Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The purpose of this funding opportunity announcement (FOA) is to invite applications to establish Trial Innovation Centers (TICs) for the Clinical and Translational Science Award (CTSA) program. The TICs will be lead centers of an innovative expert network that will accelerate the implementation of multi-site studies by the CTSA Network. National Institutes of Health (NIH) supported studies are the focus of this initiative; however, the capacity created might also be of interest and useful for trials conducted by other federal agencies, as well as by the private and non-profit sectors.

The TICs will transform the CTSA network’s ability to implement multi-site studies by adding innovative network capacity to the existing strength at the CTSA Hubs. The TICs will not be specific to one disease, but have the capacity to identify and coordinate a cadre of specialist investigators from across the CTSA network to implement studies efficiently in response to a broad range of disease specific opportunities. Select TICs, however, will have particular expertise to conduct multi-site studies with special populations, such as pediatric or geriatric subjects.

Conducting multi-site clinical research in the U.S. is often associated with implementation delays and high costs that have led to the migration of many clinical trials elsewhere. This trend threatens U.S. competitiveness, reduces economic opportunities, and deprives U.S. patients of the option to participate in research.

The delays in study start-up and the related cost burden have been attributed in part to review of one protocol by multiple Institutional Review Boards (IRBs), to the lack of user-friendly budgeting support, and to the absence of standardization of supporting research contracts and site qualification. In addition, large multi-site clinical studies supported by both public and private sectors are often sui generis, with systems or processes developed from scratch and ignored after trial completion, despite their potential utility for future studies.

With the goal of translating laboratory and clinical discoveries into better health, the NCATS CTSA program has created integrated local research and training environments that promote translational research. Taking advantage of the existing local strength and leveraging it towards building network-wide capacity, the CTSA program has launched several initiatives to transform multi-site clinical research.

One such initiative aims to develop harmonized Institutional Review Board (IRB) reliance agreements as a first step towards using central IRBs (cIRBs). Other ongoing CTSA network initiatives focus on standards in research staff training and streamlined contracting. This FOA aims to build on these initiatives. It will allow for broader access of the new tools and methods being built, and it will help make them a sustainable national resource that can help CTSA investigators and the wider community to accelerate translation.

A separate yet related initiative recently launched by the CTSA program focuses on improving participant recruitment into clinical research studies using innovative information technology and clinical research methods. These new recruitment initiatives are the subject of a separate FOA soliciting applications for Recruitment Innovation Centers (RICs), RFA-TR-15-004. NCATS anticipates that all the various components of the CTSA program the CTSA Hubs, partnering hospitals and clinics, RICs, and TICs will synergistically support multi-site research, and will develop joint operational and governance frameworks.

The NIH Institutes and Centers (ICs) have typically supported multi-site studies by building a new and unique infrastructure for each project, or multiple disease-specific networks. The new CTSA network with its RICs and TICs will transform multi-site research by reducing delays in trial start-up, will speed recruitment, and will harmonize processes across the CTSA Hubs, ultimately increasing quality and efficiency. This new environment should help the NIH ICs, as well as other federal, private and non-profit sponsors, to more quickly implement trials across disease categories and target populations, and therefore advance NCATS goal of getting more treatments, to more patients, more quickly.

This FOA is in part a response to the Institutes of Medicine (IOM) Report on the CTSA program that calls for NCATS to Develop and widely disseminate innovative research resources . (http://www.iom.edu/Reports/2013/The-CTSA-Program-at-NIH-Opportunities-for-Advancing-Clinical-and-Translational-Research.aspx).

The primary objective of the TICs and the integration of CTSA Hubs into a network is to develop, demonstrate and disseminate innovative ways to increase the quality and efficiency of multi-site clinical research. The TICs will provide support for a broad range of CTSA Network multi-site clinical studies: trials across the human life span; trials for diagnostic testing or development of therapeutics, such as drugs, biologics, and devices, as well as behavioral interventions, added to and compared with standard approaches. This might include studies intended to be used in pursuit of regulatory (FDA) approval, precision medicine studies or observational cohort studies The TICs are intended to expedite large, multi-site clinical studies such as trials or complex observational and comparative effectiveness studies, so that the terms study and trial are used interchangeably in this FOA.

The TICs will provide an innovative infrastructure that at a minimum establishes reliance IRB agreements to allow for the designation of their IRB as the single IRB of record for a given trial, and standing Master Clinical Trial Agreements (MCTAs) to facilitate contractual agreements and clinical site financial support. To accomplish this, the TIC will execute standing IRB Authorization Agreements (IAAs) and MCTAs with each CTSA Hub and its partners in the network, as well as with ad hoc sites should they be needed in a given study due to special expertise or access to patient populations. As their name implies, TICs will be also be encouraged to explore innovative approaches aimed at streamlining trial implementation, promoting high quality multi-site trials, or dissemination of successful advances in process and approach.

Translational science is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process. As such, the TICs are expected to support research by effectively fostering collaboration, implementing standardization, demonstrating and disseminating innovation, tracking performance and developing best practices for future CTSA network clinical trials. Following TIC funding, each CTSA Hub will be invited to identify TIC liaisons. The TICs and TIC liaisons will jointly develop a set of Standard Operating Procedures (SOPs) and implement Information Technology (IT) solutions to harmonize processes and provide user-friendly TIC access for the participating Hubs so that multi-site trials may be better implemented. The TICs will provide the leadership of a given multi-site study with innovative resources for efficient trial completion, and to ensure high quality operations and oversight of research projects.

The TIC Collaborative Process: a potential scenario

A Program Director/Principal Investigator (PD/PI) and/or funding source (e.g. a categorical NIH IC) of a prospective multi-site clinical trial proposes use of the CTSA Network as they develop their protocol, budget and funding plans; utilizing easily accessible information on the CTSA network provided by the TICs and/or RICs.

Once funding is obtained, the study PD/PI and/or funding source (e.g., a categorical NIH IC), would request access to a TIC. A CTSA Network Executive Committee (NEC) will have been established to review the investigator’s preliminary protocol in the context of capacity at the time and other requests. The protocol should involve several CTSA Hubs and likely benefit from TIC resources. Based on NEC feedback, NCATS may consider approving, which would initiate TIC engagement to support the trial implementation.

Following approval, the protocol and consent form template would be refined, if necessary, in collaboration between TIC staff, the study PD/PI, participating investigators, and a Protocol Development Team. Following local input, the final protocol would then undergo review and approval by the TIC designated cIRB.

As is typical for NIH multi-site studies, the NIH ICs will provide funds for clinical leadership, implementation, research cost (per participant), statistical leadership, and data management. Funds for clinical site payment for each participant enrolled will be transferred to the TIC via subcontract from the study PD/PI’s institution to be disbursed to the sites on a fee per service basis during recruitment and follow-up via amendments to the pre-established MCTAs. Each trial will be assigned to one TIC, but there will be more than one TIC available for the CTSA network.

Nothing in this scenario would preclude a funding source in concert with trial leadership and NCATS from soliciting non-CTSA clinical sites to augment the CTSA sites as planned or as a follow on action to boost recruitment.

Governance

NCATS will be responsible for organizing and providing overall support, by means of cooperative agreements, for the TICs and the CTSA network. In addition to regular grant stewardship by a program officer, a NCATS Project Scientist will be involved with the TICs as a NCATS partner, consistent with the Cooperative Agreement mechanism.

The Network Executive Committee (NEC) consisting of the TIC and RIC PD/PIs, NIH staff under the cooperative agreement mechanism and CTSA investigators will evaluate studies for their appropriateness for network access. NCATS will make final decisions regarding TIC activities and allocate studies to TICs.

A trial Lead Committee (LC) for each study will oversee day-to-day operations. The Committee will include at minimum the study PD/PI, the TIC PD/PI or designated co-investigator, the NCATS program official, the sponsoring NIH I/C program official (if applicable), the lead investigator for statistics and data management, and others as needed. It will meet by conference call on a regular basis initially to monitor startup performance and identify problems requiring leadership action and as needed later. Most trials will have virtual or in-person investigator meetings at six or twelve month intervals.

Technical Assistance Video and FAQs

A technical assistance video regarding RFA-TR-15-002: CTSA Network - Trial Innovation Centers (TICs) will be available on the NCATS website approximately two weeks after the publication date. The video will review the purpose and objectives of the FOA as presented here. All prospective applicants are invited to view the video which will be linked from the CTSA Funding Information page (http://www.ncats.nih.gov/ctsa/funding).

NCATS will post answers to frequently asked questions (FAQs) on its website at http://www.ncats.nih.gov/ctsa/funding. Submit questions to [email protected].

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• 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) 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 not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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.

The PD(s)/PI(s) for the TIC should be a clinical trials expert with a track record in successfully coordinating and implementing complex, multi-site clinical trials. The PD(s)/PI(s) are each expected to commit at least 3 months effort to the grant regardless of whether salary is requested.

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:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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

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

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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

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

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

The letter of intent should be sent to:

Petra Kaufmann, M.D., M.Sc
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0178
Fax: 301-480-3661
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• For this specific FOA, the Research Strategy section is limited to 30 pages.

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.

Applicants are strongly encouraged to name an experienced operations and management team that will support the project management and implementation of the network trials, and to list additional clinical research expertise the proposed TIC could draw upon, on an as-needed basis.

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

Applicants should budget for performing all TIC functions described. However, for the functions listed AS NEEDED they should assume that only half of the trials will require such support. They should also assume that they must provide access, oversight and basic capacity to carry out the AS NEEDED functions, but that any additional costs for the AS NEEDED functions will come with the funding of the individual trials.

As a basis for investigators of future trials to efficiently engage with the TICs, applicants should describe what will be included in the TIC support for the AS NEEDED functions, and what costs they anticipate to charge for any additional functions that will be budgeted for as part of the funding for such future individual trials. Applicants should assume the cost for in person study meetings and investigator travel will be budgeted for in the funding application for the trial.

Applicants should explicitly indicate their capacity of their research team in terms of the number of studies they can initiate and oversee for the amount requested.

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:

Specific Aims: Applicants should describe their overall vision for a TIC and their specific aims in establishing and running innovative centers that can accelerate the implementation of multi-site studies by the CTSA Network. Specific Aims should reflect that each TIC should be prepared to collaboratively work with NCATS, the study PD/PI, study sponsors, the statistical and data management lead, and the investigators at the CTSA Hubs. Specific Aims should reflect that the TIC should provide trial support that will vary with different projects depending on the complexity and stages of trial work, as well as depending on the needs and contributions of the clinical and statistical investigators and the trial sponsors.

Research Strategy: Applications must include the following information in the subsections listed below. The responsibilities and functions expected of the TIC are included within the subsections. Applicants should assume that provision of the efforts indicated "AS NEEDED" will occur in less than 50% of studies. Applicants should note whether any of the stated functions are difficult for them to perform and should describe their projected capacity to support the implementation of multi-site studies. Applicants should clearly indicate if they are proposing a pediatric or geriatric focused TIC and present institutional experience in managing clinical trials with these populations.

Applicants are encouraged to propose innovative approaches or additional functions not mentioned that help facilitate the administration and/or conduct of clinical trials, or that enhance quality and efficiency. However, caution should be exercised to focus ample attention and resources on the required TIC responsibilities to enhance their success.

Operations: Describe a plan for the TIC in the first six months of funding, in collaboration with other TICs, to establish standardized IAA, MCTA, consent and other templates, joint SOPs, shared or at least inter-operable IT systems and innovative ways for efficient multi-site trial budgeting which may include IT solutions such as SPARC (http://academicdepartments.musc.edu/sctr/sparc_request). This includes finalizing details of research cost (per participant) to sites within approved budgets, develop site payment schedule, and finalize subcontracts with sites per the MCTA. Describe how, once a trial is approved for funding, the TIC will identify and work with the CTSA designated liaison for each interested site to ensure prompt submissions and responses to requests from the cIRB, and prompt processing of trial-specific parts of the subcontracts.

Describe how the TIC will coordinate trial investigator conference calls and meetings, including organizational support for an investigator study initiation meeting. Most multi-site trials will have virtual or in-person investigator meetings at six or twelve month intervals and a small lead committee composed of selected PD/PIs that acts for the investigators and meets weekly by conference call. The TIC will provide for regular communications among the lead study PD/PI, statistical/data management PD/PI, TIC staff and the CTSA Hubs that participate in a given trial. Describe plans for close collaboration and maintaining harmonized processes based upon identified best practices. To that effect, the applicants should plan on participating in regular teleconferences with the other TICs and in at least one annual in-person meeting of the TICs.

Describe the relevant collaborative expertise and track record of the proposed TIC in supporting clinical trials, how tasks will be delegated and supervised, and how the team will communicate. Describe the SOPs the proposed TIC has in place and the processes they currently apply when coordinating multi-center projects. Provide examples and describe features of investigator meetings and research team training sessions the proposed TIC has organized.

As a baseline, provide a description of start-up timelines of up to five consecutive most recently initiated multi-site trials for which the proposed TIC provided clinical coordination, listing the following in days unless otherwise specified. The data should be presented in table format with six rows (one per consecutive trial, and one for mean [range]), and seven columns as follows:

• Name of trial
• Number of projected participants/number of projected sites
• Time from protocol submission to IRB approval at the lead site
• Time from IRB approval to first subject, first visit at the lead site
• Time from IRB approval at lead site to IRB approval at 50% and 90% of collaborating sites;
• Time from IRB approval at the lead site to the time when the first patient, first visit occurred at 50% and 90% of collaborating sites.
• Notes (optional).

Note: This table must be included in the body of the application.

The proposed TIC will provide an estimate of their capacity in terms of the number of trials they can initiate and implement. The proposed TIC should also describe how they might increase capacity on a fee-per-service basis in the future, should more sponsors and investigators than planned for wish to work with the TIC.

Collaboration: Describe how the TIC will assist the trial PD/PI and/or funding agency (e.g. a categorical NIH IC) that proposes use of the TIC/CTSA network as they develop their protocol, budget and funding plans; and will provide basic information on how to engage with the TIC in terms of work scope, processes and timelines. This description should focus on limited use of TIC resources and should be largely based on making information available online, due to the low ratio of funded trials to NIH applications. The TIC will also assist the trial PD/PI and/or funding agency in assessing the capability, capacity and preparedness of the participating sites to implement the trial; and provide recommendations and support to reconcile any gaps identified. Indicate how potential trial PD/PIs will be supported in the development phase, and integrated into the network during the implementation phases. "AS NEEDED", the TIC will work with the study investigators in the publication of manuscripts, as well as debrief participants by developing materials regarding trial findings and implications for patients, families and the general public.

Describe any special group expertise or unique strengths such as tools or approaches the proposed TIC may offer to the collaborative effort (e.g., experience in clinical trial collaborations with NIH ICs, industry partners, or patient groups). Document the timelines in project management of recent trials, and describe the collaborative leadership structure used in recent multi-center trials the proposed TIC has coordinated. Describe the vision for collaborating with the RICs, the other TICs and the CTSA Hubs and for contributing to the NEC. Describe a plan as to how ad hoc non-CTSA clinical centers may be added to the trial to augment patient recruitment.

Innovation: Applicants are encouraged to propose innovative approaches or additional functions not mentioned that help facilitate the administration and/or conduct of clinical trials, or that enhance quality and efficiency. Describe any novel or innovative approaches the proposed TIC utilizes to support the development of protocols and/or execution of multi-site trials. Describe other plans on how the proposed TIC may support trial investigators to improve the efficiency, quality, and likelihood of successful implementation for multi-site trials it supports.

IT/Informatics: Describe the plan to use electronic project communication and tracking programs to collect and manage information and documents required to support a cIRB, as well as to support streamlined subcontracting and disbursement of per-patient costs. Plans should reflect the goal to ensure efficient communication with the other TICs, with the participating CTSA sites, and sources of trial financial support, including the categorical NIH Institutes and Centers.

Contracting: Describe a plan for the TIC in the first six months of funding to establish standing MCTAs with the CTSA Hubs, which cover recurring contractual issues, such as data ownership or publication rights. Pre-negotiating these common issues will facilitate contract execution as only items such as budget agreements will need to be added as amendments to the contracts. Assume that some trials may involve a private partner via a CRADA with the NIH (see for example NeuroNEXT.org or NIHStrokeNET.org for templates and examples.) Describe a plan for the TIC in the first six months of funding to identify the relevant local contact(s), including those located in the institutional Office of General Counsel, for each site which will review and utilize the IAA and MCTA. Describe any unique experience the proposed TIC as a whole has in subcontracting with other institutions as part of multi-site trials for which the applicant institution is the lead site.

Centralized IRB (cIRB): Describe a plan for the TIC in the first six months of funding to establish processes to run a cIRB and execute IAAs with all CTSA institution Hubs and their key spokes as necessary. Key spokes are affiliates of CTSA Hubs that hold their own Federal Wide Assurance (FWA) number, are sites at which TIC coordinated studies are performed and may need their own IAA. The proposed TIC should plan to develop IAAs which clearly delineate joint and separate responsibilities for the cIRB and institution. Proposed cIRB functions should be guided by the Office for Human Research Protections (OHRP) requirements, the Secretary's Advisory Committee on Human Research Protections (SACHRP) Recommendations on Consideration of Local Context with Respect to Increasing Use of Single IRB Review (January 2013), and by best practices developed by the ongoing CTSA cIRB initiative, by the Clinical Trials Transformation Initiative (CTTI) and by existing cIRBs (e.g. NeuroNEXT, NCI, NIH StrokeNet, VA).

Describe a plan for the TIC in the first six months of funding to develop SOPs for the cIRB, including processes for determination of which sites are engaged in the research, executing an IAA, and completing all IRB reviews required by federal and state regulations. In accordance with OHRP policies, the proposed TIC should describe plans to conduct cIRB activities such as review of protocols, amendments, continuing review renewals, unanticipated problems, and reporting. The proposed TIC should plan to coordinate and document all communication and reporting between the cIRB, and the local CTSA sites, which includes maintaining documentation of all IRB approvals and review of other items or reports by the cIRB. The proposed TIC should describe plans to ensure that complete documentation and all required materials are included with the initial submission, and that all responses to any IRB comments or concerns are comprehensive and immediate. The proposed TIC should describe plans to monitor the IRB approval process and promote rapid approval through a well-developed protocol and swift response to questions raised. Documentation of standard metrics measuring successful completion of these activities is expected.

Describe any unique group experience the proposed TIC may have in serving as a single IRB in a multi-site trial. State the volume of protocols reviewed by the applicant’s institution IRB, the number of boards, the mean turnaround time, and if the IRB has experience in reviewing protocols targeted for a broad range of diseases and populations. In addition, applicants should identify up to five disease areas or population of particular clinical research expertise at their institutions for which their IRB has a track record of reviewing several protocols, and/or for which the applicants have several nationally recognized clinical research experts.

Regulatory: The proposed TIC should describe plans to provide the following functions "AS NEEDED": Convene and support activities of Data and Safety Monitoring Boards (DSMBs). Some sponsors such as some NIH ICs will use their own, existing mechanisms to facilitate DSMBs. Others will prefer to have a third party such as the TIC facilitate independent DSMBs. Collect and maintain essential documents (e.g. Forms in accordance with ICH or FDA 1572), curricula vitae, Good Clinical Practice [GCP] certifications, and other relevant material). Provide a centralized Regulatory Affairs function to assist in the preparation of regulatory documents such as Investigational New Drug (IND), Investigational Device Exception (IDE) or Orphan Drug applications, and to address other regulatory issues. Work with the PD/PI and IND sponsor (study investigator or source of funds) to obtain FDA regulatory approval for the trial (IND/IDE), report, document, and coordinate follow-up correspondence, and ensure registration of the trial and associated results with clinicaltrials.gov. In trials for which the PD/PI is a Sponsor Investigator, check that the lead institution has a process to ensure that all amendments to the protocol are also prospectively submitted to the FDA, that there is an appropriate monitoring plan for network and other sites engaged in the study, and for the submission of annual reports to the FDA. Finalize study drug packaging and labeling and other activities. Assist the study investigators in finalizing reports to the FDA, IRB, and NIH IC or sponsor. Provide guidance to the trial PD/PI or sponsor to ensure compliance with the appropriate data sharing and reporting policies. Describe any unique group experience the proposed TIC may have with supporting investigators in obtaining regulatory approval such as IND or IDE approval from the FDA, and in supporting investigators to meet their reporting requirements to the FDA.

Protocol and Consent Development: Describe a plan for the TIC in the first six months of funding to establish a Protocol Development Team that will work with the project PD/PIs, trial sponsors, collaborating investigators and NCATS staff to refine and finalize the protocols, consents and associated documents and prepare for cIRB submission. Participant perspective should be included in the context of the proposed study. For example, this could be achieved by promoting the inclusion of representatives of patients or other relevant populations on the protocol working groups. The TIC should describe plans to work with the trial PD/PI, investigators, and representatives from relevant participant communities to create a user and research-friendly consent form template that facilitates downstream use of data and samples to advance research, avoids needless confusion by offering multiple confining options, and to the extent possible, limits the consent form to the minimum number of pages necessary to ensure legally effective and informative consent. If additional information must be conveyed, the team should describe plans to create user-friendly information material such as summary sheets with graphic organizers and visual aids, or an informed consent video. In an effort to facilitate and standardize the consent process, the TIC should describe plans to encourage the use of electronic consent (informed consent video coupled with electronic signatures and centralized registration of subject enrollment in a manner that protects confidentiality). The TIC should describe plans to work with the trial PD/PI and investigators to finalize the protocol and consent template, ensuring that the final protocol recognizes and responds to issues raised by the relevant stakeholders.

Describe any unique group experience the proposed TIC may have in developing and standardizing consent templates for multi-site trials. For the 5 consecutive most recently initiated multi-site trials identified above with lead investigator at the applicant institution, please list in table format:

• Name of trial
• Total number of pages of the consent form approved at the lead site,
• Indicate if supplemental, user-friendly video or other material was provided to patients,
• Indicate if the consent form was research-friendly in terms of allowing for the downstream sharing of de-identified data and samples for research (not specified with whom, where, and for what purpose, or length of time).

Note: This table must be included in the body of the application.

Describe any unique experience the proposed TIC may have as a whole for including subjects in concept, protocol and consent template development, and to maintain ongoing engagement throughout the life cycle of the project.

Performance and Quality Monitoring: Describe a plan for the TIC in the first six months of funding to establish, in collaboration with other TICs, a process to collect common metrics to monitor the performance of clinical trials ranging from protocol development, cIRB review, contract negotiation, budget negotiation, and completion of clinical trials. Metrics to be used may be suggested. The proposed TIC should describe a plan to perform immediate and ongoing assessment of potential resource problems or site-specific issues, as well as monitor and address problems in establishing the cIRB or the MCTAs.

The proposed TIC should plan to work closely with trial leadership teams, other TICs, and NIH staff to identify inefficiencies and barriers throughout the trial life-cycle, and implement innovative process improvements while maintaining quality and safety. The proposed TIC should describe plans to track trial progress and quality, and implement corrective actions as necessary. Consider innovative means to monitor performance, such as remotely, and study this as perhaps an alternative. "AS NEEDED", the TIC will conduct for-cause site monitoring visits, e.g., for poor performance; develop a risk-based monitoring plan and conduct on-site and/or remote monitoring; and monitor participant withdrawal rates and help address problems with retention. Describe any unique group experience the proposed TIC may have in monitoring the performance of clinical sites in multi-site trials and any experience they may have as a whole in risk-based or remote monitoring.

In collaboration with NCATS and the other TICs, the proposed TIC should describe plans to develop skills enhancement opportunities for clinical research personnel. Describe the development and maintenance of standards in clinical trial management including compliance with GCP and other evidence of quality in clinical trials performance. Describe any unique experience the proposed TIC may have in providing skills development opportunities to develop their workforce in multi-site trials and promote best practices.

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, with the following modification:

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

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

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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 NCATS, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NCATS Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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

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.

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Do the proposed approaches to creating a TIC identify important problems or critical barriers to efficient and safe initiation and execution of multi-site clinical trials? Are the approaches proposed likely to be successful; attractive to clinical trial investigators and sponsors, and in this way exportable to other clinical trials in general? Does the applicant propose credible plans for creating a cIRB for large multi-site trials? Are the proposed planned activities likely to reduce the time from trial start-up to first patient randomized? Are declared metrics useful? Are the applicant’s experience and plans for designing and using MCTAs cogent and likely to reduce delays in trial start-up that often plague multi-site trials? Is the applicant proposing innovative ways to improve the efficiency and quality of multi-site studies? Does the applicant propose strategies that add value to the overall CTSA research enterprise and to other clinical trial endeavors?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Have the PD(s)/PI(s), collaborators, and other researchers collectively had substantial experience in multi-site clinical trials, cIRBs, consent templates, MCTAs, and other relevant experience? Does the research team have experience in including patients or other relevant participant communities throughout the trial life cycle in activities such as protocol and consent development? Is the overall proposed TIC staffing, including the PD/PI and other staff, well suited to make a significant impact in the conduct of multi-site clinical trials? Are there adequate contingency plans for responding to unanticipated demands for TIC services and for widely varying trial subject matter? Do the leadership and staff demonstrate an understanding of the barriers to successful design and performance of TICs and do their plans and prior experience offer reassurance that they will be successful?

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? Are innovation, creativity and interest in continuous improvement evident in the proposed methods, approaches, resources, services, and policies? Are the novel approaches proposed likely to improve the quality, safety, efficiency, and timely completion of multi-site clinical trials? Is innovation evident that will improve translational multi-site clinical trials in a generalizable way?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Will the approach proposed improve efficiency and quality across a broad range of trials assessing interventions across the human lifespan and in different disease entities? Are barriers to efficient, safe and high quality multi-site trials identified and credible solutions proposed? If applicable (i.e. if the applicants indicated that they would want to serve as a specialized TIC for example for geriatric or pediatric research), are the proposed plans likely to be successful to serve as specialized TICs for such research? Are there unique features of the proposed TIC identifiable and if so, are they likely to improve aspects of TIC performance and multi-site trial efficiency? Are there plans that increase the likelihood of successful service to trial leadership, investigators, patients, staff and other stakeholders? Is there a robust plan for a collaborative leadership structure at the TIC, and for collaborations with the other TICs, the RICs, and the CTSA Hubs? Do the applicants present appropriate plans for SOPs, timelines and project management? Do the applicants present plans which appropriately build upon current CTSA network efforts such as harmonized IRB reliance agreements, improving standards in research staff training and streamlined contracting?

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

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? Have the applicants clearly described projected capacity limits in the implementation of multi-site clinical trials assuming most require basic support and the remainder more (as needed) extensive support? Will the scientific environment at the proposed institution bring strength and efficiency to the CTSA research community in performing multi-site clinical trials? Are there institutional commitment and support to the PD/PI and staff sufficient to the task at hand, specifically; is there strong institutional commitment to serve as single IRB and contracting lead for multi-site trials? Will this academic environment of the proposed TIC institution favor and enhance the likelihood of significant innovation and performance?

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.

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

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

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

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.

Not Applicable

Not Applicable

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.

Not Applicable

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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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 Office of Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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 NCATS Advisory 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. Policies consistent with goals for resource, data sharing and sharing of software.
• Ability to begin operations immediately.

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

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

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

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

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

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

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.

Cooperative Agreement Terms and Conditions of Award

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 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.

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. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

• Coordinating all aspects of network research protocols.
• Implementation of tracking processes, metrics and milestones to assess the performance of the TIC and the clinical trials supported by the TIC.
• Engaging all participating clinical trial institutions with the TIC.
• Ensuring multi-site trial tasks delineated above under general responsibilities and assigned to the TIC, such as cIRBs, MCTAs and performance monitoring/leadership support functions, are completed in an accurate and timely fashion.
• Implementation of a data security plan that protects the research data from access by unauthorized persons.
• Facilitating collaboration between and among all trial investigators.
• Ensuring the creation and maintenance of a culture of safe and ethical conduct of human subjects research.
• Provision of gathered metrics on trial performance to trial leadership including the steering committee, the trial PI, the NIH program office, and other leadership groups.
• Participation in conference calls and meetings with leadership groups such as the steering committee.
• Participation with other selected TICs in creating a homogeneous approach to general TIC activities.
• Preparing the TIC to support multi-site trials across the spectrum of disease entities and across the lifespan.
• Ensuring informatics coordination and data exchange to facilitate research, compatibility of research systems with broadly accepted content and technical standards including those adopted by the Department of Health and Human Services for health care and public health operations, and compatibility with NIH Institute and Center endorsed common data elements.
• Implementation of a plan to create and maintain a broad culture of responsibility for safe and ethical conduct of human subjects research, which ensures scientifically and ethically flawed studies are not conducted, enrollment is tracked and futile studies are closed in a timely manner, workflow for conduct of clinical and translational research is efficient, prompt analysis of results, and dissemination of those results.
• Effecting steps toward implementation of the agreed on policies, procedures, best practices, or other measures established by NCATS.
• Provision of information to the NIH Program Officer and the NIH Project Scientist concerning progress.

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

The NIH Project Scientist (PS) will:

• Provide substantial programmatic involvement that is above and beyond the normal stewardship role in awards.
• Provide cooperation or coordination with, or assistance to, awardees in performing project activities, e.g., coordination of research networks; coordinating access to NIH supported research resources; identifying other researchers/resources for the projects.
• Participate on steering and operations committees as a voting member or in other functions responsible for helping to guide the course of long-term projects or activities; e.g., annual meetings.
• Have no involvement in normal program stewardship.
• Assess the awardee’s overall participation in and contributions to the CTSA Network and its support for development and implementation of best practices, policies, and procedures.

Additionally, an NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIH Program Official stewardship includes:

• Enforcement of general statutory, regulatory, or policy requirements.
• Approval of awardee plans prior to award and review of performance after completion.
• Evaluation of progress by reviews of technical or fiscal reports, by program visits, or with external consultants, to determine that performance is consistent with objectives, terms and conditions of the award.
• Technical assistance requested by awardees, or correcting programmatic or financial deficiencies in awardee performance.
• Scientific and technical discussions with awardees, or actions to facilitate or expedite interactions between awardees; e.g., organizing and holding meetings of investigators.

Areas of Joint Responsibility include:

• None; all responsibilities are divided between awardees and NIH staff as described above.

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 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 awardee. 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.

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

A final progress report, 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.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Todd Wilson, DO
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0768
Email: [email protected]

Laurie M. Ryan, PhD
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: [email protected]

Mohan Viswanathan, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-312-3745
Email: [email protected]

Jean D. Richelsen
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-9446
Email: [email protected]

Linda Whipp
National Institute on Aging (NIA)
Telephone: 301-402-7731
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 74 and 92.