Department of Health and Human Services

Participating Organization(s)
National Institutes of Health (NIH)
Components of Participating Organizations
National Institute of Environmental Health Sciences (NIEHS)
Funding Opportunity Title
Transition to Independent Environmental Health Research (TIEHR) Career Award (K01 Independent Basic Experimental Studies with Humans Required)
Activity Code
K01 Research Scientist Development Award - Research & Training
Announcement Type

New

Related Notices
  • July 22, 2019 - Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020. See Notice NOT-OD-19-109.
Funding Opportunity Announcement (FOA) Number
PAR-19-225
Companion Funding Opportunity

PAR-18-261, Transition to Independent Environmental Health Research (TIEHR) Career Award (K01 - Clinical Trial Required)

PAR-18-291, Transition to Independent Environmental Health Research (TIEHR) Career Award (K01-Clinical Trial Not Allowed)

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

93.113

Funding Opportunity Purpose

The Transition to Independent Environmental Health (TIEHR) Career Award is a 3-year bridge scholar development program for newly independent faculty who intend to pursue research careers in environmental health sciences. At the conclusion of the career development period the candidates are expected to demonstrate they can successfully compete for research funding in the environmental health sciences.

Note:

This Parent Funding Opportunity Announcement is for basic science experimental studies involving humans, referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants.” These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Studies conducted with specific applications toward processes or products in mind should submit under the companion ‘Independent Clinical Trial Required’ PAR 18-261

Posted Date

March 19, 2019

Open Date (Earliest Submission Date)
May 12, 2019
Letter of Intent Due Date(s)
Not Applicable
Application Due Date(s)

 Standard dates apply , by 5:00 PM local time of applicant organization.. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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.

AIDS Application Due Date(s)

Standard AIDS dates apply ,  by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

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.

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date
January 08, 2022
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the Career Development (K) Instructions in the SF424 (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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objective of the NIH Mentored Research Scientist Development Award (K01) is to provide salary and research support for a sustained period of “protected time” (3-5 years) for intensive research career development, under the guidance of an experienced mentor, or sponsor in the biomedical, behavioral or clinical sciences leading to research independence. The expectation is that, through this sustained period of research career development and training, awardees will launch independent research careers and become competitive for new research project grant (e.g., R01) funding.

The objective of the Transition to Independent Environmental Health Research (TIEHR) Career Award (K01) is to provide support to outstanding biomedical basic, behavioral or clinical investigators who are within the first 3 years of their first independent faculty appointment to develop their independent research skills through a 3-year bridge scholar development program for newly independent faculty. This award is intended to provide junior faculty with pilot funding and salary support during this critical period of career development so that the candidate can further develop his/her independent research program and, subsequently, successfully compete for research funding in the environmental health sciences at the completion of the award.

Candidates must name a mentor who has active NIEHS grant support or a substantial history of NIEHS funded research grant support to provide appropriate guidance, advice and expertise to broaden the research skills of the candidate and assist in the formation of an advisory committee to the candidate and the candidate's research.

Research projects and career development activities proposed for this FOA are expected to contribute to the mission of the NIEHS, which is to discover how the environment affects people in order to promote healthier lives.

Candidates to the TIEHR program are expected to be drawn from a variety of scientific backgrounds, including basic, mechanistic, clinical, epidemiological, computational, engineering, and/or health risk communication research. Applications submitted to the NIEHS are characterized by a research focus on exposure-health related responses from environmental agents within the mission interest of the NIEHS.

Environmental agents which are considered of primary interest for NIEHS include: industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants, particulates or fibers, fungal, and bacterial or biologically derived toxins. NIEHS also supports research which is aimed at defining health effects of the exposome, or the totality of a person’s environmental exposure, and the study of the health effects of mixtures or co-exposures with agents generally outside of NIEHS mission responsibility, if the primary goal of the study is on an exposure within the NIEHS mission interest. Agents that are considered outside the primary mission responsibility of NIEHS include, but are not limited to: alcohol, chemotherapeutic agents, radiation that is not a result of an ambient environmental exposure, smoking, except when considered as a secondary smoke exposure as a component in the indoor environment (particularly in children), drugs of abuse, pharmaceuticals, dietary nutrients, and infectious or parasitic agents. Applicants are strongly encouraged to contact NIEHS Scientific/Research staff prior to submission to determine if their project meets the goals of the TIEHR.

All applications submitted to this Funding Opportunity Announcement must propose basic science experimental studies involving humans, otherwise referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants,” that fall within the NIH definition of a clinical trial and also meet the definition of basic research. 

NIH defines basic research consistent with the definition of basic research in federal code, “the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind.” (32 CFR 272.3).

NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." (NOT-OD-15-015).

Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.  

For the purposes of this FOA, “specific application towards processes or products” refers to the application of biomedical or behavioral products, procedures, or services intended to affect a health-related outcome of the individual or a group of individuals either by better understanding the mechanism of action of an intervention or a measurable improvement in health. 

Basic experimental studies in which participants are prospectively assigned to experimental conditions and receive an intervention or experimental manipulation where the effect will be assessed for the purpose of understanding fundamental aspects of phenomena should submit under this FOA. Please refer to the table comparing Funding Opportunity Types by Clinical Trial Allowability for additional guidance on the most appropriate FOA for the type of study.

Prospective studies with humans conducted with specific applications towards processes or products in mind, including FDA Phase 0 or 1 studies, mechanistic clinical trials (e.g., those that examine the mechanisms by which an intervention works or the processes that account for an intervention's effects on clinical outcome), and safety and efficacy studies should submit under the companion announcement, PAR---18-261, TIEHR Independent Clinical Trial Required , but not under this FOA.  

 Observational studies involving humans should submit under the ‘'Independent Clinical Trial Not Allowed’ FOA. 

See Section VIII. Other Information for award authorities and regulations.
Funding Instrument
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed
New
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?

Required - Basic Experimental Studies with Humans: Only accepting applications that propose independent clinical trial(s) that also meet the definition of basic research.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget
Award budgets are composed of salary and other program-related expenses, as described below.
Award Project Period
The total project period may not exceed 3 years.

Other Award Budget Information

Salary

NIH will contribute up to $75,000  per year toward the salary of the career award recipient. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide.See also NOT-OD-17-094. 

The total NIH contribution to salary, however, may not exceed the legislatively mandated salary cap.  See: http://grants.nih.gov/grants/policy/salcap_summary.htm

Other Program-Related Expenses
NIEHS will contribute $50,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

Indirect Costs
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

1. Eligible Applicants

Eligible Organizations

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)
.
Foreign Institutions
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. 
Required Registrations

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.
  • 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.

Eligible Individuals (Program Director/Principal Investigator)

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and 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. Multiple PDs/PIs are not allowed.

Candidates must be within 3 years of their appointment to their first independent faculty position at the time of submission (receipt date) of the application. Criteria to address in determining whether the position is considered independent are listed below.  Candidates whose position is not tenure track must demonstrate institutional commitment and include documentation from the institution that the candidate has independent laboratory and/or other space, and that the position satifies the other criteria for independence including that the position:  1)  qualifies the candidate to hire postdoctoral fellows and be the responsible supervisor of graduate students;  2)  allows the candidate to attend and participate in faculty meetings;  3)  allows the candidate to apply for independent research funding as the principal investigator of an NIH R01 or equivalent research grant;  4)  is not contingent on the award of this grant application.

Applications from newly appointed faculty who have received start-up packages from their institution, which includes institutional salary support, are eligible and encouraged to apply.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).
Current and former PDs/PIs on NIH research project (R01), program project (P01), center grants (P50), sub-projects of program project (P01), sub-projects of center grants (P50), other major individual career development awards (e.g., K01, K07, K08, K22, K23, K25, K76, K99/R00), or the equivalent are not eligible. Current and former PDs/PIs of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible, as do PD/PIs of Transition Scholar (K38) awards and individuals appointed to institutional K programs (K12, KL2).

Candidates for the K01 award must have a research or health-professional doctoral degree.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, 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)
Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the career award application. K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.
Level of Effort
At the time of award, the candidate must have a “full-time” appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development during the mentored phase. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program. 

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.

After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances.  See NOT-OD-09-036 for more details.

 

Before submitting the application, the candidate must identify a mentor who will guide the proposed career development and research experience. The mentor should have active NIEHS grant support or a substantial history of NIEHS funded grant support.

The mentor may be at the same or different institution than the candidate. The candidate's previous postdoctoral mentor or any other person who has been the mentor or research supervisor for the candidate may not be named as as the mentor for the candidate on the TIEHR award. The mentor, or a member of the team of mentors, should have a successful track record of mentoring. Candidates are encouraged to identify more than one mentor, i.e., a team of mentors, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the principal mentor who will coordinate the candidate’s career development experience. The candidate must work with the mentor(s) in preparing the TIEHR application and the subsequent R01 application. The principal mentor should also agree to: (1) assist in the establishment of an advisory committee with appropriate research expertise for the candidate; (2) attend at least two meetings of the advisory committee, including one to provide feedback on an R01 draft of a grant submission; (3) mentor the candidate at meetings largely attended by other NIEHS grantees.

Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.

The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research and clinical trial.

Institutional Environment
The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.

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 Career Development (K) 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.

Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Project Summary/Abstract

Include a description of your current research, the research you propose during three year TIEHR career development award, and a summary of the proposed career development activities.

SF424(R&R) Senior/Key Person Profile Expanded
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Career Development Award Supplemental Form
The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

Candidate

Research Plan

Other Candidate Information

Mentor, Co-Mentor, Consultant, Collaborators

Environment & Institutional Commitment to the Candidate

Other Research Plan Sections

Appendix

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

 

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

Candidate Information and Goals for Career Development

Candidate’s Background

  • Describe the candidate’s commitment to a career in an area of environmental health science relevant to the mission of the NIEHS.
  • Explain how the career award will contribute to career goals, and further the candidate’s research career and ultimate impact on science.
  • Provide evidence of the candidate's potential to develop into a successful independent investigator. Usually this is evident from publications, prior research interests and experience, and letters of reference

Career Goals and Objectives?

  • Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the research and career development experiences that will occur during the career award period and (2) that justifies the need for further career development to advance the candidate's career as a new independent investigator in the environmental health sciences.
  • The candidate must demonstrate they have received training or will participate in courses such as: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects and clinical trials.

Candidate’s Plan for Career Development/Training Activities During Award Period

  • The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline is often helpful. The mentor may form a mentoring team (in addition to the advisory committee) to assist with the development of a program of study and the plan to monitor the candidate's progress through the career development program.
  • The didactic (if any) and the research aspects of the plan must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate's career goals.
  • Describe the professional responsibilities/activities including other research projects beyond the minimum required 9 person-months (75% full-time professional effort) commitment to the career award. Explain how these responsibilities/activities will help ensure career progression to further their career as an independent investigator.

 

 

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

Research Strategy

  • A sound research project that is consistent with the candidate’s level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research.
  • If the candidate is at the same institution as the former postdoctoral or other research mentor the application must also describe the relationship between the former mentor's research and the candidate’s proposed research plan. Independence must be demonstrated, and the proposed mentor should be scientifically independent of the previous mentor. The application should also describe how the research plan carried out during the 3-year transition phase will be used to develop a research grant submission. It is expected that an R01 research grant submission will be an outcome of the career development plan in the third year.

 

Training in the Responsible Conduct of Research

  • All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.
 

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

Plans and Statements of Mentor and Co-mentor(s)

  • The candidate must name a primary mentor, who, together with the candidate, who will provide advice and input into the planning, direction, and execution of the program. The candidate may also identify co-mentors as appropriate to the goals of the program.
  • The mentor(s) should be recognized as an accomplished investigator in environmental health sciences and have a track record of success in training and mentoring individuals who have gone on to become successful, independent investigators.
  • The mentor(s) should have a record of independent research support in the environmental health sciences.
  • The application must include a statement from the mentor providing: (1) information on his/her research qualifications and previous experience as a research mentor; (2) a plan that describes the nature of the mentoring that will occur during the proposed award period, including how the candidate’s independent scientific and professional career will be promoted; (3) a description of the elements of the planned research career development, including any formal course work; (4) a plan for the formation and functioning of the Advisory Committee; (5) a plan for transitioning the candidate from the current research focus of his/her career to the proposed research area, including the development of the R01 application of the candidate as an independent investigator during the project period of the award
  • The primary mentor(s) must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report and act as a mentor for the candidate to present his/her research at meetings largely attended by NIEHS grantees if the candidate is not a member of that professional society.
  • If more than one mentor is proposed, the respective areas of expertise and responsibility should be described.
  • Advisory Committee members may be established faculty at either the candidate’s institution or at another institution. Members should be chosen for their expertise in the research project proposed by the candidate. The research expertise to be sought in the Advisory Committee should be described. This Advisory Committee should meet fomally 6 months after the issuance of the award to asess progress, and 18 months after the award to provide feedback on the draft of a research project grant submission.

  • The mentor or mentoring team must provide evidence of expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed clinical trial, ancillary or feasibility study and help him/her to meet timelines.

Letters of Support from Collaborators, Contributors and Consultants

  • Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Unless also listed as senior/key personnel, collaborators and consultants do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. 
  • Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee.  These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute.  Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches. 
 

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

Description of Institutional Environment

  • The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate. 
  • Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
  • Describe the resources and facilities that will be available to the candidate, including any clinical trial-related resources, such as specialized administrative, data coordinating, enrollment, and laboratory/testing support.  If applicable, include a description of the resources and facilities available at international sites.

Institutional Commitment to the Candidate’s Research Career Development

  • The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
  • Provide assurances that the candidate will be able to devote the required effort to activities under this award.The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist.
  • Provide assurances that the candidate will have access to independent office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed research plan.
  • Provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development plan.
  • Provide assurances that the candidate holds an independent faculty position not contingent on receipt of this K01 award.

Appendix:

Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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, with the following additional instructions:

Section 1- Basic Information

1.4 Clinical Trial Questionnaire

Applications to this FOA must propose a study that falls within the NIH definition of a clinical trial and also meets the definition of basic research. Consequently, applicants must answer "yes" to the four questions on 1.4 Clinical Trial Questionnaire and complete the subsequent form fields accordingly.

 

Delayed Onset Study

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).

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.

Reference Letters

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov. 

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) using ASSIST or other electronic submission systems. 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 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.

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

Applications will be evaluated for programmatic responsiveness by the NIEHS, NIH. Applications that are nonresponsive will not be reviewed.

Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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.

Reviewers should evaluate the candidate’s potential for developing an independent research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.

For this particular announcement, note the following:The reviewers will consider that the clinical trial may include study design, methods, and intervention that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the possibility that research support provided through K awards may be sufficient to support only small feasibility studies.

Overall Impact
Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.
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.
 
  • Does the candidate have the potential to develop as an independent and productive researcher? 
  • Are the candidate's prior training and research experience appropriate for this award? 
  • Is the candidate’s academic, clinical (if relevant), and research record of high quality? 
  • Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in research? 
  • Do the reference letters address the above review criteria, and do they provide evidence that the candidate has a high potential for becoming an independent investigator.
  • Does the candidate have the potential to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study?  
  • Does the candidate have training (or plans to receive training) in data management and statistics including those relevant to clinical trials?

Career Development Plan/Career Goals and Objectives/Plan to Provide Mentoring

  • What is the likelihood that the plan will contribute substantially to the scientific development of the candidate and lead to scientific independence? 
  • Are the candidate's prior training and research experience appropriate for this award? 
  • Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence? 
  • Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?
  • If proposed, will the clinical trial experience contribute to the applicant’s research career development?

 

  • Are the proposed research question, design, and methodology of significant scientific and technical merit?
  • Is the prior research that serves as the key support for the proposed project rigorous?
  • Has the candidate included plans to address weaknesses in the rigor of prior research that serves as the key support of the proposed project?
  • Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
  • Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
  • Are the proposed research question, design, and methodology of significant scientific and technical merit?
  • Is the research plan relevant to the candidate’s research career objectives?
  • Is the research plan appropriate to the candidate's stage of research development and as a vehicle for developing the research skills described in the career development plan?
  • Will the research plan proposed likely result in a proposal for independent research funding during the third year of the award?
  • Will the proposed research lead to an independent line of research for the candidate?
  • Are the scientific rationale and need for a clinical trial, feasibility or ancillary study well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?
  • If proposing a small feasibility study, is the study warranted and will it contribute to planning and preliminary data needed for design of future larger scale clinical trials?
  • Is the clinical trial or ancillary study necessary for testing the safety, efficacy or effectiveness of an intervention, or in the case of a feasibility study necessary to establish feasibility of future clinical trial?
  • Is the study design justified and relevant to the clinical, biological, and statistical hypothesis(es) being tested?
  • Are the plans to standardize, assure quality of, and monitor adherence to, the protocol and data collection or distribution guidelines appropriate?
  • Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions, if interventions are delivered?
  • For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

  • Are the qualifications of the mentor(s) in the area of the proposed research appropriate? 
  • Does the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement? 
  • Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate? 
  • Is the mentor’s description of the elements of the research career development activities, including formal course work adequate? 
  • Is there evidence of the mentor’s, consultant’s, and/or collaborator’s previous experience in fostering the development of independent investigators? 
  • Is there evidence of the mentor's current research productivity and peer-reviewed support? 
  • Is active/pending support for the proposed research project appropriate and adequate? 
  • Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?
  • Are the sponsor's plans for the establishment of the advisory committee adequate?
  • ?Is there adequate evidence that the mentor(s) or other research collaborators will separate themselves from the research project by the third year of the award to allow the candidate to pursue the project as his/her own independent research?
  • If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development  , is there evidence of the appropriate expertise, experience, and ability on the part of the mentor(s) to guide the applicant during participation in the clinical trial?
  • Does the mentor or mentoring team have the expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet timelines?  
     

Environment & Institutional Commitment to the Candidate

  • Is there clear commitment of the sponsoring institution to ensure that a minimum of 9 person-months (75% of the candidate’s full-time professional effort) will be devoted directly to the research and career development activities described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities? 
  • Is the institutional commitment to the career development of the candidate appropriately strong? 
  • Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate? 
  • Is the environment for the candidate’s scientific and professional development of high quality? 
  • Is there assurance that the institution intends the candidate to be an integral part of its research program as an independent investigator?
  • Are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
  • Does the application adequately address the capability and ability to conduct the trial feasibility or ancillary study at the proposed site(s) or centers? If applicable, are there plans to add or drop enrollment centers, as needed, appropriate?
  • If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
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 score, but will not give separate scores for these items.

 

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

 

For research that involves human subjects but does not involve one of the 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 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.

 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.

 

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

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 score.

 

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).

 

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).  Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years.  Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.

 

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).

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.

 

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), 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.

As part of the scientific peer review, all applications:

  • 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 on the basis of established PHS referral guidelines 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 appropriate national Advisory Council or Board.
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

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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

Per NOT-OD-19-055, recipients must provide NIH with a certification that all non-exempt human subjects research has been reviewed and approved by an appropriate IRB. The date of final IRB approval is the date that all protocols in the proposed research application received IRB review and approval (i.e., the date of the last protocol approval). When human subjects research is anticipated within the period of the award but definite plans for involvement of human subjects cannot be described in the application or proposal (referred to as "delayed onset human subjects research"), prior to the involvement of human subjects in non-exempt research, the recipient must submit to the NIH awarding IC for prior approval (1) detailed information as required in the Human Subjects and Clinical Trials Information Form of the application, as well as the certification and date of final IRB approval.

Under no circumstances may NIH-supported non-exempt human subjects research be initiated prior to meeting the requirements for conducting an IRB review of protocols as well as obtaining the date of final IRB approval.NIH will not allow any funds to be used by recipients where a certification and an IRB approval date has not been provided to the funding IC.

Recipients are also reminded that any changes to study protocols that have been subject to peer review, as well as the addition of new study protocols, require the prior approval of the NIH awarding Institute or Center consistent with Section 8.1.2.5 of the NIHGPS. Such requirements are also generally described in the Funding Opportunity Announcement and/or the Notice of Award.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

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. More specifically, for K Awards, visit the Research Career Development (“K”) Awardees section of the NIH Grants Policy Statement.

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.

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. In addition, information on NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards can be found at https://grants.nih.gov/grants/policy/harassment.htm

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.

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 Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described 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.

4. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

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: GrantsInfo@nih.gov (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: support@grants.gov

Scientific/Research Contact(s)

Carol Shreffler, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3322
Email: shreffl1@niehs.nih.gov

Peer Review Contact(s)

Leroy Worth, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3340
Email: worth@niehs.nih.gov

Financial/Grants Management Contact(s)

Ashley Singh
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3328
Email: ashley.singh@nih.gov

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 Part 75.


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