Part 1. Overview Information

Key Dates

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background and Purpose

The National Institute of Environmental Health Sciences (NIEHS) invites qualified investigators from domestic institutions of higher education to apply to the Superfund Research Program (SRP) R01 Individual Research Project grant program. The mission of the NIEHS is to discover how the environment affects people in order to promote healthier lives. The NIEHS Superfund Research Program (SRP) (http://www.niehs.nih.gov/research/supported/srp/) was established under the Superfund Amendment Reauthorization Act (SARA) Section 311(a), which authorizes NIEHS to implement a university-based program of basic research for the development of: 1) advanced techniques for the detection, assessment, and evaluation of the effect of hazardous substances on human health; 2) methods to assess the risks to human health presented by hazardous substances; 3) methods and technologies to detect hazardous substances in the environment; and 4) basic biological, chemical, and physical methods to reduce the amount and/or toxicity of hazardous substances. SRP’s broad scope, as dictated by the SARA mandates, allows NIEHS to support scientific research to address the wide array of scientific uncertainties facing the national Superfund program utilizing biomedical as well as environmental science and engineering approaches. Research supported by the SRP uses mechanistic science as a foundation and, in keeping with the broad research themes of the program mandates, the SRP promotes an interdisciplinary approach to develop solutions for the safe management of hazardous substances with the ultimate goal of improving public health.

The complex problems related to sites impacted by hazardous substances require rigorous science, the expertise of multiple disciplines, and sustainable approaches. Accordingly, the NIEHS Strategic Plan of 2018 and the SRP Strategic Plan Objectives and Goals: 2015-2020 articulate a commitment to fostering innovation and advancing fundamental science through interdisciplinary research. The SRP plan highlights the importance of transdisciplinary science, (i.e. adapting technologies and approaches from one field and applying them to other fields). Forging connections between different areas of science allows the SRP to promote forward looking, or anticipatory, research to identify and address future needs such as devising more sustainable solutions to reduce exposures to hazardous substances. Sustainable processes, as defined by the National Research Council (NRC), are those that achieve net environmental, economic, and societal gains (NRC, 2011). Sustainability is a driver for improvements in remediation technologies and is also a critical consideration for the successful adoption of these new technologies. Environmentally sustainable remediation strategies use less energy and are developed using non-harmful materials relative to existing remediation technologies.

One example of a sustainable remediation solution is bioremediation, which involves the use of biota (e.g. bacteria, algae, fungi, plants, etc.) to reduce or detoxify hazardous substances in the environment. The SRP has invested significantly in bioremediation research, such as developing bioengineered plant-bacterial systems capable of extracting and degrading chlorinated compounds; developing engineered amendments to enhance bioremediation; and utilizing isotopes and gene expression signatures to monitor the progress of bioremediation. These approaches were key to advancing bioremediation and have influenced remedy selection at hazardous sites, leading to commercialization of new products, and resulting in cost savings at sites impacted by hazardous substances. More recently, genomic, transcriptomic, metagenomic, metabolomic, and gene editing approaches provide insight by probing the diversity of nature for new potential solutions to naturally degrade or stabilize contaminants. These data-rich approaches show promise for understanding bioremediation success (or failure) from the molecular level, to species, to community, and to the biogeochemical landscape. Furthermore, discoveries of new catalytic and catabolic diversity in natural systems broaden the potential success of bioremediation for cleanup of an increasing number of hazardous substances.

Concurrent advances in materials science approaches present an opportunity to further refine knowledge of the mechanisms of bioremediation and to optimize its practice. For example, nanotechnology or engineered microenvironmental systems can optimize the process of bioremediation by facilitating/adding consortia of living systems to degrade complex mixtures (bioaugmentation), and/or devising materials to create conditions optimal for bioremediation (biostimulation) in the presence of contaminants. In another example, innovative in situ stimuli-responsive materials that are designed to react, sense, and respond to external condition in a predetermined manner may have potential to enhance bioavailability, deliver nutrients, or release signal molecules to enhance bioremediation. These materials science and engineering approaches hold promise to overcome some of the limitations of bioremediation such as the speed of the process, the formation of unintended byproducts, or the inability to remediate co-contaminants simultaneously. Therefore, transdisciplinary research incorporating materials science with bioremediation could offer new breakthroughs to advance sustainable solutions for hazardous substances in the environment.

Specific Areas of Research Interest

The purpose of this FOA is to support innovative approaches to understand mechanisms of bioremediation. Bioremediation, for the purposes of this FOA, encompasses remediation using bacteria, archaea, algae, fungi, and/or plants to degrade, extract, or stabilize contaminants as part of a natural or constructed system. Applicants should assemble teams of researchers with expertise in bioremediation and materials science to propose integrated approaches to reduce the burden of contaminants in the environment. Through a transdisciplinary approach, applicants should elucidate mechanisms of bioremediation and use that knowledge to address challenging scenarios for which bioremediation may be a solution. It is expected the major outcomes of this program will be the elucidation of mechanisms impacting bioremediation success and stimulation of innovative transdisciplinary approaches incorporating materials science to optimize bioremediation. Overall, this program will facilitate cutting-edge transdisciplinary science needed to advance research in bioremediation relevant to the goals of the SRP.

Applicants are encouraged to propose advanced approaches that combine a mechanistic understanding of bioremediation and materials science including, but not limited to:

• Utilization of nanotechnology-enabled frameworks to understand the basic structural properties of microorganisms/plants and to enhance bioremediation of hazardous substances;
• Utilization of machine learning to predict optimal conditions and pathways to apply innovative materials that stimulate bioaugmentation or to customize the design of new materials to enhance mechanistic understanding and effectiveness of bioremediation;
• Integration and analysis of omics data from across several hazardous sites to discover new options for development of innovative materials for bioaugmentation/biostimulation;
• Development of controlled, engineered microenvironments to overcome biogeochemical/ecological limitations of biodegradation, to prevent formation of unintended byproducts, or to accommodate biodegradation of multiple contaminants;
• Employment of nanotech-derived devices and materials to investigate the mechanisms underlying bioremediation so that more effective remediation strategies could be created;
• Integration of novel materials science-enhanced bioamendment delivery with advanced site models to better understand biogeochemical and ecological mechanisms of bioremediation.

Applicants are expected to develop aims that elucidate the mechanisms of bioremediation through transdisciplinary research incorporating materials science. Applicants should highlight the value-added of the transdisciplinary science, including the novelty of the collaboration and/or the need for this type of collaboration to address a critical gap in the practice of bioremediation. SRP encourages applicants to highlight other innovative aspects of their applications, including the innovation of the proposed materials, and to clearly state how the proposed approach offers an advantage over current approaches, including improved energy/resource-efficiency, cost effectiveness, and/or reduced waste generation relative to other remediation technologies. Applicants are encouraged to include criteria for success such as parameters that evaluate effectiveness or a set of criteria demonstrating achievement of technical milestones. Applicants may submit applications addressing bioremediation of media relevant to Superfund (e.g. soil, groundwater, surface water, sediments, complex geological aquifers, fractured bedrock, etc). Approaches that are adaptable for in situ application are encouraged. The SRP is particularly interested in applications that address recalcitrant emerging contaminants, and mixtures (i.e. a heterogeneous group of contaminants) as these may require carefully engineered systems to maximize the efficacy of bioremediation. Applicants are encouraged to utilize platform approaches that may be adaptable/tunable for more than just one specific contaminant and/or exposure scenario.

As noted in their respective strategic plans, the NIEHS and SRP are committed to advancing the practice of data sharing, reuse, and its translation to knowledge to accelerate new breakthroughs. Therefore, research approaches funded under this FOA are intended to be broadly applicable. Applicants are expected to include a data sharing plan to describe plans to make data FAIR (findable, accessible, interoperable, and reusable), including plans for translation of the research data, products, and/or resources. Applicants should make plans to identify data-sharing platforms suitable for the data that will be generated by the project, delineate a timeline to share data, and utilize reporting standards/ontologies consistent with the field of research. Applicants are encouraged to tailor their data structure to enable integration with advanced site characterization tools (ASCT), including visualization and machine learning, to ensure more precision in their proposed bioremediation-based interventions. As an extension of the concept of data sharing, SRP recommends applicants actively engage end-users during the early stages of application development and throughout the duration of the grant, as this greatly increases the positive impact of SRP research and its utility to stakeholders. Hence, applicants are encouraged to include plans for translating their research, i.e. communicating and facilitating the application of research accomplishments to end-users. For this FOA, end-users are likely to include federal government agencies, state/local government agencies, commercial sector (e.g. remediation engineering firms), and/or non-government organizations (NGOs), etc. Applicants are encouraged, but not required, to include end-users as part of the research team.

The SRP Funding Opportunities webpage has additional resources to assist applicants for this FOA: https://www.niehs.nih.gov/research/supported/centers/srp/funding/funding2/index.cfm including suggested resources, links to other Federal emerging contaminant web pages, details about FAIR data sharing, and other tips for applicants. Applicants are encouraged to propose research that fills gaps or needs not currently addressed within the SRP (please see list of current grantees found on the following website: https://tools.niehs.nih.gov//srp/programs/index.cfm). As an outcome of this FOA, the SRP hopes to advance the practice of bioremediation in a variety of biological systems, using a diversity of materials, to address several types of hazardous substances.

Please note: this FOA seeks innovative application of materials science integrated with bioremediation; hence, nanoengineered materials, such as nano zero valent iron (NZVI) alone, or other first-generation nanoparticles, would not be responsive to this call. In addition, applications proposing the use of commercially-available nanotechnology/advanced materials for bioremediation are not responsive to this call and should inquire about Small Business Innovative Research funding:

https://www.niehs.nih.gov/research/supported/centers/srp/funding/hwaerp/index.cfm. SARA Section 101(14) excludes petroleum and natural gas for consideration as a "Hazardous Substance": https://www.niehs.nih.gov/research/supported/assets/docs/r_s/srp_program_mandates_508.pdf. Therefore, research on petroleum or natural gas (including hazardous substances associated with hydraulic fracturing) is not responsive to this FOA. The SRP is not a site-specific program, therefore, applications that are focused on a specific hazardous site will not be accepted.

Annual Meetings: To facilitate collaboration and information sharing across individuals funded under this FOA, the PD(s)/PI(s) will be expected to participate in a focused grantee meeting in year 1 and 3 of the award. This meeting will discuss the progress of awarded grants and opportunities for collaboration as well as future directions for the program. In addition, the NIEHS holds an annual Superfund Research Program grantee meeting. (For more information, see Section IV. Application and Submission Information.)

Section II. Award Information

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Section 311(a)(3) of SARA limits recipients of awards to "accredited institutions of higher education," which are defined in the Higher Education Act, 20 USC (annotated) 3381. However, grantees are permitted under the law, and encouraged by NIEHS, to subcontract as appropriate with organizations, domestic or foreign, public or private (such as universities, colleges, hospitals, laboratories, faith-based organizations, units of State and local governments, and eligible agencies of the Federal Government) as necessary to conduct portions of the research. Examples of other organizations may include generators of hazardous wastes; persons involved in the detection, assessment, evaluation, and treatment of hazardous substances; owners and operators of facilities at which hazardous substances are located; State and local governments and community organizations.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

Letter of Intent

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

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

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel (please specify bioremediation and materials science team member expertise)
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Dr. Laura Thomas
Telephone: 984.287.3328
Fax: 301-480-4462
Email: [email protected]

The Program Director/Principal Investigator must describe how their experience and training in bioremediation or materials science position them to lead this project.

The investigative team must include personnel or consultants with expertise to accomplish the goals of this FOA and would be required to include, at a minimum, at least one investigator with expertise in bioremediation and at least one investigator with expertise in materials science. The applicationshould also identify the individual(s) responsible for data management, coordination and reporting of research translation, and, as applicable, a point of contact for entering trainee (graduate and postdoctoral) data into the NIH CareerTrac database (https://careertrac.niehs.nih.gov/auth/login).

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

Meetings: The budget shall include funds to travel at least one PD/PI to a 1.5-day focused meeting for grantees of this FOA in years 1 and 3 of the award. In addition, the grantee must include funds to travel one PD/PI and at least one trainee (graduate student or postdoctoral researcher) to the 2-day SRP Annual Meeting occurring in the fall of each year. The location of the meetings (FOA-Focused meeting and SRP Annual Meeting) will rotate among the different SRP grantees and Research Triangle Park, NC.

Research Strategy: Applications should include, as part of their Research Strategy, a clearly stated hypothesis based on a mechanistic bioremediation research question(s). Applicants must describe how the research will advance fundamental knowledge and apply that knowledge to address challenging scenarios where bioremediation may be a solution. Applicants must describe the transdisciplinary science opportunity gained (value-added) from the combination of bioremediation and materials science expertise, including the novelty of the collaboration. Applicants should include success criteria and milestones to evaluate effectiveness of strategy. Applicants should include a brief statement about sustainability considerations including, but not limited to, the following: plans to assess environmental footprint of the tool/device (e.g. life cycle assessment); impacts of the proposed work on the environment (e.g. safety/toxicity of materials used in the process, end of life disposal of byproducts of the system, impacts to ecosystems, and/or implications of genetically engineered organisms, as applicable); and economic/cost advantages of the proposed process.

The following modifications also apply:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. The Data Sharing Plan should describe plans for making data Findable, Accessible, Interoperable, and Reusable (FAIR), including plans to translate project-generated data, products, and resources. This should include a general description of the types of data expected to be generated from the application, an approach for ontology (e.g. identifying/utilizing existing ontologies or developing new ones), a synopsis of proposed data management/sharing activities, and a timeline for sharing data publicly, including integrating with SRP website and/or public databases. Plans for translating findings to end-users (i.e. research translation) may include, but would not be limited to: plans to involve potential end-users throughout the duration of the project; innovative approaches (e.g. social media) to deliver outcomes to broad audiences; coordination with end-users to optimize for cost-effectiveness or sustainability of technology; plans to format SRP-generated data/findings for use in advanced site characterization tools; plans to develop technical guidelines (e.g. standard operating procedures) to aid end-users seeking to adopt the technology; and/or plans for transferring technology and/or incorporating opportunities to broaden the scenarios where the technology may be tested.

Authentication of Key Biological and/or Chemical Resources: Given the biological and materials science structure of this FOA, applicants should describe methods to ensure the identity and validity of biological resources involved in the study (e.g. microbiological, fungal, plant, etc.) as well as authenticity of materials/chemicals used in the application. For projects involving field samples or studies, methods to assure adequate standards/replicates should be described. Applicants may wish to include other aspects of quality assurance and quality control (QA/QC) procedures including, but not limited to:

• A brief description of existing QA/QC procedures (e.g. at the research institution(s) and/or within the laboratory, etc.) including how staff will be trained to implement quality assurance, and who will be responsible for training.
• A brief description of calibration procedures and performance evaluation of key analytical instrumentation.
• References to standard methods (e.g. EPA, National Institute of Standards and Technology (NIST), etc.) utilized as part of the study.
• Discussion of any computer models to be designed or utilized with associated verification and validation techniques.
• Description of procedures for the handling and custody of samples, including sample collection, identification, preservation, transportation, and storage.
• Details of data quality control such as how data will be analyzed (e.g. data/statistical analysis methods and references to software) and managed (collected, backed-up, collated, transferred, stored, documented, and shared, as appropriate). Note: this should not duplicate information provided in the "Data Sharing Plan."

Biohazards: Procedures for proper handling and disposal should be included for biological materials, hazardous chemicals, as well as procedures to ensure safe handling of advanced materials (such as nanomaterials).

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

Section V. Application Review Information

1. Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatment solutions, or services that drive this field?

In addition, specific for this FOA:

If successful, will the project enhance fundamental knowledge, new techniques, and/or the practice of bioremediation? Is the project addressing a critical challenge(s) in bioremediation for which the inclusion of materials science solutions significantly advances the practice? Does the proposed strategy have potential to be applied to just one contaminant and exposure scenario, or would it be applicable/tunable to broader contaminant types or exposure scenarios?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

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

In addition, specific for this FOA:

Are the methods to optimize bioremediation innovative? Are the materials science aspects novel to the field of bioremediation or are they incremental advances to existing practice?

Approach

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

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

In addition, specific for this FOA:

Are success criteria and milestones to evaluate effectiveness clearly articulated and reasonable? Are sustainability impacts of the application reasonable for the stage of research proposed (e.g. environmental safety of materials, end of life disposal of byproducts of the system, and implications of genetically engineered organisms, economic considerations, as applicable)?

Have the investigators described plans to address relevant environmental variables, such as geochemical/ecological conditions, bioavailability, etc?

Environment

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of thecategories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS). Does the Data Sharing Plan adequately describe plans for making data Findable, Accessible, Interoperable, and Reusable (FAIR)? Are the plans for data generation, ontology development, and proposed timeline adequate? Are plans for translating research findings to end-users adequate?

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Environmental Health Sciences. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Representation of a variety of bioremediation approaches, materials, and hazardous substances among the grants responding to this FOA.

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.htmlor call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

3. Reporting

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

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

Section VII. Agency Contacts

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

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

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

Dr. Heather Henry
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3268
Email: [email protected]

Dr. Laura Thomas
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3328
Email: [email protected]

Jenny Greer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3332
Email: [email protected]

Section VIII. Other Information

Awards are made under the authorization of Superfund Amendments and Reauthorization Act of 1986, Title I, Section III, and Title II, Section 209, Public Law 99- 499, as amended; Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, Section 311(a), Public Law 96-510; Public Health Service Act, Section 301, Public Law 78-410, as amended; Public Law 99-500. In addition, awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92; and under the authority in 42 CFR 65.5.