[Federal Register: September 26, 2006 (Volume 71, Number 186)]
[Notices]
[Page 56158-56159]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se06-86]
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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: This is an update to previous notice that the Food and Drug
Administration (FDA) will hold a public meeting October 10, 2006, on
nanotechnology as it relates to FDA-regulated products. The primary
purpose of this update is to notify the public that preregistration to
attend or speak at the public meeting will close on September 29, 2006.
The purpose of the meeting is to help FDA further its understanding of
developments in
[[Page 56159]]
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 preregister to attend or make a presentation at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/nanotechnology/. Preregistration to make a
presentation will close on September 29, 2006; however, there will be
onsite registration to attend on a first-come, first-served basis until
the room capacity is reached. Onsite registration will be open at the
meeting site at 8:30 a.m. on October 10. Once room capacity is reached,
individuals will be offered the opportunity to observe the meeting from
an overflow room located at the meeting site.
If time permits, there will be an open public session. Individuals
who have not preregistered to make a presentation can register onsite
if they wish to present public comments. While every effort will be
made to provide an open public session after all preregistered speakers
have made presentations, it is recommended that you preregister if you
would like to make a presentation. Onsite registration to make a
presentation will be taken on a first-come, first-served basis.
Individuals who register at the meeting to speak may be allotted less
time to speak than preregistered speakers, depending on the number of
registrants.
We will post the agenda at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/nanotechnology/ prior
to the meeting.
ADDRESSES: The public meeting will be held at the Natcher Auditorium,
National Institutes of Health Campus (NIH), 9000 Rockville Pike, bldg.
45, Bethesda, MD. We will also post the address for the meeting at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/nanotechnology/. Note that parking is limited on the
NIH Campus and that security procedures are in effect. For further
information on parking and security see http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/about/visitorsecurity.htm
.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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?
Previous Federal Register Notices (71 FR 19523, April 14, 2006; 71
FR 46232, August 11, 2006) contain detailed supplemental information
regarding the rationale and background for the meeting.
For more information about FDA's role regarding nanotechnology
products, see our Web page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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. The
length of the presentations will be determined by the number of
speakers who preregister and the time available. Based on the requests
received so far, the presentations are likely to be less than 8 minutes
long. In order to maximize the number of people who have the
opportunity to present their views at this public meeting, each
individual or organization will be limited to one opportunity to
present views at the meeting. However, written material of any length
can be submitted to the docket.
Individuals and organizations with common interests are encouraged
to consolidate or coordinate their presentations. FDA will give the
registered speakers an estimated timeframe for their presentations by
October 4 through email to the address provided during preregistration.
Persons should arrive early to make sure that they are present to make
their presentation in case we are ahead of schedule.
In a previous notice we indicated the possibility of holding
concurrent sessions. However, based on the number of requests for
presentation received so far it appears that all can be accommodated by
one general session. A final decision on whether there will be
concurrent sessions will be made following the cutoff date for
registration and will be communicated through the posted agenda at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/nanotechnology/ and e-mail to registered speakers.
We ask that you preregister by September 29 (see REGISTRATION) if
you intend to provide an oral presentation. If time permits, there will
be an open public session at the meeting. However, individuals who
register at the meeting to speak may be allotted less time to speak
than preregistered speakers, depending on the number of registrants.
The information provided during preregistration will help us determine
further how to organize the day.
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?
An open public docket has been established. Individuals may submit
their comments either in writing or electronically to the docket. All
comments should include the docket number found in brackets in the
heading of this document (see ADDRESSES). Submit a single copy of
electronic comments or two paper copies of any mailed comments, except
that individuals have the option of submitting 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: September 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-8242 Filed 9-21-06; 1:22 pm]
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