It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

There are 5.4 million individuals who self-identify as American Indian/Alaska Native (AI/AN) in the US, and there are 567 federally registered tribes. While characterized by many strengths and resiliencies, as a whole, AI/AN populations experience significant disparities compared to the general population across a range of health conditions and outcomes, including infant mortality, alcohol-related mortality, substance abuse, unintentional injury, homicide, suicide, depression, post-traumatic stress disorder, obesity, chronic kidney disease, asthma, diabetes, cardiovascular disease, selected cancers, and other chronic diseases. Premature death rates, while decreasing in other US racial/ethnic minority populations over the past 15 years, are increasing among AI/AN populations. However, the examination of data on AI/AN populations in aggregate may obscure the significant heterogeneity within the AI/AN population due to tribal affiliation, geographic region, and other factors. For example, gastric cancers affect AI/AN populations in different parts of the country at different rates ranging from 6.1/100,00 in the Eastern US to 24.5/100,000 in Alaska. At the same time, national survey and epidemiological studies often do not report data on AI/AN populations because the numbers are too small or AI/AN individuals are folded into the highly heterogeneous "Other" category, thus not available to interpret any health outcomes specific for AI/AN populations. For these reasons, there is a critical need to build a more comprehensive evidence base regarding the health of AI/AN populations.

Tribal Epidemiology Centers (TECs) are ideally positioned to contribute significantly to the evidence base and scientific research literature on AI/AN health. Established in 1996 under the re-authorization of the Indian Health Care Improvement Act (IHCIA) and funded by the Indian Health Service (IHS), TECs serve AI/AN communities and populations through the collection and analysis of health surveillance data, maintenance of patient registries, implementation and evaluation of public health interventions, development of health awareness campaigns, and mobilization of emergency response to public health crises. There are currently 12 TECs nationwide (see https://tribalepicenters.org/12-tecs/) that serve AI/AN populations within the 12 IHS administrative areas as well as urban AI/ANs across the nation.

Each TEC represents multiple tribal communities or urban Indian populations within the region. TECs generally fall under the umbrella of a state or regional Indian Health Board or Tribal Health Consortium that reflects partnerships with tribal leadership, healthcare organizations, and community-based organizations. TECs are specifically supported to collect data and implement public health programs responsive to the needs and priorities of AI/AN populations within the region. Examples of specific activities by current TECs include health mapping within the region to facilitate community prioritization of health needs and services, coordinating activities and outreach for the Behavioral Risk Factor Surveillance System (BRFSS), developing initiatives to improve identification of AI/AN populations in health records and state-level data collection, implementing lifestyle interventions to prevent or manage chronic disease, and coordination of public awareness campaigns such as interventions related to seat belt use and injury prevention.

This FOA will support collaborative research between TECs and other investigators on topics related to minority health and health disparities in AI/AN populations, with emphasis on areas where there are significant gaps in data and knowledge. Such partnerships are proposed to support community-responsive, scientifically rigorous projects with findings disseminated to local stakeholders, the IHS, and the scientific community. One or more TECs may collaborate with academic researchers, tribal governments or other tribal organizations, clinicians, healthcare organizations, public health organizations, school systems, faith-based organizations, or other relevant stakeholders to achieve FOA objectives.

Research projects may be observational or intervention studies and are expected to use data that have been or are currently being collected by the TEC(s). Primary data collection may be used to supplement existing data. Research study samples may consist exclusively of AI/AN populations or may include non-AI/AN populations as appropriate to address a specific research question. Appropriate pooling or comparison of health-related data across multiple TECs is strongly encouraged, as are projects that link multiple types of data sources (e.g., IHS, BRFSS, Census, Vital Statistics, health care systems, and administrative data on health-related social determinants.). Projects that do not involve using TEC-generated or TEC-compiled data or public health interventions implemented and/or evaluated by the TEC are not targeted for support under this FOA.

The areas of specific interest for participating Institutes at NIH including the following:

The National Institute on Minority Health and Health Disparities (NIMHD) has specific interest in research on areas related to but not limited to the following:

• Examination of risk, incidence, prevalence, morbidity, and mortality for understudied and significant health conditions or diseases in AI/AN populations that contribute to health disparities among AI/AN.
• Understanding of clinical presentations and management of the leading causes of morbidity and mortality among AI/AN populations such as childhood and adult asthma, cardiovascular disease, diabetes, cerebrovascular disease, depression, and common cancers.
• Understanding of or prevention of accidental deaths (including drug overdoses and motor vehicle fatalities), chronic liver disease and cirrhosis, suicide, or other causes of premature mortality in AI/AN populations.
• Identification of similarities and differences in health risks, protective factors, and health outcomes across tribes or other AI/AN population subgroups, such as urban vs. rural populations, within or across TEC catchment areas.
• Documentation of similarities and differences in health outcomes in AI/AN populations compared to non-AI/AN populations living within the same geographic region.
• Use of surveillance, cohort, or other longitudinal data to determine the impact of social and structural determinants on health over time (e.g., environmental exposures, historical trauma, economic development initiatives, court rulings over land/water rights, changes in tribal or state/Federal policies, health care system reorganization, insurance coverage changes)
• Rigorous evaluation of TEC-led public health interventions or health awareness campaigns, including evaluations within a single TEC catchment area as well as comparative effectiveness studies of similar interventions across multiple TECs.
• Development and testing of methods for research with small populations to better understand AI/AN health.
• Development and testing of AI/AN culturally relevant research measures that may be currently lacking in the field (e.g., personal well-being, health-related quality of life, risk and protective factors, historical trauma, quality of patient-clinician communication, family processes, adherence to traditional cultural beliefs and attitudes).

The National Cancer Institute (NCI) has specific interest in research on areas including but not limited to the following:

• Research to examine the impact of environmental and policy changes on tobacco, alcohol use patterns and practices, as they pertain to cancer outcomes;
• Development of epidemiology studies that can build on or enhance the data being collected by SEER to enable the development of prevention and treatment trajectories;
• Research on the role of predictors and culturally unique resilience and risk factors for cancer prevention, treatment and survivorship; and
• Studies focused on cancer prevention, treatment and outcomes in areas including but not limited to etiology; intervention (prevention or treatment); health service utilization and access; and dissemination and implementation of evidence-based interventions.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) reports that AI/AN people are less likely to drink than white Americans, but those who do drink are more likely to engage in binge and problematic drinking. They have a higher rate of past-year alcohol use disorder (AUD) compared with other racial and ethnic groups, and are approximately twice as likely to die from alcohol-related causes than the general American public. AI/AN people with AUD are less likely than whites with AUD to receive alcohol treatment services. NIAAA has specific interest in research on areas related to but not limited to the following:

• Data on the prevalence, risk, and protective factors of alcohol use, across the whole spectrum from abstinence, moderate use, problem use, extreme binge drinking, and alcohol use disorder.
• Description of types of and effectiveness of alcohol prevention and treatment interventions conducted among AI/AN people (e.g., screening and brief intervention, twelve step groups, motivational intervention, etc.)
• Data on prevalence of alcohol use diagnosis at IHS clinics both as primary diagnosis and contributing to presenting compliant such as accidental injury, depression, suicide ideation, liver cirrhosis, etc.
• Differences in patterns of alcohol use, including alcohol use disorder, and service utilization between reservation and urban dwelling AI/AN people.
• Patterns of treatment usage, including outpatient and inpatient referrals for AUDs, use of aftercare or transitional services post inpatient alcohol treatment.

The National Institute on Drug Abuse (NIDA) has specific interest in research on areas including but not limited to the following:

• Research to examine the impact of environmental, programmatic, and policy changes on substance use patterns and practices, including, for example, changes in marijuana policies at the state or tribal level,
• Studies focused on substance abuse and related factors in areas including but not limited to etiology; intervention (prevention or treatment); health service utilization; and treatment work force factors.
• Research pertaining to any aspect of opioid use disorder (OUD), including data on the nature of the problem and related factors on and/or off reservations; examining the efficacy of prevention and treatment interventions (including models that integrate treatment with healthcare); examining the impacts of increased availability of naloxone and approaches to disseminate naloxone widely; utilization of, and/or identification of factors associated with uptake of, medication assisted treatment (MAT) to treat OUD; pain management practices; characterization of workforce and/or community factors and barriers related to the treatment of OUD; a focus on pregnant women and exposure to opioids.
• Research on the role of universal predictors and culturally unique resilience and risk factors in the development, persistence or desistance of substance abuse.

The National Institute of Environmental Health Sciences (NIEHS) reports that Native Americans living in reservations and in urban settings are exposed throughout their lifetimes to a combination of environmental and social factors that affect both human and environmental health. These disproportionate and chronic exposures include heavy metals (lead, manganese, chromium, cadmium, copper and zinc) and radioactive materials from resource extractive industries, persistent organic pollutants from industrial and agricultural sources, and particulates in indoor and outdoor air from biomass fuel sources. AI/AN communities are additionally being affected by extreme seasonal variation (weather related conditions) that affect land use, culture and traditional foods, and the social and built environment. NIEHS has specific interest in research on areas including but not limited to the following:

• Use of existing epidemiological data or collection of data to examine the impact of environmental exposures (e.g., indoor air pollution, contaminated water, soil, and traditional foods) on the health in AI/AN communities.
• Use of existing longitudinal data to examine the interaction between environmental exposures and social determinants of health.
• Examination of the effects of combined environmental factors such as exposure to heavy metals and chemicals in air, soil, water, household products and in traditional foods on specific health outcomes across the lifespan and/or that increase transgenerational risk.
• Evaluation of the utility of Traditional Ecological Knowledge for environmental health studies and consideration of when TEK approaches are appropriate to inform and expand on Western scientific methods to more accurately reflect the AI/AN understanding of the interactions between human and environmental health.
• Collection of additional environmental data to better understand factors effecting the prevalence and etiology of kidney, respiratory*, metabolic, or cardiovascular diseases in AI/AN communities.

*The NIEHS does not support research on primary smoking or interventions that target primary smokers.

See Section VIII. Other Information for award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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 not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: Describe how the proposed project addresses a particular gap in data or knowledge regarding health in AI/AN populations, as well as how the project is responsive to local community needs and priorities. Describe how the proposed project will use existing data or ongoing data collection by the TEC, as well as other data sources that will be linked with TEC data if relevant. Describe the roles and responsibilities of the TEC and collaborators, including handling ownership and control of data, review of research findings, and authorship. Provide a plan for how study findings will be disseminated to local stakeholders, IHS, and the scientific community.

Letters of Support: If the applicant institution is not the TEC awardee, a letter of support from an appropriate office within the TEC institution must be included verifying an intent to collaborate on the proposed research project. Other letters of support from collaborations should be included as appropriate, including letters of tribal approval or resolutions of support if relevant. Letters should address any data use or data sharing agreements relevant to the project.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Use only for applications with due dates on or before January 24, 2018. When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Use only for applications with due dates on or after January 25, 2018. When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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 a 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

All instructions in the SF424 (R&R) Application Guide must be followed.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the project address an important gap in data or knowledge regarding health in AI/AN populations? Is the project responsive to local community needs and priorities?

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? Are the roles of TEC personnel and collaborators clearly described and appropriate? Do the investigators have appropriate expertise regarding the dissemination of findings to local stakeholders, IHS, and the scientific community?

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 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 children, justified in terms of the scientific goals and research strategy proposed?

Is it clearly described how the project will use TEC data? Does the project represent a sound approach to the use of TEC data for the proposed research question? Are other data sources to be used clearly described and appropriate? Is the plan to disseminate findings to local stakeholders, IHS, and the scientific community clearly described and appropriate?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

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.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable

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 (CSR), 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Geographic representation

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee's business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://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 http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at 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.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)

Telephone: 301-945-7573

Cerise Elliott, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: [email protected]

Jennifer Alvidrez, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9567
Email: [email protected]

Dorothy Castille, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9411
Email: [email protected]

Shobha Srinivasan, PhD
National Cancer Institute (NCI)
Phone: 240-276-6938
Email: [email protected]

Judith A. Arroyo, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-0717
Email: [email protected]

Kathy Etz, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1749
Email: [email protected]

Symma Finn, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4258
Email: [email protected]

Martha Hare, PhD
Center for Scientific Review
Telephone: 301-451-8504
Email: [email protected]

Jennifer Edwards
National Institute on Aging (NIA)
Telephone: 301-827-6689
Email: [email protected]

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Judy S. Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Grants Management Officer
Telephone: 302-443-4704
Email: [email protected]

Pamela G. Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
Email: [email protected]

Molly Puente
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1373
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.