FR Doc E9-19414

[Federal Register: August 13, 2009 (Volume 74, Number 155)]
[Rules and Regulations]
[Page 40723-40726]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au09-3]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2009-N-0665]

New Animal Drugs for Use in Animal Feeds; Oxytetracycline;
Neomycin

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 Pennfield Oil Co. The supplemental NADA
provides for the use of fixed-combination Type A medicated articles
containing oxytetracycline and neomycin sulfate to formulate two-way,
fixed-combination drug Type B and Type C medicated feeds for chickens,
turkeys, swine, cattle, and sheep. This approval reflects FDA's
effectiveness conclusions which relied on the National Academy of
Sciences/National Research Council (NAS/NRC) Drug Efficacy Study
Group's evaluation of the effectiveness of these drugs when used in
animal feed as single ingredients.

DATES: This rule is effective August 13, 2009.

FOR FURTHER INFORMATION CONTACT: Harlan Howard, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8111, e-mail: harlan.howard@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 8, 2003
(68 FR 47332), as corrected October 7, 2003 (68 FR 57911), as part of
the Drug Efficacy Study Implementation (DESI) program, CVM announced
the effective conditions of use for several drug products and use
combinations that were listed in Sec. 558.15 (21 CFR 558.15). CVM
proposed to withdraw the NADAs for those products or use combinations
lacking substantial evidence of effectiveness following a 90-day
opportunity to supplement the NADAs with labeling conforming to the
relevant findings of effectiveness.
In response to that notice, Pennfield Oil Co., (Pennfield) 14040
Industrial Rd., Omaha, NE 68144, filed a hearing request for its
approved NADA 138-939 NEO-OXY 50/50, NEO-OXY 100/100, and NEO-OXY 100/
100 MR (oxytetracycline and neomycin sulfate). These products are two-
way, fixed-combination Type A medicated articles used to make two-way
combination drug Type C medicated feeds. Pennfield subsequently filed a
supplement to NADA 138-939 to revise the labeling of these products to
comply with these findings of effectiveness. The supplemental NADA
provided for use of these fixed-combination Type A medicated articles
to formulate two-way, fixed-combination drug Type B and Type C
medicated feeds containing oxytetracycline and neomycin sulfate, in a
1:1 ratio, for several production and therapeutic indications in
chickens, turkeys, swine, cattle, and sheep. The supplemental NADA is
approved as of July 2, 2009, and the regulations are amended in 21 CFR
558.455 to reflect the approval. Pennfield has since withdrawn its
hearing request for NDA 138-939.
Approval of this supplemental NADA did not require review of any
new safety or effectiveness data. Therefore, a freedom of information
summary was not prepared.
The DESI evaluation was concerned only with the effectiveness of
the drug products and use combinations. Nothing in this document
constitutes a bar to further proceedings with respect to questions of
safety of the subject drugs in treated animals or of the drugs or their
metabolites in food products derived from treated animals.
Products that comply with FDA's findings of effectiveness are
eligible for copying, as described in the Generic Animal Drug and
Patent Term Restoration Act Policy Letter Eight, August 21, 1991 (56 FR
41561). Accordingly, sponsors may now obtain approval of abbreviated
NADAs for this fixed combination Type A medicated article.
The agency has determined under 21 CFR 25.33 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

[[Page 40724]]

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. Amend Sec. 558.455 as follows:
0
a. Revise paragraph (b);
0
b. Redesignate paragraph (d) as paragraph (e);
0
c. Add new paragraph (d); and
0
d. Revise newly redesignated paragraph (e).
The redesignation, additions, and revisions read as follows:

Sec. 558.455 Oxytetracycline and neomycin.

* * * * *
(b) Sponsors. See Nos. 048164 and 066104 in Sec. 510.600(c) of
this chapter.
* * * * *
(d) Special considerations. Cattle feeds shall bear the following
warning statement: ``Use of more than one product containing neomycin
or failure to follow withdrawal times may result in illegal drug
residues.''
(e) Indications for use--(1) Chickens. It is used in feed as
follows:

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Oxytetracycline and neomycin
sulfate amount in grams per Indications for use Limitations Sponsors
ton of feed
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(i) 10 to 50 Chickens: For increased rate Feed continuously; do not 048164
of weight gain and improved feed to chickens producing 066104
feed efficiency. eggs for human
consumption; in low
calcium feeds withdraw 3
days before slaughter.
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(ii) 100 to 200 Chickens: For control of Feed continuously for 7 to 048164
infectious synovitis caused 14 d; do not feed to 066104
by Mycoplasma synoviae; chickens producing eggs
control of fowl cholera for human consumption; in
caused by Pasteurella low calcium feed, withdraw
multocida susceptible to 3 d before slaughter.
oxytetracycline.
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(iii) 400 Chickens: For control of Feed continuously for 7 to 048164
chronic respiratory disease 14 d; do not feed to 066104
(CRD) and air sac infection chickens producing eggs
caused by M. gallisepticum for human consumption; in
and Escherichia coli low calcium feeds,
susceptible to withdraw 3 d before
oxytetracycline. slaughter.
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(iv) 500 Chickens: For reduction of Feed continuously for 5 d; 048164
mortality due to air do not feed to chickens 066104
sacculitis (air-sac- producing eggs for human
infection) caused by E. consumption; withdraw 24
coli susceptible to hours before slaughter; in
oxytetracycline. low calcium feeds withdraw
3 d before slaughter.
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(2) Turkeys. It is used in feed as follows:

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Oxytetracycline and neomycin
sulfate amount Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 10 to 50 grams per ton Growing turkeys: For Feed continuously; do not 048164
(g/ton) of feed increased rate of weight feed to turkeys producing 066104
gain and improved feed eggs for human
efficiency. consumption.
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(ii) 100 g/ton of feed Turkeys: For control of Feed continuously for 7 to 048164
hexamitiasis caused by 14 d; do not feed to 066104
Hexamita meleagridis turkeys producing eggs for
susceptible to human consumption.
oxytetracycline.
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(iii) 200 g/ton of feed Turkeys: For control of Feed continuously for 7 to 048164
infectious synovitis caused 14 d; withdraw 5 d before 066104
by M. synoviae susceptible slaughter; do not feed to
to oxytetracycline. turkeys producing eggs for
human consumption.
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(iv) To provide 25 Turkeys: For control of Feed continuously for 7 to 048164
milligrams per pound (mg/ complicating bacterial 14 d; withdraw 5 d before 066104
lb) of body weight daily. organisms associated with slaughter; do not feed to
bluecomb (transmissible turkeys producing eggs for
enteritis; coronaviral human consumption.
enteritis) susceptible to
oxytetracycline.
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(3) Swine. It is used in feed as follows:

[[Page 40725]]

(4) Cattle and sheep. It is used in feed as follows:

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Oxytetracycline and neomycin
sulfate amount Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 10 to 20 g/ton of feed Sheep: For increased rate of Feed continuously. 048164
weight gain and improved 066104
feed efficiency.
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(ii) To provide 0.05 to 0.1 Calves (up to 250 lb): For Feed continuously; in milk 048164
mg/lb of body weight daily. increased rate of weight replacers or starter feed. 066104
gain and improved feed
efficiency.
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(iii) To provide 10 mg/lb of 1. Calves and beef and Feed continuously for 7 to 048164
body weight daily. nonlactating dairy cattle: 14 d; in feed or milk 066104
For treatment of bacterial replacers. If symptoms
enteritis caused by E. coli persist after using for 2
and bacterial pneumonia or 3 days, consult a
(shipping fever complex) veterinarian. Treatment
caused by P. multocida should continue 24 to 48
susceptible to hours beyond remission of
oxytetracycline; treatment disease symptoms. A
and control of withdrawal period has not
colibacillosis (bacterial been established for use
enteritis) caused by E. in preruminating calves.
coli susceptible to Do not use in calves to be
neomycin. processed for veal. A milk
discard time has not been
established for use in
lactating dairy cattle. Do
not use in female dairy
cattle 20 months of age or
older. Withdraw 5 d before
slaughter.
2. Calves (up to 250 lb): Feed continuously for 7 to 048164
For treatment of bacterial 14 d; in milk replacers or 066104
enteritis caused by E. coli starter feed. If symptoms
susceptible to persist after using for 2
oxytetracycline; treatment or 3 days, consult a
and control of veterinarian. Treatment
colibacillosis (bacterial should continue 24 to 48
enteritis) caused by E. hours beyond remission of
coli susceptible to disease symptoms. A
neomycin. withdrawal period has not
been established for use
in preruminating calves.
Do not use in calves to be
processed for veal. A milk
discard time has not been
established for use in
lactating dairy cattle. Do
not use in female dairy
cattle 20 months of age or
older. Withdraw 5 d before
slaughter.

[[Page 40726]]

3. Sheep: For treatment of Feed continuously for 7 to 048164
bacterial enteritis caused 14 d. If symptoms persist 066104
by E. coli and bacterial after using for 2 or 3
pneumonia caused by P. days, consult a
multocida susceptible to veterinarian. Treatment
oxytetracycline; treatment should continue 24 to 48
and control of hours beyond remission of
colibacillosis (bacterial disease symptoms. Withdraw
enteritis) caused by E. 5 d before slaughter.
coli susceptible to
neomycin.
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(iv) To provide 25 mg/head/ Calves (250 to 400 lb): For Feed continuously. 048164
day increased rate of weight 066104
gain and improved feed
efficiency.
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(v) To provide 75 mg/head/ Growing cattle (over 400 Feed continuously. 048164
day lb): For increased rate of 066104
weight gain; improved feed
efficiency, and reduction
of liver condemnation due
to liver abscesses.
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(vi) To provide 0.5 to 2.0 g/ Cattle: For prevention and Feed 3 to 5 d before and 048164
head/ day treatment of the early after arrival in feedlots. 066104
stages of shipping fever A withdrawal period has
complex. not been established for
use in preruminating
calves. Do not use in
calves to be processed for
veal. A milk discard time
has not been established
for use in lactating dairy
cattle. Do not use in
female dairy cattle 20
months of age or older.
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Dated: August 7, 2009.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. E9-19414 Filed 8-12-09; 8:45 am]

BILLING CODE 4160-01-S