
[Federal Register Volume 80, Number 94 (Friday, May 15, 2015)]
[Notices]
[Page 27973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11897]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Food and Drug Administration-American Urological Association-
Society of Urologic Oncology Workshop on Partial Gland Ablation for 
Prostate Cancer; 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 the 
following public workshop entitled ``AUA-FDA-SUO Workshop on Partial 
Gland Ablation for Prostate Cancer.'' The topics to be discussed are 
the technologies and imaging used in partial gland ablation, and the 
design of clinical trials to measure the most appropriate endpoints for 
partial gland ablation for prostate cancer. The workshop will be part 
of the American Urological Association (AUA) annual meeting in New 
Orleans, LA.

DATES: The public workshop will be held on Sunday, May 17, 2015, from 1 
p.m. to 6 p.m.

ADDRESSES: The workshop will be held at the New Orleans Ernest N. 
Morial Convention Center, 900 Convention Center Blvd., New Orleans, LA 
70130.
    Registration: Persons interested in attending this workshop must 
register online for the AUA annual meeting. The facilities are limited 
and, therefore, attendance may be limited. To register for the 
workshop, please visit the AUA Web site, http://www.aua2015.org/register/.
    If you need special accommodations due to a disability, please 
contact Ms. Susan Monahan, 301-796-5661, email: 
susan.monahan@fda.hhs.gov.
    For more information on the workshop, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this workshop from the posted events list.) No commercial or 
promotional material will be permitted to be presented or distributed 
at the 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 between 9 a.m. and 4 
p.m. 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 the Division of Freedom of Information 
(ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element 
Bldg., Rockville, MD 20857. A link to the transcripts will also be 
available on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select this workshop from 
the posted events list), approximately 45 days after the workshop.

FOR FURTHER INFORMATION CONTACT: John Baxley, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G210, Silver Spring, MD 20993, 301-796-6549, email: 
john.baxley@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's Center for Devices and Radiological Health, the AUA, and the 
Society of Urologic Oncology (SUO) are cosponsoring this workshop. The 
purpose is to provide a forum to discuss the development of products 
that ablate prostatic tissue, particularly products that target 
ablation to regions of known cancer while intentionally sparing the 
remainder of the prostate from treatment.
    The majority of cases of prostate cancer diagnosed in the United 
States represent low risk, organ-confined disease, which may be 
overtreated if conventional treatment methods (i.e., radical 
prostatectomy and whole gland radiation therapy) are employed. Over the 
past decade, partial gland ablation therapies have emerged as treatment 
alternatives that can spare patients from many of the undesired side 
effects associated with standard, radical treatment. However, multiple 
challenges currently impede the adoption of partial gland ablation 
technologies, including the long natural history associated with this 
disease, imprecision in accurately diagnosing and targeting the tumor 
regions, and the lack of validated biomarkers or surrogate endpoints to 
establish clinical benefit in a reasonable period of time.
    The purposes of this public workshop are to: (1) Foster 
collaboration and receive input from experts within the scientific 
community; (2) obtain input from various stakeholders including 
patients, investigators and industry regarding the development of 
minimally invasive devices to ablate prostatic tissue; (3) foster 
clinical research; (4) discuss strategies to accelerate anticancer 
device development; and (5) provide transparency via a public forum 
regarding the regulatory challenges of developing products for 
management of patients with localized prostate cancer.

II. Topics for Discussion at the Public Workshop

    The following topics will be discussed at this workshop:
     Regulatory issues in partial gland ablation for prostate 
cancer;
     overview of technology and consensus reports;
     the use of imaging and biopsy for patient selection and 
treatment targeting; and
     the design of clinical trials to measure cancer-specific 
and patient-centered outcomes.
    The workshop will consist of formal presentations examining these 
regulatory, scientific and clinical topics, followed by panel 
discussion. During panel discussion, there will also be the opportunity 
for public participation and input.

    Dated: May 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11897 Filed 5-13-15; 11:15 am]
 BILLING CODE 4164-01-P


