24722 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Notices 

2See footnote 1. 

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] 

BILLING CODE 4160–01–P 

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Draft Guidance for Industry: Safety of 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availability of the draft guidance 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 The draft guidance, when 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on the draft guidance by July 24, 2012.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single copies of the draft guidance to the 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access to the draft guidance.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draft guidance to http:// 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comments on the draft guidance to the 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] 

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. 

SUMMARY: 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. 

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 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), 


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