[Federal Register: July 10, 2007 (Volume 72, Number 131)]
[Rules and Regulations]
[Page 37437-37439]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10jy07-7]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal Feeds; Ivermectin
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 Merial Ltd. The supplemental NADA revises
the approved concentration of ivermectin in Type C medicated feed
administered as a top dress to adult and breeding swine for the
treatment and control of various internal and external parasites.
DATES: This rule is effective July 10, 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: Merial Ltd., 3239 Satellite Blvd., Bldg.
500, Duluth, GA 30096-4640, filed a supplement to NADA 140-974 that
provides for use of IVOMEC (ivermectin) Premix for Swine, a Type A
medicated article, for the treatment and control of various internal
and external parasites. The supplement revises the approved
concentration of ivermectin in Type C medicated feed administered as a
top dress to adult and breeding swine. The supplemental NADA is
approved as of June 15, 2007, and the regulations in 21 CFR 558.300 are
amended to reflect the approval and a current format.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
FDA 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 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:
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. Revise Sec. 558.300 to read as follows:
Sec. 558.300 Ivermectin.
(a) Specifications. Type A medicated article containing 2.72 grams
ivermectin per pound (g/lb).
(b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.344 of this chapter.
(d) Special considerations. See Sec. 500.25 of this chapter.
(e) Conditions of use in swine. It is used in feed as follows:
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Ivermectin in g/ton Combination in g/ton
of feed of feed Indications for use Limitations Sponsor
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(1) 1.8 (to provide .................... Weaned, growing-finishing swine: Feed as the only feed 050604
0.1 milligram per For treatment and control of for 7 consecutive days.
kilogram (mg/kg) gastrointestinal roundworms Withdraw 5 days before
of body weight per (Ascaris suum, adults and slaughter.
day) fourth-stage larvae; Ascarops
strongylina, adults;
Hyostrongylus rubidus, adults
and fourth-stage larvae;
Oesophagostomum spp., adults
and fourth-stage larvae);
kidneyworms (Stephanurus
dentatus, adults and fourth-
stage larvae); lungworms
(Metastrongylus spp., adults);
threadworms (Strongyloides
ransomi, adults and somatic
larvae); lice (Haematopinus
suis); and mange mites
(Sarcoptes scabiei var. suis).
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(2) 1.8 (to provide Bacitracin methylene Weaned, growing-finishing swine: For use in swine feed 050604
0.1 mg/kg of body disalicylate, 10 to As in paragraph (e)(1) of this only. Feed as the only
weight per day) 30 section; and for increased rate feed for 7 consecutive
of weight gain and improved days. Withdraw 5 days
feed efficiency. before slaughter.
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[[Page 37438]]
(3) 1.8 (to provide Bacitracin methylene Weaned, growing-finishing swine: For use in swine feed 050604
0.1 mg/kg of body disalicylate, 250 As in paragraph (e)(1) of this only. Feed as the only
weight per day) section; and for control of feed for 7 consecutive
swine dysentery associated with days. Withdraw 5 days
Treponema hyodysenteriae on before slaughter.
premises with a history of
swine dysentery, but where
symptoms have not yet occurred,
or following an approved
treatment of disease condition.
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(4) 1.8 (to provide Lincomycin, 20 Weaned, growing-finishing swine: Feed as the only feed 050604
0.1 mg/kg of body For treatment and control of for 7 consecutive days.
weight per day) gastrointestinal roundworms Not to be fed to swine
(Ascaris suum, adults and that weigh more than
fourth-stage larvae; Ascarops 250 lbs. Withdraw 5
strongylina, adults; days before slaughter.
Hyostrongylus rubidus, adults Also see paragraphs
and fourth-stage larvae; (c)(1) and (c)(2) in
Oesophagostomum spp., adults Sec. 558.325 of this
and fourth-stage larvae); chapter.
kidneyworms (Stephanurus
dentatus, adults and fourth-
stage larvae); lungworms
(Metastrongylus spp., adults);
lice (Haematopinus suis); and
mange mites (Sarcoptes scabiei
var. suis); and for increased
rate of weight gain.
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(5) 1.8 (to provide Lincomycin, 40 Weaned, growing-finishing swine: Feed as the only feed 050604
0.1 mg/kg of body As in paragraph (e)(4) of this for 7 consecutive days.
weight per day) section; and for control of Not to be fed to swine
swine dysentery on premises that weigh more than
with a history of swine 250 lbs. Also see
dysentery, but where symptoms paragraphs (c)(1) and
have not yet occurred. (c)(2) in Sec.
558.325 of this
chapter. Withdraw 5
days before slaughter.
A separate feed
containing 40 g/ton
lincomycin may be
continued to complete
the lincomycin
treatment.
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(6) 1.8 (to provide Lincomycin, 100 Weaned, growing-finishing swine: Feed as the only feed 050604
0.1 mg/kg of body As in paragraph (e)(4) of this for 7 consecutive days
weight per day) section; and for treatment of followed by a separate
swine dysentery. feed containing 100 g/
ton lincomycin for an
additional 14 days to
complete the lincomycin
treatment. Withdraw 6
days before slaughter.
Not to be fed to swine
that weigh more than
250 lbs. Also see
paragraphs (c)(1) and
(c)(2) in Sec.
558.325 of this
chapter.
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(7) 1.8 (to provide Lincomycin, 200 Weaned, growing-finishing swine: Feed as the only feed 050604
0.1 mg/kg of body As in paragraph (e)(4) of this for 7 consecutive days
weight per day) section; and for reduction in followed by a separate
severity of swine mycoplasmal feed containing 200 g/
pneumonia caused by Mycoplasma ton lincomycin for an
hyopneumoniae. additional 14 days to
complete the lincomycin
treatment. Withdraw 6
days before slaughter.
Not to be fed to swine
that weigh more than
250 lbs. Also see
paragraphs (c)(1) and
(c)(2) in Sec.
558.325 of this
chapter.
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(8) 1.8 to 11.8 (to .................... Adult and breeding swine: For Feed as the only feed 050604
provide 0.1 mg/kg treatment and control of for 7 consecutive days.
of body weight per gastrointestinal roundworms Withdraw 5 days before
day) (Ascaris suum, adults and slaughter.
fourth-stage larvae; Ascarops
strongylina, adults;
Hyostrongylus rubidus, adults
and fourth-stage larvae;
Oesophagostomum spp., adults
and fourth-stage larvae);
kidneyworms (Stephanurus
dentatus, adults and fourth-
stage larvae); lungworms
(Metastrongylus spp., adults);
threadworms (Strongyloides
ransomi, adults and somatic
larvae, and prevention of
transmission of infective
larvae to piglets, via the
colostrum or milk, when fed
during gestation); lice
(Haematopinus suis); and mange
mites (Sarcoptes scabiei var.
suis).
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[[Page 37439]]
(9) 1.8 to 11.8 (to Bacitracin methylene Pregnant sows: As in paragraph Feed as the only feed 050604
provide 0.1 mg/kg disalicylate, 250 (e)(8) of this section; and for for 7 consecutive days.
of body weight per control of clostridial Withdraw 5 days before
day) enteritis caused by Clostridium slaughter. Feed
perfringens in suckling bacitracin methylene
piglets. disalicylate Type C
medicated feed to sows
from 14 days before
through 21 days after
farrowing on premises
with a history of
clostridial scours.
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(10) 18.2 to 120 .................... Adult and breeding swine: As in Top dress on daily 050604
(to provide 0.1 mg/ paragraph (e)(8) of this ration for individual
kg of body weight section. treatment for 7
per day) consecutive days.
Withdraw 5 days before
slaughter.
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Dated: June 27, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-13369 Filed 7-9-07; 8:45 am]
BILLING CODE 4160-01-S