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Project Information

Project Information


Security of America’s Medical Product Supply Chain


Project Scope:

An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine (National Academies) will conduct a study to examine the security of the United States medical product supply chain.

The committee will:

1) assess and evaluate the dependence of the United States, including the private commercial sector, States, and the Federal Government, on critical drugs and devices that are sourced or manufactured outside of the United States, which may include an analysis of:

  • the supply chain of critical drugs and devices of greatest priority to providing health care;
  • any potential public health security or national security risks associated with reliance on critical drugs and devices sourced or manufactured outside of the United States, which may include responses to previous or existing shortages or public health emergencies, such as infectious disease outbreaks, bioterror attacks, and other public health threats;
  • any existing supply chain information gaps, as applicable; and
  • potential economic impact and other considerations associated with increased domestic manufacturing; and
2) provide recommendations to improve the resiliency of the supply chain for critical drugs and devices and to address any supply vulnerabilities or potential disruptions of such products that would significantly affect or pose a threat to public health security or national security, as appropriate, which may include strategies to:
  • promote supply chain redundancy and contingency planning;
  • encourage domestic manufacturing, including consideration of economic impacts, if any;
  • improve supply chain information gaps;
  • improve planning considerations for medical product supply chain capacity during public health emergencies; and
  • promote the accessibility of such drugs and devices.

Status: Current

PIN: HMD-HSP-20-13

Project Duration (months): 24 month(s)

RSO: Shore, Carolyn



Geographic Focus:

Committee Membership

Committee Post Date: 09/01/2020

Wallace J. Hopp - (Chair)
Wallace J. Hopp, Ph.D.
Associate Professor, Stephen M. Ross School of Business, University of Michigan

Dr. Wallace J. Hopp studies the design, control and management of operations systems, with emphasis on manufacturing and supply chain systems, innovation processes, and health care systems. His teaching and research in these areas has been recognized by a number of awards, including being named a Fellow of IIE, INFORMS, SME, MSOM and POMS, and election to the National Academy of Engineering. He previously served as President of the Production and Operations Management Society (POMS) and Editor-in-Chief of the journal Management Science, and is currently a founding editor of the Management and Business Review. He is an active industry consultant, whose clients have included many Fortune 500 firms.

Mahshid Abir
Mahshid Abir, M.D.
Director, Acute Care Research Unit, University of Michigan

Dr. Abir is an Associate Professor in emergency medicine at the University of Michigan (U-M)and a Senior Physician Policy Researcher at the RAND Corporation. She is the director of the Acute Care Research Unit at the U-M Institute for Healthcare Policy and Innovation. Her health services and policy research focuses on improving acute care delivery along the continuum of care during routine and catastrophic conditions - including in the ambulatory care, prehospital, emergency department, and inpatient settings. She has been an integral member of teams of researchers at RAND developing the various aspects of the National Health Security Strategy funded by the Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), developing tools to measure hospital and healthcare coalition surge capacity in response to mass casualty incidents, and a tool designed to evaluate community disaster preparedness. More recently, Dr. Abir has led an internally funded RAND project evaluating strategies for critical care surge capacity in the U.S. in response to the COVID-19 pandemic and a project funded by the Assistant Secretary for Planning and Evaluation (ASPE) comparing national and international approaches to COVID-19-related outcome measurement.

Raquel C. Bono
Raquel C. Bono, M.D.
Head, Washington State COVID-19 Health System Response Management

Dr. Raquel Bono obtained her medical degree from Texas Tech University and her bachelor’s degree from the University of Texas at Austin. She completed a surgical internship and a general surgery residency at Naval Medical Center in Portsmouth, Virginia, and a trauma and critical care fellowship at the Eastern Virginia Graduate School of Medicine in Norfolk. Bono served in Operations Desert Shield and Desert Storm as head of casualty receiving for a fleet hospital in Saudi Arabia. Upon returning, she worked as a surgeon at Naval Medical Center in Portsmouth and as a surgical intensivist and attending surgeon at Sentara Norfolk General Hospital. Her long medical career includes service as: director of Restorative Care and director of Medical-Surgery Services at the National Naval Medical Center in Bethesda, Maryland; career planning officer for the chief of the Medical Corps; executive assistant to the 35th Navy Surgeon General; commanding officer at Naval Hospital in Jacksonville, Florida; and chief of staff and deputy director of Tricare Management Activity of the Office of the Assistant Secretary of Defense, Health Affairs. Bono’s leadership roles include service as deputy director for Medical Resources, chief of Naval Operations, and as command surgeon for the U.S. Pacific Command at Camp Smith in Hawaii. She has also served as: acting commander for the Joint Task Force National Capital Region Medical; director of the National Capital Region Medical Directorate of the Defense Health Agency; the 11th Chief, Navy Medical Corps; and director of the Defense Health Agency. Bono is a diplomat of the American Board of Surgery and also has an Executive MBA from the Carson College of Business at Washington State University. Her personal decorations include the Defense Distinguished Medal, three Defense Superior Service Medals, four Legion of Merit Medals, two Meritorious Service Medals and two Navy and Marine Corps Commendation Medals. After retiring from the Navy, Bono served as Washington State’s Director for COVID-19 Health Systems Response and subsequently as the State Director for Pandemic Health.

Robert M. Califf
Robert Califf, M.D.
Head of Clinical Policy and Strategy, Verily Life Sciences and Google Health

Robert M. Califf, MD, MACC, is the Head of Clinical Policy and Strategy for Verily and Google Health for Verily and Google Health. Prior to this Dr. Califf was the vice chancellor for health data science for the Duke University School of Medicine; director of Duke Forge, Duke’s center for health data science; and the Donald F. Fortin, MD, Professor of Cardiology. He served as Deputy Commissioner for Medical Products and Tobacco in the U.S. Food and Drug Administration (FDA) from 2015-2016, and as Commissioner of Food and Drugs from 2016-2017.

Prior to joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He was the founding director of the Duke Clinical Research Institute. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with 1,250 publications in the peer-reviewed literature. Dr. Califf is a member of the National Academy of Medicine (formerly the Institute of Medicine [IOM]). Dr. Califf has served on numerous IOM committees, and was a member of the FDA Cardiorenal Advisory Panel and FDA Science Board's Subcommittee on Science and Technology. Dr. Califf has also served on the Board of Scientific Counselors for the National Library of Medicine, as well as on advisory committees for the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Environmental Health Sciences, and the Council of the National Institute on Aging.

He has led major initiatives aimed at improving methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the FDA and Duke. He also served as the principal investigator for Duke's Clinical and Translational Science Award and the NIH Health Care Systems Research Collaboratory coordinating center, and as co-PI of the National Patient-Centered Clinical Research Network (PCORnet). He currently serves as chair of the board of the People-Centered Research Foundation, a not-for-profit organization that is supporting and extending the work of PCORnet.

Asha Devereaux
Asha Devereaux, M.D., M.P.H.
Physician, Sharp Health Care System

Dr. Asha Devereaux completed her medical degree in Biology from the University of California, San Diego, followed by a MD and MPH from Tulane University School of Medicine and Public Health. Upon graduation, she served in the United States Navy achieving the rank of Commander while receiving Board Certification in Internal Medicine, Pulmonology and Critical Care. During her 11-year Naval career, Dr. Devereaux served on the Navy Surgeon General’s Panel for Tobacco Cessation, served as Head of Medicine at Beaufort Naval Hospital, served on numerous committees and spent three years covering the USNS Mercy’s Chem/Bio ICU.

In addition to her private practice of Pulmonary medicine, she has achieved additional certification in Holistic Medicine, is currently the Co-Chair of the American Thoracic Society’s Integrative Therapies Workgroup, has Co-Chaired and remains on the Executive committee of the American College of Chest Physicians (ACCP) Mass Critical Care Task Force, has served on IOM and CDC panels for Influenza and Crisis Care, is Past-Chairman of the ACCP Disaster Response Network and is a Past-President of the California Thoracic Society. She has responded to natural disasters ranging from fires to hurricanes, with the Medical Reserve Corps, the National Disaster Medical System and currently serves as the Sr. Medical Officer for San Diego CAL-MAT. She has recently provided care in an Alternate Care Site for COVID-19 in the Imperial County.

In 2009, she was selected as a Top Doctor in San Diego and in 2017, Dr. Devereaux was named the Outstanding Pulmonologist by the California Thoracic Society.
Ozlem Ergun
Ozlem Ergun, Ph.D.
Professor, Mechanical and Industrial Engineering, Northeastern University College of Engineering

Dr. Özlem Ergun’s research focuses on the design and management of large-scale and decentralized networks. She has applied her work on network design, management, and resilience to problems arising in many critical systems including transportation, pharmaceuticals, and healthcare. She has worked with organizations that respond to emergencies and humanitarian crises around the world, including USAID, UNWFP, UNHCR, IFRC, OXFAM America, CARE USA, FEMA, USACE, CDC, AFCEMA, and MedShare International. Dr. Ergun contributes regularly to Auribus Consulting, a Boston-based management consulting firm, as a logistics and analytics expert. Dr. Ergun has also been a leader in establishing a strong community of OR/MS professionals with an interest in public programs. She was the President of INFORMS Section on Public Programs, Service and Needs in 2013. She currently serves as the Area Editor at the Operations Research journal for Policy Modeling and the Public Sector Area. Dr. Ergun is also a founding co-chair of the annual Health and Humanitarian Logistics Conference, held annually since 2009.

Erin Fox
Erin Fox, Pharm.D.
Senior Director, Drug Information and Support Services, University of Utah Health

Erin R. Fox, PharmD, BCPS, FASHP, is senior pharmacy director of Drug Information and Support Services at University of Utah Health. Erin is also Associate Professor (Adjunct), at the Department of Pharmacotherapy, University of Utah College of Pharmacy. The University of Utah Drug Information Service provides content for the ASHP Drug Shortage Resource Center and Erin serves as a media resource and advocate for changes to improve the ongoing drug shortage situation and rising drug costs. Erin is also active in both state and national pharmacy and health-related societies serving in a variety of volunteer and elected positions. Erin is recognized as an expert in drug shortages and has received the ISMP Cheers Award and ASHP Award of Excellence in recognition for her work on drug shortages. Erin has also been honored with the William A. Zellmer Lecture award for her advocacy efforts to address drug shortages and rising drug prices.

Larry Glasscock
Larry Glasscock, B.A.
Chief Operating Officer, NFH

Larry M. Glasscock is a businessperson who has been at the helm of and/or provided executive leadership for companies across a variety of segments. Presently, Mr. Glasscock holds the position of Chief Operating Officer of NFH, Inc. and serves in an executive advisory capacity for MNX Global Logistics. Mr. Glasscock serves on the Board of Kershaw’s Challenge, a public charity founded by Ellen and Clayton Kershaw and is a member of the Radiopharmaceutical Shippers and Carriers Conference. Mr. Glasscock has extensive experience in the development of unique, global supply chain solutions for healthcare and medical research companies of all types with specific leadership in nuclear medicine and immunotherapy. He is known to be particularly adept at forming partnerships and alliances for the benefit of manufacturers, researchers, treatment centers, and patients throughout the world.

Lewis Grossman
Lewis Grossman, J.D.
Professor of Law, American University, Washington School of Law

Lewis Grossman is Professor of Law at the Washington College of Law, where he has taught since 1997 and where he served as Associate Dean for Scholarship from 2008 to 2011. He teaches and writes in the areas of food and drug law, health law, American legal history, and civil procedure. He has also been a Visiting Professor of Law at Cornell Law School and a Law and Public Affairs (LAPA) Fellow at Princeton University. Prior to joining the American University faculty, he was an associate at Covington & Burling LLP in Washington, D.C. Before that, he clerked for Chief Judge Abner Mikva of the U.S. Court of Appeals for the D.C. Circuit. Professor Grossman’s scholarship has appeared in the Cornell Law Review, Law and History Review, Yale Journal of Health Policy, Law & Ethics, and Administrative Law Review, among others. He has made recent contributions to volumes published by Oxford University Press and Columbia University Press. He is the co-author of Food and Drug Law: Cases and Materials (with Peter Barton Hutt and Richard A. Merrill) and of a widely used supplement to the first-year civil procedure course titled A Documentary Companion to A Civil Action (with Robert G. Vaughn). In 2021, Oxford University Press will publish Professor Grossman’s book titled Choose Your Medicine: Freedom of Therapeutic Choice in America. He has served as a member or legal consultant on three previous committees of the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine (formerly the Institute of Medicine). Professor Grossman earned his Ph.D. in History from Yale University, where he was awarded the George Washington Egleston Prize for Best Dissertation in the Field of American History. He received a J.D. magna cum laude from Harvard Law School and a B.A. summa cum laude from Yale University.

W. Craig Vanderwagen
W. Craig Vanderwagen, M.D.
President, East East Protection, LLC

Dr. Vanderwagen is a family physician who retired as a Rear Admiral in the United States Public Health Service in 2009. He served for 25 years in the Indian Health Service, the federal program of medical and public health services for American Indians and Alaska Natives. During this period he also served as the lead health official at a number of disasters including: medical care for Kosovar refugees (1999); advisor to the Afghan Ministry of Health (2002); director of public health and advisor to the Iraq Ministry of Health (2003-2004); the USNS Mercy response to the 2004 tsunami; and commander of the public health and medical response to Hurricanes Katrina/Rita. Dr. Vanderwagen’s last federal assignment (2006-9) was as the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services (DHHS). He was responsible for leading all federal public health and medical assets in disaster response and, responsibility for guiding the $11B DHHS medical countermeasure advanced development program to address CBRN threats which now has over 100 products in the development pipeline.

Dr. Vanderwagen is a Director and General Manager of East West Protection, a Potomac MD based firm specializing in public health and medical preparedness, detection, response, and command and control systems for CBRN threats and other disasters. He is Chairman of the Advisory Board of E-N-G Mobile Systems, a a design and construction firm specializing in mobile laboratories, clean room manufacturing, and public safety vehicles. He is Immediate Past Chairman of the Board at VIDO-Intervac, a Canadian vaccine research and development company. He is also a senior partner at Martin, Blanck, and Associates, a consulting firm of retired General and Flag officers specializing in military health matters. He is a frequent public speaker on biodefense, public health preparedness, and leadership.

He and his wife of 49 years, Suzanne, have three sons and 5 grandchildren and many extended family members with whom they spend much time.

Alastair J. Wood, MB C, FRCP
Alastair Wood, M.D.
Professor, Vanderbilt University School of Medicine

Dr. Wood was Professor of both Medicine and Pharmacology at Vanderbilt University Medical School and served as Assistant Vice Chancellor for Clinical Research and Associate Dean, Vanderbilt Medical School, before being appointed Emeritus Professor of Medicine and Emeritus Professor of Pharmacology in 2006.

He served as the Drug Therapy Section Editor of the New England Journal of Medicine from 1985 to 2004. He was a Partner at Symphony Capital LLC, a Private Equity Company investing in the clinical development of novel bio-pharmaceutical products from 2006-2018.

Dr. Wood has been honored by being elected to The National Academy of Medicine (formerly the IOM), The American Association of Physicians (AAP), The American Society for Clinical Investigation (ASCI), Honorary Fellow, American Gynecological and Obstetrical Society (AGOS), Fellowship of The American College of Physicians, Fellowship of The Royal College of Physicians of London, and Fellowship of The Royal College of Physicians of Edinburgh. He was the 2005 recipient of the Rawls-Palmer Award and in 2008 received the honorary degree of Doctor of Laws, honoris causa, from the University of Dundee. Dr. Wood has served on a number of Editorial Boards including the New England Journal of Medicine Editorial Board and his research has resulted in over 300 articles, reviews and editorials.
Marta Wosinska
Marta Wosinska, Ph.D.
Deputy Director, Duke-Margolis Center for Health Policy

Marta E. Wosinska, PhD, is Consulting Professor and the Deputy Director for Policy at the Duke-Margolis Center for Health Policy. Widely recognized as an expert on health policy, economics, and regulation, Wosinska leads the Center’s Washington, DC office. In her role, she works with Duke-Margolis leadership on developing the Center’s strategy and then executes it with support of the roughly 30-person research team based in DC. Wosinska’s experience spans both academia as well as the executive and legislative branches of the federal government. In 2019, Wosinska served as an economic advisor to the US Senate Finance Committee, providing drug market analysis and expert guidance for the Committee’s bipartisan investigative and legislative work on drug pricing. Wosinska also served for over three years as Chief Healthcare Economist in the Office of Inspector General (OIG) at the US Department of Health and Human Services. Prior to OIG, Wosinska had a seven-year tenure at the US Food and Drug Administration (FDA) where she headed the Economics Staff at the Office of Strategic Programs in the Center for Drug Evaluation and Research and served as Senior Economic Advisor to FDA’s Deputy Commissioner for Medical Products and Tobacco, in both roles advising senior FDA leadership on a wide range of economic issues related to drugs and biologics.Before entering public service, Wosinska was an Assistant Professor of Marketing at the Harvard Business School, where her academic research focused on prescription drug marketing. She also was a visiting Assistant Professor at the Columbia Business School, where she developed and taught Healthcare Marketing and Marketing of Pharmaceuticals and Medical Devices. Wosinska received her PhD in economics from University of California at Berkeley and a bachelor’s degree from Arizona State University.

Matthew K. Wynia
Matthew K. Wynia, M.D., M.P.H
Director, Center for Bioethics and Humanities, University of Colorado

Dr. Wynia’s career has included developing a research institute and training programs focusing on bioethics, professionalism and policy issues (the AMA Institute for Ethics) and founding the AMA’s Center for Patient Safety. His research has focused on novel uses of survey data to inform and improve the practical management of ethical issues in health care and public policy. He has led projects on a wide variety of topics related to ethics and professionalism, including understanding and measuring the ethical climate of health care organizations and systems; ethics and quality improvement; communication, team-based care and engaging patients as members of the team; defining physician professionalism; public health and disaster ethics; medicine and the Holocaust (with the US Holocaust Memorial Museum); and inequities in health and health care. He has served on committees, expert panels and as a reviewer for the National Academies, The Joint Commission, the Hastings Center, the American Board of Medical Specialties, federal agencies, and other organizations. Dr. Wynia is the author of more than 160 published articles, chapters and essays, co-editor of several books, and co-author of a book on fairness in health care benefit design. His work has been published in JAMA, the New England Journal of Medicine, Annals of Internal Medicine, Health Affairs, and other leading medical and ethics journals, and he is a contributing editor for the American Journal of Bioethics. He has discussed his work as a guest on the BBC, ABC News, and National Public Radio, among others. Dr. Wynia is a past president of the American Society for Bioethics and Humanities (ASBH), and has chaired the Ethics Forum of the American Public Health Association (APHA) and the Ethics Committee of the Society for General Internal Medicine (SGIM).


Disclosure of Conflicts of Interest

The conflict of interest policy of the National Academies of Sciences, Engineering, and Medicine (http://www.nationalacademies.org/coi) prohibits the appointment of an individual to a committee authoring a Consensus Study Report if the individual has a conflict of interest that is relevant to the task to be performed. An exception to this prohibition is permitted if the National Academies determines that the conflict is unavoidable and the conflict is publicly disclosed. A determination of a conflict of interest for an individual is not an assessment of that individual’s actual behavior or character or ability to act objectively despite the conflicting interest.

Robert M. Califf has a conflict of interest in relation to his service on the Security of America’s Medical Product Supply Chain because he is employed by Verily Life Sciences and has current relationships with Google Health and Cytokinetics.

The National Academies has concluded that for this committee to accomplish the tasks for which it was established, its membership must include at least one person who has substantial relevant experience in FDA regulatory policy, drug and device development, drug and device manufacturing, and drug shortages. As described in his biographical summary, Dr. Califf has extensive current experience as Head of Clinical Policy and Strategy for Verily Life Sciences and Google Health in FDA regulatory policy, drug and device development and manufacturing. As Commissioner of the U.S. Food and Drug Administration (FDA), and as Deputy Commissioner for Medical Products and Tobacco, Dr. Califf gained valuable expertise and perspective on the entirety of the healthcare ecosystem, including companies, hospitals, and health systems. Additionally, Dr. Califf has led clinical research studies and clinical trials and previously served as vice chancellor of clinical and translational research and the director of the Duke Translational Medicine Institute.

The National Academies has determined that the experience and expertise of Dr. Califf is needed for the committee to accomplish the task for which it has been established. The National Academies could not find another available individual with the equivalent experience and expertise who does not have a conflict of interest. Therefore, the National Academies has concluded that the conflict is unavoidable.

The National Academies believes that Dr. Califf can serve effectively as a member of the committee, and the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the study.

Events


Event Type :  
Meeting

Description :   

The National Academies of Sciences, Engineering, and Medicine is holding a closed session meeting for the Committee on Security of America's Medical Product Supply Chain.


Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  -
Contact Email:  MedSupplyChain@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Wallace J. Hopp (Chair)
Mahshid Abir
Raquel C. Bono
Robert M. Califf
Asha Devereaux
Özlem Ergun
Erin Fox
Larry Glasscock
Lewis Grossman
W. Craig Vanderwagen
Alastair Wood
Marta Wosinska
Matthew K. Wynia

The following topics were discussed in the closed sessions:

- Committee charge and statement of task
- Committee composition
- Open Session debrief
- Overview of the consensus study process
- Planning for Q4 2020 workshop
- Work plan, project timeline, and information-gathering strategies

The following materials (written documents) were made available to the committee in the closed sessions:

- Agenda for the closed and open sessions of the committee meeting
- Committee Member biosketches
- Draft timeline for the study process
- Relevant articles
- Submitted letters from stakeholders
- Statement of Task
- The Study Process of the National Academies of Sciences, Engineering, and Medicine

Date of posting of Closed Session Summary:
September 28, 2020
Publication(s) resulting from the event:

-

Event Type :  
Meeting

Description :   

The National Academies of Sciences, Engineering, and Medicine is pleased to announce the first open session meeting for the Committee on Security of America's Medical Product Supply Chain. The public meeting will be held on September 21st, 2020 from 11:00am to 2:00pm (ET) via webinar.

This meeting will provide an opportunity for the committee to discuss their Statement of Task with representatives from the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response (the study sponsors) and gather additional information from relevant subject matter experts.



Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  -
Contact Email:  MedSupplyChain@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
Some sessions are open and some sessions are closed

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Wallace J. Hopp (Chair)
Mahshid Abir
Raquel C. Bono
Robert M. Califf
Asha Devereaux
Özlem Ergun
Erin Fox
Larry Glasscock
Lewis Grossman
W. Craig Vanderwagen
Alastair Wood
Marta Wosinska
Matthew K. Wynia

The following topics were discussed in the closed sessions:

- Committee introductions
- Conflict of interest and potential sources of bias discussion, per National Academies procedure

The following materials (written documents) were made available to the committee in the closed sessions:

- Agenda for the closed and open sessions of the committee meeting
- Committee Member biosketches
- Draft timeline for the study process
- Relevant articles
- Submitted letters from stakeholders
- Statement of Task
- The Study Process of the National Academies of Sciences, Engineering, and Medicine

Date of posting of Closed Session Summary:
September 28, 2020
Publication(s) resulting from the event:

-

Publications

  • Publications having no URL can be seen at the Public Access Records Office
Publications

No data present.