Document ID: FDA-2018-N-0001-0014
Agency: fda
Document Type: Notice
Title: Science and Regulation of Live Microbiome-Based Products Used to Prevent, Treat, or Cure Diseases in Humans; Public Workshop
Posted Date: 2018-08-17T04:00Z

[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