141st Meeting Minutes

Minutes – May 10, 2022

The National Advisory Council on Drug Abuse convened its 141st meeting at 11:00 a.m. on May 10, 2022. This meeting was conducted virtually. The closed portion of the meeting held on May 10th was for reviewing applications for Federal grant assistance and was open only to Council members and Federal employees. During the closed session, Council also met with the Chairs of the Board of Scientific Counselors to receive updates on the Intramural Program. The open portion, which was open to the public, began at 1:15 p.m. and was also video cast. The Council adjourned on May 10, 2022 at 4:34 p.m.

Council Members Present
Charles Chavkin, Ph.D. 
Anna Rose Childress, Ph.D. 
Gail D'Onofrio, M.D. 
Dennis Deer, Ph.D. 
Carlos del Rio, M.D. 
Lakshmi Devi, Ph.D. 
Amit Etkin, M.D., Ph.D. 
Daniel Goonan
Shelly Greenfield, M.D., M.P.H.
Paul Kenny, Ph.D.
Jessica Hulsey Nickel
Andrey Ostrovsky, M.D.
Travis Rieder, Ph.D.
Rajita Sinha, Ph.D.
Melissa Walls, Ph.D.
Sharon Walsh, Ph.D.

Council Chair
Nora Volkow, M.D.

Executive Secretary
Susan Weiss, Ph.D.

Non-Federal Employees Present:
Regina Carelli, Ph.D. – University of North Carolina
John Mantsch, Ph.D. – Medical College of Wisconsin

During the Open Session of Council, 223 participants joined live via videocast.

Closed Portion of the Meeting

1. Call to Order

   This portion of the meeting was closed to the public in accordance with sections 552b(c) (4) and 552b(c) (6), Title 5, U.S. Code and section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).

   Dr. Nora Volkow, Director, NIDA, called the meeting to order and welcomed the Council and staff. She reminded those present that the Federal Advisory Committee Act applies to Council meetings and that this portion of the meeting was closed to the public.

   Dr. Susan Weiss, Executive Secretary, summarized relevant NIH policies, provided detailed instructions on Council review procedures, and reminded those present about NIH confidentiality and conflict of interest policies.

2. Application Reviews

   Drs. Elena Koustova, Iván Montoya, Rita Valentino, Albert Avila, and Carlos Blanco, Directors of NIDA’s Office of Translational Initiatives and Program Innovations, Division of Therapeutics and Medical Consequences, Division of Neuroscience and Behavior, Office of Research Training Diversity, and Disparities, and Division of Epidemiology, Services and Prevention Research, presented their Division’s/Office’s assigned and peer reviewed applications for consideration by the Council. For each application, Council provided unanimous en bloc concurrence with the initial scientific review. Five administrative supplements, 2 MERIT extensions, and 4 applications for Special Council Review were presented to Council, and Council concurred with program assessments. The initial review of all Trans-NIH Initiatives, including NIH Common Fund, Blueprint, and BRAIN applications as well as foreign applications and applications with a secondary assignment to NIDA also received Council concurrence. In total, Council concurred with the initial review of 2,211 applications totaling $86,116,248 in direct costs.

   Council and staff were recused from the Council meetings during discussion of, and voting on, individual applications from their own institutions or other applications for which there was a conflict of interest, real or apparent. Conflicts of interest statements were signed by each member of the Council. Members were not required to leave the room if an application in conflict with that member was acted upon en bloc.

Open Portion of the Meeting

1. Call to Order

   Dr. Susan Weiss, NIDA, called the open portion of the meeting to order and welcomed all attendees. She reminded all in attendance that the meeting was open to the public in compliance with the Government in the Sunshine Act, was available and recorded via videocast, and indicated that any public comments can be submitted via email within 10 days of the meeting would be included in the minutes.

   She then called attention to future Council meeting dates: September 13, 2022, February 8, 2023, and May 9-10, 2023.

2. Council Rotations
   
   Dr. Weiss acknowledged the departing Council Members: Gail D’Onofrio, Carlos del Rio, Lakshmi Devi, and Christian Heidbreder. Dr. Weiss welcomed Amit Etkin as the newest NACDA member.

3. Consideration of the Minutes of Council

   The Minutes of the February 2022 NIDA Advisory Council were unanimously approved as written.

4. MERIT Award Discussion (NIH Videocast @ 0:04:20) – Susan Weiss, Ph.D., Director, Division of Extramural Research, NIDA 

   Dr. Susan Weiss presented an overview of the history of MERIT awards at NIDA as well as how other Institutes at NIH use the award. She discussed considerations for the future of NIDA MERIT awards to continue as is, revise criteria, or discontinue.

5. NIDA Director’s Report (NIH Videocast @ 0:31:50) ) – Nora Volkow, M.D., Director, NIDA

   Dr. Nora Volkow began by reviewing NIDA’s final budget for FY2021, the enacted budget for FY2022 and the proposed budget for FY2023. She provided updates on retention in the Adolescent Brain Cognitive Development Study and the use of the data generated from the study. Next, she discussed the intersection between COVID-19 and substance use disorders, including rates of cannabis use and updates on drug overdose deaths. Dr. Volkow then presented data on medication use for opioid use disorder and NIDA’s efforts in implementation science across the Clinical Trials Network, the Justice Community Opioid Innovation Network, and the HEALing Communities Study. She discussed overdose death rates in youth prior to and during the pandemic, particularly the rise in fentanyl products. Dr. Volkow proposed renaming screening and brief intervention (SBI) as “pre-addiction” to get resources and intervention for those at high levels of risk. She discussed NIDA’s Division of Therapeutics and Medical Consequences work with companies bringing innovation to treating substance use disorders. She concluded by mentioning that NIDA is proposing that the Institute be renamed the “National Institute on Drugs and Addiction”.

   Council thanked Dr. Volkow for her presentation and a discussion followed (NIH Videocast @ 1:20:00).

6. Implementation of the NIH Data Management and Sharing Policy (NIH Videocast @ 1:42:40) – Mike Lauer, M.D., Deputy Director for Extramural Research, NIH 

   Dr. Mike Lauer presented an update on the implementation of the NIH Policy for Data Management & Sharing. He reviewed the history of the policy from the 2016 Strategies on Data Management, Sharing, and Citation and the 21st Century Cures act to the implementation which begins in January 2023. The policy requires the submission of a Data Management & Sharing Plan for all NIH-funded research and compliance with the ICO-approved plan. He discussed the management and sharing of data and the timeliness of the accessibility. Dr. Lauer concluded by sharing the resources NIH has to support this policy and the outreach activities that will assist NIH grantees.

   Following the presentation, a discussion with Council occurred (NIH Videocast @ 1:58:30).

7. Concept Clearances (NIH Videocast @ 2:53:00)

   Division of Therapeutics and Medical Consequences (DTMC)
   — Behavioral & Integrative Treatment Development Program – Will M. Aklin, Ph.D., Health Scientist Administrator
   — HEAL: Therapeutics Development for Opioid Use Disorder in Patients with Comorbid Commonly Occurring Mental Disorders – Tanya Ramey, M.D., Ph.D., Medical Officer
   — HEAL: Rapidly Assessing the Public Health Impact of Emerging Opioid Threats – Aidan Hampson, Ph.D., Health Scientist Administrator

   Division of Neuroscience and Behavior (DNB)
   — HRP: Novel Tools and Pipelines for High-Resolution Spatial Characterization of HIV Infection, Persistence and Pathology in CNS Tissues in Context of Substance Use – Olivier Berton, Ph.D., Acting Branch Chief, Integrative Neuroscience Branch
   — HRP: Mechanisms and Targets at the Intersection of HIV and Addictive Drugs – Sam Ananthan, Ph.D., Branch Chief, Chemistry and Pharmacology
   — Development and Validation of Virtual Assessments to Study Children and Caregivers in Their Natural Environment – Janani Prabhakar, Ph.D., Health Scientist Administrator

   Division of Epidemiology, Services, and Prevention Research (DESPR)
   — HRP: Ending the HIV Epidemic: Focus on Justice Populations with SUD – Tisha Wiley, Ph.D., Branch Chief, Services Research Branch
   — HEAL: Workforce Interventions to Improve Addiction Care Quality and Patient Outcomes – Tisha Wiley, Ph.D., Branch Chief, Services Research Branch
   — HRP: Ending the HIV Epidemic: Focus on Justice Populations with SUD – Tisha Wiley, Ph.D., Branch Chief, Services Research Branch
   — HEAL: Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy – Shelley Su, Ph.D., Health Scientist Administrator
   — HEAL: Research to Develop Evidence Based Opioid Misuse Prevention Interventions in Community Health Centers – Sarah Steverman, Ph.D., Health Scientist Administrator
   — HEAL: Career Development Awards in Addiction Implementation Science – Lori Ducharme, Ph.D., Health Scientist Administrator
   — HEAL: Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On – Sarah Duffy, Ph.D., Associate Director for Economics Research
   — HEAL: Opioid Use Disorder Care Pathways for Individuals with Histories of Exposure to Violence – Carrie Mulford, Ph.D., Deputy Branch Chief, Services Research Branch
   — Opioid Misuse Prevention Effectiveness Research among Youth and Families involved in the Child Welfare System – Barbara Oudekerk, Ph.D., Social Behavioral Scientist Administrator
   
   Office of Translational Initiatives and Program Innovations (OTIPI)
   — CODE (Cause of Death Elucidated) in Drug Overdose: Rapid and Portable Cause of Death Detection Technologies to Improve Drug Overdose-Related Mortality Counts – Tam Nguyen, Ph.D., Health Scientist Administrator

8. Using All of Us to Research Drug Abuse Solutions (NIH Videocast @ 2:27:00) – Joshua Denny, M.D., M.S., Chief Executive Officer, All of Us, NIH 
   
   Dr. Denny presented the mission and status of the All of Us research program. He described various tools and metrics the study uses and detailed specific resources for genomics research. Dr. Denny specified data elements related to Opioid Use Disorder and highlighted studies using All of Us data related to drug abuse. He concluded by presenting the goals of the study over the next five years.

   Following the presentation, a discussion with Council occurred (NIH Videocast @ 3:52:10).

9. Public Comments (NIH Videocast @ 3:02:40)
   
   No public comments were submitted.
10. Adjourn (NIH Videocast @ 3:03:40)
    
    The 141st meeting of the National Advisory Council on Drug Abuse was adjourned at 4:34 p.m.

Certification

I hereby certify that the foregoing minutes are accurate and complete.

• Nora D. Volkow, M.D.
  Director, NIDA
  Chair
  National Advisory Council on Drug Abuse
• Susan Weiss, Ph.D.
  Executive Secretary
  National Advisory Council on Drug Abuse

Council Roster

Note: Informational materials provided to the public at the open session of the meeting may be obtained from the Executive Secretary.