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

Unprecedented and widespread damage from Hurricanes Irma and Maria has devastated the US territories of Puerto Rico (PR) and the US Virgin Islands (USVI). These disasters are different from other natural or man-made disasters that have occurred in the US because the entire population has been impacted rather than a subset of individuals within a state or region, human services across all sectors have been disrupted, and it may take several months or years for electrical power and other services to be restored across all areas. Thus, individuals in PR and USVI are experiencing collective, territory-wide disruptions as well as individual, family, and community-level hardships that may make recovery from these disasters particularly difficult. As PR and USVI residents are predominantly racial/ethnic minorities and experience disproportionately high levels of poverty, better understanding post-disaster risk, health care needs, and how best to promote resilience among individuals, families, and communities in these territories is a highly significant issue pertaining to NIH's mission to address minority health and health disparities.

Much of the existing research in the aftermath of hurricanes and other natural disasters, has focused on environmental risk factors, such as exposure to chemical or biological toxins in water, air, or soil; waterborne infectious agents; physical hazards due to fallen debris or damage to structures; or exposure to extreme heat or cold. Other research has focused on post-traumatic stress disorder and other mental health and substance abuse changes following disasters. It is critical to extend research beyond documenting the known general risk factors that populations face and their impact on both physical and mental health. Post-hurricane psychosocial stressors in PR and USVI may include but are not limited to the following:

• Grief related to the loss of loved ones, pets, home, land, or possessions
• Displacement from home or community
• Temporary or permanent separation from family members relocating to the mainland US
• Disruption of social support networks
• Limited access to food or potable water
• Limited access to needed medical care, medical treatments, or prescription medications
• Safety concerns related to physical hazards or increased levels of crime
• Financial hardship due to property damage, assuming care of loved ones, or loss of employment or wages
• Disruption of work, school, and other normal activities because of power outages, structural damage, or competing life demands
• Uncertainty about or dissatisfaction with local, territory-wide, or federal disaster responses, policies, or assistance
• Uncertainty about the timeframe for if or when normal functioning or operations will resume

These hurricane-related psychosocial stressors can produce immediate health impacts related to post-traumatic distress or other mental health issues or exacerbate existing chronic medical or psychiatric illnesses. These stressors can also lead to an increase in risk factors for subsequent chronic disease morbidity and mortality, such as poor nutrition, physical inactivity, smoking, alcohol and substance use, risky sexual behavior, and lack of adherence to health maintenance or disease self-management behaviors. Individual, family, community, and territory-level coping strategies and responses may mitigate or exacerbate the impact of these stressors on health outcomes. Examples of coping strategies that can promote resilience in the face of disaster-related stressors include seeking family and community social support, assisting others in greater need, sharing or pooling material resources across neighborhoods or social networks, re-establishing and maintaining routine activities or schedules, re-establishing health care (including behavioral health care), engaging in faith-based activities, or engaging in activities that serve as a distraction or diversion. However, helpful coping strategies observed after other disasters may not necessarily apply in the face of the potentially unique constellation of post-hurricane stressors in PR and USVI.

Research to understand risk and resilience factors as well as health care needs is critical to both inform on-going recovery efforts and to prepare for future disruptions. It is important that such research be conducted in the immediate aftermath or recovery phase of disasters, so that risk, resilience, and health status can be assessed as needs develop and transition rather than relying on retrospective data or recall of individuals. Organizations located within the territories of PR and USVI are best positioned to conduct this type of time-sensitive research.

The objective of this FOA is to better understand the short-term health risks and health impacts of the hurricanes in PR and USVI, including onset of acute conditions, exacerbation of existing chronic conditions, and risk for future onset of chronic disease. Projects supported under this FOA may be used as the basis for future studies of longer-term health impacts. Projects are expected to examine interrelationships among psychosocial stressors experienced by PR or USVI residents; individual, family, organizational, and/or community-level responses (including healthcare system responses); and current physical health or mental health status and/or risk factors for future chronic disease. Projects are expected to use an approach that encompasses multiple domains (e.g., biological, behavioral, socio-cultural, environmental, physical environment, or health system) and multiple levels (e.g., individual, interpersonal, community, societal) to understand post-hurricane health risk and resilience (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for examples of health determinants of interest). Projects are expected to be time-sensitive, such that delays in study initiation might preclude addressing certain research questions or the collection of certain types of data. Examples include collecting data before and after restoration of power, re-opening of schools, health clinics, and social service agencies.

Projects may involve primary data collection from PR or USVI residents, as well as primary or secondary data collected from organizations such as healthcare settings, schools, or social service agencies and relief efforts. For projects that involve follow-up data collection with participants, PR or USVI residents who have relocated to the US mainland since their enrollment may be retained in the study.

Projects including individuals with heightened vulnerability, including pregnant women, children, older adults, and individuals with pre-existing disabilities or chronic conditions, and cancer patients and cancer survivors, are encouraged. Projects may involve quantitative and/or qualitative methods, and the collection of information that can be used as baseline data for future longitudinal studies or follow-up studies is encouraged but not required. Community-based organizations and local healthcare service providers offering direct services and assistance to PR and USVI residents are strongly encouraged to apply in collaboration with researchers.

The following types of projects are considered non-responsive to this FOA: 1) projects enrolling participants who are not current PR or USVI residents 2) projects in PR or USVI not directly related to the recent hurricanes, 3) projects that exclusively examine hurricane-related environmental exposures, 4) animal studies, and 5) applications proposing a clinical trial.

All responsive applications responding to this FOA will be subject to an accelerated review and award process. Applications recommend for funding will receive August Council review which will be held in mid/late July 2018. The entire cycle from submission to award is expected to be within 3-4 months. However, administrative requirements and other unforeseen circumstances may delay issuance dates beyond that timeline. It may be advisable to initiate contact with relevant IRBs in preparation for this accelerated review and award process.

Investigators are strongly encouraged to contact the relevant Scientific/Research Contact listed in this FOA prior to submission to ensure that the proposed project is aligned with FOA objectives and requirements.

Different participating Institutes and Centers at NIH are interested in supporting research in the following specific areas:

The National Institute on Aging (NIA) is interested in topics that include, but are not limited to:

• Impact of disasters on the long-term care of the elderly disabled, whether residential or in-home care.
• Long-term health impacts of stressful disaster-related events, with particular concern for people with limited resources (money, social support) and people managing chronic conditions and the disabled elderly.

The National Institute of Mental Health (NIMH): Recognizing that substantial research has been conducted on mental health outcomes following disasters, including the role that many psychosocial stressors play in acute and chronic disease morbidity and mortality, NIMH will accept for consideration applications that move beyond established literature on general risk factors, patterns of need, the costs and benefits of implementing evidence-based interventions and treatments to improve mental health outcomes, and examining new ways of reducing gaps in mental health needs. Applications proposing to relate known disaster related stressors to acute and chronic mental health outcomes will not be considered for funding by NIMH.

NIMH will prioritize research in the following specific content areas, particularly where pre-disaster relevant data exists. While clinical trials are not accepted in response to this FOA, naturalistic and observational methods and designs may be appropriate depending on the research questions to be addressed.

• Studies in the context of outreach and relief efforts that document mental health outcomes of different models of outreach, assessment, and intervention;
• Observational/naturalistic studies of models for screening and follow-up care for new conditions as well as (re)establishing care for those with SMI in health care, educational, occupational, and other community settings;
• Studies of just in time training of a mental health workforce and lay extenders in evidence-based intervention methods;
• Research on the effects of services for diverse populations in disparate social, cultural, geographical, and environmental contexts;
• Research on service delivery models to reduce or eliminate known health disparities related to race, ethnicity, geography, sexual and gender minority status and/or socio-economic status, to improve outcomes in understudied populations, and to study improvements in access, engagement, and fidelity high value mental health services;
• Innovative research examining the use of telehealth and other technology to reach people at various stages of need;
• Observational/naturalistic studies to document local adaptation of evidence-based practices to identify components that surpass or fall short of expected effects;
• Research on alternative financing mechanisms that promote high quality, clinically effective, and efficient community-based care and discourage low-value services.

For any research examining access, utilization, quality, or outcomes including disparities in outcomes of interventions and services, NIMH strongly encourages measurement of putative mediators and mechanisms of change.

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 from 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

Applicant organizations must be US organizations physically located in PR or USVI.

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, 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.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Jennifer Alvidrez, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9567
Email: alvidrezjl@mail.nih.gov

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 with the following additional instructions:

Facilities & Other Resources: Describe the capacity of the applicant institution and collaborating organizations to initiate and conduct the project on an accelerated timeline.

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. The budget allocation to non-PR/USVI organizations is limited to no more than 15% of annual direct costs.

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: Provide a multi-domain, multi-level conceptual model specifying the psychosocial stressors, coping strategies or responses, and health impacts or health risk factors to be examined. Provide a rationale for the time-sensitive nature of the project (i.e., how delays in study initiation might preclude addressing certain research questions or the collection of certain types of data). Describe recruitment strategies to reach potential participants who may be difficult to reach by mail, phone, or e-mail due to post-hurricane power outages, relocation, and other disruptions. Describe how proposed research methods and measures are appropriate for assessing hurricane related stressors, coping strategies, and health impacts.

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.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

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.

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.

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? Is a clear and compelling multi-domain, multi-level conceptual model described specifying the hurricane-related psychosocial stressors, coping strategies or responses, and health impacts or health risk factors to be examined? Is the rationale for timeliness compelling?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators 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?

Are proposed research methods and measures appropriate for assessing hurricane related stressors, coping strategies, and health impacts? Are appropriate strategies described to reach potential participants who may be difficult to reach due to post-hurricane power outages, relocation, and other disruptions?

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? Do the applicant institution and collaborating institutions have the capacity to initiate and conduct the project on an accelerated timeline?

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.

Not Applicable

Not Applicable

Not Applicable

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 NIMHD, 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned 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:

• 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 distribution of projects within and across PR and USVI.

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.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 http://www.hhs.gov/ocr/civilrights/understanding/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 http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)

Telephone: 301-945-7573

For NIMHD USVI-based applications:

Jennifer Alvidrez, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9567
Email: jennifer.alvidrez@nih.gov

For NIMHD PR-based applications:

Adelaida M. Rosario, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8683
Email: adelaida.rosario@nih.gov

Paige A. Green, Ph.D., M.P.H., F.A.B.M.R.
National Cancer Institute (NCI)
Telephone: 240-276-6899
Email: paige.green@nih.gov

Amelia Karraker, PhD
National Institute on Aging (NIA)
Telephone: 301-496-3131
Email: Amelia.Karraker@nih.gov

Judith A. Arroyo, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-0717
Email: Jarroyo@mail.nih.gov

Kenneth Santora, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2933
Email: ksantora@niaid.nih.gov

Darien Weatherspoon, DDS, MPH
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5394
Email: darien.weatherspoon@nih.gov

Marsha Lopez, PhD, MHS
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6504
Email: marsha.lopez@nih.gov

Farris Tuma, ScD
National Institute of Mental Health (NIMH)
Telephone: 301-443-9232
Email: ftuma@nih.gov

Thomas Vollberg, Sr., PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8770
Email: vollbert@mail.nih.gov

Priscilla Grant, JD
National Institute on Minority Health & Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: grantp@mail.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@gab.nci.nih.gov

Eva Lawson-Lipchin
National Institute on Aging (NIA)
Telephone: 301-435-2020
Email: eva.lawson-lipchin@nih.gov

Jeffrey Thurston
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-9801
Email: jeffrey.thurston@nih.gov

Gregory Smith
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2993
Email: gs225y@nih.gov

Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov

Jennifer L. Schermerhorn
National Institute on Drug Abuse (NIDA)
Telephone: 240-631-2090
Email: SchermerhornJ@mail.nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone:301-443-2805
Email: Siscor@mail.nih.gov

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.