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Notice

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

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Request for comments.

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SUMMARY:

The Food and Drug Administration (FDA) is planning a public meeting 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 scientific issues that should be addressed; 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.

DATES AND TIMES:

The public meeting will be held in mid-October 2006. Details on the date and time of the meeting will be provided in a subsequent Federal Register notice.

ADDRESSES:

The public workshop will be held in the Washington, DC metropolitan area. The meeting address will be provided in a subsequent Federal Register notice and posted at http://www.fda.gov/​nanotechnology.

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.

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FOR FURTHER INFORMATION CONTACT:

For information about this document: 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.

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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 scientific issues that should be addressed; 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.

For more information about FDA's role regarding nanotechnology products, see our Web page at http://www.fda.gov/​nanotechnology. We are announcing our plans now to hold a meeting to give ourselves and participants ample time to prepare.

II. How Can You Participate?

Details on registration and the meeting agenda will be provided in a subsequent Federal Register notice and at http://www.fda.gov/​nanotechnology. To help us plan the logistics and agenda for the meeting, we would appreciate receiving expressions of interest from those planning on attending or presenting at the meeting, via e-mail or phone to Poppy Kendall (see FOR FURTHER INFORMATION CONTACT). We will attempt to obtain a venue and structure the meeting to accommodate the level of expressed interest and to address a range of topics, but will not begin the registration process until after publication of the subsequent Federal Register notice.

III. 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.

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Dated: March 21, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E6-5526 Filed 4-13-06; 8:45 am]

BILLING CODE 4160-01-S