[Federal Register Volume 76, Number 114 (Tuesday, June 14, 2011)]
[Notices]
[Pages 34715-34716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14643]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0530]
Draft Guidance for Industry; Considering Whether an FDA-Regulated
Product Involves the Application of Nanotechnology; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Considering
Whether an FDA-Regulated Product Involves the Application of
Nanotechnology''. This guidance is intended to provide industry with
FDA's current thinking on whether FDA-regulated products contain
nanomaterials or otherwise involve the application of nanotechnology.
The points to consider are intended to be broadly applicable to all
FDA-regulated products, with the understanding that additional guidance
may be articulated for specific product areas, as appropriate in the
future.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 15, 2011.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Policy, Office of the Commissioner, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ritu Nalubola, Office of Policy,
Office of the Commissioner,Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 4236, Silver Spring, MD 20993-0002, 301-
796-4830, e-mail: [email protected]; or Carlos Pe[ntilde]a,
Office of the Chief Scientist, Office of the Commissioner, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4264,
Silver Spring, MD 20993-0002, 301-796-4880, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Considering Whether an FDA-Regulated Product Involves the
Application of Nanotechnology''. The guidance is intended for
manufacturers, suppliers, importers, and other stakeholders. The
guidance describes FDA's current thinking on whether FDA-regulated
products contain nanomaterials or otherwise involve the application of
nanotechnology. As a first step toward developing FDA's framework for
considering whether FDA-regulated products include nanomaterials or
otherwise involve nanotechnology, the Agency has developed the points
discussed in the guidance. These points to consider are intended to be
broadly applicable to all FDA-regulated products, with the
understanding that additional guidance may be articulated for specific
product areas, as appropriate in the future. The guidance document does
not establish any regulatory definitions. Rather, it is intended to
help industry and others identify when they should consider potential
implications for regulatory status, safety, effectiveness, or public
health impact that may arise with the application of nanotechnology in
FDA-regulated products. Public input on the
[[Page 34716]]
guidance may also inform the development of any future actions, as
needed.
II. Significance of Guidance
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the Agency's current thinking on this
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternative approach may
be used if such approach satisfies the requirements of the applicable
statutes and regulations.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm or http://www.regulations.gov.
Dated: June 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14643 Filed 6-13-11; 8:45 am]
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