Required Application Instructions

It is critical that applicants follow the 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

To improve health and reduce disease burden, scientific research is best implemented at the biological, clinical and population level. The goal of this FOA is to promote research that aims to integrate individual factors with community and environmental factors. Population health studies focus on the "upstream" level determinants of health those basic and primary social factors that are fundamental to group level differences in health outcomes. Population health interventions (PHI) provide a way to advance health by linking research at a variety of different levels and allows for the consideration of scale in accounting for human interaction and environmental factors simultaneously.

PHI research has shown that many health issues can be addressed through a multi-level transdisciplinary approach, and by using a variety of study designs and methods, including classical case control and small community designed studies, experiments (including natural experiments, interrupted time series, and cluster randomized designs) and creative modeling approaches. Population health interventions often involve policies or programs, which address underlying social, economic, and environmental conditions in an effort to shift the distribution of health risks.

This funding announcement promotes research that utilizes interventions targeting multiple levels, including the individual level (behavioral, familial) and clinical/community level (including the health care system at both the regional and national level).

Applications submitted to this funding announcement should recognize the complexities of the multi-factorial origins of health outcomes, and target more than one of the following, including, but not limited to:

• Individual-level factors, such as self-management for health/disease risk factors, stress, and social support.
• Environmental factors, such as culture, social system, social context, and the built environment.
• Provider-level factors, such as improvements in access, quality of care, communication, systems for promoting trust and adherence, and patient support services (e.g., patient navigation).
• Community factors, such as place, developing a social culture of healthy lifestyles, safe environments, and increased choices of healthy foods and leisure activities.

Applicants are strongly encouraged to build multidisciplinary teams comprised of researchers from multiple social and behavioral science fields (including epidemiology and biostatistics, social work, urban planning and development, public policy, anthropology, geography, economics, psychology, sociology, etc.) as well as basic health science and clinical researchers.

Individual level interventions need to integrate high-level mechanisms/influences in their analysis. Multi-level interventions means striking a balance between both individual level and higher order effects. Applicants can consider a number of study designs and approaches, including, but not limited to:

• Use of novel or non-traditional theories (e.g., systems theory, ecological and multi-level intervention theory), methodologies (e.g., mixed methods, social network analysis, geographical information systems) and innovative measures.
• Use of pragmatic study designs and flexible statistical approaches, employment of real world data, development of metrics for implementation and services outcomes, and secondary data analysis.
• Testing of multi-level interventions that affect and inform public and health policy at the institutional, local, regional, state, and national levels, including natural experiments.
• Testing of multi-level processes and factors critical for successful integration of evidence-based interventions within real-world clinical and public health settings (e.g., families, communities, worksites, and schools).
• Determination of the most effective methods for conducting dissemination and implementation research in order to maximize population health impact.
• Discussion of the population level of impact of the proposed intervention.
• Inclusion of evaluation components (e.g., how these projects will be evaluated for project outcomes).
• Investigation of the science or questions around scaling.

All interventions should include a component of translation and sustainability, in anticipation of the eventual termination of research support and planning for continuation and dissemination of successful programs. To support sustainability, projects that link to local policy efforts are highly encouraged.

Examples of Research Topics

Applications should be relevant to both the objectives of the FOA and at least one of the participating Institutes and Centers research interests. Researchers are strongly encouraged to review the general research interests of the participating ICs and the examples of topics of interest specific to this FOA.

National Cancer Institute (NCI)

The National Cancer Institute encourages submission of applications designed to study multi-level interventions aimed at improving cancer prevention and control along any aspect of the cancer control continuum. Importantly, NCI defines multi-level broadly, to include studies that incorporate interventions addressing two or more of the following levels: individual, family, school, workplace, social network, community, as well as natural, built, economic, policy, institutional and health care environments. Additionally, studies that develop and test interventions at one level in the context of naturally occurring variation in policy or other environments are encouraged. NCI encourages intervention components to be clearly specified and explicitly linked to new, refined, or existing multi-level theories. The use of novel and alternative research and intervention designs (e.g., sequential multiple assignment randomized trial (SMART), multiphase optimization strategy (MOST), hybrid effectiveness and implementation designs and factorial experimental designs) are highly encouraged.

NCI is interested in diverse submissions - including but not limited to those that:

• Develop and test innovative multi-level interventions targeting behavioral risk factors linked to cancer occurrence and outcomes, such as: sun exposure, dietary intake, sedentary behavior/lack of physical activity, obesity, sleep, alcohol use, adherence to cancer screening guidelines, adherence to chemopreventive or chemotherapeutic regimens, and the use of tobacco or its constituents. Studies of other behaviors are also encouraged insofar as they are related to cancer prevention and control.
• Develop intervention to improve HPV vaccine uptake by integrating individual (parent-child attitudes about sexual activity), demographic information (e.g., immigration or insurance status), health-care factors (e.g. physician recommendation) and environmental factors (e.g., access to clinics).
• Examine moderation of individual level cancer control interventions by natural built, social, policy or economic environments.
• Develop and test individual behavioral interventions tailored to different environments among racial/ethnic populations and underserved low resource communities.
• Develop and test multi-level interventions incorporating geospatial information and technology designed to facilitate healthful use of the environment
• Develop and test multi-level interventions considering objective and perceived characteristics of physical and social environment that impact human health/risk behaviors.
• Translational research involving behavioral experiments or creative modeling approaches that would elucidate the role multiple levels in influencing cancer related health behaviors and health outcomes simultaneously
• Translate epidemiologic knowledge of risk factors (e.g., HPV or HCV infection) and prevention measures (e.g., vaccinations) into effective multi-level interventions in specific settings or populations, including those defined by socio-cultural group, race, ethnicity, age, gender, socioeconomic status, geography, and other factors, to address unequal burden of cancer.
• Integrate innovative combinations of data (e.g., genetic information, environmental exposures, contextual factors) to inform the design of multi-level interventions aimed at cancer prevention and control.

National Institute of Alcohol Abuse and Alcoholism (NIAAA)

The NIAAA seeks to support research that translates evidence from epidemiological and/or etiological studies into preventive interventions that may ultimately shift population means on excessive drinking and alcohol-related problems to healthier ranges. Over the last three decades, we have come to understand that health problems can best be understood in the context of the population where they exist, not just the individual. Paradigms such as the prevention paradox have been especially helpful for informing such research. The NIAAA encourages multi-level research designed to prevent/intervene on health compromising alcohol consumption related problems.

The Institute encourages theory-informed studies that include at least one intervention component from each of at least two of the following categories: (a) Individual intrapersonal level characteristics of the person (e.g., genetics, personality); interpersonal characteristics of person level interactions (e.g., dyads, small family or friend networks); (b) Organizational characteristics of the organization such as services offered, cost, other health care provider features, etc ; (c) Community characteristics of the community (i.e., measures of community social cohesion or social capital, neighborhood level socioeconomic status, crime rate, poverty, alcohol availability); (d) Macro level local, state or national characteristics (i.e., alcohol, tobacco or other drug environment, economic conditions). NIAAA is especially interested in intervention studies that include: social media, alcohol, tobacco and/or other drugs, and health-in-all strategies aimed at increasing health equity (economic, migration, etc.) as preventive interventions to address health compromising alcohol consumption.

The NIAAA encourages submission of applications designed to study preventive interventions, including but not limited to those that:

• Develop and test interventions with evidence based modules that are tailored components of multi-level preventive interventions to address excessive/risky drinking and related consequences,
• Test each component of a multi-level intervention to prevent excessive/risky drinking and related consequences, in order to assess which components have the strongest effects and for whom,
• Adapt and translate drinking interventions found effective in specific settings or populations to new contexts, larger scales, or different population groups including those defined by socio-cultural group, race, ethnicity, age, gender, socioeconomic status, geography, and other factors in an effort to reduce alcohol-related disparities,
• Use novel methods such as systems methodology, ecological momentary assessment, multi-phase optimization strategies (MOST) or others to evaluate differences in the causal effects of multi-level interventions, targeting alcohol use outcomes, across population subgroups,
• Examine the efficacy of recommendations from clinical guidelines, disseminated by the U.S. Preventive Services Task Force, related to implementing coverage for alcohol misuse prevention services as an intervention to prevent harmful alcohol use outcomes,
• Examine the mechanisms by which individual, community, and environmental intervention components work to prevent harmful alcohol use outcomes in multi-level interventions.

National Institute of Dental and Craniofacial Research (NIDCR)

Numerous studies have documented the disproportionate burden of oral disease that some segments of the U.S. population suffer. At-risk populations include low-income rural or urban dwellers; Blacks; American Indians; Alaska Natives; Asians; Native Hawaiians and other Pacific Islanders; Hispanics/Latinos and their subpopulations; those living in medically/dentally underserved areas; those with developmental or acquired disabilities; and frail and functionally dependent elders. It is widely acknowledged that the determinants of oral health disparities and inequities are complex and do not exist in isolation. Evolving theoretical frameworks and conceptual models highlight the importance of multi-level, holistic approaches that may include intersecting components, such as individual factors, interpersonal dynamics, health literacy and communications (provider-patient or peer-to-peer); community and cultural factors; and organization factors in the health delivery, social and other systems, financing and public policy realms. While the importance of these factors is recognized, most oral health research to date has focused solely on a single level, such as individual biology or behavior. The priority that NIDCR places on needed multidisciplinary, multi-level research to reduce oral health disparities and inequities is underscored in NIDCR s Strategic Plan for 2014-2019.

Needed information will come from approaches that promote:

• Innovation in health care delivery systems, including prevention, disease management and receipt of comprehensive care;
• Opportunities for the integration of oral health into primary health care, patient-centered care and other public and private systems;
• Use of technology for telehealth, telemedicine/teledentistry and m-Health;
• Optimization of financial and public policies;
• Organizational and community changes based on context and processes; and
• Tailoring of programs to population subgroups including community strength-based approaches

NIDCR encourages applications that propose the rigorous outcome evaluation of existing programs, policies, or natural history studies that address individual-, community-, organizational-level factors intended to reduce oral health disparities or inequities by:

• Improving strategies for the prevention of dental caries, periodontal disease, or oral cancer;
• Increasing provision of efficacious preventive care, such as dental sealants, and disease management;
• Reducing the incidence of untreated dental diseases;
• Improving oral care and oral health status for those with developmental and acquired disabilities; and
• Preventing oral pathologies through oral healthcare provider efforts to decrease use of tobacco products.

NOTE: NIDCR is interested in applications to this FOA for the rigorous outcome evaluation of existing programs, policies or natural history studies. NIDCR does not support under this mechanism the conduct of clinical trials. Investigators are strongly encouraged to contact NIDCR Scientific/Research staff well-prior to submitting an application to this FOA and refer to NIDCR s Clinical Trials Program.

National Institute on Drug Abuse (NIDA)

NIDA seeks theory-based research applications aimed at the development and testing of population-level approaches to drug abuse prevention. NIDA is interested in development and testing of multi-level interventions and strategies that target individual-, environmental-, and community-level factors to prevent drug use and abuse; drug-related problems and disorders (such as mental health, violence, other comorbid conditions); and substance-use related HIV acquisition and transmission in high prevalence populations. NIDA has an interest in applications that seek to prevent use and abuse of various substances and including but not limited to nicotine, marijuana, cocaine/crack, methamphetamine, club drugs, inhalants, non-medical use of prescription and over-the-counterdrugs, or any of these drugs in combination and/or with use of alcohol. In addition, NIDA is interested in research on prevention interventions that address the shifting marijuana policies as well as new policies that emerge and also interested in prevention interventions that address increasing use of e-cigarettes and other emerging tobacco products.

Under this FOA, NIDA encourages research on the following and other relevant topics:

• Development and testing of models to inform and guide the selection, tailoring, and implementation of individual evidence based components that comprise multi-level drug use and HIV prevention interventions and strategies.
• Research to test the individual components of multi-level interventions and identify those components that produce the strongest effects for given communities and subpopulations (e.g., optimization designs).
• Development and testing of implementation models and strategies for implementing multi-level interventions into systems that have the greatest potential for population health impact.
• Studies to evaluate the mediating and moderating effects of individual, community, and environmental factors on multi-level interventions to prevent drug use and HIV transmission and acquisition in high risk populations.

Research Scope

NIDCD
The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications that support its mission and advance the science in its 7 extramural programs: hearing, balance/vestibular, taste, smell, voice, speech and language. The NIDCD recently completed its National Strategic Research Plan for 2012-2016. One of the four overarching goals is improving outcomes for human communication (accelerating translation from research to practice, increasing access to health care, enhancement of delivery, quality and effectiveness of care). The NIDCD is interested in multilevel, transdisciplinary population health interventions that target underlying social, economic, and environmental conditions in an effort to improve communicative function and health outcomes for individuals with reduced hearing or other communicative disorders. The NIDCD is interested in diverse submissions- including but not limited to those that:

• Address Hearing Health Care (HHC) and other communicative health care through linking environmental processes at multiple levels (institutions, communities, neighborhoods, families, social networks) and behavioral, psychological, and biological factors.
• Develop and test individual behavioral interventions tailored to different environments among racial/ethnic populations and underserved and low resource communities.
• Address disparities in hearing and other communicative functions, the rehabilitation of persons living with a communication disorder and the ability of individuals and families to overcome the burden of these disorders in their lives.
• Conduct rigorous outcome evaluation of existing programs, policies, or natural history studies that address individual-, community-, organizational-level factors intended to reduce health disparities or inequities in HHC and other communicative health care.
• Determine the potential costs and impact of insufficient care (un-treated or under-treated) on real world function and outcomes, on topics such as quality of life, depression, stigma, motivation and community engagements.
• Address HHC and other communicative health care using family-centered, school-based and community-based settings, and primary care programs.
• Prevent hearing loss and other communication disorders through improved hearing health care and other communicative health care (e.g., reduction of exposure to noise for better hearing health and vocal health).

Note: NIDCD does not support the conduct of clinical trials under this FOA.

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:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• 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)
• Eligible Agencies of the Federal Government
• 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)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are 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).

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the 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:

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.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit 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 requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Applicants are required to follow our Post Submission Application Materials 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.

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?

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?

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

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.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• 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 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.

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.

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 progress report, 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.

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: https://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 CenterTelephone: 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

Michael Spittel
Office of Behavioral and Social Science Research (OBSSR)
Telephone: 301-451-4286
Email: spittelm@mail.nih.gov

OBSSR does not award grants. Please contact one of the IC program contacts listed below for questions regarding funding interest.

David Berrigan
National Cancer Institute (NCI)
Telephone: 240-276-6752
Email: berrigad@mail.nih.gov

Dionne C. Godette
National Institute of Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-5726
Email: dionne.godette@nih.gov

Jane Atkinson
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-435-7908
Email: jatkinso@mail.nih.gov

Jacqueline Lloyd
National Institute of Drug Abuse (NIDA)
Telephone: 301-443-8892
Email: lloydj2@nida.nih.gov

Lana Shekim, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-5061
Email: shekiml@nidcd.nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Jaclyn Crouch
Office of Behavioral and Social Science Research (OBSSR)
Telephone: 240-271-9672
Email: jaclyn.crouch@nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-564-4798
Email: rutbergd@mail.nih.gov

Edith Davis
National Institute of Drug Abuse (NIDA)
Telephone: 410.360.4734
Email: edavis1@nida.nih.gov

Carol Perry
National Cancer institute (NCI)
Telephone: 240-276-6282
Email: perryc@mail.nih.gov

Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email: myersc@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.