Document ID: FDA-2014-N-0001-0067
Agency: fda
Document Type: Notice
Title: Clinical Development of Drugs for the Prevention of Infections Caused by
Staphylococcus aureus in the Health Care Setting; Public Workshop
Posted Date: 2014-08-14T04:00Z

[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Pages 47654-47655]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19257]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Clinical Development of Drugs for the Prevention of Infections 
Caused by Staphylococcus aureus in the Health Care Setting; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop regarding the clinical development of drugs for the prevention 
of serious infections caused by Staphylococcus aureus in the health 
care setting. This public workshop is intended to provide information 
for and gain perspective from health care providers, patients and 
patient advocacy organizations, academia, and industry on various 
aspects of clinical development of drugs to prevent Staphylococcus 
aureus infections including the design of clinical trials. The input 
from this public workshop will help in developing topics for further 
discussion.
    Date and Time: The public workshop will be held on September 5, 
2014, from 8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at the DoubleTree by 
Hilton Hotel Washington DC, 8727 Colesville Rd., Silver Spring, MD 
20910. The hotel's phone number is 301-589-5200.
    Contact Persons: Carole Miller or Lori Benner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6217, Silver Spring, MD 20993-0002, 301-
796-1300.
    Registration: Registration is free for the public workshop. 
Interested parties are encouraged to register early. Seating is limited 
and will be available on a first-come, first-served basis. To register 
electronically, email registration information (including name, title, 
firm name, address, telephone, and fax number) to 
FDASTAPHWORKSHOP@fda.hhs.gov. Onsite registration the day of the 
workshop will be available, but advanced registration is preferred. 
Persons without access to the Internet can call 301-796-1300 to 
register.
    If you need a sign language interpreter or other special 
accommodations, please notify Carole Miller or Lori Benner (see Contact 
Persons) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: 
    FDA is announcing a public workshop regarding scientific 
considerations in the clinical development of drugs for the prevention 
of serious infections caused by Staphylococcus aureus in the health 
care setting. Clinical care guidelines recommend a group of 
interventions to reduce health care associated infections in certain 
patients (for example, surgical patients, patients with a central-line 
catheter such as dialysis patients, and patients admitted to the 
intensive care unit). Some experts recommend specific interventions 
(such as nasal decolonization) to prevent infections caused by 
Staphylococcus aureus. Discussions will focus on the data that may 
demonstrate a clinical benefit in different populations of patients. In 
addition, discussions will include: (1) Possible approaches to 
demonstrating the clinical benefit of one intervention component in the 
setting of a group of interventions, (2) feasible approaches to 
identifying and recruiting patients at increased risk for serious 
infections caused by Staphylococcus aureus in clinical trials, and (3) 
feasible clinical

[[Page 47655]]

trial designs that may provide evidence of efficacy to support drug 
approval.
    The Agency encourages individuals, patient advocates, industry, 
consumer groups, health care professionals, researchers, and other 
interested persons to attend this public workshop.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
A transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information (ELEM-1029), Food 
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, 
MD 20857. Transcripts will also be available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm132703.htm approximately 45 days after 
the workshop.

    Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19257 Filed 8-13-14; 8:45 am]
BILLING CODE 4164-01-P