[Federal Register: December 23, 2005 (Volume 70, Number 246)]
[Rules and Regulations]               
[Page 76163]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23de05-7]                         


[[Page 76163]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 556

 
New Animal Drugs; Moxidectin

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 new animal drug application 
(NADA) filed by Fort Dodge Animal Health, Division of Wyeth. The NADA 
provides for oral use of moxidectin solution in sheep for the treatment 
and control of a variety of internal parasites.

DATES: This rule is effective December 23, 2005.

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.gov.


SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth, 
800 Fifth St. NW., Fort Dodge, IA 50501, filed NADA 141-247 for 
CYDECTIN (moxidectin) Oral Drench for Sheep, used for the treatment and 
control of various internal parasites in sheep. The NADA is approved as 
of November 30, 2005, and the regulations are amended in part 520 (21 
CFR part 520) by adding Sec.  520.1454 and in part 556 (21 CFR part 
556) by revising Sec.  556.426 to reflect the approval. The basis of 
approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 573(c) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 360ccc-2), this approval qualifies for 7 years of 
exclusive marketing rights beginning November 30, 2005, because the new 
animal drug has been declared a designated new animal drug by FDA under 
section 573(a) of the act.
    FDA has determined under 21 CFR 25.33(d)(4) 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

21 CFR Part 520

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

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 parts 520 and 
556 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  520.1451  [Amended]

0
2. Section 520.1451 is amended by revising the section heading to read 
``Moxidectin tablets.''
0
3. Add Sec.  520.1454 to read as follows:


Sec.  520.1454  Moxidectin solution.

    (a) Specifications. Each milliliter (mL) of solution contains 1 
milligram (mg) moxidectin.
    (b) Sponsor. See No. 000856 in Sec.  510.600 of this chapter.
    (c) Related tolerances. See Sec.  556.426 of this chapter.
    (d) Special considerations. See Sec.  500.25 of this section.
    (e) Conditions of use in sheep--(1) Amount. Administer 1 mL per 11 
pounds body weight (1 mL per 5 kilograms) by mouth.
    (2) Indications for use. For the treatment and control of the adult 
and L4 larval stages of Haemonchus contortus, Teladorsagia 
circumcincta, T. trifurcata, Trichostrongylus axei, T. colubriformis, 
T. vitrinus, Cooperia curticei, C. oncophora, Oesophagostomum 
columbianum, O. venulosum, Nematodirus battus, N. filicollis, and N. 
spathiger.
    (3) Limitations. Sheep must not be slaughtered for human 
consumption within 7 days of treatment. Because a withholding time in 
milk has not been established for this product, do not use in female 
sheep providing milk for human consumption.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
4. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.
0
5. Section 556.426 is amended by adding paragraph (b)(2) and revising 
paragraph (c) to read as follows:


Sec.  556.426  Moxidectin.

* * * * *
    (b) * * *
    (2) Sheep--(i) Fat (the target tissue). The tolerance for parent 
moxidectin (the marker residue) is 900 parts per billion (ppb).
    (ii) Liver. The tolerance for parent moxidectin (the marker 
residue) is 200 ppb.
    (iii) Muscle. The tolerance for parent moxidectin (the marker 
residue) is 50 ppb.
    (c) Related conditions of use. See Sec. Sec.  520.1454 and 522.1450 
of this chapter.

    Dated: December 12, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-24386 Filed 12-22-05; 8:45 am]

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