Animal drugs, feeds, and related products: New drug applications Formalin solution,
[Federal Register: July 16, 1998 (Volume 63, Number 136)]
[Rules and Regulations]
[Page 38304-38305]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jy98-13]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Certain Other Dosage Form New Animal Drugs; Formalin Solution
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filedby Western Chemical, Inc. The supplement provides for use of formalin solution in the water of all finfish as a parasiticide and all finfish eggs as a fungicide.
EFFECTIVE DATE: July 16, 1998.
FOR FURTHER INFORMATION CONTACT: Thomas A. Bell, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1649.
SUPPLEMENTARY INFORMATION: Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 98248, is sponsor of NADA 140-989 that provides for use of Parasite-S‹Register› (formalin, an aqueous solution of 37 percent formaldehyde) in the water (tanks, raceways, and ponds) of select fish and penaeid shrimp for the control of specific external parasites, and as a fungicide for select fish eggs. Western Chemical, Inc., fileda supplemental NADA that provides for use of formalin in the water of all finfish for the control of specific external parasites and as a fungicide for all finfish eggs. The supplemental NADA is approved as of June 18, 1998, and the regulations are amended in 21 CFR 529.1030 to reflect the approval.
In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this supplement may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
The agency has carefully considered the potential environmental effects of this action. FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. The agency's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 529
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 529 is amended as follows:
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
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The authority citation for 21 CFR part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
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Section 529.1030 is amended by revising paragraphs (b)(1) and (b)(2), by redesignating paragraph (c) as paragraph (d) and reserving paragraph (c), by revising newly redesignated paragraphs (d) introductory text, (d)(1) and (d)(2)(i), and by adding paragraphs (d)(2)(iv) and (d)(2)(v) to read as follows:
Sec. 529.1030 Formalin solution.
* * * * *
(b) * * *
(1) No. 050378 for use as in paragraphs (d)(1)(iii), (d)(1)(iv), (d)(1)(v), (d)(2)(iii), (d)(2)(iv), (d)(2)(v), and (d)(3).
(2) Nos. 049968 and 051212 for use as in paragraphs (d)(1)(i), (d)(1)(ii), (d)(2)(i), (d)(2)(ii), and (d)(3). * * * * *
(c) [Reserved]
(d) Conditions of use. It is added to environmental water as follows:
(1) Indications for use. (i) Select finfish. For control of external protozoa Ichthyophthirius spp., Chilodonella spp., Costia spp., Scyphidia spp., Epistylis spp., and Trichodina spp., and monogenetic trematodes Cleidodiscus spp., Gyrodactylus spp., and Dactylogyrus spp., on salmon, trout, catfish, largemouth bass, and bluegill.
(ii) Select finfish eggs. For control of fungi of the family Saprolegniaceae on salmon, trout, and esocid eggs.
(iii) Penaeid shrimp. For control of external protozoan parasites Bodo spp., Epistylis spp., and Zoothamnium spp.
(iv) All finfish. For control of external protozoa Ichthyophthirius spp., Chilodonella spp., Costia spp., Scyphidia spp., Epistylis spp., and Trichodina spp., and monogenetic trematodes Cleidodiscus spp., Gyrodactylus spp., and Dactylogyrus spp.
(v) All finfish eggs: For control of fungi of the family Saprolegniaceae.
(2) * * *
(i) For control of external parasites on select finfish: * * * * *
(iv) For control of external parasites on all finfish:
Administer in tanks and
raceways for up to 1 Administer in earthen
Aquatic species hour (microliter/liter ponds indefinitely or part per million (‹greek-m›L/L or ppm) (‹greek-m›L/L or ppm))
Salmon and trout:
Above 50 F
Up to 170
15 to 25‹SUP›1, ‹SUP›2
Below 50 F
Up to 250
15 to 25‹SUP›1, ‹SUP›2
All other finfish
Up to 250
15 to 25‹SUP›1, ‹SUP›2
\1\ Use the lower concentration when ponds, tanks, or raceways are heavily loaded with phytoplankton or fish to avoid oxygen depletion due to the biological oxygen demand by decay of dead phytoplankton. Alternatively, a higher concentration may be used if dissolved oxygen is strictly monitored.
\2\ Although the indicated concentrations are considered safe for cold and warm water finfish, a small number of each lot or pond to be treated should always be used to check for any unusual sensitivity to formalin before proceeding.
(v) For control of fungi of the family Saprolegniaceae on all finfish eggs: Eggs
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of all finfish except Acipenseriformes, 1,000 to 2,000 ‹greek-m›L/L (ppm) for 15 minutes; eggs of Acipenseriformes, up to 1,500 ‹greek-m›L/ L (ppm) for 15 minutes. * * * * *
Dated: July 9, 1998. Stephen F. Sundlof, Director, Center for Veterinary Medicine.
[FR Doc. 98-18955Filed7-15-98; 8:45 am]
BILLING CODE 4160-01-F
