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COLOR ADDITIVE PETITION SUBMISSION
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION APPLICATION TO MARKET A NEW USE OF A COLOR ADDITIVE (Title 21, Code of Federal Regulations, 71)

Form Approval: OMB No. 0910-0016 Expiration Date: 8/31/2010 See Reverse for OMB Statement

FOR FDA USE ONLY
PETITION TYPE PETITION NUMBER RECEIVED DATE

APPLICANT INFORMATION
1. NAME OF APPLICANT 3. TELEPHONE NO. (Include Area Code) 2. DATE OF SUBMISSION 4. FACSIMILE (FAX) NO. (Include Area Code) 6. AUTHORIZED U.S. AGENT NAME & ADDRESS (Number, Street, City, State, ZIP code, Telephone & FAX number) IF APPLICABLE Name

5. APPLICANT ADDRESS (Number, Street, City, Country, and ZIP
Code or Mail Code)

Number and Street Street Address City and State City
Country Zip Code or Mail Code

Agent Name
Number and Street

State Code

Agent Address
City and State Zip Code or Mail Code

City Zip_Code
7. PETITION TITLE 8. ADDITIVE FUNCTION 9. PRODUCT

ST

Zip

Telephone No. (Include area code) Facsimile (Fax) No. (Include area code)

SUBMISSION DESCRIPTION

Food Device
10. FEE ENCLOSED

Drug

Cosmetic Nonfood use new listing ($2,600) Nonfood use amendment ($1,600)

Food use new listing ($3,000) Food use amendment ($1,800) (Attach check made out to: U.S. Food and Drug Administration) CAS NUMBER 000000000
CHEMICAL NAME

11. CHEMICAL IDENTITIES
CHEMICAL TYPE* TRADE NAME (IF ANY) STRUCTURE

P

* P ­ Primary chemical, C ­ Constituents (including residual monomers, residual solvents, impurities, by-products, catalysts, and etc.)

FDA-3504 (09/07)

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APPLICATION INFORMATION
12. TYPE OF SUBMISSION (Check One)

New Additive Petition
13. REASON FOR SUBMISSION 14. NUMBER OF VOLUMES SUBMITTED

Amendment*

Supplement *

Other

15. THIS SUBMISSION IS (Check One) Paper Paper and Electronic Electronic THIS APPLICATION CONTAINS THE FOLLOWING ITEMS: (Check all that apply) 16 Cover Letter*** Petition Table of Contents (TOC) Executive Summary 21 CFR 71.1 (C) 17 · SECTION A ­ C: Chemistry Section Chemistry Table of Contents (TOC ) Identity Use Intended Technical Effect Analytical and Methodology Studies References 18 · SECTION D: Safety Section** Safety of TOC Safety Summary Studies Genetic Toxicity Studies Acute Toxicity Studies Short Term Toxicity Studies Between 14 Days and 28 Days Subchronic Toxicity Studies 90 Days Chronic Toxicity Studies Between 6 Months and 2 Year Carcinogenicity Studies Carcinogenicity Studies with in Utero Exposure Combined Chronic Toxicity and Carcinogenicity Studies Reproductive Toxicity Studies Reproductive Toxicity with Teratology Phase Teratology Studies Immunotoxicity Studies Allergenicity Studies Metabolism and Pharmacokinetic Studies Neurotoxicity Studies Neurobehavioral Toxicity Studies Epidemiology Studies Human Clinical Studies Nutrition Studies Other Studies, e.g., Microbiology________________________________________________________________ References 19 · SECTION E - I: Administrative Section* Administrative TOC Probable Exposure Information Batch Certification Exemption Required Fee (See box 10 of page 1) Proposed Tolerance Proposed Regulation 20 · SECTION J: Environmental Section Environmental TOC Environmental Assessment Categorical Exclusion Studies References 21. SIGNATURE OF RESPONSIBLE OFFICIAL OR 22. TYPED NAME AND TITLE 23. DATE AGENT
* The cover letter for Supplement or Amendment should be placed in Administrative folder, e.g., Administrative->Correspondences->Incoming->Supplement Cover Letter.pdf. ** All of the categories in Safety Section should be placed inside of Studies folder in Safety Folder. *** Original Submission only. Public reporting burden for this collection of information is estimated to average one hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Food and Drug Administration CFSAN (HFS-265) 5100 Paint Branch Parkway College Park, MD 20740 An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it display a currently valid OMB number.

FDA-3504 (09/07)

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