Document ID: FDA-2017-N-0001-0020
Agency: fda
Document Type: Notice
Title: Bacteriophage Therapy: Scientific and Regulatory Issues; Public Workshop
Posted Date: 2017-06-08T04:00Z

[Federal Register Volume 82, Number 109 (Thursday, June 8, 2017)]
[Notices]
[Pages 26691-26692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11862]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]

Bacteriophage Therapy: Scientific and Regulatory Issues; 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 are announcing a 
public workshop entitled ``Bacteriophage Therapy: Scientific and 
Regulatory Issues.'' The purpose of the public workshop is to exchange 
information with the medical and scientific community about the 
regulatory and scientific issues associated with bacteriophage therapy.

DATES: The public workshop will be held on July 10, 2017, from 8:30 
a.m. to 5 p.m. and July 11, 2017, from 8:30 a.m. to 3 p.m. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public workshop will be held at 5601 Fishers Lane, Rm. 
1D-13, 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 the 
registration Web site provided in section III of the SUPPLEMENTARY 
INFORMATION section.

FOR FURTHER INFORMATION CONTACT: James Ginther or Cynthia Whitmarsh, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 4122, Silver 
Spring, MD 20993, Ph. 240-402-8010, email: CBERPublicEvents@fda.hhs.gov 
(subject line: Bacteriophage Public Workshop).

SUPPLEMENTARY INFORMATION:

I. Background

    Since their discovery approximately one hundred years ago, 
bacteriophages have been investigated as a way to treat bacterial 
infections. In much of the world, the discovery, development, and 
implementation of antibiotic therapies led to a loss of interest in 
bacteriophages as a means to fight infections. However, in recent 
years, interest in this form of treatment has resurged, fueled by the 
increasing prevalence of antibiotic-resistant bacteria.

II. Topics for Discussion at the Public Workshop

    The public workshop will bring together government agencies, 
academia, industry, and other stakeholders involved in research,

[[Page 26692]]

development, and regulation of bacteriophages intended for therapeutic 
use in humans. The aims of the workshop are to discuss the scientific 
and regulatory considerations for bacteriophage therapies and to 
provide a forum for the exchange of information and perspectives, with 
the ultimate goal of facilitating development and rigorous clinical 
assessment of bacteriophage therapy products.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following Web site: https://www.eventbrite.com/e/bacteriophage-therapy-public-workshop-tickets-32333252629. Persons interested in attending 
this public workshop must register online by June 29, 2017. 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. 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 disability, please 
contact James Ginther or Cynthia Whitmarsh no later than 7 days in 
advance of the workshop (see FOR FURTHER INFORMATION CONTACT).
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets 
Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A link to 
the transcript will also be available on the Internet at: https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm544294.htm.

    Dated: June 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11862 Filed 6-7-17; 8:45 am]
BILLING CODE 4164-01-P