Bulletin #16-04
February 11, 2016
CBER Issues Update to Annual Guidance Agenda 
to include Zika Virus

On Tuesday, the Center for Biologics Evaluation & Research (CBER) posted an update to their annual agenda of topics that represent possible new guidance. Access the update at:
 
Posted: 2/9/2016
 
Guidance related to Zika Virus (ZIKV) now appears on the agenda of two Offices within CBER:
 
From the Office of Cellular, Tissue and Gene Therapies (OCTGT):
  • Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry 
From the Office of Blood Research and Review (OBRR):
  • Recommendations for Donor Screening, Deferral and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus; Guidance for Industry
Both are described as "Guidance" versus "Draft Guidance" or "Final Guidance" so that determination may not have been made at this time. When any guidance is issued, comments to CBER may be submitted. How soon guidance will be issued is not divulged but this topic can be expected to be a priority.
 
The AATB's Tissue Transmitted Diseases Advisory Group (TTDAG), a sub group of the Physicians' Council, is scheduled to meet on Monday to discuss consideration for tissue donor screening and possible risk associated with ZIKV. In regard to ZIKV developments related to donor screening, the AATB has been communicating with representatives from federal agencies (FDA/CBER/DHT, CDC, OASH/HHS, HRSA) and monitoring the publication of various national and international guidelines.
 
We will keep you posted on developments.

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The American Association of Tissue Banks (AATB) -- a professional, non-profit, scientific and educational organization -- is the only national tissue banking organization in the United States. Founded in 1976, the AATB is dedicated to improving and saving lives by promoting and advancing the safety, quality and availability of donated human tissue. To fulfill that mission, 
the AATB publishes standards, accredits tissue banks and certifies personnel.