2011-26295. Data and Data Needs To Advance Risk Assessment for Emerging Infectious Diseases Relevant to Blood and Blood Products; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

The Food and Drug Administration (FDA) is announcing a public workshop entitled: “Data and Data Needs to Advance Risk Assessment for Emerging Infectious Diseases Relevant to Blood and Blood Products.” The purpose of the public workshop is to discuss data and data sources currently used by FDA, possible new sources of data, and development of new studies and information through collaboration with stakeholders. The public workshop will include presentations and panel discussions with experts from stakeholders, academia, regulated industry, and government.

Date and Time: The public workshop will be held on November 29, 2011, from 8:30 a.m. to 5 p.m.

Location: The public workshop will be held at the Gaithersburg Hilton, 620 Perry Pkwy., Gaithersburg, MD 20877, 301-977-8900.

Contact Person: Lou Gallagher, Center for Biologics Evaluation and Research (HFM-210), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-5988, e-mail: [e-mail].

Registration: Mail, fax, or e-mail your registration information (including name, title, firm name, address, telephone and fax numbers) to Lou Gallagher (see Contact Person) by November 10, 2011. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 8 a.m.

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

SUPPLEMENTARY INFORMATION:

Quantitative risk assessments (QRAs) are an important tool for evaluating the risks associated with new emerging infectious diseases (EIDs) that are relevant to blood and blood products and the benefits of mitigation options. QRAs make it possible for decisionmakers to develop policy for blood and blood product safety and availability using sound science and the best data and information available.

Rapid data collection, information sharing, and analyses estimating the magnitude and probability of risk can be expedited by proactively building and maintaining critical relationships both within the Center for Biologics Evaluation and Research (CBER) and with external stakeholders. In this public workshop, CBER is seeking access to accurate, reliable data on factors such as disease prevalence, incubation periods, behavioral risks associated with disease transmission, potential donor exposure risks, and susceptibility to EIDs, product handling, usage, and other factors.

Lack of data and information is a major challenge FDA faces when there is a new EID. The public workshop will: (1) Provide a forum for discussion of data used in conducting quantitative risk assessments for EIDs, (2) address approaches to facilitate the timely access to data required to evaluate public health measures designed to reduce the potential risk associated with EIDs that are relevant to blood and blood products, and (3) provide a forum for discussion of the development of new data sources and enhanced access to already existing data sources.

Transcripts: Please be advised that as soon as possible after a transcript of the public workshop is available, it will be accessible on the Internet at: http://www.fda.gov/​BiologicsBloodVaccines/​NewsEvents/​WorkshopsMeetingsConferences/​TranscriptsMinutes/​default.htm. Transcripts of the public workshop may also be requested in writing from the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857.

Dated: October 6, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.