Notice Number: NOT-OD-15-097

Key Dates
Release Date: April 27, 2015

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this Notice is to inform the research community who propose to use chimpanzees (Pan troglodytes) in research that the Chimpanzee Research Use (CRU) Reporting System will be fully implemented on or about April 29, 2015. The CRU Reporting System is the mechanism to submit the CRU Form information described previously in NOT-OD-14-024. The NIH Division of Program Coordination, Planning, and Strategic Initiatives provides upcoming due dates for submission of the CRU Form.

Background

On November 25, 2013, the NIH published NOT-OD-14-024 to announce that it would resume accepting grant applications, contract proposals, protocols from the NIH Intramural research program, and 3rd party project proposals for research involving the use of chimpanzees in research. The notice describes the Chimpanzee Research Use Panel (CRUP) process and timeline that the agency will follow to consider whether research proposing the use of chimpanzees is consistent with the NIH principles and criteria for use of chimpanzees in research. The notice also describes the CRU Form, indicates that the form is required, provides the questions on the form, provides due dates for submission of the CRU Form, and refers to http://dpcpsi.nih.gov/council/index.aspx for more information about the CRUP.

CRU Reporting System

The CRU Form received OMB approval (OMB No 0925-0705) on October 31, 2014. NIH developed the CRU Reporting System as the data collection tool for the CRU Form. The system is scheduled to become fully operational on or about April 29, 2015. The CRU Reporting System is the work flow and record keeping mechanism for the CRUP process for all funding mechanisms (extramural grants, contracts, Intramural protocols, and 3rd party requests for use of chimpanzees).

Extramural grant applicants who propose the use of chimpanzees in research, as well as certain other Principal Investigators whose applications may be identified as possibly involving use of chimpanzees, will experience the following changes to the grant award process.

• Upon receipt of the grant application by NIH, an automated query in the electronic Research Administration (eRA) system (the system used by NIH to support the full grant life cycle) identifies applications that contain words or phrases that may indicate the use of chimpanzees in the project. These applications will receive a chimpanzee flag in the NIH system. Before the application receives funding, this flag must be addressed by satisfying the NIH criteria for use of chimpanzees in research, or by the applicant certifying that no chimpanzees or chimpanzee biomaterials are involved.
• When the NIH Institute or Center (IC) is considering funding for an application after the two-level peer review process has been completed, an email notification will be sent from the CRU Reporting System to the principal investigator and the institutional signing official describing three possible paths for resolving the chimpanzee flag .
• The first path is for a grant application that received the chimpanzee flag designation, but the project does not involve the use of chimpanzees or chimpanzee biomaterials (defined in NOT-OD-14-024). The information provided by the applicant will be reviewed by the NIH Office of Laboratory Animal Welfare (OLAW) to verify that the project does not involve the use of chimpanzees or chimpanzee biomaterials. No substantial delay in the award process is anticipated for this path.
• The second path is for research involving chimpanzees or chimpanzee biomaterials that meets the criteria for exempt from CRUP consideration as described in NOT-OD-14-024. In this case, the grant applicant enters the CRU Reporting System and indicates that the research meets the exempt from CRUP consideration criteria and provides a justification. The information provided by the applicant will be reviewed by the NIH Office of Laboratory Animal Welfare (OLAW). No substantial delay in the award process is anticipated for this path if OLAW agrees that the research meets the exempt criteria.
• The third path is for research that involves the use of chimpanzees that does not meet the exempt criteria. In this case, the grant applicant completes the CRU Reporting Form. This form is submitted through the CRU Reporting System for consideration by the CRUP. As described in NOT-OD-14-024, the CRUP will consider the submitted information to ensure the proposed use of chimpanzees in the research project meets the NIH criteria and principles. The CRUP’s recommendation will be presented to the Council of Councils, which will provide its recommendation to the appropriate NIH Institute or Center Director(s). This process is expected to add approximately 4 months to the award cycle if the grant applicant meets the CRU Form Due date indicated in this notice. Failure to submit by the Form Due date will delay consideration by the CRUP and the Council of Councils to the next cycle.

Due Dates

The table below provides the due dates corresponding with upcoming funding cycles for research involving the use of chimpanzees.

* Applicable only to grant applications. Due dates for AIDS and AIDS-related applications are May 7 for Sep.-Oct. Advisory Council, Sept. 7 for Jan.-Feb. Advisory Council, and Jan. 7 for May-June Advisory Council. Due dates for contract proposals and intramural research protocols are specified by the contracting office and/or NIH IC.
** Dates are approximate. The NIH will communicate the final due date at the time the agency asks the applicant or offeror to complete the Chimpanzee Research Use Form.
*** Applicable to only research determined by the NIH to be subject to CRUP consideration.
**** Future dates will be available at: http://dpcpsi.nih.gov/council/futuremeetings

Inquiries

Questions about this notice and RFI can be directed to [email protected].