Food and Drug Administration-American Urological Association-Society of Urologic Oncology Workshop on Partial Gland Ablation for Prostate Cancer; Public Workshop, 27973 [2015-11897]

Download as PDF Federal Register / Vol. 80, No. 94 / Friday, May 15, 2015 / Notices will be posted to the docket at https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, or https:// www.regulations.gov. Dated: May 11, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–11685 Filed 5–14–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Food and Drug AdministrationAmerican Urological AssociationSociety of Urologic Oncology Workshop on Partial Gland Ablation for Prostate Cancer; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. 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, https://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. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:20 May 14, 2015 Jkt 235001 For more information on the workshop, please visit FDA’s Medical Devices News & Events—Workshops & Conferences calendar at https:// 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 https:// 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 https://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 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 27973 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 patientcentered 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–1211] Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is SUMMARY: E:\FR\FM\15MYN1.SGM 15MYN1

Agencies

[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.

-----------------------------------------------------------------------

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, https://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 https://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 https://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 https://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
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