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 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

For more than 20 years, the NIEHS has developed and sustained a strong base of Children’s Environmental Health (CEH) research projects through both its unsolicited program and the NIEHS and EPA Children s Environmental Health Centers (CEHC). The CEHC provided demonstrable evidence that supporting transdisciplinary research teams and science addressed major CEH challenges and contributed to the protection of our children at the local, regional, and national levels. The 2017 Impact Report provides many specific examples. https://www.epa.gov/sites/production/files/2017-10/documents/niehs_epa_childrens_centers_impact_report_2017_0.pdf.

Capitalizing on this strong base of fundamental knowledge, active research opportunities and programs about the effects of a variety of environmental exposures on children’s health, NIEHS is establishing a new CEH Center program (infrastructure grant) that will facilitate translation of the research results into tangible tools, interventions, strategies, methods, messages, and activities to protect and improve children’s health from environmental exposures and to promote environmental health equity. The Centers will also maintain a robust pipeline for new investigators, stimulate new science and mobilize prompt responses to emerging issues. These Centers will serve as resource to the scientific community and stakeholder partners and prioritize and incorporate their concerns, for example, develop solutions to protect children, provide opportunities for collaborations and access to Center expertise.

For purposes of this FOA, translational research encompasses the evolution of an idea as it moves through the various phases of research with the goal of creating an impact on human health. The NIEHS Translational Research Framework (TRF) describes five major translational research categories: fundamental questions, integration and synthesis, application and adjustment, practice, and impact. We invite potential applicants to read more about this concept of translational research and familiarize themselves with the various activities conducted in each translational research category at www.niehs.nih.gov/translation.

The objective of this FOA is to create and nurture a national network of Children's Environmental Health Research Translation Centers (CEHRT Centers) that will (1) provide the scientific community and stakeholders (broadly defined) access to state-of -the art collateral expertise in CEH as well as expertise in health communication, environmental health literacy and dissemination and implementation science to enhance and accelerate the reach and adoption of CEH knowledge and science, (2) promote external collaborations with the children's environmental health community of researchers and stakeholders, and (3) provide assistance in response to national, regional, state or local CEH issues or emergencies. To achieve this, the CEHRT center program will adopt dissemination and implementation strategies that can evolve quickly with the state of the science as well as create actionable steps to best implement, disseminate and sustain CEH knowledge, intervention and programs in the most vulnerable communities.

The Program Goals are to:

1. Support collaborations among recognized children's environmental health scientists along with partners from scientific fields not traditionally associated with environmental health science (EHS) research. These fields might include health and risk communication, dissemination and implementation science, behavioral and social sciences, engineering, economics, medicine, policy, computer science, and more. These partners will be expected to provide new ideas, strategies, and approaches for moving the CEH science into applied public health and clinical practice in order to expand the impact of CEH research findings.

2. Synthesize and use existing CEH research findings to create new messages, tools, methods/approaches, risk management strategies, public health interventions and practices, curriculums and other educational activities, clinical guidelines, policies and products that translate CEH research findings to applied products and impacts. These products can then be used and/or adapted by stakeholders, at-risk populations, affected communities, and the clinical or public health community to improve children's health.

3. Establish two distinct pilot programs. Within the Translation Core, the pilot project program will test, implement, adapt and evaluate new CEH research translational products (curriculum, messages, tools, methods, practices, etc.). In the Developmental Core, the catalyst program will consist of small pilot projects that can address time sensitive environmental health concerns in children or test new emerging areas concepts, tools or approaches in CEH science.

4. Nurture and mentor early stage investigators in CEH research with an emphasis on translation research strategies and approaches.

Specific Areas of Research Interest:

The theme or vision of the center program must be within the scientific mission of NIEHS with a focus on Children's Environmental Health to be responsive to this initiative. NIEHS is interested in research that focuses on environmental exposures, which influence the healthy development of children from early conception through adolescence and young adulthood.

Organization of a Collaborative Center CEHRT in the Context of this FOA:

The CEHRT center is to provide researchers, stakeholder and community organizations access to specialized expertise and resources not typically available through their departments, institutions, and/or professional associations. This includes access to cutting-edge technologies and approaches that are particularly timely for understanding CEH outcomes or exposures. The emphasis of the Centers infrastructure should be on developing approaches to facilitate the movement of CEH research findings into practice through a concerted program of didactic, interactive and mentored collaborative interaction. Applicants should propose a cogent program of outreach, research resources, and mentored collaborative opportunities in the specific content area through the following core activities:

Administrative Core: The applicant should present a clear model of managerial oversight, responsibilities, and commitment to this center, which includes the role of key personnel and their expertise. The research center must develop formal plans for prioritization of resources, access guidelines, quality control to enhance responsiveness to the scientific community and stakeholders. The core will be responsible for documentation of overall-effectiveness and impact of the center. In addition, the center will be expected to collaborate with other funded translation centers in the network as appropriate to eliminate duplicate efforts and leverage efforts among common themes.

Developmental Core: The Developmental Core (DC) supports a catalyst program of translational research projects directed at emerging and time-sensitive issues relevant to CEH. These projects could generate preliminary data, and develop, test, implement and evaluate new intervention/prevention/communication strategies (Goal 3). The DC would also provide professional development and career advancement for the next generation of CEH scientists by engaging them in translational pilot projects and mentorship through interdisciplinary collaborations and intellectual exchange (Goal 4). The DC will be expected to foster an innovative space for developing new science and creating a robust pipeline for the next generation of CEH scientists that support the translation of research.

Translation Core: The Translation Core (TC) is the focal point for these centers. Effective translation of research findings must draw on the collective expertise from communication, education and dissemination and implementation sciences to achieve this aim. To this end, the Core will support collaborations with partners from fields not traditionally associated with EHS research. These fields might include health and risk communication, behavioral and social sciences, engineering, economics, medicine, policy, computer science, and more. These partners will be expected to provide new ideas, strategies, and approaches for moving CEH science into applied practice in order to expand the impact of CEH research findings (Goal 1). The Core will also focus on developing specific strategies to expedite the bridging of research findings into translational products where the adoption of products will be measured and shared with key stakeholders and affected communities to improve CEH.

Examples of translational products might include: new messages, tools, methods/approaches, risk management strategies, public health interventions and practices, curriculums and educational activities, clinical guidelines, policies, and other products that translate CEH findings to applied products and impacts (Goal 2). The NIEHS Translational Research Framework values the need for research that focuses on replicating and adapting existing ideas and strategies. As such, the Translational Core will also support the implementation and dissemination of existing CEH interventions and/or practices to varied contexts and communities. The TC will work with subject matter experts within their program to develop a translation plan that draws on the NIEHS Translational Research Framework or other related frameworks or theories. Access to pilot funds to assist in these efforts and respond to outside stakeholders will be dedicated to this Core and managed by Core Leader.

Coordinating Center (optional): In addition to proposing a CEHRT Center, the applicant may propose to take on the additional role of serving as the coordinating center across all the RFA-funded CEHRT Centers. Responsibilities for the coordinating center include: developing and maintaining a central web portal, coordinating the promotion of the overall infrastructure program to the research community in various settings, coordinating trans-center activities, hosting and archiving periodic teleconferences and web-based interactions among the infrastructure PIs and senior staff, and documenting overall infrastructure outcome data with respect to how the centers are advancing the goals of this program. Up to $100,000 per year (direct costs) may be requested to take on the additional responsibility of serving as the Coordinating Center.

Workforce Diversity: While not a specific core activity, the NIH continues to encourage institutions to increase the participation of individuals currently underrepresented in the biomedical, behavioral, clinical and social sciences; this includes: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. For more information on NIH's interest in diversity, see NOT-OD-20-031. Within the context of the P2C application, applicants should describe how they will identify and facilitate approaches that would encourage the participation of underrepresented racial and ethnic minorities, persons with disabilities, and women.

Special Considerations: To be responsive to this initiative, the applicant institution must have a strong base of ongoing, independently supported, peer-reviewed research projects clearly dedicated to the study of environmental health sciences in children's health. Research focusing mainly of female or reproductive health will not be responsive to this initiative. 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 CEH base support calculation.

A special interactive webinar will be scheduled and later archived for potential applicants. In addition, a webpage of frequently asked questions (FAQs) will be posted. Updates on both the webinar and the FAQs will be available at https://www.niehs.nih.gov/research/supported/centers/prevention/index.cfm

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

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

Higher Education Institutions

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

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

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) 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.
• o NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

Additional Eligibility Criteria

There are additional eligibility criteria for applications responding to this FOA:

Multi-PD/PI required: One recognized and established research investigator in CEH (Director), and an expert (referred to as Deputy Director) with a track record in health communication with translation of science to lay audience, scientific community and public health and or medical professionals.

Active Scientists. Applicants must have active scientists working in children's environmental health that is within the scientific mission of NIEHS. Active CEH scientists must hold their primary affiliation with applicant institution or other institutions and this position (tenured or nontenured) must be permanent; Applicants need to have a strong record in scientific publications and competitiveness for peer-reviewed external funding for research within the science mission of NIEHS in CEH. Active scientists must meet the following criteria:

(1) PD/PIs must have externally-funded active CEH grants or contracts within the three most recently completed fiscal years: 2017, 2018, 2019. Grant awarded in FY 2020 may be included. Federal fiscal year runs from October 1 to September 30.

(2) PD/PIs must have strong CEH research publications in peer-reviewed journals during the three most recently completed Federal fiscal years, including FY2019.

Funding by the NIEHS.

(1) Each application must have and identify at least three active PD/PIs who have received a research grant or other significant funding from NIEHS within the three most recently completed Federal fiscal years in the area of children's environmental health at the time of submission (FY 2017, 2018, and 2019. The mechanisms that qualify are research projects (R01, R21, R00, R15), research program projects (P01, P50, P42), and individual research career development awards for faculty (K24, K08, K23).

(2) Mechanisms that do not qualify are individual pre-doctoral and/or post-doctoral fellowships (e.g., F31, F32, K99), T awards, U45, Conference grants (e.g., R13, U13) and R24, U24, P30 or U2C grants funded by NIEHS. 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.

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

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

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

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

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.

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.

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

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

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

The letter of intent should be sent to:

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

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12 pages
Admin Core	12 pages
Developmental Core	12 pages
Translation Core	12 pages
Coordinating Center (optional)	6 pages

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

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

The application should consist of the following components:

• Overall: required, 1 maximum
• Administrative Core: required, 1 maximum
• Development Core: required, 1 maximum
• Translation Core: required, 1 maximum
• Coordinating Center; optional, 1 maximum

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.

Complete entire form.

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

Follow standard instructions.

Project Summary/Abstract. Provide a Project Summary/Abstract of a Strategic Vision for the Center. Also describe the Translational Research Vision, Children's Environmental Health Identity, and the Impact of the Research Base in CEH on the goals of the CEHRT Center in how it advances the NIEHS Strategic Plan.

Project Narrative. In the project narrative (i.e., the "public health relevance" statement), briefly state the relevance of the Center's research to public health and the protection of children from environmental exposures.

Facilities & Other Resources: Explain the center's administrative position within the larger institution, including formal departments and other scientifically related centers. Explain how the scientific and institutional environments at the applicant institution contribute to the probability of success for achieving the specific aims described in the application.

Describe the organizational resources available to the center. Identify the facilities to be used, including, but not limited to, dedicated space, computer facilities and resources, laboratories, and other facilities. If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project. Relative proximity of resources and size and shape of dedicated space may be presented in either graphic or narrative form. Describe only those resources that are directly related to achieving the specific aims described in the application or that complement the proposed research resource cores. Provide any information describing the Other Resources available to the project (e.g., secure data room) and the extent to which they would be available to the project.

Describe institutional investment in the success of the center's Early Stage Investigators (ESI), e.g., resources for classes, travel, and training; collegial support such as career enrichment programs, assistance and guidance in the supervision of trainees involved with the ESI's projects, and availability of organized peer groups; logistical support such as administrative management and oversight and best practices training; and financial support such as protected time for research with salary support and coverage of supplies, equipment and technical personnel.

List types and amount of committed funding the center receives from the applicant institution. Examples include but are not limited to dedicated equipment, dedicated space, salary support for investigators or core staff, faculty appointments in subject areas relevant to the goals of the program, operating budgets, financial support for new space or equipment, and arrangements the center has to recover indirect costs. Include salaries only if the support is provided for a center-related function such as directing a center, managing a core, or similar activities. Institutional support for center and core personnel and research faculty should be reflected in the budget request. This information may be presented in tabular form.

Other attachments: Include an attachment titled "Active Research Support". The information presented in this section constitutes the center's "externally funded annual support for children's environmental health research and training" (see Award Budget in Section II).

Provide information about the proposed CEHRT Center's external funding for children's environmental health research, research training, and data collection that is within the mission of NIEHS and was received in either FY 2017 or FY 2018 or FY 2019; select one fiscal year, do not present information for all. This information may be presented in tabular form. Comparable grants awarded in FY 2020 may be listed in a separate table. Report only direct costs; do not report total costs. Report only on funding for activities that are related to CEH research; do not report all funding to all center affiliates.

Center Members (i.e. Center affiliates): Title this attachment "Center Members" and list all the Center members, including highest educational degree, institutional title, and affiliations, including department

Enter primary site only.

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

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

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

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

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

Specific Aims: Briefly state the proposed research domain(s), expertise, key resources as well as specific strategies for promoting opportunities in CEH to the larger scientific community and relevant stakeholders.

Applicants are required to identify their center's primary research area(s) in CEH to be supported through this program, the areas in which the center expects to make its most significant contributions to CEH in the next five years. The centers should include a translation plan that describes how the Center will increase the scientific impacts, innovation, productivity and translation of CEH research in their primary research area(s) and expertise. Applicant centers are required to provide evidence that the support they request through this initiative will contribute to the center achieving its specific aims.

Research Strategy: Thoroughly and clearly address the main objective of the Children's Environmental Health Translation Center (CEHRT) which is to create a research resource that will provide research expertise and opportunities in current CEH research while focusing on translation of extant CEH research to relevant partners and stakeholders.

Discuss the vision, theme and objectives and the potential impact of the proposed infrastructure center on CEH. Within this section, describe the research capacity and clearly identifiable major scientific focus areas in CEH.

Describe how the center will leverage and build on resources and expertise of the applicant and collaborative institutions. Make clear why this unique expertise and collaborations would be appropriate and timely for the field of CEH.

Describe the scope of the research and translation activities that the center proposes including the techniques, approaches, resources and opportunities that it will provide to the CEH community and stakeholders. Explain the primary target audience(s) utilizing the center research and translation resources. Describe the vulnerable populations or affected communities that will benefit from Centers translational efforts and access to resources.

Describe how support from this FOA will be leveraged to increase the center's ability to make major contributions in the primary research area over and above what could be done without this support. Describe how the experience, training, and ongoing record of accomplishments of the center's leadership and affiliates will contribute to the center's ability to make major contributions in CEH.

Describe how the research resources from this FOA will be used over and above what is already provided by the applicant's institution through other funding mechanisms.

Describe the Center members. List the center affiliates in alphabetical order, indicating whether they are active CEH scientists; other center affiliates; or technical/administrative contributors. Other pertinent information, such as disciplines (e.g., behavior science, epidemiology, sociology, anthropology, economics, public health, medicine, toxicology), academic department, or institutional affiliation (for collaborations across institutions) may be included but is not required. Information may be presented in tabular form. Include biographical sketches for all center affiliates in the appropriate component of the application.

Describe how the infrastructure center will complement or leverage existing resources and expertise provided by other funding sources. If resources are to be supported by this FOA and other sources (like EHS Core Center), describe the financial arrangements. Describe the steps taken to ensure that the resources are not duplicative of existing activities.

Briefly describe the applicant center's governance and organizational structure, providing an organizational chart; the responsibilities and authority of the Center Director (PD/PI) and Deputy Director; and the role of advisory or user committees.

Letters of Support: Include letters of support for the proposed center as a whole; letters of support specific to individual cores should be included with the appropriate component. Letters may be from collaborators or communities that would benefit from the Centers resources such as knowledge, skills and products.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Generally, Resource Sharing Plans are expected. All applications, regardless of the amount of direct costs requested for any one year, should address the following essential elements of a Data Sharing Plan:

Any software, tools or protocols that are developed under this program should be shared broadly and at least referenced on home page under resources and tools.

Any resources developed to implement broad dissemination sharing of research results should be made publicly available through a simple web interface

All CEHRT Centers 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.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (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

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

When preparing your application, use Component Type Administrative Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

List all performance sites that apply to the specific component.

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

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

Applicants must provide a detailed budget, including justification for all expenditures for the Administrative Core.

Budget forms appropriate for the specific component will be included in the application package. direct costs for the Administrative Core may not exceed $100,000 annually.

The budget for the Administrative Core must include travel for the Director and Deputy Director and core leads , and one member of the Internal Advisory Board to attend one annual CEHRT center meeting. The budget should also include costs associated with external communications as needed.

A Center should expect to host the annual CEHRT center meeting once within the project period and may want to set funds aside for this event. Please consult with program staff for details.

Items Not Allowed Under this Component of the CEHRT Center Grant Include:

1. Direct support of individual research except for Pilot Projects.
2. Salary for Director, Deputy Director, Core leaders, Collaborators, or individuals unless clearly defined roles are documented in the operation of the CEHRT Center.
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.

Specific Aims: Identify general objectives planned for the Administrative Core (AC) along with the main benchmarks that would indicate the accomplishment of these objectives.

Research Strategy: The Administrative Core will provide overall administrative and organizational oversight and management of the Center.

As part of this section, the application should address the following:

(1) Overall leadership and personnel capacity that may include but is not limited to the following;

(2) Administrative, operations and meeting support staff;

(3) Business and or legal expert staff

(4) Other staff required to support the Center as a whole

Detailed plans to support the activities of the Center including at minimum:

(1) Coordinate and integrate the CEHRT center components and activities such as workshops, retreats, and meetings.

(2) Attract early and mid-level investigators to enhance research and translation efforts in CEH from inside and outside the institution.

Provide the following information for the Administrative Core (AC):

(1) Describe how the support from this FOA will be used over and above what is already provided by the applicant's institution. Describe how the services complement or leverage administrative services provided by other sources. If administrative services are to be supported by this FOA and other sources like the NIEHS Environmental Health Core Center, please the describe the financial arrangements. Describe the steps taken to ensure that the core does not duplicate existing activities.

(2) Explain how the types of administrative services to be provided from this FOA advance the overall application's specific aims.

(3) Explain how the applicant plans to assess whether the administrative support services provided by this FOA are advancing the overall application's specific aims. Explain the procedures the applicant is planning to use to maximize efficiency of administrative services supported by this FOA.

(4) Explain eligibility and priorities for accessing core services provided by this FOA and the procedures to be used to ensure that junior scientists and outside collaborators and public use or access to core services.

(5) Describe the core's governance and organizational structure.

Leaderships Qualifications: Describe the responsibilities of the Director and Deputy Director of the Center of the Multi-PD/PI plan. The Center Director is expected to be a well-recognized and respected leader in the field of CEH with the authority to oversee the organization and operation of the CEHRT Center and to provide scientific and administrative leadership for the total program. A Deputy Director is expected to play an active role in the organization and operation as well with specific function to serve as the lead of the Translation Core to prioritize, expedite research results into practice.

Describe how the Center would make its activities, resources, and opportunities known to basic and children's environmental health scientific communities, partners and stakeholders. Highlight innovative strategies for promoting research opportunities to diverse communities for example, this may include some combination of advertisements in professional journals, newsletters, and websites; contacts with relevant research departments and funded researchers; presentations at professional meetings; and other means, as appropriate.

Also, describe how the Center would develop a web portal to promote outreach, with connection to archived research resources (e.g., research protocols, background information, reference articles, databases, and contact information, as appropriate).

Include plans for an independent advisory board to provide guidance on resources being developed and access to materials and translational activities. Indicate the types of expertise or perspectives that would be appropriate for the board. Potential board members must not be contacted until after the review of the application has been completed.

CEHRT Centers would be expected to collaborate with other Centers funded under this FOA, as appropriate; however, the level of collaboration would depend on the actual research domains that get funded under this FOA and their potential synergy.

Letters of Support: Include any letters of support from colleagues at secondary institutions including appropriate administrative officials.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix:

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.

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

When preparing your application, use Component Type Development Core.

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

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

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Development Core

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

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

Project Narrative: Do not complete. 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.

Application guide states that Project Narrative is required. However, it is only required for the Overall component.

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

List all performance sites that apply to the specific component.

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

• Research & Related Senior/Key Person Profile (Development 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.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project 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 (Development Core)

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

Annual direct costs for this core may not exceed $150,000.00 per year.

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 (Development Core)

Specific Aims: Describe the Development Core's objectives and the current and planned support and services to be provided. The specific aims for the Development Core should explicitly address how the core will focus on supporting translational CEH research to increase the scientific impact, innovation, productivity of children's environmental health researchers; increase the Center scientists' and users competitiveness for peer-reviewed external funding in children's environmental health research; and support experiences for junior scientists that will contribute to their research independence.

Research Strategy: The research strategy should address how the applicant plans to use support from this FOA to provide development activities and service beyond services and activities provided by the applicant institution including other center awards.

All applicants requesting support for a Development Core must propose a catalyst program supporting small-scale and innovative pilot projects, especially those that will provide preliminary data leading to larger research efforts improving children's environmental health, respond to emerging environmental threats, or test innovative technology to break new ground or extend into new directions. Each catalyst program application should include a translation plan. The catalyst program may provide funding for research, but may also, in addition to or instead of, provide other types of support, such as research assistant(s) or dedicated consulting or mentorship.

Researchers associated with the CEHTR Center (infrastructure grant) may be considered for pilot funding, but first- priority should be researchers who come to the infrastructure network from outside locations. The distribution of pilot funds through the catalyst program will require strategies for negotiating with secondary institutions to transfer grant funds in the most fiscally and administratively efficient manner.

The Development Core may also support other types of development activities, including but not limited to, application preparation workshops/boot camp; seminar or brown bag series; working groups; and other internal workshops and conferences. The Developmental Core will create a collaborative innovation and discovery space for Center affiliates and outside scientific community and stakeholders to engage in activities with a goal to find solutions to protect our children from environmental exposures.

Provide the following information for the Development Core:

Describe how the support from this FOA will be used to provide development services and activities above and beyond services and activities provided by the applicant institution and center, including those from NIH-funded R, P, T, F, K, or R25 programs, if applicable to the applicant center and/or its affiliates.

Describe what services and activities will be provided and how they will be provided as well as how the resource will be evaluated.

Describe how the development services and activities provided by this FOA complement and/or leverage development services and activities provided by other sources.

If development services and activities are to be supported both by this FOA and other sources, describe the financial arrangements. Describe the steps taken to ensure that the core does not duplicate existing activities.

Explain how the types of development services and activities to be provided through support from this FOA advance the overall application's specific aims.

Explain how the applicant plans to assess whether the development services and activities supported by this FOA are advancing the overall application's specific aims. Explain the procedures the applicant is planning to use, and, if applicable, has used, to maximize the efficiency of development services and activities supported by this FOA.

Explain eligibility and priorities for accessing Development Core services supported by this FOA and the procedures to be used to ensure that junior scientists and outside collaborators have access to core services.

Describe procedures for soliciting, reviewing, and selecting applications or proposed activities, including who will be involved in the review.

Describe the core's governance and organizational structure.

For the catalyst program, address all the items above and, in addition, include the following:

• Procedures for soliciting and reviewing seed grant applications from junior researchers and outside collaborators.
• How the core will prioritize the funding of applications from junior researchers and outside collaborators.
• Requirements for preparing research applications to continue or expand the research project.
• Size of awards.
• Length of award periods.
• Number of awards permitted to an individual researcher.
• Mentoring arrangements.
• Describe the core's governance and organizational structure.

Explain the institutional plans and procedures that assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects. Information in other sections may be referenced and not repeated.

Letters of Support: Include any letters of support from colleagues at secondary institutions including appropriate administrative officials.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

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.

When preparing your application, use Component Type Translation Core.

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

SF424 (R&R) Cover (Translation 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 (Translation Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Translation 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) (Translation 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 (Translation 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 (Translation Core)

Budget forms appropriate for the specific component will be included in the application package. Annual direct costs for this core is a minimum of $250,000.00 per year.

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 (Translation Core)

Specific Aims: Identify general objectives planned for the Translation Core along with the main benchmarks that would indicate the accomplishment of these objectives. This core will promote the translation of research results in the field of CEH through a variety of approaches, methods and strategies drawn from the communication, education and dissemination and implementation sciences. This core will engage researchers, clinicians and communities to work together and share knowledge and expertise to ensure the improvement of CEH through the uptake, sustainment and spread of evidence-based interventions and/or practices into real-world practices.

Research Strategy: The Translation Core will provide overall support to the success of the CEHR Translation Center.

A significant component for this Center program will be the Translation Core (TC). The Core should build upon recognized theories, strategies, or frameworks such as the NIEHS Translational Research Framework to guide their planning. The Core should focus on opportunities to expand the reach of existing CEH research results through such efforts as CEH communication and messaging, implementation and adaptation and sustainment of effective interventions and/or practices to meet contextual needs, and to widely disseminate (i.e., spread) of these messages, interventions and/or practices. Educational curriculum development is key, and the learning process has changed dramatically over the past decade with the integration of new internet-based technologies. Thus courses, workshops, and demonstrations are encouraged and may occur at the applicant institution, at national meetings, and other public venues or through virtual meeting technologies as appropriate. When possible, activities should be made available for remote viewing and archived for possible screening at later date. Importantly, there is a need from more multi-directional communication that allows for input so the learning experience may be tailored, accessible and culturally appropriate.

The Translation Core may also consider the following research areas in their applications (if applicable) such as:

• Studies of multi-level contextual factors (e.g., local, organizational, system-levels) that may influence the success of dissemination or implementation efforts. Studies of effective implementation and/or dissemination strategies to improve uptake and spread of CEH practices and/or interventions.
• Understand how effective interventions work, particularly multi-level or multi-component interventions, to inform how CEH interventions can be adapted and/or delivered with fidelity when implemented in various settings.
• Consider extant literature on barriers to and facilitators of CEH practices to improve health.

As part of this section, the applicant should address the following:

Describe how the support from this FOA will be used to provide scientific and technical services and resources above and beyond services and resources provided by the applicant institution and center as well as existing NIH grants to advance the field of CEH through translational approaches and methods.

Describe how these services and resources will be provided.

Describe how the translational services and activities provided by this FOA complement and/or leverage translation services and activities provided by other sources. If translation services and activities are to be supported both by this FOA and other sources, describe the financial arrangements. Describe the steps taken to ensure that the core does not duplicate existing activities.

Explain how the types of scientific and technical services and resources to be provided through support from this core will advance the overall application's specific aims. Explain the procedures the applicant is planning to use, and, if applicable, has used, to maximize the efficiency of scientific and technical services and resources supported by this FOA.

Explain eligibility and priorities for accessing translation core services supported by this FOA and the procedures to be used to ensure that junior scientists have access to core services as well as collaborators outside of your organization.

Describe the Core's governance and organizational structure.

This Core may also develop a pilot grant program to focus on methods, strategies and approaches used to improve and expedite the translation of the research results to targeted stakeholders with an emphasis on medical and public health communities. Procedures for soliciting, reviewing, selecting and awarding seed grant applications to help facilitate translation efforts need to be addressed.

• How the core will prioritize the funding of applications from junior researchers?
• Describe the process for reviewing and who will be selecting the awards.
• Requirements for preparing research applications to continue or expand the research project.
• Size of awards.
• Length of award periods.
• Number of awards permitted to an individual researcher.
• Mentoring arrangements.

Letters of Support: Include any letters of support from colleagues at secondary institutions including appropriate administrative officials.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

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.

When preparing your application, use Component Type Coordinating Center

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

SF424 (R&R) Cover (Coordinating Center)

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 (Coordinating Center)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Coordinating Center)

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) (Coordinating Center)

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 (Coordinating Center)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project 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 (Coordinating Center)

Budget forms appropriate for the specific component will be included in the application package. Annual direct costs for the Coordinating Center may not exceed $100,000.00 per year.

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 (Coordinating Center)

Specific Aims: In addition to proposing the CEHRT center, an applicant may propose to take on the additional role as serving as the coordinating center across all the funded P2C CEHRT

Centers. However, this responsibility is optional and is not a necessary part of a P2C application.

If interested in assuming this additional responsibility of coordinating activities across awarded Centers, briefly discuss how you would meet the specific goals of developing and maintaining a central web portal, promoting the overall infrastructure of the program to the research community and stakeholders in a variety of settings.

How would you promote and coordinate trans-center activities, host and document periodic web-based conferences and teleconferences among the centers PI and staff, and document the overall outcome products and deliverables with respect to supporting the research community and stakeholders as well as the goals of NIH?

How would you collect, organize, and disseminate information relevant to the CEHRT Center program as needed for program evaluation, planning and reporting?

Research Strategy: Provide details on the operation of a centralized web portal that will provide the research community and stakeholders with access to the overall collaborating centers and direct them to the appropriate centers and resources.

Discuss how you would promote the overall program to appropriate research and stakeholder communities and individual investigators especially through presentations, and booths at national research meetings.

Provide strategies to coordinate and integrate activities and promote best practices across the Centers. Discuss a model for hosting and archiving periodic virtual meetings, teleconferences, and occasional direct face-to-face meetings among the funded Centers (PIs and their senior staff).

Provide a framework for gathering outcomes data on the role of the program to meet its four priority goals including supporting mentored research collaborations and the potential value added of the infrastructure center program. Work with NIEHS program staff to establish milestones and metrics.

All CEHRT Centers 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.

Letters of Support: Include any letters of support from colleagues at secondary institutions including appropriate administrative officials.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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.

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.

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit 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 Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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

Select Pilot Project Pre-Approval

While Foreign Components are acceptable in the CEHRT Center, select catalyst and pilot projects partly performed in a foreign country must be approved by NIEHS before an award can be made. The catalyst or pilot project must demonstrate a highly competitive justification both to the CEHRT Center through its selection process and NIEHS. All foreign catalyst and pilot projects are subject to NIH and Federal regulations and guidelines governing the approval of such activities and will be considered case-by-case.

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

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.

In addition, for applications involving clinical trials:

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 Center 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 Center proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Core that by its nature is not innovative may be essential to advance a field.

Does the Center 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 Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Evaluate how access by the relevant stakeholders to the proposed center's research domains, translational efforts, and expertise transform the field of children's environmental health and lead to improve public health and clinical practice?

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?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the center? 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 Deputy Director, and Core Leaders demonstrate the ability to provide scientific and administrative leadership and direction?

Do the named investigators have the qualifications/background to assist in the Center efforts towards implementing the translational research vision of the Center?

Is there balance of expertise proposed with expertise in CEH along with other appropriate disciplines such as, but not limited to, Sociology, Behavioral Science, Communication Research, and Dissemination and Implementation Science?

In addition, for applications involving clinical trials

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

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

In addition, for applications 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?

Assess whether the applicants provide sufficient information or approaches to evaluate the potential for involvement in clinical and public health practices?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed Center? 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 Center is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the Center 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?

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 Center proposed? Will the Center benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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?

For components types: Admin Core, Development Core, Translation Core and Coordinating Center (optional), reviewers will consider the following review criteria in assessing and providing a score to each component.

Administrative Core

• Will the services provided by the core enable the program to achieve its specific aims and make advances in research and translation of CEH?
• Are the qualifications, experience, and commitment of core leader and other personnel appropriate?
• Will the CEHTC be able to establish itself as a recognizable entity in the field of children's environmental health?
• How appropriate are the plans describing the obtention of membership and/or how to access resources and utilize services?
• Are the plans to develop and administer the Internal Advisory Committee appropriate and are the expertise of the committee members a good fit for the Center's proposed research and translational efforts?
• Is there enough expertise and administrative support for the proposed activities?
• Does the applicant have a strong understanding of their audiences need?
• Have they proposed an appropriate strategy to promote expertise to the broader CEH research community?
• Would the proposed center web portal provide a good indication of the breadth of opportunities and resources?
• Would the website provide access to a useful array of materials and/or references?
• Did the applicant make an effort to promote opportunities to individuals currently underrepresented in the biomedical, behavioral, clinical and social sciences?
• Did the applicant describe approaches for active engagement with their identified stakeholders?
• Would the proposed center seek opportunities to interact with other centers funded under this FOA?

Development Core

• Does the applicant have an appropriate strategy for advertising the catalyst program and for reviewing and prioritizing requests?
• Has the applicant laid out appropriate criteria for prioritizing the outlay of catalyst funding?
• Are there sufficient expertise and administrative support for the proposed activities?
• Does the applicant have a strategy for following up and evaluating investments?
• Does the applicant have a plan to create a collaborative space to encourage collaboration and mentoring opportunities?
• Catalyst program- how feasible and practical are the plans to operationalize the program?
• Have they provided details on how they will advertise and encourage outside institution applications?
• Has the applicant laid out appropriate criteria for prioritizing the outlay of pilot funding?
• Is the selection process transparent and fair and equitable?
• Does the applicant have a strategy for following up and evaluating the pilot funding investments?

Translation Core

(a) Translating research information into environmental public health and clinical practice:

• Will the different type of activities in this core increase awareness and understanding of children's environmental health research?
• For the products being proposed, are they relevant to the scientific focus or the expertise of the collective center?
• Has the applicant identified the needs of its target audience and described appropriate activities to engage and reach their target audience?
• Is there adequate integration of the Translation Core within the center and its overall proposed activities?
• Is there communication between core functions and structure in place to assure integration with other funded centers?

(b) Ensuring transparency to the Children's environmental health community and deep understanding of community and other stakeholder needs

• Are the plans appropriate to increasing awareness of children's environmental health research results and concerns both regarding (re)emerging and legacy compounds that impact children's health?
• 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?
• Evaluate the plan and approaches described that will build and sustain multi-directional communication within the center, between centers and most importantly with their targeted stakeholders and the broader CEH scientific community?

(c) Leadership and staff expertise

• Is the Core leader 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?

(d) Pilot Project Program

• Does the applicant have an appropriate strategy for advertising the pilot program and reviewing and prioritizing requests?
• How feasible and practical are the plans to review and distribute funds for pilot projects?
• Does the applicant have a strategy for following up and evaluating the pilot funding investments?
• Does the Core plan to use pilot project funds in a manner that encourages innovative methods, tools and approaches to convey CEH research results of importance to stakeholders?

(e) Evaluation of deliverables and outcomes

• Are milestones in place to achieve the TC goals?
• Are the materials and activities that are described in the application culturally appropriate or do they acknowledge the need to address this as a primary concern for their success?

Coordinating Center (optional)

• Do the applicants have significant knowledge of the activities proposed in the Collaborative Centers of CEHRT program?
• Do they have sufficient understanding of the current status of the field of children's environmental health?
• Do the applicants have sufficient expertise in coordinating scientific endeavors and evaluating outcomes and deliverables?
• Have they proposed an outward focus of the program as opposed to an inward organizational strategy for coordination?
• Will the proposed team willing to work cooperatively with the NIEHS and the NIEHS CEHRT Centers Program to further the overall goals of the Program?

Additional Review Criteria

As applicable for the Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

Specific to applications 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)?

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.

When the proposed core 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.

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

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

Not Applicable.

Not Applicable.

Not Applicable.

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

Not applicable.

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

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

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

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

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

As part of the scientific peer review, all applications:

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

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

Applications will be assigned 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 National Advisory Environmental Health Sciences Councill. The following will be considered in making funding decisions:

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety

Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

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

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

• The awardee institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The awardee 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.
• While Foreign Components are acceptable in the CEHRT Center, select catalyst and pilot projects partly performed in a foreign country must be approved by NIEHS before an award can be made. The catalyst or pilot project must demonstrate a highly competitive justification both to the CEHRT Center through its selection process and NIEHS. All foreign catalyst and pilot projects are subject to NIH and Federal regulations and guidelines governing the approval of such activities and will be considered case-by-case.

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. 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 and http://www.hhs.gov/ocr/civilrights/understanding/section1557/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. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. 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.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please 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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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

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

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

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

Kimberly Gray, PhD
National Institutes of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3262
Email: [email protected]

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

Barbara Gittleman
National Institutes of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3261
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.