March 3, 2023
PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) or subsequent re-issues
PA-23-044 - Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional) or subsequent re-issues
NOT-AR-23-016 - Notice of Special Interest (NOSI): Administrative Supplements to NIAMS-funded T32 Training Grants to Better Incorporate Pain Related Research in Rheumatic, Skin and Musculoskeletal Diseases Workforce Development
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
The purpose of this announcement is to notify the research community that the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is interested in receiving urgent competitive revision and administrative supplement applications focused on cutting-edge pain research in rheumatic, skin, and musculoskeletal diseases.
Background
This announcement is consistent with the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. More than 25 million Americans suffer from daily chronic pain, a highly debilitating medical condition that is complex and difficult to manage. A large proportion of the cases are due to chronic inflammatory and musculoskeletal conditions such as arthritis and chronic low back pain. In recent decades, there has been an over reliance on the prescription of opioids for chronic pain despite their poor ability to improve function. This contributed to a significant and alarming epidemic of opioid overdose deaths and addictions. Innovative scientific approaches to improve understanding, measurement, prevention, and treatment of chronic pain in rheumatic, skin and musculoskeletal diseases are urgently needed.
Many of the diseases and conditions covered by the NIAMS mission areas cause pain, disability, or disfigurement. Some of these diseases and conditions are very common, while some are rare, affecting only a few thousand people worldwide. Pain, both acute and chronic, is one of the most important symptoms affecting mobility and quality of life for patients. Yet, the mechanisms of pain, and measures and treatment options that can prevent and alleviate pain caused by these diseases are not clearly understood and remain a critical knowledge gap within the NIAMS mission. Therefore, there is a need to accelerate research into underlying mechanisms of pain and advance cutting-edge pain research in rheumatic, skin, and musculoskeletal diseases.
Research Objectives
NIAMS is soliciting applications for urgent competitive revisions or administrative supplements to active awards that include or propose to extend to pain research. Applicants may propose to supplement a parent awards focused on pain or to address/expand a component related to pain in a biomedical and/or health-related behavioral parent research study.
Applications in response to this NOSI should be aligned with one or more of the following goals:
Goal A: Generate supporting evidence towards a future innovative study or new scientific direction in pain research in rheumatic, skin, and musculoskeletal diseases.
Goal B: Expand rheumatic, skin, and musculoskeletal disease pain research capacity (cohorts, technologies or data) beyond current research base/collaborators.
Areas of scientific interest related to these goals include:
- Immune mechanisms of pain
- Bidirectional interaction between tissue damage and pain mechanisms
- Novel pain imaging technologies
- Advanced analytical tools and technologies to identify factors that increase susceptibility to chronic pain, and pathways leading to pain symptoms
- Enhanced and standardized pain phenotyping
- Making large or critical rheumatic, musculoskeletal and/or skin disease data sets relevant to pain research FAIR (Findable, Accessible, Interoperable and Reusable)
- Leveraging existing datasets for secondary analysis and data reuse for pain research
- Identifying functional outcome measures and biomarkers for pain that could be used to assess the effects of treatments
- Studies of pain in pediatric populations or in other existing cohorts
- Social Determinants of Health (SDoH) on pain severity/response to treatment and new strategies to address health disparities and improve health equity in pain
Applications may extend beyond these areas of scientific interest but must include a strong justification.
Budget
NIAMS intends to make multiple awards based on available funds. Application budgets are limited to no more than the amount of the current year's direct cost budget, or $350,000 direct costs (whichever is less), exclusive of consortium F&A costs. The budget must reflect the actual needs of the proposed project.
Active awards with project end dates in FY 2024 or later are eligible. The award may not be in a terminal no-cost extension or entering a no-cost extension in FY 2023. All grant awards made by NIAMS are eligible for this initiative except for the following mechanisms: F30, F31, F32, F33, T32, and R13.
Investigators are strongly encouraged to contact their NIAMS Scientific Program Officer before preparing an application. All questions related to this NOSI can be addressed to NIAMS_PAIN@mail.nih.gov.
Application and Submission Information
Applications in response to this NOSI must be submitted using one of the two following targeted funding opportunities, or its subsequent reissued equivalents:
- PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
- PA-23-044 - Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional
Within Scope: An applicant that is proposing work that is within scope (e.g., expansion of existing specific aims) of the parent grant should apply to the Administrative Supplement announcement, PA-20-272. For funding consideration, applicants must include “NOT-AR-23-015” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form.
Change in Scope: Work that is considered a revision of the parent grant, i.e., expanding the scope with a new specific aim, should apply to the Urgent Competitive Revision announcement, PA-23-044. For funding consideration, applicants must include “NOT-AR-23-015” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Please note that expanding the scope must be consistent with the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis.
When developing applications in response to this NOSI, all instructions in the SF424 (R&R) Application Guide and PA-20-272 or PA-23-044 must be followed, with the following additions:
- Application Due Date(s) – June 6, 2023, by 5:00 PM local time of applicant organization. This NOSI expires on June 7, 2023. An application submitted in response to this NOSI that is received on/after the expiration date will be withdrawn.
- For funding consideration, applicants must include “NOT-AR-23-015” (without quotation marks) 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.
- Applicants must clearly state the NOSI Goal (A or B) and the NOSI Area of Scientific Interest they are addressing.
- Applicants must submit an abstract of the proposed research to show how it is relevant to pain research and related to the parent grant. For applications for an urgent competitive revision this must also include how the research will speed scientific solutions to the national opioid public health crisis. Place the abstract in the Project Summary/Abstract section of the SF424 (R&R) form.
- Clinical trials are not allowed under this NOSI.
- Requests may be for one year of support, or two years with strong justification.
- Individual requests cannot exceed the current year direct costs, up to $350,000 in direct costs exclusive of Facilities and Administrative costs on sub-contracts.
- All applications must include project milestones.
- Applicants may only apply to no more than one supplement to a given parent grant/award.
- The Research Strategy section of the application is limited to 6 pages.
- The parent award must be active when the application is submitted (e.g., within the originally reviewed and approved project period) and the proposed work must be completed within the currently approved project period for the existing parent award.
- For urgent competitive revisions to parent awards that include multiple PD/PIs, each PD/PI of the parent award must be listed as a PD/PI on the application, but another investigator or co-investigator team may lead the research project proposed in the competitive revision.
- The development of resources and data are expected to be shared consistent with plans in the parent award and consistent with NIH policy.
Review Process
Applications will be evaluated for scientific and technical merit by an appropriate internal review panel convened by NIAMS staff, in accordance with the review criteria specified in the FOA as well as these additional review criteria: The additional review criteria are:
- Does the work proposed clearly address at least one of the goals defined in this notice (NOT-AR-23-015)?
- If the application is focused on an area of scientific interest not included in the NOSI, is there a strong justification?
- Is the project likely to stimulate substantial innovations on pain research approaches and methodologies?
- If a new or enhanced research resource is proposed, does the application propose reasonable milestones and sharing and dissemination plans?
- Will projects involving human subjects address pain in one or more underrepresented population based on race/ethnicity, age, or geographic region?
- Is the parent award progressing satisfactorily/according to planned timeline and milestones?
- Is the proposed project technically feasible within the proposed budget and funding period?
- Is the overall strategy, methodology, and analyses proposed in the application well-reasoned and appropriate to accomplish the activities in the proposed project period?
- For applications under the competitive revision announcement, PA-23-044. Are the aims sufficiently distinct from those in the parent grant? Is this consistent with speeding up solutions to the opioid health crisis?
Please direct all inquiries to:
Rebecca Lenzi, Ph.D
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-402-2446
Email: NIAMS_PAIN@mail.nih.gov
and Human Services (HHS)
