[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]
BILLING CODE 4160-01-P