Office of the Director; Notice of Charter Renewal

In accordance with Title 41 of the U.S. Code of Federal Regulations, Section 102-3.65(a), notice is hereby given that the charter for the Clinical Center Research Hospital Board (CCRHB) is being renewed for an additional two-year period on June 15, 2026.

It is determined that the CCRHB is in the public interest in connection with the performance of duties imposed on the National Institutes of Health by law, and that these duties can best be performed through the advice and counsel of this group.

The Public Interest Determination follows:

National Institutes of Health

Clinical Center Research Hospital Board

Public Interest Determination

Pursuant to 41 CFR 102-3.60(a), to establish, renew, reestablish, or merge a discretionary (agency discretion) advisory committee, an agency must first consult with the General Services Administration's Committee Management Secretariat (the Secretariat) and, as part of the consultation, provide a written public interest determination approved by the head of the agency to the Secretariat with a copy to the Office of Management and Budget. In addition, pursuant to 41 CFR 102-3.35, an agency shall follow the same consultation process and document in writing the same determination of need before creating a subcommittee under a discretionary committee that is not made up entirely of members of a parent advisory committee.

Information on the following factors for the committee is provided to the Secretariat to demonstrate that renewing the committee is in the public interest:

1. Annual budget: The annual budget for the committee is $67,425.

a. Federal personnel on a full-time equivalent (FTE) basis: Federal personnel (based on full-time equivalent (FTE) usage basis) and other Federal internal costs. The estimated annual personal years of staff support are .1 at an estimated cost of $15,709.

b. Other Federal internal costs: The estimated for other Federal internal costs is 0.

c. Proposed payments to members: The estimated payment for non-Federal members is $5,400. There are no Federal members on this committee.

d. Proposed number of members: The Clinical Center Research Hospital Board (CCRHB or Board) will consist of up to 14 non-federal members, including the chair.

e. Reimbursable costs: The estimate for reimbursable costs, including members' travel expenses is $41,548.

2. If applicable, the total dollar value of grants expected to be recommended during the fiscal year: N/A.

3. Criteria for selecting members to ensure the committee has the necessary expertise and fairly balanced membership:

The Board will consist of up to 14 non-federal members, including the chair, appointed by the NIH Director (or delegee). The appointed members will consist of (a) authorities who are nationally recognized leaders in sectors related to the NIH Clinical Center's (CC) duties and authorities, including but not limited to research hospital administration/operations, clinical care, safety and quality, clinical and research compliance, or clinical research, and (b) two individuals who have participated in clinical research studies as patients. Appointed members will be selected from the academic and private sector research community, as well as the general public.

4. List of all other Federal advisory committees of the agency:

• Advisory Committee on Research on Women's Health
• Advisory Committee to the Director, National Institutes of Health
• Advisory Council on Parkinson's Research, Care and Services
• Aging and Neurodegeneration Integrated Review Group
• AIDS Research Advisory Committee, NIAID

Applied Immunology and Disease Control Integrated Review Group ( printed page 34830)

• Applied Therapeutics for Cancer Integrated Review Group
• Biobehavioral and Behavioral Processes Integrated Review Group
• Bioengineering Sciences & Technologies Integrated Review Group
• Biological Chemistry and Macromolecular Biophysics Integrated Review Group
• Board of Regents of the National Library of Medicine
• Board of Scientific Counselors Eunice Kennedy Shriver National Institute of Child Health and Human Development
• Board of Scientific Counselors National Human Genome Research Institute
• Board of Scientific Counselors of the National Heart, Lung, and Blood Institute
• Board of Scientific Counselors of the NIH Clinical Center
• Board of Scientific Counselors, Division of Translational Toxicology
• Board of Scientific Counselors, National Cancer Institute
• Board of Scientific Counselors, National Center for Complementary and Integrative Health
• Board of Scientific Counselors, National Eye Institute
• Board of Scientific Counselors, National Institute of Arthritis and Musculoskeletal and Skin Diseases
• Board of Scientific Counselors, National Institute of Biomedical Imaging and Bioengineering
• Board of Scientific Counselors, National Institute of Dental and Craniofacial Research
• Board of Scientific Counselors, National Institute of Diabetes and Digestive and Kidney Diseases
• Board of Scientific Counselors, National Institute of Environmental Health Sciences
• Board of Scientific Counselors, National Institute of Mental Health
• Board of Scientific Counselors, National Institute of Neurological Disorders and Stroke
• Board of Scientific Counselors, National Institute on Aging
• Board of Scientific Counselors, National Institute on Alcohol Abuse and Alcoholism
• Board of Scientific Counselors, National Institute on Deafness and Other Communication Disorders
• Board of Scientific Counselors, National Institute on Drug Abuse
• Board of Scientific Counselors, National Institute on Minority Health and Health Disparities and National Institute of Nursing Research
• Board of Scientific Counselors, National Library of Medicine
• Brain Disorders and Clinical Neuroscience Integrated Review Group
• Cardiovascular and Respiratory Sciences Integrated Review Group
• Cell Biology Integrated Review Group
• Center for Scientific Review Special Emphasis Panel
• Council of Councils
• Cures Acceleration Network Review Board
• Digestive, Kidney and Urological Systems Integrated Review Group
• Division of Intramural Research Board of Scientific Counselors National Institute of Allergy and Infectious Diseases
• Emerging Technologies and Training Neurosciences Integrated Review Group
• Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated Review Group
• Fogarty International Center Advisory Board
• Genes, Genomes, and Genetics Integrated Review Group
• Healthcare Delivery and Methodologies Integrated Review Group
• Infectious Diseases and Immunology A Integrated Review Group
• Infectious Diseases and Immunology B Integrated Review Group
• Integrative, Functional and Cognitive Neuroscience Integrated Review Group
• Interagency Autism Coordinating Committee
• Interagency Pain Research Coordinating Committee
• Interdisciplinary Molecular Sciences and Training Integrated Review Group
• Molecular, Cellular and Developmental Neuroscience Integrated Review Group
• Muscular Dystrophy Coordinating Committee
• Musculoskeletal, Oral, and Skin Sciences Integrated Review Group
• National Advisory Allergy and Infectious Diseases Council
• National Advisory Board on Medical Rehabilitation Research
• National Advisory Child Health and Human Development Council
• National Advisory Council for Biomedical Imaging and Bioengineering
• National Advisory Council for Complementary and Integrative Health
• National Advisory Council for Human Genome Research
• National Advisory Council for Nursing Research
• National Advisory Council on Aging
• National Advisory Council on Alcohol Abuse and Alcoholism
• National Advisory Council on Drug Abuse
• National Advisory Council on Minority Health and Health Disparities
• National Advisory Dental and Craniofacial Research Council
• National Advisory Environmental Health Sciences Council
• National Advisory Eye Council
• National Advisory General Medical Sciences Council
• National Advisory Mental Health Council
• National Advisory Neurological Disorders and Stroke Council
• National Arthritis and Musculoskeletal and Skin Diseases Advisory Council
• National Cancer Advisory Board
• National Cancer Institute Clinical Trials and Translational Research Advisory Committee
• National Cancer Institute Council of Research Advocates
• National Center for Advancing Translational Sciences Advisory Council
• National Deafness and Other Communication Disorders Advisory Council
• National Diabetes and Digestive and Kidney Diseases Advisory Council
• National Heart, Lung, and Blood Advisory Council
• National Science Advisory Board for Biosecurity
• National Toxicology Program Board of Scientific Counselors
• National Toxicology Program Special Emphasis Panel
• NIH Clinical Center Research Hospital Board
• Office of AIDS Research Advisory Council
• Office of Research Infrastructure Programs Special Emphasis Panel
• Oncology 1-Basic Translational Integrated Review Group
• Oncology 2-Translational Clinical Integrated Review Group
• Population Sciences and Epidemiology Integrated Review Group
• President's Cancer Panel
• Risk, Prevention and Health Behavior Integrated Review Group
• Scientific Advisory Committee on Alternative Toxicological Methods
• Scientific and Technical Review Board on Biomedical and Behavioral Research Facilities
• Scientific Management Review Board
• Sickle Cell Disease Advisory Committee
• Sleep Disorders Research Advisory Board

Social and Community Influences on Health Integrated Review Group ( printed page 34831)

• Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group
• Vaccine Research Center Board of Scientific Counselors National Institute of Allergy and Infectious Diseases
• Vascular and Hematology Integrated Review Group

5. Justification that the information or advice provided by the Federal advisory committee or subcommittee is not available from another Federal advisory committee, another Federal Government source, or any other more cost-effective and less burdensome source:

All members of the CCRHB are directly or indirectly associated with biomedical research, and upon acceptance of CCRHB appointment, each member is fully introduced to the unique aspects of the CC hospital which exists to provide safe delivery of patient-centric care in support of scientific research aligned with public health needs. Each year approximately 10,000 new research participants are seen at the CC as active partners in medical discovery, a partnership that has resulted in a long list of medical milestones, including the first cure of a solid tumor with chemotherapy, gene therapy, and the use of AZT to treat AIDS. The CC differs from other hospitals as it is not a general hospital, nor is it a part of a health system. There is no trauma care, no emergency room, no labor and delivery and no billing department. The mission of the CC is to provide hope through pioneering clinical research to improve human health. With our patient partners, the CC proudly is referenced as the “House of Hope.” The Board members' recommendations are invaluable because the complex nature of the CC's clinical research mission requires a unique balance and breadth of expertise not available at NIH or from other established sources. This advice and unique, expert perspectives cannot be obtained through other mechanisms.

6. If the consultation is a committee renewal, a summary of the previous accomplishments of the committee and the reasons it needs to continue:

The CCRHB is the sole entity to provide advice about hospital operations aligned with the CC's clinical research priorities. As such, the CCRHB's focus is on the complementary aims of achieving the highest standards of safety for research participants and the CC community, while fostering an environment of cutting-edge high-impact research to improve the health of Americans.

2016: The CCRHB recommended the submission of regular reports to the Board addressing Patient Safety & Quality Performance Metrics. This topic became a `standing item' for all Board meetings and members continue to receive a Current Executive Dashboard Report on Clinical and Safety Performance Metrics one week prior to each meeting for review. The CEO Presentation includes reference to these standing reports; and the CEO solicits discussion or questions from the Board, then reports are posted on the CC's website for public review.

2016—Present: Annual reports to the CCRHB are delivered by the Director, Office of Research Facilities. These reports generate discussions for planned or ongoing facility changes that directly or indirectly affect CC patients, researchers, staff, and the CC community. In October 2019, all Board members signed a letter to the NIH Director, ultimately shared with Congress during budget discussions, to address needed funding for NIH maintenance issues and facility projects to improve environment of care and specialized capabilities requests, including construction of the new Surgery, Radiology and Laboratory Medicine Wing.

A key accomplishment of the CCRHB in 2022 was to provide a comprehensive review and assessment of pediatric care at the CC, focused on the delivery of care to children, current clinical research studies, and setting a vision to consider for the future of pediatric research. With the assistance of a working group that included pediatric leaders from across the country, the CCRHB provided advice that identified strengths and areas of focused improvement to be considered going forward.

7. Explanation of why the committee/subcommittee is essential to the conduct of agency business:

The CCRHB was created in 2016 as recommended by the Advisory Committee to the NIH Director following results of an FDA visit and review of hospital operations. Per the CCRHB charter, the purpose of the Board is to advise, consult with, and make recommendations to the NIH Principal Deputy Director (or designee) and the CEO with respect to maintaining excellence in hospital operations, safety and quality, unique clinical research care requirements for CC patients, regulatory compliance, clinical research, and hospital leadership performance oversight. Currently in its 9th year, the CCRHB has provided expert guidance and recommendations related to most aspects of CC operations.

In conclusion, this public interest determination documents that renewing the committee is in the public interest, essential to the conduct of agency business, and that the information to be obtained is not already available through another advisory committee or source within the Federal Government.

Inquiries may be directed to Patricia Brandt Hansberger, Acting Director, Office of Federal Advisory Committee Policy, Office of the Director, National Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, Maryland 20892 (Mail code 4875), Telephone (301) 496-2123, or patricia.hansberger@nih.gov.