[Federal Register Volume 76, Number 194 (Thursday, October 6, 2011)]
[Notices]
[Pages 62072-62073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25597]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0648]
Center for Devices and Radiological Health; Standard Operating
Procedures for Network of Experts; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of draft standard operating procedures (SOPs) for a new
``Network of Experts.'' The draft SOPs describe a new process for staff
at the Center for Devices and Radiological Health (CDRH, the center) to
gain access to scientific, engineering, and medical expertise when it
is needed to supplement existing knowledge and expertise within the
Center.
DATES: Submit either electronic or written comments on the report by
November 7, 2011.
ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic
[[Page 62073]]
access to the document. Submit electronic comments on the preliminary
report 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. Identify comments
with the docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Nada O. Hanafi, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5422, Silver Spring, MD 20993-0002, 301-796-5427.
SUPPLEMENTARY INFORMATION:
I. Background
In September 2009, the Task Force on the Utilization of Science in
Regulatory Decision Making (Task Force) and the 510(k) Working Group
were established to address critical challenges facing the Center and
our external constituents. The 510(k) Working Group was charged with
evaluating the premarket notification (510(k)) program and exploring
actions CDRH can take to enhance our 510(k) decision making. The Task
Force was charged with making recommendations on how the Center can
quickly incorporate new science--including evolving information, novel
technologies, and new scientific methods--into its decision making in
as predictable a manner as is practical. The 510(k) Working Group and
Task Force made recommendations and then developed a plan of action for
implementation of these 510(k) and Science Recommendations. This plan
identified internal and administrative matters to be addressed and
included an action item of leveraging external expertise.
II. The Draft SOPs
FDA is announcing the availability of two draft SOPs, one entitled,
``Network of Experts--Expert Utilization Standard Operating Procedure''
and one entitled, ``Network of Experts--Expert Enrollment Standard
Operating Procedure.'' The purpose of the draft SOPs is to develop a
network of external experts to appropriately and efficiently leverage
external scientific expertise, and to describe the process for staff
engagement with external experts. The network will be built on a series
of agreements with external organizations including professional,
scientific, and medical organizations and academic institutions. The
draft SOPs describe CDRH processes for providing CDRH staff with access
to scientific, engineering, and medical expertise when it is needed to
supplement existing knowledge and expertise within CDRH. The network of
experts is designed to broaden CDRH's exposure to scientific
viewpoints, but not to provide external policy advice or opinions.
CDRH has a knowledgeable, professional internal cadre of scientific
expertise, including over 800 scientists, engineers, and clinicians.
Despite this internal resource, it is unrealistic to expect CDRH staff
to encompass all of the applicable expertise and experience necessary
to fulfill our mission given the rapidly growing variety and complexity
of medical devices. This is particularly true when it comes to new and
emerging fields of science and pioneering technologies. In these areas,
it is often necessary for our experts to gain further scientific
understanding from external sources. The Network of Experts will
facilitate this exchange.
In developing the draft SOPs, CDRH assessed best practices. CDRH is
also beginning a pilot project to use these draft SOPs on a trial
basis. Experience from the pilot, along with comments on this notice,
will further assist the agency in determining whether the draft SOPs
should be improved going forward.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. 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. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons interested in obtaining a copy of the draft SOPs may do so
by using the Internet. The draft SOP entitled: ``Network of Experts--
Expert Utilization Standard Operating Procedure'' can be obtained from
FDA's Web site at http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm271521.htm. The draft SOP entitled: ``Network of
Experts--Expert Enrollment Standard Operating Procedure'' can be
obtained from FDA's Web Site at http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm271523.htm. The draft SOPs are also
available from http://www.regulations.gov and can be located using the
docket number found in brackets in the heading of this document.
Dated: September 29, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-25597 Filed 10-5-11; 8:45 am]
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