Participating Organization(s)
National Institutes of Health (NIH)
Components of Participating Organizations

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. 

Funding Opportunity Title
Diet and Physical Activity Assessment Methodology (R21 Clinical Trial Not Allowed)
Activity Code
R21 Exploratory/Developmental Research Grant
Announcement Type
Reissue of PAR-18-112
Related Notices
None
Funding Opportunity Announcement (FOA) Number
PAR-18-857
Companion Funding Opportunity
PA-18-856, R01  Research Project Grant  
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.847, 93.393, 93.399, 93.273, 93.361, 93.307
Funding Opportunity Purpose
This Funding Opportunity Announcement (FOA) encourages innovative research to enhance the quality of measurements of dietary intake and physical activity. Applications submitted to this FOA may include development of: novel assessment approaches; better methods to evaluate instruments; assessment tools for culturally diverse populations or various age groups, including children and older adults; improved technology or applications of existing technology; statistical methods/modeling to improve assessment and/or to correct for measurement errors or biases; methods to investigate the multidimensionality of diet and physical activity behavior through pattern analysis; or integrated measurement of diet and physical activity along with the environmental context of such behaviors.  
Posted Date
July 17, 2018
Open Date (Earliest Submission Date)
September 16, 2018
Letter of Intent Due Date(s)
Not Applicable
Application Due Date(s)
Standard dates apply

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.

AIDS Application Due Date(s)
Standard AIDS dates apply by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

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.
Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date
September 08, 2021
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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.

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.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

Background

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:

     
  • 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 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 and sedentary behavior;
  • 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 image-capture or 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.      

 

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.

 

See Section VIII. Other Information for award authorities and regulations.
Funding Instrument
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed
New
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget
Direct costs are limited to $275,000 over a two-year period excluding consortium F&A costs, with no more than $200,000 in direct costs allowed in any single year.
Award Project Period
The total project period may not exceed two years.  
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

1. Eligible Applicants

Eligible Organizations

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)
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. 
Required Registrations

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.
  • 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.

Eligible Individuals (Program Director/Principal Investigator)
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.

3. Additional Information on Eligibility

 

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)

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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

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

Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
Instructions for Application Submission
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.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
 

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

R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
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.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form
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.
 

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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.

7. Other Submission Requirements and Information

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.

 
 

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

1. Criteria

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 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.

Overall Impact
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).
Scored Review Criteria
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?

Additional Review Criteria
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
Additional Review Considerations
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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), 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.

3. Anticipated Announcement and Award Dates

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.

1. Award Notices

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.

2. Administrative and National Policy Requirements

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.

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.

Cooperative Agreement Terms and Conditions of Award
Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Mary Evans, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4578 
Email: evansmary@niddk.nih.gov 

Amy Subar, Ph.D. 
National Cancer Institute (NCI)
Telephone: 240-276-6695
Email: subara@mail.nih.gov
(For research applications that focus on diet)

Richard Troiano, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6916
Email: troianor@mail.nih.gov
(For applications that focus on physical activity)

Nancy J. Emenaker, Ph.D., R.D.N., L.D., F.A.N.D..
National Cancer Institute (NCI)
Telephone: 240-276-7125
Email: emenaken@mail.nih.gov
(For research applications for dietary biomarkers, (including new objective recovery markers) and predictive biomarkers for dietary constituents and foods)

Rosalind Breslow, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-594-6231
Email: rbreslow@mail.nih.gov

Mary Roary, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-768-8305
Email: mary.roary@nih.gov

Priscah Mujuru Dr.P.H.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: (301) 594-9765
?Email: priscah.mujuru@nih.gov

Peer Review Contact(s)
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Financial/Grants Management Contact(s)
Thuthuy Nguyen
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8825
?Email: thuthuynguyen@niddk.nih.gov


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

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

Randi Freundlich, R.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: freundlichr@mail.nih.gov

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@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.
Authority and Regulations
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.


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