It is critical that applicants follow the instructions in the Research Instructions for 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

Increasing emphasis is being placed on enhancing the transformative impact of research. The traditional focus of the R01 on hypotheses, specific aims, and preliminary data result in a steady growth of knowledge, the rigidity of the process can in some cases limit creativity and innovation. Similarly, there is a perception that the most successful researchers are increasingly devoting a large portion of their effort to grant writing and other administrative duties. To that end, the RIVER program is intended to fund people, not projects, and reward outstanding researchers in the Environmental Health Sciences with a broad vision and track record of impactful research with increased scientific flexibility and stability in funding.

RIVER seeks to identify those unique individuals among the NIEHS grantee community who are most likely to benefit from a program emphasizing flexibility and sustained support to increase the impact of our research. It is felt that these scientists can demonstrate a track-record of creativity at any career stage and RIVER seeks to identify investigators at mid-career stages as well as more established investigators.

Features and Requirements:

RIVER is intended for investigators at any career stage who have demonstrated the potential to conduct outstanding, innovative research in the environmental health sciences. Because of the highly selective nature of the program, RIVER requires a Letter of Recommendation from a peer working in a similar domain of the environmental health sciences as well as a letter of support from the applicant Institution. Please refer to Section III. Eligibility Information for specific details. In short, eligibility is restricted to those individual researchers who are the Program Director/Principlal Investigator (PD/PI) on at least one single investigator (i.e., not Multi-PD/PI) R01 equivalent project which will be ending in FY17 or 18.

It is anticipated that RIVER will improve productivity and facilitate ambitious, creative research by providing a flexible and stable funding environment within a broad scientific domain with broadly stated rather than specific research goals. Key features and benefits of the program fall into two large categories: (1) freedom from traditional focused specific aims and a structured research plan which will enable investigators to pursue new directions in their research as they arise, and (2) the ability to devote increased effort to research, mentoring, and scientific service due to reduced time spent writing and managing multiple grant applications and awards.

RIVER is intended to support the majority of an individual's independent research program; as such, the R35 award which will constitute a relinquishment and consolidation of projects funded by NIEHS at the time the R35 is issued, and requires a dedication of at least 50% of the PD/PI's total effort to the project. NIEHS scientific program and grants management staff will review this information in relation to Other Support prior to award to ensure sufficient level of effort is committed to the project and to ensure no commitment overlap--commitment overlap occurs when an individual's time commitment exceeds 100 percent (i.e., 12 person months), whether salary is requested in the application.

Some efforts will be excluded from consolidation, such as:

• Research that is targeted to specific or non-independent research goals:
• NIEHS solicited programs (RFAs, PARs, and select PAs)
• Multi-PD/PI research projects
• Clinical/Interventional Trials
• Small Business awards
• Efforts that are not focused on research goals:
• Institutional Training/Career Development awards
• Conference Grants
• Research that is not funded by the NIEHS, including projects that are administered by NIEHS but are funded by other ICs or Agencies.

The R35 award budget will be based on the budgets of the projects that are consolidated into the award with an increase of 10% of the combined direct costs to encourage exploration into new research directions. Potential applicants are encouraged to discuss current awards which may be consolidated with their NIEHS Program Officer or the Program Contact for this FOA, below. The R35 award will be made for a duration of up to 7 years. In addition, the NIEHS will not consider investigator initiated applications from R35 awardees until the final year of their award.

This is a pilot program. Reissuance of this FOA, and competitive renewals of R35 awards are expected but will depend on process, programmatic evaluation, and the availability of funds.

See Section VIII. Other Information for award authorities and regulations.

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (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.

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.

Eligibility for this FOA is limited to those individual researchers who, at the time of submission, are the sole PD/PI of an R01 or equivalent (DP1, DP2, U01) award funded by the NIEHS (i.e. received a notice of grant award indicating funding from NIEHS for the project within 12 months prior to the application due date for this FOA) which will end by the end of Fiscal Year 2018 (9/30/2018).

Only single PD/PI applications are allowed. Applications with multiple PD(s)/PI(s) will not be accepted.

Applicants are required to devote at least 50% (6 calendar months) of their total effort to the R35. This requirement pertains to total support and includes all financial resources, whether Federal, non-Federal, commercial or institutional, available in direct support of an individual's research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. (Training awards, prizes or gifts are not included.)

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

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

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the instructions in the Research Instructions for 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:

Alfonso R. Latoni, PhD
Telephone: 919-541-7571
Fax: 301-480-3704
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.

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.

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:

Specific Aims: Do not use. Specific Aims are not required and should not be submitted.

Research Strategy: The research strategy is expected to evolve over the 7-year duration of a RIVER award. Therefore, rather than a detailed experimental plan, a description of the general scientific themes and approaches to be taken to address broad but critical research questions to be addressed should be provided.

1) Research Program Description:

• Discuss the broad scientific question or challenge in the environmental health sciences which will be addressed and a justification for the need of a flexible research approach to address this area.
• Discuss the goals and specific aims of the current NIEHS funded projects which will be consolidated into the R35 and how these relate to the broad vision of your research going forward.

2) Evidence of transformative impact:

• Discuss your seminal contributions, commensurate with your career stage, to the broad area which is the focus of your R35 application including contributions of novel ideas, key scientific accomplishments, experience, sustained high impact productivity or scientific service and how these will be leveraged in the proposed R35.
• This discussion should highlight the impact of research funded by NIEHS, including groundbreaking findings from previous support. Do not repeat materials adequately covered in the Biosketch.

3) Overview of the future research program:

• A detailed experimental plan is not expected and should not be included.
• Describe, through broadly defined goals, the research vision for your research program for the requested support period linking those goals to your past success and currently funded programs.
• Provide a statement of your commitment to maintaining a central focus on the environmental health sciences through the flexible research program.
• Discuss, in general terms, strategies and potential outcomes including any key innovative or unique methods which will be applied in your research program. This may include, but does not require, preliminary data but should clearly discuss the feasibility and impact of achieving your scientific vision. This should include a discussion of rigor and reproducibility.
• Discuss how a flexible approach to research with substantial effort dedicated and a sustained period of support is required to achieve a transformative impact in the environmental health sciences.

Letters of Support: Applications must include at least one Letter of Recommendation for the applicant being proposed for the RIVER Award. The Letter of Recommendation should come from a peer of the PD/PI and discuss the outstanding contributions of the applicant to the environmental health sciences and the unique qualities of this individual which make them an ideal candidate for a sustained and flexible research program.

In two pages, or less, the peer Letter of Recommendation should describe:

• A statement of the PD/PI's demonstrated outstanding contributions to the environmental health sciences which are commensurate with their career stage and the potential for the PD/PI’s research productivity and influence to continue at the same high caliber level; and
• A discussion of the unique qualities of the applicant which support the need for a flexible research opportunity.

In addition, RIVER applications require a separate Letter of Support from the applicant's institution which should be signed by the person at the institution who has the responsibility to evaluate and endorse the outstanding potential contributions of the applicant to the environmental health sciences (e.g.: Department Chair, Dean, etc.) and with the authority to commit the institution to all the requirements of the application and award.

The number of Letters of Recommendation from an individual scientist or Letters of Support from an institution is not limited.

The institutional Letter of Support should indicate:

• The PD/PI's commitment of at least 50% (6 calendar months) of their effort throughout the R35 award (see Sections I and III.1 for further explanation),
• A willingness to support the consolidation of other support from the NIEHS into the R35 award, and, and
• An agreement not to submit additional investigator-initiated applications to the NIEHS until the final year of the R35 award.

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, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. A Data Sharing Plan should address in detail the following:

• What data will be collected within the program and will and will not be shared?
• Who will have access to the data?
• How will the data sharing be accomplished, including efforts to make the data discoverable?
• Where will the data be stored and made accessible?
• When will the data be shared and what is the plan for sustainability of the data lifecycle?

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 PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

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.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

For this FOA:

A permanent change of PD/PI will not be allowed. A temporary change to maintain the project during the PD/PIs limited absence for situations such as medical conditions, disability, family circumstances or sabbatical leave may be approved.

RIVER requires the relinquishment of existing NIEHS funded research projects with the following exceptions:

• Projects which were funded through a targeted FOA (RFA, PAR, select PA) in which NIEHS participates,
• Awards that are administered by NIEHS but funded by another IC or Agency,
• Multi-PD/PI projects,
• SBIR/STTR awards,
• Clinical/Interventional trials,
• Training and Career Development projects, and
• Conference Grants.

It is expected that the PD/PI will renegotiate effort on other grants, if necessary, to meet the required 50% effort on the RIVER award. This effort must be maintained throughout the R35 except for unique, temporary, circumstances although a reduced effort may be negotiated during the final year of the R35 if the investigator receives funding for an NIEHS investigator initiated award.

The applicant agrees not to submit to NIEHS, and NIEHS will not consider funding, future investigator initiated, individual PD/PI research grants during the RIVER project period, except for applications included under the list of exempted awards. RIVER awardees may apply for investigator initiated research projects during the final year of the R35 award.

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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 components of participating organizations, NIH. 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 the instructions for post-submission materials, as described in NOT-OD-13-030.

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 NIEHS RIVER award will fund people, not projects. It is intended to provide a sustained period of flexible research activity that allows outstanding investigators the resources and freedom to pursue their research in novel and unexpected directions. Since the emphasis of the program is on flexibility, applicants are not expected to provide specific aims or experimental details but rather are asked to discuss the need for a flexible research approach to overcome the limitations of a broadly defined area of the environmental health sciences and their ideas, expertise, and qualifications to meet that need. As such, the review of applications for the R35 should focus on the need for a high risk/high reward, sustained and flexible, research effort to advance the environmental health sciences and the ability of the investigator to achieve success.

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? Is there a strong scientific premise for the project? 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?

Does the application address a critical challenge in the environmental health sciences which requires a sustained and flexible research program to overcome? Will achievement of the proposed, broadly stated, goals lead to a transformation on a specific domain within the environmental health sciences or the field as a whole?

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?

Does the PD/PI have a track record of innovation, productivity, and significant impact in the proposed field of study appropriate for their career stage? Is there evidence that this individual is likely to thrive in a research program which is not bound by specific aims and methodological details? Does the PD/PI have a track record of embracing the ideas of rigor and reproducibility and of transparency in science including data sharing and collaboration?

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?

Does the RIVER application demonstrate an innovative solution to significant challenges in the environmental health sciences and an appropriate plan to use the flexibility of the R35 mechanism to advance these innovative goals? Does the application capitalize on exploration of research in creative directions within a broadly defined theme?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Has the applicant successfully integrated the goals of their existing research activities into a scientifically valid and unified approach? Is the research plan supported by an appropriate discussion to assess the feasibility of moving the research into new directions?

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?

Has the applicant institution demonstrated appropriate support for fostering a sustained and flexible research program, assuring that the investigator will be able to dedicate appropriate resources to the RIVER program?

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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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.

Not Applicable

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.

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.

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 (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, 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 Center Telephone: 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

David M. Balshaw, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-2448
Email: [email protected]

Lisa H. Chadwick, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-491-4702
Email: [email protected]

Kimberly Gray, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0293
Email: [email protected]

Alfonso R. Latoni, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7571
Email: [email protected]

Leroy Worth Jr., PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4606
Email: [email protected]

James R. Williams
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-2860
Email: [email protected]

Bryann E. Benton
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4259
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.