PKG00263185-instructions.pdf

COVID-19 Update: EPA is providing flexibilities to applicants experiencing challenges related to COVID-19. Please see the Flexibilities Available to Organizations Impacted by COVID-19 clause in Section IV of EPA’s Solicitation Clauses.

OVERVIEW INFORMATION

U.S. Environmental Protection Agency Office of Science Advisor, Policy and Engagement Office of Research and Development Science to Achieve Results (STAR) Program

Center for Early Lifestage Vulnerabilities to Environmental Stressors

This is the initial announcement of this funding opportunity.

Funding Opportunity Number: EPA-G2020-STAR-E1, Center for Early Lifestage Vulnerabilities to Environmental Stressors

Catalog of Federal Domestic Assistance (CFDA) Number: 66.509

Solicitation Opening Date: August 27, 2020 Solicitation Closing Date: November 12, 2020: 11:59:59 pm Eastern Time

Table of Contents

SUMMARY OF PROGRAM REQUIREMENTS

Synopsis of Program Award Information Eligibility Information Application Materials Agency Contacts

I. FUNDING OPPORTUNITY DESCRIPTION

A. Introduction

B. Background C. Authority and Regulations D. Specific Areas of Interest/Expected Outputs and Outcomes E. References F. Special Requirements

II. AWARD INFORMATION

III. ELIGIBILITY INFORMATION

https://www.epa.gov/grants/epa-solicitation-clauses

A. Eligible Applicants B. Cost Sharing C. Other

IV. APPLICATION AND SUBMISSION INFORMATION

A. Grants.gov Submittal Requirements and Limited Exception Procedures B. Application Package Information C. Content and Form of Application Submission D. Submission Dates and Times E. Funding Restrictions F. Submission Instructions and Other Submission Requirements

V. APPLICATION REVIEW INFORMATION

A. Peer Review B. Relevancy Review C. Past Performance History Review D. Human Subjects Research Statement (HSRS) Review E. Evaluation of the Scientific Data Management Plan F. Funding Decisions G. Additional Provisions for Applicants Incorporated into the Solicitation

VI. AWARD ADMINISTRATION INFORMATION

A. Award Notices B. Disputes C. Administrative and National Policy Requirements

VII. AGENCY CONTACTS

Access Standard STAR Forms (https://www.epa.gov/research-grants/research-funding-opportunities-how-apply-and-required-forms) View research awarded under previous solicitations (https://www.epa.gov/research-grants/research-grant-areas)

SUMMARY OF PROGRAM REQUIREMENTS

Synopsis of Program:

The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications to support a Center for Early Lifestage Vulnerabilities to Environmental Stressors. EPA is interested in supporting a transdisciplinary research center to better understand potential causal relationships among cumulative exposures to chemicals and non-chemical environmental stressors during early lifestages and modifying factors that result in adverse developmental health effects. Developmental health outcomes may include attention deficit/hyperactivity disorder (ADHD), reduced IQ, obesity, lessened self-regulatory capacities, anxiety, depression, attention problems, lower memory function, or structural changes to the brain. The application should include the development and demonstration of novel and revolutionary quantitative methods and approaches to integrate multidisciplinary data (epidemiology, toxicology, exposure science, risk assessment, public health, social science, and environmental science).

https://www.epa.gov/research-grants/research-funding-opportunities-how-apply-and-required-forms https://www.epa.gov/research-grants/research-grant-areas https://www.epa.gov/research-grants/research-grant-areas

This solicitation provides the opportunity for the submission of applications for projects that may involve human subjects research. Human subjects research supported by the EPA is governed by EPA Regulation 40 CFR Part 26 (Protection of Human Subjects). This includes the Common Rule at subpart A and prohibitions and additional protections for pregnant women and fetuses, nursing women, and children at subparts B, C, and D. Research meeting the regulatory definition of intentional exposure research found in subpart B is prohibited by that subpart in pregnant women, nursing women, and children. Research meeting the regulatory definition of observational research found in subparts C and D is subject to the additional protections found in those subparts for pregnant women and fetuses (subpart C) and children (subpart D). All applications must include a Human Subjects Research Statement (HSRS, as described in Section IV.C.9 of this solicitation), and if the project involves human subjects research, it will be subject to an additional level of review prior to funding decisions being made as described in Sections V.D and V.F of this solicitation.

Guidance and training for investigators conducting EPA-funded research involving human subjects may be obtained here:

https://www.epa.gov/osa/basic-information-about-human-subjects-research-0 https://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title40/40cfr26_main_02.tpl

The STAR Program’s goal is to stimulate and support scientific and engineering research that advances EPA’s mission to protect human health and the environment. It is a competitive, peer-reviewed, extramural research program that provides access to the nation’s best scientists and engineers in academic and other nonprofit research institutions. STAR funds research on the environmental and public health effects of air quality, environmental changes, water quality and quantity, hazardous waste, toxic substances, and pesticides.

Award Information:

Anticipated Type of Award: Grant Estimated Number of Awards: One award Anticipated Funding Amount: $1,900,000 Potential Funding per Award: Up to a total of $1,900,000, including direct and indirect costs, with a maximum duration of 4 years. Cost-sharing is not required. Applications with budgets exceeding the total award limits will not be considered.

Eligibility Information:

Public and private nonprofit institutions/organizations, public and private institutions of higher education, and hospitals located in the U.S., state and local governments, Federally Recognized Indian Tribal Governments, and U.S. territories or possessions are eligible to apply. See full announcement for more details.

Application Materials:

To apply under this solicitation, use the application package available at Grants.gov (for further submission information see Section IV.F. “Submission Instructions and other Submission Requirements”). Note: With the exception of the current and pending support form (available at https://www.epa.gov/research-grants/research-funding-opportunities-how-apply-and-required-https://www.epa.gov/osa/basic-information-about-human-subjects-research-0 https://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title40/40cfr26_main_02.tpl forms), all necessary forms are included in the electronic application package. Make sure to include the current and pending support form in your Grants.gov submission.

If your organization is not currently registered with Grants.gov, you need to allow approximately one month to complete the registration process. Please note that the registration process also requires that your organization have a unique entity identifier (e.g., ‘DUNS number’) and a current registration with the System for Award Management (SAM) and the process of obtaining both could take a month or more. Applicants must ensure that all registration requirements are met in order to apply for this opportunity through Grants.gov and should ensure that all such requirements have been met well in advance of the submission deadline. This registration, and electronic submission of your application, must be performed by an authorized representative of your organization.

If you do not have the technical capability to utilize the Grants.gov application submission process for this solicitation, see Section IV.A below for additional guidance and instructions.

Agency Contacts:

Technical Contact: Intaek Hahn; phone: 202-564-4377; email: hahn.intaek@epa.gov Eligibility Contact: Ron Josephson; phone: 202-564-7823; email: josephson.ron@epa.gov Electronic Submissions Contact: Debra M. Jones; phone: 202-564-7839; email:

jones.debram@epa.gov

I. FUNDING OPPORTUNITY DESCRIPTION

A. Introduction

Protecting children’s health is one of the most important responsibilities of the U.S.

Environmental Protection Agency (1). EPA’s children’s health protection efforts are guided by Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks" (2), the Federal Action Plan to Reduce Childhood Lead Exposures and Associated Health Impacts (3), and legislative provisions found in the Clean Air Act, Clean Water Act, Safe Drinking Water Act, and the Toxic Substances Control Act, that specifically address children’s vulnerabilities to pollutants. The EPA’s Office of Children’s Health Protection (OCHP) plays an essential role in carrying out the agency’s mission to protect children where they live, learn, and play and works closely with EPA’s program and regional offices to ensure that all EPA actions and programs address the unique vulnerabilities of children.

EPA considers the risks to pregnant women, infants and children consistently and explicitly as part of risk assessments generated during its decision-making process, including the setting of standards to protect public health and the environment (4). Scientific evidence suggests that pollutants to which children are exposed during early lifestages (including prenatal stage) may be crucial determinants of their lifetime health (5-13). Exposures to cumulative mixtures of https://www.epa.gov/research-grants/research-funding-opportunities-how-apply-and-required-forms mailto:hahn.intaek@epa.gov mailto:josephson.ron@epa.gov mailto:jones.debram@epa.gov http://www.gpo.gov/fdsys/pkg/FR-1997-04-23/pdf/97-10695.pdf http://www.gpo.gov/fdsys/pkg/FR-1997-04-23/pdf/97-10695.pdf http://www.gpo.gov/fdsys/pkg/FR-1997-04-23/pdf/97-10695.pdf http://www.gpo.gov/fdsys/pkg/FR-1997-04-23/pdf/97-10695.pdf https://www.epa.gov/aboutepa/about-office-childrens-health-protection-ochp chemicals, along with other non-chemical environmental stressors1 such as poverty, limited access to services, and changing conditions found in our everyday environment, may pose developmental and life-long health risks to humans. Accurate and comprehensive cumulative exposure assessments are needed to conduct risk assessment, reduction, mitigation, and prevention measures.

Understanding these causal relationships between age-specific chemical exposures and certain developmental health end points in later lifestages remains an important gap in children’s health research. Quantitative methods for assessing cumulative risk which integrate multiple disciplines, such as epidemiology, toxicology, exposure science, risk assessment, public health, social science, and environmental science, are urgently needed.

Prenatal and early life exposures to pollutants such as methyl mercury, polychlorinated biphenyls (PCBs), polybrominated diphenyl ethers (PBDEs), polycyclic aromatic hydrocarbons (PAHs), and lead have shown a relationship to adverse cognitive and behavioral outcomes, demonstrating links to ADHD, reduced IQ, lessened self-regulatory capacities, anxiety, depression, attention problems, lower memory function, or structural changes to the brain (13). However, in order to develop and implement meaningful effective intervention or prevention measures for pregnant women and infants, more research is needed to advance the scientific knowledge beyond correlations or trends. Researchers need to develop quantitative methods, inclusive of all relevant chemical and non-chemical environmental stressors and modifying factors, to establish more conclusive exposure-outcome links. Key insights may be in identifying specific vulnerabilities at early lifestages and their relationships to specific health outcomes (later in early childhood) through innovative analyses of existing epidemiological (and other) data pertaining to early child development.

EPA recognizes that it is important to engage all available minds to address the environmental challenges the Nation faces. At the same time, EPA seeks to expand the environmental conversation by including members of communities which may have not previously participated in such dialogues to participate in EPA programs. For this reason, EPA strongly encourages all eligible applicants identified in Section III, including minority serving institutions (MSIs), to apply under this opportunity.

For purposes of this solicitation, the following are considered MSIs:

1. Historically Black Colleges and Universities, as defined by the Higher Education Act (20 U.S.C. § 1061). A list of these schools can be found at Historically Black Colleges and Universities;

2. Tribal Colleges and Universities (TCUs), as defined by the Higher Education Act (20 U.S.C. § 1059c(b)(3) and (d)(1)). A list of these schools can be found at American Indian Tribally Controlled Colleges and Universities;

1 Non-chemical stressors cannot be considered alone, but applicants are asked to include them as secondary or modifying variables to the primary contaminant(s)/chemical stressor(s).

https://sites.ed.gov/whhbcu/one-hundred-and-five-historically-black-colleges-and-universities/ https://sites.ed.gov/whhbcu/one-hundred-and-five-historically-black-colleges-and-universities/ https://sites.ed.gov/whiaiane/tribes-tcus/tribal-colleges-and-universities/ https://sites.ed.gov/whiaiane/tribes-tcus/tribal-colleges-and-universities/

3. Hispanic-Serving Institutions (HSIs), as defined by the Higher Education Act (20 U.S.C. § 1101a(a)(5)). A list of these schools can be found at Hispanic-Serving Institutions;

4. Asian American and Native American Pacific Islander-Serving Institutions; (AANAPISIs), as defined by the Higher Education Act (20 U.S.C. § 1059g(a)(2)). A list of these schools can be found at Asian American and Native American Pacific Islander-Serving Institutions; and

5. Predominately Black Institutions (PBIs), as defined by the Higher Education Act of 2008, 20 U.S.C. 1059e(b)(6). A list of these schools can be found at Predominately Black Institutions.

B. Background

Since early 2000, frameworks for assessing cumulative health risks for children have been developed and refined by the scientific research community. In 2003, EPA published the Framework for Cumulative Risk Assessment, which defined cumulative risk as “the combined risks from exposures to multiple agents or stressors” (14). Correspondingly, EPA defined cumulative risk assessment (CRA) as “an analysis, characterization, and possible quantification of the combined risks to health or the environment from multiple agents or stressors.” In 2006, EPA released the report entitled, A Framework for Assessing Health Risk of Environmental Exposures to Children (15), which examines the impact of potential exposures during developmental lifestages and subsequent lifestages, while emphasizing the iterative nature of the analysis phase with a multidisciplinary team. In 2009, a National Academy of Sciences advisory panel was created to review and comment on the EPA Framework for Cumulative Risk Assessment. The panel proposed that “EPA apply the term cumulative risk assessment only to an analysis that considers in some capacity all the components mentioned in EPA’s definition of cumulative risk assessment. An analysis that does not consider nonchemical environmental stressors, that considers only a subset of routes and pathways of exposure, or that does not consider vulnerability should not be termed a cumulative risk assessment” (16). In 2016, the total environment research framework (7, 17) was introduced to address comprehensive impacts of cumulative exposures to aggregated chemical and non-chemical environmental stressors.

During the same period, the National Institute of Environmental Health Sciences (NIEHS)/EPA Children’s Environmental Health and Disease Prevention Research Centers (13) and other scientific research efforts have made substantial progress and produced numerous scientific results showing potential associations or linkages between health impacts and exposures to cumulative chemical and non-chemical environmental stressors during early lifestages. These results warrant investigations beyond exposure to single chemical-health outcome links, and instead require systems-based, multi-stressor and possibly, multi-outcome approaches.

Concurrent with the changing nature of environmental issues, science and technology are evolving rapidly and offer new tools and methods for taking a systems approach to a problem (18). Scientific advances have produced enormous volumes of complex data, both structured and unstructured, originating from different sources. Big data and advanced computing capability https://www2.ed.gov/about/offices/list/ope/idues/hsi-eligibles-2016.pdf https://www.google.com/maps/d/viewer?mid=1XVkOWKMDORm53pvU0L8EPsrJC94&msa=0&ie=UTF8&t=m&z=3&source=embed&ll=40.58644586187277%2C-148.28228249999984 https://www.google.com/maps/d/viewer?mid=1wlIi3j7gtlNq_w-0NKAb2bF2VmY&ie=UTF&msa=0&ll=37.35160769312532%2C-96.17229800000001&z=4 may revolutionize how researchers establish conclusive links among exposures to chemical and non-chemical environmental stressors and health outcomes.

The scientific community has identified rapidly changing environments (e.g., extreme events, natural disasters, weather pattern changes) as some of the most influential factors in children’s health in the coming years (19-21). For example, extreme events such as the ongoing COVID-19 pandemic may have significant impacts on prenatal and early childhood environmental exposures, health, and well-being. Scientific research on how changes in chemical exposures under an extreme event such as a pandemic or natural disaster may impact prenatal and early children’s health is urgently needed.

C. Authority and Regulations

The authority for this Request for Applications (RFA) and resulting awards is contained in the Safe Drinking Water Act, 42 U.S.C. 300j-1, Section 1442; the Toxic Substances Control Act, 15 U.S.C. 2609, Section 10, as amended by P.L. 106-74; the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136r, Section 20, as amended by P.L. 106-74; the Clean Air Act, 42 U.S.C. 7403, Section 103(b)(3); and the Clean Water Act, 33 U.S.C. 1254, Section 104(b)(3).

For research with an international aspect, the above statutes are supplemented, as appropriate, by the National Environmental Policy Act, Section 102(2)(F).

Note that a project’s focus is to consist of activities within the statutory terms of EPA’s financial assistance authorities; specifically, the statute(s) listed above. Generally, a project must address the causes, effects, extent, prevention, reduction, and elimination of air pollution, water pollution, solid/hazardous waste pollution, toxic substances control, or pesticide control depending on which statute(s) is listed above. Further note applications dealing with any aspect of or related to hydraulic fracking will not be funded by EPA through this program.

Additional applicable regulations include: 2 CFR Part 200, 2 CFR Part 1500, and 40 CFR Part 40 (Research and Demonstration Grants).

D. Specific Areas of Interest/Expected Outputs and Outcomes Note to applicant: The term “output” means an environmental activity, effort, and/or associated work products related to an environmental goal or objective, that will be produced or provided over a period of time or by a specified date. The term “outcome” means the result, effect, or consequence that will occur from carrying out an environmental program or activity that is related to an environmental or programmatic goal or objective.

The activities to be funded under this announcement support Goal 3: Greater Certainty, Compliance, and Effectiveness, Objective 3.3: Prioritize Robust Science, of EPA’s FY 2018-22 Strategic Plan (https://www.epa.gov/planandbudget/strategicplan). Awards made under this announcement will further EPA’s priorities supporting robust science for Sustainable and Healthy Communities. All applications must be for projects that support the goal and objective identified above.

https://www.epa.gov/planandbudget/strategicplan.html https://www.epa.gov/planandbudget/strategicplan https://www.epa.gov/planandbudget/strategicplan.html

EPA also requires that grant applicants adequately describe environmental outputs and outcomes to be achieved under assistance agreements (see EPA Order 5700.7A1, Environmental Results under Assistance Agreements, https://www.epa.gov/grants/epa-order-57007a1-epas-policyenvironmental-results-under-epa-assistance-agreements). Applicants must include specific statements describing the environmental results of the proposed project in terms of well-defined outputs and, to the maximum extent practicable, well-defined outcomes that will demonstrate how the project will contribute to the priorities described above.

As part of its Science to Achieve Results (STAR) program, EPA is asking the scientific community to propose research to better understand potential causal relationships among cumulative exposures to chemicals and non-chemical environmental stressors during early lifestages and modifying factors that result in adverse developmental health effects. The developmental health outcomes include, but are not limited to: ADHD, reduced IQ, obesity, lessened self-regulatory capacities, anxiety, depression, attention problems, lower memory function, or structural changes to the brain. The proposed research should include the development and demonstration of novel and revolutionary quantitative methods and approaches that integrate multidisciplinary data (epidemiology, toxicology, exposure science, risk assessment, public health, social science, and environmental science).

The proposed research should be comprehensive and include specific vulnerabilities to chemicals, non-chemical environmental stressors, and modifying factors at selected early lifestages (including prenatal) for cumulative exposures as well as their linkage(s) to specific developmental health outcome(s) during early child development. Use of existing epidemiological data in conjunction with other public health, environmental, and social data to understand early life vulnerabilities to certain health outcomes with modifying factors is strongly recommended. There is a considerable amount of research data available from previous NIEHS/EPA Children’s Environmental Health and Disease Prevention Research Centers (13, 22), Pediatric Environmental Health Specialty Units (PEHSU) (23), EPA’s America's Children and the Environment (ACE) report (24), and other publicly available environmental health data, however, the data need to be used in innovative ways to obtain scientific answers to the research subtopics listed below.

The proposed research should also describe how results may be translated to support effective decision making leading to potential preventive measures, programs, educational or practical community outreach, risk communication messages, platforms, tools, or engagement efforts (see Section IV.C.12). The goal is to provide potential solutions and tools to practitioners in the field of children’s health and protection.

Research Area of Interest:

The research area of interest focuses on early lifestage (prenatal, perinatal) vulnerabilities from exposures to environmental chemical stressors which will determine health during early childhood development.

https://www.epa.gov/grants/epa-order-57007a1-epas-policy-environmental-results-under-epa-assistance-agreements https://www.epa.gov/grants/epa-order-57007a1-epas-policy-environmental-results-under-epa-assistance-agreements https://www.epa.gov/grants/epa-order-57007a1-epas-policy-environmental-results-under-epa-assistance-agreements https://www.epa.gov/grants/epa-order-57007a1-epas-policy-environmental-results-under-epa-assistance-agreements https://www.epa.gov/research-grants/niehsepa-childrens-environmental-health-and-disease-prevention-research-centers https://www.epa.gov/research-grants/niehsepa-childrens-environmental-health-and-disease-prevention-research-centers https://www.pehsu.net/About_PEHSU.html https://www.epa.gov/americaschildrenenvironment/basic-information-about-ace

Subtopics: The Center application must include two individual research projects which should include multidisciplinary teams involving appropriate expertise to address the selected research subtopics. There are seven subtopics identified below and at least two of them, in any combination, should be addressed in the research projects (e.g., one project may address one subtopic and the other one may address one subtopic; or one project may address two subtopics and the other one may address one subtopic). The applicant should clearly describe in its individual Research Project Plan Descriptions (see Section IV.C.7) how it selected the subtopics and combined them in each research project to serve as integral components of the Center.

Applications with less than two or more than two individual research project plan descriptions will be deemed ineligible (see Section III.C).

o Characterize cumulative prenatal and/or perinatal exposures to chemicals and potential consequential age-group-specific health effects.

o Identify and explain the relationship between perinatal environmental chemical exposures and adverse children’s health outcomes.

o Characterize the inter-relationships between chemical and non-chemical environmental stressors with respect to physiological responses, compensatory responses, and resultant health effects.

o Characterize the dynamic interactions between children’s developing biology, behavior, perinatal environmental chemical exposures, and outcomes.

o Identify the highest priority non-chemical environmental stressors and exposures to chemicals for women prior to and/or during pregnancy and how those exposures may impact cumulative risk for adverse birth outcomes (e.g., live births, full-term births, low birth weight, teratology).

o Characterize and explain how changes in chemical exposures under an extreme event such as a pandemic or natural disaster may impact prenatal and early children’s health.

o Identify and explain the relationship between perinatal environmental chemical exposures and other factors (socio, cultural, and environmental) that would impact risk assessment.

Applications that do not address at least two of the subtopics listed above may not be rated as highly as those that do address at least two of the subtopics. In addition to the two individual research projects, the Center application must also include the following two required Cores (see Sections IV.C.11 and IV.C.12).

• Administrative Core (AC) to provide oversight, coordination and integration of Center activities.

• Translation Core (TC) to help develop and sustain translation, communication, and community outreach activities at the Center. The TC promotes multi-directional communication between the Center and its stated target audiences on issues of prevention, environmental health literacy, and environmental public health education associated with the chemical exposures and health outcomes addressed by the Center.

Applications which do not include a center description, two individual research projects and the two required Cores will be rejected without review (see Section III.C).

Expected Outputs and Outcomes:

The expected outputs from this research will be novel and comprehensive scientific information, data and knowledge about how cumulative exposure to multiple chemicals and other environmental stressors in early lifestages are quantitatively linked to specific developmental health outcomes. Research results will also include important information on non-chemical environmental stressors and modifying factors that significantly affect vulnerability to both chemical exposure and health effects. The desired outputs should result in more accurate risk assessments leading to more effective, practical, and efficient reduction, mitigation, and prevention measures.

The expected outcomes are reductions in adverse impacts to children’s health and well-being from chemical and non-chemical environmental stressors, improved preventive policy and programs to improve health and well-being of pregnant women, infants, and children, and healthier early childhood development void of adverse effects.

To the extent practicable, research applications must embody innovation. Innovation for the purposes of this RFA is defined as the process of making changes; a new method, custom, or device. Innovative research can take the form of wholly new applications or applications that build on existing knowledge and approaches for new uses. Research Project Plan Descriptions must include a discussion on how the proposed research is innovative (see Section IV.C.7).

Reviewers will draw from the above-mentioned innovation definition in the review/evaluation process of research applications (see Section V.A).

E. References

1. U.S. EPA, Environmental Protection Agency (2019a), Protecting Children’s Health, October 2019. EPA publication number:100K19003 (https://www.epa.gov/children/protecting-childrens-health-october-2019-booklet)

2. Executive Order 13045 of April 21, 1997. Protection of Children from Environmental Health Risks and Safety Risks. Federal Register Presidential Documents, Vol. 62, No. 78 Wednesday, April 23, 1997. (https://www.govinfo.gov/content/pkg/FR-1997-04-23/pdf/97- 10695.pdf)

3. U.S. EPA, Environmental Protection Agency (2019b), Progress Report on the Federal Action Plan to Reduce Childhood Lead Exposures and Associated Health Impacts. EPA publication number:100R19005 (https://www.epa.gov/sites/production/files/2019- 10/documents/lead_action_plan_booklet_v8_004.pdf)

4. U.S. EPA, Environmental Protection Agency (2018), 2018 Reaffirmation Memo on EPA's 1995 Policy on Evaluating Health Risks to Children.

https://www.epa.gov/children/protecting-childrens-health-october-2019-booklet https://www.govinfo.gov/content/pkg/FR-1997-04-23/pdf/97-10695.pdf https://www.govinfo.gov/content/pkg/FR-1997-04-23/pdf/97-10695.pdf https://www.epa.gov/sites/production/files/2019-10/documents/lead_action_plan_booklet_v8_004.pdf https://www.epa.gov/sites/production/files/2019-10/documents/lead_action_plan_booklet_v8_004.pdf

(https://www.epa.gov/sites/production/files/2018- 10/documents/childrens_health_policy_reaffirmation_memo.10.11.18.pdf)

5. U.S. EPA, Environmental Protection Agency (2005), U.S. EPA. 630-P-03-003F.

Guidance on Selecting Age Groups for Monitoring and Assessing Childhood Exposures to Environmental Contaminants.

6. U.S. EPA, Environmental Protection Agency (2015), Children's Environmental Health Research Roadmap. U.S. EPA, Office of Research and Development, Washington, DC.

(2015). https://www.epa.gov/sites/production/files/2015- 11/documents/researchroadmap_ceh_508.pdf.

7. Tulve, N.S., Ruiz, J.D.C., Lichtveld, K., Darney, S.P., Quackenboss, J.J. (2016).

Development of a conceptual framework depicting a child's total (built, natural, social) environment in order to optimize health and well-being. Journal of Environment and Health Science 2(2):1-8.

8. Cohen Hubal, E.A., deWet, T., DuToit, L., Firestone, M.P., Ruchirawat, M., van Engelen, J., & Vickers, C. (2014). Identifying important life stages for monitoring and assessing risks from exposures to environmental contaminants: Results of a World Health Organization review. Regulatory Toxicology and Pharmacology 69(1):113-124.

9. Zota, A.R., Riederer, A.M., Ettinger, A.S., Schaider, L.A., Shine, J.P., Amarasiriwardena, C.J., Wright, R.O., & Spengler, J.D. (2016). Associations between metals in residential environmental media and exposure biomarkers over time in infants living near a mining-impacted site. J Expo Sci Environ Epidemiol 26(5): 510-519.

10. Liew, Z., Goudarzi, H. & Oulhote, Y. (2018). Developmental Exposures to Perfluoroalkyl Substances (PFASs): An Update of Associated Health Outcomes. Curr Envir Health Rpt 5: 1–19. https://doi.org/10.1007/s40572-018-0173-4

11. Vrijheid, M., Casas, M., Gascon, M., Valvi, D., Nieuwenhuijsen, M. (2016) Environmental pollutants and child health-A review of recent concerns. Int J Hyg Environ Health: 219(4-5):331-42. https://doi.org/10.1016/j.ijheh.2016.05.001

12. Pelch, K.E., Bolden, A.L., & Kwiatkowski, C.F. (2019). Environmental chemicals and autism: A scoping review of the human and animal research. Environ Health Perspect.

127(4):46001, (2019). https://doi.org/10.1289/EHP4386

13. U.S. EPA. Environmental Protection Agency. (2017). NIEHS/EPA Children's Environmental Health and Disease Prevention Research Centers Impacts Report: Protecting Children's Health Where They Live, Learn, and Play. EPA/600/R-17/407.

(https://www.epa.gov/research-grants/niehsepa-childrensenvironmental-health-and-disease-prevention-research-centers.)

14. U.S. EPA. Environmental Protection Agency. (2003). Framework for Cumulative Risk Assessment. Washington, DC. EPA/630/P-02/001F.

https://www.epa.gov/sites/production/files/2018-10/documents/childrens_health_policy_reaffirmation_memo.10.11.18.pdf https://www.epa.gov/sites/production/files/2018-10/documents/childrens_health_policy_reaffirmation_memo.10.11.18.pdf https://www.epa.gov/sites/production/files/2015-11/documents/researchroadmap_ceh_508.pdf https://www.epa.gov/sites/production/files/2015-11/documents/researchroadmap_ceh_508.pdf https://www.epa.gov/sites/production/files/2015-11/documents/researchroadmap_ceh_508.pdf https://doi.org/10.1007/s40572-018-0173-4 https://doi.org/10.1016/j.ijheh.2016.05.001 https://doi.org/10.1289/EHP4386 https://www.epa.gov/research-grants/niehsepa-childrens-environmental-health-and-disease-prevention-research-centers https://www.epa.gov/research-grants/niehsepa-childrens-environmental-health-and-disease-prevention-research-centers https://www.epa.gov/research-grants/niehsepa-childrens-environmental-health-and-disease-prevention-research-centers https://www.epa.gov/research-grants/niehsepa-childrens-environmental-health-and-disease-prevention-research-centers

(https://www.epa.gov/sites/production/files/2014- 11/documents/frmwrk_cum_risk_assmnt.pdf)

15. U.S. EPA. Environmental Protection Agency. (2006). A Framework For Assessing Health Risk Of Environmental Exposures To Children. Washington, DC, EPA/600/R- 05/093F. (https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=158363)

16. National Research Council. (2009). Enhancing the Effectiveness of Sustainability Partnerships. National Academies Press, Washington. ISBN-13: 978-0-309-12993-0.

17. U.S. EPA. Environmental Protection Agency. (2016). STAR RFA: Using a Total Environment Framework (Built, Natural, Social Environments) to Assess Life-long Health Effects of Chemical Exposures. Washington, DC.

(https://cfpub.epa.gov/ncer_abstracts/index.cfm/fuseaction/display.rfatext/rfa_id/630)

18. Burke, T.A., Cascio, W.E., Costa, D.L., Deener, K., Fontaine, T.D., Fulk, F.A., Jackson, L.E., Munns, W.R., Jr., Orme-Zavaleta, J., Slimak, M.W., & Zartarian, V.G. (2017).

Rethinking environmental protection: Meeting the challenges of a changing world.

Environmental Health Perspectives, Brief Communication, Vol 125, Issue 3: 43-49.

https://doi.org/10.1289/EHP1465.

19. Sheffield, P.E. & Landrigan, P.J. (2011). Global climate change and children’s health:

Threats and strategies for prevention. Environ Health Perspect. 119:291–298.

https://doi.org/10.1289/ehp.1002233

20. Xu, Z., Sheffield, P.E., Hu, W., Su, H., Yu, W., Qi, X., & Tong, S. (2012). Climate change and children’s health—A call for research on what works to protect children. Int. J.

Environ. Res. Public Health. 9:3298-3316. https://doi.org/10.3390/ijerph9093298

21. Garcia, D.M. & Sheehan, M.C. (2016). Extreme weather-driven disasters and children’s health. International Journal of Health Services. 46(1): 79–105.

https://doi.org/10.1177/0020731415625254

22. U.S. EPA. Environmental Protection Agency (2020). Website: NIEHS/EPA Children's Environmental Health and Disease Prevention Research Centers: Protecting Children’s Health for a Lifetime. Washington, DC. (https://www.epa.gov/research-grants/niehsepa-childrens-environmental-health-and-disease-prevention-research-centers)

23. Pediatric Environmental Health Specialty Units (PEHSUs). (2020). Website:

Reproductive and Pediatric Environmental Health Resources.

(https://www.pehsu.net/Other_Resources.html)

24. U.S. EPA. Environmental Protection Agency (2020). Website: America's Children and the Environment (ACE). Washington, DC.

(https://www.epa.gov/americaschildrenenvironment/basic-information-about-ace https://www.epa.gov/sites/production/files/2014-11/documents/frmwrk_cum_risk_assmnt.pdf https://www.epa.gov/sites/production/files/2014-11/documents/frmwrk_cum_risk_assmnt.pdf https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=158363 https://cfpub.epa.gov/ncer_abstracts/index.cfm/fuseaction/display.rfatext/rfa_id/630 https://doi.org/10.1289/EHP1465 https://doi.org/10.1289/ehp.1002233 https://doi.org/10.3390/ijerph9093298 https://doi.org/10.1177%2F0020731415625254 https://www.epa.gov/research-grants/niehsepa-childrens-environmental-health-and-disease-prevention-research-centers https://www.epa.gov/research-grants/niehsepa-childrens-environmental-health-and-disease-prevention-research-centers https://www.pehsu.net/Other_Resources.html

F. Special Requirements

It is EPA Policy to ensure that the results of EPA-funded extramural scientific research are accessible to the public to the greatest extent feasible consistent with applicable law; policies and Orders; the Agency’s mission; resource constraints; and U.S. national, homeland and economic security. This entails maximizing, at no charge, access by the public to peer-reviewed, scientific research journal publications or associated author manuscripts, and their underlying digital research data, created in whole or in part with EPA funds, while protecting personal privacy;

recognizing proprietary interests, confidential business information and intellectual property rights; and avoiding significant negative impact on intellectual property rights, innovation and U.S. competitiveness. EPA’s Policy for Increasing Access to Results of EPA-Funded Extramural Scientific Research may be accessed at: https://www.epa.gov/research/non-epa-researcher-requirements. Terms and conditions implementing this policy may be accessed at:

https://www.epa.gov/research/non-epa-researcher-requirements.

Applications submitted under this announcement shall include a Scientific Data Management Plan (SDMP) that addresses public access to EPA-funded scientific research data. See the SDMP clause in Section IV for details on the content of an SDMP. Applicants will also be asked to provide past performance information on whether journal publications or associated author manuscripts, and the associated underlying scientific research data and metadata, under prior assistance agreements were made publicly accessible. These items will be evaluated prior to award.

Reasonable, necessary, and allocable costs for data management and public access as discussed in EPA’s Policy for Increasing Access to Results of EPA-Funded Extramural Scientific Research, may be included in extramural research applications and detailed in the budget justification described in Section IV.

Agency policy and ethical considerations prevent EPA technical staff and managers from providing applicants with information that may create an unfair competitive advantage.

Consequently, EPA employees will not review, comment, advise, and/or provide technical assistance to applicants preparing applications in response to EPA RFAs. EPA employees cannot endorse any particular application.

Multiple Investigator applications may be submitted as: (1) a single Lead Principal Investigator (PI) application with Co-PI(s) or (2) a Multiple PI application (with a single Contact PI). If you choose to submit a Multiple PI application, you must follow the specific instructions provided in Sections IV. and V. of this RFA. For further information, please see the EPA Implementation Plan for Policy on Multiple Principal Investigators (https://www.epa.gov/research-grants/research-grants-guidance-and-policies).

This solicitation provides the opportunity for the submission of applications for projects that may involve human subjects research. All applications must include a Human Subjects Research Statement (HSRS; described in Section IV.C.9 of this solicitation). If the project involves human https://www.epa.gov/research/non-epa-researcher-requirements https://www.epa.gov/research/non-epa-researcher-requirements https://www.epa.gov/research/non-epa-researcher-requirements subjects research, it will be subject to an additional level of review prior to funding decisions being made as described in Sections V.D and V.F of this solicitation.

Groups of two or more eligible applicants may choose to form a consortium and submit a single application for this assistance agreement. The application must identify which organization will be the recipient of the assistance agreement and which organizations(s) will be subawardees of the recipient.

These awards may involve the collection of “Geospatial Information,” which includes information that identifies the geographic location and characteristics of natural or constructed features or boundaries on the Earth or applications, tools, and hardware associated with the generation, maintenance, or distribution of such information. This information may be derived from, among other things, a Geographic Positioning System (GPS), remote sensing, mapping, charting, and surveying technologies, or statistical data.

As described more fully in Section IV, each application must address the following items (for content and form of application submission and page limitations, see Section IV.C):

1. Center Description (5-page limit): Applications must describe the overall goals, objectives, and approach for the Center, including how the Center will pursue a multidisciplinary and thematic approach to the problems to be investigated. Applications which do not include a Center Description will be rejected without review (see Section III.C). The Center must also have two individual research projects that are integrated under the overall Center Description.

Applications which do not include the two individual research projects will be rejected without review.

2. Research Project Plan Descriptions (15-page limit for each research project plan description): Applications must contain two research projects. At least two of the seven research subtopics described above in Section I.D should be addressed. Each individual research project plan description should be described according to the instructions in Section IV.C.7 below.

Individual research project plan descriptions should explain how the project fits into the overall Center program and relates to the Center’s other projects. Applications with less than two or more than two individual research project plan descriptions will be deemed ineligible (see Section III.C).

3. Administrative Core (10-page limit): The Center must have an Administrative Core (AC) which provides oversight, coordination and integration of the Center’s activities. Applications which do not include an Administrative Core will be rejected without review (see Section

III.C).

4. Translation Core (10-page limit): The Center must have a Translation Core (TC) to help develop and sustain translation, communication, and community outreach activities at the Center.

The TC promotes multi-directional communication between the Center and its stated target audiences on issues of prevention, environmental health literacy, and environmental public health education associated with the chemical exposures and health outcomes addressed by the

Center. Applications which do not include a Translation Core will be rejected without review (see Section III.C).

II. AWARD INFORMATION

It is anticipated that a total of approximately $1,900,000 will be awarded under this announcement, depending on the availability of funds, quality of applications received, and other applicable considerations. The EPA anticipates funding one award under this RFA. Requests for amounts in excess of a total of $1,900,000 including direct and indirect costs, will not be considered. The total project period requested in an application submitted for this RFA may not exceed 4 years.

The EPA reserves the right to reject all applications and make no awards, or make fewer awards than anticipated, under this RFA. The EPA reserves the right to make additional awards under this announcement, consistent with Agency policy, if additional funding becomes available after the original selections are made. Any additional selections for awards will be made no later than six months after the original selection decisions.

In appropriate circumstances, EPA reserves the right to partially fund applications by funding discrete portions or phases of proposed projects. If EPA decides to partially fund an application, it will do so in a manner that does not prejudice any applicants or affect the basis upon which the application, or portion thereof, was evaluated and selected for award, and therefore maintains the integrity of the competition and selection process.

EPA intends to award only grants under this announcement.

Under a grant, EPA scientists and engineers are not permitted to be substantially involved in the execution of the research. However, EPA encourages interaction between its own laboratory scientists and grant Principal Investigators after the award of an EPA grant for the sole purpose of exchanging information in research areas of common interest that may add value to their respective research activities. This interaction must be incidental rather than substantial to achieving the goals of the research under a grant. Interaction that is “incidental” does not involve resource commitments by EPA.

III. ELIGIBILITY INFORMATION

A. Eligible Applicants

Public and private nonprofit institutions/organizations, public and private institutions of higher education, and hospitals located in the U.S., state and local governments, Federally Recognized Indian Tribal Governments, and U.S. territories or possessions are eligible to apply. Profit-making firms and individuals are not eligible to apply.

Non-profit organization, as defined by 2 CFR 200.70, means any corporation, trust, association, cooperative, or other organization that: (1) is operated primarily for scientific, educational, service, charitable, or similar purposes in the public interest; (2) is not organized primarily for profit; and (3) uses its net proceeds to maintain, improve, and/or expand its operations. Note that 2 CFR 200.70 specifically excludes Institutions of Higher Education from the definition of non-profit organization because they are separately defined in the regulation. While not considered to be a non-profit organization(s) as defined by 2 CFR 200.70, public or nonprofit Institutions of Higher Education are, nevertheless, eligible to submit applications under this RFA. Hospitals operated by state, tribal, or local governments or that meet the definition of nonprofit at 2 CFR

200.70 are also eligible to apply as nonprofits or as instrumentalities of the unit of government depending on the applicable law. For-profit colleges, universities, trade schools, and hospitals are ineligible. Nonprofit organizations described in Section 501(c) (4) of the Internal Revenue Code that lobby are not eligible to apply.

Foreign governments, international organizations, and non-governmental international organizations/institutions are not eligible to apply.

National laboratories funded by Federal Agencies (Federally-Funded Research and Development Centers, “FFRDCs”) may not apply. FFRDC employees may cooperate or collaborate with eligible applicants within the limits imposed by applicable legislation and regulations. They may participate in planning, conducting, and analyzing the research directed by the applicant, but may not direct projects on behalf of the applicant organization. The institution, organization, or governance receiving the award may provide funds through its assistance agreement from the EPA to an FFRDC for research personnel, supplies, equipment, and other expenses directly related to the research. However, salaries for permanent FFRDC employees may not be provided through this mechanism.

Federal Agencies may not apply. Federal employees are not eligible to serve in a principal leadership role on an assistance agreement. Federal employees may not receive salaries or augment their Agency’s appropriations through awards made under this program unless authorized by law to receive such funding.

The applicant institution may enter into an agreement with a Federal Agency to purchase or utilize unique supplies or services unavailable in the private sector to the extent authorized by law. Examples are purchase of satellite data, chemical reference standards, analyses, or use of instrumentation or other facilities not available elsewhere. A written justification for federal involvement must be included in the application. In addition, an appropriate form of assurance that documents the commitment, such as a letter of intent from the Federal Agency involved, should be included.

Potential applicants who are uncertain of their eligibility should contact Ron Josephson in the Office of Research and Development (ORD), phone: 202-564-7823, email:

josephson.ron@epa.gov.

B. Cost sharing

Institutional cost-sharing is not required.

mailto:josephson.ron@epa.gov

C. Other

Applications must substantially comply with the application submission instructions and requirements set forth in Section IV of this announcement or they will be rejected.