80 FR 27973 - Food and Drug Administration-American Urological Association-Society of Urologic Oncology Workshop on Partial Gland Ablation for Prostate Cancer; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 94 (May 15, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 94 (May 15, 2015)
| Page Range | 27973-27973 | |
| FR Document | 2015-11897 |
[Federal Register Volume 80, Number 94 (Friday, May 15, 2015)] [Notices] [Page 27973] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-11897] ----------------------------------------------------------------------- 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, http://www.aua2015.org/register/. If you need special accommodations due to a disability, please contact Ms. Susan Monahan, 301-796-5661, email: [email protected]. 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: [email protected]. 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
![Federal Register / Vol. 80, No. 94 / Friday, May 15, 2015 / Notices 27973
will be posted to the docket at http:// For more information on the the long natural history associated with
www.regulations.gov. workshop, please visit FDA’s Medical this disease, imprecision in accurately
Devices News & Events—Workshops & diagnosing and targeting the tumor
IV. Electronic Access
Conferences calendar at http:// regions, and the lack of validated
Persons with access to the Internet www.fda.gov/MedicalDevices/ biomarkers or surrogate endpoints to
may obtain the document at http:// NewsEvents/WorkshopsConferences/ establish clinical benefit in a reasonable
www.fda.gov/Drugs/Guidance default.htm. (Select this workshop from period of time.
ComplianceRegulatoryInformation/ the posted events list.) No commercial The purposes of this public workshop
Guidances/default.htm, http:// or promotional material will be are to: (1) Foster collaboration and
www.fda.gov/BiologicsBloodVaccines/ permitted to be presented or distributed receive input from experts within the
GuidanceComplianceRegulatory at the workshop. scientific community; (2) obtain input
Information/default.htm, or http:// Transcripts: Please be advised that as from various stakeholders including
www.regulations.gov. soon as a transcript is available, it will patients, investigators and industry
Dated: May 11, 2015. be accessible at http:// regarding the development of minimally
Leslie Kux, www.regulations.gov. It may be viewed invasive devices to ablate prostatic
Associate Commissioner for Policy. at the Division of Dockets Management tissue; (3) foster clinical research; (4)
[FR Doc. 2015–11685 Filed 5–14–15; 8:45 am] between 9 a.m. and 4 p.m. A transcript discuss strategies to accelerate
BILLING CODE 4164–01–P
will also be available in either hardcopy anticancer device development; and (5)
or on CD–ROM, after submission of a provide transparency via a public forum
Freedom of Information request. Written regarding the regulatory challenges of
DEPARTMENT OF HEALTH AND requests are to be sent to the Division developing products for management of
HUMAN SERVICES of Freedom of Information (ELEM– patients with localized prostate cancer.
1029), Food and Drug Administration, II. Topics for Discussion at the Public
Food and Drug Administration 12420 Parklawn Dr., Element Bldg., Workshop
[Docket No. FDA–2015–N–0001] Rockville, MD 20857. A link to the
transcripts will also be available on the The following topics will be
Food and Drug Administration- Internet at http://www.fda.gov/ discussed at this workshop:
MedicalDevices/NewsEvents/ • Regulatory issues in partial gland
American Urological Association-
WorkshopsConferences/default.htm ablation for prostate cancer;
Society of Urologic Oncology
(select this workshop from the posted • overview of technology and
Workshop on Partial Gland Ablation
events list), approximately 45 days after consensus reports;
for Prostate Cancer; Public Workshop • the use of imaging and biopsy for
the workshop.
AGENCY: Food and Drug Administration, patient selection and treatment
FOR FURTHER INFORMATION CONTACT: John targeting; and
HHS.
Baxley, Center for Devices and • the design of clinical trials to
ACTION: Notice of public workshop. Radiological Health, Food and Drug measure cancer-specific and patient-
SUMMARY: The Food and Drug Administration, 10903 New Hampshire centered outcomes.
Administration (FDA) is announcing the Ave., Bldg. 66, Rm. G210, Silver Spring, The workshop will consist of formal
following public workshop entitled MD 20993, 301–796–6549, email: presentations examining these
‘‘AUA–FDA–SUO Workshop on Partial john.baxley@fda.hhs.gov. regulatory, scientific and clinical topics,
Gland Ablation for Prostate Cancer.’’ SUPPLEMENTARY INFORMATION: followed by panel discussion. During
The topics to be discussed are the panel discussion, there will also be the
technologies and imaging used in partial I. Background
opportunity for public participation and
gland ablation, and the design of FDA’s Center for Devices and input.
clinical trials to measure the most Radiological Health, the AUA, and the Dated: May 12, 2015.
appropriate endpoints for partial gland Society of Urologic Oncology (SUO) are
Leslie Kux,
ablation for prostate cancer. The cosponsoring this workshop. The
purpose is to provide a forum to discuss Associate Commissioner for Policy.
workshop will be part of the American
Urological Association (AUA) annual the development of products that ablate [FR Doc. 2015–11897 Filed 5–13–15; 11:15 am]
meeting in New Orleans, LA. prostatic tissue, particularly products BILLING CODE 4164–01–P
DATES: The public workshop will be that target ablation to regions of known
held on Sunday, May 17, 2015, from 1 cancer while intentionally sparing the
remainder of the prostate from DEPARTMENT OF HEALTH AND
p.m. to 6 p.m.
treatment. HUMAN SERVICES
ADDRESSES: The workshop will be held
at the New Orleans Ernest N. Morial The majority of cases of prostate
Food and Drug Administration
Convention Center, 900 Convention cancer diagnosed in the United States
Center Blvd., New Orleans, LA 70130. represent low risk, organ-confined [Docket No. FDA–2015–D–1211]
Registration: Persons interested in disease, which may be overtreated if
attending this workshop must register conventional treatment methods (i.e., Revised Recommendations for
online for the AUA annual meeting. The radical prostatectomy and whole gland Reducing the Risk of Human
facilities are limited and, therefore, radiation therapy) are employed. Over Immunodeficiency Virus Transmission
by Blood and Blood Products; Draft
mstockstill on DSK4VPTVN1PROD with NOTICES
attendance may be limited. To register the past decade, partial gland ablation
for the workshop, please visit the AUA therapies have emerged as treatment Guidance for Industry; Availability
Web site, http://www.aua2015.org/ alternatives that can spare patients from AGENCY: Food and Drug Administration,
register/. many of the undesired side effects HHS.
If you need special accommodations associated with standard, radical ACTION: Notice.
due to a disability, please contact Ms. treatment. However, multiple challenges
Susan Monahan, 301–796–5661, email: currently impede the adoption of partial SUMMARY: The Food and Drug
susan.monahan@fda.hhs.gov. gland ablation technologies, including Administration (FDA or Agency) is
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Document Created: 2018-02-21 10:27:56
Document Modified: 2018-02-21 10:27:56
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public workshop. | |
| Dates | The public workshop will be held on Sunday, May 17, 2015, from 1 p.m. to 6 p.m. | |
| 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: [email protected] | |
| FR Citation | 80 FR 27973 |
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