National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Cancer Institute (NCI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Minority Health and Disease (NIMHD)
National Institute on Nursing Research (NINR)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
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 is also critical for understanding how these factors may impact health and functional status over the human lifespan. Therefore, diet and physical activity are assessed for surveillance, 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 period considered, the ease of the instrument, and the characteristics of the respondents. Efforts are underway to improve methods of assessment of dietary intake and physical activity, but much research and development remains to advance the field. Furthermore, improvements in understanding and interpreting data generated by existing instruments and the concepts they address may provide insights into differences among population subgroups, external influences, and interventions designed to change or improve dietary intake and physical activity amongst other questions.
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 strengths and limitations.
The limitations of self-administered dietary assessment instruments pose significant challenges for all population-based dietary research, as well as for intervention and/or metabolic studies, in which stringent monitoring of overall dietary composition and energy intake is desired. Therefore, novel and improved methods and tools related to objective and self-reported measures of dietary intakes are critically needed. Researchers also need 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 the mid-1990s, 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. Thus, the programmed nature of exercise facilitates reporting, although validation studies generally find a bias toward over-reporting. 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. The importance of promoting and maintaining strength, balance, and flexibility is well-known; however, little attention has been given to assessment of these types of activities.
To date, many instruments (both reported and device-based) have been developed, and some have been validated. 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. Recently, technological advances have led the collection of device-measured frequency, duration, and intensity of activity using 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; furthermore, 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. More research is needed to advance the procedures for data collection, analysis, and reporting of device-measured physical activity as well as sedentary behavior.
C. Measurement Error in Diet and Physical Activity Assessment
Diet and physical activity assessments are affected by similar sources of measurement error and techniques developed for one area may be adapted or applied to the other.
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 with 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 with 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 continues to be a critical need for more 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 regarding selection of appropriate tools.
Specific Research Objectives
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. Applications should be aimed at exploring and optimizing innovative combinations of device-based 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:
Applications for R21 awards should describe projects that are 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.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
All instructions in the SF424 (R&R) Application Guide must be followed.
The following modifications also apply:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
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.
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.
Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
Does the project address an important problem or a critical barrier to progress in the field? Is 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?
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.
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).
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.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
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Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Mary Evans, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Priscah Mujuru Dr.P.H.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: (301) 594-9765
National Cancer Institute (NCI)
Judy S. Fox
?National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Randi Freundlich, R.D.
National Institute of Nursing Research (NINR)
Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
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