[Federal Register Volume 72, Number 131 (Tuesday, July 10, 2007)]
[Rules and Regulations]
[Pages 37437-37439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-13369]


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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: 
[email protected].

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:

----------------------------------------------------------------------------------------------------------------
Ivermectin in g/ton  Combination in g/ton
      of feed               of feed               Indications for use               Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(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).
----------------------------------------------------------------------------------------------------------------
(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.
----------------------------------------------------------------------------------------------------------------

[[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.
----------------------------------------------------------------------------------------------------------------
(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.
----------------------------------------------------------------------------------------------------------------
(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.
----------------------------------------------------------------------------------------------------------------
(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.
----------------------------------------------------------------------------------------------------------------
(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.
----------------------------------------------------------------------------------------------------------------
(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).
----------------------------------------------------------------------------------------------------------------

[[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.
----------------------------------------------------------------------------------------------------------------
(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.
----------------------------------------------------------------------------------------------------------------


    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