[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Draft Guidance for Industry; Considering Whether an FDA-Regulated 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availability of a draft guidance for industry entitled ``Considering 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 15, 2011.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electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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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