[Federal Register Volume 68, Number 211 (Friday, October 31, 2003)]
[Rules and Regulations]
[Pages 62006-62007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27390]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 556


New Animal Drugs; Altrenogest

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 Intervet, Inc. The NADA provides for use of an 
altrenogest oral solution in gilts for synchronization of estrus.

DATES: This rule is effective October 31, 2003.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV 128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301 827-1600, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 405 State St., 
Millsboro, DE 19966, filed NADA 141-222 for the oral use of MATRIX 
(altrenogest) 0.22% Solution for synchronization of estrus in sexually 
mature gilts that have had at least one estrous cycle. The NADA is 
approved as of September 30, 2003, and the regulations are amended in 
21 CFR 520.48 and in part 556 (21 CFR part 556) by adding Sec.  556.36 
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.
    The agency has carefully considered the potential environmental 
impact of this action and has concluded that the action will not have a 
significant impact on the human environment and that an environmental 
impact statement is not required. FDA's finding of no significant 
impact and the evidence supporting that finding, contained in an 
environmental assessment, may be seen in the Division of Dockets 
Management (address above) between 9 a.m. and 4 p.m., Monday through 
Friday.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning September 30, 2003.
    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.

0
2. Section 520.48 is amended by revising paragraphs (c) and (d) to read 
as follows:


Sec.  520.48  Altrenogest solution.

* * * * *
    (c) Tolerances. See Sec.  556.36 of this chapter.
    (d) Conditions of use--(1)Horses--(i)Amount. 1.0 mL per 110 pounds 
body

[[Page 62007]]

weight (0.044 mg/kg) daily for 15 consecutive days.
    (ii) Indications for use. For suppression of estrus in mares.
    (iii) Limitations. For oral use in horses only; avoid contact with 
the skin. Do not administer to horses intended for use as food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Swine--(i) Amount. Administer 6.8 mL (15 mg altrenogest) per 
gilt once daily for 14 consecutive days by top-dressing on a portion of 
each gilt's daily feed.
    (ii) Indications for use. For synchronization of estrus in sexually 
mature gilts that have had at least one estrous cycle.
    (iii) Limitations. Do not use in gilts having a previous or current 
history of uterine inflammation (i.e., acute, subacute or chronic 
endometritis). Gilts must not be slaughtered for human consumption for 
21 days after the last treatment.

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

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

    Authority: 21 U.S.C. 342, 360b, 371.


0
4. Section 556.36 is added to read as follows:


Sec.  556.36  Altrenogest.

    (a) Acceptable Daily Intake (ADI). The ADI for total residues of 
altrenogest is 0.04 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Swine--(i) Liver (the target tissue). The 
tolerance for altrenogest (the marker residue) is 4 parts per billion 
(ppb).
    (ii) Muscle. The tolerance for altrenogest (the marker residue) is 
1 ppb.
    (2) [Reserved].

    Dated: October 10, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-27390 Filed 10-30-03; 8:45 am]
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