Guidance for Industry; Small Entities Compliance Guide-The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Availability

Zusammenfassung

The Food and Drug Administration (FDA) is announcing the availability of a Level 2 guidance for industry 201 entitled "Small Entities Compliance Guide--The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species." This small entities compliance guide aids industry in complying with the requirements of the final rule that published in the Federal Register of December 6, 2007. This regulation establishes administrative procedures and criteria for index listing a new animal drug for use in a minor species as provided by the Minor Use and Minor Species Animal Health Act of 2004 (MUMS).