Document ID: FDA-2011-D-0489-0001
Agency: fda
Document Type: Notice
Title: Draft Guidances for Industry: Safety of Nanomaterials in Cosmetic Products; Availability
Posted Date: 2012-04-25T04:00Z

[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Notices]
[Page 24722]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9934]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0489]

Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic 
Products; 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availability of the draft guidance entitled ``Guidance for Industry: 
Safety of Nanomaterials in Cosmetic Products.'' The draft guidance, 
when finalized, will represent FDA's current thinking on the safety 
assessment of nanomaterials in cosmetic products. This guidance is 
intended to assist industry in identifying the potential safety issues 
of nanomaterials in cosmetic products and developing a framework for 
evaluating them.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 24, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Cosmetics and Colors, Center for Food Safety 
and Applied Nutrition (HFS-100), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed 
adhesive labels to assist that office in processing your request. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Kapal Dewan, Center for Food Safety 
and Applied Nutrition (HFS-125), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-1130.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of the draft guidance entitled 
``Guidance for Industry: Safety of Nanomaterials in Cosmetic 
Products.'' The draft guidance is intended to assist industry in 
identifying the potential safety issues of nanomaterials in cosmetic 
products and developing a framework for evaluating these issues.
    The 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 the safety 
of nanomaterials in cosmetic products. 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.

II. 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.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/CosmeticGuidances or http://www.regulations.gov. Always access an FDA guidance document by using 
FDA's Web site listed previously to find the most current version of 
the guidance.

    Dated: April 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-9934 Filed 4-24-12; 8:45 am]
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