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.

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

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 across the spectrum of science supported by the NIEHS (i.e., including basic mechanistic, clinical and population based researchers) and facilitate their establishing a vibrant, independent research program in the environmental health sciences. NIEHS uses this FOA to support the NIEHS goal of assuring a continuing cadre of productive environmental health science investigators.

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 https://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, ground-breaking research initiatives and thinking to bear on the problems of how environmental exposures affect human health.

The ONES Program is specifically targeted to Early Stage Investigators and program goals include career promotion as well as the scientific project proposed. Applications for the ONES program differ from standard R01 applications in that applicants are expected to discuss their career goals in the environmental health sciences, include plans for the active participation of an external advisory committee to provide consultation and feedback, include a commitment by the institution to actively support the research program development of the Program Director/Principal Investigator (PD/PI), and a plan for career enhancement to provide new skills and experiences necessary for future research growth in the environmental health sciences. See Section IV.2 for detailed application instructions.

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.

A variety of scientific disciplines, including basic, mechanistic, clinical, epidemiological, computational, engineering, and/or health risk communication approaches, can be used to advance the NIEHS Strategic Plan. Applicants should consult the strategic plan and to ensure that 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.

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 and Centers 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 exposure factors outside the NIEHS mission responsibility will be considered nonresponsive to this announcement and will not proceed to review. However, it is appropriate to include these factors as part of research to define health effects of the exposome, or the totality of a person’s environmental exposure. These exposures may also be considered as components in the study of the health effects of mixtures, if the primary goal of the study is on an exposure within the NIEHS mission interest. Applicants are strongly encouraged to contact NIEHS Scientific/Research 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/PIs; 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 the PD/PI; 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/PIs awarded ONES grants will be requested to provide information for the evaluation during the period of the award.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

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 allowed.

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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.

PD(s)/PI(s) must be NIH defined Early Stage Investigators. See https://grants.nih.gov/grants/new_investigators/index.htm

In addition, PD/PIs must have faculty appointments which are tenure track or equivalent, generally at the level of Assistant Professor, or Research Assistant Professor, and have demonstrated outstanding abilities in basic, clinical or population-based research. Individuals must have established research independence from a mentor, and have dedicated, independent laboratory space or access to the clinical, population-based and/or public health research resources which will allow them to conduct the research proposed in the grant application as the lead, independent PD/PI.

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 the mission or the research priorities of the NIEHS as part of the initial evaluation for responsiveness.

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

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

PD(s)/PI(s) who have a scientifically distinct R01 application pending at the time of the ONES 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, PD(s)/PI(s) 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 award.

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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

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)
Telephone: 919-541-7556
Fax: 301-451-5715
Email: [email protected]

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

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.

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

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

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

Other Attachments: The PD/PI 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 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 proposed for study, and one should be an individual who can provide input into either the translation of the research to human or clinical studies, or in the case of population studies, to the relevant exposure biology research findings in model systems.

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).

All instructions in the SF424 (R&R) Application Guide must be followed. The instructions for the biographical sketch should be followed. In addition, the Personal Statement should explicitly address the PD/PI's career track vision and long-term research interests/objectives in the environmental health sciences.

Listing of previous mentors as collaborators on the research project is also strongly discouraged, but may be included with a strong justification of their specific role in the project. In these cases, the independent role of the PD/PI, the role of the previous mentor, and the focus on a new hypothesis should be made clear in the Research Strategy section of the application.

All instructions in the SF424 (R&R) Application Guide must be followed. The following additional instructions also apply:

The budget will contain both funds for the direct support of the research project and funds devoted to career enhancement.

Research Project Costs: Most PD/PIs should request up to $250,000 in direct costs in all 5 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 primarily involving secondary analysis. The PD/PI is 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.

For research applications where the PD/PI 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 unless there is a well-justified specific role for the collaborator in the application.

Career Enhancement and Advisory Committee: In addition, the PD/PI may request a total of up to $250,000 to be distributed over the 5-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.

PD/PIs 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 3.0-person-months per year. In addition, the awardees' departments are encouraged to provide an additional 25% release time from clinical, teaching, and administrative duties in order to allow the awardees to devote a larger percentage of time to research efforts.

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

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

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

Research Strategy: In the research strategy section of the application, as part of the discussion of significance, applicants should specifically address the importance of the problem or critical barrier to progress relative to improved knowledge of how environmental exposures affect human health. The discussion of innovation should specifically address how the results of the research will lead to major research advances in the environmental health sciences or have significant implications for clinical or public health practice.

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.

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

Letters of Support: The Chair of the Department where the PD/PI holds the primary academic appointment should provide a letter describing any tangible research support which has been committed to the PD/Pl. 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.

If a previous postdoctoral or research mentor remains in the same Institution as the PD/PI, a letter should be included in the application which outlines the respective roles of the applicant and the former 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.

The department is encouraged to provide release time so that the applicant will be able to devote 9 person months of his/her professional effort to research. The strength of the institutional commitment will be considered a factor in the review of the application.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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.

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

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. 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.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by National Institute of Environmental Health Sciences (NIEHS). Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIEHS Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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.

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).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? 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 understanding the underlying disease processes relevant to environmental exposure, the human biology involved in the cause, prevention, or moderation of disease, or the population burden attributable to the exposure?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?Based on the future goals section and the biographical sketch, does the PD/PI have the potential to make important research discoveries? Does the PD/PI demonstrate a long term commitment to environmental health sciences research?

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 or have important implications for clinical or environmental public health practice?

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?

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?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Not Applicable

Not Applicable

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.

Not Applicable

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Programmatic and geographical balance

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final 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.

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Carol Shreffler, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1445
Email: [email protected]

Janice B. Allen, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7556
Email: [email protected]

Barbara Gittleman, MA
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0585
Email: [email protected]

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.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.