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 Environmental Health Sciences (NIEHS)

Funding Opportunity Title

Outstanding New Environmental Scientist (ONES) Award (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices
October 27, 2014 - This RFA has been reissued as RFA-ES-15-003
Funding Opportunity Announcement (FOA) Number

RFA-ES-13-014

Companion Funding Opportunity

None

Number of Applications

Only one application per School or College within a University will be accepted. See Section III. 3. Additional Information on Eligibility.

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

93.113

Funding Opportunity Purpose

The Outstanding New Environmental Scientist (ONES) Award is intended to identify the most talented Early Stage Investigators (ESIs) who intend to make a long-term commitment to research in the Environmental Health Sciences and assist them in launching an innovative research program focused on the understanding of environmental exposure effects on people’s health.

Key Dates
Posted Date

November 25, 2013

Open Date (Earliest Submission Date)

January 28, 2014

Letter of Intent Due Date(s)

January 28, 2014

Application Due Date(s)

February 28, 2014, 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

June/July 2014

Advisory Council Review

October 2014

Earliest Start Date

December 1, 2014

Expiration Date

March 1, 2014

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.

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

An essential element of the mission of the National Institute of Environmental Health Sciences (NIEHS) is the support and career promotion of the next generation of exceptionally talented and creative new scientists who will further the understanding of the impact of environmental exposures on human health. The NIEHS supports a number of training and fellowship programs for pre and postdoctoral training, and mentored career development awards for faculty in the early stages of their career development.  Along with these training and career development programs, NIEHS initiated a program of research grants for Early Stage Investigators, The Outstanding New Environmental Scientist (ONES) Award that is designed to identify the best new biomedical investigators and facilitate their establishing a vibrant, independent research program in the environmental health sciences. This funding opportunity announcement (FOA) is a central component of the NIEHS goal of identifying and promoting the success of a cadre of new, productive environmental health science investigators.

Research Goals and Scope

The ONES program is designed to identify outstanding scientists at the formative stages of their career and assist them in launching an innovative research program with a defined impact in the environmental health sciences. These R01 research grants are targeted for researchers who are defined by the NIH as Early Stage Investigators (See http://grants.nih.gov/grants/new_investigators/index.htm.

The ONES program is designed to be highly competitive, and only a limited number are awarded per year.

Research programs supported by this announcement seek to promote career advancement of the most highly creative and promising new scientists who intend to make a long-term career commitment to research in the mainstream of the environmental health sciences, and bring innovative, groundbreaking research initiatives and thinking to bear on the problems of how environmental exposures affect human health.

In addition to the Research Plan components of a basic R01 application, applicants to this R01 FOA are required to:  1) incorporate a statement of career goals in the environmental health sciences; 2) include a discussion of previous research experience and achievements in addition to the research proposal; 3)  include plans for the active participation of an external advisory committee; 4) require demonstration of the commitment by the institution to actively support the research program development of the Principal Director/Principal Investigator (PD/PI); and 5) include specific budget elements devoted to equipment, research resources and career enhancement activities.

Research projects proposed in response to this FOA will be expected to have a defined impact on the environmental health sciences and be responsive to both the mission of the NIH and, specifically, to the mission of the NIEHS and the NIEHS 2012-2017 Strategic plan, Advancing Science, Improving Health: A Plan for Environmental Health Sciences Research.  This plan sets out a set of strategic themes and strategic goals that have been identified as priority areas for the field of environmental health sciences.  These reflect both the mission of the NIEHS, which is to discover how the environment affects people in order to promote healthier lives, and the vision of NIEHS to provide global leadership for innovative research that improves public health by preventing disease and disability. 

Applicants should consult the strategic plan and describe how the research proposed in their application addresses the goals and priority areas of the NIEHS.

Applications submitted in response to this FOA must have a research focus on exposure health related responses from environmental agents within the mission interest of the NIEHS.  The Strategic Plan emphasizes that environmental exposures within the primary mission interest of NIEHS may both manifest effects through direct toxicities and as an element in combined exposures in the totality of all types of human exposure experiences throughout the lifespan.  

Environmental agents which are considered of primary interest for NIEHS include:  industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants, particulates or fibers, fungal, and bacterial or biologically derived toxins.  Agents that are considered within the primary mission responsibility of other NIH Institutes include, but are not limited to: alcohol, chemotherapeutic agents, radiation that is not a result of an ambient environmental exposure, smoking, except when considered as a secondary smoke exposure as a component in the indoor environment (particularly in children), drugs of abuse, pharmaceuticals, dietary nutrients, and infectious or parasitic agents.  Applications which focus entirely or primarily on these exposure factors will be considered non-responsive to this announcement.  However, it is appropriate to include these factors as part of research to define effects of the exposome, and these factors may be part of applications focused on the totality of a person’s environmental exposure.  Applications that propose to study only model compounds must provide a clear, reasonable and specific description as to how research on the model compound will lead to a better understanding of the mechanisms involved in responses to specific environmental agents which are included in the mission responsibility of the NIEHS.  Applicants are strongly encouraged to contact NIEHS program staff prior to submission to determine if their project meets the goals of the ONES program. 

It is anticipated that the ONES program will be evaluated on a continuing basis by the NIEHS, to assess the impact of the program on the portfolio of the NIEHS, and on the progression of the awardees' careers.  Metrics to be used include, but are not limited to: publications, including numbers, impact factors, citations of publications; academic promotion of the PD/PI; invited talks at national/international symposia; students and postdoctoral fellows trained in the PD/PI's laboratory; honors and awards received by the PD/PI; committee service of PD/PI's; and subsequent grant support awarded. The design of the program evaluation will be determined by the Program Analysis Branch of the Division of Extramural Research and Training.  PD/PI of awarded ONES grants will be requested to provide information for the evaluation and any subsequent program evaluations for a period of up to fifteen years after the award.

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

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

Funds Available and Anticipated Number of Awards

NIEHS intends to commit $3.0 million total costs in FY 2015 to fund 5 awards.

Award Budget

For most applications, the budget for direct costs will be limited to $250,000 per year, plus the portion of the additional $250,000 budget for career enhancement which distributed over a five year award period which is requested for that budgetary year.  Note: the $250,000 career enhancement budget will be distributed over a 5-year period but does not have to be distributed evenly across each year. With strong justification, research projects which have inherently higher costs may request direct costs of up to $400,000 per year, plus career enhancement.  In no year may the total direct cost budget (research plus career enhancement) exceed $475,000 per year.

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

Only one application per school or college within a university will be accepted. For example, within a university, one application can be submitted from each of the schools of medicine, public health, arts and sciences, etc. If more than one application from the same grantee entity is submitted, none will be reviewed.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not 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.

To be eligible for this award, applicants must have a Ph.D., M.D., or equivalent graduate degree.  

Applicants must be an NIH-defined Early Stage Investigator. See http://grants.nih.gov/grants/new_investigators/index.htm

In addition, applicants must have faculty appointments which are tenure track or equivalent, generally at the level of Assistant Professor, Research Assistant Professor, and have demonstrated outstanding abilities in the basic, clinical or population-based research. Individuals must show they have established research independence from a mentor, and have dedicated, independent laboratory, clinical and/or population based research resources available to conduct the research proposed in the grant application.

Applicants must have research focus and a long-term commitment to a career in environmental health research consistent with the core mission areas of the National Institute of Environmental Health Sciences. The NIEHS will decline applications not considered central to either to the mission or the research priorities of the NIEHS as part of the initial evaluation for responsiveness.  

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

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:

PD/PI's who have a scientifically distinct R01 application pending at the time of the application due date are eligible to submit a ONES application for a different project.  However, since the ONES is limited to ESIs who do not have R01 support, individuals who receive a fundable score and accept funding for the regular R01 prior to the award of the ONES grant are not eligible to receive the ONES.  

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:

Janice B. Allen, Ph.D.
Scientific Review Officer
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
P.O. Box 12233; Mail drop K3-03
Research Triangle Park, NC 27709

For Courier delivery:
530 Davis Drive, Room 3080
Research Triangle Park, NC 27709
Telephone: 919-541-7556
Fax: 301-451-5715
Email: Allen9@niehs.nih.gov

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.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Biographical Sketch: Two narrative presentation sections, “Future Goals and Objectives,” and “Personal Statement,” respectively, should be included in the biographical sketch.  The “Future Goals and Objectives” section should briefly describe the career track vision and long-term research interests/objectives of the applicant. The “Personal Statement” section, should clearly describe the applicant's scientific development from graduate school, the postdoctoral experience(s), through the present faculty position. For each training/research experience, the applicant should describe his/her role in the laboratory or project and indicate which publications resulted from the experience.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed , with the following additional instructions:

The budget is to consist of two elements: 

Element #1: Applicants may request up to $250,000 in direct costs in all five years to conduct the research project.  This budgetary level is expected to apply to most laboratory-based projects and those epidemiology and patient-oriented studies involving secondary analysis, additional analysis of stored samples, or add-on studies to established cohorts.  Applicants are encouraged to budget sufficient travel costs within this amount to present the results of the research at a variety of high-caliber scientific meetings.  At least one of these meetings should be devoted directly to research in the environmental health sciences and be widely attended by other NIEHS grantees.

In extraordinary cases where the applicant can provide strong justification for research support above the base level of $250,000, direct costs of up to $400,000 may be requested.  Examples where this higher budgetary level might be justified include epidemiologic studies including the active recruitment of a new cohort, patient-oriented research studies, and studies which involve especially expensive methodology.  Increasing the scope of laboratory-based research is not a sufficient rationale for requesting the higher budgetary level.  Since the purpose of the ONES grant is to further the career of Early Stage Investigators, requests for salary support for senior level collaborators is strongly discouraged and will require a well-justified specific role in the application.  Previous mentors should not be listed as collaborators on the research project. 

Element #2: In addition, the applicant may request a total of up to $250,000 to be distributed over the five year period, for a combination of equipment, resource development, career enhancement experiences and dissemination of research results.  Equipment or resource development expenses must be justified on the basis of research proposed in the experimental plan or by the long-term research goals in environmental health sciences section of the research strategy.  Career enhancement activities may include such items as short courses, visits to laboratories of other scientists, Gordon Conferences, and other enrichment activities.  The Career Enhancement budget should include travel costs for external members of the advisory committee and may provide for a consulting fee to members of the advisory committee who are external to the department.  In addition, the PD/PI should budget for travel to the NIEHS campus in Research Triangle Park each year to participate in a research symposium.

The total of the direct costs for research and career enhancement may not exceed $475,000 in any one year. 

Applicants are expected to devote at least 6-person months per year to the grant. However, if during the tenure of this grant, should the PD/PI be successful in obtaining funding through another R01 or similar award, the effort on the ONES award may be negotiated with the NIEHS program staff down to no less than 3.6 person months per year.  In addition, the awardees' departments are encouraged to provide an additional 25-30% release time commencing clinical, teaching, and administrative duties in order to allow the awardees to devote a larger percentage of time to research efforts.

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:

Research Strategy: All applications should include a timeline for the proposed research and a schedule for the Advisory Committee meetings.   

The applicant is expected to form an external advisory committee. Names of Advisory Committee members should not be listed in the application.  This FOA uses the just in time concept for the External Advisory Committee members and potential members should not be contacted until after the review to avoid potential conflict situations in review.  The application should indicate the areas of expertise and scientific and anticipated input, and any critical considerations in the selection of members, at the time of submission.  As part of the just in time information prior to funding, the applicant will be asked to name the Advisory Committee members, and ask each potential member to provide a letter outlining his/her expected role and the expertise to be provided to the PD/PI's research and career experiences.

NIEHS suggests an Advisory Committee structure such as the following:  At least three scientists, two of whom are external to the Department, (one external to the University or Institution). One member should have research expertise to provide input into the exposure paradigm proposed, and one should be an individual who can provide input into the translation of the research to human or clinical studies.

The Description of the Advisory Committee should be included in the Research Strategy.

The Advisory Committee is expected to meet at least annually to provide ongoing assessment of the progress of the research, to discuss future research goals, aims, and ideas, and to provide research career guidance to the awardee during the five years of the grant.  It is expected that face-to-face meetings of the Advisory Committee will be convened at least twice during the five year grant period (once in years 1-2, and once in years 3-4). 

Letters of Support: The Chair of the Department where the applicant holds the primary academic appointment should provide a letter describing any tangible research support which has been committed to the applicant.  This may include start up packages provided to the investigator, salary commitment, protected time for research, space and equipment allocations, core facilities which will be made available without charge-back, specialized training and mini-sabbatical experiences to promote career enhancement, etc. In addition, the letter should discuss the departmental commitment to protected research time for the applicant. 

The department is encouraged to provide release time so that the applicant will be able to devote 80% of his/her professional effort to research. (See Section III.3. Additional Information on Eligibility).  The strength of the institutional commitment will be considered a factor in the review of the application. 

If a previous postdoctoral or research mentor remains in the same Institution as the applicant, a letter should be included in the application which outlines the respective roles of the applicant and the research mentor in the design and conduct of the proposed research.  The research mentor should also indicate how the proposed research program is expected to be independent from the research directions of his/her laboratory.

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.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in 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 and responsiveness by  National Institute of Environmental Health Sciences (NIEHS), NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

In order to expedite review, applicants are requested to notify the NIEHS Referral Office by email at

Allen9@niehs.nih.gov 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-13-030.

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?  How will the proposed research significantly advance knowledge in a defined problem in the environmental health sciences, specifically in terms of disease processes relevant to environmental exposure, human biology involved in the cause, prevention, or moderation of disease? 

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? Are the anticipated results expected to lead to major research advances in the environmental health sciences?

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 human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

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? Is there strong and tangible Institutional support to the career advancement of the PD/PI?

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

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 NIEHS, 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 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 National Advisory Environmental Health Sciences Council. 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.

Reports of meetings with the Advisory Committee should be provided to the NIEHS as part of the annual progress report of the grant.  On years where a face to face meeting is scheduled, a synopsis of the recommendations of the Advisory Committee prepared by the Chair should be transmitted to the Program Officer, either in the progress report or by a separate communication.

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)
Telephone: 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 CenterTelephone: 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)

Carol Shreffler, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1445
Email: shreffl1@niehs.nih.gov

Peer Review Contact(s)

Janice B. Allen, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7556
Email: Allen9@niehs.nih.gov

Financial/Grants Management Contact(s)

Barbara Gittleman, M.A.
National Institute of Environmental Health Sciences (NIEHS)
Telephone:  919-541-0585
Email: barbara.gittleman@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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