Federal Register, Volume 77 Issue 193 (Thursday, October 4, 2012)

[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
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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--

(2) Cattle--

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Tilmicosin phosphate in
grams/ton Combination in grams/ton Indications for use Limitations Sponsor
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(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