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

Diet and physical activity are lifestyle and behavioral factors that play a role in the etiology and prevention of many chronic diseases, such as cancer, coronary heart disease, and overweight/obesity as well as in maintaining weight loss. Accurate longitudinal data on physical activity and dietary intake patterns would be especially helpful in understanding how these factors may impact on health and functional status over the human lifespan. Therefore, diet and physical activity are assessed for both surveillance and epidemiological, behavioral, and clinical research purposes. The measurement of usual dietary intake or physical activity over varying intervals or in the past, by necessity, has relied on self-report instruments. Such reports are cognitively difficult for respondents, and are prone to varying degrees of measurement error depending on the time period considered, the ease of the instrument, and the characteristics of the respondents. Understanding and interpretation of instruments and the concepts they address may differ among population subgroups.

A. Dietary Assessment

Self-report dietary assessment instruments are used in a variety of research settings to estimate the consumption of individual foods or nutrients, though it is known that their ability to measure energy is especially limited. Such instruments include food records in which respondents record foods as they are consumed, detailed and standardized 24-hour recalls which query intake for the past 24-hours or previous day, food frequency questionnaires which ask individuals to report usual frequency of intake of a long list of foods over a specified time, and screeners or short food frequency instruments that target the capture of intake of one or a few foods or nutrients. Each of these self-report dietary assessment instruments has its strengths and limitations.

The limitations of self-administered dietary assessment instruments pose significant challenges for all dietary research, but particularly for intervention and/or metabolic studies, in which stringent monitoring of overall dietary composition and energy intake is desired. Although some studies provide meals to participants or include doubly labeled water assessments in addition to self-report dietary measures, these approaches are not always feasible, costly, and entail substantial participant burden (e.g. travel time to collect or eat meals at a metabolic kitchen, clinic visits) which can affect recruitment and retention. Therefore, there is a critical need for novel and improved methods and tools related to objective and self-reported measures of dietary intakes. There is also a critical need for new objective recovery (e.g., doubly labeled water for energy, 24-hour urinary nitrogen) and predictive (e.g. 24-hour urinary sucrose) biomarkers for dietary constituents and foods as well as new tools, methods and technologies for obtaining biomarkers such as improved doubly labeled water protocols and alternatives to doubly labeled water for all types of dietary research.

B. Physical Activity Assessment

Until fairly recently, the primary focus of research and recommendations regarding physical activity was on sustained vigorous exercise. Such activity is usually obtained through purposeful, programmed behavior, such as jogging, swimming, or sports participation. With these characteristics, vigorous exercise is relatively easy for respondents to report, although validation studies generally find a bias toward over-reporting. Recent physical activity guidelines have emphasized the accumulation of shorter episodes of moderate intensity physical activity and the importance of reducing sedentary time, including periods spent sitting and lying down. Moderate-intensity activity can occur in many routine daily activities. Interventions to increase physical activity obtained through moderate-intensity daily activities have achieved comparable physiologic outcomes to those that used more vigorous programmed activities. Furthermore, sedentary behaviors often replace activities of light intensity. Monitoring behavior to assess sedentary, light- or moderate-intensity activities is a challenge because of the need to assess many activities of short duration that may occur as part of routine daily functions in varying contexts, e.g., transportation, occupation, household chores, as well as recreation and sport. Current guidelines also note the importance of engaging in activities to promote strength, balance, and flexibility. Maintaining strength, balance and flexibility are important for an aging population, and may have beneficial effects for disease prevention. Little attention has been given to assessment of these types of activities.

Most evaluations of physical activity in surveillance or risk factor epidemiology rely upon retrospective questionnaire assessments. Many instruments have been developed and some have been validated. A major improvement in questionnaire assessment of physical activity was the inclusion of household sources of activity, which can be the primary context for physical activity among women. In addition, some types of questionnaires include sources of physical activity common among certain racial/ethnic groups. However, efforts to understand how various population subgroups interpret certain constructs used in physical activity questionnaires, such as leisure time activity or moderate physical activity, are limited.

Physical activity records have been shown to be quite accurate for capturing total activity; however, they are burdensome to respondents, requiring responses each time there is a change in activity throughout the day. An advantage for physical activity is the recent technological advances that allow physical activity frequency, duration, and intensity to be objectively measured by wearable monitors that can record movement, heart rate, and other physiological signals. A challenge with the use of monitors is capturing total activity to estimate energy expenditure. This is because activity monitors selectively record movement of the part of the body to which they are attached. Without supplemental data collection, activity monitors do not capture activity context (e.g., occupation, transportation, household, recreation).

High-resolution movement signals available from current accelerometer-based devices are the basis of a variety of algorithms that seek to identify activity types, in addition to improving estimates of energy expenditure. A challenge to the physical activity field is to arrive at a consensus approach to processing the acceleration data that is becoming available from a variety of devices. Another challenge is to increase the understanding of the unique and shared aspects of reported physical activity behaviors and the movement and physiological data available from devices.

C. Parallels between Diet and Physical Activity Assessment

There are many parallels between diet and physical activity assessments. For example, assessing total physical activity is analogous to assessing total energy intake, while assessing subcomponents of physical activity, such as occupational or leisure time activity, or cardiovascular or strengthening activities is analogous to assessing dietary fat or fruit and vegetable intake. Reference periods for either diet or physical activity behaviors can vary from a week to a lifetime, and may focus on recent behavior, a specific previous period, or may be recorded contemporaneously. Ideally, physical activity assessment includes type of activity and context (specified by question content or respondent), frequency of behavior, duration of behavior, and performance intensity. Estimating performance intensity or duration is similar in many ways to estimating portion size in dietary questionnaires. Respondents may not have internal reference criteria that agree with the external criteria of the investigator, and the estimates can be influenced by cultural norms or public health messages.

Self-report of both diet and, physical activity is prone to measurement error related to challenges of memory, estimation, and bias. Such error can obscure relationships between diet/physical activity and disease risk, and may distort data used for surveillance. Recent applications of measurement error theory to dietary assessment have shown that reporting error may mask potentially important relationships with other variables. Furthermore, the demonstration of correlated errors between FFQs and 24-hour recalls has indicated the strengths and limitations of using calibration studies to correct for measurement error. With regard to physical activity, , methods to evaluate measurement error and algorithms to compensate for such errors through the use of statistical models and analytic procedures remain underdeveloped.

D. Pattern Analysis in Diet and Physical Activity

Different statistical methods have been used to characterize patterns to examine the multiple dimensions of diet and/or physical activity. The current interest in diet and physical activity patterns creates a critical need to examine the reproducibility and validity of these analysis methods. For investigator-driven methods, research is needed to test how the scoring, weighting, selection and measurement of individual component items, and modeling strategies influence the validity of the index. Similarly, for data-driven methods, additional work is needed to test the most useful categorization and treatment of input variables, the statistical methods and options used to derive patterns, and the use of statistical testing to guide pattern selection. Research is also needed to examine how the use of pattern analyses may attenuate or exacerbate measurement error issues, to investigate the cultural variation in food patterns and how food grouping may be influenced by different contexts, and to evaluate the ability to measure change in dietary patterns over time.

E. Potential for Integrated Measurement of Diet, Physical Activity, and the Built Environment

Recent advances in objective measurement of movement and location through the use of global positioning systems (GPS), accelerometers, pedometers, cell phones, miniaturized video cameras and other devices for tracking individuals and individual behavior, along with powerful new analytical tools for exploring spatially referenced data using geographic information systems (GIS), have created a rich opportunity for the integrated measurement of environmental context and behavior. For example, combined GPS and accelerometer units are being used to measure both intensity of physical activity and the setting in which this activity occurred. Similarly, mobile phones, which incorporate GPS systems and cameras, could capture both serving size and dining locale. Despite the promise of such technological advances, and despite the strong interest in ecological models of health behavior, there are very few published studies describing and validating usable tools that simultaneously incorporate the measurement of diet, physical activity, and the environment. Such studies are urgently needed to guide researchers in the field as to selection of appropriate tools.

This FOA will support research pertinent to improving the measurements of diet and physical activity through the development of better instruments, innovative technologies, and/or applications of advanced statistical/analytic techniques. Research proposed in the applications should be aimed at exploring and optimizing innovative combinations of objective and self-report measures of physical activity or dietary intake in both the general population and its diverse subgroups.

Specifically, this funding opportunity is intended to support innovative research focused on assessments of dietary and physical activity patterns and the settings in which such behaviors occur, not on the determinants of these behaviors, studies of the causal association between environment and behavior, or interventions designed to modify or improve behaviors related to dietary intake or physical activity/sedentary behavior. Moreover, it is not the primary intent of this Funding Opportunity Announcement (FOA) to make minor adjustments to existing instruments (such as simply adding specific foods or activities to the already established standardized methods and questionnaires). Rather, the purpose is to promote substantive improvements in the assessment of diet and physical activity as related to public health, obesity, cancer, and chronic diseases across the lifespan.

Potential topics include, but are not limited to:

• Refine and test innovative methods of diet or physical activity assessments for use in population surveillance, epidemiological studies, and/or behavioral interventions within general populations, socio-culturally diverse populations, low-literacy respondents, individuals with physical or developmental disabilities, and/or children or other age groups;
• Develop or refine innovative methods to improve respondent self-report of diet or physical activity behavior (potential areas include non-standardized questionnaire administration or use of life-event history calendars or other recall cues to enhance retrieval of relevant information);
• Conduct validation or testing of existing instruments to assess utility in diverse populations;
• Develop or refine innovative methods to improve underreporting of energy intake among obese and overweight individuals;
• Identify factors leading to misreporting on dietary or physical activity assessment instruments;
• Develop, refine, and test analytic or statistical methods to address measurement errors in the collection of dietary and/or supplement intake data and/or physical activity data;
• Develop, refine, and test innovative methods to investigate the multidimensionality of diet and/or physical activity behaviors through pattern analyses.
• Improve methods for measuring the type of physical activity (resistance vs. aerobic) and its amount (frequency, intensity, duration), the energy cost associated with physical activity, energy intake, and energy balance.
• Improve methods for assessing intake of alcohol and particular types of food constituents, such as fat subtypes, phytochemicals, herbs, spices, and other bioactive food components.
• Validate methods for measuring dietary and/or supplement intake or physical activity using appropriate reference instruments, including biomarkers, objective measures, or physiologic outcomes such as strength and fitness.
• Develop or refine new technologies for the measurement of dietary intake and/or supplement intake or physical activity.
• Conduct cognitive testing of self-reported dietary or physical activity instruments to assess respondents' abilities to answer questions, particularly in population subgroups.
• Explore psychometric properties of instruments so that questionnaire items can be developed for various groups, compared using the same metric, or be administered with innovative approaches such as computer adaptive testing methodologies.
• Explore the potential of ecological momentary analysis (EMA) techniques in the assessment of the complex, periodic behaviors of dietary intake and physical activity.
• Develop and test new methods for accurate assessment in normal elderly and elderly with cognitive impairment or dementing diseases, which might result in difficulty remembering details of dietary intake and physical activity.
• Expand and integrate the use of direct observation, self-report, GPS, GIS and other instruments for the joint measurement of diet, physical activity, and the environments in which these activities occur. Such integrated measurement should improve the efficiency with which we can collect measures of energy balance related behavior.
• Explore new analytic methods or models that integrate multiple layers of diet and/or physical activity data.

The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research.

The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel.

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 download 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 Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

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

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.

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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.

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or bio-behavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on 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? 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? 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?

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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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

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

As part of the scientific peer review, all applications:

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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

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.

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.

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Mary Evans, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4578
Email: [email protected]

Amy Subar, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6695
Email: [email protected]
(For research applications that focus on diet)

Richard Troiano, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6916
Email: [email protected]
(For applications that focus on physical activity)

Nancy J. Emenaker, Ph.D., R.D.
National Cancer Institute (NCI)
Telephone: 240-276-7125
Email: [email protected]
(For research applications that focus on intake of herbs, spices and other bioactive food components)

Rosalind Breslow, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-594-6231
Email: [email protected]

Mary Roary, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-768-8305
Email: [email protected]

Holly Nicastro, Ph.D.
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-435-0383
Email: [email protected]

Layla Esposito, Ph.D.
Eunice Kennedy Shriver National Institute of Child and Human Development (NICHD)
Telephone: 301.435.6888
Email: [email protected]

Cindy D. Davis, Ph.D.
Office of Dietary Supplements (ODS)
Telephone: 301-435-2920
Email: [email protected]

Fungai Chanetsa, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-408-9436
Email: [email protected]

Karin Mastrangelo
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-443-3603
Email: [email protected]

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: [email protected]

Judy S. Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-443-4704
Email: [email protected]

Randi Freundlich, R.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: [email protected]

Robert Tarwater
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-402-6090
Email: [email protected]

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

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

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