[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Notices]
[Pages 41076-41077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17732]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0001]
Science and Regulation of Live Microbiome-Based Products Used To
Prevent, Treat, or Cure Diseases in Humans; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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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
uses.
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: [email protected]
(subject
[[Page 41077]]
line: Live Microbiome-Based Products Workshop).
SUPPLEMENTARY INFORMATION:
I. Background
Live microbiome-based products used to prevent, treat, or cure a
disease or condition in humans are biological products. There is
increasing interest in the use of such products for the treatment and/
or prevention of conditions such as necrotizing enterocolitis and
diarrhea. Historically, these products have presented with unique
scientific and regulatory challenges.
II. Topics for Discussion at the Public Workshop
The topics for discussion at the public workshop include the
clinical, manufacturing, and regulatory considerations for live
microbiome-based products to prevent, treat, or cure a disease or
condition in humans, and the objective is to provide a forum for the
exchange of information and perspectives on these topics.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website: https://www.eventbrite.com/e/science-and-regulation-of-live-microbiome-based-products-used-to-prevent-treat-or-cure-diseases-in-tickets-44649072578. Please provide complete contact
information for each attendee, including name, title, affiliation,
address, email, and telephone.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by August 28, 2018, midnight Eastern Time. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization. There will
be no onsite registration.
If you need special accommodations due to a disability, please
contact Loni Warren Henderson or Sherri Revell no later than September
10, 2018 (See FOR FURTHER INFORMATION CONTACT).
Dated: August 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17732 Filed 8-16-18; 8:45 am]
BILLING CODE 4164-01-P