It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) 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 initiative is funded through 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 the SOBC Common Fund Program [http://commonfund.nih.gov/behaviorchange/] is to implement a mechanisms-focused, experimental medicine approach to behavior change research and to develop the tools required to implement such an approach. An experimental medicine approach involves identifying putative intervention targets, 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 are synonymous with "mechanisms of action" and with processes that are hypothesized to be malleable and to play a causal role in producing behavior change. Behavior change, as defined here, includes the initiation, cessation, modification, maintenance, and medical regimen adherence to behaviors (e.g., diet, exercise, abstinence from substance use, behavioral regimens, treatment regimens) that have broad health implications across a wide range of clinical endpoints. Appropriate adherence to prescription medications, screenings, immunizations, behavioral regimens, etc., prescribed by a health professional or emanating from a health authority, such as guidelines from the Centers for Disease Control and Prevention (i.e., medical regimen adherence) is a highly desired health behavior outcome.

The SOBC Program seeks to promote research across disciplines on the initiation, personalization, and maintenance of behavior change that leads to an improved understanding of the underlying principles of behavior change. One seemingly intractable problem is the gap between practice and research, in which interventions shown to be efficacious under controlled conditions are not adopted for use, or are unsustainable, outside of the research context or in real world settings. This initiative seeks to bridge that gap by focusing efforts on the optimization of behavior change interventions through an explicit interrogation of putative targets/mechanisms of action at one or multiple levels of analysis that are theoretically or conceptually relevant to desired changes in health behavior(s), including medical regimen adherence. Whereas examining mechanisms of behavior change can be considered basic research, and behavioral intervention development research can be considered applied research, this FOA combines the two such that basic research is use-inspired with the goal of optimizing behavior change interventions.

Through this FOA the NIH Common Fund encourages administrative supplement applications to test how and why behavior change interventions produce and sustain desired outcomes when implemented in experimental, clinical, community, or population-level settings. The current SOBC Program focuses on putative behavior change targets in the three broad domains of self-regulation, stress reactivity and stress resilience, and, interpersonal and social processes, for which strong evidence exists that hypothesized mechanisms predict theoretically-relevant sustainable changes in health behavior(s), including medical regimen adherence.

Research encouraged through this FOA is intended to support the study of putative targets/mechanisms of action that are critical to the efficacy and effectiveness of behavior and social interventions to produce and, as feasible, sustain desired change(s) in health behavior(s), including medical regimen adherence. Research encouraged through this announcement is intended to support target validation, assay research, and development activities within three broad domains of self-regulation, stress reactivity and stress resilience, and interpersonal and social processes. The ultimate aim of this initiative is to generate use-inspired knowledge, that when applied, will maximize the potency and/or efficiency of efficacious behavior change interventions for delivery in non-research/routine settings with representative populations.

Human behavior accounts for about 40 percent of the risk associated with preventable premature deaths in the United States. Substance use and abuse, physical inactivity, poor diet, poor sleep habits, and risk-taking in a variety of contexts are among the many behaviors known to play a role in adverse health conditions. Researchers are beginning to make progress in understanding some of the basic mechanisms that account for less-than-optimal initiation and maintenance of behavior change.

Well-documented challenges to medical regimen adherence serves as one exemplar of the challenges in initiating and sustaining healthful behavior change. There is strong evidence that many patients with chronic conditions, including asthma, hypertension, diabetes, HIV/AIDS among a host of others have difficulty with medical regimen adherence. The World Health Organization notes that medical regimen adherence takes into account the extent to which a person’s behavior taking medication, following a diet, and/or executing lifestyle changes (including, for example, science based physical activity guidelines), corresponds with agreed recommendations from a health care provider . The CDC has developed health-related guidelines. Following these guidelines may be one example of medical regimen adherence. Medical regimen adherence includes, but is not limited to: adherence to prescribed medications, adherence to prescribed or recommended screening and immunization schedules, adherence to behavioral regimens recommended by a physician, dentist, or other health professional, including follow-up tests, dietary modifications, and exercise. Although a significant number of adherence interventions and guidelines focus on providing education to increase knowledge, extant data suggest that information alone is not sufficient for the initiation or maintenance of medical regimen adherence. The integration of putative targets in order to tailor an adherence intervention to particular processes holds considerable promise.

The first stage of work under SOBC (SOBC 1) capitalized on emerging basic science to accelerate investigation of common mechanisms of behavior change applicable across a broad range of health-related behaviors, linking approaches from the laboratory and the field. Through a series of activities, SOBC 1 identified the challenges to testing causal mechanisms in behavior change studies, including the need for validated consensus assays, support for incorporating mechanisms tests across the intervention development pipeline, and opportunities to study common mechanisms associated with health behaviors that impact a wide range of clinical endpoints. SOBC 1 set the stage for a mechanisms-focused, experimental medicine approach as an alternative to the inefficient multi-component intervention, black box approach. SOBC 2 seeks to use an experimental medicine approach to develop interventions that engage targets hypothesized to be putative mechanisms of change, and explicitly include tests of both target engagement and behavior change.

Historically the development and validation of behavior change interventions have not been based on explicit tests of target engagement using well-validated assays. Instead, behavior change interventions tend to combine multiple components meant to engage a variety of mechanisms of action or targets, whether specified or not. Moreover, few intervention studies are designed to test whether the intervention actually engaged the (multiple) target(s) it was meant to engage, and whether engagement of the target(s) produced the desired behavior change. As a result, even successful intervention studies do not always inform behavior change research beyond the context in which they are tested.

The SOBC Program and other interdisciplinary NIH initiatives have made concerted attempts to bridge the research to real world implementation gap with representative populations. Indeed, challenges remain in moving evidence-based health behavior change interventions into non-research settings; more often than not, interventions deemed efficacious fail to be adopted in such settings. This trend appears to be due to characteristics of the intervention and to characteristics of the delivery system. There is value both in research to modify efficacious interventions to increase use in non-research settings, and in research to modify service delivery systems to accommodate efficacious interventions. This initiative seeks to direct efforts toward the generation of use-inspired research to inform the systematic improvement of behavior change (including medical regimen adherence) trial designs to optimize outcomes and advance a more unified science of behavior change.

Recognizing that health behavior change interventions often need to be simplified (or at least modified) for use in different non-research settings, this announcement solicits research to understand how and why such interventions work (i.e., their mechanisms of action ). When the mechanisms of action of an intervention are known, modifications can be made that preserve the intervention potency as much as possible. Without an understanding of the mechanisms of action, streamlining an intervention may inadvertently eliminate its most efficacious components, and thus may severely reduce its potency. We note that for some interventions, experimental work may yield inconclusive results that warrant further experimentation, or may indicate that the intervention is already concise and cannot be further simplified.

For the purposes of this announcement, the term mechanisms of action refers to the causal explanations for an intervention’s effects. This announcement distinguishes between mechanisms of action and mediators of an intervention’s effect, recognizing that there is healthy debate among methodologists about this point. This announcement defines a mediator as a variable that is hypothesized to be part of a causal chain between an intervention and an outcome, but for which causation has not yet been established. Until a mediator is shown to cause an outcome, it cannot be considered a mechanism of action, but can be considered a putative mechanism of action. In contrast, a mechanism of action is a demonstrated part of a causal chain between an intervention and its effect. Following from these definitions, mediators may be tested as possible causal mechanisms of an intervention s effect, and such tests must be designed to allow for causal conclusions. Also for the purposes of this announcement, the term "target" refers to the putative mechanism an intervention is meant to engage in order to cause behavior change. Using this language, this initiative encourages the testing of target engagement to test hypothesized mechanisms of change in representative samples in routine settings. The putative targets/mechanisms of change and the behavior change outcomes measured should be selected based on hypothesized relevance to at least two clinical endpoints or disease conditions.

This administrative supplement initiative seeks to support the experimental manipulation of putative mechanisms of action/targets to understand how desired behavior change intervention outcome(s) are produced and/or sustained. Within the context of current NIH-funded research, activities or aims supported by this FOA are expected to:

• Specify, and provide a clear rationale or theory for, the mechanisms by which the intervention is hypothesized to cause its effect(s).
• Involve an experimental manipulation of the theory-derived putative target(s)/ mechanism(s) explaining the intervention’s effect(s). Experimental manipulation may involve manipulating intervention components theorized to be causal factors for the effects of a multi-component intervention, varying the dose of a proposed mechanism, adding or subtracting a component of an intervention, or other designs.
• Include a check of the experimental manipulation (i.e., ensuring that the hypothesized mechanisms actually changed, in the predicted way, as a result of the manipulation).
• Test whether changes observed in the hypothesized mechanism(s) predict theoretically-relevant outcome(s).

(Note that as long as causality can be inferred with a reasonable degree of certainty, experimental manipulation does not necessarily imply a randomized clinical trial design)

Additional activities may also be appropriate, but only if they serve the purpose of facilitating an experimental study of putative targets/mechanisms of action of the health behavior change intervention as implemented in experimental, clinical, community, or population-level settings.

For example, adding collaborators with expertise in studying mechanisms or expertise in methodology or relevant technology may be critical. In addition, investigators may need to improve measurement or the measurement schedule, add participants, or purchase software or technological aids, etc. In cases where experimental manipulation might contaminate the parent study, it may be necessary to recruit additional participants from the target population.

Current/active NIH-funded research across all stages of development (from early-phase intervention development studies through efficacy and effectiveness studies) can be considered for this administrative supplement announcement if proposed activities fall within the scope of the approved and funded parent award. The proposed supplement activities should be feasible and appropriate for the stage/phase and design of the parent project. Applicants are strongly encouraged to discuss potential eligibility of their funded research with the scientific/research contacts for this FOA, and program and grants management officials responsible for the parent study.

In addition to falling within scope of the approved and funded parent award, proposed activities must be appropriate to the purpose of this announcement. Appropriate activities include, but are not limited to:

• Projects that involve experimental manipulation of putative targets/mechanisms of action;
• Projects that add one or more measures/assays of a hypothesized target/mechanism;
• Projects that adapt an experimental manipulation of putative targets/mechanisms of action for a new health behavior or condition; and
• Projects that develop or adapt measures/assays of a hypothesized target/mechanism for use in experimental, clinical, community, or population-level settings.

Activities considered to fall outside the scope of the approved and funded parent project will not be eligible for this administrative supplement opportunity. Current NIH-funded research that involves animals as a critical component of a health behavior change intervention may be appropriate. However, research focused exclusively on animal models of human health behavior and social processes are not appropriate for this administrative supplement FOA. Further, activities that do not seek systematically to elucidate mechanisms of action responsible for producing and/or sustaining behavior change in experimental, clinical, community, or population-level settings are not appropriate for this announcement.

For guidance in determining whether proposed activities are within scope, applicants are strongly encouraged to contact scientific/research contacts for this FOA, and program and grants management officials responsible for the parent study.

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.

All organizations administering an eligible parent award may apply for a supplement under this announcement.

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)
• 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)

This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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. Since administrative supplements are made against active grants and cooperative agreements, many of these registrations may already be in place. 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. Grants.gov registration is only required if you plan to submit using the 'Electronic Application Submission through Grants.gov' option.

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.

Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are encouraged to work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

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

Only one administrative supplement application per parent award will be considered for this FOA. Multiple administrative supplement applications per parent award will not be considered. Since applications in response to this FOA will receive administrative review by the SOBC Program staff, and will not receive peer review, the NIH policy on resubmissions will not apply.

Applicants must prepare applications using current forms in accordance with the Application Guide.

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.

All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.

It is critical that applicants follow the instructions for their submission option (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to documented requirements 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.

All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

The Research Strategy is limited to six pages.

Administrative supplement requests for most single-project activity codes can be submitted using either paper or electronic submission processes. Administrative supplement requests for multi-project activity codes must be submitted using the paper submission process. See Activity Code section in Part 1 to determine if electronic submission is an option for your activity code.

Applicants submitting paper applications must use the PHS 398 Application Forms and the PHS 398 Application Guide.

Instructions for Electronic Application Submission through Grants.gov

Use the Apply button(s) in Part I of this announcement to access the application forms package posted at Grants.gov. If presented with more than one form package, use the Competition ID and Competition Titles provided to determine the most appropriate application forms package for your situation.

Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance:

• R&R Cover form: Select Revision in the Type of Application field.
• Research Plan form: At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.
• Project/Performance Site Location form: Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
• Sr/Key Personnel form: List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
• Budget forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities.
• R&R Other Project Information form: If applicable, attach PDF documents in the Other Attachments field indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Name the documents IACUC Documentation.pdf and/or IRB Documentation.pdf . Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement.

Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions

NIH offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User s Guide for submitting through this system is available, with the following additional guidance:

• Budget information should be entered for the grantee institution in the tabs provided for each selected budget period.
• Since there is no template or form available for subaward budget information, all subaward information must be included as a PDF attachment in the Subrecipient Budgets section showing the funds requested (by budget period) and using the same categories provided for the grantee institution. The attachment must also include any related budget justification information.
• Use the Add Other Attachments function to include the following PDF documents:
• Research Strategy including a summary or abstract of the funded parent award or project.
• If applicable, attach documents indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.

Instructions for Paper-based Submissions using the PHS 398 Application Forms

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application, with the following additional guidance:

• Checklist: Select Revision in the Type of Application field.
• Face Page (Form Page 1): On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.
• Research Plan: At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.
• Project/Performance Sites section (Form Page 2): Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
• Sr/Key Personnel section (Form Page 2): List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
• Budget for Entire Proposed Project Period (Form Page 5): A proposed budget should be submitted using the PHS 398 budget forms and should only include funds requested for the additional supplement activities.
• If applicable, attach documentation in the Appendix section indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.

The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award. Submit a signed, typewritten original of the application, including the checklist, to:

Paige Green, Ph.D., M.P.H.
Basic Biobehavioral and Psychological Sciences Branch
National Cancer Institute
National Institutes of Health
9609 Medical Center Drive, Room 3E133
Rockville, MD 20850
Telephone: 240-276-6899
Email: paige.green@nih.gov

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the Application Guide.

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 electronic 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.

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

For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.

For paper-based application submission, information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 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 using the instructions specified above.

Applicants must complete all required registrations prior to submission. 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:
For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form of the SF 424(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.

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 (SAM). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

Not Applicable

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

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

Overall Impact

NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award:

• Are the proposed activities relevant to the parent grant?
• What is the likelihood of the proposed supplemental research to contribute to identifying the mechanisms of action of a health behavior change intervention?
• What is the level of rigor and appropriateness of the proposed methodology?
• Does the proposed research team have the necessary methodological and technological expertise, to conduct and achieve the supplemental study goals?
• What is the feasibility and appropriateness of the supplemental research plan to accomplish the goals within the proposed timeframe?
• Are the statistical analyses appropriate for the proposed supplemental activities?
• What is the status of progress on the parent grant and are the proposed activities appropriate to the current stage of the project?
• If there is a data sharing plan in the parent grant, is there an adequate plan to include the data collected in this administrative supplement?
• Will the administrative supplement increase or preserve the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

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, NIH staff 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, NIH staff 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.

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

NIH staff 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.

Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

Not Applicable

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. 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. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.

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.

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.

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.

Cooperative Agreement Terms and Conditions of Award

Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Research Performance Progress Report (RPPR) and financial statements as required 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: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

Inquiries and discussion of plans for responding to this FOA are strongly encouraged. Interested applicants are encouraged to contact the Program Officer listed on the NoA of the parent award and one of the SOBC Common Fund Program representatives listed below for questions relevant to the scientific scope of the request. The institute affiliations of SOBC Common Fund Program representatives do not imply that applications are restricted to those NIH institutes missions. The SOBC Program encourages applications from awardees of all participating NIH Institutes, Centers, and Offices.

Paige Green, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6899
Email: paige.green@nih.gov

Will Aklin, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-1428
Email: aklinwm@mail.nih.gov

Melissa Riddle, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-451-3888
Email: riddleme@mail.nih.gov

Jonathan King, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-4156
Email: kingjo@nia.nih.gov

Not Applicable

Inquiries and discussion of plans for responding to this FOA are strongly encouraged. Interested applicants should contact the Grants Management Officer or specialist listed on the NoA of the parent award.

Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: dawn.mitchum@nih.gov

Michael Morse
Office of the Director, NIH
Office of Strategic Coordination (Common Fund)
Telephone: 301-435-5446

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.