Notice of Corrections to PAR-15-172 : Collaborative Innovation Award, Clinical and Translational Science Award (CTSA) Program (U01)

Notice Number: NOT-TR-15-012

Key Dates
Release Date:   May 26, 2015

Related Announcements
PAR-15-172

Issued by
National Center for Advancing Translational Sciences (NCATS)

Purpose

The purpose of this Notice is make modifications for PAR-15-172.

Part 1. Overview Information

Key Dates

Currently reads:

Scientific Merit Review

June 2016, November 2016,  March 2017, July 2017, November 2017, March 2018, July 2018, November 2018

Modified to read:

Scientific Merit Review

May 2016, November 2016,  March 2017, July 2017, November 2017, March 2018, July 2018, November 2018

Currently reads:

Advisory Council Review

October 2016, January 2017, May 2017, October 2017, January 2018,  May 2018,  October 2018, January 2019 

Modified to read:

Advisory Council Review

September 2016, January 2017, May 2017, October 2017, January 2018,  May 2018,  October 2018, January 2019 

Currently reads:

Earliest Start Dates

December 2016, April 2017, July 2017, December 2017, April 2018, July 2018, December 2018, April 2019

Modified to read:

Earliest Start Dates

September  2016,  February 2017, June 2017, October 2017, February 2018, June 2018, October 2018, February 2019

Section III. Eligibility Information

Currently reads:

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 not allowed.

Modified to read:

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.

Eligible Individuals (Program Director/Principal Investigator)

Currently Reads:

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.
Applications must involve investigators from at least 3 CTSA hubs. Each hub must have an active CTSA Award (U54) as of the due date of the application. 
The PD/PI, or contact PD/PI in applications using the multiple PD/PI option, must be employed by an Institution with an active CTSA Award (U54).  
Investigators who are not employed by an institution with an active CTSA Award, but who wish to bring an innovative project to the CTSA consortium, can co-direct a project in partnership with a CTSA investigator using the multiple PD/PI option.

Modified to Read:

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.
Applications must involve investigators from at least 3 CTSA hubs. Each hub must have an active CTSA Award (U54) as of the due date of the application. 
The PD/PI, or contact PD/PI in applications using the multiple PD/PI option, must be employed by an Institution with an active CTSA Award (U54).  For the Collaborative Innovation Awards (PAR-15-173 and PAR-15-172) the PD/PI, or contact PD/PI in applications using the multiple PD/PI option, must be employed by an Institution with an active CTSA Award (U54), or by a partner institution as identified in the application for the active CTSA award.

Investigators who are not employed by an institution with an active CTSA Award or partner Institution but who wish to bring an innovative project to the CTSA consortium, can co-direct a project in partnership with a CTSA investigator using the multiple PD/PI option.

Section IV. Application and Submission Information

Currently reads:

Letters of Support: Where relevant, include letters of support or other documentation of partnerships with the private sector (e.g., patient groups and/or industry), subcontractors, consultants, and/or other providers of personnel and facilities. For drug or device trials, provide evidence that the study drug or device will be available in sufficient quantities to ensure study feasibility. If applicable, letters from authorized Institutional officials agreeing to the proposed single IRB plan should also be included.

Modified to read:

Letters of Support:   Each collaborating investigator should include a letter of support from the PD/PI of the U54 CTSA hub that they are associated with. For multiple investigators from the same CTSA hub, one letter of support from the CTSA PI is sufficient. Where relevant, include letters of support or other documentation of partnerships with the private sector (e.g., patient groups and/or industry), subcontractors, consultants, and/or other providers of personnel and facilities. For drug or device trials, provide evidence that the study drug or device will be available in sufficient quantities to ensure study feasibility. If applicable, letters from authorized Institutional officials agreeing to the proposed single IRB plan should also be included.

Currently reads:

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.

Modified to read:

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. 

For applications that propose a clinical trial, the following items should be included in the appendix:

The protocol synopsis, which should not exceed 5 pages, including the following:

  • Study objectives (primary, secondary, exploratory) and outcome measures
  • Study design
  • A description of the intervention to be tested (if applicable)
  • Sample size, if not described in Protection of Human Subjects
  • Study population (with key inclusion/exclusion criteria),
  • Recruitment plan,
  • Study procedures and evaluations, including safety assessments
  • Overall study duration and duration of participant involvement.
  • Process to be used for obtaining informed consent
  • Draft data management plan
  • Draft quality management plan
  • Draft laboratory plan, including specimen handling, storage, tracking and processing
  • Milestone plan for clinical study progress, including recruitment goals, interim analysis, data and safety monitoring

At the time of grant submission, applicants must provide documentation from the FDA providing information on one of the following three scenarios:

(A)  The protocol has been submitted under an IND in effect and the IND/IDE is not under full or partial hold.  Under this scenario, applicants must provide documentation such as a “may proceed” email or letter from the FDA.

(B)  The protocol has been submitted under an IND/IDE and is on full or partial hold.  Under this scenario applicants must provide full documentation from the FDA on the reasons for hold and the FDA recommendations.

(C)  The protocol is exempt from an IND/IDE.  Under this scenario applicants must provide a copy of the exemption letter from the FDA.

At the applicant’s discretion, the following optional elements may also be provided in the appendix:
Non-referenced or non-published, non-standardized clinical assessments and data collection tools.
Investigator Brochures, see 21 CFR 312.23 (a)(5) for format Clinical pharmacology justifying the proposed dosing regimen

Section VII. Agency Contacts

Currently reads:

Scientific/Research Contact(s)
Philip J. Brooks, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-443-0513
Email: CTSAInnovationFOAQuestions@mail.nih.gov

Peer Review Contact(s)
Mohan Viswanathan, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-312-3745
Email: CTSAInnovationFOAQuestions@mail.nih.gov

Financial/Grants Management Contact(s)
Leslie Le   
National Center for Advancing Translational Science (NCATS)
Telephone: 301-435-0856
Email: CTSAInnovationFOAQuestions@mail.nih.gov

Modified to read:

Scientific/Research Contact(s)
Philip J. Brooks, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-443-0513
Email: pjbrooks@mail.nih.gov

Peer Review Contact(s)
Mohan Viswanathan, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-312-3745
Email: mv10f@nih.gov

Financial/Grants Management Contact(s)
Leslie Le  
National Center for Advancing Translational Science (NCATS)
Telephone: 301-435-0856
Email: LeLeslie@mail.nih.gov

Inquiries

Please direct all inquiries to:

Philip J. Brooks, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-443-0513
Email: pjbrooks@mail.nih.gov