Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The overarching goals of the Transporter Elucidation Network are to elucidate novel roles for transporter proteins (e.g., solute carrier (SLC) and ATP-binding cassette (ABC) families) and to validate existing and emerging models of their functional roles across and within the human organism. The objective of awards made to this Funding Opportunity Announcement will be to improve our understanding of the functional transport of nutrients and drugs that are directly relevant to the developing fetus and infant. This will be accomplished via a focus on the human placenta, lactating mammary gland, developing gut, and/or blood brain barrier.

After a meal or oral drug or dietary supplement ingestion, the body uses transporters to take up and distribute nutrients, metabolites, xenobiotics, and/or drugs to cells and organelles. In the case of the developing fetus and newborn infant, the placenta and lactating mammary gland are essential organs for nutrient and drug transport. Thus, the digestive tract (particularly during early development), placenta, and mammary gland form a key triad of organs responsible for nutrient and drug disposition during pregnancy and infancy. The blood brain barrier serves as a critical tissue for the developing fetal brain. Given that transporter proteins are responsible for transmembrane conveyance of nutrients, metabolites, and drugs, individual variability in transporter variants and regulation, such as those for the sodium-dependent vitamin C transporters SLC23A1 and SLC23A2, is likely to underlie individual variability in outcomes or measures in the infant observed in response to dietary or pharmacological interventions in the mother. This highlights the importance of their understanding at the allelic level in realizing precision medicine and precision nutrition.

Despite the abundance of transporters in the genome and the key role that these transporters play in the uptake and disposition of ingested nutrients and minerals, dietary metabolites, xenobiotics, dietary supplement constituents(s), and pharmaceutical drugs across cell and organelle membranes, most of these genes are poorly characterized regarding solute specificity, organ and life stage-specific distribution and expression, and functional consequence of allelic and splice variants. Transporters can exhibit specialized functions based on cellular, tissue, or developmental context such as high affinity-low capacity vs. high capacity-low affinity forms or fetal vs. adult forms. Subcellular localization of transporters, such as in the apical vs. basolateral membrane of enterocytes or localization in organellar membranes, also contributes to their functional diversity. Additionally, the relative affinity of transporters for different solutes combined with different solute milieus in cells can mean that key transporters for a solute depend on cell and tissue context. Thus, the functional role of individual transporter proteins and transport of molecules can be complex.

The current heavy reliance on mRNA expression data and inference of function in developing tissue and organ models of transport highlights the need for a concerted and systematic effort to elucidate novel transporter function and validate functional models of transport to have an accurate understanding of nutrient and drug disposition in and across organs. The necessity of fully understanding nutrient, drug, etc. transport therefore requires a two-fold approach of increasing our understanding of understudied individual transporter proteins, including their allelic variants, as well as elucidating their roles within particular organs, tissues, and cells with varying solute milieus. Advances in modeling human tissues such as the use of organoids and micro-physiological systems and the ability to collect, sort, label, and study small numbers of ex vivo human cells can now be coupled with improved analytical techniques such as mass spectrometry for drug and nutrient fluxomics across membranes and single-cell omics technologies. At the same time, advances in high throughput functional screening capabilities, high resolution cryo-electron microscopy, and bio- and chem-informatics approaches can be applied to elucidate basic properties of understudied transporter proteins. Foundational efforts on transporter proteins, such as that of the RESOLUTE Consortium (https://re-solute.eu/), can be built upon.

There is also the need to foster and enhance a skilled and diverse scientific workforce with expertise in multiple aspects of understanding transporter protein function from biochemical properties through to dynamic flux of nutrients within and across organisms.

Objectives and Scope of the Centers

Two important aspects of fully understanding the functional transport of nutrients, drugs, etc. within human cells and tissues are (A) having a detailed understanding of transporter genes and their expressed protein variants’ functions and ligands and (B) elucidating and validating the functional role of transporter proteins within specific tissues and cell types. The first aspect can be enabled by recent advances in bio- and chem-informatics approaches, many of which are now powered by artificial intelligence approaches, coupled with an increased technical capacity for small molecule screening and molecular structural determination. For the second aspect, ‘omics technologies that can be applied to ex vivo human tissues and engineered biomimetic organoid/chip systems provide new opportunities for resolving function and membrane localization of transporters in native biological contexts.

This FOA seeks to establish at least two Transporter Elucidation Centers that will work together in a Transporter Elucidation Network (TEN) in an integrated manner to increase our understanding of the understudied human solute carrier (SLC) and ATP-binding cassette (ABC) families of transporter proteins as well as how they function together and with other transporters in the placenta, lactating mammary gland, developing gut, and blood brain barrier to transport nutrients, dietary supplement constituents, and drugs.

Scientific Interest of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

TECs supported by NICHD are intended to (1) functionally validate existing and emerging models of transport of nutrients and drugs within the placenta, lactating mammary gland, and developing gut and (2) elucidate novel roles for solute carrier (SLC) and ATP-binding cassette (ABC) families in these organs. In scope are mechanistic studies addressing key developmental windows to elucidate the relationship between life stage-dependent expression and function of transporters and associated differences in xenobiotic and nutrient absorption and bioavailability (e.g., in infants vs. adolescents). Proposals may study transporter sequences and specimens from healthy individuals and/or those with known or putative transporter dysfunction.

Scientific Interest of National Institute of Drug Abuse (NIDA)

TECs supported by NIDA are intended to increase our understanding of the expression, structure, and function of SLC and ABC transporters, particularly on the cell membrane and subcellular organelles of the blood brain barrier that play a role in the transport, disposition, and pharmacological and toxicological effects of opioids, psychostimulants, and other addictive substances and treatment agents of relevance to NIDA.

Scientific Interest of Office of Dietary Supplements (ODS)

TECs supported by ODS are intended to increase the understanding of transport of dietary supplement constituents by SLC and ABC transporters.

Scientific Interest of Office of Nutrition Research (ONR)

TECs supported by ONR are intended to increase the bioinformatic understanding of SLC and ABC transporters of nutrients, metabolites, and xenobiotics. This includes: (1) identifying solutes for transporters for which a solute has not been determined except through in silico assumptions based on structure; (2) broad screening of transporters to identify other competing solutes that may not have been previously elucidated (example of vitamin C being transported by “glucose transporters”); (3) determination of the clinical relevance of haplo-insufficiencies or common allelic variants in human transporters.

TEC applicants must propose either (A) functional transport studies in at least two of the following tissues - the human placenta, lactating mammary gland, developing gut, or blood brain barrier or (B) include an informatics/screening component for SLC and/or ABC transporters and functional transport studies in at least one of the following tissues - the human placenta, lactating mammary gland, developing gut, or blood brain barrier.

Examples of types of projects to be undertaken by a Transporter Elucidation Center include, but are not limited to:

• The use of mass spectrometric techniques to measure transporter protein and nutrient levels in various layers of the human placenta at different developmental stages;
• Use of cryo-EM to determine previously unobtainable transporter protein structures to facilitate computational docking models or assays;
• Deorphanizing transporters through coupling of computational and high throughput experimental approaches to uncover endogenous ligands and solutes;
• Proteomic and metabolomic characterization of cells isolated from human milk (i.e., liquid biopsies);
• Use of a wide range of biologically relevant small molecules labeled with stable isotopes to study relative transporter affinity and fluxomics;
• Fluxomic studies in human iPSC-derived gastrointestinal organoids at various stages of development.

Applications that are not responsive to this funding announcement:

Projects listed below are not within the scope of this funding announcement. Applications proposing out of scope projects are not responsive to this FOA and will not be reviewed.

• Applications focused on studying mRNA levels of transporters in cells and tissues;
• Applications that propose work in non-human animals or non-human tissues, cells, etc.;
• Applications that propose to study transporter proteins of non-human sequence origin;
• Applications that propose clinical trials;
• Proposals for Centers that do not propose to study at least two of the following tissues: the human placenta, lactating mammary gland, developing gut, and/or blood brain barrier, or study one of those tissues along with an informatics/screening approach for ABC and/or SLC transporters.

Components of the Tissue Elucidation Network

Transporter Elucidation Network: The TEN will be made up of Transporter Elucidation Center awardees to this FOA, awardees to potential future related FOAs, the NIH TEN Working Group and other scientists and groups the Steering Committee agrees to include within the TEN. The Network structure is meant to enable the overall goals of the Transporter Elucidation program.

NIH TEN Working Group (WG): Consists of NIH programmatic staff from multiple Institutes, Centers, and Offices of the NIH. This group will be primarily responsible for the stewardship of the TEN and Transporter Elucidation program.

Steering Committee (SC): The SC will provide coordination activities for the TEN. The SC will include PDs/PIs of each of the awards and NIH TEN WG members. The SC will be chaired by a PD/PI that is nominated by the SC and approved by the NIH. The SC will establish subcommittees to oversee the development and implementation of Network policies including data release. The number of NIH votes may not exceed one third of the total number of votes on the SC. The number of votes from a multiple PI award will be one. Votes will inform recommendations to the NIH.

Subject Matter Experts (SMEs): The NIH TEN WG will recruit outside experts (non-awardees) of relevance to the TEN to provide advice to NIH. The NIH TEN WG may solicit from the SMEs input on progress made by individual awardee, progress made towards the overall goals of the TEN, and any changes in scope or governance that might help the make the output of the TEN more effective and useful to the biomedical community.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

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)

Local 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)

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• 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)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are 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.

• System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active 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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Aaron C. Pawlyk, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-7299
Email: aaron.pawlyk@nih.gov

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

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.

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

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

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

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, with the following additional instructions:

A significant time commitment (3.0 person months) should be made between the Principal Investigator(s), and for MPI applications each PI having no fewer than 1.2 person months.

Applicants should describe the budget associated with meeting the needs of their Resource Sharing Plan.

Budgeting should include travel and lodging for representatives of the Center to attend:

• Annual meetings of the Transporter Elucidation Network PDs/PIs;
• Ad hoc meetings called by the TEN SC or the NICHD to discuss research findings and plan cooperative projects, to promulgate data sharing, and to discuss standardization of procedures across the Transporter Elucidation Network.

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

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:

TEC applicants must propose either (A) functional transport studies in at least two of the following tissues - the human placenta, lactating mammary gland, developing gut, or blood brain barrier or (B) include an informatics/screening component for SLC and/or ABC transporters and functional transport studies in at least one of the following tissues - the human placenta, lactating mammary gland, developing gut, or blood brain barrier.

Specific Aims: The Specific Aims should describe the overall vision for the proposed Transporter Elucidation Center (TEC) and how it will meet the Research Objectives as stated above in this FOA. Explain the critical barriers to progress in elucidating transporter characterization and function and how the proposed Specific Aims will contribute to a solution. Explain how the proposed project will improve scientific knowledge and research infrastructure by generating and using new data, tools, and/or experimental approaches.

Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation, and Approach.

Significance: For the proposed Transporter Elucidation Center, describe:

• The importance of the problems and critical barriers to advancing the functional understanding of transporters that the proposed TEC will focus on;
• How the resources of the proposed TEC will improve scientific knowledge and research infrastructure, and how it will ultimately enable future projects on transporters;
• How the concepts, methods, technologies, and/or approaches used to understand drug and nutrient transporter will be changed if the proposed aims are achieved;
• How the TEC will foster the training and career development of a diverse set of students, post-doctoral fellows, and junior faculty.

Innovation: For the Transporter Elucidation Center, address:

• How the proposed research seeks to shift current understanding of transporter proteins and/or drug and nutrient transport through the generation of novel data, tools, and/or technologies;
• Describe how the project will leverage and capitalize, but not duplicate, previous efforts and approaches such as those undertaken by KOMP, RESOLUTE, etc.

Approach: Applicants should address, at a minimum, the following elements:

• Provide preliminary data indicating the applicants’ ability to conduct the research proposed for the TEC;
• Clearly define barriers to understanding transporter function that are preventing the advancement of the understanding of drug and nutrient transport;
• Describe the research that the TEC will undertake and how this research directly relates to barriers in the field;
• For applications that include an informatics/screening component, explain how that approach will inform research on the placenta, lactating mammary gland, developing gut, and/or blood brain barrier;
• Explain the importance of the proposed tool/data validation strategy in the context of the development of new information gathered around transporter proteins and their in vivo function;
• Concisely and adequately describe the capability of the proposed Center to process, analyze, and deposit data into external repositories;
• Explain how the proposed Center will build upon and not duplicate activities undertaken by other relevant programs, such as, RESOLUTE or KOMP,
• Provide examples of future research projects relating to transporter characterization and/or drug and nutrient transport not currently possible that will be enabled through enhanced research infrastructure after the completion of the proposed research project;
• Define the deliverables, timeline, and milestones for the Center and how they align with the goals of this FOA;

Articulate how the Center will reprioritize and adjust activities, deliverables, timeline, and milestones on an annual basis (in the RPPR) based on feedback from the Transporter Elucidation Network Steering Committee (TEN SC), external Subject Matter Experts, and NIH staff.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Applicants should indicate their willingness to abide by all data deposition, quality control metrics, standardization, metadata requirements, data and software release, and public copyright license policies developed by the SC and approved by NIH staff. A primary goal of the Centers is to facilitate discoveries of the broad scientific community for the improvement of public health. Restrictive licensing and sharing practices for Center-generated data, tools, and resources could substantially diminish their value and public benefit. Accordingly, awardees should manage data, resources, protocols, tools, and software in a way that achieves this goal. The NIH expects that the awardees, through the TEN Steering Committee, will develop such policies, methods, and standards in concert with the NIH. These policies, methods, and standards will remain consistent with NIH-wide and NICHD policies on data and resource sharing.

Specific Plan for Data Sharing: Consistent with achieving the goals of this program, the NICHD expects that information such as collected data, technical protocols, and any other metadata collected under this FOA is to be deposited as appropriate into existing, publicly available data repositories that are easily accessible, and in machine readable format. For human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. Where appropriate, applicants should identify such repositories and plans for deposition. For datatypes that lack suitable public repositories, applicants should indicate their willingness to identify an appropriate alternative solution that is consistent with achieving the goals of the program. If applicable, applicants must abide by the NIH Genomic Data Sharing Policy (https://osp.od.nih.gov/scientific-sharing/genomic-data-sharing/) and should indicate their agreement to it in the data sharing plan.

Specific Plan for Protocol, Tool, and Reagent Sharing: In accomplishing the goals of the Transporter Elucidation Centers, it is likely that investigators will develop protocols, tools, and reagents that would be of broad use in the research community. The NIH intends that protocols, tools, and reagents generated by the Centers be broadly available and distributed at minimal cost, and without undue intellectual property constraints, so that they can be as widely used as possible, thus enabling downstream investigations in maternal and pediatric therapeutics. For all applications where applicable, the applicant should discuss plans for sharing and distribution of non-data resources that will be generated by the proposed project, including models, protocols, biomaterials, and reagents.

Specific Plan for Sharing Software: A software dissemination plan is expected in applications that are developing software. There is no prescribed single license for software produced in this project; however, reviewers will be asked to comment on the software sharing and dissemination plan based on its likely impact. Applicants are asked to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others. This proposal may include a plan to incorporate the enhancements into the official core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution. A dissemination plan guided by the following principles is thought to promote the largest impact:

• The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of training, research institutions, and government laboratories.
• The terms should permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• The software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
• The terms of software availability should include the ability of researchers outside of the Centers and its collaborating projects to modify the source code and to share modifications with other colleagues. An applicant should take responsibility for creating the original and subsequent official versions of a piece of software.

Applicants should also be familiar with the NIH statements regarding intellectual property of resources developed with Federal funds (NIH Research Tools Policy (http://grants.nih.gov/grants/intell-property_64FR72090.pdf) and other related NIH sharing policies at http://sharing.nih.gov).

Prior to funding, NICHD Program Staff may negotiate modifications to the Sharing Plan with the applicant.

When involving human subjects research, clinical research, and/or NIH-defined 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.

Delayed Onset Study

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

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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.

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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.

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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.

Section V. Application Review Information

1. Criteria

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

Overall Impact

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

Scored Review Criteria

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

Significance

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

Specific to this FOA: How will successful completion of the proposed project advance the stated goals of the Transporter Elucidation Network and overcome the critical barriers identified by the applicant? Are the proposed model system(s) likely to generate information and resources that are meaningful to transporter function in humans? If successful, how will the outcomes of the proposed project enable future projects on transporters?

Investigator(s)

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

Specific to this FOA: How does the team bring a variety of expertise to achieve the goals of the individual Transporter Elucidation Center and the collaborative, overarching goals of the Transporter Elucidation Network? To what extent does the investigator team have enough expertise with the models to be studied? Is there evidence for synergistic interactions among PDs/PIs? How adequately are staff identified who will be able to manage, curate and perform quality control on the data produced by the Team and harmonize and share that data with the Network?

Innovation

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

Specific to this FOA: How will the proposed outcomes of the project shift the current understanding of human transporter function? How adequately does the project describe plans to avoid duplication of existing efforts and resources?

Approach

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

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

Specific to this FOA: How will the proposed studies, if accomplished, advance our understanding of the transmission of nutrients, drugs, and/or dietary supplement constituents from mother to infant and overcome critical barriers in the field? How will the proposed studies, if accomplished, advance our understanding beyond that of mRNA expression studies? How likely are the proposed studies to increase the knowledge around interindividual variability in transporter function as relevant to precision medicine and/or nutrition? If applicable, how will proposed informatics/screening approaches advance the understating of the human placenta, lactating mammary gland, developing gut, and/or blood brain barrier? To what extent are appropriate, evaluative, and quantitative deliverables and milestones provided with clear metrics and plan for annual reprioritization? How will the proposed deliverables and milestones facilitate accomplishing the overall goals of the Transporter Elucidation Network?

Environment

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

Specific to this FOA: How well is the proposed Transporter Elucidation Center integrated into other activities at the applicant's institution and does it leverage existing efforts?

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.

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; (3)  Genomic Data Sharing Plan (GDS); and (4) Specific Plan for Sharing Software.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NICHD, 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 will receive a written critique.

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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development Council. 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.
• Evidence that the applicant and investigators are committed to policies as established by the SC including with regard to confidentiality, sharing of information and resources, and cooperative interaction.
• Evidence of previous productive, cooperative, collaborative interaction.
• Evidence that the project will contribute to the variety of technical and intellectual approaches amongst the entire set of Transporter Elucidation Centers.
   

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.

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

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, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about 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, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

The PD(s)/PI(s) will have the primary responsibility for:

• Staffing
  • Obtaining prior written approval of the NIH Grants Management Specialist, in consultation with the Program Official for any change in any of the key personnel identified in the Notice of Grant Award.
  • For multi-PI awards, designating a PI to be its voting representative on the network Steering Committee.
• Determining research approaches, designing protocols, and setting project milestones.
• Conducting the scientific research in the project, reporting progress and milestones or objectives to NIH staff, reporting results to the scientific community, and disseminating approaches, methods, and tools broadly.
• Working with the other recipients to maximize impact of the Transporter Elucidation Network and meet program goals and objectives.
• Agreeing to the governance of the Transporter Elucidation Network through the SC and the NIH staff.
• Actively participating in the Transporter Elucidation Network SC, including attending both in-person and teleconference meetings, and participating in collaborative activities and subcommittees. At least one in-person SC meeting will be held per year, for which Transporter Elucidation Center recipients will pay the travel for their attending members.
• Updating goals and milestones at the time of award and providing summaries of progress toward those goals at least yearly, as requested by NIH. The milestones will be reviewed annually (and at other times, if necessary), and new milestones will be negotiated, as needed by working with the NIH Program Staff and Project Scientists as appropriate.
• Ensuring that data are deposited in a timely manner in the appropriate public databases as agreed upon by the Transporter Elucidation Network SC and approved by the NIH.
• Ensuring that software and other tools and resources developed as part of this project are made publicly available according to SC policies, and that results of the project are published in a timely manner.
• Agreeing to abide by any policies -- including those regarding intellectual property, data and software release, publication of Transporter Elucidation Network papers, quality control metrics, standardization, metadata requirements, and public copyright licensing -- that are recommended by the TEN SC and approved by the NIH, as well as applicable NIH policies, laws, and regulations.
• Being prepared for annual administrative site visits by NIH staff.
• Agreeing to participate in the collaborative activities of the TEN and agreeing not to disclose confidential information obtained from other members of the TEN.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
• Publishing and publicly disseminating study results, in accordance with Network and NIH policies, including publishing results on ClinicalTrials.gov and submitting study publications to the PubMed Central within the required timeframes.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

A Program Official and a Grants Manager will be responsible for overall grant stewardship. An NIH Project Scientist will provide scientific input to the Network.

NIH Program Official

In addition to general grant stewardship, a NICHD Program Official will:

• Provide the standard programmatic oversight and stewardship of the projects, including review of pre-award and award documents/requirements, review of progress reports and budgets, and any other programmatic issues that may arise.
• Monitor progress of study milestones to ensure that the objectives are being met and that all regulatory, fiscal, and administrative matters are handled according to NIH guidelines. Continuation of funding will be dependent upon the recipient’s ability to show adequate progress towards milestone accomplishment.
• Have the option to recommend, following consultation with the NIH TEN WG, the withholding or reduction of support from any project that substantially fails to achieve its goals according to the milestones agreed to at the time of the award. NIH reserves the right to withhold funding or curtail an award in the event of: (a) Substantive changes in the project, or failure to make sufficient progress toward the project milestones, including timely pre-publication deposition of data or reagents in accordance with approved Sharing Plans; or (b) Ethical or conflict of interest issues.

NIH Project Scientists

NIH Project Scientists will have substantial programmatic involvement that is above and beyond the typical stewardship role in other awards. As described below, the Project Scientist will:

• Monitor study progress, of each participating Center and of the Network as a whole, through recipient’s annual reports, network study reports, site visits, etc.

• One or more NIH Program Staff will serve as Project Scientists (PSs), for each Transporter Elucidation Center award and, as appropriate, to oversee collaborative projects amongst Center recipients and/or other Network members.
• The PS will serve as the scientific representative of the NIH to the investigators in accordance with policies and procedures of the cooperative agreement mechanism. If there is more than one PS, one of them will be designated as the Lead PS.
• Provide substantial scientific/programmatic support and input for study design, implementation, results analysis, publication, and development of solutions to major problems.
• Serve as NIH’s voting representative on the Steering Committee and all Network subcommittees.
• The NIH TEN WG will provide final assessment, review, and approval of TEN project milestones and any renegotiation.

Other NIH Program Staff

• May serve on sub-committees of the TEN SC, as needed. The staff will assist the TEN SC in developing operating guidelines and consistent policies for dealing with situations that require coordinated actions.
• Will help the TEN SC members to coordinate the group process of exchanging information about research approaches and protocol designs and of developing additional TEN policies.
• Will review and approve, in consultation with SMEs (as needed), recommendations and plans provided by the TEN SC for collaborative activities amongst TEN recipients or outside groups.

Areas of Joint Responsibility include:

Close interaction among the participating investigators will be required, as well as significant involvement from the NIH, to develop the Transporter Elucidation Network. The recipients, the PSs, and other designated NIH Staff will participate in the annual in-person SC meeting and scheduled conference calls and share information on data resources, methodologies, analytical tools, as well as data and preliminary results. PDs/PIs, key co-investigators and pre- and post-doctoral trainees, especially those who are members of under-represented minority groups or those from different but related disciplines, are eligible to attend these meetings. SMEs will attend the annual in person meetings. Other government staff may attend the TEN SC meetings.

The TEN SC will serve as the main scientific body of the TE Network, with the following roles:

• All parties will agree to accept the coordinating role of the group and the participatory and cooperative nature of the group process. As part of this, all parties will form a joint Steering Committee to govern the Network, consisting of:
  • One PI from each Center (one vote per center)
  • NIH Project Scientist (voting member)
• The SC will be responsible for coordinating the activities of the TEN projects and is the committee through which the NIH TEN WG formally interacts with the TEN investigators. SC membership will include the PI(s) of each Project, (limited to one vote for a Project with multiple PIs) and NIH staff appointed by the NIH TEN WG (voting limited to one third of total SC votes). The TEN SC Chair(s) will be appointed by the NIH and drawn from the individual project PIs. The TEN SC may add additional, non-voting, members, as needed.
• As part of its governance responsibilities, the Steering Committee will develop a network Policies and Procedures Manual that delineates the structure and function of the Network, its standard operating procedures, and general rules (e.g., publication authorship). NIH Program Staff will help ensure that these policies follow NIH and other Federal guidelines and appropriately address the strategic interests and stewardship responsibilities of the NIH. The Steering Committee will vote on the overall Network Policies and Procedures Manual and any amendments; the NIH Program Official will have approval authority for this.
• The SC may choose to open Network membership to collaborators not funded through the TEN Program, provided that such members agree to abide by policies enacted by the SC. The SC may generate additional conditions that apply to non-recipient members of the Network.
• The TEN SC may set up subcommittees as needed to address particular issues. These subcommittees will include representatives from the TEN and the NIH and possibly other experts. The TEN SC will have the overall responsibility of assessing and prioritizing the progress of the various subcommittees. It is anticipated that multiple subcommittees may need to be formed, for example, to address topics such as:
  • Data and Reagent Deposition and Sharing
  • Quality Control and Validation
  • Publications and Outreach

Subject Matter Experts (SMEs):

• The SMEs will provide input and advice to the NIH TEN WG. This could include reviewing and evaluating the progress of the entire TEN or individual recipients as well as recommending changes in priorities for the TEN based on scientific advances within and outside of the TEN. The SMEs will be senior, scientific experts who are not directly involved in the activities of the TEN. NIH will appoint the SMEs.
• The SMEs will meet at least once a year in conjunction with a meeting of the TEN. The SMEs may individually confer with the NIH TNC WG by phone or web at other times of the year, as needed.
• Annually, the SMEs will provide individual assessments to the NIH of the progress of the TEN and will present recommendations regarding any changes in the TEN as necessary.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipients's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, 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 instructions, 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

Patricia A. Haggerty, Ph.D.
NIH Office of Dietary Supplements
Phone: 301-529-4884
Email: patricia.haggerty@nih.gov

Christopher Lynch, PhD
Office of Nutrition Research (ONR)
Division of Program Coordination, Planning, and Strategic Initiatives
Office of the NIH Director
Telephone: 301-827-3988
Email: Christopher.Lynch@nih.gov

Aaron C. Pawlyk, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-7299
Email: aaron.pawlyk@nih.govaaron.pawlyk@nih.gov

Subramaniam Ananthan, Ph.D.
National Institute on Drug Abuse (NIDA)
Phone: 301-435-2199
E-mail: sam.ananthan@nih.gov

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov

Marianne Galczynski
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1170
Email: marianne.galczynski@nih.gov

Pamela G Fleming
National Institute on Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Section VIII. Other Information

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

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.