2010-10040. Emerging Infectious Diseases: Evaluation to Implementation for Transfusion and Transplantation Safety and Quantitative Risk Assessment: Blood Safety and Availability; Public Workshops

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshops.

The Food and Drug Administration (FDA) is announcing two public workshops entitled “Emerging Infectious Diseases: Evaluation to Implementation for Transfusion and Transplantation Safety” (EID public workshop) and “Quantitative Risk Assessment: Blood Safety and Availability” (QRA public workshop), respectively. The workshops have been scheduled on consecutive days to allow interested parties to attend both. The EID public workshop is a 2-day workshop; the purpose is to review the strategies used for identification, prioritization, and response to EID that are relevant to blood, cells, tissues and organs. The workshop has been planned in partnership with the HHS Office of Science and Public Health, Centers for Disease Control and Prevention, National Institutes of Health and Health Resources Services Administration. The QRA public workshop is a 1-day workshop; the purpose is to review the scientific principles of risk assessment and to discuss the role of risk assessment in the regulatory process, specifically as it relates to blood safety and availability. The public workshops will feature presentations, case studies and round table discussions led by national and international experts from government, academia and industry.

Date and Time: The EID public workshop will be held on May 11 and 12, 2010, from 8:00 a.m. to 5:30 p.m., each day. The QRA public workshop will be held on May 13, 2010, from 8:30 a.m. to 5:00 p.m.

Location: Both public workshops will be held at the Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.

Contact Person: Persons interested in the EID public workshop should contact Rhonda Dawson, Center for Biologics Evaluation and Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, Suite 550N, Rockville, MD 20852-1448, 301-827-6129, FAX: [phone], e-mail: [e-mail].

Persons interested in the QRA public workshop should contact Mark O. Walderhaug, Center for Biologics Evaluation and Research (HFM-210), Food and Drug Administration, 1401 Rockville Pike, Suite 400S, Rockville, MD 20852-1448, 301-827-6028, FAX: [phone], e-mail: [e-mail].

Registration: Mail or fax your registration information (including name, title, firm name, address, telephone and fax numbers) to the appropriate contact person (see Contact Person) by May 5, 2010. There is no registration fee for either public workshop. Early registration is recommended because seating is limited. Registration on the days of the public workshops will be provided on a space available basis beginning at 7:30 a.m.

If you need special accommodations due to a disability, please contact the appropriate contact person (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION:

FDA is announcing the following two public workshops:

1. EID Public Workshop

The characterization of risk from, and prioritization of response to, emerging infectious diseases relevant to blood, cells, tissue and organ safety has always been a complicated process. In terms of preparedness, when multiple EID agents threaten blood, cells, tissue and organ safety, it can be a challenge to prioritize efforts to address the resulting risk related issues since there is no single approach or formula that guarantees an ideal prioritization process. The EID public workshop will address processes for early threat detection and risk reduction of EID agents that are relevant to blood, cells, tissues and organs, including methods of “horizon scanning,” risk assessment, risk communication and application of emerging pathogen detection and pathogen reduction technologies. In addition, the workshop will discuss research needed to help address issues regarding appropriate screening and testing for donors of human organs, cells, and tissues for transplantation.

The first day of the workshop will focus on transfusion safety and include discussions on the following topics: (1) The identification, surveillance and prioritization of EID agents in the United States (U.S.) and internationally; (2) risk assessment methodologies; and (3) tools to address EIDs, including pathogen reduction technologies, microarray sequencing and prion detection capabilities. The second day of the workshop will address organ, cell and tissue transplantation safety. Topics for discussion include the following: (1) The regulatory frameworks for cells, tissue and organ transplantation; (2) approaches to the identification and evaluation of EIDs in the U.S. and internationally; (3) risk assessment methodologies; and (4) current research priorities, limitations and opportunities.

2. QRA Public Workshop

FDA's mission to protect public health is a complex challenge that frequently requires regulators to use sophisticated analyses of risk and benefit to reach informed decisions concerning the safety and effectiveness of therapeutics. To reach optimal decisions, regulators will often use a risk analysis that involves a deliberative process of risk management, risk communication and risk assessment. The workshop aims to increase the transparency of the decision-making process at FDA by increasing public understanding of risk assessment in the regulatory process for blood products.

Risk assessment is a process that reflects a structured approach of hazard identification, hazard characterization, exposure assessment and risk characterization. The QRA public workshop is designed to enhance understanding of the agency's operations and decision-making process in this regard. The workshop will discuss the principles of risk assessment, and a detailed case study using a recent risk assessment related to blood safety and availability will be presented.

Transcripts: Transcripts of the public workshop may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page. A transcript of the public workshop will be available on the Internet at http://www.fda.gov/​BiologicsBloodVaccines/​NewsEvents/​WorkshopsMeetingsConferences/​TranscriptsMinutes/​default.htm.

Dated: April 26, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.