New Animal Drugs; Change of Sponsor's Address; Monensin; Spinosad; Tilmicosin, 60622-60624 [2012-24475]

Download as PDF 60622 Federal Register / Vol. 77, No. 193 / Thursday, October 4, 2012 / Rules and Regulations d. Add to the end of paragraph (c) the phrase ‘‘, except for an appeal related to records originating in the Office of the Inspector General’’. The revision reads as follows: ■ ■ § 1212.701 Associate Deputy Administrator. (a) * * * (5) Establish a position of Center Privacy Manager to assist in carrying out the responsibilities listed in this section. * * * * * ■ 19. In newly redesignated § 1212.705: ■ a. Revise paragraph (a)(1); ■ b. In paragraph (a)(3), remove the word ‘‘Assistant’’ and add in its place ‘‘Associate’’; ■ c. In paragraph (a)(7), remove the reference ‘‘§ 1212.203(g)(1) through (12)’’ and add in its place ‘‘§ 1212.203(f)(1) through (12)’’; ■ d. In paragraph (a)(12), remove ‘‘14 CFR’’ and add in its place ‘‘§ ’’ and add the words ‘‘of this part’’ after ‘‘1212.203’’; ■ e. In paragraph (c), remove the word ‘‘Installation’’ and add in its place ‘‘Center’’ and remove the reference ‘‘§ 1212.703(a)(4) and (b)’’ and add in its place ‘‘§ 1212.704(a)(4) and (5)’’ ■ * * * * * §§ 1212.702 through 1212.706 [Redesignated as §§ 1212.703 through 1212.707] 16. Redesignate §§ 1212.702 through 1212.706 as §§ 1212.703 through 1212.707 and add a new § 1212.702 to read as follows: ■ § 1212.702 The Inspector General. The Inspector General is responsible for: (a) Making final Agency determinations on appeals related to records originating with the Office of the Inspector General (§ 1212.400), and (b) Authorizing an extension for making a final determination on an appeal related to records originating with the Office of the Inspector General (§ 1212.400(e)). ■ 17. In newly redesignated § 1212.703: ■ a. Revise the section heading; ■ b. In paragraph (a) introductory text, remove the phrase ‘‘Associate Administrator for Management Systems and Facilities’’ and add in its place ‘‘NASA Chief Information Officer’’; ■ c. In paragraph (b): ■ i. Remove the phrase ‘‘Associate Administrator for Management Systems and Facilities’’ and add in its place ‘‘Chief Information Officer’’; ■ ii. Remove the words ‘‘Privacy Officer’’ and add in its place ‘‘NASA Privacy Act Officer’’; and ■ iii. Remove the word ‘‘or’’ and the phrase ‘‘reporting directly to the Associate Administrator for Management Systems and Facilities’’. The revision reads as follows: § 1212.703 Officer. emcdonald on DSK67QTVN1PROD with RULES * * * * ■ 18. In newly redesignated § 1212.704: ■ a. Revise the section heading; ■ b. In paragraph (a) introductory text, remove the word ‘‘Installations’’ and add in its place ‘‘Centers’’; ■ c. In paragraph (a)(3), remove the reference ‘‘§ 1212.203(g)’’ and add in its place ‘‘§ 1212.203(f)’’; ■ d. In paragraph (a)(4), remove the reference ‘‘§ 1212.704’’ and add in its place ‘‘§ 1212.705’’; VerDate Mar<15>2010 15:04 Oct 03, 2012 Jkt 229001 § 1212.704 Headquarters and Field Centers or Component Facilities. § 1212.705 System manager. (a) * * * (1) Overall compliance with this part, NASA Policy Directive (NPD) 1382.17 and NASA Procedural Requirements (NPR) 1382.1. * * * * * Charles F. Bolden, Jr., Administrator. [FR Doc. 2012–23645 Filed 10–3–12; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, and 558 NASA Chief Information * e. Add paragraph (a)(5); and f. Remove and reserve paragraph (b). The revision reads as follows: [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. The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect SUMMARY: PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 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. 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: https:// 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: https://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. SUPPLEMENTARY INFORMATION: E:\FR\FM\04OCR1.SGM 04OCR1 60623 Federal Register / Vol. 77, No. 193 / Thursday, October 4, 2012 / Rules and Regulations TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS APPROVED DURING AUGUST 2012 Sponsor New animal drug product name Action 141–343 Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285. PULMOTIL 90 (tilmicosin phosphate) plus RUMENSIN 90 (monensin) Type A medicated articles. 141–277 Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285. COMFORTIS (spinosad) Chewable Tablets. Original approval for use in two-way, combination drug type B and type C medicated feeds for cattle fed in confinement for slaughter. Supplemental approval for use in cats to kill fleas and for the prevention and treatment of flea infestations (Ctenocephalides felis) for 1 month on cats and kittens 14 weeks of age and older and 2 pounds of body weight or greater. NADA 21 CFR section FOIA summary NEPA review 558.355 558.618 yes .............. CE 1 520.2130 yes ............... CE 1 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. (1) * * * Drug labeler code Firm name and address * * * Baxter Healthcare Corp., One Baxter Pkwy., Deerfield, IL 60015. * * * * * 010019 * * (2) * * * 21 CFR Part 520 Animal drugs. Drug labeler code Firm name and address 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 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS PART 510—NEW ANIMAL DRUGS ■ * * * * * 010019 ........ Baxter Healthcare Corp., One Baxter Pkwy., Deerfield, IL 60015. * * * * * 3. The authority citation for 21 CFR part 520 continues to read as follows: 1. The authority citation for 21 CFR part 510 continues to read as follows: ■ Authority: 21 U.S.C. 360b. Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 4. Revise § 520.2130 to read as follows: ■ 2. In § 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: § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * (c) * * * VerDate Mar<15>2010 * * 15:04 Oct 03, 2012 Jkt 229001 PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 5. The authority citation for 21 CFR part 558 continues to read as follows: ■ Authority: 21 U.S.C. 360b, 371. 6. In § 558.355, redesignate paragraph (f)(8)(iv) as paragraph (f)(8)(v); and add new paragraph (f)(8)(iv) to read as follows: ■ § 558.355 ■ emcdonald on DSK67QTVN1PROD with RULES (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. § 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 § 510.600 of this chapter. (c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PO 00000 Frm 00005 Fmt 4700 Monensin. * Sfmt 4700 * * * * (f) * * * (8) * * * (iv) Tilmicosin alone or in combination as in § 558.618. * * * * * ■ 7. In § 558.618, remove and reserve paragraph (c)(3)(ii); and revise paragraph (e) to read as follows: E:\FR\FM\04OCR1.SGM 04OCR1 60624 Federal Register / Vol. 77, No. 193 / Thursday, October 4, 2012 / Rules and Regulations § 558.618 Tilmicosin. * * * * (e) * * * (1) Swine— * Tilmicosin phosphate in grams/ton Combination in grams/ton Indications for use Limitations (i) 181 to 363 .... ........................... Swine: For the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida. (ii) [Reserved] ... ........................... ........................................................... Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an anticipated disease 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. ......................................................................................... Sponsor 000986 000986 (2) Cattle— Combination in grams/ton Indications for use Limitations (i) 568 to 757 .... ........................... Beef and nonlactating dairy cattle: 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. (ii) 568 to 757 ... Monensin, 5 to 40. (iii) 568 to 757 .. emcdonald on DSK67QTVN1PROD with RULES Tilmicosin phosphate in grams/ton Monensin, 10 to 40. Cattle fed in confinement for slaughter: For improved feed efficiency; and for the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10 percent of the animals in the group. Cattle fed in confinement for slaughter: For prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10 percent of the animals in the group. Feed continuously for 14 days to provide 12.5 milligrams/kilogram/head/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these 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. Feed continuously for 14 days to provide 12.5 milligrams tilmicosin/kilogram/head/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these 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 pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. See § 558.355(d) of this chapter. Feed continuously for 14 days to provide 12.5 milligrams tilmicosin/kilogram/head/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these 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 pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. See § 558.355(d) of this chapter. 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 VerDate Mar<15>2010 16:14 Oct 03, 2012 Jkt 229001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\04OCR1.SGM 04OCR1 Sponsor 000986 000986 000986

Agencies

[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]

=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: https://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: https://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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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--

----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

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

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