Notice of Change to the Agent Selection and Conditions of Award for PAR-16-111 “Cooperative Agreement to Develop Targeted Agents for Use with Systemic Agents Plus Radiotherapy (U01)”

Notice Number: NOT-CA-16-039

Key Dates
Release Date:   April 18, 2016

Related Announcements
PAR-16-111    

Issued by
National Cancer Institute (NCI)

Purpose

The purpose of this Notice is to notify the community of new guidelines that are relevant to PAR-16-111 "Cooperative Agreement to Develop Targeted Agents for Use with Systemic Agents Plus Radiotherapy (U01)".

This Notice revises and clarifies the procedures and the terms and conditions for obtaining National Cancer Institute / Cancer Therapy Evaluation Program (NCI/CTEP) molecularly targeted experimental drugs for the pre-clinical studies to be executed under a cooperative agreement described in PAR-16-111.

The following sections have been modified (in italics)

Section I. Funding Opportunity Description
Specific Research Objectives

Current language:

1. Agent selection

  • Applicants submitting research projects in response to this FOA should select and justify the CTEP agent(s) they wish to investigate.
  • Applicants should obtain approvals for studies with the selected agent(s) with the assistance of CTEP drug monitors and Investigational Drug Branch program staff.
  • Upon Company approval, agents will be provided under an NCI CRADA.

New language:

1. Agent selection

  • Applicants submitting research projects in response to this FOA should select and justify the CTEP agent(s) they wish to investigate. CTEP available agents may be found at http://ctep.cancer.gov/industryCollaborations2/agreements_agents.htm
  • Applicants should obtain approvals for studies with the selected agent(s) with the assistance of CTEP drug monitors and Regulatory Affairs Branch staff. CTEP non-clinical request form is available at http://ctep.cancer.gov/industryCollaborations2/agreements_agents.htm; the “Requested Agent(s) “section should include the requested agent(s), and the Funding Opportunity Announcement Number (PAR-16-111).
  • Upon Collaborator approval, agents will be provided under an NCI/CTEP Material Transfer Agreement (MTA) –Commercial Collaborator(s), and subject to the terms and condition of an NCI/CTEP Cooperative Research and Development Agreement (CRADA) and/or Clinical Trials Agreement (CTA).  CTEP model CTA, MTA and CRADA are available at CTEP (http://ctep.cancer.gov/industryCollaborations2/model_agreements.htm)

Section VI. Award Administration Information
Cooperative Agreement Terms and Conditions of Award

Current language:

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 Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. 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.

New language:

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 Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. 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.

Investigational agents used in this program, and under the Cooperative Agreement, are supplied to the National Cancer Institute (NCI) by the pharmaceutical Collaborator, and are subject to the terms and conditions, to include the Intellectual Property rights and the Manuscript and Publications obligations, of the Cooperative Research and Development Agreement (CRADA), or the Clinical Trial Agreement (CTA) between the National Cancer Institute (NCI) Division of Cancer Treatment and Diagnosis (DCTD) and the NCI pharmaceutical Collaborator.  To learn more about guidelines for Collaborator with Industry see http://ctep.cancer.gov/industryCollaborations2/default.htm.

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Eric Bernhard, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5704
Email: bernhardej@mail.nih.gov