Substantial Evidence of Effectiveness of New Animal Drugs

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 514
[Docket No. 97N-0435]

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Food and Drug Administration (FDA), as directed by the Animal Drug Availability Act of 1996 (ADAA), is proposing to amend its new animal drug regulations to further define the term "substantial evidence." The purpose of this proposed regulation is to encourage the submission of new animal drug applications (NADA’s) and supplemental NADA’s for single ingredient and combination new animal drugs.

The proposal also encourages dose range labeling.

DATES: Submit written comments on the proposed rule by February 3, 1998. Submit written comments on the information collection requirements by December 5, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Submit written comments on the information collection requirements to the Office of Management and Budget (OMB), New Executive Office Bldg., 725 17^th St. NW., rm. 10235, Washington, DC 20503, Attn.: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Herman M. Schoenemann, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1638.