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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 558

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: New Animal Drugs for Use in Animal Feeds; Oxytetracycline

DATES: This rule is effective December 13, 2007.

DOCUMENT 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.

SUMMARY: Oxytetracycline,

SUPPLEMENTAL INFORMATION

Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, filed a supplement to NADA 138938 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 zeroday 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 (HFA305), 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. 801808.
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:
PART 558NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.
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 200gram per pound articles in paragraph (a)(2) of this section contain oxytetracycline dihydrate expressed in terms of an equivalent amount of oxytetracycline hydrochloride. Another 100gram 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 zeroday
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 zeroday
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, zeroday
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, zeroday
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. E724146 Filed 121207; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Joan C. Gotthardt, Center for Veterinary Medicine (HFV130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018277571, email:
joan.gotthardt@fda.hhs.gov.