[Federal Register Volume 71, Number 174 (Friday, September 8, 2006)]
[Rules and Regulations]
[Pages 53005-53006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14899]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558


New Animal Drugs; Zilpaterol

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 a zilpaterol 
hydrochloride Type A medicated article to formulate Type B and Type C 
medicated feeds for cattle fed in confinement for slaughter.

DATES: This rule is effective September 8, 2006.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-120), 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, 29160 Intervet 
Lane, Millsboro, DE 19966, filed NADA 141-258 for the oral use of 
ZILMAX (zilpaterol hydrochloride 4.8%) Type A medicated article to 
formulate Type B (liquid and dry) and Type C medicated cattle feeds 
used for increased rate of weight gain, improved feed efficiency, and 
increased carcass leanness in cattle fed in confinement for slaughter 
during the last 20 to 40 days on feed. The NADA is approved as of 
August 10, 2006, and the regulations are amended in part 556 (21 CFR 
part 556) and part 558 (21 CFR part 558) by adding new Sec. Sec.  
556.765 and 558.665 and by amending Sec.  558.4 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 between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval 
qualifies for 5 years of marketing exclusivity beginning August 10, 
2006.
    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 556

    Animal drugs, Foods.

21 CFR Part 558

    Animal drugs, Animal feeds.

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 556 and 
558 are amended as follows:

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

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

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

0
2. Add Sec.  556.765 to read as follows:


Sec.  556.765  Zilpaterol.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
zilpaterol is 0.083 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The 
tolerance for zilpaterol freebase (the marker residue) is 12 parts per 
billion (ppb).
    (ii) [Reserved]
    (2) [Reserved]

[[Page 53006]]

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
3. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

0
4. In paragraph (d) of Sec.  558.4, in the ``Category II'' table, 
alphabetically add an entry for ``Zilpaterol'' to read as follows:


Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                                       CATEGORY II
--------------------------------------------------------------------------------------------------------------------------------------------------------
                   Drug                       Assay limits percent\1\ Type A           Type B maximum (100x)         Assay limits percent\1\ Type B/C\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
Zilpaterol                                                             90-110                     680 g/t (0.075%)                        80-110/75-115
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Percent of labeled amount.
\2\Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a Type B
  medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of
  dilution of a Type B medicated feed with lower assay limits to make Type C medicated feed.

* * * * *

0
5. Add Sec.  558.665 to read as follows:


Sec.  558.665  Zilpaterol.

    (a) Specifications. Type A medicated articles containing 21.77 
grams (g) zilpaterol hydrochloride per pound.
    (b) Approvals. See No. 057926 in Sec.  510.600(c) of this chapter.
    (c) Tolerances. See Sec.  556.765 of this chapter.
    (d)Special considerations--(1) Labeling of Type B and Type C cattle 
feeds shall bear the following:
    (i) Do not allow horses or other equines access to feed containing 
zilpaterol.
    (ii) Not for use in animals intended for breeding.
    (iii) Do not use in veal calves.
    (2) Type B Liquid Feeds can be manufactured containing 68 to 680 g 
zilpaterol hydrochloride/ton. The liquid Type B feeds must be 
maintained at a pH of 3.8 to 7.5. For liquid feeds stored in 
recirculating tank systems: Recirculate immediately prior to use for 
not less than 10 minutes, moving not less than 1 percent of the tank 
contents per minute from the bottom of the tank to the top. Recirculate 
daily as described even when not used. For liquid feeds stored in 
mechanical, air or other agitation-type tank systems: Agitate 
immediately prior to use for not less than 10 minutes, creating a 
turbulence at the bottom of the tank that is visible at the top. 
Agitate daily as described even when not used.
    (3) Do not pellet medicated feeds containing zilpaterol.
    (e) Conditions of use in cattle--(1) Amount. 6.8 g/ton of feed to 
provide 60 to 90 milligrams zilpaterol hydrochloride per head per day.
    (2) Indications for use. For increased rate of weight gain, 
improved feed efficiency and increased carcass leanness in cattle fed 
in confinement for slaughter during the last 20 to 40 days on feed.
    (3) Limitations. Feed continuously as the sole ration during the 
last 20 to 40 days on feed. Withdrawal period: 3 days.

    Dated: August 29, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-14899 Filed 9-7-06; 8:45 am]
BILLING CODE 4160-01-S