Revolutionizing Innovative, Visionary Environmental Health Research (RIVER) (RFA-ES-16-008)

Revolutionizing Innovative, Visionary Environmental Health Research (RIVER) (RFA-ES-16-008) is sponsored by National Institute of Environmental Health Sciences (NIEHS) - NIH. The NIEHS RIVER program provides support for outstanding investigators in the Environmental Health Sciences, giving them intellectual and administrative freedom and sustained support to pursue their research in novel directions.

Expired RFA-ES-16-008: Revolutionizing Innovative, Visionary Environmental health Research (RIVER) (R35) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Institute of Environmental Health Sciences ( NIEHS ) Funding Opportunity Title Revolutionizing Innovative, Visionary Environmental health Research (RIVER) (R35) R35 Outstanding Investigator Award February 7, 2018 - This RFA has been reissued as RFA-ES-18-004 .

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose The NIEHS Revolutionizing Innovative, Visionary Environmental health Research (RIVER) program seeks to provide support for the majority of the independent research program for outstanding investigators in the Environmental Health Sciences, giving them intellectual and administrative freedom, as well as sustained support to pursue their research in novel directions in order to achieve greater impacts.

The program seeks to identify individuals, regardless of career stage, with a track record of innovative and impactful research and combine their existing investigator-initiated research into a single seven year award with direct costs of up to $750,000 based on current NIEHS funding. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) October 24, 2016, by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date. No late applications will be accepted for this Funding Opportunity Announcement. 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) 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 I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Full Text of Announcement Section I. Funding Opportunity Description 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 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. 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 solicited programs (RFAs, PARs, and select PAs) Efforts that are not focused on research goals: Training/Career Development awards 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.

VIII. Other Information for award authorities and regulations. Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Funds Available and Anticipated Number of Awards NIEHS intends to commit $5 M in FY 2017 to fund 4-5 Application budgets are limited to the combined total Direct Costs of NIEHS funded projects to be consolidated into the R35 award as outlined above, plus 10%, not to exceed a total direct costs of $750,000 annually.

The budget requested needs to reflect the actual needs of the Applicants may request up to 8 years of support, which must be justified within the actual needs of the proposed research program. 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 Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession 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 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 Foreign components, as defined in the NIH Grants Policy Statement , are allowed. 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 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 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. 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.

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 must have an active DUNS number and SAM registration in order to complete the 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.

Eligible Individuals (Program Director/Principal 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 This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. Section IV. Application and Submission Information 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. 2. Content and Form of Application Submission 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 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 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: All page limitations described in the SF424 Application Page Limits must be followed.

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 All instructions in the SF424 (R&R) Application Guide SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Aims: Do not use.

Specific Aims are not required and should not 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. 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 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. 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 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 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.

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 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? Do not use the Appendix to circumvent page limits.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application PHS Inclusion Enrollment Report When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide Foreign (non-U.S.) institutions must follow policies Grants Policy Statement , and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM) 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 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 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 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. 5.

Intergovernmental Review This initiative is not subject to intergovernmental 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 . 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 Clinical/Interventional trials, Training and Career Development projects, and 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 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. 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 Electronically . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must for Applicants Experiencing System Issues . For assistance with application submission, contact the Application Submission Contacts in Section VII .

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. 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 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 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 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 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 Additional Review Criteria As applicable for the project proposed, reviewers will evaluate the following additional items while