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 Heart, Lung, and Blood Institute (NHLBI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title

Home and Family Based Approaches for the Prevention or Management of Overweight or Obesity in Early Childhood (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PA-10-127

Related Notices

  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
  • 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

PA-13-153

Companion Funding Opportunity

PA-13-154, R21 Exploratory/Developmental Research Grant Award  

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.847, 93.837, 93.865 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites Research Project Grant (R01) applications from institutions/organizations that propose randomized clinical trials testing novel home- or family-based interventions for the prevention or management of overweight in infancy and early childhood.  Tested interventions can use behavioral (including dietary and physical activity), environmental, or other relevant approaches.

Applications should focus on infants and young children (to age 6 years) and emphasize the role of home environment and the influence of family/extended family members and parents (including guardians/ substantial care providers) within the child's home environment.  The direct goal of this initiative is to fund research that will advance knowledge for innovative approaches to the prevention or management of overweight in children less than 6 years of age, with potential for future translation to applications either in the home or linked to a community setting.  Research should consider the familial mechanisms of behavior such as the role of families in the initiation, support, and reinforcement of fundamental food and beverage consumption, physical activity practices, and sedentary behaviors.  In addition, it is of interest to elucidate various underlying behavioral determinants that are crucial to initiate or sustain changes in behaviors that impact energy balance.  Research designs may include linkages with other settings (e.g., daycare, pre-school, or other community venues) or other care providers (e.g., health care providers or teachers) but must include infants or children less than age 6 years as the primary study participant along with parents, and/or other family members residing with the child.  The overarching goal is to identify interventions that influence parent and child behaviors that contribute to inappropriate weight gain, and thereby improve subsequent health status in childhood, adolescence, and adulthood for which overweight is a known risk factor. 

Key Dates
Posted Date

March 22, 2013

Open Date (Earliest Submission Date)

May 5, 2013

Letter of Intent Due Date(s)

Not Applicable.

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

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)

Not Applicable

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

May 8, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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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

Research Objectives 

This FOA requests innovative applications for randomized controlled trials to test novel approaches for the prevention or management of overweight in infants and children (up to 6 years of age at the time of enrollment) in the context of the home environment, including parental/family involvement.  Prevention and management are generally guided by levels of age-appropriate weight status based on the 2000 CDC weight-for-length or BMI-for-age growth charts for boys or girls.  Primary prevention is the prevention of inappropriate weight gain in children currently at a healthy weight (BMI or weight-for-length below the eighty-fifth percentile).  Secondary prevention is the prevention of inappropriate weight gain in youths currently at risk of overweight (BMI greater than or equal to the eighty-fifth percentile to less than the ninety-fifth percentile).  Tertiary prevention in children already overweight (BMI greater than or equal to the ninety-fifth percentile) includes the prevention of further weight gain (i.e., weight maintenance) or the prevention of weight regain among those who have lost weight.  Secondary and tertiary prevention are consistent with interventions for the management of overweight.  Behavioral intervention approaches that include weight loss in overweight children are considered a part of overweight management and therefore, would be appropriate for this FOA.  An Expert Committee has recommended that for primary care practice, in general weight maintenance should be the goal for children ages 2-5 years unless the BMI is greater than 21 kg/m2, in which case weight loss of up to 1 lb/month may be acceptable; weight goals to improve BMI percentile in children less than 2 years of age were indicated as not applicable (Barlow, 2007).  Intervention strategies for prevention or management must be assessed by the child’s weight status as the primary outcome measure, based on the 2000 CDC BMI-for-age or weight-for-length growth charts for boys and girls (percentiles or corresponding z-scores).  For this FOA, the home or primary physical residence of the child is the target site for intervention research that focuses on the role and mechanism of the parents, family, and/or the home environment in the initiation, support, and reinforcement of fundamental food and beverage consumption, physical activity practices, and sedentary behaviors, or other behavioral determinants associated with these practices.  However, the “research” intervention (e.g. delivery of information) might occur elsewhere.  “Parents” may be the biological or adoptive parent(s), legal guardian(s), or persons otherwise acting in the role as primary caregiver(s) of the child.

Background Information

The most recent nationally representative survey data for the years 2003-2006 estimate that 12.4% of all children ages 2 through 5 years residing in the United States are overweight (BMI greater than or equal to 95th percentile of the 2000 CDC BMI growth charts) and an additional 16% are at risk of overweight (BMI 85th to less than the 95th percentile).  Therefore, approximately one-fourth of all toddler and pre-school children in the United States are estimated to be overweight or at risk of overweight (Ogden et al., 2008).  Racial/ethnic disparities have been reported from a nationally representative sample of US children 4 years of age with the highest prevalence among American Indian/Native Alaskan pre-school children for whom obesity is twice as common as in non-Hispanic white or Asian children with an intermediate prevalence among Hispanic and non-Hispanic black children (Anderson and Whitaker, 2009). Harnack et al. (2009) reported a low awareness among parents of overweight status of their pre-school children, concluding this is concerning because parents of overweight children who do not recognize their child’s weight status may be unlikely to engage in obesity prevention efforts.  Approximately one-third of children ages 6-11 years (33.3%) and adolescents ages 12-19 years (34.1%) are either at risk of overweight or are overweight.  It has been known for some time that weight status tends to track across childhood.  By the age of 8 years, most children are in the BMI percentile channel that they will follow until the end of growth in late adolescence (Rolland-Cachera et al., 1988).  Taveras et al. (2009) reported that whereas weight-for-length (WFL) at birth was only minimally associated with subsequent overweight, rapid gains in WFL in the first 6 months of life were associated with sharply increased risk of later obesity, suggesting that early interventions to prevent rapid increase in weight status in the first months of life may help reduce children’s risk of obesity later in childhood.  In another study, children who were overweight at age 13 years had gained more weight by the age of 2 or 3 years than their normal-weight peers (Lagstrom et al., 2008).  Others have shown that BMI tracks over time from childhood through adolescence and into adulthood (Guo et al., 1994; Guo et al., 2002).  A prospective study from Australia reported that being overweight at 5 years was associated with BMI and overweight status of young adults at age 21 years (Mamun et al., 2009).  The importance of the tracking phenomenon for overweight lies in the well-established knowledge that increased body weight in adulthood is highly associated with increased health risk.  A study from Israel (Shibli et al., 2008) indicated evidence of increased health risk in overweight infants and toddlers (less than or equal to age 2 years; weight-for-length greater than or equal to 95th percentile).  BMI has been reported to be the strongest childhood predictor of adult metabolic syndrome (Burns et al., 2009).  An imbalance between excess dietary energy intake and inadequate energy expenditure are ultimately the determinants of overweight status.  At young ages, increases in prevalence of overweight may be influenced by a shift in eating patterns towards larger portion size of energy-dense foods (Lioret et al., 2009).  Data from the Feeding Infants and Toddlers Study (FITS) (January 2006 supplement J Am Diet Assoc) indicate that parents may be responsible for feeding patterns and eating habits introduced very early in life that may last a lifetime.  Patterns of physical activity and physical inactivity may begin at early ages in the home environment.  When combined with a diet of highly energy dense foods, this pattern of inactivity may help explain the increasing prevalence of overweight among young children.  In early childhood the home environment may be crucial in establishing the framework for reinforcement of knowledge or practices consistent with energy balance. There is evidence that children who remain home during the preschool years with their parents are less likely to be obese than children cared for by other family, friends, or neighbors (Maher et al., 2008), suggesting there may be need for a larger role for parents in the management of their children when they are away from home.  In addition to diet and activity, other factors that may also influence the development of overweight in preschool children need further investigation.  For example Taveras et al. (2008) reported that daily sleep duration of less than 12 hours during infancy appears to be a risk factor for overweight and adiposity in preschool-aged children.  Parental social stress, time limitations, work responsibilities, and absence, or other factors that may strain parent/child interactions may also be of interest.  An evidence/technology assessment report (Whitlock et al., 2008) that examined weight management interventions in clinical and non-clinical community settings found that available research studies primarily enrolled children and adolescents ages 5 to 18 years and no studies targeted those less than 5 years of age suggesting a significant research gap for this age range.

Scientific Knowledge To Be Achieved through Research Supported by This Program  

 This FOA is designed to encourage research applications that will identify behavioral and environmental interventions appropriate for infants and young children (less than age 6 years) with potential to improve prevention or management of overweight and obesity in childhood and contribute to reduced overweight later in life.

Objectives of this Research Program

This initiative is predicated on the belief that within the home environment, parents of infants and young children can be taught to recognize children’s weight status and can serve as highly influential role models for dietary and physical activity behaviors, as gatekeepers for foods and beverages that are brought into the home environment, and as regulators of portion size, of foods eaten away from home, and of screen time (e.g., television viewing, computer use, video games, etc.), free play time, and other sedentary and physical activity behaviors.  Parents have the ability to influence the development of fundamental eating, physical activity, and other influential behaviors at an early age for their children and they have the ability to provide or withhold reinforcement for these behaviors. Additionally it is likely important that the rest of the family follows the principles of a healthy lifestyle so they can serve as capable teachers, facilitators, and role models.  This FOA encourages creative ways to explore the potential of parents and other caregivers including in-home day-care providers and older siblings in the home, as conduits to reach children with appropriate energy balance messages and behaviors, modify the physical environment of the home to make it more conducive to energy balance, or otherwise have a positive impact on appropriate weight gain of young children through various mediating behavioral factors.

Research and experimental approaches being sought to achieve this program’s objectives 

The types of research and experimental approaches that are being sought are randomized clinical trial study designs.  Behavioral interventions (e.g., self-monitoring, reinforcement strategies, motivational interviewing, and skills training) may be included in combination with approaches to change the home environment.  Interventions based on well-established theory or existing data are encouraged; however, due to the need to explore innovative approaches, novel approaches that are based on clinical experience and are well justified will be considered.  Novel or innovative approaches that are accompanied by a convincing rationale for their use are encouraged.  Applications targeting groups or populations at high risk for the development of obesity are also encouraged.  Observational or descriptive studies designed to examine the correlates of overweight in the absence of an intervention will not be considered appropriate for this FOA. 

Projects that include a multi-disciplinary team of investigators with knowledge and experience in working with infants and young children, parents, child care providers and other primary caregivers, as well as experts on overweight and randomized clinical trials are encouraged.  Relevant disciplines would include early childhood development and education, in addition to other behavioral and social scientists as appropriate, depending on the nature of the interventions proposed.

In general, applications for interventions should reflect an understanding of the developmental needs, differences, and trajectories of infants and young children during the early childhood period (birth-age 5 years) across cognitive, physical, social and emotional domains and processes.

Examples of research topics include but are not limited to those listed below

Section II. Award Information
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
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (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

 Application budgets are not limited, but need to reflect the actual needs of the proposed project.

Award Project Period

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

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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.   

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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

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.

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

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.

R&R or Modular Budget

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

PHS 398 Cover Letter

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 (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-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. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

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 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.

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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Applications for Multi-center Clinical Studies

Applications for investigator-initiated multi-center clinical studies that are submitted as R01 applications will not be accepted under this FOA.  NIDDK supports investigator-initiated, multi-center clinical trials exclusively through a two part grant process using the U34 and U01 mechanisms.  Further information is available at: http://www2.niddk.nih.gov/Research/ClinicalResearch/multicenterclinicalresearch.htm.

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 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/PI, 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 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 recommended for 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 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 (CSR)  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:

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/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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, SAM 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 annual Non-Competing Progress Report (PHS 2590 or RPPR) 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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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

Scientific/Research Contact(s)

Robert J. Kuczmarski, Dr.P.H.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 451-8354
Fax: (301) 480-8300
Email: Robert.Kuczmarski@nih.gov  

Josephine Boyington, PhD, MPH 
Division of Cardiovascular Sciences
Prevention and Population Sciences Program
Clinical Application and Prevention Branch
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: (301) 435-0446
Fax: (301) 480-1864
Email: boyingtonje@mail.nih.gov   

Lynne Haverkos, MD, MPH
Program Director
Child Development and Behavior Branch/Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: (301) 435-6881
Fax: (301) 480-0230
Email: Lynne.Haverkos@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
Grants Management Specialist
National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-8825
Fax: (301) 594-9523
Email: tn122r@nih.gov

Tammi L. Simpson, MA, MBA
Grants Management Specialist
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: (301) 435-0150
Fax: (301) 451-5642
Email: simpsontl@mail.nih.gov 

Bryan S. Clark, MBA
Chief Grants Management Officer
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: (301) 435-6975
Fax: (301) 451-5510
Email: clarkb@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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