Part 1. Overview Information

Key Dates

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). 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 2. Full Text of Announcement

Section I. Funding Opportunity Description

The NIEHS Environmental Health Sciences Core Centers (EHS CC) Program uses a P30 grant mechanism 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 environmental health sciences. An EHS CC is expected to support innovation and be on the cutting edge of science. As such, research activities should cross a variety of disciplines to bring multiple perspectives and approaches to bear on significant environmental health research questions and health impacts. The interdisciplinary nature of an EHS CC should 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 and as such lead to translational research opportunities. As intellectual hubs for environmental health research, the membership of EHS CC's is expected to include thought leaders from the field who are well-positioned to 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 prepare future leaders in the field, and pioneer efforts in community engagement. Ultimately the EHS CC should create a flexible structure that allows center members with different expertise to come together to answer complex and/or emerging questions and capitalize on the latest scientific trends. 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 (CEC). In addition, EHS Cores are expected to attract established and promising investigators into environmental health research and provide opportunities for career enhancement. Finally, this FOA requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below).

With the release of the translational research (TR) framework for the environmental health sciences (https://www.niehs.nih.gov/translation), it is expected that an EHS CC facilitate translational research that encompasses all aspects of an EHS CC. The TR framework is an innovative tool that incorporates the dynamic nature of environmental health research to inform and facilitate the use of scientific/public health advances across the translational spectrum to accelerate improving the health of individuals and the public.

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. 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.

NIEHS upholds that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenoues teams. There are many benefits that flow from a diverse scientific workforce including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likliehood that underserved populations participate in, and benefit fromresearch, and enhancing public trust (NOT-OD-20-031). The NIEHS recognizes that many investigators share these values and endeavor to incorporate diverse perspectives into their projects and change the culture of science. Therefore, applications submitted in response to this FOA must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scietific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions. Applicants are strongly encouraged to read the FOA instructions carefully and view the available PEDP guidance material.

Applicants are strongly encouraged to consult with the scientific contact as you plan to develop an application prior to submitting to this FOA.

The NIEHS will hold an informational webinar/Q&A session Friday January 20, 2023,  from 1:00pm-3:00pm EDT on Zoom (Registration is required. Please register here .

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• 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)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

To be eligible for an EHS CC award, the applicant institution must have an already funded research base of at least $3 million per year in direct costs of supported Environmental Health Sciences projects that are related to the NIEHS Mission and Strategic Plan. The projects must include a focus on environmental exposures and health. These may be a mix of NIH, Federal and privately funded awards or career development awards. However at least 50% of the research base must be from the NIH.

Example of NIH peer reviewed mechanisms that may be included for determining eligibility: DP1, DP2, R00, R01, R03, R15, R21, R24, R25, R33, R35, R37, R41, R42, R43, R44, P01, P20, P30s other than the EHSCC, P42, P50, SC1, SC2, U01, U10, U19, U24, U54, U56, UH2, UH3, UG3, K and F series awards.

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 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.

• System for Award Management (SAM) – 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. 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 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. 

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST 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.

2. Content and Form of Application Submission

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.

Letter of Intent

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

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

• 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:

Varsha Shukla, PhD
Telephone: 984-287-3288
Fax: 301-480-5217
Email: [email protected]

Page Limitations

All page limitations 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 an application to this FOA.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application may consist of the following components:

• Overall: required
• Administrative Core: required
• Translational Research Support Core (TRSC): required
• Facility Cores: required: minimum of 1; maximum of 4
• Community Engagement Core (CEC): required
• Pilot Project Program: required

Overall Component

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

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project Summary/Abstract. Provide a Project Summary/Abstract of a Strategic Vision for the EHS CC. Also describe the Translational Research Vision, 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 EHS CC'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 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 filename provided for the attachment will be the name used for the bookmark in the application image. There are two Other Attachments that are required. Applications that do not include these two attachments will be considered non-responsive and withdrawn.

Table Listing Non-key/senior personnel associated with the Center (use file name: Center Members)

• Organize table alphabetically by Last Name.
• Include the following information: Name, Institution, Title at Institution, Affiliation, Role within Center

Plan for Enhancing Diverse Perspectives (PEDP) (use file name: PEDP)

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance participation of investigators from diverse backgrounds, including groups historically underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
  
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

Applicants are strongly encouraged to read the FOA instructions carefully and view the available PEDP guidance material.

Project/Performance Site Locations (Overall)

Enter primary site only.

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

Research and Related Senior/Key Person Profile (Overall)

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

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

Budget (Overall)

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

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

PHS 398 Research Plan (Overall)

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

Specific Aims: The specific aims for the Center should describe the strategic vision including translational research 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, translational research, 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 key partner 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.

Translational Research Vision - Describe your translational research vision and how it will support the overall goals of your Center. Provide examples of how the EHS CC structure facilitates TR. Provide details on staff and resources that will be drawn upon to implement the Center's TR vision.

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 if an applicant chooses to include a listing of research grant support, it must be uploaded under "Other Attachments" in the Overall section and titled "Grant Support" .

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.

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

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

Only 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 human subjects research, clinical research, and/or NIH-defined 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, 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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form (Overall)

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

Administrative Core

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

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

SF424 (R&R) Cover (Adminisrative 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 (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrartive 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) (Administrative Core)

List all performance sites that apply to the specific component.

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

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

• 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 (Adminstrative Core)

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

Other Budget Information

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

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. 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.

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 CCmeeting 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.

PHS 398 Research Plan (Administrative Core)

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

The most commonly referenced Research Plan attachments are listed below for your convenience. FOA–specific instructions are required for the Specific Aims and the Research Strategy in each component. FOA-specific instructions are optional for Letters of Support. Delete “Letters of Support” if there are no FOA-specific instructions.

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.
• Maintain records 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.

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.

Appendix:

Only 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 (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined 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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Translational Research Support Core (TRSC)

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

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

SF424 (R&R) Cover (Translational Research Support 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 (Translational Research Support Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Translational Research Support 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) (Translational Research Support 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 (Translational Research Support 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 (Translational Research Support 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 (Translational Research Support Core)

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

Specific Aims: The Translational Research Support Core (TRSC) is intended to facilitate translational research findings along the spectrum from basic and/or clinical research to the applied or public health arenas. State the aims for the TRSC.

Research Strategy: The TRSC provides resources to facilitate the progression of environmental health sciences from fundamental questions through testing and practice and public health impact to inform affected communities for improved public health, and/or clinical practice. The TRSC should 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 TRSC 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 TRSC can facilitate and support partnerships between study investigators and human populations, communities, or health care providers. Description of services, equipment, and other activities of this core need to be well documented. When applicable, procedures for collecting, storing, and distributing biological samples should be included in the application. Partnerships with other units at the institution that support these types of activities should be described.

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.

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 (Translational Research Support 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

Note:Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Facility Cores

When preparing your application in ASSIST, use Component Type ‘Facility 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 their 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. Use of summary tables to demonstrate core usage and accomplishments to advance the Centers Strategic Vision is encouraged. Detailed Facility Core Usage tables are no longer required to be submitted under "Other Attachments."

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

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 (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 Informationform 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

Note:Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Community Engagement Core (CEC)

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

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.

New applications should devote a minimum of $100,000 direct costs annually to the CEC. Renewals should devote a minimum of $150,000 direct costs annually to the CEC.

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. State the specific aims of the CEC and include anticipated impacts for these aims.

Research Strategy: Describe the CEC’s vision, objective, and plans to accomplish each of the following three critical functions. 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.

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.

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 (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

Note:Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Pilot Project Program

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 for 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:

• Provide initial support for new investigators to establish new lines of research;
• Allow exploration of possible innovative new directions representing a significant departure from ongoing funded research for established investigators in environmental health sciences;
• Stimulate investigators from other areas of endeavor to apply their expertise to environmental health research and environmental medicine; and
• 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.

For renewals, summarize pilot accomplishments during the preceding performance period that demonstrate the level of success in reaching previously stated goals (for example grant support, publications, etc). Use of summary tables to demonstrate accomplishments to advance the Centers Strategic Vision is encouraged. Detailed Pilot Project tables are no longer required to be submitted under “Other Attachments.”

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

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 (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

Note:Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and NIEHSs, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.

In order to expedite review, applicants are requested to notify the NIEHS Scientific Review Officerby 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.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

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

Significance

Does the EHS CC address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the EHSCC are achieved, how will scientific knowledge, technical capability, and/or public health/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?

To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the EHS CC?

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 research 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? Will the research supported by the EHS CC likely contribute to understanding of environmental health sciences and, ultimately, public health?

In addition, for applications involving 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?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the EHS CC? 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? Do the named investigators have the qualifications/background to assist in the Center efforts towards implementing the translational research vision of the Center?

Has the application demonstrated a clear plan to ensure diversity across all levels of the investigative team?

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the EHS CC?

In addition, for applications involving 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?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

In addition, for applications involving 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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? 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?

Will the structure of the EHS CC likely facilitate translational research? Will the translational efforts proposed in environmental health research lead towards concrete strategies that protect and improve human health? 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?

Are the timelines and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

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

In addition, for applications involving 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?

Environment

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

Does the EHS CC demonstrate that it includes the skills, technologies, and capacity to foster interdisciplinary, state-of-the-art, and innovative research that would lead to important discoveries or major scientific advances in the chosen areas of focus? Are the size and breadth of the research grant base in the EHS CC directly relevant to environmental health sciences and to the theme of the EHS CC placing special emphasis on NIEHS-supported grants? Does the EHS CC take advantage of the capability of its research base to maximize scientific productivity, particularly through interdisciplinary coordination and collaboration?

Do the presence, stature, and effectiveness of the NIEHS EHS CC represent an established organizational component within the institution?Is the level of institutional commitment appropriate and demonstrative of significant support to the EHS CC? Is the scientific environment appropriate and conducive towards the translational efforts proposed in the Center?

To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g. collaborative arrangements, geographic diversity, instututional support) contribute to the success of the EHS CC?

In addition, for applications involving 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?

Additional Review Criteria - Cores

For components types: Admin Core, Core [use for: Translational Research Support Core, Facility Core(s), Community Engagement Core] and Project (use for Pilot Project Program) reviewers will consider the following review criteria in assessing and providing a score to each core/project:

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?

Translational Research Support Core

• Will the services offered foster the integration of fundamental science, public health research, including epidemiology and intervention studies, and patient-oriented clinical research?
• Will the services offered facilitate the implementation of the TR vision?
• 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, multi-directional 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 key partner needs

• Is the composition of the Stakeholder Advisory Board (SAB) appropriate for the goals of the CEC 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

As applicable for the EHS CCproposed, 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 involving 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)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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.

Biohazards

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

Resubmissions

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

Renewals

For Renewals, the committee will consider the progress made in the last funding period. The following questions should 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 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?

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not 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 EHS CCproposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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 will receive a written critique.

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.

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

Applications will be assigned on the basis of established PHS referral guidelines 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 Natioanl 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.
• Relevance of the proposed project to program priorities, including the PEDP.

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. 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.

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 and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient 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).

Prior Approval of Pilot Projects

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

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH 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, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including a gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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.

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

When multiple years are involved, recipients 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help  (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

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

Varsha Shukla, PhD
National Institutue of Environmental Health Sciences
Telephone: 984-287-3288
Email: [email protected]

James R. Williams
National Institute of Environmental Health Sciences
Telephone: 984-287-3338
Email: [email protected]

Section VIII. Other Information

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

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 and 2 CFR Part 200.