Reissue of PAR-16-355
NOT-OD-19-128 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research
NOT-OD-19-137 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research
93.307, 93.866, 93.172
The purpose of this Funding Opportunity Announcement (FOA) is to support and accelerate human epigenomic investigations focused on identifying and characterizing the mechanisms by which social experiences at various stages in life, both positive and negative, affect gene function and thereby influence health trajectories or modify disease risk in racial/ethnic minority and other health disparity populations.
September 10, 2019
30 days prior to the application due date
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
November 6, 2019, November 6, 2020, November 8, 2021
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.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
Purpose and Background
The purpose of this Funding Opportunity Announcement (FOA) is to support human-based epigenomic investigations focused on identifying and characterizing the mechanisms by which social context and experiences at various stages in life, both positive and negative, affect gene function and thereby influence health trajectories or modify disease risk in racial/ethnic minority and other health disparity populations.
Although scientific and technological discoveries have improved the health of the U.S. population overall, racial/ethnic minority populations, socioeconomically disadvantaged populations, and rural populations continue to experience a disproportionate burden of disease and other adverse health conditions. As the Nation’s steward of biomedical and behavioral research, NIH has devoted considerable resources to characterize the root causes of health disparities, uncovering a complex web of interconnected factors, including social, biological, behavioral, environmental, and societal factors. Integrative mechanistic studies examining the dynamic interplay of multiple factors across the life course are needed to better understand and address the drivers of health disparities and inform the development of effective interventions.
NIH has made significant investments through the Common Fund program on epigenomics research (http://commonfund.nih.gov/epigenomics/overview.aspx) focused mainly on the development of epigenomic technologies, creation of standard reagents for quantitative measurements, analytical tools, and the construction of epigenome maps. However, genomic and epigenomic data from U.S. racial/ethnic minorities, especially American Indian/Alaska Natives and other health disparity populations remain quite limited and recent advancements have not been applied toward understanding the basis for unequal burden of disease in health disparity populations. Since social determinants of health are known to influence health disparities, research towards understanding the effect of social environment on epigenomic changes may lead to better understanding of the underlying mechanisms of health disparities.
Recent studies suggest that social stressors and/or protective factors may affect health status through epigenomic modifications of various biological pathways. The epigenome includes histone modifications, non-coding RNAs, chromatin remodeling and, most notably, DNA methylation that affect gene expression and cellular phenotypes. Epigenomic studies of social influences hold great promise to identify classes of genes and/or specific biological pathways through which social factors might act, and mechanisms through which social environments might affect minority health and health disparities.
Health disparities have been widely linked to regional variations in exposure to chemical and nonchemical stressors. Individuals living in disadvantaged neighborhoods are often exposed to various types of stressors, both physical (e.g., noise pollution, lack of green space) and social (e.g., food desert, violence or threat of violence, discrimination, residential segregation and psychosocial stress). Health disparities may arise not only because of higher levels of exposure to environmental hazards among certain population groups, but also as a result of the synergistic effect of exposure to multiple environmental hazards and social stressors. How these stressors affect the individual epigenome in different racial and ethnic groups and what pathways are ultimately related to the causes of health disparities in these populations is unknown. Operating through epigenomic changes, adverse social and environmental experiences early in life may predispose an individual to dysfunctional physiological responses and to future stressors in adulthood, which in turn might influence risk of obesity, cancer, stroke, mental illness and other adverse health outcomes. Exposure to protective or resiliency factors may also buffer some of these adversities, however the mechanisms on how they operate on our health are not very clear.
Furthermore, the study of epigenomic variations within/between populations offers a unique opportunity to understand how exposures from the environment, diet, lifestyle, and other factors, interact with genes to influence health and disease across the lifespan. By identifying epigenetic modifications and the underlying pathways early before the onset of diseases, it may be possible to tailor interventions to prevent chronic conditions or diseases later in life. Research towards understanding the effect of various social experiences (both positive and negative) on epigenomic changes may lead to better understanding of mechanisms that will result in innovative strategies in disease diagnosis, prevention and/or clinical improvements in personalized care and reduction of health disparities.
The overarching objectives of this initiative are to 1) advance understanding of mechanisms by which social factors lead to epigenetic changes that affect minority health and/or health disparities, and (2) promote epigenetics research to better predict disease risk or resiliency among health disparity populations.
Minority health is defined as health characteristics and attributes of US racial and/or ethnic minority populations (Black or African American, Hispanics or Latinos, American Indian/Alaska Native, Asian American, Native Hawaiian and other Pacific Islanders). Health disparities are defined as health differences that adversely affect socially disadvantaged populations based on one or more health outcomes. Projects must include a focus on one or more NIH-designated health disparity populations in the United States, which include racial and ethnic minorities, socioeconomically disadvantaged populations, underserved rural populations, and sexual/gender minorities.
Social determinants of health are the conditions in which people are born, grow, live, work and age. These social determinants have been known to drive health disparities, however the underlying mechanisms are not clear. Successful projects will inform our understanding about how social determinants (both positive and negative) may affect human biology through the epigenome and possible mechanisms driving health disparities. (See the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for examples of health determinants of interest).? Projects should link epigenetic changes to a functional outcome such as gene/protein expression and to a phenotype/health outcome in the study population.
Projects should focus on one or more health disparity populations in the U.S. and will support human-based epigenomic research with a particular focus on examining epigenetic modifications that are of social origin or are substantially influenced at a population level by social processes. Projects are encouraged to consider the influence of resiliency or protective factors that may buffer some of the adverse effects across the life span in health disparity populations. Projects may cover any range of topic areas and designs, including basic, translational, epidemiological or observational studies or secondary data analysis (leveraging existing datasets e.g., NHANES, Jackson Heart Study, ECHO, All of Us program, etc.) in one or more health disparity populations.
Projects should integrate social determinants of health and epigenomic analysis in the same study. Projects that focus only on exploring epigenomic changes without the integration of social factors or that focus on exploring social factors with no integration of epigenomics processes are not a priority for funding under this FOA.
This initiative is also intended to promote collaborations that will combine the knowledge and scientific expertise of social scientists, public health researchers and molecular biologists. Interdisciplinary efforts are strongly encouraged, including bioinformatics, biostatistics, molecular biology, epidemiology, social sciences, public health and clinical medicine to develop innovative integrative strategies for health disparities research.
Projects should include patient or participant biospecimens for epigenetic analysis that are representative of the health disparity population(s). The rationale for measuring epigenomic changes in easily accessible tissues such as saliva, buccal swabs, urine, blood, exosomes, other accessible biological tissue, should be considered for relevance to the disease outcomes studied. Projects limited to studies in animal models are not a priority for funding under this FOA.
Specific Areas of Research Interest
Research objectives of interest include but are not limited to:
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. Only those application types listed here are allowed for this FOA.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The scope of the proposed project should determine the project period. The maximum project 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.
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:
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:
Rina Das, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
All instructions in the SF424 (R&R) Application Guide must be followed.
Significance: Describe how the project will contribute to the understanding of epigenetic influences in minority health and/or health disparities. Describe how the project will improve our understanding of the interplay and underlying mechanism by which various social determinants of health (both positive or negative) influence the epigenome and how these biological changes may contribute to health disparities.
Provide scientific rationale for a focus on the studied NIH designated U.S. health disparity populations within the project.
Investigator: Describe the inclusion of appropriate range of expertise from different disciplines of the research team such as social science, or public health and molecular biology without duplicating information in the biosketches.
Approach: Indicate how the project integrates relevant disciplines in a meaningful and appropriate way for minority health or health disparities research, especially the integration of social determinants of health with biological factors and health disparities research. Describe appropriate approaches relevant to each health disparity population that is the focus of research. Describe approaches on how the projects informs on the underlying pathways and links the epigenetic changes to a functional outcome and to a phenotype/health outcome.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.
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.Delayed Onset Study
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.
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.
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?
To what extent can the project contribute to the understanding of epigenetic influences on minority health and/or the reduction of health disparities? To what extent will the study improve understanding of underlying mechanisms on how social determinants of health may affect human epigenomic variation and how these changes may lead to health disparities? Is a compelling scientific rationale provided for the focus on the specific health disparity population(s) within the project?
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?
Is there appropriate range of expertise on the research team representing different disciplines such as social science, public health and molecular biology?
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?
To what extent does the project integrate relevant disciplines in a meaningful and appropriate way for minority health or health disparities research? Have the investigators integrated social or environmental factors with biological factors adequately to understand the dynamic interplay of these factors? To what extent have the investigators included relevant approaches focused on health disparity populations? To what extent will the proposed approach likely help to delineate underlying mechanisms linking observed or hypothesized epigenetic changes with a health-related phenotype or health outcome?
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 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 Center for Scientific review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.As part of the scientific peer review, all applications:
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:
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.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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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Contact Center Telephone: 800-518-4726
Rina Das, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Lucia Hindorff, Ph.D.
National Human Genome Research Institute
Amelia Karraker, PhD
National Institute on Aging (NIA)
National Institute on Aging (NIA)
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