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          Guidance for Industry: Templates for Reporting Toxicology DataSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Guidance for Industry: Templates for Reporting Toxicology Data 
					
		
		April 2005


	 

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    PrintDocket Number:
		    FDA-2020-D-1941
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


*This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach or have any questions regarding this document contact Adejoke Ogungbesan at FDA's Office of Food Additive Safety, 5001 Campus Drive, College Park, Maryland, 20740-3835, 240-402-1229.*

The reader is advised that the use of the word "should" in the text of Agency guidance documents means that something is suggested or recommended, but not required.

The Food and Drug Administration (FDA) is making available nine templates related to the submission of toxicology data. Templates for: 1) Subchronic Toxicity Study in Rodents, 2) Subchronic Toxicity Study in Dogs, 3) Genetic Toxicity Study: *in vitro* Bacterial Reverse Mutation (Ames) Test, 4) Genetic Toxicity Study: *in vitro* Mouse Lymphoma Thymidine Kinase Gene Mutation Assay, 5) Genetic Toxicity Study: Mammalian Erythrocyte Micronucleus Test, 6)Genetic Toxicity Study: *in vitro* Mammalian Chromosomal Aberration Test, 7) Chronic Toxicity Study with an *in utero* phase, 8) Chronic (1 year) Dog Toxicity Study, and 9) Two-Generation Reproduction Toxicity Study. These templates provide optional tools for industry in submitting summary toxicology data from the respective studies in support of petitions and notifications for safe use of food and color additives. The purpose of this guidance is to assist industry in preparing toxicology reports using standardized formats and vocabularies that are consistent with current Agency recommendations for toxicological information. Their use will expedite the evaluation process of toxicology information by the Agency since data will be presented in a consistent, predictable, format for evaluation. An Experimental Study Calculation Guide has also been provided for convenience of industry.

This guidance explains FDA's current thinking and recommendations that the Agency considers appropriate in submitting toxicology reports in support of petitions and notifications for food and color additives. However, these toxicology data templates are not substitutes for the Federal Food, Drug, and Cosmetic Act (FFDCA) or the Code of Federal Regulations (CFR). FDA will consider the information adequate if it is submitted in accordance with applicable statutes and regulations. Requirements for toxicity data and information in support of food and color additives can be found in 21 CFR Parts 71, 170, and 171. The Agency also has provided guidances on toxicology recommendations for specific product categories such as food contact substances, direct food additives, color additives, and GRAS notifications. These are available on the Agency's Internet site at Food Ingredients and Packaging Guidance Documents.

Other templates may be made available in the future as the Agency continues to develop templates for other types of toxicity studies.

Toxicology Templates

These templates are available in accessible HTML or Microsoft Word documents. The accessible HTML versions are for use with a screen reader for the visually impaired.

Document Title
			Accessible HTML Document
			Word 2000 Template1. Subchronic Toxicity Study in Rodents
			Accessible version
			template (474KB)2. Subchronic Toxicity Study in Dogs
			Accessible version
			template (610KB)3. Genetic Toxicity Study: *in vitro* Bacterial Reverse Mutation (Ames) Test
			Accessible version
			template (250 KB)4. Genetic Toxicity Study: *in vitro* Mouse Lymphoma Thymidine Kinase Gene Mutation Assay
			Accessible version
			template (176KB)5. Genetic Toxicity Study: Mammalian Erythrocyte Micronucleus Test
			Accessible version
			template(117KB)6. Genetic Toxicity Study: *in vitro* Mammalian Chromosomal Aberration Test
			Accessible version
			template (201KB)7. Chronic Toxicity Study with an *in utero* phase
			Accessible version
			template (962KB)8. Chronic (1 Year) Dog Toxicity Study Template
			Accessible version
			template (1.1MB)9. Two-Generation Reproduction Toxicity Study
			Accessible version
			template (86KB)*Also available:* Experimental Study Calculation Guide
			Available as a Excel spreadsheet (86KB).

Related Information

Ingredients, Additives, GRAS & Packaging Guidance Documents & Regulatory InformationSubmit Comments
	   		  			    		Submit Comments Online
					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
						If unable to submit comments online, please mail written comments to:
						Dockets Management
							Food and Drug Administration
							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All written comments should be identified with this document's docket number: FDA-2020-D-1941.

                                                                                  Content current as of:
      09/20/2018
         
                  
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