[Federal Register Volume 77, Number 162 (Tuesday, August 21, 2012)]
[Notices]
[Pages 50514-50515]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20469]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0891]
Post-Approval Studies 2012 Workshop: Design, Methodology, and
Role in Evidence Appraisal Throughout the Total Product Life Cycle;
Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Post-Approval Studies 2012
Workshop: Design, Methodology, and Role in Evidence Appraisal
Throughout the Total Product Life Cycle.'' The topics of discussion
will include lessons learned from previous experiences with post-
approval studies, improvement of implementation strategies for post-
approval studies, best practices, and innovative methodologies for
evidence appraisal.
Date and Time: The public workshop will be held on August 30, 2012,
from 8 a.m. to 5 p.m.
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. Entrance for the public
workshop participants (non-FDA employees) is through Building 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: Nilsa Loyo-Berrios, Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3214, Silver Spring, MD 20993, 301-796-
8528, email: Nilsa.Loyo-Berrios @fda.hhs.gov or Danica Marinac-Dabic,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4110, Silver
Spring, MD 20993, 301-796-6689, email: [email protected].
Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by 5 p.m. on August 23, 2012. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. Onsite registration will not be available on the day of
the public workshop.
If you need special accommodations due to a disability, please
contact Cindy Garris, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. 4321,
Silver Spring, MD 20993, 301-796-5861, email:
[email protected].
To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public workshop from the posted events list.) Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email,
[[Page 50515]]
and telephone number. Those without Internet access should contact
Nilsa Loyo-Berrios to register (see Contact Persons). Registrants will
receive confirmation after they have been accepted. You will be
notified if you are on a waiting list.
Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by 5 p.m. on August 28, 2012. Early registration is
recommended because Webcast connections are limited. Organizations are
requested to register all participants, but to view using one
connection per location. Web cast participants will be sent technical
system requirements after registration and will be sent connection
access information after August 23, 2012. If you have never attended a
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get
a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site
addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
Comments: FDA is holding this public workshop to provide an update
and obtain stakeholders input on post-approval studies ordered at the
time of device approval. In order to permit the widest possible
opportunity to obtain public comment, FDA is soliciting either
electronic or written comments on all aspects of the public workshop
topics. The deadline for submitting comments related to this public
workshop is September 30, 2012.
Regardless of attendance at the public workshop, interested persons
may submit either written comments regarding this document to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 or electronic comments
to http://www.regulations.gov. It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. In addition, when responding to specific
questions as outlined in section II of this document, please identify
the question 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, and will be posted to the docket at http://www.regulations.gov.
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 (see Comments). 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
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (Select this public workshop from the posted events list).
SUPPLEMENTARY INFORMATION:
I. Background
Post-approval studies (PAS) are imposed as conditions of approval
for some class III devices regulated under premarket approval (PMA)
regulations and are an important public health tool for developing
additional evidence on device performance in the postmarket setting. In
order for PAS to be most effective, studies must be well-designed,
scientifically sound, meaningful and feasible, and must provide
complete and timely information. PMA conditions of approval studies are
constructed to ask for specific, detailed data in a subsequent PAS
relating to unanswered questions in premarket data. However, there are
often opportunities for leveraging the design and conduct of PAS,
enhancing its utility to other important stakeholders. In addition to
the direct role of PMA holders, the role of other public health
partners is expanding, as evidenced by a number of efforts external to
CDRH that are directly or indirectly involved in collecting and
analyzing data relevant to estimating medical device use and risk and
in communicating risk to target populations. To ensure a successful PAS
program, CDRH, regulated industry, clinical researchers, and other
stakeholders must remain well-informed and engaged in continuous
dialogue regarding the design, implementation, reporting, and use of
PAS and the resultant data. Further, it is the Center's desire to
ensure this dialogue results in studies that maximize the public health
impact by producing data that is informative to a range of
stakeholders.
II. Topics for Discussion at the Public Workshop
We intend to discuss a large number of issues at the workshop,
including, but not limited to the following: (1) PAS within the Total
Product Life Cycle, (2) best practices and improvement of PAS
implementation strategies, (3) PAS impact on public health and medical
device innovation, and (4) opportunities for innovative uses of PAS
data.
Dated: August 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20469 Filed 8-20-12; 8:45 am]
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