[Federal Register Volume 73, Number 153 (Thursday, August 7, 2008)]
[Pages 46022-46024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18132]



Food and Drug Administration

[Docket No. FDA-2008-N-0416]

Consideration of FDA-Regulated Products That May Contain 
Nanoscale Materials; Public Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public meeting; request for comments.


SUMMARY:  The Food and Drug Administration (FDA) is announcing a public 
meeting and a request for comments including available data to gather 
information that will assist the agency in further implementing the 
recommendations of the Nanotechnology Task Force Report (the Report) 
relating to the development of agency guidances. The Report's 
recommendations covered foods (including dietary supplements), food and 
color additives (including food contact substances), animal drugs and 
feeds, cosmetics, human drugs and biologics, and medical devices. In 
addition to requesting comments in response to the questions in this 
notice and those that will be discussed at the public meeting, FDA is 
announcing a request for available data and information on the effects 
of nanoscale materials on quality, safety, and, where relevant, 
effectiveness of products subject to FDA oversight.

DATES:  The public meeting will be held on September 8, 2008, from 8:30 
a.m. to 5 p.m. Anyone who wishes to speak at the meeting must register 
and submit a summary of the presentation and an electronic copy of the 
presentation by Tuesday, September 2, 2008. See section IV of the 
SUPPLEMENTARY INFORMATION section of this document for details on how 
to register. Submit written or electronic comments by Friday, October 
24, 2008.

ADDRESSES:  The public meeting will be held at the University Systems 
of Maryland Shady Grove Center/Universities, 9630 Gudelsky Dr., 
Rockville, MD 20850 (http://www.shadygrove.umd.edu/conference).\1\ 
There is parking near the building.

    \1\ FDA has verified the Web site address, but FDA is not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.

    Submit written comments, available data, and other information 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.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Megan Clark, Office of Policy, Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
827-3360, e-mail: [email protected].


I. Background

    Nanotechnology allows scientists to work on the scale of molecules 
to create, explore, and manipulate materials measured in nanometers; 
billionths of a meter. In July 2007, FDA issued the Report analyzing 
scientific and regulatory considerations relating to the safety and 
effectiveness of FDA-regulated products containing nanoscale materials 
regulated by FDA, and making recommendations regarding these 
considerations. Additionally, the Report summarized the state of the 
science for biological interactions with nanoscale materials. The 
Report also recommended that FDA coordinate with other Federal agencies 
and the private sector in research and other activities to increase 
general scientific understanding and facilitate assessment of data 
needs for regulated products. This coordination includes developing an 
infrastructure to share and leverage knowledge and build upon 
information from individual studies of nanoscale materials.
    The agency has been considering development of guidances 
recommended in the Report and believes that holding a public meeting 
and announcing this request for comments and available data will 
provide information that will assist in this task. In addition, FDA is 
working with the National Institutes of Health (particularly the 
NanoHealth Enterprise) to explore methods for receiving and sharing 
data relating to, for example, general product development, including 
research on failed product candidates, and biological interactions of 
certain characteristics of nanoscale materials. Such a data repository 
could allow FDA and other stakeholders to share data and methods, and 
to develop models of biological interaction that could then inform 
product development and review.

II. Meeting Agenda

    The primary purpose of the meeting is to determine what factors the 
agency should consider in providing guidance on:
    1. The information and data that may be needed to demonstrate the 
safety and effectiveness of FDA-regulated products containing nanoscale 
materials and

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    2. The circumstances under which a product's regulatory status 
might change due to the presence or use of nanoscale materials (for 
example, making a device no longer exempt from 510(k) submission 
    The meeting will begin with a plenary session at which FDA will 
review the goals of the meeting and give a general overview of the 
analysis and findings of the Nanotechnology Task Force and agency 
activities since publication of the Report in July 2007. The plenary 
session will frame topics that apply generally to all FDA-regulated 
    Immediately following the plenary session, FDA will hold breakout 
sessions that will be structured to allow brief presentations by those 
who have submitted requests to speak in accordance with the 
instructions in this document. We encourage those speaking to provide 
detailed comments, information, and available data to the docket, and 
use time at the meeting to give a general overview of the submitted 
comments to facilitate discussion during the product-specific sessions. 
There will be a brief period set aside during these sessions to allow 
attendees who did not register to speak an opportunity to offer 
comments. These breakout sessions will be organized around the 
following product categories identified in the Report for which the 
agency has been considering the need for guidance:
     Medical devices, including diagnostics (combination 
products may also be discussed in this session);
     Prescription drugs, including biological drugs, animal 
drugs and over-the-counter (OTC) drugs, including sunscreens;
     Food and color additives, including food contact 
     Dietary supplements; and
    These sessions will generally cover the following questions:
    1. What characteristics of nanoscale materials in FDA-regulated 
products should be identified and evaluated to ensure the safety and, 
where relevant, effectiveness of these products?
    2. What assessment tools are available (including test methods and 
standards) for evaluating the characteristics of nanoscale materials 
that may affect the safety, effectiveness, and quality of FDA-regulated 
     How reliable are these tools?
     How widely available are these tools?
     Are these tools practical for regulatory use or do they 
have aspects that render them impractical?
     What additional tools should FDA and industry consider 
developing to evaluate the characteristics of nanoscale materials?
    3. Are there unique features of the manufacturing process for 
products containing nanoscale materials? If so, how should these 
features be evaluated?
     Is the manufacturing process for nanoscale materials 
different from that of conventional materials? If so, how?
     What parameters are critical when manufacturing products 
containing nanoscale materials?
     What unique challenges are there for ``scale-up'' of 
manufacturing for products using nanoscale materials?
     How do potentially unique features of nanoscale materials, 
such as particle size, shape, and surface charge, affect what should be 
considered in the development of controls, standards, and 
specifications for manufacturing?
    4. Are there particular aspects of product formulation, processing, 
or storage that can affect the quality, safety, or effectiveness of 
products containing nanoscale materials, including as excipients?
    5. What has been your experience with products containing nanoscale 
materials? Have you avoided these products due to specific concerns 
about aspects of development, characterization, or manufacturing?
    6. What additional questions focusing on characterization 
(including stability) and manufacturing aspects of products containing 
nanoscale materials should be addressed in this forum or otherwise 
brought to the attention of FDA?
    The agency may develop additional questions for discussion during 
the breakout sessions and if so, they will be posted on the agency's 
Web site at http://www.FDA.gov by Monday, August 11, 2008, and posted 
to the FDA Docket No. FDA-2008-N-0416.
    In addition to providing comments and information in response to 
the questions in this document and otherwise discussed at the public 
meeting, FDA is requesting that interested stakeholders submit comments 
which include available data and information on topics identified in 
the Report. We are requesting any available data that:
     Identify OTC drug products that contain or may contain 
nanoscale versions of ingredients included in an OTC monograph;
     Identify nanoscale versions of previously approved food 
and color additives;
     Address the effects of nanoscale materials on the safety 
and, where relevant, effectiveness of FDA-regulated products, including 
both existing products that are changed to contain (or contain greater 
proportions of) nanoscale materials and new products made with 
nanoscale materials;
     Address the effects that nanoscale versions of larger 
sized materials have on bioavailability; and
     Address whether and how the presence of nanoscale 
materials affects the manufacturing processes for the various types of 
FDA-regulated products, including both products that require premarket 
authorization and those products that do not.

Reporting Formats

    We are not requesting a specific format or reporting structure for 
comments which include such available data. However, we prefer data in 
electronic form where possible, in order to facilitate access and to 
reduce paper use. We are asking for available data related to specific 
products and, therefore, request that any submitted data be identified 
as pertaining to a particular product or category of products. We also 
request that you identify your data submission as being a comment in 
response to this document, and refer to the docket number found in 
brackets in the heading of this document. See section IV. COMMENTS, on 
how to submit comments.

III. Meeting Registration, Agenda, and Transcript

    Seating will be available on a first-come, first-served basis. If 
you need special accommodations because of a disability, please inform 
Megan Clark (see FOR FURTHER INFORMATION CONTACT) at least 7 days in 
    Registration for Speaking Attendees: If you wish to make an oral 
presentation at the meeting, you must register and submit a summary of 
your presentation to Megan Clark by Tuesday, September 2, 2008, via e-
mail to [email protected]. When registering, you must provide the 
following information: (1) The product-specific breakout session at 
which you wish to present; (2) the specific topic or issue to be 
addressed; (3) your name, title, company or organization, address, 
phone number, and e-mail address; and (4) the approximate, desired 
duration of your presentation. FDA encourages persons and groups having 
similar interests to consolidate their information for presentation 
through a single representative. After reviewing the requests to 
present, we will contact each participant with the amount of time 
available and the approximate time the participant's presentation is 
scheduled to begin. Presenters must send electronic copies of their 
presentations in Microsoft PowerPoint,

[[Page 46024]]

Microsoft Word, or Adobe Portable Document Format (PDF) to Megan Clark 
at [email protected] by Tuesday, September 2, 2008.
    Meeting Agenda and Transcript: The agenda for the public meeting 
will be available on FDA's Web site at http://www.fda.gov/nanotechnology2008. After the meeting, the agenda, presentations, and 
transcript will be placed on file in the Division of Dockets Management 
under the docket number found in the heading of this document and on 
FDA's Web site.
    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. 
It may be viewed at the Division of Dockets Managment (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information (HFI-35), Office 
of Management Programs, Food and Drug Administration, 5600 Fishers 
Lane, rm. 6-30, Rockville, MD 20857.

IV. Comments

    Regardless of attendance at the meeting, interested persons may 
submit to the Division of Dockets Management (see ADDRESSES) written or 
electronic comments related to the questions and the focus of this 
public meeting, as well as comments including available data and 
information submitted in response to the data call. All relevant data 
and information should be submitted with the written comments. 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 posted without 
change to http://www.regulations.gov, including any personal 
information provided. Received comments may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS), FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: July 31, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-18132 Filed 8-6-08; 8:45 am]