Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Environmental Health Sciences (NIEHS)

Funding Opportunity Title

Innovative Bioavailability Assays to Assess the Effectiveness of Contaminated Sediment Remediation (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • December 1, 2010 - See Notice NOT-ES-11-002 Notice of Informational Web Seminar.

Funding Opportunity Announcement (FOA) Number

RFA-ES-11-005

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestics Assistance (CFDA) Number(s)

 93.113, 93.143

FOA Purpose

The National Institute of Environmental Health Sciences (NIEHS) invites qualified investigators from domestic institutions of higher education to submit an application for a Superfund Research Program (SRP) Individual Research Project Grant (R01).  This funding opportunity announcement (FOA) encourages the research community to develop innovative bioavailability assays to determine the effectiveness of contaminated sediment remediation.  

Key Dates
Posted Date
Open Date (Earliest Submission Date)

January 17, 2011

Letter of Intent Due Date

January 18, 2011

Application Due Date(s)

February 17, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

June 2011

Advisory Council Review

August 2011

Earliest Start Date(s)

September 1, 2011

Expiration Date

February 18, 2011

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The mission of the National Institute of Environmental Health Sciences (NIEHS) is to promote research that will ultimately reduce the burden of human illness and dysfunction from environmental causes.  The 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 program 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 toxicity of hazardous substances.

In keeping with the broad research themes of the program mandates, the SRP endorses a holistic approach to understanding risks and developing solutions for the safe management of hazardous substances with the ultimate goal of improving public health.  Remediation efforts are primarily driven by risk-based clean up goals which are intended to protect humans and ecosystems from the negative effects of hazardous substances.  As part of a public health organization, the SRP has an opportunity to ensure that the remediation has been effective in protecting human health, referred to here as “remediation effectiveness.”

Remediation effectiveness is particularly difficult to assess in contaminated sediments because of the vast spatial and temporal scales involved in aquatic ecosystems as well as the complex human exposure pathways.  While there are some challenges associated with evaluating the remedy performance (i.e. achievement of sediment cleanup levels maintained over time), it is much more difficult to demonstrate a short-term reduction in biological receptors (e.g. reduced fish and shellfish tissue levels) and predict long-term reductions.  Therefore, it is unclear if efforts and expense involved in sediment site remediation will diminish long-term human health consequences.

At the basis of this challenge is the difficulty in measuring bioavailability.  Bioavailability refers to the individual physical, chemical, and biological interactions that determine the exposure of biota to chemicals associated with soils and sediments.  Numerous processes can combine in varied aquatic environments to affect the bioavailability of contaminants in sediments and their subsequent uptake by organisms at all levels of the food web.  In theory, reduction in contaminant bioavailability can be a critical achievement for remediation approaches to effectively protect health.  As a remediation strategy reduces the bioavailable portion of a contaminant, there is a subsequent reduction in uptake and exposure, and therefore, toxic effect.  However, new tools are needed to assess bioavailability linking mechanistic understanding (e.g., molecular form of contaminant) to the rates of release from sediments (e.g., rate of transfer to the aqueous phase), and pathways of biouptake.  Furthermore, these tools must be robust, reproducible, and defendable against challenges associated with contaminated sediment sites such as multiple contaminants and sources; variety of operations; patchwork of areas; extended period of implementation, etc.

Purpose

This Funding Opportunity Announcement (FOA) calls for the development of innovative assays of bioavailability that may be used to determine the effectiveness of sediment remediation in reducing risks to humans.  By utilizing tools applicable in a remediation scenario, there is an implication that these techniques are useful for more than just initial site assessment or risk characterization.  Rather, these tools also target downstream effects that indicate a reduction in risk to humans has been accomplished as a result of the remediation application.  For example, the assay would provide an early indication of a reduction in food chain transfer with data outputs useful for human exposure assessment.  The ultimate goals of this FOA are two-fold: first, to develop and introduce new tools to assess whether remediation efforts are protective of human health; and second, to increase use of bioavailability in risk assessment through providing scientifically-valid, practical, and cost-effective tools.

Scope of Research

SRP encourages an interdisciplinary approach to this FOA including, in addition to assay development, expertise in remediation technology, pathways of exposure, fate and transport, etc.  Applicants should:

Suggested research areas that would be applicable to determining the effectiveness of a remediation strategy in reducing bioavailability include but are not limited to the following:

Measures of bioavailability may include but would not be limited to chemical, biological, geochemical, or geophysical processes such as: novel extractions techniques, mineral analyses, element speciation, stable isotope analysis, molecular techniques, etc.  Investigators are encouraged to utilize innovative technologies, devices, and platforms such as high throughput approaches, -omics, in vitro testing, lab-on-chip, advanced imaging/spectroscopy, in situ passive samplers, biomimetic techniques, etc.  Use of multiple assays for cross-validation of bioavailability measures is encouraged.  Utilization of state-of the-science predictive modeling (e.g. partition modeling) in conjunction with an assay development / validation study is encouraged; however, development of new predictive models alone will not be responsive to this FOA.  Proposals for biomarker development without clear linkages to contaminated sediment risk assessment / management will not be considered responsive to this FOA. 

Researchers may consider assay development for ongoing remedial strategies, but are also encouraged to develop tools appropriate for assessing effectiveness of new remedial technologies.  As many new (particularly in situ) remediation approaches target bioavailability reduction, tools to verify reduction in exposure risk may enhance regulatory acceptance of that technique.  For the purposes of this FOA, remediation effectiveness is defined as a reduction in risk to human health relative to initial baseline levels and/or relative to background levels of contamination as a result of remediation activity.  Although numerous phenomena could influence remediation effectiveness (e.g. erosion of caps, recontamination, or misplaced dredging), this FOA is limited to proposals that address bioavailability.

As applicable, researchers are encouraged to work with sediment sites undergoing remediation.  This may involve utilization of sediment samples for laboratory-based experiments; utilization of a conceptual site model as a basis for developing the most effective detection technologies; or utilization of field/sampling data from such sites.  Use of archived samples is also encouraged, provided sample preservation has been sufficiently robust for the characteristics being measured. 

For the purposes of this FOA, applications should address hazardous substances that are of concern at contaminated sediment sites including, but not limited to, the following: dioxins, metals (particularly mercury), polychlorinated biphenyls (PCBs), polycyclic aromatic hydrocarbons (PAHs).  Persistent, bioaccumulative and toxic (PBT) contaminants are highly relevant to this FOA due to their role in human exposure risk related to contaminated sediments.  Although the driver of remedial efforts for contaminated sediments is usually the human exposure risk due to fish/shellfish consumption, applications proposing research on other exposure pathways are acceptable provided there is a plausible (or, for field sites, a demonstrated) exposure risk to humans.  Proposals must be relevant to human exposure risk/endpoints; therefore, tools and assays addressing ecological risk assessment (e.g. community analyses, ecological diversity indicators) are not responsive to this FOA.

SRP encourages applicants to refer to the SRP Strategic Plan (http://tools.niehs.nih.gov/srp/about/Strategic%20Plan.pdf), which outlines priorities and direction of the program for the next five years.  In particular, SRP encourages networking among grantees and between grantees and stakeholders as a mechanism to maximize the relevance and impact of the research program.  Hence, investigators are encouraged to explore opportunities for interacting with other grantees and stakeholders of shared research interests.  (SRP’s primary stakeholders are its sister Superfund programs at EPA and ATSDR.  Additional stakeholders include other federal agencies, state, local, and tribal entities responsible for the myriad sites impacted by hazardous substances, as well as the individuals and communities living near hazardous waste sites.)  SRP encourages investigator-initiated research translation as a way to accelerate the application of research advances for use by end-users.  As relevant to this FOA, investigators should interact with field practitioners in the development of their assays to ensure that the data outputs are useful in informing risk assessment and management.  Lastly, SRP encourages innovative approaches to technology development through trans-disciplinary research (synthesis and extension of disciplinary boundaries) as well as utilizing cutting-edge research tools.

Please note: applicants proposing demonstration of tools with commercial potential should consider applying for the SRP Small Business Innovation Research / Small Business Technology Transfer Research (SBIR/STTR) Grants (R43-44/R41-42) (http://www.niehs.nih.gov/research/supported/programs/sbir/hwaerp.cfm).

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIEHS intends to commit in FY 2011 $1.6 million for approximately 5 - 6 awards.  

Award Budget

An applicant may request a budget for direct costs up to $200,000 per year. Facilities and Administrative (F&A) costs requested by third party consortia or subcontracts are not included in the direct cost limitation; see NOT-OD-05-004, November 2, 2004.

Award Project Period

Scope of the proposed project should determine the project period. The maximum period is 3 years.  

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

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

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

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

Section 311(a)(3) of the Superfund Amendment Reauthorization Act (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.  

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

For Courier delivery:

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

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

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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 Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). 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 by the Center for Scientific Review and responsiveness by NIEHS, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Annual Meeting

It is the intent of the NIEHS to hold annual grantee meetings. Funds for travel by appropriate staff (i.e., Principal Investigator and a student) to attend a three-day meeting shall be included in the budget for each year.  The location of the meeting site will rotate among the different SRP grantees and Research Triangle Park, NC. A report of attendees at the annual meeting is required in the non-competing continuation progress report.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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, treatments, services, or preventative interventions that drive this field?  If successful, would the project provide data, information, and knowledge to inform the risk assessment and remediation management processes for contaminated sediment sites?  Will the project provide a rigorous scientific basis for effective decision-making? If the project were successful, would it lead to incremental advance, or would it provide a substantial step forward?

Investigator(s)    

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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? Are the appropriate areas of expertise represented among co-investigators or collaborators to adequately address the interdisciplinary nature of this FOA?

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?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

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?   

Additional Review Criteria

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

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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.

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

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  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Heather Henry, Ph.D.
Program Officer
Center for Risk and Integrated Sciences
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
P.O. Box 12233 K3-04
Research Triangle Park, NC 27709
Telephone:  919-541-5330
Email:  henryh@niehs.nih.gov

Peer Review Contact(s)

Sally E. Eckert-Tillotta, Ph.D.
Scientific Review Officer
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
P.O. Box 12233; Mail drop K3-03
Research Triangle Park, NC 27709

For Courier delivery:
530 Davis Drive, Room 3076
Research Triangle Park, NC 27560
Telephone: 919- 541-1446
Email: eckertt1@niehs.nih.gov

Financial/Grants Management Contact(s)

Lisa Archer Edwards, M.B.A.
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
111 T.W. Alexander Drive
P.O. Box 12233, K3-11
Research Triangle Park, North Carolina 27709
Telephone: 919-541-0751
FAX: 301-451-5334
E-mail: archer@niehs.nih.gov

Michelle Victalino
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
P.O. Box 12233, K3-11
Research Triangle Park, North Carolina 27709
530 Davis Dr. Keystone Bldg. Rm 3047
Morrisville, NC 27560
Telephone: 919-316-4666
E-mail: victalinom@niehs.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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.


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