[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Pages 12763-12764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04232]



Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Fecal Microbiota for Transplantation; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.


    The Food and Drug Administration (FDA), Center for Biologics 
Evaluation and Research (CBER), and the National Institutes of Health, 
National Institute of Allergy and Infectious Diseases (NIAID), are 
announcing a public workshop entitled ``Fecal Microbiota for 
Transplantation.'' The purpose of the public workshop is to exchange 
information with the medical and scientific community about the 
regulatory and scientific issues associated with fecal microbiota for 
transplantation (FMT).

[[Page 12764]]

    Date and Time: The public workshop will be held on May 2 and 3, 
2013, from 8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at Lister Hill Center 
Auditorium, National Institutes of Health, Bldg. 38A, 8600 Rockville 
Pike, Bethesda, MD 20894. Preregistered participants will receive 
additional information on security procedures, parking, and public 
transportation with their email registration confirmation.
    Contact Person: Chris Nguyen, Center for Biologics Evaluation and 
Research (HFM-49), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-2000, FAX: 301-827-3079, 
email: [email protected] (subject line: FMT Workshop).
    Registration: Mail or fax your registration information (including 
name, title, firm name, address, telephone, and fax numbers) to Chris 
Nguyen (see Contact Person) or email to [email protected] 
(subject line: FMT Workshop Registration) by April 18, 2013. 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 8 a.m.
    If you need special accommodations due to a disability, please 
contact Chris Nguyen (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: Fecal microbiota samples that have been 
isolated from healthy individuals are being investigated for use in the 
treatment of Clostridium difficile colitis. Published data from case 
studies and metaanalyses suggest that the use of fecal microbiota to 
restore gut flora may be an effective therapy in the management of 
refractory C. difficile infection. However, the efficacy of this 
intervention has not yet been demonstrated in controlled clinical 
trials. Such controlled trials are needed to demonstrate the safety and 
effectiveness of FMT products for C. difficile infection refractory to 
conventional therapy. FMT is also being considered as a treatment for 
inflammatory bowel disease, obesity, and other disorders, and 
controlled trials are needed in these settings as well.
    Clinical studies to evaluate the safety and efficacy of FMT are 
regulated by FDA. FDA's primary objectives in reviewing an 
investigational new drug application are, in all phases of the 
investigation, to assure the safety and rights of subjects, and, in 
Phases 2 and 3, to help insure that the quality of the scientific 
evaluation of the product is adequate to permit an evaluation of safety 
and effectiveness. In addition, the complex nature of FMT products 
presents specific scientific and regulatory challenges.
    To facilitate clinical development of FMT, CBER and NIAID are 
holding this workshop to provide a forum for the exchange of 
information, knowledge, and experience between CBER, NIAID, and the 
scientific-medical community.
    Transcripts: Please be advised that as soon as possible after a 
transcript of the public workshop is available, it will be accessible 
at: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm. 
Transcripts of the public workshop may also be requested in writing 
from the Division of Freedom of Information (ELEM-1029), Food and Drug 
Administration, 12420 Parklawn Dr., Rockville, MD 20857.

    Dated: February 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04232 Filed 2-22-13; 8:45 am]