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 using ASSIST or an institutional system-to-system solution; 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.

It is critical that applicants follow the Multi-Project (M) 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.

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

The NIEHS Environmental Health Sciences Core Centers (EHS CC) Program is intended to bring together investigators currently funded by NIH or other Federal or non-Federal sources to enhance the effectiveness of existing research and extend the focus of research for the environmental health sciences. An EHS CC should support innovation and be on the cutting edge of science. It is expected that research activities will cross a variety of disciplines to bring multiple perspectives and approaches to bear on significant problems. It is expected that the interdisciplinary nature of an EHS CC will have a synergistic effect that results in greater depth, breadth, quality, innovation and productivity beyond what individual scientists would be likely to attain by working independently. As intellectual hubs for environmental health research, the membership of EHS CC's is expected to be the thought leaders for the field as well as advance the goals of the NIEHS Strategic Plan (http://www.niehs.nih.gov/about/strategicplan/.)

The overall goals for the EHS CC Program are to enhance the capabilities of existing programs in environmental health sciences, assist with building programmatic and scientific capacity, lead in the development of novel research directions, recruit and groom future leaders in the field, and pioneer efforts in community engagement. The EHS CC grant provides facilities and resources to accelerate research along the spectrum from basic mechanistic and toxicological science to population and public health and dissemination. It should create a structure and flexibility that allow center members with different expertise to come together to answer complex and/or emerging questions and capitalize on the latest scientific trends leading to improved strategies towards preventing environmentally-induced disorders. 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.

NIEHS considers community engagement and multi-directional communication as essential activities to advance the goals and relevance of an EHS CC. Therefore, the structure of the Center should facilitate multi-directional interaction with communities and EHS CC members through the required Community Engagement Core. In addition, EHS Cores are expected to attract established and promising investigators into environmental health research and provide opportunities for career enhancement.

To qualify for an EHS CC, the applicant institution must have a 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. The research base must exist prior to the submission of an application and will be considered by program staff to determine eligibility. See Section III.1 Eligible Applicants for more detailed description of EHS base support calculation.

See Section VIII. Other Information for award authorities and regulations.

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

To be eligible for an EHS CC award, the applicant institution must demonstrate that they have a minimum of three active NIEHS-supported research awards from three distinct PDs/PIs who are members of the proposed Center. At the time of submission of an application, the qualifying awards must have at least 1 full active year remaining.

Acceptable support includes R00, R01, R03, R21, R33, R37, R43, R44, P01, P42, P50, U01, U19, U24, U2C, and or Research Career Development Awards (K-grants). Each multi-component (e.g. P01, P50, or U19) award will count as one qualifying research project regardless of the location of the parent grant.

T-awards, U45, and Conference awards (R13, U13) do not count towards this requirement. Furthermore, grants and cooperative agreements in extension periods, either with or without additional funds, as well as supplements of any kind, do not count toward this requirement.

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.

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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.

It is critical that applicants follow the Multi-Project (M) 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.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Linda Bass, PhD
Telephone: 984-287-3236
Fax: 919-541-2503
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12 pages
Admin Core	12 pages
Core [use for: - Integrative Health Sciences Facility Core - Facility Core(s) - Community Engagement Core	12 pages
Project (use for Pilot Project Program)	6 pages

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

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: required
• Administrative Core: required; maximum of 1
• Integrated Health Sciences Facility Core (IHSFC): required
• Facility Cores: at least one is required
• Community Engagement Core: required
• Pilot Project Program: required

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.

Complete entire form.

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

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 in how it advances the NIEHS Strategic Plan.

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 unit 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 CC 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. The filename provided for each attachment will be the name used for the bookmark in the application image.

Grant Support - Title this attachment "Grant Support" and include all Federal and nonfederal grant support for EHS CC members. Include Grant numbers, levels of effort for the PD/PI, complete title, EHS CC collaborators, annual direct costs, and the funding period. List NIEHS supported grants first in the list. Table A1 and Table A2 are provided as suggested formats applicants may use to prepare this required information (see https://www.niehs.nih.gov/research/supported/centers/core/guidelines/index.cfm

Center Members - Title this attachment "Center Members" and list all the EHS Core Center Members including highest educational degree, Institutional title, and affiliation including department. Include personnel effort if known. Tables B1 and B2 are provided as suggested formats applicants may use to prepare this required information (see https://www.niehs.nih.gov/research/supported/centers/core/guidelines/index.cfm.

Facility Core Use - Title this attachment "Facility Core Use" and for each proposed Facility Core, indicate the project name, center member, type of support, services used, and notable outcomes. Table C is provided as suggested format applicants may use to prepare this required information (see https://www.niehs.nih.gov/research/supported/centers/core/guidelines/index.cfm.

Pre-formatted Tables are available as suggested formats applicants may use to facilitate completion and can be downloaded from: https://www.niehs.nih.gov/research/supported/centers/core/guidelines/index.cfm

Applicants may prepare their own Tables or formats in place of the preformatted forms. All Tables must be converted to pdf for uploading.

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.

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.

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.

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

Specific Aims: The specific aims for the Center should describe the strategic vision, theme, and goals to be accomplished.

Research Strategy: Provide a written strategy for how the EHS CC will implement its vision and which future directions will likely be followed during the project period. The plan should outline the existing skills, technologies and scientific research base, and communication and community engagement expertise at the institution. This plan should describe how the Center is advancing the NIEHS Strategic Plan. It should describe how the Core Center will enhance ongoing projects, identify and bring in outstanding new projects, respond to future challenges and opportunities, and promote collaborations, advances in technology, and progress in environmental health sciences. 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 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 basic mechanistic and toxicological science to population and 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.

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 as well as how the facility/service cores contribute to advancing Center goals. Provide an overview of the research supported by the EHS CC and its likely impact on understanding environmental health and, ultimately, public health. Describe how the central themes and goals integrate with the needs and concerns of the target audience(s). Describe short and long-term goals and measures of success. Describe examples of research conducted by Center members or teams that have successfully been translated to the identified audience(s) or identify plans to translate research findings during the project period. Describe new or innovative tools or methods to support the Center's emphasis. Document how the Center forms, organizes, and leads its teams towards answering complex questions and the role of target audience(s) or stakeholder 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.

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 used 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, instrumentation or other infrastructure 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 are expected to interact with early career investigators in the Center.

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 existence of a strong research capability in environmental health sciences is fundamental to establishment or continuation of an EHS CC. To qualify for support, an institution must demonstrate this research capability to have a clearly identifiable, major scientific focus in environmental health research. Describe the Environmental Health Identity and Impact of the Research Base on the plans for promoting translational research and outreach efforts. Please note that a listing of research grant support from NIH and sources other than HHS should be listed as described above in "Other Attachments." Prior to submission of an application, the proposed Center Director is encouraged to consult with Institute Scientific/Research Staff regarding the adequacy of the research base.

Progress Report Publication List: For renewal applications, 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 as a suggested format for applicant assistance with this requirement (see https://www.niehs.nih.gov/research/supported/centers/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 as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done (e.g., Pilot Project Program), unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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.

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources: Assisting new investigators in attaining independent status or established investigators in developing new promising areas of expertise is an objective of the Center. Include a description of the resources available to them that are distinct from access to existing core usage.

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.

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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 research grants that are relevant to the environmental health sciences and for which an EHS CC member is designated as the PD/PI. The sum of qualifying NIEHS support (as defined below) plus 0.1 multiplied by other qualifying NIH funded grants is used to find the maximum allowable Direct Cost of an application.

For applications competing for FY2019 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. Renewal grant applications that will be peer-reviewed between the time of submission and award may be included in the base calculation. (NOTE: if renewal is not funded, the base calculation will be adjusted accordingly and may affect DC amount received.)

iii. NIEHS: K-awards, P01, P42, P50, R00, R01, R03, R21, R33, R37, R43, R44, U01, U19, U24, U2C.

iv. Other NIH Institutes: K-awards, P01, P50/P60, R01, R03, R21, R33, R37, U01, U19, U24, U2C

v. 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.

vi. To encourage new disciplines and researchers into the environmental health sciences, Grant support derived from a pilot project, regardless of the NIH IC issuing the award can be counted at 100% for the first grant funding period.

vii. NIH issued grants that resulted from an FOA that NIEHS participated in can be counted at 100% for the first grant funding period when NIEHS has secondary assignment.

viii. Not included, regardless of institute: T-awards, U45, and Conference awards (R13, U13). Furthermore, grants and cooperative agreements in extension periods, either with or without additional funds, as well as supplements of any kind, are not to be included.

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

Other Budget Information

Budget to cultivate junior and mid-level and recruited investigators to enhance their careers and research programs in environmental health sciences should be included in the administrative core budget. Direct costs for the sum of activities should not exceed $150,000 annually. This figure does not include salary for the EHS CC's "Junior Investigator" or "Recruited Center Investigator". Allowable expenses include:

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 fellows are eligible for this position.
• The New Investigator indicated in the application 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.

Recruited Center Investigators:

• 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. 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 (for example have transitioned to an R00 award) and will provide critical expertise.

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.

At a minimum, the greater of $80,000 Direct Costs or 10% of the total direct costs are to be devoted annually to the Community Engagement Core (CEC).

In non-competing years, EHS CC with Direct Costs of less than $1M may re-calculate the budget and request an additional $50,000 in direct costs by demonstrating a significant increase of NIEHS support. Increases in the award will be based on determination by NIEHS Program Staff and availability of funds.

All travel associated with the annual EHS CC Meeting or External Advisory Board members should be budgeted within the Administrative Core.

CEC is to budget travel for its field or community work, etc. within the CEC section.

Annual EHS CC Meetings: Each Center must budget at least $5,000 per year to support the annual EHS CC Meetings in venues to be determined in collaboration with the Center Investigators and NIEHS. These funds can be used for travel costs of EHS CC members to travel to the annual 2 - 3-day meeting. At a minimum the Director, CEC Director, and Administrative Assistant should plan to attend. Other center members, especially junior investigators are also encouraged to attend. An EHS CC should expect to host the EHS CC meeting once within the project period and may want to set funds aside for the event. Please consult with program staff for details. Travel budget should also include travel for 1-2 CEC staff to attend annual Partnerships for Environmental Public Health (PEPH) meeting.

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, Collaborators, or individuals unless clearly defined roles are documented in the operation of the EHS CC.
3. Travel to workshops or scientific meetings, except for junior, mid-level and recruited investigators for cultivating career enhancements.
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.

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

Specific Aims: The administrative core provides oversight and coordination of EHS CC activities. State the aims of the Administrative Core.

Research Strategy: Applicants should describe the administrative structure of the Center and the roles and responsibilities of all key personnel. The administrative core is responsible for overseeing organizational structure, budgeting and reporting functions and provides the leadership for scientific and programmatic activities of the EHS CC.

Through the required Administrative Core, the Center Director provides leadership and guidance in fulfilling the stated objective of his or her Center. It is expected that the organization of the Administrative Core will provide a supportive structure sufficient to promote the scientific vision of the center and to accomplish the following:

• Coordinate and integrate EHS CC components and activities.
• Cultivate junior and mid-level and recruited investigators to enhance careers and research programs in environmental health sciences
• Assess productivity, effectiveness, and appropriateness of EHS CC activities and determine EHS CC membership, assessment of scientific opportunities and areas for collaboration among EHS CC members.
• Organize EHS CC activities, such as retreats, invitation of consultants, meetings, and focus 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.
• Organize Internal and External Advisory Groups.
• Interact with other EHS CCs, the NIEHS, and other appropriate individuals, groups, organizations.

Coordination and integration: 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; strategies for stimulating interaction among center members (i.e., retreats, invitation of consultants, meetings, and focus groups). In addition, describe direct lines of communication between the Administrative Core and Community Engagement Cores (as well as with the other cores, as appropriate).

Cultivating careers: Describe a plan bringing in junior investigators and cultivating their careers for assistance towards independent status. Include examples of planned scientific enrichment activities for selected investigators such as assistance and guidance, mini-sabbaticals, special lectures, visiting scientist symposia, seminars, workshops, and short courses both at the parent institution or off-site. This plan can reference but should not repeat information about resources described in the Facilities & Other Resources.

Center Assessment: Describe how the center will monitor productivity, effectiveness, and appropriateness of EHS CC activities (record keeping of core usage, meeting minutes, etc.).

In addition, 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. For new applications, do not list potential EAC members in the application. Additionally, potential EAC members should not be contacted prior to review.

Leadership Qualifications: Describe the responsibilities of the Director and Deputy Director of the Center. The Center Director is expected to have 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 is expected to play an active role in the organization and operation of the EHS CC and to serve in the absence of the Director.

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 as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix:

Limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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 (Integrated Health Sciences Facility Core)

Complete only the following fields:

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

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

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Integrated 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. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Integrated 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 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 (Integrated Health Sciences Facility Core)

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

Specific Aims: The Integrative Health Sciences Facility Core (IHSFC) is intended to facilitate translational research findings bi-directionally along the spectrum from basic and/or clinical research to the applied or public health arenas. State the aims for the IHSFC.

Research Strategy: The IHSFC provides resources to facilitate the progression of environmental health sciences from basic mechanistic and toxicological research to use by affected communities for improved public health, and/or clinical practice. 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:

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 therapeutic strategies 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 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 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 needs 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.

Without duplicating the information in the Facility Core Use table in the Overall component, the application should include a summary 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, highlight key activities carried out during an earlier performance period for the teams or a center entity that have advanced the Center vision and/or scientific focus.

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: 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 as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Integrated Health Sciences Facility Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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 (Facility Cores)

Complete only the following fields:

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

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. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

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)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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 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: The intent of Facility Cores is 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. State the specific aims of the Facility Core.

Research Strategy: A central function of the EHS CC grant through its support of Facility Cores is to furnish groups of EHS CC investigators with technologies, services, or instrumentation that will enhance the research progress. 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.

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.

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/or training on unique technologies. 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 should explain the organization and proposed mode of operation of the proposed 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 user 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 Core 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: 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 as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide

PHS Human Subjects and Clinical Trials Information (Facility Cores)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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 (Community Engagement Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Community Engagement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Community 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. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Community 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 Engagement Core)

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

Specific Aims: The Community Engagement Core (CEC) promotes multi-directional communication among the EHS CC and its identified audience(s) on issues of environmental health literacy, environmental public health, and prevention. CEC ensures responsiveness and relevance to community needs through collaborative efforts that foster dialogue and interactions among the identified audience and Center members. While CECs may choose to align their vision and goals to the principles of community-based participatory research (CBPR), the CECs are not required to conduct CBPR.

Research Strategy: Describe the CEC's vision, objective, and plans to accomplish each of the following three critical functions. State anticipated impacts of these efforts on environmental public health.

• Translate and disseminate EHS CC research results into environmental public health knowledge for identified audience(s). Goal: to increase awareness and understanding of environmental health research being conducted at the EHS CC.
• Communicate audience issues, needs, and concerns to EHS CC members. Goal: to inform and guide EHS CC members in developing appropriate research activities that address the expressed needs of the identified audience(s).
• Advance the field of community engagement and environmental health communication. Goal: to promote different engagement models for national implementation. In this context, CECs may use social science/communication research approaches to examine the impacts and outcomes of their work.

Describe how the stated objectives, activities, and products are aligned with the research strengths and focus of the EHS CC. In addition, explain how objectives, activities, and products are appropriate to the needs of the identified audience. It is important to describe CEC plans for measuring the impact of these activities.

CECs must:

• Identify one or more audience(s) most appropriate to the mission of the EHS CC. For the purposes of the EHS CC Program, there are four audiences of interest: Community, Policy-makers, Public Health and/or Health Care Professionals, and Educators.
• Establish a Stakeholder Advisory Board (SAB) to facilitate and strengthen multi-directional interaction between the EHS CC and partners. For renewal applications, current SAB members should be listed.
• Possess the appropriate expertise for the identified audience and outlined activities. CECs should be directed by staff trained in public health, behavioral and social science research, outreach and education, and/or other relevant disciplines.

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 CEC:

• Collaborations among CECs in EHS CCs are desirable. Support of collaborations can be from NIEHS/NIH or other agencies and foundations.
• All CEC-produced materials should be submitted to NIEHS' Partnerships for Environmental Public Health (PEPH) Resource Center. https://connect.niehs.nih.gov/peph/index.cfm?directTo=peph.landing.
• CECs are eligible for pilot project funding to advance CEC aims and pursue new opportunities. However, CECs may not include epidemiology, clinical trials, or clinical services delivery. CEC is not intended to give medical, legal, political, social, or economic advice.
• 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 CEC.

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 as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.)

PHS Human Subjects and Clinical Trials Information (Community Engagement Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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:

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

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. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

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)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Pilot Project Program)

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

It is suggested that up to 25% of the annual direct costs be allocated to Pilot Project support.

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: The intent of the Pilot Project Program is support short-term projects to explore the feasibility of new areas of study which lead to collection of sufficient data to pursue support through other funding mechanisms. State the aims for the Pilot Project Program.

Research Strategy: A Pilot Project Program is an integral part of the EHS CCs. The Pilot Project Program should support short-term projects to explore the feasibility of new areas of study which lead to collection of sufficient data to pursue support through other funding mechanisms. 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.

The Research Strategy should include a plan to support pilot studies to advance the goals of the Core Center. Pilot project studies can include basic mechanistic and toxicological, clinical biomedical, epidemiological, educational, behavioral and social science, and communication research or community engaged activities. A description of a plan to solicit, review, and administer pilot grants must be included. Criteria for review of pilot studies must be developed and included in the application. Include a clear description of the process designed to award and assess progress in pilot projects.

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. 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 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: 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 as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Pilot Project Program)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

This initiative is not subject to intergovernmental review.

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.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by the National Institute of Environmental Health Sciences, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIEHS Scientific Review Officer by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Important Update: See NOT-OD-18-228 for updated inclusion and human subjects review language for due dates on or after January 25, 2019.

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.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the EHS CC 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 EHS CC proposed).

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 EHS CC that by its nature is not innovative may be essential to advance a field.

Does the EHS CC address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the EHS CC 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?

In addition, for applications proposing clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

Do the Center Director and Core leaders 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?

In addition, for applications proposing clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

In addition, for applications proposing clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the EHS CC? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the EHS CC 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?

In addition, for applications proposing clinical trials

Does the application adequately address the following, if applicable.

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

In addition, for applications proposing clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

As applicable for the EHS CC 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

• Does the applicant articulate a clear and practical set of goals?
• Are the goals reasonable and attainable in consideration of the expertise, facilities, and funds available?
• Are the EHS CC's plans sufficient to promote multi-disciplinary studies and collaborations, especially among basic scientists and clinical researchers?
• Do the goals and approaches outlined for the individual components support the strategic vision and goals for the EHS CC?
• Does the Vision suggest and present plans to encourage collaboration, sharing of resources within the EHS CC, and steps towards translational science and dissemination as appropriate and consistent for achieving the goals of the program?
• Are the goals outlined in the Vision likely to lead to advances in environmental health sciences or related fields, career opportunities for early stage investigators to obtain independent status, improved community engagement, and/or public health?

Institutional Commitment

• Is the level of institutional commitment appropriate and demonstrative of significant support to the EHS CC?
• Do the presence, stature, and effectiveness of the NIEHS EHS CC represent an established organizational component within the institution?

For components types: Admin Core, Core [use for: Integrative Health Sciences Facility Core, Facility Core(s), Community Engagement Core] and Project (use for Pilot Project Program) reviewers will consider the following review criteria in providing component scores:

Administrative Core

• Is the administrative structure designed for effective management of the EHS CC?
• Are the strategies employed by the EHS CC for future research leaders in environmental health sciences, environmental medicine, and public health appropriate?
• How well does the EHS CC plan and carry out recruiting and supporting new investigators?
• Is the EHS CC's plan for providing cross-discipline experiences for junior and established investigators sufficient to learn current and necessary techniques that are absent from their research programs?
• Has the EHS CC established itself as a recognizable entity in the fields of environmental health sciences and environmental medicine and public health?
• How well does the EHS CC plan for initiating, continuing, and discontinuing individual membership?
• Is the percent effort of the administrative staff of the EHS CC appropriate, in terms of their qualifications and contributions to the specialized needs and conduct of the EHS CC's research activities?
• What are the EHS CC's plans for using the Internal Advisory Committee and External Advisory Committee? Is the expertise of the advisory committees adequate?

Integrative Health Sciences Facility Core

• Will the services offered for technologies foster the integration of basic science, public health research, including epidemiology and intervention studies, and patient-oriented clinical research?
• Is the research support adequate to improve early detection, prevention, and/or therapy for environmentally related disorders?
• How well do the EHS CC and community based organizations support partnerships between researchers that will impact on the conduct of clinical and public health research?

Facility Cores

• What is the Core's utility to the overall EHS CC and its membership?
• How well does the proposed Facility Core respond to the needs of the EHS CC membership and the chosen scientific or outreach focus of the application? Do the plans suggest outstanding quality?
• Are plans presented for quality control and to provide the services or materials within reasonable timeframes?
• Are the Facility Cores and their services and materials timely and at the frontier of technology appropriate for the research the EHS CC plans to support?
• Is the Facility Core cost-effective?
• What are the overall qualifications of the personnel involved?

Community Engagement Core

(a) Vision and Objective

• Is the CEC a logical outgrowth of the EHS CC theme?
• Will the CEC lead to a mutually-beneficial, bidirectional relationship between the academic institution and the identified audience(s)? Are the environmental problems they plan to address aligned to EHS CC?
• Are objectives for CEC clear and measurable? Do they prioritize short, mid and long-term activities? Are evaluation plans defined to measure the impact of core activities? If so, are the evaluation plans appropriate?

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

• Are outreach and educational engagement programs proposed to increase awareness and understanding of environmental health research being conducted at the EHS CC? For the products being proposed, are they relevant to the theme of the EHS CC and to the needs of the identified audience?
• With respect to the CEC's defined audience, are the plans, activities, and coordination for the proposed CEC, appropriate?
• Is there adequate integration of the CEC into the EHS CC and its proposed activities?

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

• Is the composition of the Stakeholder Advisory Board (SAB) adequate and what is the contribution of this group to administrative decisions?
• Other than the SAB, are the plans appropriate to increasing EHS CC awareness of community concerns?
• Do the plans adequately describe a process for maintaining transparent communications between the identified audience and the academic partners throughout the entire process of the activity?
• Does the plan address methods of building and sustaining community partnerships and community participation?

>(d) Leadership and staff expertise

• Is the CEC Director qualified for the position? Does he or she demonstrate appropriate education and expertise in public health, behavioral and social science research, outreach, health communication, or other relevant disciplines? Are his or her education and expertise aligned to the vision and objectives of the CEC? Does the investigator provide previous experience/evidence for conducting community engagement activities/projects?

Pilot Project Program

• How feasible and practical are the EHS CC plans to review and distribute funds for pilots?
• Does the EHS CC plan to use pilot project funds in a manner that encourages innovative ideas of importance to environmental health sciences?
• Will the EHS CC use the Pilot Project Program to fill gaps in research areas relevant to the scientific focus of the EHS CC?
• Are there adequate plans to use pilot projects to support the career enhancement of early stage investigators?

As applicable for the EHS CC 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.

Study Timeline

Specific to applications proposing clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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.

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.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

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.

For Renewals, the committee will consider the progress made in the last funding period. The following questions will be addressed:

• Are the overall quality and productivity of the Center members appropriate, especially as related to collaborative research opportunities between basic, applied, and clinical research targeted by the Center?
• Is there evidence that the Center stimulated and increased the productivity of Center members and supported novel approaches to environmental health science research? Has the Center made major progress and achievements since its last renewal?
• Have there been any changes in the environmental health sciences research orientation of the Center? If yes, what progress and opportunities have these changes presented to Center members?
• What were the Center's major accomplishments in the preceding project period and how did they build upon its successes? Was the Center successful in translating basic science advances to the bedside, to public health, or to prevention or from the applied areas back to the laboratory for refinement and improved understanding of mechanisms?

Specifically, for Leadership and Expertise for all Center components reviewers will address the following:

• Is there evidence that significant discoveries or major accomplishments have occurred since the last review?
• Is there evidence of the effectiveness of the Center in developing novel technologies and building upon research opportunities?
• What is the past performance of each senior leader in overseeing the planning, integration, and coordination of research involved in the Center?

Specifically, for Cultivating careers, reviewers will address the following:

• Has the Center been successful in attracting promising candidates?
• Are the provided examples for cultivating careers appropriate and practical for modern science and career progression? Are the offered resources and opportunities appropriate for cutting edge environmental health sciences?
• Have the candidates demonstrated appropriate upward progression in their academic careers? Are reasonable levels of such progression provided, such as publications in reputable journals, senior authorship, grant funding, increasing obligations from the Institution, and promotion?

Specifically, for Pilot Projects reviewers will address the following:

• How well did the Center review and distribute funds for the pilot projects?
• Were pilot project funds used in a manner that encourages innovative ideas of importance to environmental health sciences?
• Did the Center use the Pilot Project Program to fill gaps in research areas relevant to the scientific focus of the Center?
• Have pilot project funds been used to stimulate scientifically productive interactions and collaborations?

Specifically, for Community Engagement Cores reviewers will address the following:

• What is the past progress of the Center in the development of an effective CEC?
• What impact has the Center had on the target audience?
• What impact has the CEC 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?

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 recommended for 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.

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.

Not Applicable.

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).

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) Genomic Data Sharing Plan .

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

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

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA. For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award (e.g., to clarify issues, address and evaluate concerns, provide documentation). All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file. Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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

• The awardee institution will provide NIEHS with written study protocols that address risks and protections for human subjects in accordance with NIH's Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIEHS with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support(Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Claudia Thompson, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3330
Email: [email protected]

Linda Bass, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3236
Email: [email protected]

Lisa Edwards, MBA
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3258 1
Email: [email protected]

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.

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 Part 75.