[Federal Register Volume 73, Number 153 (Thursday, August 7, 2008)]
[Notices]
[Pages 46022-46024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18132]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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.
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\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.
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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].
SUPPLEMENTARY INFORMATION:
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
requirements).
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
products.
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
substances;
Dietary supplements; and
Cosmetics.
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
products?
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
advance.
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,
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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]
BILLING CODE 4160-01-S