Notice of Intent to Publish a Funding Opportunity Announcement for HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
Notice Number:
NOT-NS-20-020

Key Dates

Release Date:
December 26, 2019
Estimated Publication Date of Funding Opportunity Announcement:
January 20, 2020
First Estimated Application Due Date:
March 24, 2020
Earliest Estimated Award Date:
August 31, 2020
Earliest Estimated Start Date:
August 31, 2020
Related Announcements
None
Issued by
National Institute of Neurological Disorders and Stroke ( NINDS)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

National Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

National Cancer Institute (NCI)

Purpose

The purpose of this Notice is to inform potential applicants that the National Institute of Neurological Disorders and Stroke (NINDS) intends to publish a re-issuance of funding opportunity announcement RFA-NS-19-021 to solicit applications for clinical trial planning and implementation to generate evidence-based pain management best practices for the use of existing medications or devices for specific pain conditions.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The funding opportunity announcement is expected to be published in December 2019 with an expected application due date in March 2020. Applicant organizations may submit more than one application, provided each application proposes a distinct clinical trial.

This funding opportunity announcement will utilize the UG3/UH3 bi-phasic activity code.

Research Initiative Details

Most chronic pain management is delivered in the primary care settings where providers have few evidence-based guidelines to support their clinical decisions. Acute pain management often is delivered in emergency departments, hospital settings or dental clinics where reliance on treatment with opioids increases risks for Opioid Use Disorder (OUD). Adults with pain due to injury, neck and back pain, abdominal pain or headache make up over 33 million ER visits per year. . Evidence for best pain care practices in these settings are lacking, not only for acute pain relief, but also for prevention of chronic pain and OUD. In addition, quality, precision pain care following surgical or other procedures with medications including opioids and other pharmacological therapies and devices would provide a more robust evidence base to guide providers in these settings, would promote tailored acute pain care, and reduce reliance on opioids.

This re-release HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) will prioritize the following areas of interest to generate evidence-based pain management best practices for the use of existing medications or devices for specific pain conditions. The guidelines should be of use to providers in primary care, emergency departments, dental clinics, and hospital settings. The pain conditions of high priority are:

  • pain management in emergency departments, dental clinics, primary care and hospitals;
  • chronic overlapping pain conditions;
  • best practices for effective analgesics when appropriate;
  • pain management in individuals at risk of or with OUD;
  • pain management in those with co-occurring mental health disorders; and
  • Non cancer pain management in persons with medical comorbidities

Research testing behavioral interventions to manage pain will not be considered as high priority projects since several currently funded HEAL trials are testing behavioral interventions for pain management. Investigators wishing to test the effectiveness of behavioral interventions should contact program officials from individual ICs to find an appropriate FOA. Research testing software or decision-making tools that help providers and patients determine the most effective and safe methods for pharmacological or device pain management are allowed.

Funding Information
Estimated Total Funding

$800,000 total costs for FY2020; $2,000,000 total costs per year for FY2021, FY2022, FY2023, FY2024

Expected Number of Awards
Up to 2.
Estimated Award Ceiling

Up to $500,000 direct cost for the one-year UG3 phase and up to $1,000,000 per year direct cost for the UH3 phase for no more than 4 years. Note that the Trial Innovation Network will provide infrastructure including the data management system, clinical coordination, and support for trial document development such as the manual of procedures. These costs should not be included in the UG3/UH3 budgets.

Primary CFDA Numbers
93.853
Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization Applications are not being solicited at this time.
Inquiries
Please direct all inquiries to:

Linda L. Porter, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
301-435-7572
porterl@ninds.nih.gov
Jane C. Atkinson, DDS
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-6031
Email: jatkinso@mail.nih.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices