[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Pages 47654-47655]
From the Federal Register Online via the Government Publishing 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
[email protected]. 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