EXPIRED
National Institutes of Health (NIH)
This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the Office of the NIH Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/). The FOA will be administered by the National Institute on Drug Abuse (NIDA/NIH) (http://www.nida.nih.gov) on behalf of the NIH.
Science of Behavior Change: Revision Applications for Use-inspired Research to Optimize Adherence, Behavior Change Interventions, and Outcomes (U01)
U01 Research Project Cooperative Agreements
New
RFA-RM-17-023
RFA-RM-17-024 R34 Planning Grant
RFA-RM-17-022 R01 Research Project Grant
RFA-RM-17-028 R21 Exploratory/Developmental Research Grant
93.310
Supported by the NIH Common Fund (Common Fund) Science of Behavior Change (SOBC) Program, this Funding Opportunity Announcement (FOA) solicits competitive revision (formerly known as a competitive supplement) applications to NIH-supported clinical trials awarded as research project U01 cooperative agreements. (See information about the new NIH clinical trial definition at https://osp.od.nih.gov/clinical-research/clinical-trials/.) The goal of the SOBC Program is to advance a mechanisms-focused, experimental medicine approach to behavior change research. Funded projects in the SOBC Research Network (https://commonfund.nih.gov/behaviorchange/fundedresearch) have developed experimental manipulations, assays, and/or measures (hereafter referred to as assays for brevity) to support an experimental medicine approach to behavior change research. The SOBC Measures Repository is accessible from the SOBC Research Network Open Science Framework (OSF) page at https://osf.io/zp7b4. The goal of this FOA is to accelerate the adaptation, validation, and translation of SOBC Research Network assays for use in ongoing clinical trials. This FOA calls for the integration of SOBC Research Network assays into active NIH-supported clinical trials of drugs, devices, procedures, or behavior modifications. The active NIH-supported clinical trial used to respond to this FOA does not have to be a behavior change trial or identify behavior change as a primary outcome. The integration of SOBC Research Network assays into ongoing clinical trials will accelerate the development of interventions and experimental manipulations that have been shown to engage specific mechanisms of behavior change and the development of assays that verify engagement of those behavior change targets.
September 18, 2017
November 5, 2017
November 5, 2017
December 5, 2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date. No late applications will be accepted for this Funding Opportunity Announcement.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
May 2018
July 2018
December 6, 2017
Not Applicable
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
The overarching mission of the SOBC Program is to implement a mechanisms-focused, experimental medicine approach to behavior change research and to develop the assays required to implement such an approach. An experimental medicine approach involves four steps: 1) identifying putative intervention targets; 2) developing assays (measures) to permit verification of target engagement; 3) engaging the target through experimentation or intervention; and 4) testing the degree to which target engagement produces the desired behavior change. 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, and maintenance of behaviors (e.g., diet, exercise, abstinence from substance use, adherence to prevention or treatment protocols) that have broad health implications across a wide range of functional and clinical outcomes and disease conditions. Appropriate adherence to prescriptions, screenings, immunizations, behavioral regimens, and the like, as prescribed by a health professional or as an evidence-based recommendation of an authorized entity, such the Centers for Disease Control and Prevention or the U.S. Preventive Services Task Force, is a highly-desired health behavior outcome.
Historically the development and validation of behavior change interventions have not included explicitly controlled interrogations of putative target engagement using well-validated measures or assays. Few intervention studies have been designed to test whether the intervention engaged the target(s) it was meant to engage, and whether engagement of the target(s) produced the desired behavior change. In the absence of explicit tests of how and for whom interventions work, interventions deemed successful are difficult to implement in other populations or settings. This widens the gap between research and practice, in which interventions, demonstrated to be efficacious under controlled conditions, are not adopted for use, or are not sustainable, in different research environments, clinical practices, and community- or population-level settings.
To encourage progress toward solving the challenges outlined above, the SOBC Program promotes an experimental medicine approach to behavior change research. This approach requires an explicit interrogation of the putative target(s)/mechanism(s) of action at one or multiple levels of analysis (e.g., neuroimaging, behavioral observation, or self-report). To date, the SOBC program has funded the development and testing of specific experimental manipulations meant to engage specific health-related targets, and the development and testing of measures or assays to verify target engagement. The SOBC Program focuses on putative targets in three broad domains: self-regulation; stress reactivity and stress resilience; and interpersonal and social processes. Evidence suggests mechanisms of action within these domains predict theoretically-relevant sustainable changes in health behaviors, functional and clinical outcomes, or disease conditions.
Research Objectives
The primary purpose of this revision FOA is to encourage the adaptation, validation, and verification of assays meant to engage and verify engagement of behavior change targets hypothesized to be malleable, and responsible for behavior change. Activities and aims supported through this FOA must leverage at least one SOBC Research Network assay related to a putative target from the self-regulation, stress reactivity and stress resilience, or interpersonal and social processes domains. The SOBC Measures Repository is accessible from the SOBC Research Network OSF page at https://osf.io/zp7b4. Applicants must use an NIH-supported clinical trial as the empirical context for target verification/validation, engagement through experimentation or intervention, and examination of the degree to which engagement produces a behavior change relevant to the purpose, goals, or outcomes of the parent trial. (See information about the new NIH clinical trial definition at https://osp.od.nih.gov/clinical-research/clinical-trials/.) Required elements of the proposed revision activity include: (1) a well-justified scientific rationale or theory for the selection of the putative target(s)/mechanism(s) of action; (2) use of one or more SOBC Research Network assays; and (3) a behavior change outcome relevant to the parent trial.
Revision applications can support a significant expansion of the scope or research protocol approved and funded for the parent trial. The proposed research scope must meet the aims of the SOBC Program as outlined in this FOA. The justification for the scope expansion should include clear rationale or theory for the mechanism(s) of action by which the intervention is hypothesized to cause a behavior change outcome relevant to the parent trial. Further, activities and aims proposed must include these two steps:
1. Identify a putative target(s)/mechanism(s) of action in one of the three SOBC Program target domains implicated in a behavioral outcome relevant to the purpose, goals, or outcomes of the parent trial
2. Use a SOBC Research Network assay to engage the identified target(s) or verify target engagement
Applications that also include this third step are highly desirable.
3. Test the degree to which engaging the putative target(s) produces a desired change in a behavioral outcome relevant to the purpose, goals or outcomes of the parent trial.
Appropriate activities include, but are not limited to, activities that:
Additional activities may be appropriate if they serve the purpose of facilitating an experimental medicine approach to study putative target(s)/mechanism(s) of action from the SOBC Program domains of self-regulation, stress reactivity and stress resilience, and interpersonal and social processes. Adding collaborators with expertise in behavior change, the SOBC Program target domains, or clinical trial methodology might be appropriate to meeting the aims proposed in response to this FOA. In cases in which experimental manipulation might contaminate the parent trial, it may be necessary to recruit additional participants from the target population, add additional arms or conditions to the parent trial, and/or design a sub-study in which only a sub-sample of the parent trial participates. Applications should justify how the work conducted for the proposed project will lay the foundation for a systematic improvement of behavior change trial designs to advance a more unified science of behavior change.
Relevant active U01 cooperative agreements across all stages of clinical trial development (from early-phase intervention development studies through efficacy and effectiveness studies) potentially are eligible for this competitive revision announcement. An administering Institute/Center/Office (ICO) can deem any active NIH-supported clinical trial awarded as an U01 cooperative agreements scientifically and programmatically eligible for this opportunity.
Before applying, all applicants are strongly encouraged to discuss proposed aims and activities in response to this FOA with the parent award Program Official and one of the SOBC Common Fund Program Scientific/Research contacts listed in this FOA.
Awardees will be required to attend the Fiscal Year 2019 annual SOBC Research Network Steering Committee meeting to be held for 2 days in or near Bethesda, Maryland.
Responsiveness
Applications that do not propose to use SOBC Research Network measures, assays, and/or experimental manipulations will be deemed non-responsive and will not be reviewed.
Activities/aims for competitive revision applications that do not 1) Identify a putative target(s)/mechanism(s) of action in one of the three SOBC Program target domains implicated in a behavioral outcome relevant to the purpose, goals, or outcomes of the parent trial and 2) Use an SOBC Research Network assay to engage the identified target(s) or verify target engagement are not responsive to this FOA.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
Revision
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Application budgets are limited to $500,000 per year in direct costs and should not exceed the budget of the parent award. All application budgets should reflect the actual needs of the proposed project.
The scope of the proposed project should determine the project period. The maximum project period is 2 years, but the project cannot extend beyond the end date of the parent award.
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
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
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. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. 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:
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:
The letter of intent should be sent to:
Will M. Aklin, Ph.D.
National Institute on Drug Abuse
Telephone: 301-827-5909
Fax: 301-443-2599
Email: will.aklin@nih.gov
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. Note that awardees will be required to attend the Fiscal Year 2019 annual SOBC Research Network Steering Committee meeting to be held for 2 days in or near Bethesda, Maryland. Application budgets should include sufficient funds for at least one Principal Investigator to attend and present at this meeting.
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:
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:
Applications are expected to include a Data Sharing Plan that includes commitment to data sharing and explains procedures for sharing protocols, data, and results obtained using the funding from the proposed revision with Network members and the public, following their initial publication, consistent with achieving the goals of the program. In addition to any project-specific plan, protocols, data, and results are expected to be shared on the same platforms that currently support data sharing within the SOBC Research Network, which include linkage to the Open Science Framework. All awardees will therefore be required to have an Open Science Framework account and a public-facing page.
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.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) 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 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 the SOBC Common Fund Program, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the primary scientific contact, Dr. Will M. Aklin (NIDA) by email at will.aklin@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
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.
For this particular announcement, note the following:
Reviewers will assign a single impact score for the competing revision application that focuses on an experimental medicine approach to behavior change through the activities described in Section I of this announcement. Reviewers will evaluate the potential of the proposed application to advance implementation of a mechanisms-focused, experimental medicine approach to behavior change research. Reviewers are asked to consider the following questions specific to this FOA:
Does the application include a well-justified scientific rationale or theory for the selection of the putative target(s)/mechanism(s) of action (required) implicated in a behavioral outcome relevant to the purpose, goals, or outcomes of the parent trial (required)? To what extent do the proposed activities test the degree to which engaging the putative target(s) produces a desired change in a behavioral outcome relevant to the purpose, goals or outcomes of the parent trial?
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?
Specific to this FOA: How would this project relate to the overall SOBC Program goal to advance an experimental medicine approach to behavior change? Are the SOBC Research Network assays proposed to be used in the application likely to influence behavior change science? Is the selection of the putative target(s)/mechanism(s) of action, the SOBC Research Network tool, and the behavior change outcome relevant to the parent trial well justified?
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?
Specific to this FOA: Does the application propose to use an SOBC Research Network tool in a novel or understudied experimental, clinical, community, or population level setting? If so, is the proposed use well justified and powered to provide meaningful results? Does the application address how work conducted under this project will lay the foundation for a systematic improvement of behavior change trial designs, advancing a more unified science of behavior change?
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?
Specific to this FOA: Is a clear rationale or theory for the mechanism(s) of action by which the intervention or experimental manipulation is hypothesized to cause a behavior change outcome relevant to the parent trial articulated?
Does the proposed approach have potential to generate evidence supporting the utility and generalizability of SOBC Research Network assays and target engagement strategies for future implementation in behavior change trials?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (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.
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
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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. Applications will be reviewed by a Special Emphasis Panel, and not by the same locus of review as the parent award, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
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
Terms and Conditions as specified in the parent award remain in effect.
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 RPPR, 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: 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
Will M. Aklin, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-5909
Email: will.aklin@nih.gov
Paige Green, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6899
Email: paige.green@nih.gov
Jonathan W. King, PhD
National Institute on Aging (NIA)
Telephone: 301-594-5942
Email: jonathan.king@nih.gov
Melissa W. Riddle, PhD
National Institute of Dental and Craniofacial Research
(NIDCR)
Telephone: 301-451-3888
Email: melissa.riddle@nih.gov
Maribeth Champoux, PhD
Center for Scientific Review (CSR)
Telephone: 301-594-3163
Email: maribeth.champoux@nih.gov
Chris Darby
Office of Strategic Coordination (OSC) - The Common Fund
Telephone: 301-480-1059
Email: chris.darby@nih.gov
Pamela Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
Email: pfleming@nida.nih.gov
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.