[Federal Register Volume 73, Number 153 (Thursday, August 7, 2008)]
[Rules and Regulations]
[Pages 45874-45875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18129]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2008-N-0039]
New Animal Drugs For Use in Animal Feeds; Oxytetracycline
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Phibro Animal Health. The supplemental NADA
provides for use of oxytetracycline dihydrate in Type C medicated feeds
for the control of mortality in freshwater-reared salmonids due to
coldwater disease and for the control of mortality in freshwater-reared
Oncorhynchus mykiss due to columnaris disease.
DATES: This rule is effective August 7, 2008.
FOR FURTHER INFORMATION CONTACT: Donald A. Prater, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8343, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: Phibro Animal Health, 65 Challenger Rd., 3d
floor, Ridgefield Park, NJ 07660, filed a supplement to NADA 38-439 for
TERRAMYCIN 200 for Fish (oxytetracycline dihydrate) Type A medicated
article used for control of certain bacterial diseases in several
species of fish and for skeletal marking of Pacific salmon. The
supplement provides for use of oxytetracycline dihydrate in Type C
medicated feeds for
[[Page 45875]]
the control of mortality in freshwater-reared salmonids due to
coldwater disease associated with Flavobacterium psychrophilum and for
the control of mortality in freshwater-reared Oncorhynchus mykiss due
to columnaris disease associated with Flavobacterium columnare. The
supplemental NADA is approved as of July 6, 2008, and the regulations
are amended in 21 CFR 558.450 to reflect the approval.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(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.
Under section 573(c) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360ccc-2(c)), this supplemental approval qualifies
for 7 years of exclusive marketing rights beginning on the date of
approval because the new animal drug has been declared a designated new
animal drug by FDA under section 573(a) of the act.
The agency has carefully considered the potential environmental
impact of this action and has concluded that the action will not have a
significant impact on the human environment and that an environmental
impact statement is not required. FDA's finding of no significant
impact and the evidence supporting that finding, contained in an
environmental assessment, may be seen in the Division of Dockets
Management (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.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
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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 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
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1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
2. In Sec. 558.450, in the table in paragraph (d)(5)(v), in the
``Limitations'' column, remove ``; do not administer when water
temperature is below 9 [deg]C (48.2 [deg]F)''; redesignate paragraph
(d)(5)(vi) as paragraph (d)(5)(vii); and add new paragraph (d)(5)(vi)
to read as follows:
Sec. 558.450 Oxytetracycline.
* * * * *
(d) * * *
(5) * * *
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Oxytetracycline amount Indications for use Limitations Sponsor
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* * * * * * *
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(vi) 3.75 g/100 lb of fish/ 1. Freshwater-reared salmonids: Administer in mixed ration for 10 066104
day For control of mortality due to d; do not liberate fish or
coldwater disease associated with slaughter fish for food for 21 d
Flavobacterium psychrophilum. following the last administration
of medicated feed.
2. Freshwater-reared Oncorhynchus Administer in mixed ration for 10 066104
mykiss: For control of mortality d; do not liberate fish or
due to columnaris disease slaughter fish for food for 21 d
associated with Flavobacterium following the last administration
columnare. of medicated feed.
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Dated: July 28, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-18129 Filed 8-6-08; 8:45 am]
BILLING CODE 4160-01-S