New Animal Drugs for Use in Animal Feeds; Oxytetracycline, 70774-70776 [E7-24146]
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70774
Federal Register / Vol. 72, No. 239 / Thursday, December 13, 2007 / Rules and Regulations
Shell Lake, WI, Shell Lake Muni, Takeoff
Minimums and Obstacle DP, Orig
[FR Doc. E7–23840 Filed 12–12–07; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
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
Pennfield Oil Co. that provides for a
zero-day preslaughter withdrawal time
following use of oxytetracycline in
turkey and swine feed.
DATES: This rule is effective December
13, 2007.
FOR FURTHER INFORMATION CONTACT: Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7571, email:
joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pennfield
Oil Co., 14040 Industrial Rd., Omaha,
NE 68144, filed a supplement to NADA
138–938 for PENNOX (oxytetracycline)
Type A medicated articles used for
making medicated feeds for the
treatment of various bacterial diseases of
livestock and fish. The supplemental
NADA provides for a zero-day
withdrawal time prior to slaughter when
Type C medicated feeds containing
oxytetracycline are fed to turkeys or
swine and for minor label revisions. The
supplemental application is approved as
of November 26, 2007, and the
regulations are amended in 21 CFR
558.450 to reflect the approval, an
editorial change, and a current format.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii),
summaries of safety and effectiveness
data and information submitted to
support approval of these applications
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.
The agency has determined under 21
CFR 25.33(a)(1) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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.
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:
I
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
2. In § 558.450, revise paragraphs
(a)(1), (a)(2), (b)(3), and (d) to read as
follows:
I
§ 558.450
Oxytetracycline.
(a) * * *
(1) 10, 20, 30, 50, 100, and 200 grams
per pound to No. 066104 in § 510.600(c)
of this chapter.
(2) 50, 100, and 200 grams per pound
to No. 048164 in § 510.600(c) of this
chapter.
(b) * * *
(3) 50-, 100-, and 200-gram per pound
articles in paragraph (a)(2) of this
section contain oxytetracycline
dihydrate expressed in terms of an
equivalent amount of oxytetracycline
hydrochloride. Another 100-gram per
pound article in paragraph (a)(2) of this
section contains oxytetracycline
hydrochloride.
*
*
*
*
*
(d) Conditions of use—(1) Chickens—
Oxytetracycline amount
Indications for use
Limitations
Sponsor
(i) 10 to 50 grams per ton
(g/ton)
Chickens: For increased rate of weight gain and
improved feed efficiency.
Feed continuously; do not feed to chickens producing eggs for human consumption.
066104,
048164
(ii) 100 to 200 g/ton
Chickens: For control of infectious synovitis
caused by Mycoplasma synoviae and control
of fowl cholera caused by Pasteurella
multocida susceptible to oxytetracycline.
Feed continuously for 7 to 14 days (d); do not
feed to chickens producing eggs for human
consumption; in low calcium feeds, withdraw 3
d before slaughter.
066104,
048164
(iii) 400 g/ton
Chickens: For control of chronic respiratory disease (CRD) and air sac infection caused by
Mycoplasma gallisepticum and Escherichia coli
susceptible to oxytetracycline.
Feed continuously for 7 to 14 d; do not feed to
chickens producing eggs for human consumption; in low calcium feeds, withdraw 3 d before
slaughter.
066104,
048164
(iv) 500 g/ton
Chickens: For reduction of mortality due to air
sacculitis (air sac infection) caused by E. coli
susceptible to oxytetracycline.
Feed continuously for 5 d; do not feed to chickens producing eggs for human consumption;
withdraw 24 hours before slaughter; in low calcium feeds, withdraw 3 d before slaughter.
066104,
048164
rwilkins on PROD1PC63 with RULES
(2) Turkeys—
Oxytetracycline amount
(i) 10 to 50 g/ton
VerDate Aug<31>2005
Indications for use
Limitations
Growing turkeys: For increased rate of weight
gain and improved feed efficiency.
16:31 Dec 12, 2007
Jkt 214001
PO 00000
Frm 00012
Fmt 4700
Feed continuously; do not feed to turkeys producing eggs for human consumption.
Sfmt 4700
E:\FR\FM\13DER1.SGM
13DER1
Sponsor
066104,
048164
Federal Register / Vol. 72, No. 239 / Thursday, December 13, 2007 / Rules and Regulations
Oxytetracycline amount
Indications for use
Limitations
70775
Sponsor
(ii) 100 g/ton
Turkeys: For control of hexamitiasis caused by
Hexamita meleagridis susceptible to oxytetracycline.
Feed continuously for 7 to 14 d; do not feed to
turkeys producing eggs for human consumption.
066104,
048164
(iii) 200 g/ton
Turkeys: For control of infectious synovitis
caused by M. synoviae susceptible to oxytetracycline.
Feed continuously for 7 to 14 d; for No. 066104
withdraw 5 d before slaughter; for No. 048164
zero-day withdrawal time; do not feed to turkeys producing eggs for human consumption.
066104,
048164
(iv) 25 milligrams/pound
(mg/lb) of body weight
daily
Turkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to oxytetracycline.
Feed continuously for 7 to 14 d; for No. 066104
withdraw 5 d before slaughter; for No. 048164
zero-day withdrawal time; do not feed to turkeys producing eggs for human consumption.
066104,
048164
Indications for use
Limitations
(3) Swine—
Oxytetracycline amount
Sponsor
(i) 10 to 50 g/ton
Swine: For increased rate of weight gain and improved feed efficiency.
Feed continuously.
066104,
048164
(ii) 10 mg/lb of body
weight daily
1. Swine: For treatment of bacterial enteritis
caused by E. coli and Salmonella choleraesuis
susceptible to oxytetracycline and treatment of
bacterial pneumonia caused by P. multocida
susceptible to oxytetracycline.
2. Breeding swine: For control and treatment of
leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by
Leptospira pomona susceptible to oxytetracycline.
Feed continuously for 7 to 14 d.
066104,
048164
Feed continuously for 14 d.
066104,
048164
(4) Cattle—
Oxytetracycline amount
Indications for use
Limitations
Sponsor
(i) 0.05 to 0.1 mg/lb of
body weight daily
Calves (up to 250 lb): For increased rate of
weight gain and improved feed efficiency.
Feed continuously in milk replacer or starter
feed.
066104,
048164
(ii) 10 mg/lb of body
weight daily
1. Calves and beef and nonlactating dairy cattle:
For treatment of bacterial enteritis caused by
E. coli and bacterial pneumonia (shipping fever
complex) caused by P. multocida susceptible
to oxytetracycline.
2. Calves: For treatment of bacterial enteritis
caused by E. coli susceptible to oxytetracycline.
Feed continuously for 7 to 14 d; for No. 048164,
withdraw 5 d before slaughter; for No. 066104,
zero-day withdrawal time.
066104,
048164
Feed continuously for 7 to 14 d in milk replacer
or starter feed; for No. 048164, withdraw 5 d
before slaughter; for No. 066104, zero-day
withdrawal time.
066104,
048164
(iii) 25 mg/head/day
Calves (250 to 400 lb): For increased rate of
weight gain and improved feed efficiency.
Feed continuously.
066104,
048164
(iv) 75 mg/head/day
Growing cattle (over 400 lb): For increased rate
of weight gain, improved feed efficiency, and
reduction of liver condemnation due to liver abscesses.
Feed continuously.
066104,
048164
(v) 0.5 to 2.0 g/head/day
Cattle: For prevention and treatment of the early
stages of shipping fever complex.
Feed 3 to 5 d before and after arrival in feedlots.
066104,
048164
Indications for use
Limitations
(5) Minor species—
rwilkins on PROD1PC63 with RULES
Oxytetracycline amount
(i) 10 to 20 g/ton
VerDate Aug<31>2005
Sheep: For increased rate of weight gain and improved feed efficiency.
16:31 Dec 12, 2007
Jkt 214001
PO 00000
Frm 00013
Fmt 4700
Feed continuously.
Sfmt 4700
E:\FR\FM\13DER1.SGM
Sponsor
066104,
048164
13DER1
70776
Federal Register / Vol. 72, No. 239 / Thursday, December 13, 2007 / Rules and Regulations
Oxytetracycline amount
Indications for use
Limitations
Sponsor
(ii) 10 mg/lb of body
weight daily
Sheep: For treatment of bacterial enteritis
caused by E. coli and bacterial pneumonia
caused by P. multocida susceptible to oxytetracycline.
Feed continuously for 7 to 14 d; withdraw 5 d before slaughter.
066104,
048164
(iii) 200 mg/colony
Honey bees: For control of American foulbrood
caused by Paenibacillus larvae and European
foulbrood caused by Streptococcus pluton susceptible to oxytetracycline.
Remove at least 6 weeks prior to main honey
flow.
066104,
048164
(iv) 250 mg/kilogram of
fish/day (11.35 g/100 lb
of fish/day)
Pacific salmon: For marking of skeletal tissue.
For salmon not over 30 g body weight; administer as sole ration for 4 consecutive days; fish
not to be liberated for at least 7 d following the
last administration of medicated feed.
066104
(v) 2.5 to 3.75 g/100 lb of
fish/day
1. Salmonids: For control of ulcer disease
caused by Hemophilus piscium, furunculosis
caused by Aeromonas salmonicida, bacterial
hemorrhagic septicemia caused by A.
liquefaciens, and pseudomonas disease.
2. Catfish: For control of bacterial hemorrhagic
septicemia caused by A. liquefaciens and
pseudomonas disease.
Administer in mixed ration for 10 d; do not liberate fish or slaughter fish for food for 21 d following the last administration of medicated
feed; do not administer when water temperature is below 9 °C (48.2 °F).
Administer in mixed ration for 10 d; do not liberate fish or slaughter fish for food for 21 d following the last administration of medicated
feed; do not administer when water temperature is below 16.7 °C (62 °F).
066104
Lobsters: For control of gaffkemia caused by
Aerococcus viridans.
Administer as sole ration for 5 consecutive days;
withdraw medicated feed 30 d before harvesting lobsters.
066104
(vi) 1 g/lb of medicated
feed
(6) Oxytetracycline may be used in
accordance with the provisions of this
section in the combinations as follows:
(i) Carbadox as in § 558.115.
(ii) Lasalocid as in § 558.311.
(iii) Melengestrol acetate as in
§ 558.342.
(iv) Robenidine hydrochloride as in
§ 558.515.
(v) Salinomycin as in § 558.550.
Dated: December 5, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–24146 Filed 12–12–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal
Feeds; Ractopamine
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
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
Elanco Animal Health. The
supplemental NADA provides for an
rwilkins on PROD1PC63 with RULES
SUMMARY:
VerDate Aug<31>2005
16:31 Dec 12, 2007
Jkt 214001
increased level of monensin in threeway combination Type C medicated
feeds containing ractopamine,
melengestrol, and monensin for heifers
fed in confinement for slaughter.
DATES: This rule is effective December
13, 2007.
FOR FURTHER INFORMATION CONTACT:
Daniel A. Benz, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0223, email: daniel.benz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 141–234 that
provides for use of OPTAFLEXX
(ractopamine hydrochloride), MGA
(melengestrol acetate), and RUMENSIN
(monensin USP) Type A medicated
articles to make dry and liquid threeway combination Type C medicated
feeds used for increased rate of weight
gain, improved feed efficiency, and
increased carcass leanness; for
prevention and control of coccidiosis
due to Eimeria bovis and E. zuernii; and
for suppression of estrus (heat) in
heifers fed in confinement for slaughter
during the last 28 to 42 days on feed.
The supplemental NADA provides for
an increased level of monensin. The
supplemental NADA is approved as of
November 20, 2007, and the regulations
in 21 CFR 558.500 are amended to
reflect the approval.
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
066104
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.
The agency has determined under 21
CFR 25.33(a)(2) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor environmental impact statement is
required.
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.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
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:
I
E:\FR\FM\13DER1.SGM
13DER1
]]>Agencies
[Federal Register Volume 72, Number 239 (Thursday, December 13, 2007)]
[Rules and Regulations]
[Pages 70774-70776]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24146]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
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 Pennfield Oil Co. that provides for a zero-
day preslaughter withdrawal time following use of oxytetracycline in
turkey and swine feed.
DATES: This rule is effective December 13, 2007.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail:
joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pennfield Oil Co., 14040 Industrial Rd.,
Omaha, NE 68144, filed a supplement to NADA 138-938 for PENNOX
(oxytetracycline) Type A medicated articles used for making medicated
feeds for the treatment of various bacterial diseases of livestock and
fish. The supplemental NADA provides for a zero-day withdrawal time
prior to slaughter when Type C medicated feeds containing
oxytetracycline are fed to turkeys or swine and for minor label
revisions. The supplemental application is approved as of November 26,
2007, and the regulations are amended in 21 CFR 558.450 to reflect the
approval, an editorial change, and a current format.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), summaries of safety and
effectiveness data and information submitted to support approval of
these applications 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.
The agency has determined under 21 CFR 25.33(a)(1) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
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, revise paragraphs (a)(1), (a)(2), (b)(3), and (d)
to read as follows:
Sec. 558.450 Oxytetracycline.
(a) * * *
(1) 10, 20, 30, 50, 100, and 200 grams per pound to No. 066104 in
Sec. 510.600(c) of this chapter.
(2) 50, 100, and 200 grams per pound to No. 048164 in Sec.
510.600(c) of this chapter.
(b) * * *
(3) 50-, 100-, and 200-gram per pound articles in paragraph (a)(2)
of this section contain oxytetracycline dihydrate expressed in terms of
an equivalent amount of oxytetracycline hydrochloride. Another 100-gram
per pound article in paragraph (a)(2) of this section contains
oxytetracycline hydrochloride.
* * * * *
(d) Conditions of use--(1) Chickens--
------------------------------------------------------------------------
Oxytetracycline
amount Indications for use Limitations Sponsor
------------------------------------------------------------------------
(i) 10 to 50 Chickens: For Feed continuously; 066104,
grams per ton (g/ increased rate of do not feed to 048164
ton) weight gain and chickens producing
improved feed eggs for human
efficiency. consumption.
------------------------------------------------------------------------
(ii) 100 to 200 g/ Chickens: For Feed continuously 066104,
ton control of for 7 to 14 days 048164
infectious (d); do not feed to
synovitis caused by chickens producing
Mycoplasma synoviae eggs for human
and control of fowl consumption; in low
cholera caused by calcium feeds,
Pasteurella withdraw 3 d before
multocida slaughter.
susceptible to
oxytetracycline.
------------------------------------------------------------------------
(iii) 400 g/ton Chickens: For Feed continuously 066104,
control of chronic for 7 to 14 d; do 048164
respiratory disease not feed to
(CRD) and air sac chickens producing
infection caused by eggs for human
Mycoplasma consumption; in low
gallisepticum and calcium feeds,
Escherichia coli withdraw 3 d before
susceptible to slaughter.
oxytetracycline.
------------------------------------------------------------------------
(iv) 500 g/ton Chickens: For Feed continuously 066104,
reduction of for 5 d; do not 048164
mortality due to feed to chickens
air sacculitis (air producing eggs for
sac infection) human consumption;
caused by E. coli withdraw 24 hours
susceptible to before slaughter;
oxytetracycline. in low calcium
feeds, withdraw 3 d
before slaughter.
------------------------------------------------------------------------
(2) Turkeys--
------------------------------------------------------------------------
Oxytetracycline
amount Indications for use Limitations Sponsor
------------------------------------------------------------------------
(i) 10 to 50 g/ Growing turkeys: For Feed continuously; 066104,
ton increased rate of do not feed to 048164
weight gain and turkeys producing
improved feed eggs for human
efficiency. consumption.
------------------------------------------------------------------------
[[Page 70775]]
(ii) 100 g/ton Turkeys: For control Feed continuously 066104,
of hexamitiasis for 7 to 14 d; do 048164
caused by Hexamita not feed to turkeys
meleagridis producing eggs for
susceptible to human consumption.
oxytetracycline.
------------------------------------------------------------------------
(iii) 200 g/ton Turkeys: For control Feed continuously 066104,
of infectious for 7 to 14 d; for 048164
synovitis caused by No. 066104 withdraw
M. synoviae 5 d before
susceptible to slaughter; for No.
oxytetracycline. 048164 zero-day
withdrawal time; do
not feed to turkeys
producing eggs for
human consumption.
------------------------------------------------------------------------
(iv) 25 Turkeys: For control Feed continuously 066104,
milligrams/pound of complicating for 7 to 14 d; for 048164
(mg/lb) of body bacterial organisms No. 066104 withdraw
weight daily associated with 5 d before
bluecomb slaughter; for No.
(transmissible 048164 zero-day
enteritis; withdrawal time; do
coronaviral not feed to turkeys
enteritis) producing eggs for
susceptible to human consumption.
oxytetracycline.
------------------------------------------------------------------------
(3) Swine--
------------------------------------------------------------------------
Oxytetracycline
amount Indications for use Limitations Sponsor
------------------------------------------------------------------------
(i) 10 to 50 g/ Swine: For increased Feed continuously. 066104,
ton rate of weight gain 048164
and improved feed
efficiency.
------------------------------------------------------------------------
(ii) 10 mg/lb of 1. Swine: For Feed continuously 066104,
body weight treatment of for 7 to 14 d. 048164
daily bacterial enteritis
caused by E. coli
and Salmonella
choleraesuis
susceptible to
oxytetracycline and
treatment of
bacterial pneumonia
caused by P.
multocida
susceptible to
oxytetracycline.
2. Breeding swine: Feed continuously 066104,
For control and for 14 d. 048164
treatment of
leptospirosis
(reducing the
incidence of
abortion and
shedding of
leptospirae) caused
by Leptospira
pomona susceptible
to oxytetracycline.
------------------------------------------------------------------------
(4) Cattle--
------------------------------------------------------------------------
Oxytetracycline
amount Indications for use Limitations Sponsor
------------------------------------------------------------------------
(i) 0.05 to 0.1 Calves (up to 250 Feed continuously in 066104,
mg/lb of body lb): For increased milk replacer or 048164
weight daily rate of weight gain starter feed.
and improved feed
efficiency.
------------------------------------------------------------------------
(ii) 10 mg/lb of 1. Calves and beef Feed continuously 066104,
body weight and nonlactating for 7 to 14 d; for 048164
daily dairy cattle: For No. 048164,
treatment of withdraw 5 d before
bacterial enteritis slaughter; for No.
caused by E. coli 066104, zero-day
and bacterial withdrawal time.
pneumonia (shipping
fever complex)
caused by P.
multocida
susceptible to
oxytetracycline.
2. Calves: For Feed continuously 066104,
treatment of for 7 to 14 d in 048164
bacterial enteritis milk replacer or
caused by E. coli starter feed; for
susceptible to No. 048164,
oxytetracycline. withdraw 5 d before
slaughter; for No.
066104, zero-day
withdrawal time.
------------------------------------------------------------------------
(iii) 25 mg/head/ Calves (250 to 400 Feed continuously. 066104,
day lb): For increased 048164
rate of weight gain
and improved feed
efficiency.
------------------------------------------------------------------------
(iv) 75 mg/head/ Growing cattle (over Feed continuously. 066104,
day 400 lb): For 048164
increased rate of
weight gain,
improved feed
efficiency, and
reduction of liver
condemnation due to
liver abscesses.
------------------------------------------------------------------------
(v) 0.5 to 2.0 g/ Cattle: For Feed 3 to 5 d before 066104,
head/day prevention and and after arrival 048164
treatment of the in feedlots.
early stages of
shipping fever
complex.
------------------------------------------------------------------------
(5) Minor species--
------------------------------------------------------------------------
Oxytetracycline
amount Indications for use Limitations Sponsor
------------------------------------------------------------------------
(i) 10 to 20 g/ Sheep: For increased Feed continuously. 066104,
ton rate of weight gain 048164
and improved feed
efficiency.
------------------------------------------------------------------------
[[Page 70776]]
(ii) 10 mg/lb of Sheep: For treatment Feed continuously 066104,
body weight of bacterial for 7 to 14 d; 048164
daily enteritis caused by withdraw 5 d before
E. coli and slaughter.
bacterial pneumonia
caused by P.
multocida
susceptible to
oxytetracycline.
------------------------------------------------------------------------
(iii) 200 mg/ Honey bees: For Remove at least 6 066104,
colony control of American weeks prior to main 048164
foulbrood caused by honey flow.
Paenibacillus
larvae and European
foulbrood caused by
Streptococcus
pluton susceptible
to oxytetracycline.
------------------------------------------------------------------------
(iv) 250 mg/ Pacific salmon: For For salmon not over 066104
kilogram of fish/ marking of skeletal 30 g body weight;
day (11.35 g/100 tissue. administer as sole
lb of fish/day) ration for 4
consecutive days;
fish not to be
liberated for at
least 7 d following
the last
administration of
medicated feed.
------------------------------------------------------------------------
(v) 2.5 to 3.75 g/ 1. Salmonids: For Administer in mixed 066104
100 lb of fish/ control of ulcer ration for 10 d; do
day disease caused by not liberate fish
Hemophilus piscium, or slaughter fish
furunculosis caused for food for 21 d
by Aeromonas following the last
salmonicida, administration of
bacterial medicated feed; do
hemorrhagic not administer when
septicemia caused water temperature
by A. liquefaciens, is below 9 [deg]C
and pseudomonas (48.2 [deg]F).
disease.
2. Catfish: For Administer in mixed 066104
control of ration for 10 d; do
bacterial not liberate fish
hemorrhagic or slaughter fish
septicemia caused for food for 21 d
by A. liquefaciens following the last
and pseudomonas administration of
disease. medicated feed; do
not administer when
water temperature
is below 16.7
[deg]C (62 [deg]F).
------------------------------------------------------------------------
(vi) 1 g/lb of Lobsters: For Administer as sole 066104
medicated feed control of ration for 5
gaffkemia caused by consecutive days;
Aerococcus withdraw medicated
viridans. feed 30 d before
harvesting
lobsters.
------------------------------------------------------------------------
(6) Oxytetracycline may be used in accordance with the provisions
of this section in the combinations as follows:
(i) Carbadox as in Sec. 558.115.
(ii) Lasalocid as in Sec. 558.311.
(iii) Melengestrol acetate as in Sec. 558.342.
(iv) Robenidine hydrochloride as in Sec. 558.515.
(v) Salinomycin as in Sec. 558.550.
Dated: December 5, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-24146 Filed 12-12-07; 8:45 am]
BILLING CODE 4160-01-S
