Notice of Change to FOA PAR-19-099: Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative Innovation Award (U01 Clinical Trial Optional)

Notice Number: NOT-TR-19-016

Key Dates
Release Date : February 21, 2019

Related Announcements
PAR-19-099

Issued by
National Center for Advancing Translational Sciences (NCATS)

Purpose

Please note the following changes:

Currently Reads:

Part 1. Overview Information

Funding Opportunity Purpose

The Clinical and Translational Science Award (CTSA) Program Collaborative Innovation Award (CCIA) supports collaborative research activities that develop innovative solutions that will improve the efficiency, quality and impact of turning laboratory, clinic and community observations into interventions that improve the health of individuals and the public. This funding opportunity announcement (FOA) will support investigators from three or more CTSA Program hub institutions (see below under Eligible Individuals) to either: 1) form new collaborations, or to 2) significantly expand the scientific scope of existing collaborations, or to 3) engage new collaborators in pre-existing collaborations to solve a translational science problem no one hub can solve alone, or disseminate a solution to a translational science problem developed at one hub to other hubs, in so doing testing its robustness to different hub environments and structures and adapting it for further dissemination within outside the CTSA Program consortium if appropriate.

Key Dates

Scientific Merit Review

June 2019, October 2019, February 2020, June 2020, October 2020, February 2021, June 2021, October 2022, February 2023

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The Clinical and Translational Science Award (CTSA) Program Collaborative Innovation Award (CCIA) supports collaborative research activities that develop innovative solutions that will improve the efficiency, quality and impact of turning laboratory, clinic and community observations into interventions that improve the health of individuals and the public. This funding opportunity announcement (FOA) will support investigators from three or more CTSA Program hub institutions (see below under Eligible Individuals) to either: 1) form new collaborations, or to 2) significantly expand the scientific scope of existing collaborations, or to 3) engage new collaborators in pre-existing collaborations to solve a translational science problem no one hub can solve alone, or disseminate a solution to a translational science problem developed at one hub to other hubs, in so doing testing its robustness to different hub environments and structures and adapting it for further dissemination outside the CTSA Program consortium if appropriate.

Section III. Eligibility Information

1.Eligible Applicants

Eligible Organizations

An application must involve investigators who are supported by CTSA Program hub institutions from at least three different and currently funded CTSA Program hubs as of the due date of the application. A CTSA Program hub is defined as a UL1 award with a linked KL2 award and an optional TL1 award. A hub that is in no-cost extension (NCE) status is not considered a currently funded CTSA Program hub (see https://ncats.nih.gov/ctsa/about/hubs). CTSA Program hub institutions include the recipients of the CTSA Program hub award, as well as any institutions listed as partners in the CTSA Program hub UL1 awards.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

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

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

System for Award Management (SAM) 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.

Eligible Individuals (Program Director/Principal Investigator)

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/PI or contact PD/PI must be employed by and/or a recipient of funding from a currently funded CTSA Program hub institution as defined above in Eligible Organizations. Investigators who are not employed by and/or a recipient of funding from a CTSA Program hub institution but who wish to bring an innovative project to the CTSA Program, can co-direct a project in partnership with a contact PD/PI who is employed by a currently funded CTSA Program hub institution using the multiple PD/PI option.

See Required Letters of Support

Revised to Read:

Part 1. Overview Information

Funding Opportunity Purpose

The Clinical and Translational Science Award (CTSA) Program Collaborative Innovation Award (CCIA) supports collaborative research activities that develop innovative solutions that will improve the efficiency, quality and impact of turning laboratory, clinic and community observations into interventions that improve the health of individuals and the public. This funding opportunity announcement (FOA) will support investigators from three or more CTSA Program hub institutions (see below under Eligible Individuals) to either: 1) form new collaborations, or to 2) significantly expand the scientific scope of existing collaborations, or to 3) engage new collaborators in pre-existing collaborations to solve a translational science problem no one hub can solve alone, or disseminate a solution to a translational science problem developed at one hub to other hubs, in so doing testing its robustness to different hub environments and structures and adapting it for further dissemination within and outside the CTSA Program consortium if appropriate.

Key Dates

Scientific Merit Review

June 2019, October 2019, February 2020, June 2020, October 2020, February 2021, June 2021, October 2021, February 2022

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The Clinical and Translational Science Award (CTSA) Program Collaborative Innovation Award (CCIA) supports collaborative research activities that develop innovative solutions that will improve the efficiency, quality and impact of turning laboratory, clinic and community observations into interventions that improve the health of individuals and the public. This funding opportunity announcement (FOA) will support investigators from three or more CTSA Program hub institutions (see below under Eligible Individuals) to either: 1) form new collaborations, or to 2) significantly expand the scientific scope of existing collaborations, or to 3) engage new collaborators in pre-existing collaborations to solve a translational science problem no one hub can solve alone, or disseminate a solution to a translational science problem developed at one hub to other hubs, in so doing testing its robustness to different hub environments and structures and adapting it for further dissemination within and outside the CTSA Program consortium if appropriate.

Section III. Eligibility Information

1.Eligible Applicants

Eligible Organizations

An application must involve investigators who are supported by CTSA Program hub institutions from at least three different and currently funded CTSA Program hubs as of the due date of the application or alternatively, an application may involve investigators from at least two different and currently funded CTSA Program hubs (of which one must be the contact PI on the application) and one or more currently funded NIH Institutional Development Award (IDeA) Program Infrastructure for Clinical and Translational Research (IDeA-CTR) participating institution, as of the due date of the application. A CTSA Program hub is defined as a UL1 award with a linked KL2 award and an optional TL1 award. A hub that is in no-cost extension (NCE) status is not considered a currently funded CTSA Program hub (see https://ncats.nih.gov/ctsa/about/hubs). CTSA Program hub institutions include the recipients of the CTSA Program hub award, as well as any institutions listed as partners in the CTSA Program hub UL1 awards. An IDeA-CTR participating institution is defined as the lead institution of an IDeA-CTR award or any of the partner institutions of the IDeA-CTR award. An IDeA-CTR participating institution that is in no-cost extension (NCE) status is not considered “currently funded.”

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

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

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

System for Award Management (SAM) 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.

Eligible Individuals (Program Director/Principal Investigator)

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 contact PD/PI must be employed by and/or a recipient of funding from a currently funded CTSA Program hub institution as defined above in Eligible Organizations. Investigators who are not employed by and/or a recipient of funding from a CTSA Program hub institution (such as investigators whom are employed by an IDeA-CTR participating institution), but who wish to bring an innovative project to the CTSA Program, can co-direct a project using the multiple PD/PI option in partnership with a contact PD/PI who holds employment or funding from a currently funded CTSA Program hub institution.

See Required Letters of Support.

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

H. Timothy Hsiao, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8928
Email: timothy.hsiao@mail.nih.gov