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Federal Register / Vol. 71, No.

184 / Friday, September 22, 2006 / Notices 55491

DEPARTMENT OF HEALTH AND deliberations and for 30 minutes near inviting vendors of automatic
HUMAN SERVICES the end of the committee deliberations. identification technologies to display
Time allotted for each presentation may their products for the educational
Food and Drug Administration be limited. Those desiring to make benefits of FDA and other attendees.
formal oral presentations should notify DATES AND TIMES: The public meeting
Neurological Devices Panel of the the contact person and submit a brief will be held on Wednesday, October 25,
Medical Devices Advisory Committee; statement of the general nature of the 2006, from 9 a.m. to 4 p.m. Registration
Notice of Meeting evidence or arguments they wish to to attend the meeting, to present at the
AGENCY: Food and Drug Administration, present, the names and addresses of meeting, and to participate in the
HHS. proposed participants, and an vendor display must be received by
indication of the approximate time October 10, 2006. Submit written
ACTION: Notice.
requested to make their presentation on comments by November 9, 2006.
This notice announces a forthcoming or before October 17, 2006.
You may register electronically at
meeting of a public advisory committee Persons attending FDA’s advisory
www.fda.gov/cdrh/ocd/udi/index.html
of the Food and Drug Administration committee meetings are advised that the
(see SUPPLEMENTARY INFORMATION,
(FDA). The meeting will be open to the agency is not responsible for providing
section V of this document for
public. access to electrical outlets.
FDA welcomes the attendance of the information on registration.
Name of Committee: Neurological
public at its advisory committee ADDRESSES: The public meeting will be
Devices Panel of the Medical Devices
meetings and will make every effort to held at the Gaithersburg Marriott
Advisory Committee.
accommodate persons with physical Washingtonian Center, 9751
General Function of the Committee:
disabilities or special needs. If you Washingtonian Blvd., Gaithersburg, MD
To provide advice and
require special accommodations due to 20878, 1–301–590–0044.
recommendations to the agency on
FDA’s regulatory issues. a disability, please contact AnnMarie A block of rooms is being held for the
Date and Time: The meeting will be Williams, Conference Management evening of Tuesday, October 24, 2006.
held on October 31, 2006, from 8 a.m. Staff, at 301–827–7291, at least 7 days Please mention the ‘‘FDA UDI Meeting’’
to 6 p.m. in advance of the meeting. when calling the hotel.
Location: Hilton Washington DC Notice of this meeting is given under Submit written comments to the
North/Gaithersburg, Ballroom Salons C, the Federal Advisory Committee Act (5 Division of Dockets Management (HFA–
D, and E, 620 Perry Pkwy., Gaithersburg, U.S.C. app. 2). 305), Food and Drug Administration,
MD. Dated: September 18, 2006. 5630 Fishers Lane, rm. 1061, Rockville,
Contact Person: Janet L. Scudiero, Randall W. Lutter,
MD 20852. Submit electronic comments
Center for Devices and Radiological to http://www.fda.gov/dockets/
Associate Commissioner for Policy and
Health (HFZ–410), Food and Drug Planning.
ecomments. All comments should be
Administration, 9200 Corporate Blvd., identified with the docket number
[FR Doc. 06–8114 Filed 9–21–06; 8:45 am]
Rockville, MD 20850, 301–594–1184, or found in brackets in the heading of this
BILLING CODE 4160–01–S
FDA Advisory Committee Information document.
Line, 1–800–741–8138 (301–443–0572 FOR FURTHER INFORMATION CONTACT:
in the Washington, DC area), code DEPARTMENT OF HEALTH AND David Racine or Jay Crowley, Center for
3014512513. Please call the Information HUMAN SERVICES Devices and Radiological Health (HFZ–
Line for up-to-date information on this 500), Food and Drug Administration,
meeting. [Docket No. 2006N–0292] 1350 Piccard Dr., Rockville, MD 20850,
Agenda: The committee will discuss 240–276–3400, e-mail:
and make recommendations on a Unique Device Identification; Notice of CDRHUDI@fda.hhs.gov
premarket notification application for a Public Meeting If you need special accommodations
device intended for the treatment of AGENCY: Food and Drug Administration, due to a disability, please contact Ann
major depressive disorder. The HHS. Marie Williams at 301–827–7291 at least
committee will also hear and discuss 7 days in advance of the meeting.
ACTION:Notice of public meeting and
the post approval study reports for two vendor display. SUPPLEMENTARY INFORMATION:
recently approved neurological device
premarket approval applications. SUMMARY: The Food and Drug
I. Background
Background information for the topics, Administration (FDA) is announcing a In the Federal Register of February
including the agenda and questions for public meeting and vendor display to 26, 2004, we published a final rule (the
the committee, will be available to the discuss the issues associated with the ‘‘bar code rule’’) (69 FR 9120) requiring
public 1 business day before the development, implementation, and use bar codes on certain human drug and
meeting on the Internet at http:// of a unique device identification (UDI) biological products to help reduce
www.fda.gov/cdrh/panel (click on system and the use of various automatic medication errors in hospitals and other
Upcoming CDRH Advisory Panel/ identification technologies. We are health care settings. The bar code is
Committee Meetings). inviting individuals, companies, intended to enable health care
Procedure: Interested persons may organizations, and other stakeholders to professionals to use bar code scanning
present data, information, or views, attend this public meeting, which will equipment in conjunction with
orally or in writing, on issues pending focus on the development and computerized medication
before the committee. Written implementation of a UDI system; the administration systems to verify that the
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submissions may be made to the contact benefits and costs of a UDI system; the right drug, in the right dose, is being
person on or before October 17, 2006. use of automatic identification given to the right patient at the right
Oral presentations from the public will technologies; and the development, time. This rule (now codified at 21 CFR
be scheduled for 30 minutes at the maintenance, and use of a repository for 201.25 and 610.67) requires that
beginning of the committee UDI related information. We are also manufacturers encode the unique

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55492 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices

National Drug Code (NDC) number in a comments on the topic from the whom should the UDI with its
linear bar code on the product’s label. audience. Though limited, at the end of associated minimum data set be made
The bar code rule, however, does not the day there will be time for other publicly available?
apply to medical devices. In the bar presentations.
code rule, we stated that, unlike drugs, D. The Use of Automatic Identification
medical devices do not have a III. Scope of Discussion Technologies
standardized, unique identifying system We will hold a public meeting on 1. Should the UDI be both human
comparable to the NDC number, and October 25, 2006, from 9 a.m. to 4 p.m. readable and encoded in an automatic
that the absence of such a system to discuss the development, identification technology? Should a UDI
complicates efforts to put bar codes on implementation, and use of a unique be based on the use of a specific
medical devices for purposes of device identification system. We technology (e.g., linear bar code) or be
preventing medical errors (69 FR 9120 anticipate discussions among an invited nonspecific?
at 9132). panel and other members of the public 2. If a bar code is recommended, is a
Since the issuance of the final bar on these issues and we intend to focus specific type of symbology preferred?
code rule, various entities have asked on these main areas and the following Should the bar code be ‘‘compatible’’’
that we revisit the issue of bar coding specific questions: with those used for the drug bar code
medical devices to improve patient rule? Should the UDI be on the device
safety, improve quality of care, and A. The Benefits and Costs of a UDI itself (e.g., laser-etched) for certain
encourage cost effectiveness of health System devices?
care, e.g., by improving delivery and 1. What public health and patient
supply chain efficiency. In response to IV. Vendor Display
safety benefits could be gained from
this, FDA met with various having a standardized UDI system? How There will be no fee for participating
stakeholders, including device would such a system contribute to in the vendor display. For the purposes
manufacturers and distributors, hospital meeting device recall and adverse event of this meeting, we are only interested
associations, and other Federal agencies reporting requirements, and to reducing in displays from vendors of automatic
to solicit information and comments medical error? identification technologies that can be
about employing a uniform system for 2. What are the setup costs measured used to identify medical devices. At the
the unique identification of medical in time and other resources associated time of registration, you will be asked to
devices. with the development, implementation, submit a short summary of your
As a result of these meetings, FDA has and use of a UDI system? What product. We can accommodate 15
learned that the majority of stakeholders infrastructure or technological vendors at this meeting. When vendor
support the development of a uniform advancements are needed for hospitals registration reaches this number,
system of unique identifiers as a way to and other device user facilities to be additional vendor display registrants
improve patient safety and recognize able to capture and use UDI for basic will be placed on a wait-list. If you have
other ancillary benefits such as better inventory control and recall completion been placed on the wait-list, we will
management of the purchase, purposes? How costly are these notify you by e-mail or telephone if you
distribution, and use of medical devices. advancements? become confirmed. There will be no
However, there were a variety of onsite registration for vendors. Each
opinions and experiences about how B. Design and Implementation of a vendor will be provided with a 6-foot
best to implement such a system. We System of UDI tabletop space. Please note that Internet
therefore published a notice in the 1. How should a UDI system be access will not be available.
Federal Register of August 11, 2006 (71 developed? What attributes or elements One purpose of this meeting is to gain
FR 46233) (http://www.fda.gov/OHRMS/ of a device should be used to create the greater understanding of various
DOCKETS/98fr/06-6870.pdf) requesting UDI? Should unique device identifiers automatic identification technologies.
comments by November 9, 2006, to help be considered for all devices? At what Therefore, we are inviting
the agency understand how the use of unit of packaging (that is, unit of use) manufacturers and organizations that
a unique device identification system should UDIs be considered (for market or have in development
could improve patient safety, for example, the unit of use could be a box automatic identification technologies,
example, by reducing medical errors, of examination gloves or an infusion which could be used with medical
facilitating device recalls, and pump)? Should UDIs be considered for devices, to display these technologies.
improving medical device adverse event different levels of packaging? Questions about whether your product
reporting. We are now announcing a 2. What are the incentives for or technology would fall within the
public meeting to further discuss the establishing a uniform, standardized scope of this vendor display should be
issues around UDI and the use of system of UDIs? What are the barriers directed to the contact persons (see FOR
various automatic identification for establishing UDIs? What suggestions FURTHER INFORMATION CONTACT).
technologies. would you have for overcoming these
barriers? V. Registration
II. Meeting Format Registration is necessary if you would
The meeting will be divided into four C. The Development, Maintenance, and like to present at the meeting or
sessions, each one focused on one of the Use of a Repository for UDI-related participate in the vendor display.
four main topic areas (described in Information Registration is also necessary to attend
section III of this document (Scope of 1. What is the minimum data set that the meeting and vendor display because
Discussion)). Each session will begin should be associated with a UDI? Would space is limited.
with an invited presentation to describe this minimum data set differ for You may register to present at the
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the issue and will be followed by a different devices? What other data meeting or participate in the vendor
moderated discussion with an invited would improve patient safety? display at www.fda.gov/cdrh/ocd/udi/
representative panel. Following this 2. How should the UDI and its index.html, no later than October 10,
discussion, the moderator will open up associated minimum data set be 2006. The registration form will instruct
the discussion to questions and obtained and maintained? How and by you as to the information you should

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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 55493

provide (such as name, address, You may also request a copy of the whether the information shall have
telephone number, e-mail address, transcript by writing to our Freedom of practical utility; (b) the accuracy of the
whether you wish to make a Information Office (HFI–35), Food and agency’s estimate of the burden of the
presentation or participate in the vendor Drug Administration, 5600 Fishers proposed collection of information; (c)
display and how to provide FDA with Lane, rm. 12A–16, Rockville, MD 20857. ways to enhance the quality, utility, and
a summary of your presentation or We anticipate that transcripts will be clarity of the information to be
product). available approximately 10 days after collected; and (d) ways to minimize the
You may register to attend the the public meeting at a cost of 10 cents burden of the collection of information
meeting at www.fda.gov/cdrh/ocd/udi/ per page. The transcripts will also be on respondents, including through the
index.html. Seating is limited to 300 available for public examination at the use of automated collection techniques
persons, and if capacity is reached, Division of Dockets Management (HFA– or other forms of information
registration will close. If you register as 305), 5630 Fishers Lane, rm. 1061, technology.
a presenter or to participate in the Rockville, MD 20852, between 9 a.m.
vendor display, you do not need to also and 4 p.m., Monday through Friday. Proposed Project: The Stem Cell
register as an attendee. Dated: September 15, 2006. Therapeutic Outcomes Database—
Because of time constraints, vendors (New)
Jeffrey Shuren,
may register either to present at the
meeting or participate in the vendor Assistant Commissioner for Policy. The Stem Cell Therapeutic and
display. You may not register for both. [FR Doc. 06–7969 Filed 9–21–06; 8:45 am] Research Act of 2005 provides for the
If you choose to participate in the BILLING CODE 4160–01–S collection and maintenance of human
vendor display, you will have the blood stem cells for the treatment of
opportunity to share information about patients and research. The Health
your products with the FDA and other DEPARTMENT OF HEALTH AND Resources and Services
attendees when they visit your display. HUMAN SERVICES Administration’s (HRSA), Healthcare
Because of the format of the meeting, Systems Bureau (HSB), is establishing
Health Resources and Services
we will only have a short time for the Stem Cell Therapeutic Outcomes
Administration
additional presentations. We encourage Database. Operation of this database
attendees to raise their issues and Agency Information Collection necessitates certain record keeping and
concerns during the discussion portion Activities: Proposed Collection: reporting requirements in order to
of the four main topic areas. We also Comment Request perform the functions related to
encourage persons and groups having hematopoietic stem cell transplantation
similar interests to consolidate their In compliance with the requirement under contract to HHS. The Act requires
information and present it through a for opportunity for public comment on the Secretary to contract for the
single representative. By October 16, proposed data collection projects collection and maintenance of
2006, we will schedule each (section 3506(c)(2)(A) of Title 44, United information related to patients who
presentation and, by e-mail or States Code, as amended by the have received stem cell therapeutic
telephone, notify each participant who Paperwork Reduction Act of 1995, Pub. products and to do so using a
will present of the time allotted to the L. 104–13), the Health Resources and standardized, electronic format. Data
person and the approximate time the Services Administration (HRSA) will be collected from transplant centers
person’s presentation is scheduled to publishes periodic summaries of in a manner similar to the data
begin. The time allotted for proposed projects being developed for
collection activities conducted by The
presentations may be between 5 to 15 submission to the Office of Management
Center for International Blood and
minutes, depending on the number of and Budget (OMB) under the Paperwork
Marrow Transplant Research (CIBMTR)
people who wish to present. Confirmed Reduction Act of 1995. To request more
and will be used for ongoing analysis of
presenters need to send final electronic information on the proposed project or
transplant outcomes. HRSA will use the
presentations in Microsoft PowerPoint, to obtain a copy of the data collection
information in order to carry out its
Microsoft Word, or PDF by October 20, plans and draft instruments, call the
HRSA Reports Clearance Officer at (301) statutory responsibilities. Information is
2006 to CDRHUDI@fda.hhs.gov. needed to monitor the clinical status of
443–1129.
VI. Transcripts Comments are invited on: (a) Whether transplantation, and to provide the
The meeting will be transcribed and the proposed collection of information Secretary with an annual report of
will be available on the Internet at is necessary for the proper performance transplant center-specific survival data.
www.fda.gov/cdrh/ocd/udi/index.html. of the functions of the agency, including The estimate of burden is as follows:

Responses
Number of re- Total re- Hours per re- Total burden
Record keeping per respond-
sponses sponses sponse hours
ent

Baseline Patient/Day of Transplant Data ........................ 250 40 8,000 2.25 18,000


Product Receipt/Analysis/Preparation Data ..................... 250 40 8,000 1 8,000
100-Day Post-Transplant Data ........................................ 250 40 8,000 2.25 18,000
6-Month Post Transplant Data ......................................... 250 28 5,538 2.25 12,460.5
12-Month Post-Transplant Data ....................................... 250 22 4,308 2.25 9,693
Annual Post-Transplant Data (year two and beyond) ..... 250 40 8,000 2.25 18,000
Death Information ............................................................ 250 25 4,923 0.5 2,461.5
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Total .......................................................................... 250 ........................ 46,769 .......................... 86,615

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