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

Environmental Health Sciences (EHS) Core Centers (P30)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of RFA-ES-12-002

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-ES-13-002

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed as described in Section III. 3. Additional Information on Eligibility.

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

93.113 

Funding Opportunity Purpose

The National Institute of Environmental Health Sciences (NIEHS) invites applications from qualified institutions for support of Environmental Health Sciences Core Centers (EHS CC). The Centers are designed to establish leadership and support for programs of excellence in environmental health sciences by providing scientific guidance, technology, and career development opportunities for promising investigators. A Core Center Grant is an institutional award to support centralized scientific resources and facilities shared by investigators with existing research projects. By providing structure and resources, this support is intended to enhance the ability of scientists working in the field of environmental health sciences to identify and capitalize on emerging opportunities that will translate into advances improving the understanding of the relationships among environmental exposures, human biology, and disease.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

January 14, 2013

Letter of Intent Due Date(s)

January 14, 2013

Application Due Date(s)

February 13, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

August 2013

Advisory Council Review

January 2014

Earliest Start Date

April 2014

Expiration Date

February 14, 2013

Due Dates for E.O. 12372

Not Applicable

**ASSIST – electronic application submission required**

This FOA uses NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

The overall goal of the EHS Core Center is to enhance the capabilities of existing programs in environmental health sciences, to assist with building the programmatic and scientific capacity for environmental health sciences, and to support the development of future directions and future leaders needed for the field to mature. The EHS CC must be an identifiable organizational unit within a single university, medical center, or a consortium of cooperating institutions with a university affiliation. The EHS CC grant mechanism provides core support to foster integration, coordination, and interdisciplinary cooperation among a group of established investigators conducting high-quality research clearly related to the effects of environmental factors on human health. The NIEHS uses this mechanism to integrate and build upon existing programs and institutional resources such as university-wide facilities and services that encourage and enhance research on environmentally-induced disorders. While the EHS CC grant provides support for core resources and facilities to be used by Center investigators, it does not provide direct funding for ongoing research projects, although limited funds are provided for pilot projects, support for recruitment, and career development of promising investigators in environmental health sciences.

To qualify for an EHS CC, the applicant institution must already have a substantial base of ongoing, independently supported, peer-reviewed research projects clearly dedicated to the study of environmental health sciences or environmental medicine, a substantial portion of which should be supported by NIEHS. This currently funded research base provides the major support for a group of investigators who would benefit from shared resources. The research base must exist prior to the submission of an application and will be considered by program staff.  Focus, relevance, interrelationships, quality, productivity, and, to some extent, quantity, are all considerations in judging the adequacy of the research base.

In order to provide increased flexibility in organization and structure of the EHS CC, the Director may develop a dynamic structure which meets the on-going intellectual needs of the members. This structure can change as the intellectual needs change to accommodate new opportunities for collaboration. Research Cores are not required as organizational units but are allowed. The proposed Center organization must include the required components outlined below. Beyond those, no additional structure is imposed by NIEHS.

NIEHS considers community engagement to be a major goal of the EHS CC and a Community Outreach and Engagement Core is required.

Please note that the Director’s Fund is no longer an allowable expense

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
Renewal
Resubmission
Revision

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

Funds Available and Anticipated Number of Awards

NIEHS intends to commit $6 million for FY2014 to allow funding up to 3 - 4 awards. Future year amounts will depend on annual appropriations.

Award Budget

New or first-time applicants are eligible to apply for up to 4 years of support. New applications are limited to $600,000 direct costs in the first year; $700,000 direct costs in the second year; $800,000 direct costs in the third year; and $900,000 direct costs in the fourth year. A minimum of $100,000 direct costs is to be devoted annually to the Community Outreach and Engagement Core (COEC).

Award Project Period

New or first-time applicants can apply for up to 4 years of support. Renewal applications may request up to 5 years of support.   

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

Governments

Other

Foreign Institutions

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

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

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) and component Project Leads that are not yet registered in eRA Commons must work with their institutional officials to register. Also, institutional officials at the applicant organization should ensure that the eRA Commons account for the contact PD/PI is affiliated with their organization.

eRA Commons accounts are necessary to use ASSIST to prepare and submit applications.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

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.

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 PHS 398 Application Guide. 

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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

To qualify for the EHS CC grant, members of the proposed EHS CC must have a minimum of three active NIEHS-supported research grants from three distinct principal investigators. Further information is provided below.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants can access 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.

Applicants will use NIH’s ASSIST system, rather than Grants.gov’s downloadable forms, to prepare and submit applications through Grants.gov to NIH.

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 and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

Linda Bass, Ph.D.
Scientific Review Officer
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 530, Room 3074
P.O. Box 12233 (K3-03)
530 Davis Drive
Research Triangle Park, NC 27713
Telephone: (919) 541-1307
Fax: (919) 541-2503
Email:  bass@niehs.nih.gov

Application Submission

Applications submitted to this FOA will be made up of a collection of application components. All applications will include an ‘Overall’ component that provides information regarding the application as a whole, as well as a combination of additional component types. Applicants should select the appropriate application component types in ASSIST when preparing applications. Note, eRA Commons accounts are necessary to use ASSIST to prepare and submit applications.

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12 pages

Admin Core

  • Use for: Administrative Core and Leadership component

12 pages

Institutional Org

  • Use for: Institutional Commitment and Organization component

6 pages

Pilot Program

  • Use for: Pilot Projects Program component

6 pages

Careers

  • Use for: Career Development for Environmental Health Investigators component

6 pages

Core

  • Use for:
    • Integrative Health Sciences Facility Core
    • Facility Cores
    • Community Outreach and Engagement Core (COEC)

12 pages


Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed. Note that Tables A through E are not page limited.

General Instruction Clarifications for Multi-Project Applications

The following table provides instruction clarification for the information required in the Overall component of a multi-project application versus information required for all other components included in the application.

Form

Overall component

All other components

SF424 (R&R) cover

Complete entire form

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

Project /Performance Site Location(s)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Budget

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Research & Related Senior/Key Person Profile

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field in the Project Director/Principal Investigator section.

List Senior/Key persons that are working in multiple components in each relevant component.

Include a single 4-page Biographical Sketch for each Senior/Key person covering the entire application regardless of the number of components in which they participate.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Research & Related Other Project Information

Follow standard instructions.

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Optional

PHS 398 Cover Page Supplement

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Enter Human Embryonic Stem Cells in each relevant component.

PHS 398 Research Plan

For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

For Resubmission and Revision applications, an Introduction to Application is allowed for each component.


Additional Component-specific Instructions

Center Components (Structure of Application)

In order to be considered for funding, each application must have a minimum of two Facility Cores (one of which is an Integrated Health Sciences Facility Core), Administrative Core, Community Outreach and Engagement Core (COEC), Career Development Program, and Pilot Project Program. Research cores are optional.

Overall Component

Other Project Information (Overall Component)

Project Summary/Abstract. For the Overall Component, provide a Project/Summary/Abstract  of the Strategic Vision.  Also describe the Environmental Health Identity and the Impact of the Research Base on the goals of the EHS Core Center.

Recent Changes to the EHS CC Application: The application must indicate a minimum of three distinct active NIEHS-supported research grants from three member principal investigators with at least 1 full year of activity remaining at the time of submission, not including administrative extensions, either with or without additional funds. This requirement supersedes the previous description that did not indicate a minimum length of time remaining on the qualifying grants. The Director’s Fund is no longer an allowable expense.

Project Narrative. In the project narrative (i.e. the "public health relevance" statement), briefly state the relevance of the Center’s research to public health.

Other Attachments. The following "Other Attachments" should be included with the overall component in order to aid in the review of applications.  The filename provided for each attachment will be the name used for the bookmark in the application image.

Pre-formatted Tables A - E are available for applicant use to facilitate completion; they can be downloaded from: http://www.niehs.nih.gov/research/supported/dert/sphb/programs/core/guidelines/index.cfm.

Applicants may use another format for Tables A - E, if preferred but all Tables should be converted to pdf for uploading.

Research & Related Senior/Key Person Profile (Overall Component)

The application must name the Center Director who will serve as the Program Director/Principal Investigator (PD/PI) of the Center. In the Overall component, the Role of "PD/PI" should be specified for the Center Director.

PHS398 Research Plan (Overall Component)

Specific Aims. A Strategic Vision, theme, and set of goals must be developed and described in the application. The Center Director must provide a written strategy for how the EHS CC will implement this vision and which future directions will likely be followed during the project period. The plan will outline the existing skills, technologies and scientific research base and other resources at an institution. This plan should describe how the Core Center will enhance ongoing projects, assist in the introduction of outstanding new projects, respond to future challenges and opportunities, and promote collaborations, advances in technology, and progress in environmental health sciences. The Center Director must detail expected scientific outcomes including a description of anticipated impact on human disease and public health. An organizational chart should be included to illustrate the structure, interactions, and leaders of the EHS CC.

The application must define, in this section, the eligibility criteria for EHS CC membership and note which individuals play key leadership roles in the EHS CC. Indicate the steps to engage full and/or junior members in EHS CC activities and to enhance collaborations and translational research among Center members. Describe how established investigators / outreach experts will be engaged as advisors or mentors for early stage career Center members.

Research Strategy. The Strategic Vision must address the following critical elements:

Theme – Provide the central theme(s) of the EHS CC and the likely supported research, resources, and relevance to environmental medicine. The theme may be broad or focused, depending upon the goals of the EHS CC.

Goals and directions – Describe current and future directions for the EHS CC in the forthcoming project period. How will the research supported by the EHS CC impact the understanding of environmental health sciences and, ultimately, public health? Describe the short, mid and long-term goals and measures of success. What are the likely advances expected in the field of environmental health and how can these advances be applied to human disease and public health? Describe any basic science work that has successfully been translated to the bedside or community or plans to enhance that translation in the next project period. What expected, widely-applicable research tools and scientific advances will emerge from the Center’s emphasis? Document how the Center will organize and lead the team towards these advances. Identify levels of risk for these goals, potential roadblocks to achieving them, and how the Center might respond to these challenges. Renewal applications must also describe the accomplishments of the Center in the preceding project period and how it intends to build upon its successes. These accomplishments should be presented, as appropriate in the areas of basic science, clinical research, public health, and prevention. The impact of Center-based science should be discussed in detail.

Integration of investigators of multiple skills and talents – Outline steps the EHS CC will take to promote interdisciplinary studies and collaborations, especially among basic scientists and clinical researchers. What types of initiatives will stimulate the teams and attract high-caliber professionals? To what degree will high-risk/high-payoff research that may require long-term support be implemented?

Building research capacity – Provide details on the special talents and resources that will be drawn to and built upon at the EHS CC. How will these talents be harnessed and used to promote new collaborations and produce multidimensional teams to address more complex questions? Include a plan for bringing investigators into the EHS CC from within and outside the area of environmental health sciences. What expertise will these individuals share with the EHS CC? Describe academic and research partnerships that will be pursued by the EHS CC to advance its goals and missions.

Provide a plan to determine the need for services and instrumentation of the EHS CC. Address the steps that will ensure that the EHS CC proceeds at the cutting edge of technology and concepts. It is expected that facility cores needs may change with time. Include information on the process of re-evaluation of needs and implementation of changes.

Research Cores, if included, are to be discussed within the Strategic Vision. Brief examples of ongoing or planned research should be discussed as appropriate with reference to the supporting Facility Core. Do not provide an exhaustive list of ongoing incremental research. Weave significant findings and advances throughout the narrative of this section to demonstrate the leadership and impact of the center on building its environmental health sciences program.

Plans for a COEC must indicate how this entity will integrate with the EHS CC and fulfill its mission with the target audience(s).

Within this section, describe the research capacity and clearly identifiable major scientific focus in environmental health and related biomedical research. The EHS CC grant mechanism fosters interdisciplinary cooperation among established investigators conducting high-quality research in environmental health science. Therefore, existence of a strong research capability in environmental health sciences is fundamental to establishment of a new, or continuation of an existing, EHS CC.

As a minimum qualification, the membership at the applicant institution or consortium must have a minimum of three active NIEHS-supported research grants from three distinct principal investigators. At the time of submission of a new or renewal application, the qualifying grants must have at least 1 full active year remaining not including administrative extensions, either with or without additional funds. Acceptable grant support includes R01, R21, R37, RC1, RC2, P01, P42, P50, Cooperative Agreements (U-grants) or Research Career Development Awards (K-grants), Conference awards are not acceptable. Each multi-component (e.g. P01, P50, or U01) award will count as one qualifying research project. A sub-project of a multi-component award (e.g. P01) that is sub-contracted to the applicant institution can be counted only once towards the research base. Renewal applications need to describe how the existing EHS CC facilitated a leading role in environmental health at its home and associated institutions and should document the outcomes and impact of the EHS CC on research efforts during the preceding funding period. This should include a summary of research highlights which were accomplished as a result of EHS CC infrastructure and support, how facilities were made available to the maximum number of qualified investigators, the changes in resources that might have been made to accommodate altered user needs and/or increased demand, a composite list of publications, examples of subsequent funding for new directions highlighting collaborations fostered by the EHS CC, and career advances and training outcomes.

Please note that the requirement for qualifying grant support of three distinct active NIEHS-supported research grants from three member principal investigators with at least 1 full year of activity remaining at the time of submission supersedes the previous description that did not indicate a minimum length of time remaining on the qualifying grants.

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. A Resource Sharing Plan should be included, as appropriate, for the overall Center for data-sharing activities that involve multiple projects and/or cores.  This plan for sharing data should describe coordinating efforts of the overall Center regarding sharing of data within and/or beyond the EHS Core Center. 

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.

Administrative Core (Required)

When preparing your component in ASSIST, use Component Type of "Admin Core'"

Other Project Information (Admin Core)

Other Attachments. The core should include a "Relation to Overall Center" statement included in the "SF 424 Research and Related Other Project Information" section under the "Other Attachments Section". This should be loaded as a file titled "Relation to Overall Center" under the "SF424 (R&R)Research & Related Other Project Information" under "Other Attachments." In this statement, clearly state the relevance of the core to the goals of the overall Center, how this core integrates with other projects and cores, and how the findings/activities of this core assist in solving the problem(s) that the Center is addressing. Interactions with the Research Translation Core should also be included.

Research & Related Senior/Key Person Profile (Admin Core)

This component oversees organizational, budgeting and reporting aspects and provides the leadership for scientific and programmatic activities of the EHS CC. Include in this section a description of the Center Director and Deputy Director. The application must name the Center Director who will serve as the Program Director/Principal Investigator (PD/PI) of the Center and Core Leader of the Administrative Core.  Through the required Administrative Core, the Center Director provides leadership and guidance in fulfilling the stated objective of his or her Center.  To accomplish this, the applicant must create within the Administrative Core an infrastructure that promotes cross-discipline interactions among all of the projects and cores and ensures research translation. The structure of this core will provide the Center Director with a mechanism for planning and coordinating research and core activities; integrating cross-discipline research; overseeing fiscal and resource management; and quality management.

The Center Director should be listed in the Project Director/Principal Investigator section of the form using a Project Role of 'Other' and an Other Project Role Category of 'Center Director'.

The Deputy Director should be listed with other Senior/Key Persons using a Project Role of 'Other' and an Other Project Role Category of 'Deputy Director'.

PHS398 Research Plan (Admin Core)

Research Strategy. Within the Research Strategy, the application should describe how the Administrative Core will take a leadership role in ensuring the synthesis of findings and activities from research projects and cores towards solving the central problem proposed by the Center.  In addition, direct lines of communication between the Administrative Core and Research Translation Core (as well as with the other cores, as appropriate) should be delineated, as all of these cores serve critical roles for Center integration.

It is expected that organization of the Administrative Core will provide a supportive structure sufficient to ensure accomplishment of the following:

The administrative structure must include an Internal Advisory Committee (IAC) and an External Advisory Committee (EAC). Renewal applications must document the functions and effectiveness of the External and Internal Advisory Committees.

The Center Director is expected to be of appropriate experience with authority to oversee the organization and operation of the EHS CC and to provide scientific and administrative leadership for the total program. The Center Director should devote at least 2.4 months annual effort to the EHS CC. A Deputy Center Director must also be designated to serve in the absence of the Director, with other responsibilities described. The background and scientific and administrative expertise and responsibilities of the Center Director and the Deputy Director should be described fully in the application. It is expected that the Center Director will have considerable experience as a leader in environmental health sciences. For competing renewals, an assessment of past performance is required. It is expected that the both the Center Director, as well as the Deputy Center Director will have distinguished records of scientific and administrative accomplishment. Please briefly describe plans for new EHS CC leadership in the event that either of these individuals is to be replaced – either temporarily or permanently - with respected Scientist/Administrators of superior talents and abilities.

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

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

R&R Budget (Admin Core)

Allowable Budget

New or first-time applicants are eligible to apply for up to 4 years of support. New applications are limited to requests for no more than $600,000 in direct costs in the first year; $700,000 in direct costs in the second year; $800,000 in direct costs in the third year; and $900,000 in direct costs in the fourth year. A minimum of $100,000 direct costs are to be devoted annually to COEC.

Renewal applications may request up to 5 years of support and up to $1,100,000 per year direct costs. A minimum of $100,000 direct costs are to be devoted annually to COEC.

Travel

All travel should be budgeted within the Administrative Core. Travel costs are to be budgeted for the annual 2 - 3 day meeting at a minimum for the Director, COEC Director, and Administrative Assistant. EHS CC should expect to host such a meeting once within the project period and should budget for the event. Please consult with program staff for details.

Items Not Allowable Under a P30 EHS Core Center Grant Include:

1. Direct support of individual research except for Pilot Projects.

2. Salary for Co-Directors, Co-investigators, or individuals without clearly defined roles in the operation of the EHS CC.

3. Salary and support for central institutional administrative personnel or activities such as public relations, as typically paid from institutional overhead charges.

4. Travel to workshops or scientific meetings, other than in the course of Career Development such as for Named New Investigators,

5. Page and publication charges

6. Director’s Funds or Discretionary Funds.

Institutional Commitment and Organization Component (Required)

When preparing your component in ASSIST, use Component Type of 'Institutional Org'.

Other Project Information (Institutional Commitment and Organization Component)

Other Attachments. Charts and Tables related to the Institutional Commitment at the applicant institution such as organization charts should be included in SF 424 Research and Related Other Project Information" section under the "Other Attachments Section." This should be loaded as a file titled "Relation to Overall Center" under the "SF424 (R&R) Research & Related Other Project Information" under "Other Attachments."

PHS398 Research Plan (Institutional Commitment and Organization Component)

Research Strategy. Address the commitment of the parent organization or any of its partners to the EHS CC and its goals. The parent institution is expected to recognize the EHS CC as a formal organizational component and provide documented evidence of space dedicated to the needs of the Center, protected time to devote to Center activities, staff recruitment, dedicated equipment, or other financial support for the proposed Center. The parent institution should provide assurance of its commitment to continuing support of the EHS Core Center in the event of a change in directorship and a well-defined plan for this eventuality should be in place. In addition, it is expected that the Institution will support the goal of providing to Center members’ priority access to Institution’s and Center’s facilities and services at minimal or reduced cost.

The organization and structure of the EHS CC should reflect the goals of the center, encourage collaboration, develop and implement EHS CC -wide initiatives, and promote the use of shared resources and pilot project funds. The structure can change as needed based on new scientific opportunities and partnerships. This major underpinning of the EHS CC allows for modifications of programmatic and scientific activities and areas of support to fully capitalize on the most exciting research opportunities in environmental health sciences.

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

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

Pilot Projects Program (Required)

When preparing your component in ASSIST, use Component Type of 'Pilot Program'.

PHS398 Research Plan (Pilot Projects Program)

Research Strategy. Inclusion of a Pilot Projects Program is an integral part of the EHS CCs. The "Research Strategy" for this section should include a plan to support pilot studies for basic or clinical biomedical, epidemiological, educational, or behavioral research. The description of a plan to solicit, review, and administer pilot grants must be included in the Administrative Core and a separate budget, including the total request for pilots, must be submitted. Criteria for review of pilot studies must be developed and included in the application. The Pilot Projects Program should support short-term projects to explore the feasibility of new areas of study which leads to collection of sufficient data to pursue support through other funding mechanisms. Include a clear description of the process designed to award and evaluate progress in pilot projects. Investigators are encouraged to consult with NIEHS program staff for submission of new NIH applications based on pilot project-supported data.

Renewal applications should provide documentation of the existing pilot projects program. Include the process for application review and award and the measures of success, such as publications, subsequent funding, and career advancement of the sponsored individuals. A renewal application should include: historical overview of the Pilot Project Program during the last program period; a description of the management of the program; and a listing of all pilot projects which were supported during the last project period.

The basis for grant support (as cited in the included Table) resulting from pilot projects should be discussed briefly in the application. For example, funds for preliminary data collection, use of Center facilities, or guidance and/or collaborations dependent upon within the Center could be cited as appropriate.

Pilot Projects are intended to:

(a) Provide initial support for new investigators to establish new lines of research;

(b) Allow exploration of possible innovative new directions representing a significant departure from ongoing funded research for established investigators in environmental health sciences. Ideas of particular importance in environmental health sciences are paramount;

(c) Stimulate investigators from other areas of endeavor to apply their expertise to environmental health research and environmental medicine; and

(d) Foster opportunities that meet goals set out in the EHS CC Plan. Pilot projects should strive to fill in gaps in research areas relevant to the scientific focus of the EHS CC.

For renewals, summarize activities carried out during the preceding performance period. Clearly delineate and report the specific allocations of grant funds to the pilot projects program for each year of funding, providing details as described earlier.

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

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

Research & Related Senior/Key Person Profile (Pilot Project Program)

The Pilot Project leader/staff should have the appropriate scientific and policy background to effectively work within their Center to mentor new and/or established scientists in environmental health related areas.

R&R Budget (Pilot Projects Program)

It is expected that about 25% of the direct costs of each year's budget is allocated to their support, although greater amounts may be requested with justification.

Allowable costs for Pilot Projects include salary support for the Core Leader and other participating staff.

Integrated Health Sciences Facility Core (Required)

When preparing your component in ASSIST, use Component Type of 'Core'.

The Integrative Health Sciences Facility Core is required and should be designed to facilitate the translation research findings along the spectrum from basic and/or clinical research to the applied or public health arenas. This Core provides new and critical resources that will be a vital component of the progression of environmental health sciences from the bench to the bedside and to affected communities. It is expected that the concepts and goals of environmental medicine will be integrated into the range of activities that the greater EHS CC undertakes.

PHS398 Research Plan (Integrated Health Sciences Facility Core)

Research Strategy. This Core is to be designed to support collaborative efforts among basic scientists, clinical researchers, and/or public health practitioners by:

Among its functions, the Integrative Health Sciences Facility Core may provide services that capitalize on access to well-characterized patients and control subjects for research projects. These can include study subject recruitment and retention activities, and follow-up by mail, phone or in-person to gather needed data for research projects. Clinical services may include clinical laboratory or other assessments, pathology services, collection, processing and long-term storage of human tissue samples, blood, urine or other biospecimens, and preparation of questionnaires or other assessment tools. The IHSFC can facilitate and support partnerships between study investigators and human populations or communities, health care providers or others. Description of services, equipment, and other activities of this core need to be well documented. When applicable, procedures for collecting, storing, and distributing biological samples should be included in the application. Partnerships with other units at the institution which support these types of activities

As for all Facility Cores, the application should include a description of the types of research projects and/or clinical trials that use or plan to use the core. Include specific examples and the likely benefits to other research activities.

For renewals, summarize activities carried out during the preceding performance period. Include core utilization by individual members and associated projects where appropriate. 

Letters of Support. As for all Facility Cores, the application should include a description of the types of research projects and/or clinical trials that use or plan to use the core. Include specific examples and the likely benefits to other research activities.

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

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

Research & Related Senior/Key Person Profile (Integrated Health Sciences Facility Core)

The IHSFC leader and staff should have the appropriate scientific and policy background to effectively work with and serve the membership and enhance collaborations among the teams.

R&R Budget (Integrated Health Sciences Facility Core)

Support may be provided for the following:

Technical Support Personnel.

Facility Cores (Required)

When preparing your component in ASSIST, use Component Type of 'Core'.

The major function of the EHS CC grant is to support Facility Cores which are designed to furnish groups of EHS CC investigators with techniques, services, or instrumentation that will enhance the research in progress, consolidate manpower effort, and contribute to cost effectiveness. At least three investigators with independently funded projects and demonstrated need for such a core service form the minimum required research base to establish a core facility. Additionally, the minimum of three funded investigator users does not in itself provide sufficient justification for establishment of a Facility Core. The EHS CC must have at least two facility cores, one of which must be the Integrative Health Sciences Facility Core, which is described above.

PHS398 Research Plan (Facility Cores)

Research Strategy. Describe the Facility cores. Facility cores should draw on EHS CC research needs, including, but not limited to: animal use and transgenic, imaging, tissue culture, pathology support, biostatistics and statistical support, oligonucleotide synthesis, analytical chemistry, proteomics, bioinformatics, exposure assessment, and handling of human tissue specimens. Establishment and continued support for Facility Cores by an EHS CC application must be justified on the basis of use by independently funded EHS CC investigators. The utilization of Facility Cores by pilot projects is encouraged. Use of core facilities by projects funded by research and development contracts will be evaluated on an individual basis. In general, use of Core facilities by contracts must be paid in full from the contract funds, not from the EHS CC grant funds.

Facility cores for the EHS CC should be unique and duplicate services or facilities that already exist at the parent or collaborating institutions or can be purchased commercially. University-wide facility cores providing services in areas relevant to environmental health research have become more widely available at many research centers. EHS CCs should utilize existing facility cores where appropriate and describe in the application how members of the EHS CC would receive priority access, favorable cost arrangements, and training on unique technologies. If facilities within a university-wide facility are not sufficient to meet the needs of the EHS CC, then the applicant is to provide information on the existing facilities and on how the Center and greater university facility plan to partner. Proposed Center facility cores that appear to replicate services already available at the applicant institution will not be allowed without extensive justification. Facility cores should not duplicate services that can be purchased in the private sector at prices below University-derived costs. 

The application must provide the total operating budget for each Facility Core together with the percentage of support requested from the Center Grant. User logs or similar information used to complete the on-line form should be maintained and made available on request to the NIEHS in order to validate the extent of use and degree of sharing. In the case of new proposed Centers or new Facility Cores within an existing Center, similar information regarding anticipated use of the Cores should be provided. Define the use or expected use of the Facility Core by Center members and/or projects in terms of Low, Medium, or High (on a scale of 1-3).

Each Facility Core must have a designated leader who will be responsible for core activities. The application should explain the organization and proposed mode of operation of each core. It should include a plan for prioritizing investigator use of the core as well as a definition of qualified proposed and potential users. This definition need not be too narrow, since limited use of a core might be an enticement to established investigators in other fields to lend their expertise to the field of environmental health. The use of the Facility Core for training purposes is encouraged and, if so planned, a description of the extent of and approach to this training should be included. 

Although Facility Cores are meant to provide services for Center members, they also play an important role in developing new methodologies, adapting instrumentation for Center needs, and educating Center members of the value and utility of services and methods. Funds can be designated to support these aspects of the Facility Cores and discussion of how these activities will be performed should be included in the application.

For renewals, summarize activities carried out during the preceding performance period. Include core utilization by individual members and associated projects where appropriate. 

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

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

Research & Related Senior/Key Person Profile (Facility Cores)

The Facility Core leaders and staff should have the appropriate scientific and policy background to effectively work with and serve the membership and enhance collaborations among the teams.

The Facility Core Leader should be listed in the Project Director/Principal Investigator section of the form using a Project Role of 'Other' and an Other Project Role Category of "Facility Core Leaders"

Career Development for Environmental Health Investigators (Required)

When preparing your component in ASSIST, use the Component Type of "Careers".

The EHS CCs mechanism encourages clinical and basic scientists with a broad range of skills to work together on a unified theme. Therefore, it presents a rich environment for young translational and clinical investigators to be exposed to and develop additional research skills. Mid-level investigators and scientists in other fields may also be attracted by opportunities in the Center to focus their attention on issues in environmental health sciences and human disease. Financial support can be provided for training and mentoring of physician scientists to study environmental health issues that are relevant to translational and clinical research or public health. In addition environmental health scientists can be supported to engage in activities which increase their understanding of clinical research. The objective of this activity would be to assist new investigators in progressing to more senior status and eventual NIEHS funding by enhancing their research skills and knowledge in translational and clinical research. These activities can be constituted as an independent Facility Core or as part of the Administrative Core.

PHS398 Research Plan (Career Development for Environmental Health Investigators)

Research Strategy. Describe the target candidates, operation, and plans for Career Development. The career development activities should be directed by an investigator with strong mentoring credentials who will devote a defined percent effort (0.5 months suggested). To facilitate mentoring and multidisciplinary developmental activities, active involvement by senior investigators within the EHS CC is strongly encouraged in an effort to match mentors with candidates. The plan for career development activities will be evaluated in terms of potential effectiveness in developing the skills and research capabilities of investigators as reflected in the following required elements of the application:

In order to increase diversity in the student and faculty populations and the participation of individuals currently under-represented in the biomedical, clinical, behavioral, and social sciences, applicants are encouraged to designate new and recruited investigators from the following groups: women, under-represented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.

Direct costs for the sum of career development activities should not exceed $150,000 annually. This figure does not include salary for the EHS CC’s “New Investigator” or “Recruited Center Investigator” described above. Assisting new investigators in attaining independent status or established investigators in developing new promising areas of expertise should be an objective of the Core activities. Sponsored participants should be encouraged to apply for NIEHS sponsored Career Development Awards, independent research grants, or other types of independent support. Contact with NIEHS program staff is encouraged at an early stage in submission of new applications.

The following activities are consistent with this aspect of the EHS CC.

For renewals, summarize activities carried out during the preceding performance period.

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

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

Research & Related Senior/Key Person Profile (Career Development for Environmental Health Investigators)

The career development activities should be directed by an individual with strong mentoring credentials who will devote a defined percent effort (0.5 months suggested). To facilitate mentoring and multidisciplinary developmental activities, active involvement by senior investigators within the EHS CC is strongly encouraged in an effort to match mentors with candidates. The component lead should be listed in the Project Director/Principal Investigator section of the form using a Project Role of 'Other' and an Other Project Role Category of "Mentor"

Community Outreach and Engagement Core (Required)

When preparing your component in ASSIST, use Component Type of "Core".

NIEHS Environmental Health Research EHS CCs are in a unique position to develop and sustain community outreach and engagement activities through their Community Outreach and Engagement Core (COEC). Programs developed by COECs will lead the field of environmental health outreach and engagement at the local and national level. To ensure responsiveness and relevance to community needs, the COEC promotes bi-directional communication between the EHS CC and its stated target audiences on issues of prevention, policy making, and environmental public health.

PHS398 Research Plan (Community Outreach and Engagement Core)

Research Strategy. Describe plans for the COEC to address the two critical objectives of the COEC: translating research results into knowledge for professional and public stakeholders; and increasing EHS CC understanding of community and stakeholder needs for the purposes of guiding appropriate research activities. The COEC must demonstrate that its objectives, activities, and products are aligned and integrated with the research strengths and focus of the EHS CC.

The specific goals of the COEC are to:

For guidance on evaluation, applicants are encouraged to review the PEPH Evaluation Metrics Manual at http://www.niehs.nih.gov/pephmetrics

For the purposes of the EHS CC Program, there are three target audiences of interest: Community, Policy-makers, and Public Health and/or Health Care Professionals. COECs are required to choose at least one target audience but may select more than one.

Guidelines for the COEC include:

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

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

Research & Related Senior/Key Person Profile (Community Outreach and Engagement Core)

The Community Outreach and Engagement Core leaders and staff should have the appropriate background and experience to effectively work with and serve the EHS CC membership and target communities and to promote bi-directional communications. The COEC must demonstrate that its highly skilled staff and proposed plans will foster transparent communications between the identified audience and academic members, will lead to effective products, and build and sustain community participation.

R&R Budget (Community Outreach and Engagement Core)

The following costs are allowable for COEC:

Resource Sharing Plan. A Resource Sharing Plan should be included, as appropriate, for the overall EHS CC for data-sharing activities that involve multiple projects and/or cores.  This plan should be included within the "Overall" component in ASSIST.  This plan for sharing data should describe coordinating efforts of the overall EHS CC regarding sharing of data. 

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

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

Foreign Institutions

Not Applicable

3. Submission Dates and Times

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

Organizations must submit applications via 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.

Applicants are responsible for viewing their application before the deadline 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) and component Project Leads 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.

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 (SAM). 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 the National Institute of Environmental Health NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

Scored Review Criteria - Overall

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? Are the EHS CC’s plans targeted toward building research capacity?  Will the plans, as proposed, attract investigators to the EHS CC from within and outside environmental health sciences?  Will the research supported by the EHS CC likely contribute to understanding of environmental health sciences and, ultimately, 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? Does the EHS Core Center Director or Facility Core leader demonstrate the ability to provide scientific and administrative leadership and direction? Does the application indicate that the Center Director has the authority to appoint new members to the Center and discontinue membership status, when appropriate?  Is the Deputy Director qualified to serve in the absence of the Director? 

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?   

Approach

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

If the EHC Core Center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion 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? Does the EHS CC demonstrate the skills, technologies, and capacity to foster interdisciplinary, state-of-the-art, and innovative research that would lead to important discoveries or major scientific advances in the chosen areas of focus? Are the size and breadth of the research grant base in the EHS CC directly relevant to environmental health sciences and to the theme of the EHS CC, placing special emphasis on NIEHS-supported grants? Does the EHS CC take advantage of the capability of its research base to maximize scientific productivity, particularly through interdisciplinary coordination and collaboration?   

Additional Review Criteria - Overall

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.

Strategic Vision:

Institutional Commitment:

Career Development for Environmental Health Investigators:

Administrative Core:

Facility/Service Cores:

Integrative Health Sciences Facility Core:

Pilot Project Program:

Community Outreach and Engagement Core (COEC):

(a) Vision and Objective

(b) Translating research information into environmental public health knowledge:

(c) Ensuring EHS CC understanding of community and other stakeholder needs

(d) Leadership and staff expertise

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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

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

Renewals

For Renewals, the committee will consider the Progress made in the last funding period.

Specifically, for Leadership and Expertise, both overall in the Center and also in the COEC, reviewers will address the following:

Specifically, for Pilot Projects reviewers will address the following:

Specifically, for Career Development reviewers will address the following:

Specifically for Community Outreach and Engagement Cores reviewers will address the following:

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not for recommended approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Environmental Health Sciences, 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.

Prior Approval of Pilot Projects

Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation. 

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 RPRR) and financial statements, as required in the NIH Grants Policy Statement. Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the  NIH Grants Policy Statement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
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

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Leslie Reinlib, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone:  919-541-4998
Email:  reinlib@niehs.nih.gov

Peer Review Contact(s)

Linda Bass, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 541-1307
Email:  bass@niehs.nih.gov

Financial/Grants Management Contact(s)

Aaron Nicholas
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 541-0039
E-mail: nicholaa@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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