Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Center for Advancing Translational Sciences (NCATS)
New
None
93.350
The purpose of this Funding Opportunity Announcement (FOA) is to support intramural-extramural collaborations on late-stage translational science projects between NCATS Therapeutic Development Branch (TDB) and extramural researchers, for therapeutic development of small molecules, biologics, or gene therapies. The UG3 phase will provide support for late stage pre-clinical work and clinical trial planning that is conducted at applicant institutions. The goal of any collaboration with TDB is to enable an IND application by the end of the UG3 phase. If UG3 milestones are met and an IND is cleared, support may be provided for an early stage clinical trials in the UH3 phase that will be conducted at the applicant institutions.
January 9, 2021
February 9, 2021; June 9, 2021; February 9, 2022; June 9, 2022; February 9, 2023; June 9, 2023
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
Not Applicable.
June 2021, November 2021, June 2022, November 2022, June 2023, November 2023
October 2021, January 2022, October 2022, January 2023, October 2023, January 2024
January 2022
Not Applicable
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.
Overview
The National Center for Advancing Translational Sciences (NCATS) was established to transform the translational science process so that new treatments and cures for disease can be delivered to patients faster. The Drug Development Collaboratory is designed to enhance latent synergies across NCATS laboratories (intramural) and applicant institutions (extramural) programs to build a more comprehensive therapeutic development path than either arm of NCATS can provide alone. It represents a collaboration across multiple programs and divisions with shared interests to advance therapeutics for both common and rare diseases into clinical testing.
NCATS Therapeutic Development Branch
This FOA requires partnerships with intramural investigators at NCATS Therapeutic Development Branch (TDB) (https://ncats.nih.gov/about/center/org/dpi/collaborate#late-stage-translation). The goal is to catalyze translational research by offering prospective applicants the opportunity to collaborate with NCATS TDB scientists to develop new therapies. The NCATS intramural program contains a breadth of scientific capabilities and is agnostic to the therapeutic indications that may be proposed for collaboration. NCATS TDB can de-risk therapeutic candidates through the optimization and pre-clinical testing of therapies. TDB has expertise including in medicinal chemistry, evaluation of functional activity, toxicity, potency, pharmacokinetics, pharmacodynamics, efficacy, biomarker development, dose optimization, and scheduling for in vivo activity. TDB expertise that may be pertinent to applications submitted to this FOA includes, but is not limited to, optimizing drug delivery strategies, optimizing formulation, designing late-stage pre-clinical studies for regulatory approval, developing milestones, and planning the clinical trial design.
Proposed studies should focus on addressing any regulatory requirements for safety, toxicity, and drug dosing in the patient population before conducting a clinical trial. Specifically, projects submitted in response to this FOA should be designed to generate data of sufficient quality to support successful Investigational New Drug (IND) applications to the Food and Drug Administration (FDA). Of note, TDB has expertise in conducting studies needed for filing an IND application with the FDA. At minimum, the selected therapeutic candidate for a project must have data showing clear efficacy in a relevant animal model(s), promising drug metabolism and pharmacokinetic properties, and initial non-Good Laboratory Practice safety studies demonstrating no gross toxicities. In addition, applicants will provide disease-specific knowledge and expertise, access to models/assays, and access to patient populations.
Leveraging Existing Research Resources:
Applicants are strongly encouraged to leverage existing NCATS clinical trial infrastructure, whenever possible. Learn more at the Rare Disease Clinical Research Network (RDCRN) or Clinical and Translational Science Award (CTSA) websites. NCATS support may be provided to optimize pre-clinical testing of therapies with the goal of generating quality data to support IND applications.
Prior Consultation
Potential applicants are required to discuss their proposed projects with the NCATS Therapeutic Development Branch (https://ncats.nih.gov/about/center/org/dpi/collaborate#late-stage-translation) and include in their application a letter of support from the Scientific Director of NCATS Division of Preclinical Innovation (DPI) that documents agreement to participate in the proposed collaboration.
Applicants are strongly encouraged to consult with NCATS Extramural Program Staff early on in the planning of an application. This early contact will provide an opportunity to discuss and clarify NIH policies and guidelines, including the scope of the project and intent of this FOA.
Research Scope
This funding opportunity seeks to encourage late-stage translational science project collaborations with NCATS Therapeutic Development Branch (TDB), including therapeutic development of small molecules, biologics, or gene therapies.
The Research Objective of this FOA is to support translation partnerships between therapeutic development scientists who work within NCATS laboratories (intramural) and applicant institutions (extramural). Partnerships that receive support for this FOA will be a bridge between intramural capabilities in NCATS Therapeutic Development Branch with support for early-stage clinical trials at applicant institutions that comes from NCATS Drug Development Partnership Programs. This allows continuity of support for early-stage clinical trials once an IND has been approved by the FDA.
Investigators or companies who have identified a promising candidate can form joint project teams with NCATS TDB staff including Bridging Interventional Development Gaps (BrIDGs) and Therapeutics for Rare and Neglected Diseases (TRND) scientists to develop IND-ready therapies for consideration by the FDA for clinical testing. The overall combination of partners may assist in developing approaches for optimal drug delivery method, formulation, regulatory strategy, milestone development, and clinical trial planning and site-readiness.
Applications for this initiative must be submitted by the extramural applicant institution, with the NCATS intramural scientist(s) integrated into the application as described in the Collaboration Plan. Participation of the NCATS intramural investigator(s) is limited to the UG3 phase of research only. This intramural-extramural collaboration will be described in a required Collaboration Plan.
Entry Criteria
Projects must meet the following requirements prior to applying:
Preparatory Activities for the UG3 Phase
NCATS places a priority on projects with the potential to address system-wide bottlenecks in the translational science research process, or projects that use or seek to develop broader platform technologies that could subsequently be applied to benefit other disease areas.
UG3/UH3 Phases of Research
All projects will have two phases. The UG3 phase, for up to 3 years, is designed to support a project with specific milestones to be accomplished by the end of the period. The UH3 phase is to provide funding for up to 4 additional years following successful completion of the UG3. UG3 projects that meet their milestones will be administratively considered by NCATS and prioritized for transition to the UH3 phase. Investigators submitting to this FOA must address both UG3 and UH3 phases.
This funding opportunity includes activities in both intramural and extramural laboratories.
The UG3 Phase
The initial UG3 phase will provide support for late stage pre-clinical work and clinical trial planning that is conducted at applicant institutions. The scope of the UG3 phase collaboration with intramural includes novel drug delivery strategies, optimal formulation, regulatory strategy, and optimal clinical trial design. Supported partnerships will generate data and materials necessary for the filing of an IND application. The goal of any collaboration with TDB is to enable an IND application by the end of the UG3 phase.
Activities for the UG3 phase may include:
Grant applications should provide clear, measurable milestones to be accomplished at the end of the UG3.
If UG3 milestones are met and an IND is cleared, support may be provided in the UH3 phase for an early stage clinical trial for a rare or common disease that will be conducted at the applicant institution(s).
The UH3 Phase
Funding for the UH3 phase is contingent on successfully meeting the milestones in the UG3 phase (see Section VI. Award Administration Information, 1. Award Notices for further information). The UH3 phase supports the next step in the development of the intervention. The application is expected to provide quantifiable milestones to determine success of the UH3.
In the UH3 phase of the project, NCATS may support clinical trial activities through the end of Phase II for all diseases or conditions, and through the end of Phase III for a rare disease or condition. NCATS strongly encourages applicants to involve patients or their representatives in the planning of the trial, as appropriate.
Activities for the UH3 may include:
Research Areas of Interest
Key priorities of this FOA are as follows:
Activities Considered Outside of Scope of this FOA
Examples of activities that are non-responsive to this FOA and will not proceed to peer review:
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
The project period is limited to 3 years for the UG3 phase and 4 years for the UH3 phase.
The maximum project period is 7 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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. This means that the NIH will not accept:
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.
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:
The letter of intent should be sent to:
NCATS Letters of Intent
301-827-9549
[email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
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.
For applications that propose a Phase III clinical trial or its equivalent for a rare or neglected disease only:
The applicant must provide documentation that the application meets the criteria for Phase III rare disease or condition clinical trial. The NCATS program official may provide a letter confirming that the indication meets the definition of a rare and neglected disease. NCATS will not provide support for a Phase III trial for a disease that affects more than 200,000 people in the U.S.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Budget Justification:
Because of the anticipated complexity of the budget information and the need to clearly delineate costs for the extramural awardee, applicants must submit a detailed R&R budget. Submission of a Modular Budget is NOT allowed for this FOA.
The budget request for this FOA must distinguish between extramural costs and the NIH intramural investigator costs. Extramural costs are associated with the extramural investigator and the applicant organization. NIH intramural investigator costs are those required by the intramural investigator for carrying out the proposed work and which are specifically identified with the project.
Extramural Costs
Extramural costs may include such items as salary support for the extramural PD/PI and staff at the applicant organization, supplies, data analysis, and other allowable costs for work performed at the (extramural) applicant organization, as well as travel costs for the extramural investigator(s). Extramural costs may also include travel costs for any patients not already at the clinical study site. The PD/PI and up to one other key personnel with complementary expertise are required to attend semi-annual program meetings. The meetings will alternate between NCATS, Rockville, MD and extramural site(s). Funds to attend these meetings should be budgeted in the application. Extramural costs should also include travel costs for in-person meetings with NCATS intramural collaborators.
F&A (Indirect) Costs: Applicant organizations are reminded that Facilities and Administrative (F&A) or indirect costs are allowable for only the allowable extramural costs of the project.
Intramural Costs
The requests by NIH intramural scientists will be limited to the incremental costs required for participation specifically identified within the Collaboration Plan, and detailed below under Section IV.7. Resources required need to be determined before the research protocol can be approved by the NCATS. Prospective applicants are strongly encouraged to contact NCATS staff to discuss intramural investigator costs. Once the intramural investigator costs are known, the extramural applicant will enter this amount as a "subaward" budget in the application, and attach appropriate justification and documentation, including any spreadsheets as appropriate. The NCATS TDB’s costs and intramural investigators costs will not be included in the award paid to the grantee. Support for intramural participation will be provided by a budget allocation within the NIH. Any IND-enabling work, regulatory assistance, or other work conducted in NCATS intramural laboratories will be supported by the NCATS intramural research program, and it will not come from the applicant institution’s budget (extramural funds).
Peer reviewers will evaluate the appropriateness of the IRP staff and budget request for the work proposed and will therefore need to know the level of effort being proposed to conduct the work.
The Budget should include:
Additional Guidance on Budget Preparation
The application budget should reflect actual needs of the proposed project and align with the distribution of the work during the project. The budget requests for this FOA are more complex and will require more coordination than those of other programs. Therefore, extramural investigators are encouraged to begin discussions about logistics and budget issues with their intramural collaborators and with NIH staff in the early phases of application preparation.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy
Significance:
Innovation:
Approach:
Applicants should delineate the research strategy by work that will be conducted in each year of the UG3 and UH3.
Overall Strategy and Analyses:
Projects should have clear, testable hypotheses and the research plan should use quantifiable measures for making a go/no-go decision. A statistician should be consulted to make sure all experiments have adequate power and statistical rigor. Justification and statistical calculation for the proposed number of animals for applicable in vivo models should be included.
UG3 Phase Pre-clinical Studies:
The intent of the pre-clinical studies is to collect data needed to inform the clinical trial design and to collect data needed in an IND application. Experimental studies to support such a decision should be well designed, of sufficient power and statistical rigor, and include the appropriate controls. Applicants should describe how they will achieve unbiased results when describing the experimental design of the proposed studies. If any non-clinical safety studies are necessary, please follow the following guidance: https://www.fda.gov/downloads/drugs/guidances/ucm073246.pdf
For Pediatric Indications:
Juvenile animal studies to assess the potential drug toxicity in one or more species may be needed for pediatric indications. Describe proposed pre-clinical juvenile toxicity studies to support clinical trials in children, if these have not been completed. Investigators should consider the FDA's Guidance on Nonclinical Safety Evaluation of Pediatric Drug Products in designing pre-clinical toxicity studies. (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079247.pdf)
Dosing Information:
Describe studies to determine the right dose, duration, time of treatment, or patients to treat.
UG3 Phase Clinical Trial Planning:
The clinical trial planning period is intended for time and financial support to collect feasibility data, complete all planning, design, and documentation that is necessary before starting a clinical trial. The clinical trial planning section must include plans for collecting feasibility data. This data collection should use existing datasets and resources (e.g., databases), whenever possible. Depending on the project, it may be helpful to assess feasibility using patient samples (e.g., estimate the prevalence of a genotype that affects drug metabolism). The applicant should demonstrate that there is an appropriate and interested patient population by conducting interviews, surveys, focus groups or prior performance at the site. The feasibility data collection will provide the following types of information:
In addition to the feasibility data collection, the clinical trial research planning period during the UG3 should state how the planning period will be used and specify the timing of the activities to be carried out during the planning period, including participants in the planning process and their roles. These activities may include the following:
UH3 Phase I Clinical Trial:
If a Phase I clinical trial is needed, provide an overall plan to assess the validity of the biological hypothesis. Include the following:
UH3 Phase II Clinical Trial:
Provide an overall plan for the preliminary efficacy signal Phase II clinical trial. Include the following:
UH3 Rare Disease Clinical Trial:
Data Elements: Describe which disease manifestations are likely to develop, and when; which are likely to persist; and which disease signs predict development of the most important disease manifestations.
Future Plans: Describe the commercial potential of the therapeutic as a development candidate and potential challenges for commercialization of the therapeutic for the new disease indication
Preliminary Studies:
Preliminary studies include any data and information that validate feasibility for studies that address the Specific Aims.
Partnering Request with NCATS Intramural:
The applicant institution must initiate a Partnering Request with the Therapeutic Development Branch (TDB) at least 16 weeks prior to preparing an application for funding. Prior to contacting NCATS intramural, applicants should develop a brief, structured summary of the proposed project, not to exceed two pages. This summary should describe the therapeutic agent, the disease, the goals for improved therapies, the available efficacy and safety data in the disease-relevant models, and the particular NCATS resources necessary to advance the project to a successful regulatory filing stage. The narrative should not include proprietary, confidential information or trade secrets, but should be generally informative to persons working in related fields. Learn more: [email protected]
Letters of Support:
1. Letter of Support from NCATS Intramural:
Applications submitted in response to this FOA must include a current (i.e., within 2 months of application due date) letter from the Scientific Director of the NCATS Division of Preclinical Innovation to confirm that the NCATS Therapeutic Development Branch Laboratory will be able to accommodate the proposed research and that the NCATS intramural scientist(s) will be able to collaborate on the project, as delineated in the required Collaboration Plan. Applications submitted without this letter of support will be considered incomplete and will not be reviewed.
2. Letter of Support from Applicant Institution on CRADA:
This collaborative translational research between NCATS intramural scientists and extramural investigators will involve a Cooperative Research and Development Agreement (CRADA), which will need to be executed for projects deemed scientifically meritorious by peer review. NCATS will provide CRADA template documents to help streamline the interaction between NCATS intramural scientists and extramural investigators. These template agreements can be found on https://ncats.nih.gov/alliances/forms. Questions regarding any of these agreements can be referred to the NCATS Office of Strategic Alliances at [email protected]. Applicants should review this document and consult with their institutions about their willingness to agree to the conditions well in advance of submitting an application to this FOA. The CRADA will need to be executed after the application has been identified for funding. While the CRADA may not be in place before the award is made, a statement from the applicant’s Sponsored Research Office (or equivalent) that they agree, in principle, to the conditions of the CRADA should be included in the application. Failure to include this statement could result in delays should the application be identified for funding.
3. Letter of Support from the Therapeutic Provider:
For projects that obtain a non-commercially available therapeutic (asset) from a pharmaceutical partner only, the application must include a letter documenting access to the asset and associated data needed for filing an investigator-sponsored IND application to conduct the proposed clinical trials (e.g., a letter indicating that a Collaborative Research Agreement is being executed, and the PD/PI has the right to cross-reference specific sections of the pharmaceutical company partner's IND/Drug Master File, etc.). The letter of support should indicate the timeframe for expected delivery of the asset and how long the partner is committed to provide manufacturing and technical support.
In many cases pharmaceutical companies may publicly offer commercially owned assets on an Open Innovation website that invites applicants to test new therapeutic uses or to provide ideas for novel drug delivery or formulation, for which partial support could be provided by the intramural program. It is appropriate for applicants to include open innovation collaborations with external asset providers. NCATS encourages the use of existing template legal agreements for such collaborations, when they are already publicly available (see https://ncats.nih.gov/ntu/assets/agreements or https://ncats.nih.gov/pubs/features/ntu-template).
Please note that Resubmissions need an updated letter of support from the participating pharmaceutical partner (i.e., within 2 months of the resubmission application due date), who is under no obligation to make an asset available for longer than one application cycle.
4. Letter(s) of Support from Collaborator(s):
Letters from other collaborators/consultants confirming participation should also be included.
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:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Collaboration Plan
Applications must include a proposed Collaboration Plan, describing how the collaboration with NCATS intramural will be maintained throughout the duration of the award. The filename "Collaboration Plan-PI-NAME.pdf" should be used and will be reflected in the final image bookmarking for easy access by reviewers. The Collaboration Plan is limited to 2 pages.
Suggested areas to address include:
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.
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.
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.
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 field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Requests of $500,000 or more for direct costs in any year
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
Applications Involving the NIH Intramural Research Program
The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.
If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.
Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.
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.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
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.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
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).
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?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
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?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Specific to this FOA: Does the Collaboration Plan adequately cover the roles and responsibilities of the intramural and extramural partners?
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?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Specific to this FOA: Does this application include an adequate partnership with NCATS intramural for optimal drug delivery strategy, optimal formulation, design of regulatory studies, milestone development, or clinical trial planning?
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?
Does the application adequately address the following, if applicable:
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Specific to this FOA: Is an IND likely to be cleared by the end of the UG3? Are the milestones at the end of the UG3 phase appropriate and feasible? Does the application include any element that can improve the success or efficiency of translational science? Are there any aspects of the study design that can be applied to future therapeutic development studies to improve the efficiency of getting new therapies to patients?
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?
If proposed, 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 at the proposed site(s) or centers? Are the 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?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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.
Study Timeline
Specific to applications involving clinical trials
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)?
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
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.
Renewals
Not Applicable.
Revisions
Not Applicable.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
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
Not Applicable.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCATS, 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.
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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available 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.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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.
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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities.
The PD(s)/PI(s) will have the primary responsibility for:
NCATS Intramural will be responsible for:
NIH extramural staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The Project Scientists will:
The Program Official will:
Areas of Joint Responsibility include:
Since the purpose of this FOA is to establish and/or further develop collaborative arrangements between extramural and intramural investigators, many responsibilities are shared between awardees and NIH staff and will require close coordination. Responsibilities will be divided between awardees and NIH staff, as described above.
Annual progress reports will be prepared and submitted by the extramural institutions, with the participation and input of the intramural investigator(s) and should include the project findings, publications, impact of the project, a description of what NCATS intramural resources were utilized and the new intramural-extramural partnerships that developed. This will be evaluated by the program official or program director.
The Collaboration Plan will cover how the following activities will be shared during the UG3 phase between NCATS intramural and the applicant institution: Determining the experimental research approaches, designing protocols, setting project milestones and go/no go decision points, and conducting the project within the guidelines of the FOA.
Convene quarterly meetings (in person or by video or audio teleconference) to monitor progress on the research project plan and to address issues or activities that impact the project or progress on the milestones.
Clinical Trial Oversight Committee (CTOC):
Each awardee's project will have a CTOC. The CTOC will include: the PD(s)/PI(s), key personnel, the NIH Project Scientist (voting), the NIH Program Official (ex officio), and any external scientist(s) that the PI invites.
The CTOC will:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award 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 member chosen by the individual awardee, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. This special dispute resolution procedure does not alter the awardee'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. Follow special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
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.
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: [email protected] (preferred method of contact)
Telephone: 301-637-3015
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Extramural Program Official
Steven Pittenger, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-5810
Email: [email protected]
Intramural Partnering Requests
Donald C. Lo, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301.827.1844
Email: [email protected]
Rani Khan, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Phone: 301-594-7319
E-mail: [email protected]
Gloria Velez
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0875
Email: [email protected]
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.