Form FDA3504 Color Additive Petition Submission

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: 11/30/2006
See Reverse for OMB Statement

FOR FDA USE ONLY
PETITION
TYPE

PETITION
NUMBER

RECEIVED DATE

APPLICANT INFORMATION
1. NAME OF APPLICANT

2. DATE OF SUBMISSION

3. TELEPHONE NO. (Include Area Code)

4. FACSIMILE (FAX) NO. (Include Area Code)

5. APPLICANT ADDRESS (Number, Street, City, Country, and ZIP

6. AUTHORIZED U.S. AGENT NAME & ADDRESS (Number, Street,
City, State, ZIP code, Telephone & FAX number) IF APPLICABLE
Name

Code or Mail Code)

Number and Street
Street Address
City and State
City

Agent Name
Number and Street

State Code

Country

Agent Address
City and State

City

Zip Code or Mail Code

ST

Zip

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

Zip Code or Mail Code

Zip_Code

SUBMISSION DESCRIPTION
7. PETITION TITLE
8. ADDITIVE FUNCTION

Food
Device

Drug

9. PRODUCT

Cosmetic

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

10. FEE ENCLOSED

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

11. CHEMICAL IDENTITIES
CHEMICAL
TYPE*

CAS NUMBER

P

000000000

CHEMICAL NAME

TRADE NAME (IF ANY)

STRUCTURE

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

FDA-3504 (11/03)

Page 1 of 2

APPLICATION INFORMATION
12. TYPE OF SUBMISSION (Check One)

New Additive Petition

Amendment*

Supplement *

Other

13. REASON FOR SUBMISSION
14. NUMBER OF VOLUMES SUBMITTED

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 (11/03)

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