Source: https://www.fda.gov/animal-veterinary/generally-recognized-safe-gras-notification-program/how-submit-gras-notice-cvm
Timestamp: 2019-07-17 13:31:24
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How to Submit a GRAS Notice to CVM | FDA
In this section: Generally Recognized as Safe (GRAS) Notification Program
This information was excerpted from Federal Register 81 FR 54959 August 17, 2016. Additional information on the GRAS program may be accessed from the Center for Veterinary Medicine's Animal GRAS Notification Program page.
Any person may notify FDA of a view that a substance is not subject to the premarket approval requirements of section 409 of the Federal Food, Drug, and Cosmetic Act based on that person’s conclusion that the substance is GRAS under the conditions of its intended use. Notifiers should submit copies of their notices of GRAS conclusion to the Division of Animal Feeds (HFV-220), Office of Surveillance and Compliance, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855.
Notifiers should submit the following information (as described in 21 CFR 570.220 through 570.255):
21 CFR 570.220 General requirements applicable to a GRAS notice.
(a) A GRAS notice has seven parts as required by 21 CFR 570.225 through 570.255. You must submit the data and information specified in each of these parts on separate pages or sets of pages.
21 CFR 570.225 part 1 of a GRAS notice: Signed statements and certification.
(5) Inform us of the statutory basis for your conclusion of GRAS status (i.e., through scientific procedures in accordance with 21 CFR 570.30(a) and (b) or through experience based on common use in animal food in accordance with 21 CFR 570.30(a) and (c));
21 CFR 570.230 part 2 of a GRAS notice: Identity, method of manufacture, specifications, and physical or technical effect.
(a) Scientific data and information that identifies the notified substance. (1) Examples of appropriate data and information include the chemical name, applicable registry numbers (such as a Chemical Abstracts Service (CAS) registry number or an Enzyme Commission (EC) number), empirical formula, structural formula, quantitative composition, and characteristic properties.
21 CFR 570.235 part 3 of a GRAS notice: Target animal and human exposures.
(1) The amount of the notified substance that different target animal species are likely to consume in the animal food (including drinking water) as part of the animal’s total diet, including the intended use and all other sources in the total diet; and
(4) The data and information you rely on to establish the amount of the notified substance and the amounts of any other substance in accordance with paragraphs (a)(1) through (a)(3) of this section that different target animal species are likely to consume in the animal food (including drinking water) as part of the animal’s total diet; and
21 CFR 570.240 part 4 of a GRAS notice: Self-limiting levels of use.
21 CFR 570.245 part 5 of a GRAS notice: Experience based on common use in food before 1958.
21 CFR 570.250 part 6 of a GRAS notice: Narrative.
(a)(1) You must explain why the data and information in your notice provide a basis for your view that the notified substance is safe under the conditions of its intended use for both the target animal and for humans consuming human food derived from food-producing animals. In your explanation, you must address the safety of the notified substance, considering all animal food (including drinking water) as part of the animal’s total diet, taking into account any chemically or pharmacologically related substances in such diet. In your explanation, you must also address the safety of the notified substance in regard to human exposure, considering all dietary sources and taking into account any chemically or pharmacologically related substances;
(2) In your explanation, you must identify what specific data and information that you discuss in accordance with paragraph (a)(1) of this section are generally available, and what specific data and information that you discuss in accordance with paragraph (a)(1) of this section are not generally available, by providing citations to the list of data and information that you include in part 7 of your GRAS notice in accordance with 21 CFR 570.255;
(c) You must either: (1) Identify, discuss, and place in context, data and information that are, or may appear to be, inconsistent with your conclusion of GRAS status, regardless of whether those data and information are generally available; or
21 CFR 570.255 part 7 of a GRAS notice: List of supporting data and information in your GRAS notice.
(a) In part 7 of your GRAS notice, you must include a list of all of the data and information that you discuss in part 6 of your GRAS notice to provide a basis for your view that the notified substance is safe under the conditions of its intended use as described in accordance with 21 CFR 570.250(a)(1).