Emerging Infectious Diseases: Evaluation to Implementation for Transfusion and Transplantation Safety and Quantitative Risk Assessment: Blood Safety and Availability; Public Workshops, 22817-22818 [2010-10040]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 75, Number 83 (Friday, April 30, 2010)]
[Notices]
[Pages 22817-22818]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10040]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


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.

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    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: 301-827-2843, 
e-mail: rhonda.dawson@fda.hhs.gov.
    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: 301-827-0648, e-mail: 
mark.walderhaug@fda.hhs.gov.
    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

[[Page 22818]]

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 https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.

    Dated: April 26, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10040 Filed 4-29-10; 8:45 am]
BILLING CODE 4160-01-S