Department of Health
and Human Services (HHS)
and Human Services (HHS)
The purpose of this funding opportunity announcement (FOA) is to encourage research to integrate/harmonize existing data sets from preventive intervention trials implemented early in life to: 1) examine risk and protective factors relevant to later mental health outcomes in childhood, adolescence and young adulthood; and 2) determine whether preventive interventions delivered earlier in life have long-term effects, and/or cross-over effects (e.g., unanticipated beneficial effects), on important mental health outcomes, including serious mental illness (e.g., depression, anxiety, suicide ideation and behaviors, psychosis behaviors).
February 6, 2019
April 2, 2019 and December 2, 2019.
May 2, 2019; January 2, 2020, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
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
July 2019 and March 2020
October 2019 and May 2020
December 2019 and July 2020
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
There is a growing body of literature reporting on the benefits of preventive interventions for substance abuse and internalizing/externalizing behaviors, delivered in childhood, on the long-term outcomes of mental health and reduced substance use. Findings from this research demonstrate that (1) intervening early in development and targeting proximal risk and protective factors can have an impact on a broad array of distal outcomes; and (2) preventive interventions can have unanticipated beneficial effects on outcomes not specifically targeted by the intervention (cross-over effects). Indeed, there is a small body of evidence providing proof of concept that preventive interventions aimed at reducing a number of risk factors for suicide (e.g., substance use, externalizing, and internalizing behavior) can prevent suicidal ideation and behaviors. New technological and analytic approaches for harmonizing/integrating data sets hold potential for increasing statistical power and facilitating the detection of the impact of prevention interventions, in general, among important subgroups (e.g., sexual gender minority youth, racial/ethnic minority youth), and in the case of low base rate behaviors (e.g., psychosis, suicide ideation and behaviors).
Purpose/Research Objectives:
The purpose of this funding opportunity announcement (FOA) is to encourage research to integrate/harmonize existing data sets from preventive intervention trials implemented early in life to: 1) examine risk and protective factors relevant to later mental health outcomes in childhood, adolescence and young adulthood; and 2) determine whether preventive interventions delivered earlier in life have long-term effects, and/or cross-over effects (e.g., unanticipated beneficial effects), on important mental health outcomes, including serious mental illness that typically emerges in adolescence or young adulthood (e.g., depression, anxiety, suicide ideation and behaviors, psychosis behaviors, violence/aggression).
Scientific knowledge to be achieved through research supported by this FOA, including information regarding which prevention interventions have an impact on which mental health outcomes, for which populations, and under what conditions, could provide a foundation for future research on and for more targeted deployment of interventions. Information about intervention targets and strategies that are most strongly associated with preventive effects could be used to refine preventive interventions to enhance their potency and efficiency. It would potentially provide evidence for beginning earlier in the life course to intervene on proximal risk factors that are likely to have effects on multiple mental health outcomes later in life (e.g., suicide ideation and behaviors, psychosis behaviors). Information regarding important moderators of intervention effects and data regarding the impact of interventions among important subgroups could be used to identify opportunities for refining interventions for refractory groups and to inform the development and deployment of more targeted, personalized approaches. Ultimately, results of this research will contribute to an evidence base that can be used by communities to guide their efforts to reduce risk for mental health disorders.
NIMH Specific Areas of Research Interest:
Appropriate topics include, but are not limited to studies that:
NCCIH Specific Areas of Research Interest:
Appropriate topics include, but are not limited to studies that:
ORWH Specific Areas of Research Interest:
The Office of Research on Women’s Health (ORWH) is part of the Office of the Director of NIH and works in partnership with the NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH, and throughout the scientific community. In particular, ORWH is interested in co funding applications that include adequate plans to address sex as a biological variable (SABV) including plans to disaggregate data by sex/gender with a focus on examining sex and gender influences on health and disease and their impact on the health of women. Applicants are encouraged to discuss applications with the ORWH contact listed under Agency Contacts. The 2019 2023 Trans-NIH strategic plan for Women's Health Research: "Advancing Science for the Health of Women highlights research priorities to improve the health of women. The Trans-NIH Strategic Plan for the Health of Women covering FY 2019 - 2023 is available on the ORWH website (https://www.nih.gov/women/strategicplan) for additional guidance.
Scale and Scope of Studies Covered Under this Announcement
This FOA is intended to support integration and re-analysis of existing data sets from trials of preventive interventions. For purposes of this announcement, it is essential that prevention data sets be integrated (applications that propose analysis of data from a single trial or parallel analyses of separate trials are not considered responsive). The use of existing administrative data, such as electronic medical records, health care claims data, social media, criminal justice data, can be integrated with prevention data sets to examine outcomes of interest (provided original consent allows for such data access and provisions are in place for safeguarding personally identifiable information). However, primary data collection (re-assessment of original trial participants) is beyond the scope of FOA, and applications that include plans for primary data collection will be considered non-responsive.
Applications that address questions using integrated prevention data sets are particularly encouraged to include: 1) examination of risk and protective factors relevant to outcomes of interest (i.e., factors that mediate and/or moderate outcomes); 2) analyses to better understand common mediators of intervention effects across trials (e.g., sustained improvement in self-regulation, family communication); 3) analyses to test whether the intervention engages the proximal target(s)/mechanism(s) that were specifically targeted by the original intervention and to examine whether changes in the original target(s)/mechanism(s) account for cross-over- and/or longer-term- effects; and 4) examination of subgroups of populations (e.g., age, gender, racial/ethnic, and sexual orientation) to better understand what works, for whom, and under what conditions.
For the purposes of this FOA, levels of preventive interventions can include universal, selective, and indicated interventions, as well as tiered approaches (using more than one level of prevention intervention). The period of the life span in which the prevention interventions were implemented can include prenatal through adolescence. Long-term and/or cross-over effects can be examined. Projects that examine the long-term impact of prevention interventions delivered earlier in life (e.g., in early childhood or adolescence) on longer-term outcomes (e.g., the emergence of serious mental illnesses such as depression, bipolar disorder, psychosis, or suicidal behavior in adolescence or young adulthood) are especially encouraged. Projects that examine the potential of cross-over effects (unanticipated beneficial effects on outcomes that were not the primary focus of the prevention intervention being studied) should propose analyses that were not included as part of the original study. The observation period for long-term and/or cross-over effects will depend on the age and developmental period at the time of the initial intervention and on the nature of and typical age of onset for the outcomes of interest. For long-term effects we encourage age and developmentally appropriate outcomes beyond the original study period of the trial. Justification for length of follow-up is needed.
We encourage harmonization of databases where data can be publically shared. When possible, investigators funded under this FOA are encouraged to share data via the NIMH Data Archive (https://data-archive.nimh.nih.gov/ndct/about ). The NIMH Data Archive is willing to work with applicants to determine what data can be shared (e.g., electronic medical record data; National Death Index acquired data). The NIMH Data Archive can also provide a private cloud-based storage site that will facilitate the proposed work. Applicants who are interested in exploring this possibility should contact the NIMH Data Archive help desk (ndahelp@mail.nih.gov) .
Effective prevention and treatment of mental illness have the potential to reduce morbidity and mortality associated with intentional injury (i.e., suicide attempts and deaths, see: www.suicide-research-agenda.org). Integration of extant data from prevention trials can facilitate examination of the impact of interventions on low base-rate events, including suicidal behavior. Accordingly, under this FOA, NIMH strongly encourages examination of the impact of preventive interventions on suicidal behavior in order to advance understanding of how effective prevention and treatment of mental disorders might impact suicide relevant outcomes.
This FOA is one of several FOAs participating in a program called, Ending Disparities in Mental Health (EDify-MH) (https://www.nimh.nih.gov/about/organization/gmh/ending-disparities-in-mental-health-edify-mh.shtml). The EDIfy-MH program stimulates and encourages mental health disparities research that spans the NIMH strategic research priorities , from basic science to services research, and across the lifespan, in the United States and worldwide. EDIfy-MH aims to generate research to identify and better understand the genetic, neurobiological, psychosocial, and other environmental mechanisms/ factors that underlie disparities in order to address and eliminate mental health disparities domestically and globally.
Each FOA under the EDIfy-MH program addresses a particular aspect of disparities in mental health. Specifically, this FOA focuses on the integration of prevention data sets to better understand the long-term and/or cross-over effects of prevention interventions and encourages, but is not limited to, projects that focus on examination of outcomes of preventive interventions among racial/ethnic minority groups, sexual and gender minorities, individuals living in rural areas, socioeconomically disadvantaged persons, or any other subgroup with documented disparities in prevalence of mental illnesses, mental illness trajectories, access to preventive and treatment intervention services, and quality and outcomes of mental health care.
Potential applicants are strongly encouraged to consult with NIH staff as early as possible when developing plans for an application (see Scientific/Research Contacts, Section VII ). This early contact will provide an opportunity to clarify NIH policies and guidelines and help to identify whether the proposed project is consistent with NIMH program priorities and the goals of this FOA.
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.
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The following NIH components intend to commit the following amounts in FY 2020:
NIMH intends to commit $3 million total costs in FY 2020 to fund 4-6 awards.
NCCIH intends to commit $500,000 total costs in FY 2020 to fund 1 award.
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
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.
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.
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:
Email: NIMHpeerreview@mail.nih.gov
All instructions in the SF424 (R&R) Application Guide must be followed.
Applicants should request funds for one trip per year by the PI for an annual meeting to be held at NIH in Bethesda, MD. The purpose of these meetings is to discuss lessons learned among other grantees, in operational and scientific challenges and advances. Budget should include cost of integrating the data and preparing it for submission to the NIMH National Data Archive.
Research Strategy:
Research supported through this FOA should focus on novel, transformative approaches that leverage and aggregate existing prevention datasets to advance our understanding of the long-term and/or cross-over effects (unanticipated beneficial effects) of prevention interventions on important mental health outcomes.
Significance:
Investigators:
Innovation:
Approach:
Timeline and Milestones: A timeline must be included as part of the Research Strategy and should include a distinct final section, entitled Milestones , that briefly proposes operationally-defined indicators of progress at critical junctures. This timeline might include, for example, data acquisition, integration, and application of various statistical approaches, and interpretation. These milestones should be tailored to the unique scope of each project and written concretely enough to evaluate exactly what will have been achieved during the course of the project.
Letters of Support:When multiple datasets are proposed to be aggregated, a clearly documented commitment by the data owners must be provided in the application and documentation that the informed consent documents permit such aggregation. Likewise, if the application includes leveraging healthcare or other types of data, appropriate permissions for using these data for research purposes must be included.
The following modifications also apply:
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.
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.
In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at nimhreferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
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.
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?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators 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?
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?
Because this FOA requests the use of existing data sets, does the application describe the characteristics of the samples with regard to gender, race, ethnicity and children?
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.
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.
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.
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.
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.
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Eve Reider, Ph.D
National Institute of Mental Health (NIMH)
Telephone: 301-443-4045
Email: ereider@mail.nih.gov
Della White, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone:301-827-6358
Email: whitede@mail.nih.gov
Rebecca DelCarmen-Wiggins, Ph.D.
Office of Research on Women’s Health (ORWH)
Telephone: 301-451-8689
Email: rdelcarm@mail.nih.gov
Nick Gaiano, Ph. D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: nick.gaiano@nih.gov
Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov
Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: Carows@mail.nih.gov
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