RFA_Exposure_July 2021 FINAL.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 Center for Public Health and Environmental Assessment Office of Research and Development

COLLECTION OF CONCORDANT MULTIMEDIA

MEASUREMENTS TO EVALUATE PFAS HUMAN

EXPOSURE PATHWAYS

This is the initial announcement of this funding opportunity.

Funding Opportunity Number: EPA-G2021-ORD-D1

Catalog of Federal Domestic Assistance (CFDA) Number: 66.511

Solicitation Opening Date: July 7, 2021 Solicitation Closing Date: August 23, 2021: 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. Special Requirements

II. AWARD INFORMATION

III. ELIGIBILITY INFORMATION

A. Eligible Applicants B. Cost Sharing C. Other https://www.epa.gov/grants/epa-solicitation-clauses

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

For Updates and Additional Information (https://www.epa.gov/research-grants/research-funding-opportunities) Access Standard 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’s (EPA) Center for Public Health and Environmental Assessment (CPHEA) in coordination with EPA’s Safe and Healthy Communities National Research Program, is requesting applications to supplement exposure measurements in cohorts where biomonitoring is being conducted for per- and poly-fluoroalkyl substances (PFAS). The data developed should enable or improve interpretation of biomonitoring data and inform understanding of the important sources and pathways related to personal exposures to PFAS chemicals. The overarching intention is to advance PFAS human exposure measurement methodologies and encourage common collection of concordant information that will increase impact of individual studies and enable understanding of the most important PFAS exposure pathways.

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

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.6.c 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

Award Information:

Anticipated Type of Award: Grant Estimated Number of Awards: Approximately 2 awards Anticipated Funding Amount: Approximately $500,000 total for all awards Potential Funding per Award: Up to a total of $250,000, including direct and indirect costs, with a maximum duration of 3 years. Cost-sharing is not required. Applications with budgets exceeding the total award limits will not be considered.

Eligibility Information:

This solicitation is available to each U.S. State, territory and possession, Federally Recognized Indian Tribal Governments of the U.S., and the District of Columbia; public and private universities and colleges, public and private nonprofit institutions, hospitals, and laboratories located in the U.S. and its territories or possessions; State and local government departments; and foreign entities. Profit-making firms and individuals are not eligible to receive assistance agreements from the EPA under this program. 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-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 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 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 https://www.epa.gov/research-grants/research-funding-opportunities-how-apply-and-required-forms 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 appropriate internet access 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: David Kelley; phone: 202-564-0251; email: kelley.dave@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

An urgent, high-priority research area identified by the EPA is to expand the understanding of the environmental risks posed by per- and poly-fluoroalkyl substances (PFAS) and identify practical approaches to manage their potential environmental impacts. EPA is issuing this Request for Applications (RFA) to support research to better understand important exposure pathways of PFAS in impacted communities and in the general population. EPA’s Center for Public Health and Environmental Assessment (CPHEA) in coordination with EPA’s Safe and Healthy Communities National Research Program is requesting applications to supplement extant PFAS human exposure studies, where PFAS biomonitoring is being conducted, with residential and personal exposure measures. PFAS are a broad group of compounds that have unique properties which have resulted in their widespread use in industrial, commercial and consumer applications and products. The EPA is committed to supporting the public (states, tribes, and local communities) in understanding PFAS impacts and reducing PFAS risks to the public through implementation of the PFAS Action Plan (https://www.epa.gov/pfas/epas-pfas-action-plan) which calls for research into hazard, exposure, treatment and remediation.

The Office of Research and Development’s (ORD) Consolidated Research/Training/Fellowships program supports research and development to: (1) determine the environmental effects of air quality, drinking water, water quality, hazardous waste, toxic substances, and pesticides; (2) identify, develop, and demonstrate effective pollution control techniques; (3) perform risk assessments to characterize the potential adverse health effects of human exposures to environmental hazards; and (4) facilitate training and program participant support in these areas.

Awards made under this program further EPA’s priorities supporting robust science for air quality, safe and sustainable water resources, sustainable and healthy communities, chemical safety, and human health risk assessment.

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 mailto:kelley.dave@epa.gov mailto:josephson.ron@epa.gov mailto:jones.debram@epa.gov https://www.epa.gov/pfas/epas-pfas-action-plan https://www.epa.gov/pfas/epas-pfas-action-plan 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(2)). 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;

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(b)(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

PFAS are a large group of several thousand industrial chemicals that are used in many consumer products and industrial and manufacturing applications. Contributors to environmental releases include: 1) fire training and fire response; 2) industrial releases from primary and secondary production and manufacturing; 3) landfills; and 4) wastewater treatment operations. The pervasive nature of PFAS-containing products, their resistance to metabolic and environmental degradation, their mobility, and their potential for bioaccumulation and toxicity present serious environmental health challenges. In addition, PFAS chemicals may be present in and released from a vast number of building materials and consumer products in residential environments.

The ubiquitous presence of PFAS chemicals in humans as demonstrated by the National Health and Nutrition Examination Survey (NHANES) suggests that exposure sources beyond contaminated water may play an important role. Measurement data on the nature and level of PFAS in the residential environment and diet is required to understand and mitigate important pathways for human exposure. EPA’s CPHEA seeks to advance application and evaluation of a general protocol that can be implemented across PFAS cohort studies to generate important exposure data for priority pathways. Responsive proposals should include collection of environmental and personal exposure measures and analysis for a common set of PFAS chemicals (e.g., those measured in NHANES) as well as Total Organic Fluorine (TOF). The data developed should enable or improve interpretation of PFAS biomonitoring data and inform 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/ 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 understanding of the important sources and pathways related to personal exposures to PFAS chemicals.

The overarching goal is to advance PFAS exposure measurement methodologies and encourage common collection of concordant information that will increase impact of individual studies and enable understanding of the most important PFAS exposure pathways. The strongest proposals will include a nested protocol to include a minimal set of measurements implemented for all participants in the biomonitoring study cohort, while PFAS measurements in a larger set of media is piloted in a smaller subset of participants. Proposals that implement collection of measurements that are concordant at the community/cohort level as well as at the individual level are preferred.

C. Authority and Regulations

The authorities for this RFA and resulting awards are 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, and the Clean Air Act, 42 U.S.C. 7403, Section 103(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 EPA’s FY 2018-22 Strategic Plan (https://www.epa.gov/planandbudget/strategicplan). 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. All applications must be for projects that support the goal and objective identified above. Awards made under this announcement will advance the goals of EPA’s Consolidated Research/Training/Fellowships program by furthering EPA’s priorities supporting robust science for Sustainable and Healthy https://www.epa.gov/planandbudget/strategicplan

Communities. Specifically, this research will contribute toward the Sustainable and Healthy Communities goal of assessing the impact of pollution on vulnerable groups and other susceptible populations.

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-policy-environmental-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.

The Agency is soliciting research that proposes and evaluates innovative protocols for measuring human exposure to PFAS chemicals in cohorts where biomonitoring is being conducted. The objective is to advance common exposure measurement protocols that can be implemented across PFAS cohort studies to generate important exposure data for priority pathways.

This RFA solicits applications that address at least two of the following key questions:

• What is the contribution of drinking water, dietary intake, and other sources and/or media in the residential environment to PFAS exposure in the general population?

• How much variability in PFAS serum levels can be explained by water consumption and from other exposure sources/pathways and how much is not explained?

• What is the minimal set of measurements that can be implemented to classify individual exposure levels?

• How can measured data be used to estimate PFAS exposures of vulnerable groups, impacted communities, and the general population to inform decisions and mitigation actions?

Applications that do not address at least two of the key questions listed above may not be rated as highly as those that do. Responsive proposals should include collection of environmental and personal exposure measures and analysis for a common set of PFAS chemicals (e.g., those measured in NHANES) as well as Total Organic Fluorine (TOF). Protocols implemented to collect measurements that are concordant at the community/cohort level as well as at the individual level are preferred. Further, because applicants are strongly encouraged to leverage funded studies where a cohort has been recruited, and where PFAS biomonitoring of study participants is underway (or planned), the application should describe the study, cohort and funding sources. The application must also include a collaboration and engagement plan (see Section IV.C.6.e) demonstrating commitment on the part of the Principal Investigator (PI) for the cohort that will serve as the partner study to help meet the objectives of this application.

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

Research that would be responsive to this RFA includes, but is not limited to, the following:

nested protocols where a minimal set of measurements is implemented for all participants in biomonitoring studies, while PFAS measurements in a larger set of media is piloted in a smaller subset of participants. For example, for the first tier, information collected in the partner study (e.g., targeted PFAS levels in serum, known PFAS sources in the community, basic survey questions) could be leveraged to select a stratified sample for further measurements of community and individual level exposure. A minimal set of concordant exposure measurements could be proposed and implemented on the stratified sample to include tap water and house dust in addition to the serum being collected in the partner study. Proposed analytes could be extended beyond the targeted minimal set of NHANES PFAS measured in the partner study to include additional PFAS chemicals and Total Organic Fluorine (TOF).

For the next tier, a pilot set of multimedia measurements could be proposed with the objective of developing and evaluating methodologies to close the mass balance and inform interventions to reduce exposures to highly exposed groups. This pilot could be implemented on study participants from the partner study that have been identified as highly exposed based on serum levels. Additional measurements that could be proposed include: residential indoor air, residential outdoor air, residential soil, surface wipes, duplicate or regional diet, building and/or consumer products, etc.

Outputs expected from this research may include:

(1) Exposure measurement data concordant with biomonitoring data for a targeted set of PFAS chemicals in a study population;

(2) Evaluated protocols and SOPs for measuring a targeted set of PFAS in the residential environment.

Outcomes expected from this research may include:

(1) Improved interpretation of PFAS biomonitoring data; and

(2) Greater understanding of the important sources and pathways related to personal exposures to PFAS chemicals.

Collaboration and Engagement Plan

Applicants are strongly encouraged to leverage funded studies where a cohort has been recruited, and where PFAS biomonitoring of study participants is underway (or planned). Collaboration and cooperative partnerships are strongly encouraged in the design and execution of the proposed research. Therefore, applications must include a Collaboration and Engagement Plan.

Applications should, at minimum, describe: a) the extant study, cohort, and funding sources for the partner study that will be leveraged; b) how the applicant will work in partnership with the PI for the cohort that will serve as the partner study to effectively design and implement the proposed project; and c) to the extent possible, how this research will be coordinated with and/or complement other projects or activities being performed by others that will result in a greater positive impact.

The collaboration and engagement plan should:

• Describe the type of collaboration/engagement proposed, including description of the extant study, cohort, and funding sources for the partner study that will be leveraged, how the applicant will work in partnership with the PI for the cohort that will serve as the partner study to effectively design and implement the proposed project, and what role the collaboration will play in the overall project including the degree of partner engagement in the conceptualization, design, methods, analyses and implementation of the research.

• Describe how the collaboration/engagement will enhance the capacity of the project to more effectively interpret results of PFAS biomonitoring data.

• Describe how you will coordinate activities of the project with related or complementary projects and studies.

• Describe how you will ensure that the collaboration/engagement will materialize during project performance. Describe the partner(s)’ intent to participate in the proposed research including evidence of support of an active partnership with the partner study (e.g., letter(s) of intent or support from the PI for the cohort that will serve as the partner study). Any letters demonstrating evidence of collaboration and support should be included as part of section IV.C.10.a. Letters of Intent/Letters of Support.

Applicants that do not plan on collaborating/engaging with other groups in project performance must still include a collaboration and engagement plan in their application describing how they will be able to effectively perform and complete the project without such collaboration/engagement.

E. 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 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 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.6.c of this solicitation). 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.

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.

Because applicants are strongly encouraged to leverage funded studies where a cohort has been (is being) recruited, and where PFAS biomonitoring of study participants is underway (or planned), EPA does not intend to provide funds for participant recruitment nor for biomonitoring. Thus, in the application, information must be provided describing the extant study, cohort, and funding sources (see Section IV.C.6.e).

II. AWARD INFORMATION

It is anticipated that a total of approximately $500,000 will be awarded under this announcement, depending on the availability of funds, quality of applications received and other applicable considerations. The EPA anticipates funding approximately two awards under this RFA.

Requests for amounts in excess of a total of $250,000, including direct and indirect costs, will not be considered. The total project period requested in an application submitted for this RFA may not exceed 3 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

This solicitation is available to each U.S. State, territory and possession, Federally Recognized Indian Tribal Governments of the U.S., and the District of Columbia; public and private universities and colleges, public and private nonprofit institutions, hospitals, and laboratories located in the U.S. and its territories or possessions; State and local government departments; and foreign entities. Profit-making firms and individuals are not eligible to receive assistance agreements from the EPA under this program.

Non-profit organization, as defined by 2 CFR 200.1, means any corporation, trust, association, cooperative or other organization, not including institutions of higher education (IHEs), 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 net proceeds to maintain, improve, or expand the operations of the organization. Note that 2 CFR 200.1 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 200.1, 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 200.1 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.

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.

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. In addition, where a page limitation is expressed in Section IV with respect to parts of the application, pages in excess of the page limit will not be reviewed. In addition, applications must be submitted through Grants.gov as stated in Section IV of this announcement (except in the limited circumstances where another mode of submission is specifically allowed for as explained in mailto:josephson.ron@epa.gov https://www.grants.gov/

Section IV) on or before the application submission deadline published in Section IV of this announcement. Applicants are responsible for following the submission instructions in Section IV of this announcement (see Section IV.F. “Submission Instructions and Other Submission Requirements” for further information) to ensure that their application is submitted timely.

Applications submitted after the submission deadline will be considered late and deemed ineligible without further consideration unless the applicant can clearly demonstrate that it was late due to EPA mishandling or because of technical problems associated with Grants.gov or relevant SAM.gov system issues. An applicant’s failure to timely submit their application through Grants.gov because they did not timely or properly register in SAM.gov or Grants.gov will not be considered an acceptable reason to consider a late submission.

In order to be deemed eligible, the application must include a Collaboration and Engagement Plan (see Section IV.C.6.e.) that demonstrates collaboration/engagement with partner(s) in the design and execution of the proposed research or how the applicant will be able to effectively perform and complete the project without such collaboration/engagement.

Also, applications exceeding the funding limits or project period term described herein will be rejected without review. Further, applications that fail to demonstrate a public purpose of support or stimulation (e.g., by proposing research which primarily benefits a Federal program or provides a service for a Federal agency) will not be funded.

Applications deemed ineligible for funding consideration will be notified within fifteen calendar days of the ineligibility determination.

IV. APPLICATION AND SUBMISSION INFORMATION

Additional provisions that apply to this solicitation and/or awards made under this solicitation, including but not limited to those related to confidential business information, contracts and subawards under grants, and proposal assistance and communications, can be found at https://www2.epa.gov/grants/epa-solicitation-clauses.

These, and the other provisions that can be found at the website link, are important, and applicants must review them when preparing applications for this solicitation. If you are unable to access these provisions electronically at the website above, please communicate with the EPA contact listed in this solicitation to obtain the provisions.

Formal instructions for submission through Grants.gov are in Section F.

A. Grants.gov Submittal Requirements and Limited Exception Procedures Applicants must apply electronically through Grants.gov under this funding opportunity based on the grants.gov instructions in this announcement. If your organization has no access to the internet or access is very limited, you may request an exception for the remainder of this calendar year by following the procedures outlined here. Please note that your request must be received at least 15 calendar days before the application due date to allow enough time to https://www.grants.gov/ http://www.sam.gov/ https://www.grants.gov/ http://www.sam.gov/ https://www.grants.gov/ https://www2.epa.gov/grants/epa-solicitation-clauses https://www.epa.gov/grants/exceptions-grantsgov-submission-requirement negotiate alternative submission methods. Issues with submissions with respect to this opportunity only are addressed in section F. Submission Instructions and Other Submission Requirements below.

B. Application Package Information

Use the application package available at Grants.gov (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-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.

An email will be sent by ORD to the Lead/Contact PI and the Administrative Contact (see below) to acknowledge receipt of the application and transmit other important information. The email will be sent from receipt.application@epa.gov; emails to this address will not be accepted.

If you do not receive an email acknowledgement within 10 calendar days of the submission closing date, immediately inform the Electronic Submissions Contact shown in this solicitation.

Failure to do so may result in your application not being reviewed. See Section IV.F.

“Submission Instructions and Other Submission Requirements” for additional information regarding the application receipt acknowledgment.

C. Content and Form of Application Submission

The application is made by submitting the materials described below. Applications must contain all information requested and be submitted in the formats described.

1. Standard Form 424

The applicant must complete Standard Form 424. Instructions for completion of the SF424 are included with the form. However, note that EPA requires that the entire requested dollar amount appear on the SF424, not simply the proposed first year expenses. The form must contain the signature of an authorized representative of the applying organization.

Applicants are required to provide a DUNS number when applying for federal grants or cooperative agreements. Organizations may receive a DUNS number, at no cost, by calling the dedicated toll-free request line at 1-866-705-5711, or visiting the website at:

https://www.dnb.com.

This program is eligible for coverage under E.O. 12372, "Intergovernmental Review of Federal Programs." An applicant should consult the office or official designated as the single point of contact in his or her State for more information on the process the State requires to be followed in applying for assistance, if the State has selected the https://www.grants.gov/ mailto:receipt.application@epa.gov https://www.dnb.com/ program for review. EPA financial assistance programs and activities subject to intergovernmental review that have been selected for review under State single point of contact procedures are identified at https://www.epa.gov/grants/epa-financial-assistance-programs-subject-executive-order-12372-and-section-204-demonstration. Applicants for programs or activities subject to Intergovernmental Review that have not been selected for State single point of contact review must provide directly affected State, areawide, regional, and local entities at least 60 days to review their application following notification by EPA that the application has been selected for funding as provided by 40 CFR 29.8(a) and (c).

2. Key Contacts

The applicant must complete the “Key Contacts” form found in the Grants.gov application package. An “Additional Key Contacts” form is also available at https://www.epa.gov/research-grants/research-funding-opportunities-how-apply-and-required-forms. The Key Contacts form should also be completed for major sub-agreements (i.e., primary investigators). Do not include information for consultants or other contractors. Please make certain that all contact information is accurate.

For Multiple PI applications: The Additional Key Contacts form must be completed (see Section I.F. for further information). Note: The Contact PI must be affiliated with the institution submitting the application. EPA will direct all communications related to scientific, technical, and budgetary aspects of the project to the Contact PI; however, any information regarding an application will be shared with any PI upon request. The Contact PI is to be listed on the Key Contact Form as the Project Manager/Principal Investigator (the term Project Manager is used on the Grants.gov form, the term Principal Investigator is used on the form located at https://www.epa.gov/research-grants/research-funding-opportunities-how-apply-and-required-forms). For additional PIs, complete the Major Co-Investigator fields and identify PI status next to the name (e.g., “Name: John Smith, Principal Investigator”).

3. EPA Form 4700-4, Preaward Compliance Review Report for All Applicants and Recipients Requesting EPA Financial Assistance (available at https://www.epa.gov/research-grants/research-funding-opportunities-how-apply-and-required-forms).

4. Table of Contents Provide a list of the major subdivisions of the application indicating the page number on which each section begins.

5. Abstract (1 page)

The abstract is a very important document in the review process. Therefore, it is critical that the abstract accurately describes the research being proposed and conveys all the essential elements of the research.

https://www.epa.gov/grants/epa-financial-assistance-programs-subject-executive-order-12372-and-section-204-demonstration https://www.epa.gov/grants/epa-financial-assistance-programs-subject-executive-order-12372-and-section-204-demonstration https://www.grants.gov/

The abstract must include the information described below (a-h). Examples of abstracts for current grants may be found on EPA’s Research Grants website.

a. Funding Opportunity Title and Number for this application.

b. Project Title: Use the exact title of your project as it appears in the application. The title must be brief yet represent the major thrust of the project. Because the title will be used by those not familiar with the project, use more commonly understood terminology. Do not use general phrases such as “research on.”

c. Investigators: For applications with multiple investigators, state whether this is a single Lead

PI (with co-PIs) or Multiple PI application (see Section I.F.). For Lead PI applications, list the Lead PI, then the name(s) of each co-PI who will significantly contribute to the project.

For Multiple PI applications, list the Contact PI, then the name(s) of each additional PI.

Provide a website URL or an email contact address for additional information.

d. Institution(s): In the same order as the list of investigators, list the name, city and state of each participating university or other applicant institution. The institution applying for assistance must be clearly identified.

e. Project Period and Location: Show the proposed project beginning and ending dates and the performance site(s)/geographical location(s) where the work will be conducted.

f. Project Cost: Show the total funding requested from the EPA (include direct and indirect costs for all years).

g. Project Summary: Provide three subsections addressing: (1) the objectives of the study

(including any hypotheses that will be tested), (2) the experimental approach to be used (a description of the proposed project) and (3) the expected results (outputs/outcomes) of the project and how it addresses the research needs identified in the solicitation, including the estimated improvement in risk assessment or risk management that will result from successful completion of the proposed work.

h. Supplemental Keywords: Without duplicating terms already used in the text of the abstract, list keywords to assist database searchers in finding your research. A list of suggested keywords may be found at: https://www.epa.gov/research-grants/research-funding-opportunities-how-apply-and-required-forms.

6. Research Plan, Quality Assurance Statement, Human Subjects Research Statement, Scientific Data Management Plan, Collaboration and Engagement Plan, and References

a. Research Plan (15 pages)

Applications should focus on a limited number of research objectives that adequately and clearly demonstrate that they meet the RFA requirements. Explicitly state the main hypotheses that you https://www.epa.gov/research-grants will investigate, the data you will create or use, the analytical tools you will use to investigate these hypotheses or analyze these data and the results you expect to achieve. Research methods must be clearly stated so that reviewers can evaluate the appropriateness of your approach and the tools you intend to use. A statement such as: “we will evaluate the data using the usual statistical methods” is not specific enough for peer reviewers.

This description must not exceed fifteen (15) consecutively numbered (bottom center), 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins. While these guidelines on page size, point type and margins establish the minimum type size requirements, applicants are advised that readability is of paramount importance and should take precedence in selection of an appropriate font for use in the application.

The description must provide the following information:

(1) Objectives: List the objectives of the proposed research and the hypotheses being tested during the project, and briefly state why the intended research is important, how it supports the Agency’s research priorities and how it fulfills the requirements of the solicitation. This section should also include any background or introductory information that would help explain the objectives of the study. If this application is to expand upon research supported by an existing or former assistance agreement awarded under an EPA program, indicate the number of the agreement and provide a brief report of progress and results achieved under it.

(2) Approach/Activities: Outline the research design, methods and techniques that you intend to use in meeting the objectives stated above.

(3) Expected Results, Benefits, Outputs and Outcomes: Describe the expected outputs and outcomes resulting from the project. This section should also discuss how the research results will lead to solutions to environmental problems and improve the public’s ability to protect the environment and human health. A clear, concise description will help ORD and peer reviewers understand the merits of the research.

(4) Project Management: Discuss other information relevant to the potential success of the project. This should include facilities, personnel expertise/experience, project schedules with associated milestones and target dates, proposed management, interactions with other institutions, etc. Describe the approach, procedures and controls for ensuring that awarded grant funds will be expended in a timely and efficient manner and detail how project objectives will be successfully achieved within the grant period.