
[Federal Register: August 7, 2008 (Volume 73, Number 153)]
[Rules and Regulations]               
[Page 45874-45875]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au08-6]                         

=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: 
donald.prater@fda.hhs.gov.

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.

0
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

0
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) * * *

----------------------------------------------------------------------------------------------------------------
   Oxytetracycline amount            Indications for use                     Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
(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.
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------


    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
