46232 Federal Register / Vol. 71, No. 155 / Friday, August 11, 2006 / Notices 

Dated: August 4, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E6–13114 Filed 8–10–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0107] 

Food and Drug AdministrationRegulated Products Containing 

Nanotechnology Materials; Public 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) will hold a public 

meeting October 10, 2006, on FDAregulated products containing 

nanotechnology materials, and has 

opened a docket on FDA-regulated 

products containing nanotechnology 

materials. The purpose of the meeting 

will be to help FDA further its 

understanding of developments in 

nanotechnology materials that pertain to 

FDA-regulated products. FDA is 

interested in learning about the kinds of 

new nanotechnology material products 

under development in the areas of foods 

(including dietary supplements), food 

and color additives, animal feeds, 

cosmetics, drugs and biologics, and 

medical devices, whether there are new 

or emerging scientific issues that should 

be brought to FDA’s attention, and any 

other scientific issues about which the 

regulated industry, academia, and the 

interested public may wish to inform 

FDA concerning the use of 

nanotechnology materials in FDAregulated products. 

DATES AND TIMES: The public meeting 

will be held October 10, 2006, from 9 

a.m. to 5 p.m. 

REGISTRATION: You may register at 

http://www.fda.gov/nanotechnology/. 

We will also post the agenda at http:// 

www.fda.gov/nanotechnology/ prior to 

the meeting. 

ADDRESSES: The public workshop will 

be held at the Natcher Auditorium, 

National Institutes of Health Campus, 

9000 Rockville Pike, bldg. 45, Bethesda, 

MD. We will also post the address for 

the meeting at http://www.fda.gov/ 

nanotechnology/. 

Written or electronic comments may 

be submitted by November 10, 2006. 

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: 

Poppy Kendall, Food and Drug 

Administration (HF–11), 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

3360, FAX: 301–594–6777, e-mail: 

poppy.kendall@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Why Are We Holding a Public 

Meeting? 

Nanotechnology is defined in a 

variety of ways. The National 

Nanotechnology Initiative (a U.S. 

Government research and development 

coordinating program) refers to 

nanotechnology as ‘‘the understanding 

and control of matter at dimensions of 

roughly 1 to 100 nanometers, where 

unique phenomena enable novel 

applications’’ (http://www.nano.gov). A 

nanometer is a billionth of a meter, and 

is approximately the width of 10 

hydrogen atoms lined up side by side. 

(A human hair is about 80,000 

nanometers in width. Deoxyribonucleic 

acid (DNA) is about 2.5 nanometers in 

width.) 

Due to their small size and extremely 

high ratio of surface area to volume, 

nanotechnology materials often have 

chemical or physical properties that are 

different from those of their larger 

counterparts. Such differences include 

altered magnetic properties, altered 

electrical or optical activity, increased 

structural integrity, and increased 

chemical and biological activity. 

Because of these properties, 

nanotechnology materials have great 

potential for use in a vast array of 

products. Also because of some of their 

special properties, they may pose 

different safety issues than their larger 

counterparts. Of particular interest to 

FDA, nanotechnology materials may 

enable new developments in implants 

and prosthetics, drug delivery, and food 

processing, and may already be in use 

in some cosmetics and sunscreens. As 

part of its critical path initiative, FDA is 

interested in learning if there are 

opportunities for it to help overcome 

scientific hurdles that may be inhibiting 

the use of nanotechnology in medical 

product development. 

We will be holding this meeting 

because we are interested in learning 

about the kinds of new nanotechnology 

material products under development in 

the areas of foods (including dietary 

supplements), food and color additives, 

animal feeds, cosmetics, drugs and 

biologics, and medical devices, whether 

there are new or emerging scientific 

issues that should be brought to FDA’s 

attention, including issues related to the 

safety of nanotechnology materials, and 

any other issues about which the 

regulated industry, academia, and the 

interested public may wish to inform 

FDA concerning the use of 

nanotechnology materials in FDAregulated products. 

The public meeting will be chaired by 

the FDA Nanotechnology Task Force. 

Acting FDA Commissioner Andrew von 

Eschenbach created this internal task 

force to help the agency evaluate the 

increasing use of nanotechnology 

materials in FDA-regulated products. 

For more information about FDA’s 

role regarding nanotechnology products, 

see our Web page at http://www.fda.gov/ 

nanotechnology/. 

II. How Can You Participate? 

You can participate through oral 

presentation at the meeting or through 

written or electronic material submitted 

to the docket. In response to the first 

notice of this meeting (71 FR 19523, 

April 14, 2006) we received a large 

number of responses indicating interest 

in attending and presenting, and the 

responses indicated interest in a variety 

of topics. Therefore, in order to provide 

the most value to those attending who 

may be interested in a particular topic, 

we are likely to divide the meeting into 

topic areas (for separate, concurrent 

sessions on those topics) and one 

general session. Participants would be 

asked to express a preference for either 

one of the concurrent sessions or the 

general session in which to make a 

presentation. Time allotted for each 

presentation will depend on the 

presentation requests received for that 

session. Furthermore, given the number 

of responses received, it is likely that it 

will be necessary to limit presentations 

to one per individual/organization. 

In addition to a session that has a 

more general focus, we are considering 

the following three breakout sessions: 

(1) Topically-administered drugs, 

biologics, devices and cosmetics; (2) 

other drugs, biologics and devices; (3) 

foods (including dietary supplements) 

and food and color additives, and 

animal Feeds. 

We ask that you register early (see 

REGISTRATION) if you intend to provide 

an oral presentation. The information 

provided during registration will help 

us determine further how to organize 

the day. The final agenda will depend 


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Federal Register / Vol. 71, No. 155 / Friday, August 11, 2006 / Notices 46233 

on the nature of the requests made for 

presentations. 

III. Will Meeting Transcripts Be 

Available? 

Following the meeting, transcripts 

will be available for review at the 

Division of Dockets Management (see 

ADDRESSES). 

IV. How Should You Send Comments 

on the Issues? 

Interested persons may submit written 

or electronic comments to the Division 

of Dockets Management (see 

ADDRESSES). Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

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. 

Dated: August 1, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–6867 Filed 8–8–06; 3:14 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0292] 

Unique Device Identification; Request 

for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing this 

notice to request comments to help the 

agency understand how the use of a 

unique device identification (UDI) 

system may improve patient safety, e.g., 

by reducing medical errors, facilitating 

device recalls, and improving medical 

device adverse event reporting. We are 

also interested in understanding the 

issues associated with the use of various 

automatic identification technologies 

(e.g., bar code, radiofrequency 

identification). We invite comments 

about specific UDI issues for medical 

devices. 

DATES: Submit written or electronic 

comments by November 9, 2006. 

ADDRESSES: Submit written comments 

concerning this document 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. 

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. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On 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 

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, including 

members of Congress and a consortium 

of hospital groups, have asked that we 

revisit the issue of bar coding medical 

devices to improve patient safety; 

improve quality of care; and encourage 

cost effectiveness, e.g., of health care by 

improving delivery and supply chain 

efficiency (Refs. 1 and 2). 

A. Stakeholder Meetings 

In response to the interest in 

revisiting the issue of bar coding 

medical devices, FDA met with various 

stakeholders, including device 

manufacturers and distributors, hospital 

associations, and other Federal agencies 

such as the Agency for Healthcare 

Research and Quality, Department of 

Defense, Department of Veterans Affairs, 

and Centers for Medicare and Medicaid 

Services to solicit information and 

comments about employing a uniform 

system for the unique identification of 

medical devices. (References 3 and 5 

contain summaries of some of these 

meetings). We were interested in 

hearing views about the value of a 

uniform system of unique identifiers for 

medical devices, what efforts or 

initiatives are currently ongoing among 

stakeholders, and the use of various 

automatic identification technologies. 

We were also interested in FDA’s role 

related to the establishment and use of 

a UDI system and whether FDA should 

consider a voluntary or a mandatory 

approach for such a system. 

As a result of these meetings, FDA 

learned that the majority of stakeholders 

support the development of a uniform 

system of unique identifiers as a way to 

improve patient safety and recognized 

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. 

B. Report on Automatic and Unique 

Identification of Medical Devices 

In addition to holding stakeholder 

meetings, we commissioned two reports 

from outside experts to provide: A 

general overview of some of the most 

prevalent technologies available to 

support automatic identification of 

medical devices, the current published 

positions and standards of various 

stakeholders, and highlights of some of 

the general applications reported in the 

literature involving the use of such 

systems for medical devices. (See Refs. 

4 and 6 and http://www.fda.gov/cdrh/ 

ocd/udi/). The reports identified several 

potential benefits to widespread use of 

UDI, such as reducing medical errors, 

facilitating recalls, improving medical 

device reporting, and identifying 

incompatibility with devices or 

potential allergic reactions. The reports 

further indicated that many issues have 

to be addressed prior to successful 

implementation of UDI for devices, 

including determining the technology 

needed to utilize UDI effectively, 

identifying the data needed for patient 

safety; development, maintenance, and 

validation of a central data repository; 

and harmonizing UDIs for the 

international marketplace. 

II. UDI Development and 

Implementation 

We are interested in receiving 

comment on the possible role that a 

unique device identification system 

could have on improving patient safety, 

for example, by reducing medical errors, 

facilitating device recalls, and 

improving medical device adverse event 

reporting. In addition, we are interested 


hsrobinson on PROD1PC67 with NOTICES1