Guidance for Industry; Small Entities Compliance Guide-Designation of New Animal Drugs for Minor Uses or Minor Species; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 200 entitled "Small Entities Compliance Guide--Designation of New Animal Drugs for Minor Uses or Minor Species." This small entities compliance guide (SECG) aids industry in complying with the requirements of the final rule that published in the Federal Register of July 26, 2007. The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) establishes new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species.