[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Pages 36534-36535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15033]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0530]


Guidance for Industry: Considering Whether a Food and Drug 
Administration-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 or we) is announcing the 
availability of a guidance entitled ``Guidance for Industry: 
Considering Whether an FDA-Regulated Product Involves the Application 
of Nanotechnology.'' This guidance explains FDA's current thinking on 
determining whether FDA-regulated products involve the application of 
nanotechnology. The guidance identifies two Points to Consider, which 
address both particle dimensions and dimension-dependent properties or 
phenomena. If either point applies to a given product, industry and FDA 
should consider whether evaluations of safety, effectiveness, public 
health impact, or regulatory status of that product have identified and 
adequately addressed any unique properties or behaviors of the product. 
These two Points to Consider are intended to provide an initial 
screening tool that can be broadly applied to all FDA-regulated 
products, with the understanding that these points are subject to 
change in the future as new information becomes available.

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance 
entitled ``Guidance for Industry: Considering Whether an FDA-Regulated 
Product Involves the Application of Nanotechnology'' 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 guidance.
    Submit electronic comments on the 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,email: Ritu.Nalubola@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance entitled 
``Guidance for Industry: Considering Whether an FDA-Regulated Product 
Involves the Application of Nanotechnology.''
    This guidance is intended for manufacturers, suppliers, importers, 
and other stakeholders. It describes FDA's current thinking on 
determining whether FDA-regulated products involve the application of 
nanotechnology. In the Federal Register of June 14, 2011 (76 FR 34715), 
we made available a draft guidance entitled ``Draft Guidance for 
Industry: Considering Whether an FDA-Regulated Product Involves the 
Application of Nanotechnology'' and gave interested parties an 
opportunity to submit comments by August 15, 2011, for us to consider 
before beginning work on the final version of the guidance. We received 
several comments on the draft guidance and have modified the final 
guidance, where appropriate. The guidance announced in this notice 
finalizes the draft guidance dated June 2011.
    This guidance provides an overarching framework for FDA's approach 
to the regulation of nanotechnology products. Based on our current 
scientific and technical understanding of nanomaterials and their 
characteristics, FDA believes that evaluations of safety, 
effectiveness, public health impact, or regulatory status of 
nanotechnology products should consider any unique properties and 
behaviors that the application of nanotechnology may impart. This 
guidance identifies two Points to Consider that should be applied when 
considering whether FDA-regulated products involve the application of 
nanotechnology. These Points address both particle dimensions and 
dimension-dependent properties or phenomena. If either point applies to 
a given product, industry and FDA should consider whether the 
evaluations of safety, effectiveness, public health impact, or 
regulatory status of that product have identified and adequately 
addressed any unique properties or behaviors of the product.
    These two Points to Consider are intended to provide an initial 
screening tool that can be broadly applied to all FDA-regulated 
products, with the understanding that these points are subject to 
change in the future as new information becomes available. In 
particular, FDA may further refine these points, either as applicable 
broadly to all FDA-regulated products or as applicable to particular 
products or classes of products, as justified by scientific 
information.
    We will consider future revisions to our approach, including 
developing regulatory definitions relevant to nanotechnology, as 
warranted and in keeping with evolving scientific understanding. FDA 
may also provide additional guidance, including product-specific 
guidance documents, to address issues such as the regulatory status, 
safety, effectiveness, performance, quality, or public health impact of 
nanotechnology products.
    We urge industry to consult early with FDA so that any questions 
related to the regulatory status, safety, effectiveness, or public 
health impact of products that involve the application of 
nanotechnology can be appropriately and adequately addressed.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
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. You may use an alternative approach if such approach 
satisfies the requirements of applicable statutes and regulations.

III. Comments

    Interested persons may submit either electronic comments regarding 
the guidance to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

[[Page 36535]]

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm or http://www.regulations.gov. Use the FDA Web site listed 
in the previous sentence to find the most current version of the 
guidance.

    Dated: June 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15033 Filed 6-26-14; 8:45 am]
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