Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability, 24722 [2012-9934]

Download as PDF 24722 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Notices FDA/Government/Students.2 There will also be a 1-day rate of $425 for OCRA members and $475 for non-members. The registration fee will cover actual expenses, including refreshments, lunch, materials, parking, and speaker expenses. If you need special accommodations due to a disability, please contact Linda Hartley (see Contact) at least 10 days before the conference. Dated: April 20, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–9968 Filed 4–24–12; 8:45 am] Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments on the draft guidance to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.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: BILLING CODE 4160–01–P I. Background DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0489] Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability AGENCY: Food and Drug Administration, HHS.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. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.’’ The draft guidance, when finalized, will represent FDA’s current thinking on the safety assessment of nanomaterials in cosmetic products.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 24, 2012. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition (HFS–100), Food and Drug Administration, 5100 Paint Branch Pkwy., College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. pmangrum on DSK3VPTVN1PROD with NOTICES SUMMARY: 2 See footnote 1. VerDate Mar<15>2010 15:14 Apr 24, 2012 Jkt 226001 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 https://www.fda.gov/CosmeticGuidances or https://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. PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Dated: April 17, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–9934 Filed 4–24–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0490] Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients That Are Color Additives; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients That Are Color Additives.’’ The draft guidance, when finalized, will explain FDA’s current thinking on the factors to be considered when determining whether changes in manufacturing process, including the intentional reduction in particle size to the nanoscale, for a food substance already in the market affects the safety and regulatory status of the food substance, and whether a new regulatory submission to FDA is warranted. SUMMARY: 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 written or electronic comments on the draft guidance by July 24, 2012. ADDRESSES: Submit written requests for single copies of the draft guidance entitled ‘‘Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients That Are Color Additives’’ to the Office of Food Additive Safety (HFS–200), DATES: E:\FR\FM\25APN1.SGM 25APN1

Agencies

[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.

-----------------------------------------------------------------------

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 https://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 https://www.fda.gov/CosmeticGuidances or https://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]
BILLING CODE 4160-01-P
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