This Notice of Special Interest (NOSI) calls for research on pain management in the context of opioid use or opioid use disorder (OUD). In particular, NIAMS is interested in providing data-driven evidence regarding effective mechanisms for reducing reliance on opioids while maintaining quality of life. Funds for Competitive Revisions to active grants are available as part of the NIH HEAL (Helping to End Addiction Long-termSM) Initiative and awardees will operate within the Back Pain Consortium (BACPAC) Research Program, a part of the NIH HEAL InitiativeSM. Investigators with active grants in the area of chronic pain and/or addiction are encouraged to apply. This award has two phases, a one-year Planning Phase and a two to three year Research Project Phase.

Background

Back Pain is the major form of chronic pain among adults worldwide and the most common, non-cancer reason for opioid prescription in the US. The NIH HEAL InitiativeSM is a trans-NIH initiative with the aims of improving treatments for opioid misuse and addiction; and enhancing pain management, by understanding the biological underpinnings of chronic pain and accelerating the discovery and development of non-addictive treatments for pain. The Back Pain Consortium (BACPAC) Research Program, part of the NIH HEAL InitiativeSM, provides a platform for research at the intersection of pain management and opioid use or opioid use disorder (OUD). BACPAC is a patient-centric translational research initiative, that is taking a biopsychosocial approach to the study of chronic low back pain (cLBP) and the need for more effective and personalized treatments.

Research Objectives

In order to effectively reduce reliance on opioids in the treatment of chronic low back pain while maintaining quality of life, NIAMS is encouraging the submission of applications for Competitive Revisions to active grants to provide evidence-based data to inform clinical practice guidelines.

Research areas of interest include:

Project Planning Phase - What are the key questions providers and patients have with respect to opioid use for managing chronic pain? Questions of interest might be patient-centric and/or provider-focused, e.g., When is it appropriate to prescribe opioids for chronic pain; if someone is already taking opioids for pain management what are the most effective means for reducing this dependence; what alternatives exist?

Research Project Phase - Investigators should propose strategies to test the most effective means of managing pain while reducing dependence on opioids with the intent of informing clinical practice.

Award Information

NIAMS intends to commit $320,000 in FY2020, the Planning Phase, and $800,000 each year of the Research Project Phase, FY2021 through FY2023, to fund up to two awards. Budget and research project length should reflect project needs, and the parent grant must be active throughout the duration of the Competitive Revision.

Awardees are expected to share data and resources consistent with the guidelines and policies of the NIH, the NIH HEAL InitiativeSM, and as developed by the Steering Committee of the BACPAC Research Program. Adherence to these guidelines and policies will be required in the terms and conditions of award.

Application and Submission Information

Applications in response to this NOSI must be submitted using the following target funding opportunity:

• PA-18-935 Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)
• Eligible activity codes for applications to PA-18-935 are dependent upon the target Institute, Center, or Office (ICO). Table 1 lists the activity codes that will be accepted by each participating ICO.

Table 1: Eligible Activity Codes by Participating ICO

Activity Code	NIAMS	NIBIB	NINR	NIMHD	NICHD	NIAAA	NCATS	NCCIH	NIDA	NINDS
DP1 NIH Director’s Pioneer Award	Yes	Yes	No	No	No	No	No	Yes	Yes	Yes
P01 Research Program Projects	No	No	No	No	No	No	No	Yes	Yes	No
P41 Research Program Projects and Centers	No	Yes	No	No	No	No	No	No	No	No
P50 Specialized Center	Yes	No	No	No	No	Yes	No	Yes	Yes	No
R01 Research Project Grant	Yes	Yes	Yes	Yes	No	Yes	Yes	Yes	Yes	Yes
R35 Outstanding Investigator Award	No	No	No	No	No	No	No	No	Yes	No
R61 Phase 1 Exploratory/Developmental Grant	Yes	No	No	No	No	No	No	Yes	Yes	Yes
U01 Research Project Cooperative Agreements	Yes	Yes	Yes	No	No	Yes	Yes	Yes	Yes	Yes
U18 Research Demonstration- Cooperative Agreements	Yes	Yes	No	No	No	No	No	No	Yes	Yes
U19 Research Program Cooperative Agreement	Yes	No	No	No	Yes	No	No	No	Yes	Yes
U24 Resource-Related Research Projects Cooperative Agreements	Yes	Yes	No	No	Yes	No	Yes	No	Yes	Yes
U54 Specialized Center- Cooperative Agreements	Yes	Yes	No	Yes	No	No	Yes	Yes	Yes	No
U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements	No	No	No	No	No	No	No	No	Yes	No
UF1 Multi-Year Funded Research Project Cooperative Agreement	No	No	No	No	No	No	No	No	Yes	No
UG1 Clinical Research Cooperative Agreements-Single Project	Yes	No	No	No	No	No	No	No	Yes	Yes
UH3 Exploratory/Developmental Phased Award Cooperative Agreement	Yes	Yes	No	No	No	No	Yes	Yes	Yes	Yes
UM1 Multi-Component Research Project Cooperative Agreements	No	No	No	No	No	No	No	No	Yes	No

All instructions in the SF424 (R&R) Application Guide and PA-18-935 must be followed, with the following additions:

• The Research Strategy section of the application is limited to 12 pages.
• The award project period of the Competitive Revision must be three to four years, with one year for the Planning Phase and two to three years for the Research Project Phase.
• The deadline for applications is March 13, 2020 5:00 PM local time of the applicant organization. This NOSI expires on March 14, 2020. An application submitted in response to this NOSI that is received on March 14, 2020 or later, will be withdrawn.

• Applications should must be submitted to PA-18-935, “Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement Clinical Trial Optional)" using the application forms package with the Competition ID “NOT-AR-20-016-FORMS-E”

• IMPORTANT: For funding consideration, all applicants must designate NOT-AR-20-016 in the Agency Routing Identifier field (Box 4b) of the SF424 (R&R) Form. Applications without this information in Box 4b will not be considered for this initiative.
• Applications non-responsive to the terms of this Notice will be not be considered for this initiative.
• Review criteria, in addition to those described in PA-18-935, include the following:
  • Does the PI(s)/PD(s) have expertise in pain management and/or addiction appropriate for the study of low back pain and opioid use?
  • Does the application propose to engage patients, providers, other relevant stakeholders in identifying key questions regarding pain management and opioid use, curtailment, alternatives to opioids?
  • If successful, does the application have the potential to inform clinical decision making?
  • Has the PI(s)/PD(s) considered how their work might interface with or avail of the BACPAC research program?
• Investigators planning to submit an application in response to the NOSI are strongly encouraged to contact the appropriate Institute or Center contact listed in the NOSI to discuss the proposed project in the context of the parent award. Questions specific to this NOSI should be sent to [email protected].

Applications nonresponsive to terms of this NOSI will be not be considered for the NOSI initiative.