
[Federal Register Volume 78, Number 51 (Friday, March 15, 2013)]
[Notices]
[Pages 16513-16514]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05987]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Application of Advances in Nucleic Acid and Protein Based 
Detection Methods to Multiplex Detection of Transfusion-Transmissible 
Agents and Blood Cell Antigens in Blood Donations; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled: ``Application of Advances in Nucleic Acid and 
Protein Based Detection Methods to Multiplex Detection of Transfusion-
Transmissible Agents and Blood Cell Antigens in Blood Donations.'' The 
purpose of this public workshop is to discuss research and development 
of multiplex assays and the use of these tests in blood donor screening 
and blood cell antigen typing. The public workshop has been planned in 
partnership with the AABB (formerly known as the American Association 
of Blood Banks), Advanced Medical Technology Association (AdvaMed), 
America's Blood Centers, Department of Defense, Department of Health 
and Human Services Office of the Assistant Secretary for Health, and 
the National Heart, Lung and Blood Institute, National Institutes of 
Health. The public workshop will include presentations and panel 
discussions by experts from academic institutions, blood 
establishments, industry, and government agencies.
    Date and Time: The public workshop will be held on April 10, 2013, 
from 8 a.m. to 5:30 p.m., and April 11, 2013, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held in the Main Auditorium, 
Natcher Conference Center, National Institutes of Health, Bldg. 45, 
Bethesda, MD 20892.
    Contact Person: Jennifer Scharpf, Center for Biologics Evaluation 
and Research (HFM-300), Food and Drug Administration, 1401 Rockville 
Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6128, FAX: 301-827-
2843, email: CBEROBRRWorkshops@fda.hhs.gov.
    Registration: Mail, fax, or email your registration information 
(including name, title, firm name, address, telephone and fax numbers, 
and email address) to Jennifer Scharpf (see Contact Person) by April 1, 
2013. 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 7:30 a.m. If you need special accommodations due to 
a disability, please contact Jennifer Scharpf (see Contact Person) at 
least 7 days in advance.

SUPPLEMENTARY INFORMATION: The objectives of the workshop are to review 
the status of multiplex platforms and the technological advances in 
gene based and protein based pathogen and blood cell antigen detection 
methods and to discuss the scientific pathways to support the 
development of multiplex assays to screen blood donors for blood-borne 
pathogens and blood cell antigen typing.
    The first day of this workshop will include presentations and panel 
discussions on the following topics: (1) Blood safety and infectious 
agents, (2) advances in blood-borne pathogen detection, and (3) 
molecular DNA-based typing of blood cell antigens.
    The second day of the workshop will include presentations and 
discussion on the following topics: (1) Highly multiplexed technologies 
in blood donor screening; (2) bioinformatics, data

[[Page 16514]]

analysis, and data management issues; (3) perspectives in developing 
multiplex devices for donor screening; and (4) workshop summary and 
conclusions.
    Transcripts: Please be advised that as soon as possible after a 
transcript of the public workshop is available, it will be accessible 
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: March 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05987 Filed 3-14-13; 8:45 am]
BILLING CODE 4160-01-P


