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Advisory Committee on Blood & Tissue Safety & Availability (ACBTSA) U.S. Department of Health & Human Services

Forty-Fifth Meeting, November 13 & 14, 2014

Double Tree Hotel
300 Army Navy Dr
Arlington, VA 22202

Thursday, November, 13, 2014

07:30

(30 min)

Doors Open

Open to Public

08:00

(10 min)

Call to Order

Jay Menitove, MD

Committee Chair

08:10

(5 min)

Roll Call 

James Berger

Executive Secretary

Committee Business

08:15

(20 min)

Principal Deputy Assistant Secretary for Health’s Charge to the Committee 

Wanda Jones, DrPH

HHS Principal Deputy Assistant Secretary for Health

Blood Donor Policy for Men who have Sex with Men

08:35

(15 min)

Introduction to MSM Blood Donor Deferral Policy Discussion

James Berger

Executive Secretary

08:50

(20 min)

Origin, Evolution, and Effectiveness of MSM Blood Donor Deferral Policy

Alan E. Williams, Ph.D.

Associate Director, Office of Blood

Research and Review

CBER, FDA

09:10

(20 min)

Current Epidemiology of HIV in the US

Amy Lansky, PhD, MPH

Deputy Director for Surveillance, Epidemiology, and Laboratory Sciences

Division of HIV/AIDS Prevention, CDC

09:30

(40 min)

Retrovirus Epidemiology Donor Study-II (REDS-II) TTI Marker Prevalence and Risk Factor Study

Simone Glynn, MD, MSc, MPH

Branch Chief Blood Epidemiology and Clinical

Therapeutics Branch

National Heart, Blood, and Lung Institute

10:10

Break (10 min)

10:20

(40 min)

Results of the Recipient Epidemiology and Donor Evaluation Study – III (REDS-III) Blood Donation Rules Opinion Study (Blood DROPS)

Brian Custer, PhD, MPH

Associate Investigator

Epidemiology and Health Research

Policy Blood Systems Research Institute

11:00

(20 min)

Cognitive Interviewing Evaluation of the UDHQ: Results and Next Steps

Kristen Miller, Ph.D. and Stephanie Willson, Ph.D.

National Center for Health Statistics

11:20

(20 min)

The Australia MSM Blood Donor Deferral Experience

Richard Benjamin MD, PhD, FRCPath

Chief Medical Director

American Red Cross

11:40

(20 min)

Discussion of MSM Blood Policy Deferral Options

Harvey Alter, MD

Chief, Clinical Studies

Associate Director of Research

Department of Transfusion Medicine, NIH

12:00

(45 min)

Open Public Hearing (all sessions/ considerations)

12:45

Lunch Break (45 min)

01:30

(2 hrs)

Committee Questions, Discussion, and Recommendations

03:30

Adjournment

Jay Menitove, MD

Committee Chair

Friday, November, 14, 2014

07:30

(30 min)

Doors Open

Open to Public

08:00

(5 min)

Call to Order

Jay Menitove, MD

Committee Chair

08:05

(10 min)

Roll Call

James Berger

Executive Secretary

Advisory Committee Update

08:15

(15 min)

Subcommittee Update: Informed Consent in Transfusion and Transplantation 

Jim Bowman, MD

Medical Director

Division of Transplantation

HHS/HRSA

Hemoglobin S Testing in Blood Donors

08:30

(30 min)

Hemoglobin S Testing in Blood Donors 

Orieji Illoh, MD

Deputy Director

Division of Blood Components and Devices

FDA/CBER/OBRR

09:00

(30 min)

Presidential Commission for the Study of Bioethical Issues: Ethical Implications of Incidental Findings

Lisa M. Lee, PhD, MS

Executive Director

Presidential Commission for the Study of Bioethical Issues

09:30

(30 min)

Ethical Issues in Sickle Screening

Norman Fost, MD, MPH

Professor Emeritus Departments of Pediatrics and Medical History & Bioethics

University of Wisconsin School of Medicine and Public Health

10:00

(30 min)

Returning hematoglobinopathy results to blood donors: ethical considerations

Steven Joffe, MD, MPH

Emanuel and Robert Hart Associate

Professor

Vice-Chair, Department of Medical Ethics and Health Policy

University of Pennsylvania Perelman School of Medicine

10:30

Break (10 min)

10:40

(20 min)

Sickle Cell Testing in Independent Blood Centers

Louis M. Katz, MD

Chief Medical Officer

America’s Blood Center

11:00

(30 min)

Blood Center Perspective

Yelena Ginzburg, MD

Medical Director, Medical Programs and Services

New York Blood Center

11:30

(30 min)

Sourcing and Transfusing RBC for Selected

Populations and Responding to Donors with

Positive Sickle Screening

Naomi L. C. Luban, M.D.

Director, Transfusion Medicine, The Edward J. Miller Jr. Blood Donor Center

Vice Chair for Academic Affairs, Children’s National Medical Center

Professor, Pediatrics and Pathology, The George Washington University School of Medicine

12:00

(15 min)

Patient and Family Perspective on Hemoglobin S testing

Larry Allen

Executive Secretary, Committee of Ten Thousand

12:15

Lunch Break (45 min)

01:00

(25 min)

Open Public Hearing (all sessions/ considerations)

Emerging Infectious Diseases

01:25

(25 min)

Public Health Perspective on a Progressively Emerging Threat

Alfred DeMaria, MD

Medical Director, Bureau of Infectious Disease

Massachusetts Department of Public Health

01:50

(25 min)

Transfusion Transmitted Babesiosis: Perspectives from the NYBC Experience

Beth Shaz, MD

Chief Medical Officer

New York Blood Center

02:15

(25 min)

Ethical Issues for selective Infectious Disease Testing

Richard Benjamin MD, PhD, FRCPath

Chief Medical Director

American Red Cross

02:40 

(2 hrs)

Committee Questions, Discussion, and Recommendations

04:40

Adjournment

Jay Menitove, MD

Committee Chair


Content created by Assistant Secretary for Health - Adv. Com./Blood/Tissue Safety
Content last reviewed on November 12, 2014