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 Core Centers (EHS CC) (P30)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of RFA-ES-13-002

Related Notices

  • January 24, 2014 - See Notice NOT-ES-14-003. Notice of Informational Webinar & Updated Tables.

Funding Opportunity Announcement (FOA) Number

RFA-ES-13-012

Companion Funding Opportunity

Not Applicable

Number of Applications

Only one application per institution is allowed as defined in 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) invites applications from qualified institutions for support of Environmental Health Sciences Core Centers (EHS CC). An EHS CC is 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

December 20, 2013

Open Date (Earliest Submission Date)

March 22, 2014

Letter of Intent Due Date(s)

March 22, 2014

Application Due Date(s)

April 22, 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

August 2014

Advisory Council Review

January 2015

Earliest Start Date

April 1, 2015

Expiration Date

April 23, 2014

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available 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 Environmental Health Sciences Core Center (EHS CC) enhances the capabilities of existing programs in environmental health sciences, assists with building programmatic and scientific capacity, leads in development of novel research directions, recruits and grooms future leaders in the field, and pioneers efforts in community engagement.  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 provides core support to accelerate and deepen the insights into research along the spectrum from basic science findings to population and public health and dissemination.  The NIEHS approach is for this mechanism to foster integration, coordination, and translational cooperation among investigators conducting high-quality research clearly related to the effects of environmental factors on human health, to integrate and build upon existing programs in order to answer complex questions leading to improved strategies towards preventing environmentally-induced disorders and interacting bi-directionally with affected communities.  While the EHS CC grant provides support for core resources and facilities, it does not provide direct funding for research projects, although limited funds are provided for pilot projects.

To qualify for a 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.  

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

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 fund an estimate of 4 - 6 awards, corresponding to a total of $7.5M, for fiscal year 2015.  Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to $1.3M Direct Costs per year.

Award Project Period

The project period is limited to 5 years.

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

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

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.

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 (as described in the NIH Grants Policy Statement), except for submission:

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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

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.
National Institute of Environmental Health Sciences (NIEHS)
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

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12 pages

Admin Core

12 pages

Cores

(Use for Integrative Health Sciences Facility Core (IHSFC), each Facility Core, and Community Outreach and Engagement Core (COEC))

12 pages

Pilot Proj Program

6 pages

Career Dev Core (Use for Career Development Core)

6 pages


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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project Summary/Abstract. Provide a Project Summary/Abstract of a Strategic Vision for the Center.  Also describe the Environmental Health Identity and the Impact of the Research Base on the goals of the EHS CC.

The application must indicate a minimum of three distinct active NIEHS-supported research grants from three-member PDs/PIs with at least 1 full year of activity remaining at the time of submission, not including administrative extensions, either with or without additional funds.

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.

Facilities and Other Resources: Describe the Institutional Commitment for the proposed EHS CC at the applicant institution.  Document previous and planned institutional support: e.g., financial, personnel, positions, and/or priority access to resources.  Also describe the organizational position of the EHS CC in the institutional hierarchy.

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.

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 and can be downloaded from: http://www.niehs.nih.gov/research/supported/dert/programs/core/guidelines/index.cfm

Applicants may prepare their own Tables or formats in place of Tables A - E, but all Tables should be converted to pdf for uploading.

Project/Performance Site Location(s) (Overall)

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.

Research & Related Senior/Key Person Profile (Overall)

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.

Budget (Overall)

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.

PHS 398 Research Plan          (Overall)

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

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 health.  The theme may be broad or focused, depending upon the goals of the EHS CC but should indicate translational elements along the spectrum from laboratory research to public health, disease prevention, and community engagement.  Within this section, describe the research capacity and clearly identifiable major scientific focus in environmental health and related biomedical research.  Include identification of target communities and steps or plans to engage them. 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.

Goals and directions – Describe current and future directions for the EHS CC in the forthcoming project period.  The impact of Center-based science should be discussed in detail.

Provide an overview of the research supported by the EHS CC and its likely impact on the understanding of environmental health sciences and, ultimately, public health.  Describe how the central themes and goals integrate with the needs and concerns of the target communities. Describe short and long-term goals and measures of success.  Provide expected likely advances in the field of environmental health and the impact these advances will likely have on disease and public health.  Describe basic science work of the Center members or teams that has successfully been translated to the bedside or community or plans to translate it in the project period. Describe expected, widely-applicable research tools that will emerge from the Center’s emphasis. Document how the Center forms, organizes, and leads its teams towards answering complex questions and the role of target communities or community advisors in these decisions.  Identify levels of risk for these goals, potential roadblocks to achieving them, and how the Center might respond to these challenges. Applications might also describe the earlier accomplishments of the Center teams - either funded or not by NIEHS - 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, disease prevention, and community engagement.  Plans for COEC must indicate how this entity will integrate with the EHS CC, interact with target audiences, and promote the vision of the Center.

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, and, where appropriate, community engagement experts.  Explain the types of initiatives planned to stimulate teams and attract high-caliber professionals.  Describe the expected level of high-risk/high-payoff research that may require long-term support.

Building research capacity – Provide details on the special talents and resources that will be drawn to and built upon at the EHS CC. Offer how these talents will be harnessed to promote new collaborations and produce multidimensional teams to address complex questions.  Include a plan for bringing investigators into the EHS CC from within and outside the area of environmental health sciences and needed expertise.  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.  As it is expected that facility core needs will change over time, include the process to evaluate needs and implement changes.

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/community engagement experts will be engaged as advisors or mentors for early stage career Center members.

Steps taken to encourage research and/or Outreach Teams that focus complementary expertise on complex and emerging questions in environmental health should be discussed within the Strategic Vision.  Steps taken to encourage such activities and brief examples of ongoing or planned research should be discussed as appropriate with reference to  supporting Facility Cores.  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.

For renewals, summarize activities carried out during the preceding performance period that demonstrate the level of success in reaching previously stated goals.

Environmental Health Identity and Impact of Research Base - The EHS CC 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 or continuation of a EHS CC.  To qualify for support, an institution must demonstrate this research capability so as to have a clearly identifiable, major scientific focus in environmental health research.  Consequently, an existing program of excellence in biomedical research in the field of environmental health science is a basic prerequisite for establishment of a EHS CC and it must demonstrate it can capitalize upon these research capabilities and resources to significantly advance understanding of its chosen scientific focus.  Please describe the Environmental Health Identity and Impact of the Research Base on the plans for promoting translational research and outreach efforts.

To successfully compete for funding, the membership at the applicant institution or consortium must have a minimum of three active NIEHS-supported research grants from three distinct PDs/PIs.  At the time of submission of a competing 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, R03, R21, R37, P01, P42, P50, Cooperative Agreements (U-grants) or Research Career Development Awards (K-grants).  Conference awards (R13, U13) are not acceptable.  Each multi-component (e.g. P01, P50, or U01) award will count as one qualifying research project regardless of the location of the parent grant.

Research grant support from NIH and sources other than PHS should be listed and will be considered in the determination of its suitability of focus on environmental health sciences if the research is (1) related to human health in areas where there is evidence for the involvement of environmental factors in disease etiology or phenotypic expression, (2) of outstanding quality, and (3) funded based on peer or internal review of rigor comparable to that of PHS.

NIEHS will make the final decision in determining whether the applicant EHS CC Institution has the critical mass of grants, investigators, and projects in the area of environmental health.  Prior to submission of an application, the proposed Center Director is encouraged to consult with Institute Staff regarding the adequacy of the research base.

Progress Report Publication List: Include a list of publications related to or derived from EHS CC support or assistance.  Indicate whether the EHS CC was cited in the acknowledgments and provide the PMCID.  Table D is provided for applicant assistance with this requirement (see http://www.niehs.nih.gov/research/supported/dert/programs/core/guidelines/index.cfm)

Letters of Support: Letters of support should be provided where appropriate to demonstrate collaboration, access to resources, institutional commitment, etc.

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:

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

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

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

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Administrative Core)

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.

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

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.

Budget (Administrative Core)

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

Allowable Budget for the EHS CC

Allowable Direct Costs are based on the Direct Costs of NIH grants led as PD/PI by EHS CC members. The sum of qualifying NIEHS support (as defined below) plus 0.1 multiplied by other qualifying NIH funded grants are used to find the maximum allowable Direct Cost of an application.

For applications competing for FY2015 funding, the allowable Direct Cost level is determined by Table 1.

=============================================

Table 1

--------

Qualifying NIH Support                              Allowable

[NIEHS + 0.1 (other NIH)]                                    Direct Costs

-----------------------------------                     --------------

Up to and including $3,000,000                $   700,000

$3,000,001 - $10,000,000                                    $1,000,000

Above $10,000,000                                  $1,300,000

=============================================

In the following example, if an Institution's membership includes PDs/PIs on NIEHS grants with Direct Costs totaling $2.0M and other NIH grants with Direct Costs totaling $6M, the maximal allowable budget would be $700,000 as calculated, below:

Qualifying Support = [$2.0M + 0.1($6M) ] = $2.0M + $0.6M = $2.6M

The calculated value of Qualifying Support is less than $3M and, according to Table 1, allows a request of $700,000 Direct Costs.

Budgets are limited to $1.3M Direct Costs in any one year.

Qualifying Grants and Cooperative Agreements:

i.   All qualifying support must have at least 1 active year remaining at the time of submission and be clearly focused on environmental health science.

ii. NIEHS: K-awards, P01, P42, R01, R03, R21, R37, U01, U19

iii.  Other NIH Institutes: K-awards, P01, R01, R03, R21, R37, U01

iv. In the case of multicomponent projects such as P01 or P42 only costs of the sub-project led by the EHS CC member may be included.

v. Not included, regardless of institute: R43, R44, T-awards, U45, clinical trials, grants and cooperative agreements in extension periods, either with or without additional funds, supplements of any kind.

NIEHS Program Staff will make the final determination on whether a grant qualifies for inclusion in budget calculations. All grants, in particular those supported by non-NIEHS Institutes, must clearly focus on Environmental Health Science.

Other Budget Information

COEC is to budget travel for its field or community work, etc. within that section.

Annual EHS CC Meetings: Each Center must budget $5,000 per year to support the annual EHS CC Meetings in venues to be determined in collaboration with the Center Investigators and NIEHS. Travel costs should also budget for EHS CC members to travel to 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 may want to set funds aside for the event. Please consult with program staff for details.

Items Not Allowed Under a P30 EHS CC Grant Include:

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

2. Salary for Co-Directors, Co-investigators, or individuals unless clearly defined roles are documented in the operation of the EHS CC.

3. Travel to workshops or scientific meetings, other than training in the course of Career Development activities.

4. Page and publication charges.

5. Director’s Funds or Discretionary Fund.

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.

PHS 398 Research Plan          (Administrative Core)

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

Specific Aims: State the aims of the Administrative Core.

Research Strategy: 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 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 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. 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, as well as the Deputy Center Director, will have considerable experience as a leader in environmental health sciences and distinguished records of scientific and administrative accomplishment. Summarize examples of administrative and scientific leadership carried out during earlier performance periods. If applicable, cite accomplishments of the Director and Deputy Director as heads of academic departments, multi-component research programs, or center entities.

The Deputy Director is expected to play an active role in the organization and operation of the EHS CC. The roles and authorities are left to the team to develop, but potential responsibilities include oversight of Career Development, Pilot Projects, one or more Research Core activities, or other Leadership activities.

It is expected that leadership will transition within a reasonable period. Please briefly describe plans for a succession plan for EHS CC leadership to maintain the entity at the pinnacle of the field, either temporarily or permanently.

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 Community Outreach and Engagement Cores (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.  Do not list potential EAC members in the application.

Letters of Support: Include letters of support where appropriate to demonstrate collaborations, access to resources, institutional commitment, etc.

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.

Integrative Health Sciences Facility Core

When preparing your application in ASSIST, use Component Type 'Core.’

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

SF424 (R&R) Cover (Integrative Health Sciences Facility Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Integrative Health Sciences Facility Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Integrative Health Sciences Facility Core)

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:  Do not complete.

Project /Performance Site Location(s) (Integrative Health Sciences Facility Core)

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.

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

Budget (Integrative Health Sciences Facility Core)

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

For a list of allowed or restricted budget items, please see the Budget section under Administrative Core above.

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.

PHS 398 Research Plan          (Integrative Health Sciences Facility Core)

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

Specific Aims: State the aims for the Integrative Health Sciences Facility Core (IHSFC). The IHSFC is required and should be designed to facilitate translational research findings bi-directionally 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 laboratory to affected communities and public health. It is expected that the concepts and goals of environmental health will be integrated into the range of activities that the greater EHS CC undertakes.

Research Strategy: The IHSFC Core is to be designed to support collaborative efforts among basic scientists, clinical researchers, community engagement experts, and/or public health practitioners by:

Among its functions, the IHSFC may provide services that capitalize on access to well-characterized patient groups 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. Among its roles, the IHSFC can facilitate and support partnerships between study investigators and human populations, communities, or health care providers. 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 that support these types of activities should be described.

As for all 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. If applicable, summarize activities carried out during an earlier performance period for the teams or a center entity.

For renewals, summarize activities carried out during the preceding performance period that demonstrate the level of success in reaching previously stated goals.

Letters of Support: Include letters of support where appropriate to demonstrate collaborations, access to resources, institutional commitment, etc.

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:

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  (Integrative Health Sciences Facility Core)

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 (Integrative Health Sciences Facility Core)

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

Facility Cores

When preparing your application in ASSIST, use Component Type ‘Core’.

A central function and process of the EHS CC grant is through support of Facility Cores which are designed to furnish groups of EHS CC investigators with technologies, 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 or service form the minimum required research base to establish a core facility. The minimum set of 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.

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

SF424 (R&R) Cover (Facility Cores)

Complete only the following fields:

PHS 398 Cover Page Supplement (Facility Cores)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Facility Cores)

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:  Do not complete.

Project /Performance Site Location(s) (Facility Cores)

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.

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

Budget (Facility Cores)

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

For a list of allowed or restricted budget items, please see the Budget section under Administrative Core above.

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.

PHS 398 Research Plan          (Facility Cores)

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

Specific Aims: State the specific aims of the Facility Core.

Research Strategy:  Describe the Facility Core. 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 a 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.

Facility Cores for the EHS CC should be unique and not 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 that demonstrate the level of success in reaching previously stated goals.

Letters of Support: Include letters of support where appropriate to demonstrate collaborations, access to resources, institutional commitment, etc.

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:

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  (Facility Cores)

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 (Facility Cores)

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

Community Outreach and Engagement Core

When preparing your application in ASSIST, use Component Type ‘Core.’

The EHS CC occupies a unique position to develop and sustain community outreach and engagement activities through their 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 (broadly defined) needs, the COEC promotes multi-directional communication among the EHS CC and its stated target audiences on issues of prevention, environmental health literacy, and environmental public health.

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

SF424 (R&R) Cover (Community Outreach and Engagement Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Community Outreach and Engagement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Community Outreach and Engagement Core)

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:  Do not complete.

Project /Performance Site Location(s) (Community Outreach and Engagement Core)

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.

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

Budget (Community Outreach and Engagement Core)

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

For a list of allowed or restricted budget items, please see the Budget section under Administrative Core above.

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.

PHS 398 Research Plan          (Community Outreach and Engagement Core)

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

Specific Aims: State the aims for the Community Outreach and Engagement Core (COEC). The EHS CC occupies a unique position to develop and sustain community outreach and engagement activities through their 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 (broadly defined) needs, the COEC promotes multi-directional communication among the EHS CC and its stated target audiences on issues of prevention, environmental health literacy, and environmental public health.

Research Strategy: Describe the COEC’s vision and objective to conduct each of the following three critical functions.

1. Translate and disseminate EHS CC research results into environmental public health knowledge for identified audience(s). COECs develop and implement appropriate outreach and engagement programs to increase awareness and understanding of environmental health research being conducted at the EHS CC.

2. Communicate audience issues, needs, and concerns to EHS CC members. In working with community-based organizations, disease advocacy groups, and other local, state, or regional partners to enhance dialogue, as well as fostering interactions with Center members on environmental health issues the informs and guides CCTEH members in developing appropriate research activities that address the expressed needs.

3. Advance the field of community engagement. Evaluate outreach models, disseminate results at local and national levels, and promote models for national implementation.

The objectives, activities, and products outlined in the strategy must be aligned and integrated with the research strengths and focus of the EHS CC.

COECs must:

As part of their plan on how they will carry-out these three key functions, COECs should:

state clear and measurable objectives;

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

Additional program notes for the COEC that may be addressed include:

Although COEC is not intended to include human subject research, epidemiology, clinical trials, clinical services delivery, or community-engaged research, the Core may be useful in establishing a relationship with a community-based organization that could form the foundation of a research grant application. In such cases, COEC proposals may be considered for pilot project funding. COEC activities should not go beyond public and community education concerning environmental disease risk and/or hazard exposure recognition, as the COEC is not intended to give medical, legal, political, social, or economic advice.

All COEC-produced materials must be submitted to the Partnerships for Environmental Public Health (PEPH) Resource Center. https://connect.niehs.nih.gov/peph/index.cfm?directTo=peph.landing.

For renewals, summarize activities carried out during the preceding performance period that demonstrate the level of success in reaching previously stated goals. Clearly delineate and report the specific activities, products, integration with other Center activities, etc. that document the accomplishments of the COEC.

Letters of Support: Include letters of support where appropriate to demonstrate collaborations, access to resources, institutional commitment, etc.

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:

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  (Community Outreach and Engagement Core)

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 (Community Outreach and Engagement Core)

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

Pilot Project Program

When preparing your application in ASSIST, use Component Type ‘Pilot Proj Program.’

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

SF424 (R&R) Cover (Pilot Project Program)

Complete only the following fields:

PHS 398 Cover Page Supplement (Pilot Project Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Project Program)

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:  Do not complete.

Other Attachments: Please title an attachment "Pilot Projects" and list all Pilot Projects supported all or in part by the EHS CC.  Include the years funded, awardee, amount of funds for the pilot, title, publications derived from support, and resulting grants funded (including annual direct costs, grant number, and funding agency).  Table E is provided for applicant assistance with this requirement (see http://www.niehs.nih.gov/research/supported/dert/programs/core/guidelines/index.cfm).

Project /Performance Site Location(s) (Pilot Project Program)

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.

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

Budget (Pilot Project Program)

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

It is expected that about 25% of the annual direct costs will be allocated to Pilot Project support, although greater amounts may be requested with justification.

For a list of allowed or restricted budget items, please see the Budget section under Administrative Core above. However, considerable discretion is allowed for funding of pilot projects and reasonable costs associated with research projects are permitted. Conference Travel to present findings is not allowed. In addition, the Pilot Projects Program may include a reasonable level of salary support for the Project Leader and other participating staff.

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.

PHS 398 Research Plan          (Pilot Project Program)

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

Specific Aims: State the aims for the Pilot Project Program.

Research Strategy: A Pilot Project 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 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 Project 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.

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;

(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.

While Foreign Components are not acceptable in the EHS CC, select pilot projects partly performed in a foreign country may be approved by NIEHS after an award is made. The pilot project must demonstrate a highly compelling justification both to the EHS CC through its selection process and to NIEHS. All foreign pilot projects are subject to NIH and Federal regulations and guidelines governing the approval of such activities and will be considered case-by-case.

A renewal or re-submitted 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 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. 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.

Letters of Support: Include letters of support where appropriate to demonstrate collaborations, access to resources, institutional commitment, etc.

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:

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  (Pilot Project Program)

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 (Pilot Project Program)

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

Career Development Core

When preparing your application in ASSIST, use Component Type ‘Career Dev Core.’ The Career Development Core activities can be constituted as an independent Program or as part of the Administrative Core, but please describe the activities in this section.

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

SF424 (R&R) Cover (Career Development Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Career Development Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Career Development Core)

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:  Do not complete.

Project /Performance Site Location(s) (Career Development Core)

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.

Research & Related Senior/Key Person Profile (Career Development Core)

Budget (Career Development Core)

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

For a list of allowed or restricted budget items, please see the Budget section under Administrative Core above. However, considerable leniency is provided to Career Development candidates regarding training and travel, as detailed below.

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”.

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.

PHS 398 Research Plan          (Career Development Core)

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

Specific Aims: Present the aims for Career Development.

Research Strategy: The EHS CC Program encourages clinical and basic scientists with a broad range of skills to work together on a unified theme presenting a rich environment for young investigators to be exposed to and develop skills. To this end, a Career Development Program is required. 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. Optimally, the Career Development activity would 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.

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:

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 Career Development in the EHS CC:

New Investigator

Temporary salary support (up to 9 months effort) for 1 - 2 years and equipment may be provided in the application for a named New Investigator in a specified area of research. The investigator can work in the basic sciences, clinical research, or public health disciplines relevant to environmental health. Former post-doctoral assistants and fellows are eligible for this position.

Recruited Center Investigators

The EHS CC grant may provide partial salary support (up to 9 months effort) for not more than 2 years, technical support, and equipment for independent investigators newly recruited from outside the Center. This mechanism is intended to infuse Center research with novel technologies and approaches by supporting independent investigators. The recruit would be expected to bring new technologies or novel scientific areas of expertise into the environmental health sciences arena that enhance the Center’s research capabilities. Former graduate students and postdoctoral fellows of Center members should not be considered for support unless, in exceptional cases, it can be demonstrated that they have established independent research careers and will provide critical expertise.

For renewal applications, summarize activities carried out during the preceding performance period that demonstrate the level of success in reaching previously stated goals. Clearly delineate and report the specific activities, products, publications, candidate selection and training, integration with COEC activities, etc. that document the accomplishments of this Center component.

Letters of Support: Include letters of support where appropriate to demonstrate collaborations, access to resources, institutional commitment, etc.

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:

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  (Career Development Core)

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 (Career Development Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in 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) using ASSIST or other electronic submission systems. 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 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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 Sciences, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

In order to expedite review, applicants are requested to notify the NIEHS Scientific Review Officer, Dr Bass by email at bass@niehs.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.

Overall Impact - Overall

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 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 Director or Facility Core leader demonstrate the ability to provide scientific and administrative leadership and direction? Does the application indicate that the Director has the authority to appoint new members to the EHS CC 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 project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

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

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 that it includes 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

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.

Overall/Strategic Vision:

Institutional Org/Commitment:

Administrative Core:

Facility/Service Cores:

Integrative Health Sciences Facility Core:

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

Pilot Project Program:

Career Development for Environmental Health Investigators:

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

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. The following questions will be addressed:

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:

What is the past progress of the Center in the development of an effective COEC? What impact has the Center had on the target audience? What impact has the COEC had on the Center?  What types of educational and outreach materials have been created as part of the COEC? Are they relevant to the science of the Center?

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project.

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 Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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 Center Telephone: 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)

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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