81 FR 46928 - Pre-Clinical Evaluation of Red Blood Cells for Transfusion; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 138 (July 19, 2016)

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Pre-Clinical Evaluation of Red Blood Cells for Transfusion.'' The purpose of the public workshop is to discuss new methodologies for pre-clinical evaluation of the safety and efficacy of red blood cell transfusion products. The workshop has been planned in partnership with the National Heart, Lung, and Blood Institute; National Institutes of Health (NIH); the Department of Defense; and the Office of the Assistant Secretary for Health, Department of Health and Human Services. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government Agencies.

[Federal Register Volume 81, Number 138 (Tuesday, July 19, 2016)]
[Notices]
[Pages 46928-46929]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-17008]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Pre-Clinical Evaluation of Red Blood Cells for Transfusion; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Pre-Clinical Evaluation of Red Blood Cells for 
Transfusion.'' The purpose of the public workshop is to discuss new 
methodologies for pre-clinical evaluation of the safety and efficacy of 
red blood cell transfusion products. The workshop has been planned in 
partnership with the National Heart, Lung, and Blood Institute; 
National Institutes of Health (NIH); the Department of Defense; and the 
Office of the Assistant Secretary for Health, Department of Health and 
Human Services. The workshop will include presentations and panel 
discussions by experts from academic institutions, industry, and 
government Agencies.

DATES: The public workshop will be held on October 6, 2016, from 8 a.m. 
to 5 p.m. and on October 7 from 9 a.m. to 1 p.m. See the SUPPLEMENTARY 
INFORMATION section for registration date and information.

ADDRESSES: The public workshop will be held at the Ruth Kirschstein

[[Page 46929]]

Auditorium, Natcher Conference Center, Bldg. 45, National Institutes of 
Health Campus, 9000 Rockville Pike, Bethesda, MD 20892. The entrance 
for the public workshop participants (non-NIH employees) is through the 
NIH Gateway Center located adjacent to the Medical Center Metro, where 
routine security check procedures will be performed. Please visit the 
following Web site for NIH campus location, parking, security, and 
travel information: http://www.nih.gov/about/visitor/index.htm. Please 
visit the following Web site for information on the Natcher Conference 
Center: http://www.genome.gov/11007522.

FOR FURTHER INFORMATION CONTACT: Matthew Morrison, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, rm. 3128, Silver Spring, MD 20993, 240-402-
8126, [email protected]. For questions email: 
[email protected] (Subject line: Red Blood Cell (RBC) 
Workshop).

SUPPLEMENTARY INFORMATION: The purpose of the public workshop is to 
discuss new methodologies for pre-clinical evaluation of the safety and 
efficacy of red blood cell transfusion products including potential 
identification of biomarkers measurable during red cell storage that 
could predict the in vivo functionality of transfused red blood cells. 
The first day of the workshop will include presentations and panel 
discussions on the following topics: (1) Overview of red blood cells 
for transfusion; (2) methods for determining the suitability of red 
blood cells for transfusion; (3) new methods for detecting red blood 
cell processing and storage legions; and (4) the use of animal models 
of oxygen delivery as markers of red blood cell safety and efficacy in 
the acute bleeding and trauma resuscitation settings.
    The second day of the workshop will include presentations and panel 
discussions on the potential mechanisms of red blood cell transfusion-
associated toxicity and a summary of all workshop panel discussions, 
identified gaps, and future directions.
    Registration: Please visit the following Web site to register for 
the workshop by September 23, 2016: https://www.eventbrite.com/e/pre-clinical-evaluation-of-red-blood-cells-for-transfusion-registration-25813463765. 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 Matthew Morrison (see FOR FURTHER INFORMATION CONTACT) at least 
7 days in advance.
    Transcripts: Please be advised that as soon as possible after a 
transcript of this public workshop is available, it will be accessible 
at: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm507890.htm.

    Dated: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17008 Filed 7-18-16; 8:45 am]
 BILLING CODE 4164-01-P