[Federal Register: August 11, 2006 (Volume 71, Number 155)]
[Notices]
[Page 46232-46233]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11au06-77]
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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/.
gy/.
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
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