New Animal Drugs for Use in Animal Feeds: Oxytetracycline; Neomycin
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
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.
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:
Oxytetracycline and neomycin sulfate amount in grams per
Indications for use
Limitations
Sponsors ton of feed
(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.
(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.
(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.
(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.
(2) Turkeys. It is used in feed as follows:
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.
(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.
(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.
(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.
(3) Swine. It is used in feed as follows:
Page 40725
Oxytetracycline and neomycin sulfate amount
Indications for use
Limitations
Sponsors
(i) 10 to 50 g/ton of feed
Swine: For increased rate of Feed continuously.
048164 weight gain and improved
066104 feed efficiency.
(ii) To provide 10 mg/lb of 1. Swine: For treatment of
Feed continuously for 7 to
048164 body weight daily.
bacterial enteritis caused 14 d; withdraw 5 d before
066104 by E. coli and Salmonella
slaughter. choleraesuis and treatment of bacterial pneumonia caused by P. multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin. 2. Breeding swine: For
Feed continuously for not
048164 control and treatment of
more than 14 d; withdraw 5
066104 leptospirosis (reducing the d before slaughter. incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline.
(4) Cattle and sheep. It is used in feed as follows:
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.
(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.
(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
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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.
(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.
(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.
(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.
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
