[Federal Register Volume 75, Number 83 (Friday, April 30, 2010)]
[Notices]
[Pages 22817-22818]
From the Federal Register Online via the Government Publishing 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: [email protected].
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:
[email protected].
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 http://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