[Federal Register Volume 76, Number 215 (Monday, November 7, 2011)]
[Notices]
[Pages 68769-68770]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28722]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Bridging the Idea Development Evaluation Assessment and Long-Term
Initiative and Total Product Life Cycle Approaches for Evidence
Development for Surgical Medical Devices and Procedures; Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Bridging the IDEAL and TPLC Approaches for Evidence
Development for Surgical Medical Devices and Procedures.'' The purpose
of the public workshop is to provide a forum for discussion among FDA,
governmental agencies, academia, physicians, and various stakeholders
to further refine and advance the Idea Development Evaluation
Assessment and Long-Term (IDEAL) initiative and Total Product Life
Cycle (TPLC) frameworks related to evidence generation and evaluation
for surgical devices and procedures.
Date and Time: The meeting will be held on December 2, 2011, from 8
a.m. to 5:30 p.m. Participants are encouraged to arrive early to ensure
time for parking and security screening before the meeting. Submit
electronic and written comments by January 6, 2012.
Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
meeting participants (non-FDA employees) is through Bldg. 1 where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Contact Persons: Samantha Jacobs, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4113, Silver Spring, MD 20993, (301) 796-6897,
email: Samantha.jacobs@fda.hhs.gov; or Danica Marinac-Dabic, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4113, Silver Spring, MD 20993, (301)
796-6689, email: danica.marinac-dabic@fda.hhs.gov.
Registration: There is no fee to attend the public workshop, but
attendees must register in advance. Registration will be on a first-
come, first-served basis. Persons interested in attending this workshop
must register online at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ by November 25, 2011. Non-U.S. citizens are
subject to additional security screening, and they should register as
soon as possible. For those without Internet access, please call the
contact person to register. Onsite registration is not available.
If you need special accommodations due to a disability, please
contact Susan Monahan at susan.monahan@fda.hhs.gov at least 7 days in
advance.
Comments: Regardless of attendance at the public workshop,
interested persons may submit either electronic or written comments
until January 6, 2012. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. It is no longer necessary to send two copies of mailed
comments. Identify comments with the docket number found in brackets in
the heading of this document. In addition, when responding to specific
topics as outlined in section III of this document, please identify the
topic you are addressing. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
SUPPLEMENTARY INFORMATION:
I. Why are we holding this public workshop?
The purpose of the public workshop is to facilitate discussion
among FDA, governmental agencies, academia, clinicians, and the key
stakeholders in the scientific community on issues related to evidence
generation and evaluation for surgical devices and procedures. Based on
complementary methodological frameworks of the IDEAL and TPLC
initiatives, more comprehensive and applicable models and methodologies
will be developed.
II. Who is the target audience for this public workshop? Who should
attend this public workshop?
This workshop is open to all interested parties. The target
audience is comprised of professionals in the scientific community
interested in advancing the infrastructure and methodology for
evaluating surgical devices and procedures.
III. What are the topics we intend to address at the public workshop?
We intend to discuss a large number of issues at the workshop,
including, but not limited to, the following:
The IDEAL and the FDA TPLC approach for evaluation of new
medical devices, surgical operations, and invasive medical procedures;
Unique study designs and reporting methods for evaluation
of medical devices and surgeries;
Innovative methodologies and scientific infrastructure to
promote innovation;
The role of registries and observational studies during
device life cycle; and
Integrating innovation, evaluation, and dissemination
pathways for medical devices, surgical operations, and invasive medical
procedures.
IV. Where can I find out more about this public workshop?
Background information on the public workshop, registration
information, the agenda, information about lodging, and other relevant
information will be posted, as it becomes available, on the Internet at
http://www.fda.gov/cdrh/meetings.html.
Transcripts: Please be advised that as soon as a transcript is
available, it will
[[Page 68770]]
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. 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.
Dated: November 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28722 Filed 11-4-11; 8:45 am]
BILLING CODE 4160-01-P