Notice of Correction to Cooperative Agreement Terms and Conditions of Award for RFA-NS-19-020 "HEAL Initiative: Optimization of Non-addictive Therapies (Small Molecules and Biologics) to Treat Pain (U44 - Clinical Trial Not Allowed)".

Notice Number: NOT-NS-19-033

Key Dates
Release Date : February 05, 2019

Related Announcements
RFA-NS-19-020

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this notice is to amend missing information under the Cooperative Agreement Terms and Conditions of Award for RFA-NS-19-020 "HEAL Initiative: Optimization of Non-addictive Therapies (Small Molecules and Biologics) to Treat Pain (U44 - Clinical Trial Not Allowed)".  The Cooperative Agreement Terms and Conditions of Award have been modified to include information that was erroneously omitted.

Currently Reads:

Section VI. Award Administration Information

2. Administrative and National Policy Requirements

Cooperative Agreement Terms and Conditions of Award

Not Applicable

Modified to Read:

Section VI. Award Administration Information

2. Administrative and National Policy Requirements

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 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.

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

  • Determining experimental approaches, designing protocols, conducting experiments, and analyzing and interpreting research data for studies funded through this UG3/UH3.
  • Hosting a face-to-face meeting at the outset of the project and working with NIH staff to assist in the development of a project milestone plan.
  • Presenting project updates (including raw data, when requested) in regular conference calls or other intermittent face-to-face meetings.
  • Coordinating and participating with NIH staff in all aspects of scientific and technical management of the project.
  • Implementing all scientific and policy decisions approved by NIH staff or an oversight committee.
  • Submitting periodic milestone progress reports in a standard format, as agreed upon at the initiation.
  • Preparing for annual administrative site visits by NIH Program staff.
  • Awardees agree to participate in the overall coordination of NIH research efforts in translational research in pain. This participation may include collaboration and consultation with other translational research awardees, and the sharing of information, data, and research materials.
  • Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
  • Working closely with his/her institution's technology transfer officials to ensure that royalty agreements, patent filings, and all other necessary intellectual property arrangements are completed in a timely manner. Awardees are responsible for pursuing patent protection.

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

  • Each project will have the support of one or more Project Scientists from NIH program staff who are assigned an administrative role for the target or pain condition being studied and have expertise in the implementation of NINDS cooperative agreement programs.
  • The NIH Project Scientists will have substantial scientific/programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants.
  • NIH Project Scientists will assist in the development of a finalized project milestone plan at the outset of the project and approve the final milestone language for incorporation into the award notice.
  • NIH Project Scientists will be responsible for assessing the progress of the projects toward the accomplishment of specified milestones, and for recommending if further funds should be released to the project.
  • NIH Project Scientists will coordinate and participate in meetings to discuss project status, planning, and implementation.
  • The NIH Project scientists will serve as scientific liaisons among the awardee and other NIH program staff and report periodically on the progress of the project to NIH leadership.
  • NIH Project Scientists will facilitate the establishment of contacts and collaborations between awardees and other persons or organizations whose participation will assist with the accomplishment of project goals. These persons or organizations may include the FDA, disease voluntary organizations, pharmaceutical companies, or research organizations that can provide essential services on contract.
  • An important part of the NIH HEAL Initiative is the coordination of research efforts across different funding mechanisms and research structures, and coordination among efforts aimed at different pain conditions. NIH Project Scientists will have the primary responsibility for this overall coordination and provide a perspective on the priorities of the HEAL Initiative and other NIH translational programs.
  • Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program director may also serve as an NIH Project Scientist.

Leadership of the Institute/Center funding the project will make decisions on project continuation with input from NIH staff and/or any established oversight committee, based on:

  • Successful achievement of milestones
  • The overall feasibility of project advancement, considering data that may not have been captured in milestones
  • Based on emerging and published literature on competition for the disease indication and drug target
  • Program priorities
  • Availability of funds

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. 

All other aspects of this FOA remain the same.

Inquiries

Please direct all inquiries to:

Charles Cywin
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-1779
Email: charles.cywin@nih.gov