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 Institute of Mental Health (NIMH) (No Longer Participating per NOT-MH-14-001)
Office of Dietary Supplements (ODS)

Funding Opportunity Title

Small Grants for New Investigators to Promote Diversity in Health-Related Research (R03)

Activity Code

R03 Small Grant Program

Announcement Type

Reissue of PAR-09-223

Related Notices

  • June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • November 14, 2013 - See Notice NOT-MH-14-001. Notice to Discontinue Participation of NIMH.
  • 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-13-074

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.847; 93.242

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to provide support for New Investigators from backgrounds nationally underrepresented in biomedical research to conduct small research projects in the scientific mission areas of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Mental Health (NIMH) and the Office of Dietary Supplements (ODS).  The scientific mission areas of the Institutes and Office are: NIDDK -diabetes, endocrinology, metabolism, digestive diseases, hepatology, obesity, nutrition, kidney, urology, or hematology; NIMH – factors contributing to mental disorders, the trajectories of mental disorders, pre-emption and treatment of mental disorders, identify and improve interventions for mental illness; and ODS – all types of research in which the primary emphasis is the investigation of dietary supplements and/or their ingredients. The NIDDK, NIMH and ODS recognize the need to promote diversity in the health-related research workforce by increasing the pool of highly trained researchers from diverse backgrounds conducting research in areas of importance to these Institutes and Office. The R03 grant mechanism supports different types of projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. The R03 is intended to support small research projects that can be carried out in a short period of time with limited resources with the ultimate goal of providing the preliminary data for a R01-equivalent application.

Key Dates
Posted Date

January 7, 2013

Open Date (Earliest Submission Date)

May 16, 2013

Letter of Intent Due Date(s)

Year 1: May 16, 2013
Year 2: May 16, 2014
Year 3: May 16, 2015

Application Due Date(s)

Year 1: June 16, 2013, by 5:00 PM local time of applicant organization.
Year 2: June 16, 2014, by 5:00 PM local time of applicant organization.
Year 3: June 16, 2015, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Year 1: September 7, 2013, by 5:00 PM local time of applicant organization.
Year 2: September 7, 2014, by 5:00 PM local time of applicant organization.
Year 3: September 7, 2015, by 5:00 PM local time of applicant organization.

Scientific Merit Review

Year 1: October/November, 2013
Year 2: October/November, 2014
Year 3: October/November, 2015

Advisory Council Review

Year 1: January, 2014
Year 2: January, 2015
Year 3: January, 2016

Earliest Start Date

Year 1: April, 2014
Year 2: April, 2015
Year 3: April, 2016

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 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

Purpose:

This FOA is intended to provide support for New Investigators from diverse backgrounds underrepresented nationally in biomedical research who are interested in conducting research projects in the scientific mission areas of the NIDDK, the NIMH and the ODS, with the purpose of providing the preliminary data to support a R01-equivalent application.

NIDDK Mission:

The mission of the NIDDK is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life.

NIMH Mission:

The mission of NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure. For the Institute to continue fulfilling this vital public health mission, it must foster innovative thinking and ensure that a full array of novel scientific perspectives are used to further discovery in the evolving science of brain, behavior, and experience. In this way, breakthroughs in science can become breakthroughs for all people with mental illnesses. In support of this mission, NIMH will generate research and promote research training to fulfill the following four objectives:

ODS Mission:

The mission of ODS is to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population.

In addition to their respective missions, these institutes and offices recognize that the entry of New Investigators into the ranks of independent, NIH-funded researchers is essential to improve the overall health of this country's biomedical research enterprise. As a result, NIH and the participating components of the organization are deeply committed to the research support of New Investigators. This program will enable New Investigators to successfully gain additional research experience while transitioning to independence, and obtain preliminary data on which to base a subsequent research grant application (i.e., R01-equivalent) within the scientific mission areas of the NIDDK, NIMH and ODS.

Background

In 2003, the NIDDK collaborated with the National Center for Research Resources (NCRR) in a FOA entitled "Clinical Research Education and Career Development (CRECD) in Minority Institutions (RFA-RR-03-007, available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-03-007.html). The purpose of this FOA was to support the development and implementation of curriculum-dependent programs to train selected doctoral and postdoctoral candidates in clinical research in minority serving institutions with professional schools offering doctoral degrees. The goal was to produce well-trained clinical researchers from underrepresented backgrounds who could subsequently lead clinical research projects as PD/PIs on R01 or R01-equivalent awards.

In 2006, the Office of Minority Health Research Coordination (OMHRC) at the NIDDK released the funding opportunity announcement RFA-DK-06-015, “NIDDK Mentored Clinical Scientist Award to Promote Diversity in Health-Related Research (K08)” (available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-06-015.html). This RFA gave special consideration for funding to those candidates who graduated from the CRECD program with a Master's Degree in Clinical Research. Once again, the goal was to produce well-trained clinical researchers from underrepresented backgrounds who could subsequently lead clinical research projects as PD/PIs on R01 or R01-equivalent awards. Unfortunately, this request for applications (RFA) did not gain much attention within the target audience of clinical scientists from diverse backgrounds.

Following the Office’s review of the K08 program’s achievement of the stated objectives, the Office determined that the K08 failed to achieve its goals of promoting “diversity in the health-related workforce by increasing the number of highly trained clinical researchers from diverse backgrounds with the cultural competence and sensitivity to conduct laboratory or clinical research in health disparities and who possess the ability to successfully recruit and retain a diversity of subjects into clinical research.” After consultation with the NIDDK Advisory Council, the Office identified that less than three percent (3%) of all PD/PIs, and less than one percent of New Investigators (1%) on R01 and R01-equivalent awards in the NIDDK were individuals from underrepresented (i.e., racial or ethnic minorities) backgrounds. As a result of these data, a new program was developed in order to address the program objective to “strengthen the capacity for clinical research focused on eliminating health disparities by increasing the number of clinician scientists from ethnically diverse and disadvantaged backgrounds in the health-related research workforce.”

Subsequently, the OMHRC released the FOA PAR-09-223, “NIDDK Small Grants for Clinical Scientists to Promote Diversity in Health-Related Research (R03)” (available at: http://grants.nih.gov/grants/guide/pa-files/PAR-09-223.html). Given the data presented to the NIDDK Advisory Council which found that less than one percent (1%) of PD/PIs with R01 or R01-equivalent awards met the eligibility criteria for New Investigators, the Office concluded that the Institute needed an FOA that supported the transition of post-doctoral and early career investigators to become New Investigators. Similar to the earlier K08 FOA, this FOA sought to produce well-trained clinical researchers from underrepresented backgrounds who could subsequently lead clinical research projects as PD/PIs on R01 or R01-equivalent awards with the preliminary data generated by the R03 award.

Diversity:

The 2010 U.S. Census data shows that while White non-Hispanics are still numerically and proportionally the largest major race and ethnic group in the United States, significant changes in the demographics of the U.S. are underway. More than one-half of the growth in the U.S. total population between the 2000 and 2010 Census was due to the increase in the Hispanic ethnic population. Similarly, the Asian alone racial population grew faster than any other major race group between the 2000 and 2010 Census, a staggering 43 percent. Finally, California, Hawaii, New Mexico, Texas and the District of Columbia now have more than 50 percent of their total population being members of a minority (e.g., non-White) group.

As the population of the U.S. continues to diversify, the members of non-White racial and Hispanic ethnic groups continue to be disproportionately underrepresented in the research workforce of the U.S. The business sector of the U.S. economy have long-embraced the advantages of diversity in their organizations, reporting benefits ranging from improved flexibility, creativity, competitiveness, higher levels of critical analysis, better problem solving, and improved reputation of the business as an employer of choice.

The NIH recognizes a unique and compelling need to promote diversity in the NIH-funded biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; improve the quality of the educational and training environment; balance and broaden the perspective in setting research priorities; improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nations capacity to address and eliminate health disparities.

There is abundant evidence that the biomedical and educational enterprise will directly benefit from broader inclusion. Recent studies have supported the argument that diversity enhances the quality of education in multiple settings. Studies have suggested that racially and culturally concordant scientific staff may be more successful in recruiting individuals from minority groups into clinical trials. Racially similar physician-patient dyads also may be related to greater patient satisfaction in ways that could enhance communication and participation in clinical research settings. There is limited evidence that individuals who have participated in the NIH administrative supplement program preferentially conduct research in areas related to health disparities or minority health. There is no question that the need for a diverse workforce permeates all aspects of the nation's health-related research effort.

New Investigators:

For many individuals interested in pursuing biomedical, behavioral or clinical research careers, the long hours, low pay, and the decades of work before achieving independent research funding often proves too formidable for them to pursue a research career. As noted by the National Research Council (NRC) in their recent publication, “Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research,” (National Academies Press, 2005; available at: http://www.nap.edu/catalog.php?record_id=11249), the creative spirit and high-risk high-reward research proposals by new investigators is being sacrificed in favor of more conservative research with a better probability of being funded.

The NRC also recommended several policies for the NIH to enact in order to support New Investigators, including the following:

5.1. “NIH should establish a program to promote the conduct of innovative research by scientists transitioning into their first independent positions. These research grants … would provide sufficient funding and resources for promising scientists to initiate an independent research program and allow for increased risk-taking….”

As such, the Office, Institute and the NIDDK Advisory Council concluded that an FOA  New Investigators would be the most efficient means of increasing the representation of PD/PIs from underrepresented backgrounds, and thereby increase the diversity of the NIDDK PD/PIs of R01 and R01-equivalent awards.

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
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

The total direct costs for a R03 application submitted in response to this funding opportunity announcement are limited to $125,000 per year.

Award Project Period

The total project period for an R03 application submitted in response to this funding opportunity announcement may not exceed three (3) 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 must complete the following registrations as described in the SF424 (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 Directors/Principal Investigators (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 6 weeks prior to the application due date.

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.

Applicants must fit the following four criteria:

A. New Investigators

B. Eligible Health Professional or Doctoral Degree

C. Underrepresented PD(s)/PI(s)

D. US Citizenship, Noncitizen National, or Permanent Resident

A. New Investigators

For definitions of New Investigators, as well as conditions applying, please see: http://grants.nih.gov/grants/new_investigators/.

B. Eligible Health Professional or Doctoral Degrees:

Eligible doctoral degrees include the MD, DO, DDS, DVM, PsyD, DrPH, OD and PhD. Applicants must have completed a minimum of 2 to 4 years of postdoctoral research experience at the time of application.

C. Underrepresented PD(s)/PI(s):

The eligible PD/PI must meet one of the following eligibility criteria in order to demonstrate that she/he is from a group identified as nationally underrepresented in the biomedical and behavioral research workforce on a national level:

1. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27and the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2011). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders.

2. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

D. Citizenship Requirements:

The demonstration of underrepresented in science and engineering is based upon data from the National Center for Education Statistics (NCES) survey of Integrated Postsecondary Education Data System. The NCES and graduate enrollment data refers only to US Citizens, US Noncitizen Nationals and US Permanent Residents. Therefore, by the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status. Individuals on temporary or student visas are not eligible.

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:

Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide. However, due to the once a year submission due dates corresponding to Cycle III, all resubmissions will be accepted one year following the original 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Francisco O. Calvo, Ph.D.
Chief, NIDDK Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard
II Democracy Plaza, Room 752, MSC 5452
Bethesda, MD  20892-5452
Telephone: 301-594-8897
Email: calvof@mail.nih.gov

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:

Letters of Support

Letter of Eligibility:  Applicants are required to attach a letter from the institution certifying eligibility of the PD/PI candidate for this program. The certification letter must be on institutional letterhead and scanned so that an institutional official signature is visible.

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, with the following modifications:

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 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 before the deadline 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.

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 (SAM). 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.

In order to expedite review, applicants are requested to notify the NIDDK or NIMH Referral Offices by e-mail at calvof@mail.nih.gov or armstrda@mail.nih.gov, respectively, when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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.

For this particular announcement, note the following:

The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

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

Not Applicable

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 NIDDK or the NIMH, 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:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 submitted in response to this FOA. 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. 

4. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Within ten years of making awards under this program, the NIDDK will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program.  Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.

The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

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)

Kevin D. McBryde, M.D.
Program Director
Office of Minority Health Research Coordination
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
6707 Democracy Boulevard
II Democracy Plaza, Room 906-B, MSC 5454
Bethesda, MD  20892-5454
Telephone: 301-594-9652
Email:mcbrydekd@mail.nih.gov

LeShawndra N. Price, Ph.D.
Deputy Director for Research
Office for Research on Disparities & Global Mental Health
Chief, Mental Health Disparities
National Institute of Mental Health
National Institutes of Health
6001 Executive Boulevard
Room 8130, MSC 9659
Bethesda, MD  30892-9659
Telephone: 301-594-7963
E-mail: lprice@mail.nih.gov

Cindy D. Davis, Ph.D.
Director of Grants and Extramural Activities
Office of Dietary Supplements
National Institutes of Health
6100 Executive Boulevard
Room 3B01, MSC 7517
Rockville, MD  20892-7517
Telephone: 301-435-2920
E-mail: 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).

Francisco O. Calvo, Ph.D.
Chief, NIDDK Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard
II Democracy Plaza, Room 752, MSC 5452
Bethesda, MD  20892-5452
Telephone: 301-594-8897
Email: calvof@mail.nih.gov

Financial/Grants Management Contact(s)

Carolyn S. Kofa
Grants Management Specialist
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7687
Email:kofac@mail.nih.gov

Rebecca D. Claycamp, M.S., C.R.A.
Chief, Grants Management Officer
Grants Management Branch
National Institute of Mental Health (NIMH)
Telephone: 301-402-7111
Email: rclaycam@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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