AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
SUMMARY: The Food and Drug Administration (FDA) Center for Biologics
Evaluation and Research and the National Institutes of Health, National
Institute of Allergy and Infectious Diseases (NIAID) are announcing a
public workshop entitled "Science and Regulation of Live Microbiome-
Based Products Used to Prevent, Treat, or Cure Diseases in Humans."
The purpose of the public workshop is to exchange information with the
scientific community about the clinical, manufacturing, and regulatory
considerations associated with live microbiome-based products, when
administered to prevent, treat, or cure a disease or condition in
humans. The public workshop will bring together government Agencies,
academia, industry, and other stakeholders involved in research,
development, and regulation of live microbiome-based products for such
DATES: The public workshop will be held on September 17, 2018, from 9
a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will be held at the NIAID Conference
Center, 5601 Fishers Lane, Rm. 1D13, Rockville, MD 20852. Entrance for
public workshop participants is through the lobby, where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.niaid.nih.gov/about/visitor-information.
FOR FURTHER INFORMATION CONTACT: Loni Warren Henderson or Sherri
Revell, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1118, Silver
Spring, MD 20993, 240-402-8010, email: CBERPublicEvents@fda.hhs.gov
line: Live Microbiome-Based Products Workshop).