National Institute of Environmental Health Sciences (NIEHS)
- January 5, 2022 - This announcement has been reissued as RFA-ES-22-001
- July 31, 2019 - Notice to Terminate RFA-ES-18-009. See Notice NOT-ES-19-016.
- December 18, 2018 - Notice of Change in Key Dates for RFA-ES-18-009. See Notice NOT-ES-19-005.
- November 26, 2018 - NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Research Grant Applications. See Notice NOT-OD-18-228.
The ultimate goal is to maintain and maximize NIEHS cohort investments within the environmental epidemiology community by supporting the infrastructure needed to prepare for future research opportunities and to promote broader scientific collaborations.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
New Date July 31, 2019 per issuance of NOT-ES-19-016. (Original Expiration Date: December 05, 2020)
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.
Purpose
This Funding Opportunity Announcement solicits grant applications to provide support for the maintenance of existing environmental epidemiology cohorts and their associated biorepositories; for the collection or development of additional measures; to facilitate follow-up of study participants especially during key windows of susceptibility, and to provide a structure to facilitate broader sharing of data and resources with the scientific community. The scope of the application must address a critical research need and strategic interest that aligns with the mission of the NIEHS. Investigators are encouraged to visit the NIEHS website for additional information about the mission and research priorities of the NIEHS http://www.niehs.nih.gov/about/strategicplan/.
Background
The NIEHS has a considerable investment in supporting observational population studies in which groups of people with a set of characteristics or exposures are followed systematically over time to discern the relationships between environmental exposures and health outcomes during different life stages. These studies will be referred to as Environmental Epidemiology cohorts (EEC) and include cohort and case-control design. These studies have helped advance fundamental insights into key environmental, lifestyle, and genetic determinants of environmentally related health outcomes. NIEHS recognizes that EECs are a valuable resource that benefit the entire environmental health community.
The goal of this program is to provide stability to existing EECs by supporting the necessary infrastructure to retain trained field personnel essential to continue ongoing longitudinal data collection, to follow-up study participants, and to preserve the integrity and quality of specimen collection. By creating stable funding for EEC maintenance and to provide an opportunity for data preparation and a structure to facilitate and ensure data sharing, the research community will have greater freedom to pursue new and interesting research directions through other mechanisms.
Scope of the FOA
Each resource grant can focus on two categories of activities: (1) maintenance and resource infrastructure enrichment for existing EECs and (2) enrichment of EEC data management and sharing as appropriate and consistent with achieving the goals of the program. Examples of activities that can be supported under this FOA include, but are not limited to the following:
(1) Maintenance and resource infrastructure enrichment for existing EECs:
Cohort maintenance and related activities:
- Ongoing recruitment and retention of the target study population.
- Expansion of recruitment to enroll special populations to enhance the breadth of the science or power of the cohort.
- Re-consenting of participants for broad data sharing as appropriate and consistent with achieving the goals of the program.
- Continuation and enhancement of sample collection and management of existing biorepositories and environmental sample repositories.
- Continuation and enhancement of community engagement and outreach activities.
Enrichment of resource infrastructure within the cohort:
- Development and implementation of biospecimen collection, processing and preservation methods to enhance efficiency, yield, reproducibility and stability.
- Validation of exposure and or health outcome data to improve exposure disease classification. For example, assessing the comparability of self-reported data versus medical record or biomarker information, or the assessment of how well a biomarker measured through non-invasive means compares to gold standard or other target tissue or other standards. This also may include an opportunity to integrate or validate emerging exposure or exposure response technologies.
- Development and testing of new methods to improve/enhance exposure classification to short-lived chemicals, multiple chemicals, nonchemical stressors, cumulative exposures or exposure to mixtures. For example, repeated urinary sampling to improve assessment of short-lived compounds, testing other biological or questionnaire assessments to enhance measures of stress such as cortisol or teleomere length.
(2) Enrichment of EEC data management and sharing:
Development of infrastructure to support broad sharing of data, including activities related to making data findable, accessible, interoperable and reusable such as:
- Implementation of an improved quality assurance and quality control plan across the full data lifecycle, including the identification and handling of potentially erroneous or missing values.
- Enabling data discovery and integration through development and utilization of standard, unambiguous terminology. This includes creation or enhancement of data dictionaries and ontologies. The use of descriptive terms from existing biomedical ontologies (e.g. NCBO BioPortal, https://bioportal.bioontology.org) is highly encouraged.
- Development and application of methodologies to support interoperability of EEC data with other relevant data sets, including implementation of common data and metadata standards and evaluation of their utility to support data integration.
- Formatting and depositing individual-level de-identified data in an existing repository.
- Development and implementation of a searchable web-based platform for data sharing and integration.
- Linkage and integration of multiple data sets from different sources such as health records and environmental data sources.
- Development or implementation of techniques for data visualization and/or big data analytics.
Applicants are encouraged to bring in new expertise in areas including data architecture, database administration, information science, data science, and data engineering.
To be responsive to this FOA, applications must include significant activities for enrichment of EEC data management and sharing ?w?i?t?h? ?d?a?t?a? milestones.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Resubmission
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Need help determining whether you are doing a clinical trial?
NIEHS intends to commit $2.5 million in FY2019 to fund 5-6 awards. Future year amounts will depend on annual appropriations.
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)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- System for Award Management (SAM) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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
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)
1. Requesting an Application Package
Buttons to access the online ASSIST system or to download application forms 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
It is critical that applicants follow the instructions in the Research (R) 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.For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
The letter of intent should be sent to:
Dr. Linda K. Bass
Telephone: 984-287-3236
Fax: 919-541-2503
Email: [email protected]
All instructions in the SF424 (R&R) Application Guide must be followed.
Specific Aims: Provide specific aims for the maintenance and enhancement of the cohort, as well as methods to facilitate broader use of data and sample resources.
Research Strategy: The Research Strategy must consist of the following sections:
Cohort Overview
- Overall description and summary of the proposed EEC.
- Summary describing the EEC accomplishments related to both the infrastructure and the supported research including clinical and public health significance of the research using this cohort. Include a summary of the population, enrollment over time, data and biological specimen collection, and follow-up of cohort since the past project period. If a data sharing plan was implemented, include a report describing any or all data sharing activities.
- The application should describe in detail the scientific rationale for the need to continue this cohort and the value and opportunities to the broader research agenda that this cohort will be designed to support in the immediate, intermediate, and long-term time frame.
Action Plan for Cohort Maintenance and Resource Infrastructure Enrichment
- Cohort Maintenance: The application must clearly define catchment area or sampling frame and what activities are necessary to achieve the goals of the resource as well as justify the new study questions, additional recruitment and or sample/data enhancement.
- Resource Infrastructure: The application must describe the research team's plan for resource infrastructure enhancements aimed to support validation of data, improved exposure characterization, data preparation within cohort and data preparation for data linkage and across cohort collaborations.
Action Plan for Enrichment of EEC Data Management and Sharing
- The application should describe how the proposed enhancements will facilitate broader sharing of data with the scientific community.
- The application must clearly describe the methods used to make data findable, accessible, interoperable, and reusable. As appropriate, describe efforts for harmonization and alignment with existing (meta)data standards.
- Description of milestones and timelines for making data publicly available.
Leadership and the Administrative Core
- Leadership: The use of the multiple PD/PI is strongly encouraged. Since this application includes a strong data infrastructure component, appropriate expertise should be included to complement the scientific oversight and leadership.
- Administrative Core: Describe the administrative model for the proposed activities, including responsibilities for communication, decision making, and oversight. Please provide a summary of the types and funding sources that were used to establish and maintain EEC to date.
The following modifications also apply:
All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan. The plan should include the following items:
- Statement of the investigator's commitment to share data.
- Description of the type and amount of digital data to be managed over the life of the proposed project.
- Description of the data to be shared and the rationale for selecting those data for sharing (i.e. raw vs processed data, aggregate vs individual level data).
- Description of data standards, including formats, data identifiers, metadata and other data documentation to be used for collected data and rationale for their selection.
- Description of mechanisms for providing access to or sharing data. Use of publicly accessible data repositories is encouraged.
- Description of tools, including software, needed to access and/or interpret the data.
- Delineation of who will be responsible for data management, both during data collection and analysis and after the completion of the project, if applicable.
- Provisions for reuse and redistribution of the data.
- Description of timelines and metrics for data sharing.
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.
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)
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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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.
Section V. Application Review Information
Important Update: See NOT-OD-18-228 for updated inclusion and human subjects review language for due dates on or after January 25, 2019.
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.
For this particular announcement, note the following:
The R24 seeks to support research projects contributing to improvement of the capability of studies and to develop resources to serve biomedical research. Since the science is limited, the grant application will contain details about the value of the cohort as it relates to the success of the research conducted using the cohort, the level of innovation, and the potential to significantly advance biomedical research, the opportunities that may arise by supporting the continuation of cohort to others and unique contribution to the field.
Reviewers will emphasize the base of science and knowledge created using the extant Environmental Epidemiology Cohort, the opportunity for future collaboration outside the applicant's network of collaborators, the quality of the existing data collected and the added value to continue support. Reviewers will look at past progress of grants using cohort, publications, and science translation.
Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?
Specific to this FOA: How will maintenance of the cohort improve scientific knowledge and improve public health? How will the project improve access to the cohort data and resources for the broader scientific community? How will the successful completion of the proposed aims provide knowledge to advance current research concepts, methods, technologies or prevention strategies in the field of environmental health?
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?
Does the applicant have experience overseeing selection and management of subawards, if needed?
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?
Specific to this FOA: Does the proposed EEC infrastructure have the ability to support innovative and yet broad research agenda? Are they proposing to use state-of-the-art tools and technologies to maintain and or enhance cohort recruitment/attainment, collect relevant environmental exposure data and biological samples to assist in improved exposure characterization, and manage cohort data? Have they developed a cogent and operable process, policy and infrastructure to support broad sharing of cohort data and biological specimens?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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 children, justified in terms of the scientific goals and research strategy proposed?
For data sharing plan, reviewers will evaluate each of the elements of the plan and whether the proposed plan will likely lead to broader sharing of the data.
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?
Are resources available within the scientific environment to support electronic information handling?
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 Guidelines for the Review of Human Subjects.
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 children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Not Applicable
Not Applicable
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Sharing Model Organisms; and (2) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
- 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.
- 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.
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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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’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.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights 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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or 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
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
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 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]
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3262
Email:[email protected]
Christopher G. Duncan, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3256
Email:[email protected]
Linda K. Bass, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3236
Email:[email protected]
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3261
Email:[email protected]
