Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 55491 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Neurological Devices Panel of the 

Medical Devices Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Neurological 

Devices Panel of the Medical Devices 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on October 31, 2006, from 8 a.m. 

to 6 p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, Ballroom Salons C, 

D, and E, 620 Perry Pkwy., Gaithersburg, 

MD. 

Contact Person: Janet L. Scudiero, 

Center for Devices and Radiological 

Health (HFZ–410), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 301–594–1184, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512513. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: The committee will discuss 

and make recommendations on a 

premarket notification application for a 

device intended for the treatment of 

major depressive disorder. The 

committee will also hear and discuss 

the post approval study reports for two 

recently approved neurological device 

premarket approval applications. 

Background information for the topics, 

including the agenda and questions for 

the committee, will be available to the 

public 1 business day before the 

meeting on the Internet at http:// 

www.fda.gov/cdrh/panel (click on 

Upcoming CDRH Advisory Panel/ 

Committee Meetings). 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before October 17, 2006. 

Oral presentations from the public will 

be scheduled for 30 minutes at the 

beginning of the committee 

deliberations and for 30 minutes near 

the end of the committee deliberations. 

Time allotted for each presentation may 

be limited. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before October 17, 2006. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact AnnMarie 

Williams, Conference Management 

Staff, at 301–827–7291, at least 7 days 

in advance of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 18, 2006. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. 06–8114 Filed 9–21–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Docket No. 2006N–0292] 

Unique Device Identification; Notice of 

Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting and 

vendor display. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting and vendor display to 

discuss the issues associated with the 

development, implementation, and use 

of a unique device identification (UDI) 

system and the use of various automatic 

identification technologies. We are 

inviting individuals, companies, 

organizations, and other stakeholders to 

attend this public meeting, which will 

focus on the development and 

implementation of a UDI system; the 

benefits and costs of a UDI system; the 

use of automatic identification 

technologies; and the development, 

maintenance, and use of a repository for 

UDI related information. We are also 

inviting vendors of automatic 

identification technologies to display 

their products for the educational 

benefits of FDA and other attendees. 

DATES AND TIMES: The public meeting 

will be held on Wednesday, October 25, 

2006, from 9 a.m. to 4 p.m. Registration 

to attend the meeting, to present at the 

meeting, and to participate in the 

vendor display must be received by 

October 10, 2006. Submit written 

comments by November 9, 2006. 

You may register electronically at 

www.fda.gov/cdrh/ocd/udi/index.html 

(see SUPPLEMENTARY INFORMATION, 

section V of this document for 

information on registration. 

ADDRESSES: The public meeting will be 

held at the Gaithersburg Marriott 

Washingtonian Center, 9751 

Washingtonian Blvd., Gaithersburg, MD 

20878, 1–301–590–0044. 

A block of rooms is being held for the 

evening of Tuesday, October 24, 2006. 

Please mention the ‘‘FDA UDI Meeting’’

when calling the hotel. 

Submit written comments to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to http://www.fda.gov/dockets/ 

ecomments. All comments should be 

identified with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

David Racine or Jay Crowley, Center for 

Devices and Radiological Health (HFZ–

500), Food and Drug Administration, 

1350 Piccard Dr., Rockville, MD 20850, 

240–276–3400, e-mail: 

CDRHUDI@fda.hhs.gov 

If you need special accommodations 

due to a disability, please contact Ann 

Marie Williams at 301–827–7291 at least 

7 days in advance of the meeting. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of February 

26, 2004, we published a final rule (the 

‘‘bar code rule’’) (69 FR 9120) requiring 

bar codes on certain human drug and 

biological products to help reduce 

medication errors in hospitals and other 

health care settings. The bar code is 

intended to enable health care 

professionals to use bar code scanning 

equipment in conjunction with 

computerized medication 

administration systems to verify that the 

right drug, in the right dose, is being 

given to the right patient at the right 

time. This rule (now codified at 21 CFR 

201.25 and 610.67) requires that 

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 

linear bar code on the product’s label. 

The bar code rule, however, does not 

apply to medical devices. In the bar 

code rule, we stated that, unlike drugs, 

medical devices do not have a 

standardized, unique identifying system 

comparable to the NDC number, and 

that the absence of such a system 

complicates efforts to put bar codes on 

medical devices for purposes of 

preventing medical errors (69 FR 9120 

at 9132). 

Since the issuance of the final bar 

code rule, various entities have asked 

that we revisit the issue of bar coding 

medical devices to improve patient 

safety, improve quality of care, and 

encourage cost effectiveness of health 

care, e.g., by improving delivery and 

supply chain efficiency. In response to 

this, FDA met with various 

stakeholders, including device 

manufacturers and distributors, hospital 

associations, and other Federal agencies 

to solicit information and comments 

about employing a uniform system for 

the unique identification of medical 

devices. 

As a result of these meetings, FDA has 

learned that the majority of stakeholders 

support the development of a uniform 

system of unique identifiers as a way to 

improve patient safety and recognize 

other ancillary benefits such as better 

management of the purchase, 

distribution, and use of medical devices. 

However, there were a variety of 

opinions and experiences about how 

best to implement such a system. We 

therefore published a notice in the 

Federal Register of August 11, 2006 (71 

FR 46233) (http://www.fda.gov/OHRMS/ 

DOCKETS/98fr/06-6870.pdf) requesting 

comments by November 9, 2006, to help 

the agency understand how the use of 

a unique device identification system 

could improve patient safety, for 

example, by reducing medical errors, 

facilitating device recalls, and 

improving medical device adverse event 

reporting. We are now announcing a 

public meeting to further discuss the 

issues around UDI and the use of 

various automatic identification 

technologies. 

II. Meeting Format 

The meeting will be divided into four 

sessions, each one focused on one of the 

four main topic areas (described in 

section III of this document (Scope of 

Discussion)). Each session will begin 

with an invited presentation to describe 

the issue and will be followed by a 

moderated discussion with an invited 

representative panel. Following this 

discussion, the moderator will open up 

the discussion to questions and 

comments on the topic from the 

audience. Though limited, at the end of 

the day there will be time for other 

presentations. 

III. Scope of Discussion 

We will hold a public meeting on 

October 25, 2006, from 9 a.m. to 4 p.m. 

to discuss the development, 

implementation, and use of a unique 

device identification system. We 

anticipate discussions among an invited 

panel and other members of the public 

on these issues and we intend to focus 

on these main areas and the following 

specific questions: 

A. The Benefits and Costs of a UDI 

System 

1. What public health and patient 

safety benefits could be gained from 

having a standardized UDI system? How 

would such a system contribute to 

meeting device recall and adverse event 

reporting requirements, and to reducing 

medical error? 

2. What are the setup costs measured 

in time and other resources associated 

with the development, implementation, 

and use of a UDI system? What 

infrastructure or technological 

advancements are needed for hospitals 

and other device user facilities to be 

able to capture and use UDI for basic 

inventory control and recall completion 

purposes? How costly are these 

advancements? 

B. Design and Implementation of a 

System of UDI 

1. How should a UDI system be 

developed? What attributes or elements 

of a device should be used to create the 

UDI? Should unique device identifiers 

be considered for all devices? At what 

unit of packaging (that is, unit of use) 

should UDIs be considered (for 

example, the unit of use could be a box 

of examination gloves or an infusion 

pump)? Should UDIs be considered for 

different levels of packaging? 

2. What are the incentives for 

establishing a uniform, standardized 

system of UDIs? What are the barriers 

for establishing UDIs? What suggestions 

would you have for overcoming these 

barriers? 

C. The Development, Maintenance, and 

Use of a Repository for UDI-related 

Information 

1. What is the minimum data set that 

should be associated with a UDI? Would 

this minimum data set differ for 

different devices? What other data 

would improve patient safety? 

2. How should the UDI and its 

associated minimum data set be 

obtained and maintained? How and by 

whom should the UDI with its 

associated minimum data set be made 

publicly available? 

D. The Use of Automatic Identification 

Technologies 

1. Should the UDI be both human 

readable and encoded in an automatic 

identification technology? Should a UDI 

be based on the use of a specific 

technology (e.g., linear bar code) or be 

nonspecific? 

2. If a bar code is recommended, is a 

specific type of symbology preferred? 

Should the bar code be ‘‘compatible’’’

with those used for the drug bar code 

rule? Should the UDI be on the device 

itself (e.g., laser-etched) for certain 

devices? 

IV. Vendor Display 

There will be no fee for participating 

in the vendor display. For the purposes 

of this meeting, we are only interested 

in displays from vendors of automatic 

identification technologies that can be 

used to identify medical devices. At the 

time of registration, you will be asked to 

submit a short summary of your 

product. We can accommodate 15 

vendors at this meeting. When vendor 

registration reaches this number, 

additional vendor display registrants 

will be placed on a wait-list. If you have 

been placed on the wait-list, we will 

notify you by e-mail or telephone if you 

become confirmed. There will be no 

onsite registration for vendors. Each 

vendor will be provided with a 6-foot 

tabletop space. Please note that Internet 

access will not be available. 

One purpose of this meeting is to gain 

greater understanding of various 

automatic identification technologies. 

Therefore, we are inviting 

manufacturers and organizations that 

market or have in development 

automatic identification technologies, 

which could be used with medical 

devices, to display these technologies. 

Questions about whether your product 

or technology would fall within the 

scope of this vendor display should be 

directed to the contact persons (see FOR

FURTHER INFORMATION CONTACT). 

V. Registration 

Registration is necessary if you would 

like to present at the meeting or 

participate in the vendor display. 

Registration is also necessary to attend 

the meeting and vendor display because 

space is limited. 

You may register to present at the 

meeting or participate in the vendor 

display at www.fda.gov/cdrh/ocd/udi/ 

index.html, no later than October 10, 

2006. The registration form will instruct 

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, 

telephone number, e-mail address, 

whether you wish to make a 

presentation or participate in the vendor 

display and how to provide FDA with 

a summary of your presentation or 

product). 

You may register to attend the 

meeting at www.fda.gov/cdrh/ocd/udi/ 

index.html. Seating is limited to 300 

persons, and if capacity is reached, 

registration will close. If you register as 

a presenter or to participate in the 

vendor display, you do not need to also 

register as an attendee. 

Because of time constraints, vendors 

may register either to present at the 

meeting or participate in the vendor 

display. You may not register for both. 

If you choose to participate in the 

vendor display, you will have the 

opportunity to share information about 

your products with the FDA and other 

attendees when they visit your display. 

Because of the format of the meeting, 

we will only have a short time for 

additional presentations. We encourage 

attendees to raise their issues and 

concerns during the discussion portion 

of the four main topic areas. We also 

encourage persons and groups having 

similar interests to consolidate their 

information and present it through a 

single representative. By October 16, 

2006, we will schedule each 

presentation and, by e-mail or 

telephone, notify each participant who 

will present of the time allotted to the 

person and the approximate time the 

person’s presentation is scheduled to 

begin. The time allotted for 

presentations may be between 5 to 15 

minutes, depending on the number of 

people who wish to present. Confirmed 

presenters need to send final electronic 

presentations in Microsoft PowerPoint, 

Microsoft Word, or PDF by October 20, 

2006 to CDRHUDI@fda.hhs.gov. 

VI. Transcripts 

The meeting will be transcribed and 

will be available on the Internet at 

www.fda.gov/cdrh/ocd/udi/index.html. 

You may also request a copy of the 

transcript by writing to our Freedom of 

Information Office (HFI–35), Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 12A–16, Rockville, MD 20857. 

We anticipate that transcripts will be 

available approximately 10 days after 

the public meeting at a cost of 10 cents 

per page. The transcripts will also be 

available for public examination at the 

Division of Dockets Management (HFA–

305), 5630 Fishers Lane, rm. 1061, 

Rockville, MD 20852, between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: September 15, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–7969 Filed 9–21–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, call the 

HRSA Reports Clearance Officer at (301) 

443–1129. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: The Stem Cell 

Therapeutic Outcomes Database—

(New) 

The Stem Cell Therapeutic and 

Research Act of 2005 provides for the 

collection and maintenance of human 

blood stem cells for the treatment of 

patients and research. The Health 

Resources and Services 

Administration’s (HRSA), Healthcare 

Systems Bureau (HSB), is establishing 

the Stem Cell Therapeutic Outcomes 

Database. Operation of this database 

necessitates certain record keeping and 

reporting requirements in order to 

perform the functions related to 

hematopoietic stem cell transplantation 

under contract to HHS. The Act requires 

the Secretary to contract for the 

collection and maintenance of 

information related to patients who 

have received stem cell therapeutic 

products and to do so using a 

standardized, electronic format. Data 

will be collected from transplant centers 

in a manner similar to the data 

collection activities conducted by The 

Center for International Blood and 

Marrow Transplant Research (CIBMTR) 

and will be used for ongoing analysis of 

transplant outcomes. HRSA will use the 

information in order to carry out its 

statutory responsibilities. Information is 

needed to monitor the clinical status of 

transplantation, and to provide the 

Secretary with an annual report of 

transplant center-specific survival data. 

The estimate of burden is as follows: 

Record keeping Number of responses 

Responses 

per respondent 

Total responses Hours per response Total burden 

hours 

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 

Total .......................................................................... 250 ........................ 46,769 .......................... 86,615 


sroberts on PROD1PC70 with NOTICES