It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Purpose:

This (FOA) is intended to provide funding to encourage research projects that seek to explain underlying mechanisms and predict health behaviors within individuals over time utilizing intensive longitudinal, within-person protocols that leverage recent advances in mobile and wireless sensor technologies and big data analytics. The research projects will collect and analyze data, disseminate project findings, and work collaboratively with each other and the research coordinating center (supported under RFA-OD-17-005).

Background:

The purpose of the Longitudinal Health Behaviors initiative is to establish a cooperative agreement network of 5 U01 projects and 1 U24 Research Coordinating Center (RCC), to collaboratively study factors that influence key health behaviors in the dynamic environment of individuals, using intensive longitudinal data collection and analytic methods. The network will also assess how study results can be leveraged to introduce innovations into longstanding behavioral theories to advance the field of theory-driven behavior change interventions. The knowledge gained will inform the development of personalized prevention strategies and best implementation strategies for communities, including health disparity populations, towards the goal of reducing disease risk and maintaining ideal health.

Behavioral science places strong emphasis on theoretical models to systematically explain and predict behaviors and events influencing health outcomes. Although these theories are useful frameworks for developing behavioral change interventions, their ability to explain and predict behavior has been only modestly successful.

Advances in health behavior theories and in our understanding of theoretical constructs are limited by a number of factors. Research on health behavior theory is inadequate and fragmented, limiting the potential to refine and improve theories based on empirical findings. Numerous theories co-exist, often with overlapping theoretical constructs, making the theories difficult to competitively test. Also, many constructs and target behaviors are measured via retrospective self-report instruments, some of questionable reliability and validity, which may contribute to weak explanatory relationships. Measurements are often made at a single time point, even though health behaviors and underlying theoretical constructs are inherently dynamic processes that change over time and interact with the environment. As such, this limits our ability to fully understand modifiable health behaviors that unfold over time within an interplay of psychological, social, and environmental factors that contribute to disease risk. Health behavior research, particularly the development of more effective intervention designs for targeting health behaviors, will not progress substantially without a new approach to the development and testing of dynamic theories.

Recent technological and methodological advances provide the field with new approaches for the development and testing of health behavior theories that have the potential to overcome the aforementioned limitations. The rapidly developing area of smartphone and portable sensor technologies has made it possible to continuously collect real-time data and perform intensive longitudinal assessments of individuals in their natural environments, oftentimes in an unobtrusive manner. In concert with advances in big data analytic techniques such as machine learning and computational dynamic modeling, data capture from sensing and EMA approaches allows researchers to assess behaviors and factors that affect these behaviors in ways previously not possible. By leveraging big data and analytic tools with recent advances in mobile and wireless sensor technologies that collect multi-dimensional data across contexts and time, we can enhance predictive value of theories and develop actionable effective health behavior interventions that are personalized for individuals.

The research funded by this initiative will examine theoretical constructs and health behaviors from a different scientific perspective and approach than has been traditionally used and is critical for moving health behavior science towards more effective health behavior interventions for reducing disease. Health behavior theories have developed and been evaluated primarily from a between-person perspective, attempting to explain why some people engage in health behaviors while others do not. While such questions remain important, this between-person focus has contributed to theoretical research that is predominately cross-sectional in nature and that emphasizes dispositional variables such as attitudes and normative beliefs which are relatively static over time and more trait-like in nature.

In contrast, a within-person approach to health behavior theory research seeks to explain why a given individual engages in healthy or risky behaviors at one time versus another. Within-person analysis of intensive longitudinal data is likely to provide insight into the dynamic factors in the physical, social, and/or built environment that facilitate or hinder engaging in certain behaviors at specific points in time, in addition to the interaction between factors.

This initiative will leverage advances in sensing, EMA and modeling to improve current models of behavior and behavioral change. This initiative will encourage measurement methods that reduce respondent reporting burden, which has constrained most studies to a few data points per day to measure only a few factors influencing behavior.

Scope and Objectives

To meet the research goals of this program, the U01 research applications will be expected to:

• Develop within-subject, intensive longitudinal studies of factors considered by existing theories to influence one or more health behaviors. Projects are encouraged to achieve efficiencies by studying multiple behaviors and their interactions that contribute to disease risk or maintaining ideal health.
• Address one or more theoretical constructs considered by existing health behavior theories or constructs that are not a focus of traditional theories that might have explanatory power from a within-subject perspective, as well as one or more contextual factors that may modify associations among intrapersonal factors with engagement in health behaviors at any given time.
• Utilize cutting edge technologies to assess the presence or absence of the targeted behavior(s) and constructs in real time, emphasizing methods with minimal respondent burden (e.g. sensor technologies). Selected technologies should be developed and validated, and data on sensitivity, specificity and reliability should be provided.
• The duration of intensive longitudinal data collection should reflect the hypothesized time period needed to observe changes in constructs and target behaviors. Projects with durations longer than 6 months are preferable.
• Sample a wide array of individuals who represent different initial behavioral states, different histories of the behavior, and different environmental contexts, including health disparity populations. Consideration will be given to samples drawn from existing cohorts, from which a wealth of additional data, including genetic and phenotypic data, can be leveraged.
• Where adequate existing data are not available, conduct preliminary measurement research during the first year to provide information about the choice of approach (not the feasibility). Pilot research should serve one of the following purposes: 1. Adapting existing measures of theoretical constructs for within-subject research, 2. To determine if and how novel sources of information (e.g., social media, online and mobile tools, sensor technology) can be used to estimate constructs traditionally obtained via self-report, and 3. For behaviors that cannot be continually assessed, determine the periodicity of assessments relative to the behaviors of interest.
• Use analytic approaches consistent with temporally dense big data to test the explanatory and predictive influences of constructs on target behaviors. Modeling approaches should address methods for handling missing data, scales, complex behavioral phenotyping, and other data analysis issues.

Specific Interests:

Applicants are strongly encouraged to contact the Scientific/Research Contact (see Section VII.,

Agency Contacts) of the IC that most closely matches their research focus to determine the IC's

interest in the proposed research topic. Examples of high interest topics for participating ICs include

but are not limited to:

NCI is interested in supporting research in the following specific content areas:

• Projects that incorporate geospatial factors into data collection and analysis plans to account for data collection across diverse places
• Incorporate data from multiple levels (e.g., biological, intrapersonal, interpersonal, community, policy) and types (e.g., self-report; sensor data) to explain and understand risky behaviors such as alcohol use, sedentary behavior, smoking, and poor diet.

NIAAA is interested in supporting research in the following specific content areas:

• Use of wearable sensors to measure abstinence and drinking behavior as outcomes in clinical trials of either behavioral or pharmacological therapies.
• Use of EMA designs to identify emotional, attitudinal, contextual, and social triggers of relapse following alcohol treatment.
• Epidemiological studies of the influence of mood states, environmental cues, and social contexts in the occurrence of heavy drinking occasions.

NIDA is interested in supporting research in the following specific content areas:

• Applications that use longitudinal data collection methods in the context of NIH’s HIV/AIDS high research priority areas https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html among drug using populations.
• Applications that conduct pharmacological and non-pharmacological interventions for individuals with co-morbid substance use disorders and HIV/AIDS that make use of longitudinal monitoring of treatment adherence, including potential for drug-drug interactions in the case of pharmacologic interventions.
• Studies in the context of addressing NIH high priority HIV/AIDS research that address new technologies and their applications to social phenomena such as natural language processing of structure and content of naturally occurring material on social media networks, and analysis of the functioning and impact of social networks.
• Studies in the context of addressing NIH high priority HIV/AIDS research that address new technologies and their applications to make more reliable and valid predictions of patient-level risk or treatment adherence.

NIMH is interested in supporting research that posits and tests fundamental theoretical constructs and models of behavior that are parameterized. The long-term goals of this behavioral research should be to identify quantifiable and predictable points at which interventions might be most effective and to facilitate future investigations linking these change points to neurobiological and/or neurodevelopmental processes. NIMH will prioritize research in the following specific content areas:

• Studies utilizing sensor technology in real world settings to identify imminent risk for suicidal (ideation or attempt) or self-injurious behavior. Applicants are encouraged to refer to A Prioritized Research Agenda for Suicide Prevention and Short-term Research Objective 2C (http://actionallianceforsuicideprevention.org/sites/actionallianceforsuicideprevention.org/files/Agenda.pdf)
• Incorporation of wearable sensors into studies of eating disorders to identify factors that predict variation in clinical symptoms and/or relapse following treatment (e.g., binge eating, purging, and social withdrawal).
• Technology that can identify, with a high degree of probability, environmental, behavioral, and biological triggers of psychotic or manic episodes.
• Use of sensor technology to measure trajectories of irritability and emotional dysregulation in youth and that can be used for early prediction of psychopathology.
• EMA assessments that measure real-time fluctuation (episodic) and intensity of emotional states in children.

Not Responsive for This FOA

Examples of research projects that are not responsive for this FOA include, but are not limited to:

• Research projects focused solely on studies in laboratory environments where stimulus conditions are systematically varied over multiple observations.
• Research projects focused on the development of new technologies. While some additional programming may be required to integrate or customize an existing technology for the specific research project, these efforts should be sufficiently limited.
• Although usability, acceptability, and feasibility of the technology or sensor implemented in the project may be considered as secondary research questions, they should not be the primary objectives of applications submitted to this FOA.

Data Harmonization and Sharing

Because of the likelihood that some funded applications will examine similar types of health behaviors and address interconnected questions relating to health behavior theory, awardees of this FOA will be encouraged to participate in post-award standardization and harmonization efforts, as scientifically appropriate.

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

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
• 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 not 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).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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

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

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:

Dana Wolff-Hughes, PhD
Phone: 301-496-0979
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.

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

Travel: Applicants are required to include travel support for up to two investigators from their research team to attend the annual meeting. In the budget, a travel budget of one trip per year to these meetings should be included

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:

Specific Aims: Outline the general objectives of the proposed Research Project and the overall approach to achieving these goals.

Research Strategy: Applications should describe and include following information:

• Address how the research project meets the scope and objectives outlined in Section I.
• A concise description of the overall strategy, methodology and analyses to be used to accomplish the goals and specific aims of the study
• Identify clearly which health behaviors and health behavior theories will be investigated
• Specify techniques for minimizing respondent burden and maximizing compliance with study protocols.
• Address the technical and consent issues related to access of participants digital footprints in their daily interactions with technology. Applications are expected to address the considerable privacy and security protections that will need to be in place to implement appropriate consent process and access.
• Explain how the research project will contribute to the goals of the Intensive Longitudinal Health Behaviors Initiative
• Explain how expected findings may advance health behavior theories and inform improvements in interventions
• A discussion of responsibilities as part of the multi-center collaborative project
• Specify how a team-based approach will be implemented that includes theoreticians, technologists, methodologists with intensive longitudinal expertise, and statistical and computational experts
• What you may offer for other Network projects: List unique strengths of your team that may be useful for other awardees.

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, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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 PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

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? Is there a strong scientific premise for the project? 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?

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

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? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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?

Specific to this FOA: Are the sensor technologies sufficiently well developed to yield data with acceptable levels of sensitivity, specificity and reliability? How user friendly are they for study participants asked to use them over prolonged periods, in terms of cognitive understanding, physical comfort, and privacy? Are adequate measures taken to protect privacy and confidentiality, and to address missing data and other potential problems affecting the analysis?

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.

Not Applicable

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 Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

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

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

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

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

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

• All aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms.
• Establishing goals and objectives that are realistic, measureable, and time-oriented for all phases of the project
• Participating in the development of common measures and methods for assessing health behavior;
• Sharing data with investigators within the Network as well as with qualified investigators who are not part of the Network or NIH;
• Serving as voting members on the Steering Committee;
• Participating in in-person scientific meetings once a year, and monthly teleconferences;
• Abiding by the Intensive Longitudinal Health Behaviors governance document, which will be developed during the first year of funding, and by decisions of the Steering Committee;
• Providing information to the NIH Program Directors and NIH Project Scientists concerning progress by submitting annual progress reports in a standard format, and by providing additional information as needed;
• Hosting annual site visits to be conducted by NIH staff;
• Cooperating with NIH Project Scientists in the program evaluation process;
• Committing a minimum of 2.4-person-months effort per year to the award; and
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

NIH Project Scientists will have the following responsibilities:

• Advising on the development of common measures and methods for assessing health behaviors;
• Participating in the development and conduct of trans-network research as appropriate;
• Collaborating with Network investigators in some shared activities, including co-authoring papers if appropriate;
• Serving as members on the Steering Committee;
• Participating in in-person scientific meetings once a year, monthly Steering Committee teleconferences, and working group and committee calls on a weekly, bi-monthly or as-needed basis;
• Monitoring the operations of the RCC and the U01 research projects, and making recommendations on overall project directions and allocations of project funds;
• Reviewing the individual progress of the RCC and U01 research projects, as well as the progress of network collaborations;
• Assisting the Network awardees as a liaison in stimulating their broader interactions with other NIH programs to disseminate results and outcomes from the program and effectively leverage existing NIH resources and infrastructures;
• Evaluating the adherence of Network awardees to the approved data sharing plans and intellectual property plans; and
• Conducting site visits for the RCC and all the U01 projects annually.
• Additionally, an NIH Program staff member will serve as Program Official, who will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the Notice of Award.

Areas of Joint Responsibility include:

Steering Committee: The Steering Committee will serve as the operational governing board for the network. The Steering Committee will be composed of the following voting members:

• The PD(s)/PI(s) of the RCC who will collectively have one vote
• The PD(s)/PI(s) of the U01 research projects who will have one collective vote per project
• The NIH Project Scientists who will collectively have one vote

Key co-investigators and pre- and postdoctoral trainees, in addition to the PD(s)/PI(s), are eligible to attend Steering Committee meetings. An Intensive Longitudinal Health Behaviors PI selected by voting members will chair the Steering Committee on a rotating basis. The Steering Committee will convene shortly after funding to review draft policies and procedures to guide Network activities.

The Steering Committee will meet at least monthly via teleconference or videoconference to share information on planning, study progress and challenges, preliminary results and analyses in progress. One of these meetings should occur during an annual meeting of Intensive Longitudinal Health Behaviors Network Principal Investigators and key study investigators, and the respective NIH program staff.

The Network will establish working groups and subgroups to address scientific and administrative issues and to implement Network policies and goals. See Terms and Conditions, Section VI.2 for additional information.

Dispute Resolution:

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

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.

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

The Office of Behavioral and Social Sciences (OBSSR) does not accept assignment of applications or manage awards that are funded. Please contact one of the ICs listed below for inquiries regarding the suitability of the proposed project for the FOA and the IC’s research portfolio.

Dana Wolff-Hughes, PhD
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-496-0979
Email: [email protected]

Richard P. Moser, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6915
Email: [email protected]

Michael Hilton, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-9402
Email: [email protected]

Richard A. Jenkins PhD
National institute on Drug Abuse (NIDA)
Telephone: 301-443-1923
Email: [email protected]

Kathleen C. Anderson, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-5944
Email: [email protected]

Weijia Ni, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-594-3292
Email: [email protected]

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Edith Davis
National institute on Drug Abuse (NIDA)
Telephone: 301-827-6697
Email: [email protected]

Rebecca Claycamp, CRA
National Institute of Mental Health (NIMH)
Telephone: 301-443-2811
Email: [email protected]

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 Part 75.