/UH3 award and the U24 RCC award as well as additional investigators and NIH staff as appropriate. The Steering Committee will have subcommittees including one for each of the three target behavioral domains, and other subcommittees as deemed appropriate.

SOBC Working Group: The trans-NIH committee of NIH staff members that lead the NIH SOBC Common Fund Program. See http://commonfund.nih.gov/behaviorchange/members for more information.

Target Validation Project: One of the UH2/UH3 awards working on one of the three behavioral domains, namely, Self-regulation, Stress Reactivity and Resilience, or Interpersonal and Social Processes.

The PD(s)/PI(s) will have the primary responsibility for defining the details for the U24 project within the guidelines of this FOA and for performing the scientific activities. The PD(s)/PI(s) will agree to accept close coordination, cooperation, and participation of NIH Science of Behavior Change (SOBC) program staff in those aspects of scientific, and technical management of the project as described under "NIH Program Staff Responsibilities." For institutions/organizations proposing multiple PD/PI projects, all PD(s)/PI(s) will share the rights and responsibilities of an individual award as described by the NIH Multiple Program Director/Principal Investigator Policy (http://www.grants.nih.gov/grants/multi_pi/).

The PD(s)/PI(s) of the SOBC RCC will:

• Set project metrics and milestones for the goals of the RCC;
• Participate as a voting member of the Steering Committee and join relevant subcommittees created by the Steering Committee.
• Participate with the other Steering Committee members in determining the group process of setting research priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted;
• Fully disclose all database schema, algorithms, software source code, and methods to the other members of the SOBC Research Network and the broader scientific community for purposes of scientific evaluation;
• Work with the PD(s)/PI(s) of UH2/UH3 Target Validation Projects to facilitate the integrative analysis of data;
• Share results according to the data release policy developed for and by the Steering Committee;
• Plan and participate in outreach and dissemination activities, including developing, hosting, and maintaining a public website for the SOBC Research Network, attending workshops to discuss the project's progress, coordinating the publication of research results, and other coordination, outreach, and dissemination activities as determined by the Steering Committee;
• Submit periodic progress reports in a standard format, as agreed upon by the Steering Committee and External Scientific Panel (ESP);
• Accept and implement the common guidelines and procedures approved by the Steering Committee, ESP, and the SOBC Working Group;
• Accept and participate in the cooperative nature of the SOBC Research Network;
• Respond promptly and cooperatively for requests for information or input from the Steering Committee, SOBC Working Group, or ESP;
• Participate in quarterly conference calls with Project Scientists and/or other members of the SOBC Research Network including the Target Validation Projects, as scheduled and agreed upon by the Steering Committee;
• Attend a face-to-face kick off meeting in October or November of 2015 in the DC metro area that will be organized by NIH.
• In coordination with SOBC Working Group staff, plan, facilitate, and attend the face-to-face overlapping Steering Committee and ESP meetings to be held in the Washington, DC metro area or other location as determined by the Steering Committee.

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

The NIH Project Scientist assigned to the RCC will have substantial scientific and programmatic involvement that is above and beyond the normal stewardship role in awards through technical assistance, advice and coordination, as described below. However, the role of NIH Project Scientist will be to facilitate, not direct, the activities. It is anticipated that decisions in all activities will be reached by consensus of the Steering Committee and the Project Scientists will be given the opportunity to offer input to this process.

The NIH Project Scientist shall participate as a member of the Steering Committee where the Project Scientists may vote, but their combined votes will count as a maximum of one-third of the total number of votes.

The NIH Project Scientist will:

• Participate as a voting member of the Steering Committee and join relevant subcommittees;
• Participate with the other Steering Committee members in facilitating (not directing) the group process of setting research priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted;
• Serve as a liaison between the PD(s)/PI(s) and the ESP, the SOBC Working Group, the Common Fund Program, and individual Institutes and Centers;
• Attend annual face-to-face Steering Committee meetings as a voting member and assist in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action;
• Periodically report progress to the SOBC Working Group;
• Lend relevant expertise and overall knowledge of NIH-sponsored research to facilitate the selection of scientists not affiliated with the awardee institutions to serve on the ESP;
• Serve on subcommittees of the Steering Committee as appropriate;
• Provide advice in the management and conduct of SOBC-funded activities;
• Participate in data analyses, interpretation, and where warranted, co-authorship of the publication of results of studies conducted through the SOBC Research Network;
• Assist awardees in the development, if needed, of policies for dealing with situations that require coordinated action;
• Retain the option to recommend, with recommendations from the ESP, the withholding or reduction of support from any cooperative agreement that substantially: 1) fails to achieve its goals according to the milestones agreed to at the time of award; 2) fails to maintain state-of-the-art capabilities; or 3) fails to comply with the Terms and Conditions of the award.

Additionally, a Program Official from the administering IC will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Project Scientist is not required to be from the administering Institute, Center, or Office. A single individual may not serve the roles of both Program Official and Project Scientist.

Areas of Joint Responsibility include:

A Steering Committee will serve as the main governing board of the SOBC Research Network. The Steering Committee membership will include NIH Project Scientists and the PD(s)/PI(s) of each awarded cooperative agreement. The PD(s)/PI(s) of each UH2/UH3 project will have one vote on the Steering Committee. For projects functioning under a multiple PI structure, the multiple PD(s)/PI(s) will be expected to cast one collective vote. The Project Scientists may vote, but their combined votes will count as a maximum of one-third of the total number of votes. The PI of the Resource and Coordinating Center will serve as chair of the Steering Committee, for the first award year. Thereafter, members may serve as chair on a rotating basis, as agreed by the Steering Committee. Additional members may be added by action of the Steering Committee. Other NIH staff may attend the Steering Committee meetings if their expertise is required for specific discussions.

The Steering Committee will:

• Discuss progress in meeting the goals and milestones of the UH2/UH3 projects;
• Develop recommendations for uniform procedures and policies necessary to meet the goals of the SOBC Research Network.
• Adoption of procedures and policies developed by the Steering Committee will require concurrence by the ESP;
• Serve as a venue for coordination on the improvement of assay development and target validation scientific methods, for example by disseminating best practices and collectively evaluating new procedures, resources, and technologies;
• Designate subcommittees as appropriate;
• Each full member will have one vote. PD/PI members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

External Scientific Panel:

The External Scientific Panel (ESP) will be responsible for reviewing and evaluating the progress of the SOBC Research Network projects toward meeting their individual and collective goals and milestones. The ESP will provide recommendations to the SOBC Working Group about continued support of the components of the SOBC Research Network. The ESP is composed of four to six senior scientists with relevant expertise who are not PD(s)/PI(s) of a project involved in the SOBC Research Network. The membership of the ESP may be enlarged permanently, or on an ad hoc basis, as needed.

The ESP will meet face-to-face at least once a year, to overlap with the annual Steering Committee meeting. During part of this meeting, there will be a joint meeting with the Steering Committee to allow the ESP to interact directly with the awardees. Annually, the ESP will make recommendations regarding progress of the SOBC Research Network and present advice to the SOBC Working Group about changes, if any, which may be necessary in the SOBC Research Network.

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 arbitration. An Arbitration Panel will be convened, composed of 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 arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

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 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.

Awardees may also be required to submit periodic (biannually) progress reports in a standard format, as agreed upon by the Steering Committee and the ESP. As needed, the NIH may request information essential to an assessment of the effectiveness of the SOBC Research Network. Accordingly, recipients are hereby notified that awardees may be asked to provide information for program evaluation purposes, both locally and at the national level.

Additional reporting will be required for studies involving human subjects. In addition to progress reports, awardees will be expected to submit regular reports on adherence to Good Clinical Practices, including reviews of informed consent procedures, data quality, and participant safety. The content, format, and frequency of these reports will be established before human subjects recruitment begins

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

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National Center for Complementary and Alternative Medicine (NCCAM)
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National Center for Advancing Translational Sciences (NCATS)
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Jeff Ball
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Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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