[Federal Register Volume 76, Number 237 (Friday, December 9, 2011)]
[Rules and Regulations]
[Pages 76894-76895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-31613]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2011-N-0003]


New Animal Drugs for Use in Animal Feeds; Tilmicosin

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 Elanco Animal Health, a division of Eli 
Lilly & Co. The supplemental NADA provides for use of tilmicosin Type C 
medicated feeds by veterinary feed directive for the control of bovine 
respiratory disease in groups of beef and nonlactating dairy cattle.

DATES: This rule is effective December 9, 2011.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, (240) 276-8341, email: 
[email protected].

SUPPLEMENTARY INFORMATION: Elanco Animal Health, a division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a 
supplement to NADA 141-064 for PULMOTIL 90 (tilmicosin phosphate) Type 
A medicated article. The supplemental NADA provides for the use of 
tilmicosin Type C medicated feeds by veterinary feed directive for the 
control of bovine respiratory disease (BRD) associated with Mannheimia 
haemolytica, Pasteurella multocida, and Histophilus somni in groups of 
beef and nonlactating dairy cattle where active BRD has been diagnosed 
in at least 10 percent of the animals in the group. The supplemental 
NADA is approved as of August 19, 2011, and 21 CFR 558.4 and 558.618 
are amended to reflect the approval.
    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 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval 
qualifies for 3 years of marketing exclusivity beginning on the date of 
approval.
    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.
    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.

    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 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.


Sec.  558.4  [Amended]

0
2. In paragraph (d) of Sec.  558.4, in the ``Category II'' table, in 
the ``Type B maximum (100x)'' column, in the entry for ``Tilmicosin'', 
remove ``18.2 g/lb (4.0%)'' and in its place add ``37.9 g/lb (8.35%)''.

0
3. In Sec.  558.618, revise paragraphs (a), (c), and (e) to read as 
follows:


Sec.  558.618  Tilmicosin.

    (a) Specifications. Type A medicated article containing 90.7 grams 
(g) per pound tilmicosin as tilmicosin phosphate (200 g per kilogram).
* * * * *
    (c) Special considerations--(1) Tilmicosin medicated feeds are 
restricted to use under a veterinary feed directive (VFD). See Sec.  
558.6 of this chapter for required label statements and other 
limitations.
    (2) VFDs for tilmicosin phosphate shall not be refilled.
    (3) Labeling of tilmicosin Type B or Type C medicated feeds must 
bear the following warnings:
    (i) Do not allow horses or other equines access to feeds containing 
tilmicosin.
    (ii) Use of antibacterial drugs in the absence of a susceptible 
bacterial infection is unlikely to provide benefit to treated animals 
and may increase the risk of the development of drug-resistant 
pathogenic bacteria.
    (4) Special considerations for use of tilmicosin medicated swine 
feeds include the following:
    (i) The expiration date of VFDs for tilmicosin must not exceed 90 
days from the time of issuance.
    (ii) Labeling of tilmicosin Type B or Type C medicated feeds for 
swine must bear the following warning: ``Do not use in any feeds 
containing bentonite. Bentonite in feeds may affect the efficacy of 
tilmicosin.''
    (iii) Feed containing tilmicosin shall not be fed to pigs for more 
than 21 days during each phase of production without ceasing 
administration for reevaluation of antimicrobial use by a licensed 
veterinarian before reinitiating a further course of therapy with an 
appropriate antimicrobial.
    (5) Special consideration for use of tilmicosin medicated cattle 
feeds include the following:
    (i) The expiration date of VFDs for cattle must not exceed 45 days 
from the time of issuance.
    (ii) Labeling of tilmicosin Type B or Type C medicated feeds for 
cattle must bear the following warning: ``Do not use in any feeds 
containing bentonite, cottonseed meal, or cottonseed hulls. Bentonite, 
cottonseed meal, or cottonseed hulls in feeds may affect the efficacy 
of tilmicosin.''
    (iii) To assure both food safety and responsible use in cattle, 
administration of feed containing tilmicosin to cattle

[[Page 76895]]

experiencing an outbreak of BRD must be initiated during the first 45 
days of the production period, shall not exceed a single 14-
consecutive-day treatment, should not occur concurrent with or 
following administration of an injectable macrolide, and should not 
occur within 3 days following administration of a nonmacrolide 
injectable BRD therapy. Tilmicosin medicated feed treatment has not 
been evaluated in cattle with severe clinical disease. Cattle with 
severe clinical illness should be evaluated for individual treatment 
with an alternative non-macrolide therapy.
* * * * *
    (e) Conditions of use. It is used in feed as follows:

------------------------------------------------------------------------
 Tilmicosin phosphate in   Indications for
        grams/ton                use          Limitations      Sponsor
------------------------------------------------------------------------
(1) 181 to 363...........  Swine: For the   Feed                  000986
                            control of       continuously
                            swine            as the sole
                            respiratory      ration for 21-
                            disease          day period,
                            associated       beginning
                            with             approximately
                            Actinobacillus   7 days before
                            pleuropneumoni   an anticipated
                            ae and           disease
                            Pasteurella      outbreak. The
                            multocida.       safety of
                                             tilmicosin has
                                             not been
                                             established in
                                             male swine
                                             intended for
                                             breeding
                                             purposes.
                                             Swine intended
                                             for human
                                             consumption
                                             must not be
                                             slaughtered
                                             within 7 days
                                             of the last
                                             treatment with
                                             this drug
                                             product.
(2) 568 to 757...........  Cattle: For the  Feed                  000986
                            control of       continuously
                            bovine           for 14 days to
                            respiratory      provide 12.5
                            disease (BRD)    milligrams/
                            associated       kilogram/head/
                            with             day. The
                            Mannheimia       safety of
                            haemolytica,     tilmicosin has
                            Pasteurella      not been
                            multocida, and   established in
                            Histophilus      cattle
                            somni in         intended for
                            groups of beef   breeding
                            and              purposes. This
                            nonlactating     drug product
                            dairy cattle,    is not
                            where active     approved for
                            BRD has been     use in female
                            diagnosed in     dairy cattle
                            at least 10      20 months of
                            percent of the   age or older.
                            animals in the   Use in these
                            group.           cattle may
                                             cause drug
                                             residues in
                                             milk. This
                                             drug product
                                             is not
                                             approved for
                                             use in calves
                                             intended to be
                                             processed for
                                             veal.
                                            A withdrawal
                                             period has not
                                             been
                                             established in
                                             preruminating
                                             calves. Cattle
                                             intended for
                                             human
                                             consumption
                                             must not be
                                             slaughtered
                                             within 28 days
                                             of the last
                                             treatment with
                                             this drug
                                             product.
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    Dated: December 5, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-31613 Filed 12-8-11; 8:45 am]
BILLING CODE 4160-01-P