[Federal Register Volume 61, Number 203 (Friday, October 18, 1996)] [Notices] [Pages 54445-54446] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-26682] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 96N-0327] Use of Formalin Solution on All Finfish; Availability of Data
Agency
Food and Drug Administration, HHS.
Action
Notice.
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Summary
The Food and Drug Administration (FDA) is announcing the availability of target animal safety and effectiveness data, human food safety data, and environmental data to be used in support of a new animal drug application (NADA) or supplemental NADA for control of certain external protozoa and monogenetic trematodes on all finfish and certain fungi on the eggs of all finfish through water treatment with formalin solution. The data, contained in Public Master File (PMF) 5228, were compiled under National Research Support Project No. 7 (NRSP-7), a national agricultural program for obtaining clearances for use of new drugs in minor animal species or in any animal species for the control of diseases that occur infrequently or in limited geographical areas.
Addresses
Submit NADA's or supplemental NADA's to the Document
Control Unit (HFV-199), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-3125.
For Further Information Contact
Naba K. Das, Center for Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1659.
Supplementary Information
The use of formalin solution on finfish is a new animal drug use under section 201(v) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(v)). As a new animal drug, formalin solution is subject to section 512 of the act (21 U.S.C. 360b), which requires that its use on finfish be the subject of an approved NADA or supplemental NADA. Finfish are a minor species under Sec. 514.1(d)(1)(ii) (21 CFR 514.1(d)(1)(ii)). Formalin solution is currently approved for control of: (1) Certain external, protozoan parasites and monogenetic trematodes on salmon, trout, catfish, largemouth bass, and bluegill; and (2) fungi of the family Saprolegniaceae on salmon, trout, and esocid eggs in accordance with 21 CFR 529.1030. The NRSP-7 Project, Southern and Western Regions (University of Florida, Gainesville, Florida and University of California, Davis, California), has filed data and information that demonstrate safety and effectiveness to all other finfish when they are administered formalin solution for the above mentioned conditions of use. NRSP-7 has also filed human food safety data and an environmental assessment (EA), amended by the Center for Veterinary Medicine, that adequately addresses the potential impacts due to the expanded use of the drug product. Approval of an application based on the data and information in this file requires additional information concerning the potential environmental impact of the manufacturing process. The abbreviated EA will be displayed when the NADA is approved, so that the manufacturing site environmental impact can be included in the assessment. The EA filed by NRSP-7 may be seen at the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday. The data and information are contained in PMF 5228. Sponsors of NADA's or supplemental NADA's may, without further authorization, refer to the PMF to support approval of an application filed under Sec. 514.1(d) (21 CFR 514.1(d)). An NADA or supplemental NADA must include, in addition to reference to the PMF, animal drug labeling and other data needed for approval, such as manufacturing methods, facilities, and controls, and information addressing the potential environmental impacts (including occupational) of the manufacturing process. Persons desiring more information concerning the PMF or requirements for approval of an NADA may contact Naba K. Das (address above). In accordance with the freedom of information provisions of part 20 (21 CFR part 20) and 21 CFR 514.11(e)(2)(ii), a summary of target animal safety, effectiveness, and human safety data and information provided in this PMF to support approval of an application may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday.
Dated: October 7, 1996. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 96-26682 Filed 10-17-96; 8:45 am] BILLING CODE 4160-01-F