Draft Guidance for Industry; Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology”.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 15, 2011.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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Ritu.Nalubola@fda.hhs.gov; or Carlos Peña, 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: Carlos.Pena@fda.hhs.gov.

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FDA is announcing the availability of a draft guidance for industry entitled “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology”.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 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.