Department of Health and Human Services

Part 1. Overview Information
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), (http://www.cancer.gov)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute of Nursing Research (NINR), (http://www.ninr.nih.gov/)
Office of Dietary Supplements (ODS), (http://dietary-supplements.info.nih.gov/)

Funding Opportunity Title

Improving Diet and Physical Activity Assessment (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PAR-09-224

Related Notices

  • October 18, 2013 - See Notice NOT-OD-14-003. Guidance on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PAR-12-198

Companion Funding Opportunity

PAR-12-197, Improving Diet and Physical Activity Assessment (R21)

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.847, 93.273, 93.865, 93.837, 93.361, 93.399, 93.393

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA), issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of Nursing Research (NINR), and the National Institutes of Health (NIH) Office of the Director (OD) Office of Dietary Supplements (ODS), encourages innovative research to enhance the quality of measurements of dietary intake and physical activity. Applications submitted under 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 older adults; improved technology or applications of existing technology; statistical methods to assess or 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.  

Key Dates
Posted Date

June 6, 2012

Open Date (Earliest Submission Date)

January 5, 2013  

Letter of Intent Due Date

Not Applicable.

Application Due Date(s)

For new applications: February 5, 2013; (Extended to November 1, 2013 per NOT-OD-14-003), Originally October 5, 2013; June 5, 2014; February 5, 2015; (alternating standard R01 receipt dates)

For renewal, resubmission, and revision applications: March 5, 2013; November 5, 2013; July 5, 2014; March 5, 2015 (alternating standard R01 receipt dates), by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

June/July 2013; February/March 2014; October/November 2014; June/July 2015  

Advisory Council Review

October 2013, May 2014, January 2015, October 2015

Earliest Start Date(s)

December 2013, July 2014, April 2015, December 2015

Expiration Date

September 8, 2015

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.


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Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Overview, Background, and Rationale

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/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

Dietary assessment instruments are used in a variety of research settings to estimate the consumption of individual foods or nutrients as well as overall energy intake. Such instruments run the gamut from food records in which respondents record all foods as they are consumed, to detailed and standardized 24-hour recalls of all food or drink ingested in the past day, to food frequency questionnaires in which individuals are asked to report usual frequency of intake of a long list of foods over a specified time, to food frequency questionnaires (sometimes called screeners) which ask about usual frequency of intake of a group of foods targeting a specific food group or nutrient. Each of these self-report dietary assessment instruments is successfully used in various research or public health settings. However, each has flaws and limitations as to the amount of information obtained, the quality of the data, and the analytic techniques used to provide nutrient or food group estimates.

Food records are used in a number of nutrition research settings to measure dietary intake over a single time period, usually 3 to 7 days. For such records to be reasonably accurate, respondents need to be motivated, trained, and literate. The strength of the food record approach is that it provides specific details on the amount and kind of food consumed. Methods for food recording have improved over time and include such innovations as electronic scales or computer entry programs. However, records have important limitations. First, there is consistent research showing that when individuals are asked to record what they eat, they modify their eating habits to make the task easier and/or to represent their diet in a more positive way. In addition, the quality of diet recording is known to decline with increasing numbers of days. Moreover, energy estimates based on self-report records for some respondents tend to be lower than those required for energy balance. This pattern indicates that such respondents are either under-eating and/or under-reporting their intake. Even with accurate reporting, a diet record is not thought to represent usual intake, unless it is consistently observed over different time intervals and seasons.

Twenty-four-hour dietary recalls, in which a trained interviewer asks and probes respondents to report the kind and amount of all food and drink consumed the previous day, are currently used to monitor group mean intakes in the population. It is generally accepted that a single 24-hour recall does not represent usual individual intake and cannot be used to estimate population intake distributions of nutrients or food groups. Multiple recalls are required to represent usual intake of all nutrients and foods, and nutrients and food groups that are only infrequently consumed require many days of recall. Methods to collect recalls vary from paper-and-pencil to computerized systems. The more highly sophisticated systems have standardized probes, multiple passes of intake over the day to prompt recall, and "forgotten” foods lists. Such innovations in the recall methods have led to improvements in prompting recall and, therefore, improved estimates of nutrient intake among respondents. However, recalls, like records, are prone to underreporting, although the extent of underreporting may vary by quality of the recall. Underreporting is likely due to problems involving memory, difficulty in reporting portion size, and biases of the respondents.

Food frequency questionnaires (FFQs) are self-administered instruments in which respondents are presented with a long list of items and asked to report usual frequency of consumption over a specific time period (usually 1 year). The strengths of the FFQ method are that it is designed to obtain data regarding usual intake and is much less costly to administer and code than recalls or records. Therefore, the FFQ has been the method of choice for large-scale epidemiological studies. However, FFQs lack the detail and specificity of records or recalls. The food list found on FFQs is, by design, largely composed of frequently consumed foods. The nutrient database lacks specificity and relies on nutrient content of the most common form in which foods are consumed rather than on specific forms. Usual portion sizes are either assumed or queried in a general fashion. In addition, completing FFQs is cognitively difficult, requiring good memory and estimation skills. There are many well-developed FFQs available for use by investigators; therefore, development from scratch is not generally necessary for most research efforts. Many FFQs available today can be adapted to meet particular research needs. There have been limited efforts to adapt FFQs for culturally specific populations and there is a continuing need to adapt instruments as research in diverse and distinct socio-cultural populations expands.

Extensive research has led to the general acceptance that FFQs are prone to more and/or different kinds of error than records or recalls. FFQs have commonly been calibrated with recalls or records, which are considered to be more precise. However, given that there is measurement error in all dietary assessment methods, various methods employing measurement error models and energy adjustment are used to assess validity or to adjust relative risks for disease outcomes. More recently, intake biomarkers such as doubly labeled water for energy expenditure or urinary nitrogen for protein intake have been used to better understand the structure of measurement error and to devise methods to correct for this error in epidemiological studies.

The limitations of self-administered dietary assessment instruments also pose significant challenges for dietary intervention and/or metabolic studies, especially in situations when stringent monitoring of overall dietary composition and energy intake is required. Such studies have often been designed to provide meals to the study subjects or include doubly labeled water assessments in addition to the self-report dietary measures. However, these approaches are not always feasible, often entail substantial time commitment on part of the study subjects and study personnel (e.g., preparation and distribution of meals from the metabolic kitchen, travel time of the study participants to collect or eat their meals at the metabolic kitchen), and may run the risk of increasing study subject burden, thereby affecting retention and future recruitment of study subjects. In this regard, there is a critical need for objective and accurate dietary assessment instruments and methodologies (e.g., new nutrient biomarkers, improved doubly labeled water protocols, and alternatives to doubly labeled water) for dietary intervention and/or metabolic studies.

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. 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. However, monitoring behavior to assess 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.

Physical activity records have been shown to be quite accurate for capturing total activity. Records can provide desired details regarding activity context, the type of activity (e.g., aerobic, strengthening, or flexibility exercise), as well as frequency, intensity, and duration. However, like diet records, they are burdensome to respondents, requiring responses each time there is a change in activity throughout the day. An advantage for physical activity, in contrast to diet, is that recent technological advances allow physical activity frequency, duration, and intensity to be objectively measured by wearable monitors that can record movement and/or heart rate. A challenge with the use of monitors is capturing total activity. This is because activity monitors selectively record movement of the part of the body to which they are attached. Activity monitors worn on the hip primarily capture locomotion, but not upper body movement; if worn on the wrist, locomotion is not accurately recorded. Without supplemental data collection, activity monitors do not capture activity context (e.g., occupation, transportation, household, recreation).

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.

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.

As with diet and other self-reported behaviors, physical activity assessment is prone to measurement error. This error is related to the same challenges of memory, estimation, and bias found in dietary assessment instruments. Many aspects of physical activity, especially those associated with low to moderate intensity, are routine and therefore not salient enough to be recalled well by a respondent. Measurement error can obscure relationships between 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 called into question the common calibration study approach. Research pertinent to the assessment of physical activity has lagged behind the improvements in estimates of dietary intake. In particular, methods to evaluate measurement errors and algorithms to compensate for such errors through the use of statistical models and analytic procedures remain underdeveloped. It may be possible, however, to capitalize on recent advances in addressing dietary measurement errors as a basis for exploring means to characterize and handle measurement errors in estimates of physical activity as well.

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. Dietary patterns have been examined a priori using investigator-driven methods such as score-based index analyses, a posteriori using data-driven methods such as cluster analysis and factor analysis, and more recently, reduced rank regression. These approaches have also been combined in some analyses. Similar methods can be used with physical activity, but this application has been limited thus far. Other methods such as neural networks and classification and regression trees hold promise for new ways to explain the complexity of diet and physical activity patterns.

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, a combined GPS and accelerometer unit could be used to measure both intensity of physical activity and the setting in which this activity occurred. Similarly, cell 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 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.

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. 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 or on studies of the causal association between environment and 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 (e.g., Nutrition Data System for Research, USDA 5 Pass Method, NCI Diet History Questionnaire, NCI Automated Self-Administered 24-hour recall (ASA-24), Block FFQ, Seven-Day Physical Activity Recall, International Physical Assessment Questionnaire). 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.

Potential topics include, but are not limited to:

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

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

Expected direct cost amounts for individual awards range from $200,000 to $650,000.

Award Project Period

The scope of the proposed project should determine the project period.  The maximum period is 5 years for an R01 project.  

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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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

For-Profit Organizations

Governments

Other

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 must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.   

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the 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.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

PHS 398 Research Plan Component

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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

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

Foreign Institutions

Foreign (non-US) 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. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.   

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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.

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 SF 424(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.

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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.  

Section V. Application Review Information

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.

Overall Impact

Reviewers will provide an overall impact/priority 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.

Significance

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?  

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

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?   

Approach

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 clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

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/priority score, but will not give separate scores for these items.   

Protections for Human Subjects

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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.

Biohazards

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.

Resubmissions

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.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not for recommended approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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/priority score.   

Applications from Foreign Organizations

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.

Select Agent Research

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).

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) 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.

Section VI. Award Administration Information

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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) 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. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Mary Evans, Ph.D.
Director, Special Projects in Nutrition, Obesity, and Digestive Diseases
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 681
Bethesda, MD 20892-5450
Telephone: (301) 594-4578
Fax: (301) 480-8300
Email: evansmary@niddk.nih.gov

Amy Subar, Ph.D.
Division of Cancer Control and Population Sciences (DCCPS)
National Cancer Institute (NCI)
6130 Executive Boulevard, EPN Room 4005, MSC 7344
Bethesda, MD 20892-7344
Telephone: (301) 594-0831
Fax: (301) 435-3710
Email: subara@mail.nih.gov

(For research applications that focus on diet)

Richard Troiano, Ph.D.
Division of Cancer Control and Population Sciences (DCCPS)
National Cancer Institute (NCI)
6130 Executive Boulevard, EPN Room 4005, MSC 7344
Bethesda, MD 20892-7344
Telephone: (301) 435-6822
Fax: (301) 435-3710
Email: troianor@mail.nih.gov

(For research applications that focus on physical activity)

Nancy J. Emenaker, Ph.D., R.D.
Division of Cancer Prevention (DCP)
National Cancer Institute (NCI)
6130 Executive Boulevard, EPN Room 3158, MSC 7362
Bethesda, MD 20892-7328 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-0116
Fax: 301-480-3925
Email: emenaken@mail.nih.gov

(For research applications that focus on intake of herbs, spices and other bioactive food components)

Catherine (Cay) Loria, Ph.D., M.S., M.A.
Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive, Suite 10018
Bethesda, MD 20892-7936
Telephone: (301) 435-0702
Fax: (301) 480-5158
Email: loriac@mail.nih.gov

Rosalind Breslow, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
5635 Fishers Lane, MSC 9304
Bethesda, MD 20892
Telephone:  301-594-6231
Fax: 301.443.8614
Email: rbreslow@mail.nih.gov

Regina M. Bures, PhD
Demographic and Behavioral Sciences Branch
Center for Population Research
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD  20852 (for express/courier service; non-USPS service)
Telephone: 301- 496-9485
Email: regina.bures@nih.gov

Paul A. Cotton, PhD, RD
Health Behavior & Minority Health
Division of Extramural Activities
National Institute of Nursing Research (NINR)
6701 Democracy Boulevard, Suite. 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 402-6423
Fax: (301) 451-5647
Email: cottonp@mail.nih.gov

Cindy D. Davis, Ph.D.
Director of Grants and Extramural Activities
Office of Dietary Supplements
National Institutes of Health
6100 Executive Blvd., Room 3B01, MSC 7517
Bethesda, Maryland 20892-7517
Tel: (301) 435-2920
Fax: (301) 480-1845
Email: davisci@mail.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)

Gene McGeehan
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Blvd., Room 732, MSC 5456
Bethesda, MD20892-5456
Telephone: (301) 594-0417
Fax: (301) 594-9523
Email: mcgeehane@niddk.nih.gov

Carol Perry
Grants Portfolio Branch
National Cancer Institute (NCI)
Executive Plaza South
6120 Executive Blvd, EPS Suite 243, MSC 7150
Bethesda, MD 20892-7150
Telephone: (301) 496-7205
Fax: (301) 496-8601
Email: perryc@mail.nih.gov

Robert L. Tarwater
Grants Management Specialist
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive, Room 7150
Bethesda, Maryland 20892-7926
Telephone: (301) 402-6090
Fax: (301) 451-5462
Email: tarwater@nih.gov

Judy Fox
Grants Management Specialist
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
5635 Fishers Lane, MSC 9304
Bethesda, MD 20892
Telephone: 301-443-3891
Fax: (301) 443-3891
Email: jfox@mail.nih.gov

Ted Williams
Grants Management Specialist
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8A17L
Rockville, Maryland 20852
Telephone: 301-435-6996
Fax: (301) 451-5510
Email: williate@mail.nih.gov

Judy L. Sint
Grants Management Specialist
Office of Grants Management
National Institute of Nursing Research (NINR), NIH
6701 Democracy Blvd., Room 730
One Democracy Plaza
Bethesda, MD  20892-4870 (Courier use 20817)
Phone: 301-402-6959
e-mail: sintj@mail.nih.gov

Section VIII. Other Information

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 Parts 74 and 92.


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