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-11-001

Related Notices

  • December 14, 2011 - See Notice NOT-ES-12-005. The purpose of this Notice is to provide clarification on the number of applications an Institution is permitted to submit.

Funding Opportunity Announcement (FOA) Number

RFA-ES-12-002

Companion FOA

None

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 

FOA 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

November 28, 2011

Letter of Intent Due Date

January 14, 2012

Application Due Date(s)

February 14, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

August 2012

Advisory Council Review

January 2013

Earliest Start Date(s)

April 2013

Expiration Date

February 15, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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 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

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIEHS intends to fund about 4 awards, corresponding to a total of $6 million, for fiscal year 2013. Future year amounts will depend on annual appropriations.

Award Budget

New or first-time applicants can 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. Renewal applications may request up to 5 years of support and up to $1,100,000 direct costs per year. For all applications, both new and renewal, the total request must include a Community Outreach and Engagement Core (COEC, formerly Community Outreach and Education Core) to which a minimum of $100,000 direct costs must be devoted each year.

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

For-Profit Organizations

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 PHS398 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 Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 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

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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 must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must 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

Page Limitations

All page limitations described in the PHS398 Application Guide and as indicated below must be followed, with the following requirements:

1. Strategic Vision and Impact on Environmental Health – 12 pages

2. Environmental Health Identity and Impact of Research Base – 12 pages

3. Center Director - 6 pages

4. Career Development – 6 pages

5. Institutional Commitment – 6 pages

6. Administrative Core – 12 pages

7. Each Facility Core – 12 pages

8. Pilot Projects – 12 pages

9. COEC – 12 pages.

Tables A through E are self-explanatory and will be useful in preparing the application. The information for the Tables are indicated in the appropriate sections of this FOA and are available to download at:

Table A: http://www.niehs.nih.gov/research/supported/centers/core/docs/table-a-grantsupport-07.pdf

Table B: http://www.niehs.nih.gov/research/supported/centers/core/docs/tableb-members-07.pdf

Table C: http://www.niehs.nih.gov/research/supported/centers/core/docs/tablec-facilityuse-07.pdf

Table D: http://www.niehs.nih.gov/research/supported/centers/core/docs/tabled-pubs-07.pdf

Table E: http://www.niehs.nih.gov/research/supported/centers/core/docs/tablee-pilots-07.pdf

The Tables do not count towards page limits.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

General Description and Required Components

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. The proposed Center organization must include the required components outlined below. Beyond those, no additional structure is imposed by NIEHS.

The required components are:

1. Center Director: the designated leader of the EHS CC who provides scientific and administrative leadership for the total program. The Center Director is required to commit a minimum of 2.4 months annual effort to the Center.

2. Administrative Core: oversees organizational, budgeting and reporting aspects and provides the leadership for scientific and programmatic activities of the EHS CC.

3. Pilot Projects Program: required and is considered to be an integral part of the support provided. This program provides modest support for new initiatives or feasibility projects for either new

investigators or for established investigators who are moving into research areas of direct interest to the EHS Core Centers. Up to 25% of the budget may be allocated to the pilot projects program.

4. Facility Cores: the major function of the EHS CC through sharing facilities and enhancing research or improving cost effectiveness of services, techniques, or instrumentation used by the member investigators. Cores should extend, support, and contribute to the work of the Center members. The facility cores are expected to be dynamic and respond to the needs of EHS CC investigators as these needs evolve.  A Center should have a minimum of two facility cores - including the required Integrative Health Sciences Facility Core (see below) - and each facility core must serve at least three users.

The Integrated Health Sciences Facility Core is intended to facilitate translational and clinical investigations, either patient-oriented or population-based research that enhances translation of basic research findings into practical applications for patients and communities. Services available through this Core may, for example, provide the opportunity for Center members to obtain clinical samples and patient data needed for their research. These services could be directed at studies of the pathogenesis, early detection of disease or of preventive strategies in at-risk or patient populations.

5. Career Development Program for Environmental Health Investigators: Emphasis on early stage investigators is strongly encouraged. The application may also promote training and bring new expertise into the area of environmental health sciences by supporting the career development of established investigators.

6. Community Outreach and Engagement Core (COEC): serves as a bi-directional resource for information and expertise to surrounding communities, stakeholders, and Center members to further scientific collaborations and dissemination of research results. Kindergarten - Grade12 curriculum development is not allowed as a COEC activity.

Tables A through E – These tables are provided to assist applicants in documenting many of the required elements of the application. Applicants are encouraged to download the latest using the links, below.

REQUIRED ELEMENTS IN THE APPLICATION

A. Strategic Vision and Impact on Environmental Health

A 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.

This plan 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.

Provide a plan to evaluate emerging opportunities in environmental health sciences and describe how the Director’s Fund and other EHS CC resources (facility cores and pilot projects) will be re-deployed to capitalize on exciting new challenges.

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).

B. Environmental Health Identity and Impact of Research Base

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. 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 an EHS CC. Furthermore, an EHS CC must be able to capitalize upon these research capabilities and resources to advance significantly our understanding of its chosen scientific focus.

An applicant institution or consortium must have a minimum of three active NIEHS-supported research grants from three distinct principal investigators in order to qualify for the EHS CC grant at the time of submission of a new or renewal application. Acceptable grant support includes R01, R21, R37, RC1, RC2, P01, P42, P50, Cooperative Agreements (U-grants) or Research Career Development Awards (K-grants), not including administrative extensions, either with or without additional funds. 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.

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 by an entity using peer or internal review of rigor comparable to that of PHS. NIEHS will have 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.

Applicants must detail grants and funding sources in this section by completing, for example, Table A: Grant Support (http://www.niehs.nih.gov/research/supported/centers/core/docs/table-a-grantsupport-07.pdf) and by describing environmental health sciences research at the applicant institution(s) that emphasizes the focus, interactions, relationships, and scientific excellence of the projects and investigators and the impact on advancing scientific knowledge relevant to environmental health issues. Include in the Appendix a brief abstract of approximately one half of a page for each project.

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. To assist in preparing the application, Table D1: Publications Resulting from EHS CC Involvement, and, if appropriate, Table D2: Publications Resulting from Pilot Program Funding Applicants, which have been preformatted to facilitate completion, can be downloaded from the NIEHS website at http://www.niehs.nih.gov/research/supported/centers/core/docs/tabled-pubs-07.pdf.  Measures of accomplishment also include: pilot projects that led to NIH or other peer-reviewed research applications; new or improved tools, discoveries, or patented inventions (and documentation of the wide use of such tools); training and recruiting of new investigators who have advanced in their careers in environmental health; and, where applicable, outreach to affected communities and appropriate educational outcomes.

C. Center Director

Each applicant institution will specify an experienced and respected Center Director 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. 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.

D. Career Development for Environmental Health Investigators

Emphasis on career development for environmental health scientists is strongly encouraged. The application should address plans that will promote training of new investigators and bring new expertise into the area of environmental health sciences by supporting the career development of established investigators. Specify the plans to cross-train researchers in current techniques that are absent from the EHS CC or individual research programs. Training and cross-training may include collaborations that will introduce a focus on human subjects and tissues into laboratory-based studies. NIEHS strongly encourages training and career development of women and underrepresented minorities.

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

1. New Investigator

Temporary salary support (up to 9 months) 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.

This investigator is eligible to compete for support for up to 2 years through the pilot project program. Subsequently recruited individuals are to be named by the Center Director and submitted for approval to the EHS CC's Internal or External Advisory Board, as appropriate.

2. Recruited Center Investigators

The EHS CC grant may provide partial salary support (up to 9 months), 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, ideally, who are at the beginning stages of their research careers, and will add needed expertise to the Center structure. 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.

Funds awarded under this section may be used for salary, technical support, and equipment. The remaining salary support for the Recruited Center Investigator must be derived from other than Center funds. For each investigator, the duration of support as a Recruited Center Investigator will be limited to no more than 2 years. Specific individuals to be awarded Recruited Center Investigator support need not be identified in the application, but the amount budgeted for this purpose should be declared, and, to the extent possible, the types of individuals sought and their expected roles in the Center described. Renewal applications should include a discussion of how these funds were used in the previous project period in terms of who was recruited and how these individuals benefit the Center programs.

3. Career Development Activities in Translational and Clinical Research

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.

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:

A discussion of how mentoring and the professional development of the investigators will be achieved, including their progression to a more independent status.

A plan for monitoring the progress of the career development of selected investigators.

Examples of planned scientific enrichment activities for selected investigators including training experiences, mini-sabbaticals, special lectures, visiting scientist symposia, seminars, workshops, and short courses both at the parent institution or off-site.

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.

E. Institutional Commitment

The Institutional Commitment at the applicant institution will be a major consideration in ensuring the goals of the EHS CC. The parent institution should 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.

Organizational and Operational Elements of EHS Core Centers

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.

The application should include a description of the organization and structure of the EHS CC and illustrate all components in an organizational chart.

EHS CC Components

1. Administrative Core

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

Coordination and integration of EHS CC components and activities.

Assessment of productivity, effectiveness, and appropriateness of EHS CC activities and determination of EHS CC membership assessment of scientific opportunities and areas for collaboration among EHS CC members.

Organization of EHS CC activities, such as retreats, invitation of consultants, meetings, and focus groups.

Organization of the Internal and External Advisory Groups.

Recordkeeping of meeting minutes and measures of success including: use of EHS CC facilities, publications, pilot project awards, and new grant applications resulting from preliminary data enabled by the EHS CC.

Interactions with other EHS CCs, the NIEHS, and other appropriate individuals, groups, or organizations.

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 Administrative Core may include a Director’s Fund to be used in rapid response to special needs and to exploit emerging scientific advances and novel opportunities. The EHS CC may devote to this Fund up to ten percent of the annual budget or $100,000 direct costs, whichever is less. Examples of opportunities for the Director’s Fund include, but are not limited to: recruiting additional investigators or engaging collaborators with needed expertise; fostering translation of advances to the human disease, prevention, or public health arena; updating equipment to advance the available technology, productivity, and scientific discovery; and responding to unforeseen events with a direct environmental health connection and related community engagement activities. Expected uses of these funds should be described in the application. A process for expending the Director’s Fund should be briefly described in the application and input should be sought from the EHS CC's governing boards and external advisors when making allocations. Decisions regarding the Director’s Fund and subsequent outcomes should be described in annual progress reports. No more than $100,000 (direct costs) may be placed within the Director’s Fund in any budget period. In general, no more than $200,000 (direct costs) will be approved for carry-forward within the Director’s Fund.

To assist in preparing the application Table B: EHS CC Members, that has been formatted to facilitate completion, can be downloaded from the NIEHS website pdf and inserted into this section: http://www.niehs.nih.gov/research/supported/centers/core/docs/tableb-members-07.pdf.

2. Facility Cores

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 below. To assist in preparing the application, Table C: Facility Core Use, which has been formatted to facilitate completion, is provided and can be downloaded from the NIEHS website at http://www.niehs.nih.gov/research/supported/centers/core/docs/tablec-facilityuse-07.pdf.  Separate Tables, such as Table C, are to be provided for each 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 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 are not to 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.

3. Integrative Health Sciences Facility 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.

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

Providing services and access to instrumentation and technologies that foster integration of basic science, public health research including epidemiology and intervention studies, and patient-oriented clinical research.

Supporting research to improve early detection, prevention, and/or therapy for environmentally–related disorders.

Enhancing partnerships between researchers and community based organizations that impact on conduct of clinical and public health research.

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 (e.g. Clinical and Translational Science Awards) are encouraged and letters of support should be included in the application. 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.

4. Pilot Projects Program

Inclusion of a Pilot Projects Program is required and is an integral part of the EHS CCs. A plan to support pilot studies for basic or clinical biomedical, epidemiological, educational, or behavioral research should be included and budgeted in the application. 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. Up to 25% of the direct cost budget for each year should be allocated to the Center Pilot Projects Program to 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. To assist in preparing the application, Tables E1: Pilot Projects Outcomes and E2: Grant Details for Pilot Projects, which have been formatted to facilitate completion, are provided and can be downloaded from the NIEHS website at http://www.niehs.nih.gov/research/supported/centers/core/docs/tablee-pilots-07.pdf.

The basis for grant support (as cited in the 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.

Institutional Review Board (IRB) review and approval are required for Pilot Projects that involve human subjects' research.

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.

5. Support efforts of the Community Outreach and Engagement Core

As the leaders in the field, NIEHS Environmental Health Research EHS CCs are in a unique position to develop and sustain community outreach and education activities. The COEC fosters bi-directional interaction between the EHS CC and its target audience and serves as a resource for information and expertise to surrounding communities, stakeholders, and Center members to further scientific collaborations and dissemination of research results. The COEC takes the lead in promoting bi-directional communication with its stated target communities on issues of prevention, policy making, and environmental public health. A key objective of the COEC is the translation of research information into knowledge for various professional and public stakeholders. The COEC must demonstrate that the objectives, activities, and products are aligned and integrated with the research strengths and focus of their Center. A key objective is to ensure Center understanding of community and other stakeholder needs, as well as to ensure more effective dissemination of Center research in appropriate venues.

Programs developed by COECs will lead the field of environmental health outreach and education at the local and national level. The specific goals of the COEC are to:

Develop partnerships with stakeholders to translate and disseminate EHS CC science, in addition to communicating community concerns to Center members.

Work with community-based organizations, disease advocacy groups, and other local, state, or regional partners to enhance the dialogue on environmental health issues in their regions.

Develop and implement appropriate outreach and educational programs to increase awareness and understanding of environmental health research being conducted at the EHS CCs.

Evaluate outreach models, disseminate results at local and national levels, and promote models for national implementation.

To meet these goals, it is essential for COECs to state clear and measurable objectives; possess appropriate expertise to fulfill their stated objectives; identify specific environmental problems; demonstrate alignment to research strength and focus of the Center; identify existing and future partners; prioritize short, mid, and long-term activities to be implemented; list and describe expected products; state anticipated impacts and their significance for environmental public health; and define evaluation tools to measure the impact of core activities.

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 one target audience, but may select more than one. Examples of activities are in the EHS CC Application Guidelines at: 

(a) The COEC is required to establish a Stakeholder Advisory Board to strengthen the bi-directional interaction between the EHS CC and partners. The purpose of this advisory group is to ensure Center understanding of community and other stakeholder needs, as well as to insure more effective dissemination of Center research in appropriate venues. The EHS CC should develop a specific plan and set of integrated activities for COEC, particularly with respect to the EHS CC’s defined community and target audience. COEC must be a logical outgrowth of the scientific focus of the EHS CC and exhibit the potential for mutual benefit due to interactions with EHS CC investigators.

(b) COECs must possess the appropriate expertise for the identified target audience and outlined activities. It is important that COECs be directed by staff trained in public health, outreach and education, and other relevant disciplines at a Master’s or Doctoral level.

(c) Collaborations among COECs in EHS CCs are desirable. Support of collaborations can be from NIEHS/NIH or other agencies and foundations.

(d) COECs are encouraged to collaborate with NIEHS staff within the Division of Extramural Research and the Office of Communication and Public Liaison in developing printed and audiovisual educational materials. These outreach activities must be identified as programs supported by the EHS CC. All COEC-produced materials must be submitted to the Partnerships for Environmental Public Health (PEPH) Resource Center.

(e) Support for appropriate staff positions, travel, equipment, and supplies for this activity is allowed.

(f) Although COEC is not intended to include human subject research, epidemiology, clinical trials, clinical services delivery, or community-based 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, appropriate COEC proposals may be considered for pilot project funding. The program 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. As stated above, community based participatory research (CBPR) is not intended to be the goal of the COEC. However, certain CBPR goals may be approached in concert with the COEC in terms of establishing community relations and education.

(g) K-12 curriculum development is not allowed as a COEC activity

Tables

To assist in preparing the application, Table A: Grant Support; Table B: Center Members; Table C: Facility Core Use, that has been formatted to facilitate completion, is provided and can be downloaded from:

Table A: http://www.niehs.nih.gov/research/supported/centers/core/docs/table-a-grantsupport-07.pdf

Table B: http://www.niehs.nih.gov/research/supported/centers/core/docs/tableb-members-07.pdf

Table C: http://www.niehs.nih.gov/research/supported/centers/core/docs/tablec-facilityuse-07.pdf

Renewal applications will also find the following tables useful: Table D1: Publications Resulting from Center Involvement; Table D2: Publications Resulting from Pilot Project Funding, Table E1: Pilot Projects and Outcomes; and Table E2: Grant Details for Funded Pilot Projects.

Table D: http://www.niehs.nih.gov/research/supported/centers/core/docs/tabled-pubs-07.pdf

Table E: http://www.niehs.nih.gov/research/supported/centers/core/docs/tablee-pilots-07.pdf

Do not place Tables in the appendix.

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 PHS398 Application Guide, with the following modification:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide,

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the Naitional Institute of Environmental Health Sciences, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Allowable Budget Items

New or first-time applicants can 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.

To aid in review of the application, it is recommended that separate budget pages be prepared for each of the following elements:

1. Administrative Core

2. Each Facility Core

3. Career Development (if separate from the Administrative Core)

4. Pilot Projects

5. COEC

A. Personnel Salaries

Salaries are permitted only for the following:

1. Senior Leadership including the Director, Deputy Director, and Facility Core Leaders.

2. Core Center Leaders including designated directors or coordinators of the identified Facility and Research Cores of the application. For each Facility Core or Research Core, a single Leader or Director must be identified.

Salaries for Co-Directors, consultants, or other investigators within a Facility or Research Core are not permitted without significant, extraordinary justification. If present, terms such as Co-investigators, etc must be clearly defined and the roles of such individuals are to be clearly justified in order to qualify for salary support. This aspect of the application will be considered by the reviewers as will the proposed level of effort for the stated role.

3. Recruited Center Investigators, Named New Investigators

4. Administrative and Technical Support Personnel.

5. Trainees and Career Development Support: Allowable costs for Career Development include salary support for the Core Leader and other participating senior investigators and staff, travel costs for new investigators, and costs for courses, seminars, workshops, and other activities directly related to the career mentoring plan.

Approval from NIEHS will be required for salaries beyond the senior leadership or other individuals specifically described in this section.

B. Equipment/Facilities

This category includes items for broad use in the Center within a Facility Core. Center grant funding is particularly useful for purchases and operations of large items of equipment which are difficult to justify in individual grant applications. When equipment is requested, similar items already available must be reported and a clear justification of the function for the new ones must be provided. The application should provide a list of potential users and projects, giving grant numbers, if possible. The applicant must also provide, on the budget justification page, any duplicate requests which have been made for funding the equipment requested.

C. Supplies

Consumable supplies, such as office materials, glassware, animals, chemicals, etc. may be requested, provided they are items used in common by Center personnel and serve to reduce the cost requirements for individual projects. The requested budget for supplies should be in the appropriate Administrative, Facility, or COEC Core providing this service.

D. Travel

All travel should be budgeted within the appropriate core unit. Appropriate travel requests include:

1. Annual Centers Meeting: A two day annual meeting of the EHS Core Centers Program will be held at a location associated with a Center determined by the Center Directors in consultation with NIEHS Staff. It is expected that a new or competitively renewed Center will be available during its project period to host such a meeting. Applicants must budget travel costs associated with the meeting for the Center Director, Deputy Director, COEC Director, and an administrator in their application. Funds may also be allocated for other Center members, as appropriate, and trainees such as the Named New Investigator to attend the annual meeting.

2. Travel of scientific, technical, or administrative staff for training that would enhance the quality or is required to maintain the operation of a Facility Core or COEC operation.

3. Travel of Named New Investigators and Newly Recruited Center Investigators to relevant scientific meetings.

E. Consultants

Travel and expenses for consultants and members of the External Advisory Committee and their associated costs may be included. Support of consultants must be fully justified in terms of program needs.

F. Pilot Projects

Pilot projects are required and up to 25% of the direct costs of each year's budget may be allocated to their support.

Competitive and non-competitive renewal applications should 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.

G. Other Expenses

Maintenance contracts on general use equipment, duplication costs for annual reports, computer rentals, etc., may be included if fully justified by the application. Requests for funds for equipment maintenance must specify what items are to be maintained, the total yearly cost for maintaining each item, the main users of the item, any other source requesting funding for maintenance of these items, and the amount being contributed from other sources.  Publication costs and page charges related to research results of pilot projects are allowed. However, publication costs and page charges for dissemination of other research results by staff investigators are not allowable. Costs of developing, printing, and distributing educational materials are permissible to the extent authorized by PHS policy. Inclusion of a statement recognizing that the document was created in whole or in part with NIEHS/NIH funds should be included on publications. The requested budget for these expenses should be in the appropriate Administrative, Facility, or COEC Core providing this service.

H. Alterations and Renovations

Funds for alteration and renovation of existing facilities may be requested so long as required for operation of Center programs. However, NIEHS Staff should be consulted as early as possible in the planning of these facilities for special instructions, limitations, etc. Funds for alterations and renovation will not be allowed unless there will be at least 2 years remaining on the grant at completion of the proposed alterations and renovations.

I. Contracts and Consortium Arrangements

These require special budgetary and reporting formats. The NIEHS staff should be consulted prior to submission for special instructions.

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

1. Direct support of individual research projects.

2. Salary and support for central institutional administrative personnel, usually paid from institutional overhead charges.

3. Salary and support for administrative activities such as public relations.

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

5. Page and publication charges for staff investigators.     

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.

Overall Impact - Overall

Reviewers will provide an overall impact/priority 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?   

Investigator(s)

Are the Center Director 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the Center Director or Facility Core leader have 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 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 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?   Strategic Vision and Influence on Environmental Health: Are the plans for the current and future direction of the EHS CC clear and appropriate? How will the research supported by the EHS CC shape our understanding of environmental health sciences and, ultimately, public health? Are the EHS CC’s plans sufficient to promote multi-disciplinary studies and collaborations, especially among basic scientists and clinical researchers? Are the EHS CC’s plans targeted toward building research capacity?  Will the plans, as proposed, bring investigators into the EHS CC from within and outside environmental health sciences?

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 have the skills, technologies, and capacity to foster interdisciplinary, state-of-the-art, and innovative research that would lead to results in important discoveries or major scientific advances in the chosen areas of scientific 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/priority score, but will not give separate scores for these items.

For Institutional Commitment, the following review criteria will be included:

For Career Development for Environmental Health Investigators, the following review criteria will be included:

The Administrative Core will be assessed based on the following criteria:

The Facility/Service Cores will be assessed based on the following criteria:

      The Integrative Health Sciences Facility Core will be assessed based on the following 

      criteria:

The Pilot Project Program will be assessed based on the following criteria:

The Community Outreach and Engagement Core (COEC) will be assessed based on the following criteria:

(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, and the following additional criteria needsto be addressed for all categories:

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

Specifically, for Pilot Projects please address the following:

Specifically, for Career Development please address the following:

Specifically for Community Outreach and Engagement Cores the following should be addressed:

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/priority 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. Review assignments 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 response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and 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(s)/PI(s) 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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) 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

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
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Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
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