National Institute of Mental Health (NIMH)
Reissue of RFA-MH-19-235
The overall goal of this Funding Opportunity Announcement (FOA) is to identify, in animals, in vivo neurophysiological and behavioral measures for use as assays in the early screening phase of treatment development. The FOA will support efforts to optimize and evaluate measures of neurophysiological and behavioral processes that may serve as surrogate markers of neural processes of clinical interest based on available knowledge of the neurobiology of mental illnesses. The screening assays thus developed from this FOA are expected to build upon systems neurobiology and clinical neuroscience to enhance the scientific value of preclinical animal data contributing to a therapeutic development pipeline by assessing the impact of therapeutic targets and treatment candidates on neurobiological mechanisms of clinical relevance to mental illnesses.
The objectives of the FOA will be accomplished by supporting basic and translational neuroscientists who are committed to improving the efficiency and scientific value of the therapeutic development pipeline by advancing the discovery of in vivo physiological and behavioral measures reflecting circuit engagement as tools for early phase target validation and therapeutic screening for mental illness treatment development. The efforts supported by this initiative focus on measures in animals as a first step in generating translational assay measures that are adaptable across early therapeutic screens in animals to evaluation in humans. As such, this FOA may be considered a prequel to build a suite of assays that are evaluated in future projects for coherence of assay performance between the preclinical species and healthy humans. In summary, this FOA will support efforts to improve the tool kit of assays available for early phase testing of novel therapeutic agents by incorporating measures proximal to neural systems that impact mental health.
May 29, 2019
The first standard application due date for this FOA is October 5, 2019.
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.
It is critical that applicants follow the instructions in 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 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.
Background and Research Objectives
Despite large investments by pharmaceutical and biotech industries, the last 20 years have yielded few novel treatments to address unmet needs for individuals suffering with mental illnesses. Multiple factors have contributed to the low success rate, including insufficient understanding of disease pathophysiology and the basis for heterogeneity in presentation and treatment response of patients within categorical diagnoses. The NIMH supports efforts such as the Research Domains Criteria (RDoC) project to transform diagnostics (NIMH Strategic Plan for Research) by promoting research that extends beyond the current symptom-based diagnostic categories (i.e., Diagnostic and Statistical Manual, DSM) to identify functional domains whose disruption contributes significantly to disability across diagnoses. However, RDoC was designed to provide a context to examine functional domains and relevant neurobiology in humans, not in animals. While clinical neuroscience advances our understanding of circuit disruptions driving behavioral deficits in humans, the need for comparable efforts in basic neuroscience has become evident, particularly across the therapeutic development pipeline where behavioral screens in animals often contribute to the selection of lead candidates for the development of novel treatments for mental illnesses. The goal of this FOA is to address this gap by supporting the initial development and testing of innovative neurophysiological and behavioral measures that have potential to serve as translational screening assays in preclinical species.
The poor predictive value of current preclinical screening model systems in therapeutic development for neurological and mental disorders is well recognized by the pharmaceutical industry and was recently the topic of a high profile workshop (see National Academies of Sciences, Engineering and Medicine report, Therapeutic Development in the Absence of Predictive Animal Models of Nervous System Disorders: Proceedings of a Workshop). Commonly used batteries of behavioral assays in rodents such as the forced swim test, tail suspension test, elevated plus maze, novelty induced suppression, novelty induced feeding suppression, sucrose preference, open field activity test, and reversal of drug induced hyperlocomotion or grooming are useful in some contexts, such as addressing effects of novel ligands on brain and pharmacodynamic responses. However, these measures do not reflect specific neural processes or predict efficacy and relationships between these measures in animals and behavioral deficits or neural activity irregularities in patients is unknown.
Technical advances in neuroscience, including those generated through the BRAIN initiative, now provide tremendous opportunities to understand the functional impact of cell and circuit diversity and identify novel therapeutic targets. Still, while the neurobiology underlying target identification has advanced, neuroscience-based approaches to screen potential targets and treatment candidates in the therapeutic development pipeline have not kept pace. The current FOA is built on the premise that it is possible to develop neurophysiological and behavioral measures in animals that mirror a subset of brain activities and functional domains suggested by clinical neuroscience to impact mental health and disability, here defined as potentially “clinically relevant”. To advance such measures as assays for treatment development, this FOA encourages applications aimed at addressing three specific goals; 1) identification and optimization of measures that reflect clinically relevant brain processes that are potentially conserved between preclinical species and humans, 2) evaluation of the sensitivity and selectivity of the potential measures as screening assays by examining their performance in response to perturbations such as drugs, and 3) testing the role of the brain pathways hypothesized to underlie the physiological and/or behavioral assay measure. Completion of these goals is expected to unveil novel, research-based physiological and/or behavioral assays that are poised for cross validation against results of similar measures in humans and then potential use as preclinical assay measures in a treatment development pipeline for mental illnesses. Thus, while human testing is not a component of this FOA, the measures to be developed in animals through this FOA should be designed so the coherence, or lack of concurrence, of the assay performance across species to humans can be assessed in future projects. In this way, assays developed here may be considered the preclinical prequel to subsequent projects aimed at evaluating the assays for coherence of performance between the preclinical species and healthy humans.
The FOA supports the initial stages in the development, optimization, and evaluation of novel in vivo measures as potential assays in early (pre-first in human) screening of therapeutic candidates. Assays may include neurophysiological and/or behavioral measures. Key considerations are listed below but at a minimum, measures should be amenable to study in live animals and in future studies in humans, and they must be innovative.
Priority will be given to applications that include all three of the following phases:
Potential applicants are strongly encouraged to read the Frequently Asked Questions (FAQs) for this FOA and to contact NIMH Scientific/Research Contacts(s) prior to preparing an application.
This FOA aims to stimulate the development of in vivo assays to address translational gaps in treatment development for mental illnesses. Support will be provided for assay development efforts in animals that propose quantitative measures of neurophysiological and/or behavioral processes where there is reasonable evidence to suggest that measure is a potential contributor to functional deficits of individuals with mental illnesses (e.g., cognitive function, impulsivity, and motivation, etc.).
Examples of relevant neurophysiological and/or behavioral measures for development and evaluation as assays include, but are not limited to:
Mechanistic testing of underlying brain pathways will be tailored to the proposed assay measure. For example, studies might examine if specific changes in dopamine signaling to striatum or prefrontal cortex reliably predict speed or accuracy of reward contingency learning. These studies are critical for advancing a new generation of in vivo assays for therapeutic development that are be grounded in a clinically-meaningful neurobiological context.
The main emphasis must be on developing novel, clinically relevant measures as assays. While the neurophysiological or behavioral measures may not be innovative by themselves, their inclusion in a therapeutic development pipeline must be novel.
Since this work is expected to identify and optimize novel assay measures that can subsequently be compared with measures in healthy humans, it is imperative that proposed neurophysiological and behavioral assay measures be feasible to perform in healthy humans.
Projects Not Supported by this Announcement Include:
All projects must propose a timeline for completion of the required components of assay development, including assay measure optimization (1), evaluation of assay performance (2), and mechanistic testing (3). If more than one measure is proposed for optimization, the timeline must include plans for optimization of each measure. An additional milestone should outline plans and a timeline for dissemination of results, regardless of outcome.
Applicants are strongly encouraged to refer to the FAQs for this PAR-19-289 .
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets are not limited but need to reflect the actual needs of the proposed project. It is expected that budgets of $250,000 direct costs per year or less will be adequate for most projects proposing to optimize just one measure.
The scope of the proposed project should determine the project period. The maximum period is 5 years.
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
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.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace 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 instructions in the SF424 (R&R) Application Guide must be followed.
Specific Aims: Provide the overall goals for the entire application. The Specific Aims section should include distinct Aims for each of the three phases (assay optimization, performance evaluation, and mechanistic testing).
Research Strategy: Organize the Research Strategy in the subsections identified below.
Applicants should describe the three phases within these subsections as described, including milestones for each phase.
Approach: This section should cover the application as a whole as well as the three phases with the appropriate headers within the text.
Specific goals and feasibility milestones must be clear and linked to the timeline for completing the studies in no more than 5 years. Separate milestones should be proposed for each of the 3 study components for assay optimization and testing. The milestones should be quantifiable and scientifically justified. If more than one measure is proposed, separate milestones should be provided for each. Required milestones are expected to address assay measure optimization (1), evaluation of assay performance (2), and mechanistic testing (3). An additional milestone should outline plans and a timeline for dissemination of results, regardless of outcome.
The following modifications also apply:
While it is understood that many of the approaches and early data generated through this FOA will be at an early proof-of-concept stage, a central goal is to contribute a toolset that facilitates the adoption of robust, experimentally based measures in the early phases of a therapeutic development pipeline for mental illnesses. Regardless of study outcomes or publication status, the experimental protocols and data generated through this FOA will be valuable to the research community by indicating assay measures with ambiguous relationships to brain circuits as well as those poised for assessment of potential predictive value in future cross species comparisons.
Accordingly, all applications are expected to include a detailed Data and Experimental Protocol sharing plan that specifies how data will be shared and who will be responsible for managing sharing of all protocols and data, consistent with achieving the goals of this program.
Applicants should include the following key elements:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Is there a reasonable likelihood that completion of the research objectives could lead to a novel assay that allows for more biologically linked prediction of effects of novel therapeutic treatment candidates from preclinical species to humans? Does the assay measure assess a brain process of relevance to mental illnesses (i.e., is there a reasonable chance that the assay measure could show a difference in patients with mental illnesses)?
Is a strong rationale or is evidence provided to support the choice of manipulation for evaluating the performance of the assay measure?
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 investigative team have the breadth of expertise to perform all planned experiments?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Does the project offer the potential for developing a novel approach for evaluating potential new treatments for mental illnesses?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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?
Evaluation of the approach should emphasize the biological rationale, the ability of the planned experiments to contribute towards building innovative and useful preclinical assays and approaches in a therapeutic development pipeline.
Will proposed studies directly modify the circuits and directly record effects on circuit activity during simultaneous measurement of the physiological or behavioral measure?
Does the application include a subset of experiments to evaluate relationships between brain activity changes and physiological/behavioral assay measures (mechanistic studies of step 3) in response to the same perturbations evaluated in the performance evaluation step 2?
Does the project provide alternate strategies should results suggest the tested circuit is not critical for the measure?
Are power analyses and associated assumptions for the determination of sample size, statistical handling of the data, procedures used for addressing sex as a biological variable, blinding and randomization appropriately detailed?
Are plans for data analysis and interpretation clear? Has the investigator indicated outcomes that would constitute a go/no go decision for further measure development and implementation in a therapeutic discovery pipeline?
Is the choice of neurophysiological and/or behavioral measures well justified in terms of potential relevance to functional deficits in humans with mental illnesses and feasibility to perform the measure in animals in the current project and in humans in future studies?
Does the PD/PI present a solid rationale to support possible conservation of brain processes and circuitry underlying the measures across humans and the preclinical species?
Do the proposed measures have potential to either directly or indirectly assess activity or function within targeted circuits in both the preclinical species and humans in future studies?
Is there a strong rationale behind the choice of preclinical species, assays, and endpoints for all studies?
Are the goals and procedures to be completed in each stage clear and complete?
For step 1, optimization; are goals of the optimization step clear and will attainment of the goals facilitate future comparison of assay performance with humans? Are the strategies appropriate?
For step 2, performance evaluation; is an acceptable rationale provided for the choice of perturbation, including dose, route, and timing of intervention in relation to testing? For example, if the perturbation is a drug, is dose selection based on brain target occupancy?
For step 3, mechanistic testing; are proposed experiments appropriate for testing the involvement of hypothesized circuits in driving the physiological/behavioral assay measures?
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 individuals of all ages (including children and older adults), 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?
For research that involves human subjects but does not involve one of the 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 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 individuals of all ages (including children and older adults) 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.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals, the committee will consider the progress made in the last funding period.
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.
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, 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.
Information regarding the disposition of applications is available 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.
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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.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.
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.
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