[Federal Register Volume 71, Number 155 (Friday, August 11, 2006)]
[Notices]
[Pages 46232-46233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-6867]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0107]


Food and Drug Administration-Regulated Products Containing 
Nanotechnology Materials; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) will hold a public 
meeting October 10, 2006, on FDA-regulated 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 FDA-regulated 
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: <a href="/cdn-cgi/l/email-protection#eb9b849b9b92c5808e858f8a8787ab8d8f8ac5838398c58c849d"><span class="__cf_email__" data-cfemail="d0a0bfa0a0a9febbb5beb4b1bcbc90b6b4b1feb8b8a3feb7bfa6">[email protected]</span></a>.

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 
FDA-regulated 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

[[Page 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


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