Council Minutes -- May 2020

The 140th Meeting
May 26, 2020

CONTENTS

1. CALL TO ORDER
2. REPORT: Working Group on Program
3. ADJOURMENT
4. REVIEW OF APPLICATIONS
5. CERTIFICATION

Attachment A: Roster of the National Advisory Council on Aging
Attachment B: Director's Status Report to Council
Attachment C: May 2020 minutes in PDF format (259K)

The 140th meeting of the National Advisory Council on Aging (NACA) was convened on Tuesday, May 26, 2020, at 1 p.m. by teleconference. The Council met via teleconference because of the ongoing COVID-19 pandemic. Dr. Richard Hodes, Director, National Institute on Aging (NIA), presided.

The teleconference was open to the public on Tuesday, May 26, from 1:00 p.m. to 1:50 p.m. In accordance with the provisions of Public Law 92–463, the teleconference was closed to the public on Tuesday, May 26, from 2 p.m. to 5 p.m. for the review, discussion, and evaluation of grant applications in accordance with the provisions set forth in Sections 552(b)(c)(4) and 552(b)(c)(6), Title 5, U.S. Code and Section 10(d) of the Public Law 92–463.¹

Council Participants:

Mr. James Appleby
Dr. David A. Bennett
Dr. Shalender Bhasin
Ms. Meryl Comer
Dr. Monica A. Driscoll
Dr. Terry T. Fulmer
Dr. Alison M. Goate
Dr. Margaret A. Goodell
Dr. J Taylor Harden
Dr. David M. Holtzman
Dr. Stephen B. Kritchevsky
Ms. Susan K. Peschin
Dr. Eric Michael Reiman
Dr. Clifford James Rosen
Dr. Amy Jo Wagers
Dr. Keith E. Whitfield

Ex Officio Participants:

Dr. Sarah Ruiz, Administration for Community Living

The Council Roster, which gives titles, affiliations, and terms of appointment, is appended to these minutes as attachment A.

In Addition to NIA Staff, Other Federal Employees Present:

Dr. Devon Oskvig, Centers for Scientific Review

Members of the Public Present:

Dr. Iman Aganj, Massachusetts General Hospital
Ms. Jessica Bateman, American Neurological Association
Dr. Carolyn Best, American Urological Association
Dr. Karen Cruickshank, University of Wisconsin
Ms. Trish D’Antonio, Gerontological Society of America
Dr. Nicole Fowler, Indiana University School of Medicine
Dr. Molly Puente, North Carolina State University
Dr. Diane Hannemann, IQ Solutions
Dr. Susan Hickman, Indiana University
Dr. Rose Maria Li, Rose Li and Associates, Inc.
Dr. Frances McFarland, Rose Li and Associates, Inc.
Ms. Pam Morrison, IQ Solutions, Inc.
Dr. Alex Movila, Nova Southwestern University
Dr. Elizabeth O’Hare, Lewis-Burke Associates
Mr. Adam Paulsen, University of Wisconsin
Dr. Daniel Roh, Boston University
Dr. Ruth Tappen, Florida Atlantic University
Ms. Fran Valentine, Indiana University Center for Aging Research

1. CALL TO ORDER

Dr. Hodes welcomed members to the open session of the 140th NACA meeting and called the teleconference to order at 1:00 p.m. on Tuesday, May 26, 2020. Dr. Kenneth Santora, new Director of the NIA Division of Extramural Activities and Executive Secretary of NACA, introduced himself.

1. Director's Status Report and Discussion

Dr. Hodes acknowledged the hardships everyone is enduring as a result of the pandemic and thanked Council members for carrying out their role in helping NIA manage the research it supports. He reassured Council members that NIA has been just as busy, if not more so, in the three months since the crisis began as it accommodates increased activity related to COVID-19 in addition to its regular workload. He welcomed questions from Council members.

Dr. Terry Fulmer noted the devastating impact that COVID-19 is having on the older population. She commended the National Institute of Allergy and Infectious Diseases (NIAID) on its job as the public face addressing the crisis and asked how NIA is being highlighted in NIH’s work on COVID-19. Dr. Hodes noted a multibillion-dollar effort across NIH, in which NIA is taking a lead role. One initiative led by NIA, the NIH Office of Behavioral and Social Sciences Research (OBSSR), and the National Institute on Minority Health and Health Disparities (NIMHD) is focusing on the social, behavioral, and economic aspects of COVID-19. The lead Institutes, along with a dozen others, are merging their resources to support these efforts. NIA is also taking a lead in the Rapid Acceleration of Diagnostics (RADx), an initiative focused on rapidly advancing diagnostics for COVID-19. NIA and NIMHD are leading RADx-UP, which will focus on older and underserved populations. Dr. Hodes noted that other initiatives are under development and will be announced in the coming weeks.

Dr. Stephen Kritchevksy noted the impact of COVID-19 on clinical research projects as a result of limitations on interactions between researchers and study participants. Dr. Shalender Bhasin commented that enrolling older adults, especially those who are frail, will continue to be difficult after the crisis abates. Along with Dr. Eric Reiman, they asked about contingency plans, grant applications, and funding considerations in light of COVID-19. Dr. Hodes noted that these issues are foremost in everyone’s minds at NIH and that NIH will need help from Councils and investigators to navigate these issues. He encouraged investigators to contact program staff about specific circumstances. Dr. Santora added that NIH and NIA are approaching these issues with maximum flexibility and that it is difficult to develop general guidance because impacts, needs, and funding considerations differ case by case. He noted that peer review is continuing and that the receipt dates have not changed, but NIA is allowing an additional 2 weeks through July for its sponsored initiatives. Regarding investigators who are already funded and restarting their laboratories, Dr. Santora asked that they wait until their next reports or even the end of their current grants to identify what is necessary to complete the projects they have proposed. For applications that have already been submitted, NIA may work with investigators on contingency plans or delaying the start of their grants, again on a case-by-case basis.

Dr. Clifford Rosen noted questions that Council members are receiving from their constituents with respect to how supplemental appropriations are used. Dr. Hodes commented that public funds have been appropriated specifically to NIAID, NHLBI, and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) to address the infectious diseases, cardiopulmonary, and technological issues related to COVID-19 and its management. Although these Institutes are responsible for executing specific initiatives, they are sharing resources with other Institutes and Centers. Dr. Hodes added that a larger supplemental appropriation has gone to the NIH Office of the Director for trans-NIH initiatives. Specific Institutes or Centers (ICs) take leadership roles for these initiatives and work across ICs to identify priorities, and the funding opportunity and research are administered by the most appropriate IC.

2. Future Meeting Dates

• September 8–9, 2020 (Tuesday and Wednesday, Building 45)
• January 12–13, 2021 (Tuesday and Wednesday, Building 31)
• May 11–12, 2021 (Tuesday and Wednesday, Building 31)
• September 14–15, 2021 (Tuesday and Wednesday, Building 45)
• January 25–26, 2022 (Tuesday and Wednesday, Building 45)
• May 5–6, 2022 (Thursday and Friday, Building 45)
• September 7–8, 2022 (Wednesday and Thursday, Building 45)

3. Consideration of Minutes of the Last Meeting

The minutes of the January 2020 Council meeting were considered. A motion was made, seconded, and passed unanimously to approve the minutes.

2. REPORT: WORKING GROUP ON PROGRAM

1. Clinical Trials Advisory Panel Report (CTAP)

Dr. Kritchevsky reported that CTAP met on April 10 to consider a proposal for a placebo-controlled trial assessing whether the drug RTP101 reduces the incidence of severe COVID-19 in individuals older than 65 years. Although CTAP was highly enthusiastic about the proposal, the Panel had some questions regarding study design and endpoint definition. The resTORbio team has addressed these concerns. In response to recommendations from CTAP, the team plans to move forward with pilot studies before conducting a larger trial.

2. RFA/RFP Concept Clearances

Drs. Rosen and Kritchevsky reviewed one concept, “Continuation of Look AHEAD (Action for Health in Diabetes).” Launched in the early 2000s, Look AHEAD is a randomized trial to assess the impact of an intensive lifestyle intervention among individuals with type 2 diabetes. Although the intervention succeeded in inducing long-term changes in weight and physical activity, compared with a diabetes education/support control, it did not affect cardiovascular outcomes. The intervention concluded in 2012. The proposed concept will support continued follow up to assess long-term outcomes and legacy effects in the Look AHEAD cohort (mean age 77 years). Drs. Rosen and Kritchevsky expressed enthusiasm for continuation, noting the ability to follow this cohort into their mid-80s, identify the influence of midlife status on health and function in later life, and address questions about Alzheimer’s disease (AD) and related dementias (ADRD) among the 25 percent of the cohort that has had diabetes for more than 30 years. Council questions and discussion focused on the number of potential applications in this limited competition, the potential for ancillary studies, and the fraction of the original cohort that will still be followed. A motion to concur with the continuation was forwarded, seconded, and passed.

3. May 2020 Statistical Data on NIA Extramural Grants

Dr. Santora noted that NIA received 2,091 applications for the May 2020 Council meeting. This was the highest number of applications received, representing an increase of 300 applications from the last Council meeting and 600 more compared with the May 2019 Council meeting. Almost all the applications fell into the Research Project Grant (RPG) category, and most focused on AD. Most RPG applications fared well in scientific peer review, scoring in the 1 to 10 and 11 to 20 range.

3. ADJOURNMENT

The open session of the 140th meeting of the National Advisory Council on Aging adjourned at 1:50 p.m. on May 26, 2020. The next meeting is scheduled for September 8–9, 2020.

4. REVIEW OF APPLICATIONS

This portion of the meeting was closed to the public, in accordance with the determination that it concerned matters exempt from mandatory disclosure under Sections 552(b)(c)(4) and 552(b)(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix).¹

A total of 2,170 applications requesting $4,847,201,930 for all years underwent initial review. The Council recommended 1,162 awards for a total of $2,795,174,586 for all years. The actual funding of the awards recommended is determined by the availability of funds, percentile ranks, priority scores, and program relevance.

5. CERTIFICATION

I hereby certify that, to the best of my knowledge, the foregoing minutes and attachments are accurate and complete.²

Richard J. Hodes, M.D.
Chairman, National Advisory Council on Aging
Director, National Institute on Aging

Prepared by Kenneth Santora, Ph.D.
With assistance by Rose Li and Associates, Inc.

1. For the record, it is noted that members absented themselves from the meeting when the Council discussed applications (a) from their respective institutions or (b) in which a conflict of interest may have occurred. This procedure only applied to applications that were discussed individually, not to "en bloc" actions. (Back to text)
2. These minutes will be approved formally by Council at the next meeting on September 8-9, 2020, and corrections or notations will be stated in the minutes of that meeting. (Back to text)

Attachment A: Roster of the National Advisory Council on Aging

COMMITTEE ROSTER
NATIONAL ADVISORY COUNCIL ON AGING
NATIONAL INSTITUTE ON AGING

CHAIRPERSON

Hodes, Richard J., MD
Director, National Institute on Aging
National Institutes of Health
Bethesda, MD 20892-2292

MEMBERS

Appleby, James, MPH
Executive Director & CEO
The Gerontological Society of America
1220 L Street NW, Suite 901
Washington, DC 20005

Bennett, David Alan, MD
Director
Rush Alzheimer's Disease Center
Rush University Medical Center
600 South Paulina Street, Suite 1028
Chicago, IL 60612

Bhasin, Shalender, MD
Professor of Medicine, Harvard Medical School
Director, Claude D. Pepper Older Americans Independence Center
Brigham and Women's Hospital
Boston, MA 02115

Comer, Meryl
President and CEO
Geoffrey Beene Foundation
Alzheimer's Initiative
Washington, DC 20895

Crimmins, Eileen M., PhD
AARP Professor of Gerontology
Andrus Gerontology Center
Davis School of Gerontology
University of Southern California

Driscoll, Monica A., PhD
Professor, Department of Molecular
Biology and Biochemistry
Rutgers, The State University of New Jersey
Piscataway, NJ 08854

Goate, Alison M, PhD
Professor and Director
Icahn School of Medicine
Alzheimer's Research Center
New York, NY 10029

Goodell, Margaret A., PhD
Professor and Director
Stem Cells and Regenerative Medicine Center
Baylor College of Medicine
Houston, TX 77030

Harden, J. Taylor, PhD
Emeritus Director
National Hartford Center of Gerontological Nursing Excellence
Reston, VA 20191

Holtzman, David M., MD
Professor and Chairman
Department of Neurology
Washington University School of Medicine
St. Louis, MO 63110

Kritchevsky, Stephen B., PhD
Professor
Sticht Center for Healthy Aging and Alzheimer's Prevention
Wake Forest Baptist Medical Center
Winston-Salem, NC 27157-1207

Moffitt, Terrie E., PhD
Nannerl O. Keohane University Professor
Department of Psychology and Neuroscience, Psychiatry and Behavioral Sciences and Center for Genomic and Computational Biology
Duke University
Durham, NC 27708

Peschin, Susan K., MHS
President and CEO
Alliance for Aging Research
Washington, DC 20006

Reiman, Eric Michael, MD
Executive Director
Banner Alzheimer's Institute
Phoenix, AZ 85006

Rosen, Clifford James, MD
Director of Clinical and Translational Research
Maine Medical Center
Scarborough, ME 04074

Wagers, Amy Jo, PhD
Professor
Harvard University Medical School
Department of Stem Cell and Regenerative Biology
Cambridge, MA 02138

Whitfield, Keith E., PhD
Provost and Senior VP for Academic Affairs
Wayne State University
Office of The Provost
Detroit, MI 48202

EX OFFICIO

Azar, Alex II
Secretary
U.S. Department of Health and Human Services
Washington, DC 20201

Collins, Francis S., PhD, MD
Director, National Institutes of Health
Bethesda, MD 20892

Iyengar, Vijeth, PhD
Presidential Management Fellow (Stem)
Administration for Community Living/AOA
U.S. Department of Health and Human Services
Washington, DC 20005

Ruiz, Sarah PhD
National Institute on Disability, Independent Living and Rehabilitation Research
Administration for Community Living, DHHS
Washington, DC 20201

EXECUTIVE SECRETARY

Santora, Kenneth, PhD
Director, Division of Extramural Activities
National Institute on Aging
Bethesda, MD 20814

SLATE MEMBER(S)

Fulmer, Terry T., FAAN, PhD, RN
President
The John A. Hartford Foundation
New York, NY 10022