[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Notices]
[Page 24722]
From the Federal Register Online via the Government Publishing 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Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic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availability of the draft guidance entitled ``Guidance for Industry: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 The draft guidance,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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 24, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Cosmetics and Colors, Center for Food Safety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draft guidance.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to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FDA is announcing the availability of the draft guidance entitled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 The draft guidance is intended to assist industry in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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