Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Environmental Health Sciences (NIEHS)

Funding Opportunity Title

Validation and Demonstration of Devices for Environmental Exposure Assessment (R21/R33)

Activity Code

R21/R33 Phased Innovation Award

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-ES-13-013  

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.113 

Funding Opportunity Purpose

This funding opportunity announcement (FOA) is intended to facilitate the translation of prototype devices for characterization of personal exposures into field use by supporting a phased validation effort involving a partnership between tool developers and environmental epidemiologists.  In the initial (R21) phase, the focus is on iterative refinement of the prototype based on evaluation in a pilot scale study.  The goal of this phase is to demonstrate data quality, tool reliability, and usability in a real world and relevant setting.  The second (R33) phase will involve larger scale application in a larger epidemiological study to demonstrate the added scientific value of the tool in terms of both improved exposure assessment and estimation of exposure-health outcome relationships. 

Funding for the second phase requires an evaluation of the successful attainment of quantitative milestones and Go/No-Go decision points established in the application and through negotiation.

Key Dates
Posted Date

November 12, 2013

Open Date (Earliest Submission Date)

January 4, 2014

Letter of Intent Due Date(s)

January 4, 2014

Application Due Date(s)

February 4, 2014, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2014

Advisory Council Review

October 2014

Earliest Start Date

December 1, 2014

Expiration Date

February 5, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Background

One of the challenges in the study of environmental health is the ability to comprehensively characterize an individual’s environment including simultaneous assessment of exposures to multiple chemical toxicants, dietary intake, physical activity, psychosocial stress, the use of addictive substances and the biological responses to those factors.  The National Institutes of Health (NIH) and other governmental agencies have supported several projects to develop new devices to address these shortcomings.   Perhaps the largest coordinated investment in this area has been in the NIH Genes, Environment, and Health Initiative's Exposure Biology Program (http://www.niehs.nih.gov/research/supported/dert/cris/programs/exposure/index.cfm); however, other efforts have been supported at NIEHS and across NIH including the Superfund Research Program (http://www.niehs.nih.gov/research/supported/dert/cris/programs/srp/index.cfm), numerous SBIR Programs, and investigator-initiated R21 and R01 projects.  The result of these investments has been the creation of prototype tools for characterizing the personal environment that are well poised for validation and translation into epidemiological studies.

This FOA will support a focused, phased innovation (R21/R33) program to facilitate the translation of these, or similar, tools into environmental epidemiology and public health intervention studies.  The effort will include three major foci.

During the R21 phase the focus will be on:

During the R33 phase the focus will be on:

The development of technologies and their translation into usable tools is a complex process ranging from fundamental engineering development, prototyping, validation under both controlled laboratory and real world conditions and application in less controlled, field settings. A critical gap in the translation from developmental technology to usable tool is in the transition from bench-top validation under controlled environments to field validation under the complex and variable conditions that reflect real world environments.  More than any other step in the technology development paradigm, this effort relies on interdisciplinary cooperation and integration of distinct expertise, and has proven to be a significant barrier to the wide-spread use of emerging exposure assessment technologies.

Application of emerging tools for characterizing the personal environment in epidemiological studies depends on the validation of these products in terms of (1) the feasibility, reliability, and robustness of the application of these new approaches and (2) the ability of the measures to add valuable information to the study.  Acceptance by the community of prototype devices (including measures of chemical exposures, diet, activity and stress) will require extensive documentation of the sensitivity and specificity of their measures under carefully controlled conditions and in comparison to existing gold standards, where such standards exist.  In addition, it is essential that there be an evaluation and optimization of the ease-of-use, reliability under real-world conditions, compliance, and feasibility of use in the target population. 

A comprehensive program is needed to bridge the gap between tool development and the application to environmental epidemiology and public health intervention studies. We are supporting this phased innovation program to create partnerships between tool developers and environmental epidemiologists to validate prototype sensor devices.  Given the limited scope of the program, only prototype systems that already have been well characterized in controlled laboratory settings are eligible and it is anticipated that projects will leverage infrastructure of existing epidemiological studies to assess the added scientific value of the tool. 

Objectives

The primary goal of the NIEHS Exposure Biology Program is to support the development, validation, and application of approaches that will enable a shift in the perspective of exposure assessment to focus on the total personal environment including the integration of multiple chemical toxicants, incorporation of lifestyle factors into exposure assessment, and to enable analysis on temporal and spatial scales that are relevant to the variation of the environment experienced at the personal scale.  While a major focus is on the expansion of the capabilities of exposure assessment technologies, the Exposure Biology Program is equally focused on the importance of developing tools that pose minimal burden on the eventual users of the technology, both the individual participant and the study investigators.

Applications to this program must measure at least one environmental toxicant at the personal level on a temporal and spatial scale relevant to the variation of exposure to that toxicant in space and time in the environment.  This can either be through direct measurement of analytes at the point of contact or for analytes with very little variation in the environment through a field deployable assessment of toxicant levels in readily accessible biological samples (saliva, tears, finger prick blood, urine).  For instance, an applicant may choose on a wearable system to measure particulate matter (PM) or volatile organic compound (VOC) exposures, or both, associated with traffic and other sources in the environment justifying the scale of the measurement to the variation of an individual's exposure to traffic (morning and afternoon peaks corresponding to rush hour) and other sources such as cooking or cigarette smoking.  An applicant could also choose to validate a sensor system that measures heavy metals in a finger prick of blood. This program is not intended to support additional development of prototypes to jointly measure both environmental toxicants as well as other lifestyle factors, such as diet, physical activity, or psychosocial stress; nor is it intended to support additional development of prototypes to integrate exposure assessment with assessment of biological response.  However, use of prototypes that already incorporate such multi-faceted capabilities is allowable and encouraged.

Examples of appropriate prototypes could include but are not limited to:

Projects seeking to measure surrogates for personal exposure such as contaminant levels in food or drinking water or ambient levels of airborne pollutants are not appropriate for this FOA.

The goal of this program will be accomplished in a two-phase R21/R33 program.  Transition from the R21 (pilot) to R33 (scale up) phase will be dependent on successful attainment of quantitative milestones and Go/No-Go decision points.

R21 Phase

The initial activity is a two-year exploratory research project focused on assessing and optimizing the performance of the tool at pilot scale in an appropriate test cohort.  The R21 phase is not intended to support the development of a prototype; rather applicants must have an existing prototype system that has been well characterized in controlled laboratory settings.  The application should explicitly indicate the analyte(s) measured and provide performance metrics including, but not limited to, preliminary data on sensitivity, specificity, and robustness as well as target needs of the test cohort. 

The research to be conducted in phase I includes:

Applicants must develop a set of appropriate, quantitative milestones and a Go/No-Go decision matrix that must be adequately demonstrated by the completion of the R21 phase to transition into the second, scale-up, phase.  Final milestones will be negotiated with program staff as a term and condition of the award.  These must address at a minimum:

Validity

Usability:

R33 Phase

Following administrative review of progress in the R21 phase relative to the quantitative milestones, each R21 may progress into an R33 phase focusing on larger scale application of the finalized device in the targeted cohort.  The intent of the R33 phase is to demonstrate the added scientific value of the device over currently accepted practices being used in an epidemiological study.  This will be a three- to four-year evaluation based on the needs of the study and the duration of the R21 phase.  No project may extend beyond a five year funding span for the combined R21 and R33 phases; the total project timeline should allow realistic time frames for manufacturing and IRB approval as well as the field studies in both phases.  As such, it is anticipated that projects will leverage infrastructure of an existing epidemiological study.  While the R33 phase of the project can include additional participant interaction and data collection, it is unlikely that creation of a de novo cohort will be feasible within the time and budget constraints of this program. 

The R33 phase will compare results from the prototype device to currently accepted exposure metrics to assess the relative scientific value of the new technology as an exposure assessment tool.  Validation of sensor devices should include application of sensor devices to cohort studies in which exposure assessment is currently conducted indirectly via questionnaire or modeling approaches, or directly through ambient or other personal exposure monitors or biomonitoring.  Secondary goals of this phase are to determine the ability to test novel hypotheses related to the simultaneous analysis of multiple components of the personal environment or the temporal/spatial resolution of personal monitors and evaluate the effectiveness of data analysis approaches including efforts to intensively monitor subpopulations with the new devices and extrapolate to a larger population.

Applicants must propose a study design and a set of appropriate comparative analyses to demonstrate the added scientific value of the device as compared to currently accepted exposure metrics.  Such analyses should not only evaluate how the incorporation of new devices impacts exposure assessment but also the subsequent potential impacts on estimated exposure-disease relationships.  Possible evaluations may include, but are not limited to:

Appropriate involvement of the tool developers in the R33 phase can include, for instance, oversight of device manufacture and QA/QC; efforts to optimize supporting documentation, calibration and error reporting methods; and consultation on performance issues but there should be no effort to refine the device itself in this phase of the project.  Other support should be sought for refinement of device design or expansion of capabilities.

Phase Transition

Transition to the R33 is not automatic, and not all R21s are expected to result in an R33 award. The materials in the transition package will be reviewed by NIEHS Program staff on the basis of:

If at the completion of the R21 phase the investigators do not feel that adequate progress towards milestones has been achieved, they may request up to one year of no-cost extension.  At any point during that year they may submit an R33 transition package as described above.  Only in unusual circumstances will a second no-cost period be granted for the R21 phase.   A no-cost extension will not count against the five year time limit of the study.

Responsiveness

Upon receipt, all applications will be reviewed by program staff for responsiveness to the FOA as described in the preceding sections.  Applications proposing to develop a new prototype device, or incorporate additional capabilities into an existing prototype in the absence of a focus on validation will be deemed non-responsive and not reviewed.  Likewise, failure to include detailed plans for both pilot evaluation in the R21 phase, scale-up demonstration in the R33 phase and quantitative milestones and Go/No Go decision points will result in the application being judged non-responsive.

The intent of this program is to validate technologies to objectively measure personal exposures; therefore, projects seeking to measure surrogates for personal exposure such as contaminant levels in food or drinking water or ambient levels of airborne pollutants are not appropriate to this FOA and will not be reviewed.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

NIEHS intends to fund an estimate of 5-8 Phase I (R21) awards, corresponding to a total of $1.5 M, for fiscal year 2015.

Future year funding amounts and the number of awards transitioning to the R33 phase will depend on annual appropriations.

Award Budget

Support for the R21 phase cannot exceed two years and direct costs are limited to $275,000 over the R21 two-year period, with no more than $150,000 in direct costs in any single year of the R21 phase.  

The R33 phase may not exceed four years and direct costs are limited to $1.4 M with no more than $375,000 in direct costs in any single year of the R33 phase.

Proposed budgets must reflect the actual needs of the proposed project.

Award Project Period

The total project period for an application submitted in response to this FOA may not exceed 5 years for the combined R21 and R33 phases.  

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This program requires a partnership between the tool developers and environmental epidemiologists; therefore, the use of Multiple PDs/PIs is strongly encouraged.  The relative responsibilities of these individuals may shift over the course of the proposed project, particularly with the transition to the R33 phase.  This should be clearly described in the leadership plan. 

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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

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

The letter of intent should be sent to:

Sally E. Tilotta, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1446
Email: Sally.Tilotta@nih.gov

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: The R21 and R33 phases should have distinct and clearly enumerated specific aims; both phases should be included in a single specific aims section.

Research Strategy:  This should contain a single background section which gives detailed justification for the component(s) of the personal environment being measured, the need for improved measures and new assessment technologies, a detailed description of the prototype including a detailed description of validation efforts to date and a description of the settings in which it can be applied in both the short and long terms.  An important distinction between the R21 phase of the requested R21/R33 application and a traditional R21 application is that in this program, applicants are expected to include extensive preliminary data on the prototype including validation under controlled laboratory conditions and, potentially, limited field validation.

The Research Strategy should also include a dedicated section detailing plans for the R21 phase including discussion of the feasibility of the proposed approach to demonstrate the validity and usability of the prototype, and the research strategy and methods for the R21 Phase.  This section must also include detailed quantitative milestones and Go/No-Go decision points to be achieved by the completion of the R21 phase and a Gantt chart timeline.  Milestones should not be a restatement of the R21 specific aims.

The Research Strategy will also include a detailed description of the R33 Phase. The R33 Phase must describe the effort to demonstrate the added scientific value of the prototype device in sufficient detail to permit reviewers to assess the significance and innovation of the proposed work and the strength of the experimental design.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.  

6. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Each application will be evaluated as a whole.  The criterion scores and the overall impact score should be viewed as a reflection of the committee's assessment of the merit for both phases. 

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Will the project result in a tool that will expand the capabilities of scientific areas including environmental epidemiology, citizen science or community-based participatory research?  What is the likelihood that the validated device will lead to improvements in public health?    

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Is the project a true partnership between the tool developers and end users?  Are the relative responsibilities of the key investigators during both the R21 and R33 phases clearly outlined? 

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?  Is a novel approach to tool validation proposed? Will the validated exposure assessment device provide novel data and open new hypotheses for environmental epidemiology?      

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

Are the proposed milestones appropriate, quantifiable, and achievable?  Will the proposed plan for the R21 adequately demonstrate the successful completion of the milestones? Is the timeline realistic as proposed?

Are the milestones and Go/No-Go decision points of the R21 phase adequate to evaluate the transition to the R33 phase of the application? Are the proposed design and analytical plan outlined in the R33 phase adequate to assess/demonstrate added scientific value of the new device?  

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

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable  

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources..

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIEHS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Environmental Health Sciences Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

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.

No less than two months prior to the end of the R21 phase, awardees may submit an R33 transition package, which includes an R21 progress report detailing progress towards the quantitative milestones and Go/No-Go decision points.  In addition, the transition package should include a clear description of how research or budget proposed in the original application for the R33 phase will be altered based on the findings of the pilot studies in the R21 phase.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

David M. Balshaw, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-2448
Email: Balshaw@niehs.nih.gov

Peer Review Contact(s)

Sally E. Tilotta, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1446
Email: Sally.Tilotta@nih.gov

Financial/Grants Management Contact(s)

James Williams
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1403
Email: williamsjr@niehs.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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