Reissue of PAR -17-150
See Notices of Special Interest associated with this funding opportunity
October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018.
September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice NOT-OD-21-181.
August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice NOT-OD-21-169.
August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170
April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109
January 4, 2021 - Notice of Special Interest (NOSI): Leveraging Population-based Cancer Registry Data to Study Health Disparities. See Notice NOT-CA-21-020.
March 10, 2020 - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available. See Notice NOT-OD-20-077.July 26, 2019- Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128
August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137
PAR-20-088, R01 Research project Grant
93.307, 93.394, 93.393, 93.395, 93.396, 93.399
The purpose of the initiative is to support multidisciplinary exploratory or developmental research to understand the underlying etiologic factors and mechanisms that contribute to population-level disparities in chronic liver diseases and liver cancer in the U.S.
January 14, 2020
30 days prior to the application due date
April 1, 2020, April 1, 2021, and April 1, 2022
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.
July 2020, July 2021, July 2022
October 2020, October 2021, October 2022
December 2020, December2021, December 2022
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.
The purpose of this Funding Opportunity Announcement (FOA) is to support multidisciplinary exploratory or developmental research to understand the underlying social, cultural, clinical, environmental or biological factors responsible for the increase in chronic liver diseases and liver cancer and the mechanisms that explain documented liver cancer disparities by race and ethnicity in the US. Hepatocellular carcinoma (HCC) is the most common type of liver cancer in the United States and most relevant for the purpose of this FOA.
HCC is one of the fastest rising causes of cancer-related deaths in the U.S., with disparities observed in cancer incidence and survival among racial/ethnic minority populations. HCC has been shown to disproportionately affect disadvantaged populations, with higher rates and worse survival among racial/ethnic minorities and individuals of low socioeconomic status (SES) compared to other groups. Liver cancer rates are highest among Asians, particularly among Laotians, Vietnamese and Cambodians. In recent years, Latinos had the greatest increase in liver cancer incidence (+35.8%) and Latino men are now just behind Asian men in incidence. Surveillance, Epidemiology, and End Results (SEER) data indicate that liver cancer incidence rates have continued to rise. In 2013 the rates were highest especially among American Indians/Alaska Natives and Latinos compared to Non-Hispanic Whites (hence referred as Whites). Recent reports indicate that U.S.-born South Texas Latinos have the highest rates of HCC incidence in the country with rates 3 to 4 times higher than Whites. Although U.S.-born Latinos tend to have higher cancer rates than immigrants, this difference is most striking for liver cancer. In addition, men are about three times as likely to develop liver cancers and more than twice as likely as women to die from these cancers.
Multiple overlapping factors acting at different levels—biological, behavioral, environmental, cultural and societal—contribute to health disparities in the U.S. Social determinants of health, such as economic adversity, financial insecurity, occupational shift work, neighborhood deprivation, exposure to chronic and major life stressors, and discrimination and residential segregation, are known to play key roles in driving health disparities but little is known about how social determinants interact with biological and behavioral risk and protective factors to influence liver disease and liver cancer disparities. Better understanding of the causes and underlying mechanisms driving disparities in chronic liver diseases and cancer is needed to inform the development of effective prevention and treatment strategies for at-risk populations.
Established risk factors for liver diseases and liver cancer include chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections, heavy and chronic alcohol consumption, genetic predisposition, cirrhosis of any cause, exposure to selected toxins, and tobacco smoking. Diabetes is also associated with an increased risk of hepatocellular carcinoma (HCC) and antecedent obesity likely contributes. Also, co-infection with HIV in individuals with chronic infections with either HBV or HCV leads to worse clinical outcomes. The prevalence of these risk factors, their interactions and underlying mechanisms may be different among various racial and ethnic minority sub-populations.
Nonalcoholic fatty liver disease (NAFLD leading to nonalcoholic steatohepatitis (NASH) are the major causes of chronic liver disease that may progress to cirrhosis and then HCC. The disease burden of fatty liver disease mirrors the rapid recent rise in the incidence of diabetes and obesity, especially among Latinos. Because fatty liver/NASH is a complex disease state and a probable precursor to liver cancer, there may be an interplay of multiple determinants of health, Progress in the field requires integrative studies examining interactions between multiple risk and protective factors for NAFLD/NASH and the underlying mechanisms that drive incidence, severity and progression to cirrhosis and/or liver cancer and result in health disparities especially among various understudied U.S. racial/ethnic minority sub-populations.
Increased risk of central obesity and subsequent diabetes in some racial/ethnic minority populations confers additional risk for the development of advanced fibrosis and cirrhosis on those who consume excess alcohol. High incidence of alcohol use together with the prevalence of genetic risk alleles for the development of fatty liver disease may increase the susceptibility of development of advanced liver disease and progression to HCC. Liver cirrhosis is one of the common risk factors for liver cancer; prevalence and mortality from cirrhosis is higher in Latinos and in American Indian populations compared to the general population. Expanded efforts are therefore needed to understand the interplay of the various genetic, social and environmental causes of liver diseases and cancer disparities and the underlying mechanisms that operate in various racial/ethnic minority populations.
Fungal toxins, such as aflatoxins and fumonisins, which may contaminate corn, soybean and other crops, are also implicated as a causal factor in HCC. Racial/ethnic minority populations may have elevated exposures to these toxins due to dietary practices, growing their own crops, and high representation in agricultural and food processing jobs. Concerted efforts are needed to promote comprehensive research on understanding the complex causes of chronic liver diseases and HCC disparities to inform the development of effective prevention and treatment strategies for at-risk populations and reduce health disparities.
The overarching objectives of this initiative are to understand the etiologic factors and underlying mechanisms responsible for documented chronic liver diseases and cancer disparities among U.S. racial/ethnic minority and socioeconomically disadvantaged populations. The focus of this initiative is on the causes for increase in both the incidence and mortality rates of chronic liver disease and cancer among these populations.
Many potential individual, contextual and structural factors influence liver disease/cancer health disparities. Prior studies examining the causes of health disparities have been conducted in disciplinary siloes, therefore, this FOA invites multidisciplinary research to understand the influence of multiple factors and the mechanisms through which they operate. Integrative mechanistic studies examining the dynamic interplay of multiple risk and protective factors acting across the life course are needed to better understand and address the drivers of health disparities. NIMHD has a specific interest in projects that examine the impact of multiple determinants (biological, behavioral, socio-cultural, environmental, physical environment, health system) acting at multiple levels (i.e., individual, interpersonal, community, societal) on health outcomes (see the NIMHD Research Framework, https://nimhd.nih.gov/about/overview/research-framework/ for examples of health determinants of interest).
Projects should include a focus on one or more NIH-designated U.S. health disparity populations, which include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, sexual and gender minorities and underserved rural populations. For health disparity populations with a significant proportion of immigrants, comparison of health factors between the U.S. and country of origin, length of stay may be considered when appropriate. Projects should include U.S. population-based studies. Projects limited to studies solely in animal models will not be considered for funding under this FOA.
Studies for this initiative may include multidisciplinary translational, behavioral, social, clinical or epidemiological projects. In addition, projects can involve primary and/or secondary data collection and analysis. Because the goal of this initiative is to better understand the underlying causes and mechanisms of documented racial/ethnic and SES disparities in chronic liver diseases and liver cancer, studies whose sole purpose is to assess incidence of liver disease/cancer in specific populations or sub-populations are not a priority for this FOA.
Projects are strongly encouraged to involve collaborations, where appropriate, among relevant stakeholders in U.S. health disparity population groups, such as researchers, community organizations, clinicians, health systems, public health organizations, consumer advocacy groups, and faith-based organizations. As appropriate for the research questions posed, inclusion of key community members in the conceptualization, planning and implementation of the research are encouraged (but not required) to generate better-informed hypotheses and enhance the translation of the research results into practice.
Specific Areas of Research Interest
Areas of research interest in U.S. health disparity populations include but are not limited to the following:
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 total project period may not exceed 2 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
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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:
Dr. Rina Das
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Describe how the project will contribute to the understanding of etiologic factors and mechanisms that explain chronic liver disease/cancer disparities or how that influences minority health and health disparities.
Describe how the project uses a multidisciplinary approach, including descriptions of the discipline and expertise of the research team, to understand the complex factors that underlie disparities in chronic liver disease and liver cancer in U.S. health disparity populations.
Describe to what extent does the project include examination of multiple factors and or factors acting at multiple levels, that may influence the health disparities in liver diseases or liver cancer.
Applications which include a Foreign component need to address the importance to U.S. health disparity populations.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.
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.For this particular announcement, note the following:
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
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?
In addition, specific to the FOA, to what extent can the project contribute to the understanding of the etiology and/or mechanisms that influence disparities in liver disease and or liver cancer in U.S. health disparity populations? 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?
In addition, specific to the FOA, are the breadth and inclusiveness (e.g. disciplines and expertise) of the research team such as social science, or public health or molecular biology expertise, appropriate to the scope of the proposed multidisciplinary research?
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?
In addition, specific to the FOA, to what extent does the project propose multidisciplinary research that integrates relevant disciplines and approaches in a meaningful and appropriate way to study disparities in chronic liver diseases and or liver cancer in U.S. health disparity populations? To what extent does the project include examination of multiple factors and or factors acting at multiple levels that may influence health disparities in liver diseases and/or liver cancer?
If a foreign component is included, does the justification explain how the research relates to U.S. health disparity populations?
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 thecategories 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 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 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.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. 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.
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.htmlor 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 agreementsare 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.
Finding Help Online:http://grants.nih.gov/support/(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email:GrantsInfo@nih.gov(preferred method of contact)
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Contact Center Telephone: 800-518-4726
Rina Das, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Emmanuel A. Taylor, M.Sc., Dr.PH.
National Cancer Institute (NCI)
Jo Ann S. Rinaudo, PhD
Division of Cancer Prevention
National Cancer Institute (NCI)
Tram Kim Lam, PhD, MPH
The Division of Cancer Control and Population Sciences
National Cancer Institute (NCI)
Betsy Read-Connole, PhD
Division of Cancer Biology
National Cancer Institute (NCI)
Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
National Cancer Institute (NCI)
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