
[Federal Register Volume 77, Number 193 (Thursday, October 4, 2012)]
[Rules and Regulations]
[Pages 60622-60624]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24475]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 558

[Docket No. FDA-2012-N-0002]


New Animal Drugs; Change of Sponsor's Address; Monensin; 
Spinosad; 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 actions for new animal drug 
applications (NADAs) during August 2012 and to reflect a change of 
sponsor's address for Baxter Healthcare Corp. FDA is also informing the 
public of the availability of summaries of the basis of approval and of 
environmental review documents, where applicable.

DATES: This rule is effective October 4, 2012.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9019, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect original and supplemental approval actions during August 
2012, as listed in table 1 of this document. In addition, FDA is 
informing the public of the availability, where applicable, of 
documentation of environmental review required under the National 
Environmental Policy Act (NEPA) and, for actions requiring review of 
safety or effectiveness data, summaries of the basis of approval (FOI 
Summaries) under the Freedom of Information Act (FOIA). These public 
documents 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. Persons 
with access to the Internet may obtain these documents at the Center 
for Veterinary Medicine FOIA Electronic Reading Room. FOI Summaries may 
be found listed by application number at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/default.htm. Environmental assessments and findings of no significant 
impact may be found listed by the established name of the active 
pharmaceutical ingredient at: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/EnvironmentalAssessments/ucm300656.htm.
    Also, Baxter Healthcare Corp., 95 Spring St., New Providence, NJ 
07974, has informed FDA of a change of address to One Baxter Pkwy., 
Deerfield, IL 60015. Accordingly, the Agency is amending the 
regulations in 21 CFR 510.600(c) to reflect this change.

[[Page 60623]]



                                          Table 1--Original and Supplemental NADAs Approved During August 2012
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                                               New animal drug                                21 CFR
        NADA                Sponsor              product name              Action             section          FOIA  summary            NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-343............  Elanco Animal Health,  PULMOTIL 90            Original approval for         558.355  yes...................  CE \1\
                      A Division of Eli      (tilmicosin            use in two-way,              558.618
                      Lilly & Co., Lilly     phosphate) plus        combination drug
                      Corporate Center,      RUMENSIN 90            type B and type C
                      Indianapolis, IN       (monensin) Type A      medicated feeds for
                      46285.                 medicated articles.    cattle fed in
                                                                    confinement for
                                                                    slaughter.
141-277............  Elanco Animal Health,  COMFORTIS (spinosad)   Supplemental approval        520.2130  yes...................  CE \1\
                      A Division of Eli      Chewable Tablets.      for use in cats to
                      Lilly & Co., Lilly                            kill fleas and for
                      Corporate Center,                             the prevention and
                      Indianapolis, IN                              treatment of flea
                      46285.                                        infestations
                                                                    (Ctenocephalides
                                                                    felis) for 1 month
                                                                    on cats and kittens
                                                                    14 weeks of age and
                                                                    older and 2 pounds
                                                                    of body weight or
                                                                    greater.
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\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental
  assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the
  human environment.

    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 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 520

    Animal drugs.

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 parts 510, 
520, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


0
2. In Sec.  510.600, in the table in paragraph (c)(1), revise the entry 
for ``Baxter Healthcare Corp.''; and in the table in paragraph (c)(2), 
revise the entry for ``010019'' to read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                                * * * * *
Baxter Healthcare Corp., One Baxter Pkwy., Deerfield, IL          010019
 60015.
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
          Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
010019..............................  Baxter Healthcare Corp., One
                                       Baxter Pkwy., Deerfield, IL
                                       60015.
 
                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


0
4. Revise Sec.  520.2130 to read as follows:


Sec.  520.2130  Spinosad.

    (a) Specifications. Each chewable tablet contains 90, 140, 270, 
560, 810, or 1620 milligrams (mg) spinosad.
    (b) Sponsor. See No. 000986 in Sec.  510.600 of this chapter.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs--(i) Amount. Administer tablets 
once a month at a recommended minimum dosage of 13.5 mg per pound (30 
mg per kilogram) of body weight.
    (ii) Indications for use. To kill fleas and for the prevention and 
treatment of flea infestations (Ctenocephalides felis) for 1 month on 
dogs and puppies 14 weeks of age and older and 3.3 pounds of body 
weight or greater.
    (2) Cats--(i) Amount. Administer tablets once a month at a minimum 
dosage of 22.5 mg per pound (50 mg per kilogram) of body weight.
    (ii) Indications for use. To kill fleas and for the prevention and 
treatment of flea infestations (C. felis) for 1 month on cats and 
kittens 14 weeks of age and older and 2 pounds of body weight or 
greater.

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

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

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


0
6. In Sec.  558.355, redesignate paragraph (f)(8)(iv) as paragraph 
(f)(8)(v); and add new paragraph (f)(8)(iv) to read as follows:


Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (8) * * *
    (iv) Tilmicosin alone or in combination as in Sec.  558.618.
* * * * *

0
7. In Sec.  558.618, remove and reserve paragraph (c)(3)(ii); and 
revise paragraph (e) to read as follows:

[[Page 60624]]

Sec.  558.618  Tilmicosin.

* * * * *
    (e) * * *
    (1) Swine--

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 Tilmicosin  phosphate  in
         grams/ton            Combination in grams/ton    Indications for use        Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 181 to 363.............  ..........................  Swine: For the         Feed continuously as      000986
                                                          control of swine       the sole ration for
                                                          respiratory disease    21-day period,
                                                          associated with        beginning
                                                          Actinobacillus         approximately 7 days
                                                          pleuropneumoniae and   before an
                                                          Pasteurella            anticipated disease
                                                          multocida.             outbreak. The 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.
(ii) [Reserved]............  ..........................  .....................  .....................     000986
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     (2) Cattle--

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 Tilmicosin  phosphate  in
         grams/ton           Combination in grams/ton    Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 568 to 757............  ..........................  Beef and nonlactating  Feed continuously for      000986
                                                         dairy cattle: For      14 days to provide
                                                         the control of         12.5 milligrams/
                                                         bovine respiratory     kilogram/head/day.
                                                         disease (BRD)          The safety of
                                                         associated with        tilmicosin has not
                                                         Mannheimia             been established in
                                                         haemolytica,           cattle intended for
                                                         Pasteurella            breeding purposes.
                                                         multocida, and         This drug product is
                                                         Histophilus somni in   not approved for use
                                                         groups of beef and     in female dairy
                                                         nonlactating dairy     cattle 20 months of
                                                         cattle, where active   age or older. Use in
                                                         BRD has been           these cattle may
                                                         diagnosed in at        cause drug residues
                                                         least 10 percent of    in milk. This drug
                                                         the animals in the     product is not
                                                         group.                 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.
(ii) 568 to 757...........  Monensin, 5 to 40.........  Cattle fed in          Feed continuously for      000986
                                                         confinement for        14 days to provide
                                                         slaughter: For         12.5 milligrams
                                                         improved feed          tilmicosin/kilogram/
                                                         efficiency; and for    head/day. The safety
                                                         the control of         of tilmicosin has not
                                                         bovine respiratory     been established in
                                                         disease (BRD)          cattle intended for
                                                         associated with        breeding purposes.
                                                         Mannheimia             This drug product is
                                                         haemolytica,           not approved for use
                                                         Pasteurella            in female dairy
                                                         multocida, and         cattle 20 months of
                                                         Histophilus somni in   age or older. Use in
                                                         groups of cattle fed   these cattle may
                                                         in confinement for     cause drug residues
                                                         slaughter, where       in milk. This drug
                                                         active BRD has been    product is not
                                                         diagnosed in at        approved for use in
                                                         least 10 percent of    calves intended to be
                                                         the animals in the     processed for veal. A
                                                         group.                 withdrawal period has
                                                                                not been established
                                                                                in pre-ruminating
                                                                                calves. Cattle
                                                                                intended for human
                                                                                consumption must not
                                                                                be slaughtered within
                                                                                28 days of the last
                                                                                treatment with this
                                                                                drug product. See
                                                                                Sec.   558.355(d) of
                                                                                this chapter.
(iii) 568 to 757..........  Monensin, 10 to 40........  Cattle fed in          Feed continuously for      000986
                                                         confinement for        14 days to provide
                                                         slaughter: For         12.5 milligrams
                                                         prevention and         tilmicosin/kilogram/
                                                         control of             head/day. The safety
                                                         coccidiosis due to     of tilmicosin has not
                                                         Eimeria bovis and E.   been established in
                                                         zuernii; and for the   cattle intended for
                                                         control of bovine      breeding purposes.
                                                         respiratory disease    This drug product is
                                                         (BRD) associated       not approved for use
                                                         with Mannheimia        in female dairy
                                                         haemolytica,           cattle 20 months of
                                                         Pasteurella            age or older. Use in
                                                         multocida, and         these cattle may
                                                         Histophilus somni in   cause drug residues
                                                         groups of cattle fed   in milk. This drug
                                                         in confinement for     product is not
                                                         slaughter, where       approved for use in
                                                         active BRD has been    calves intended to be
                                                         diagnosed in at        processed for veal. A
                                                         least 10 percent of    withdrawal period has
                                                         the animals in the     not been established
                                                         group.                 in pre-ruminating
                                                                                calves. Cattle
                                                                                intended for human
                                                                                consumption must not
                                                                                be slaughtered within
                                                                                28 days of the last
                                                                                treatment with this
                                                                                drug product. See
                                                                                Sec.   558.355(d) of
                                                                                this chapter.
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    Dated: September 28, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-24475 Filed 10-3-12; 8:45 am]
BILLING CODE 4160-01-P


