[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]


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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

[[Page 54446]]

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