New Animal Drugs For Use in Animal Feeds; Monensin, 68478-68479 [E7-23519]

Download as PDF 68478 Federal Register / Vol. 72, No. 233 / Wednesday, December 5, 2007 / Rules and Regulations animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Belcher Pharmaceuticals, Inc. The ANADA provides for veterinary prescription use of carprofen caplets in dogs. DATES: This rule is effective December 5, List of Subjects § 520.309 21 CFR Part 510 I FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov. Belcher Pharmaceuticals, Inc., 12393 Belcher Rd., Suite 420, Largo, FL 33773, filed ANADA 200–397 for VETPROFEN (carprofen) Caplets. The ANADA provides for veterinary prescription use in dogs for the relief of pain and inflammation associated with osteoarthritis, and for the control of postoperative pain associated with soft tissue and orthopedic surgeries. Belcher Pharmaceuticals, Inc.’s VETPROFEN Caplets are approved as a generic copy of RIMADYL Caplets, sponsored by Pfizer, Inc., under NADA 141–053. The ANADA is approved as of November 7, 2007, and 21 CFR 520.309 is amended to reflect the approval. In addition, Belcher Pharmaceuticals, Inc., has not been previously listed in the animal drug regulations as a sponsor of an approved application. At this time, 21 CFR 510.600(c) is being amended to add entries for the firm. In accordance with the freedom of information provisions of 21 CFR part 20 and 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 determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. 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. sroberts on PROD1PC70 with RULES SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 17:07 Dec 04, 2007 Jkt 214001 4. In paragraph (b)(2) of § 520.309, remove ‘‘No. 000115’’ and add in its place ‘‘Nos. 000115 and 062250’’. Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. Dated: November 20, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–23516 Filed 12–4–07; 8:45 am] 21 CFR Part 520 2007. [Amended] Animal drugs. BILLING CODE 4160–01–S 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 and 520 are amended as follows: I PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: I Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 2. Section 510.600 is amended in the table in paragraph (c)(1) by alphabetically adding a new entry for ‘‘Belcher Pharmaceuticals, Inc.’’ and in the table in paragraph (c)(2) by numerically adding a new entry for ‘‘062250’’ to read as follows: I § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * (c) * * * (1) * * * * * Firm name and address * * * Belcher Pharmaceuticals, Inc., 12393 Belcher Rd., suite 420, Largo, FL 33773 * * * Drug labeler code * 062250 * * * (2) * * * Drug labeler code * 062250 * * * Firm name and address * * * Belcher Pharmaceuticals, Inc., 12393 Belcher Rd., suite 420, Largo, FL 33773 * * * PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs For Use in Animal Feeds; Monensin 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 of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA revises the concentration of monensin in two-way Type B and Type C medicated feeds containing monensin and tylosin to cattle fed in confinement for slaughter and a revision to bacterial pathogen nomenclature. DATES: This rule is effective December 5, 2007. FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary Medicine (HFV–126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–0223, e-mail: daniel.benz@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 104–646 that provides for use of RUMENSIN (monensin USP) and TYLAN (tylosin phosphate) Type A medicated articles to make dry and liquid two-way combination medicated feeds for cattle fed in confinement for slaughter. The supplemental NADA provides for an increased level of monensin in combination Type B and Type C medicated feeds and a revision to bacterial pathogen nomenclature. The supplemental NADA is approved as of October 30, 2007, and the regulations in 21 CFR 558.355 are amended to reflect the approval. E:\FR\FM\05DER1.SGM 05DER1 Federal Register / Vol. 72, No. 233 / Wednesday, December 5, 2007 / Rules and Regulations 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 determined under 21 CFR 25.33(a)(2) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor environmental impact statement is required. 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 the 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: I instructions as in § 558.625(c) of this chapter. * * * * * (xii) Amount per ton. Monensin, 10 to 40 grams; plus tylosin, 8 to 10 grams. (a) Indications for use. Cattle fed in confinement for slaughter: For prevention and control of coccidiosis due to E. bovis and E. zuernii; and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes. (b) Limitations. Feed only to cattle being fed in confinement for slaughter. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligrams monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 480 milligrams per head per day; and 60 to 90 milligrams of tylosin per head per day. * * * * * Dated: November 20, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–23519 Filed 12–4–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 21 CFR Part 558 1. The authority citation for 21 CFR part 558 continues to read as follows: New Animal Drugs For Use in Animal Feeds; Monensin USP I Authority: 21 U.S.C. 360b, 371. AGENCY: 2. In § 558.355, revise paragraphs (f)(3)(ii) and (f)(3)(xii) to read as follows: I § 558.355 Monensin. sroberts on PROD1PC70 with RULES * * * * * (f) * * * (3) * * * (ii) Amount per ton. Monensin, 5 to 40 grams; plus tylosin, 8 to 10 grams. (a) Indications for use. Cattle fed in confinement for slaughter: For improved feed efficiency; and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes. (b) Limitations. Feed only to cattle being fed in confinement for slaughter. Feed continuously as sole ration at the rate of 50 to 480 milligrams of monensin and 60 to 90 milligrams of tylosin per head per day. Combination drug liquid Type B medicated feeds may be used to manufacture dry Type C medicated feeds and shall conform to mixing VerDate Aug<31>2005 17:07 Dec 04, 2007 Jkt 214001 Food and Drug Administration, HHS. Final rule; technical amendment. ACTION: 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. The supplemental NADA removes the requirement for 30-day expiration on labeling of monensin Type C medicated feeds for several classes of cattle and goats. DATES: This rule is effective December 5, 2007. FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary Medicine (HFV–126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–0223, e-mail: daniel.benz@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli Lilly PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 68479 & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 95–735 that provides for use of RUMENSIN 80 (monensin) Type A medicated articles. The supplement removes the requirement for 30-day expiration on labeling of monensin Type C medicated feeds for several classes of cattle and goats. The supplemental NADA is approved as of November 9, 2007, and the regulations in 21 CFR 558.355 are amended to reflect the approval. In addition, the regulations are being amended to remove a redundant entry for combination use of monensin USP and melengestrol acetate, with or without tylosin phosphate, in medicated feed for heifers fed in confinement for slaughter. This action is being taken to improve the clarity of the regulations. Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required. The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor environmental impact statement is required. 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. I Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 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 1. The authority citation for 21 CFR part 558 continues to read as follows: I Authority: 21 U.S.C. 360b, 371. 2. In § 558.355, remove and reserve paragraphs (d)(2), (d)(3), and (f)(3)(viii); and revise paragraph (f)(6)(i)(b)(1) to read as follows: I § 558.355 Monensin. * * * * * (f) * * * (6) * * * (i) * * * (b) * * * (1) Feed continuously. Feed only to goats being fed in confinement. Do not E:\FR\FM\05DER1.SGM 05DER1

Agencies

[Federal Register Volume 72, Number 233 (Wednesday, December 5, 2007)]
[Rules and Regulations]
[Pages 68478-68479]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23519]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use in Animal Feeds; Monensin

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 of a supplemental new animal drug 
application (NADA) filed by Elanco Animal Health. The supplemental NADA 
revises the concentration of monensin in two-way Type B and Type C 
medicated feeds containing monensin and tylosin to cattle fed in 
confinement for slaughter and a revision to bacterial pathogen 
nomenclature.

DATES: This rule is effective December 5, 2007.

FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223, e-mail: daniel.benz@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a 
supplement to NADA 104-646 that provides for use of RUMENSIN (monensin 
USP) and TYLAN (tylosin phosphate) Type A medicated articles to make 
dry and liquid two-way combination medicated feeds for cattle fed in 
confinement for slaughter. The supplemental NADA provides for an 
increased level of monensin in combination Type B and Type C medicated 
feeds and a revision to bacterial pathogen nomenclature. The 
supplemental NADA is approved as of October 30, 2007, and the 
regulations in 21 CFR 558.355 are amended to reflect the approval.

[[Page 68479]]

    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 determined under 21 CFR 25.33(a)(2) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor environmental impact statement is 
required.
    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.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
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.

0
2. In Sec.  558.355, revise paragraphs (f)(3)(ii) and (f)(3)(xii) to 
read as follows:


Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (3) * * *
    (ii) Amount per ton. Monensin, 5 to 40 grams; plus tylosin, 8 to 10 
grams.
    (a) Indications for use. Cattle fed in confinement for slaughter: 
For improved feed efficiency; and reduction of incidence of liver 
abscesses caused by Fusobacterium necrophorum and Arcanobacterium 
(Actinomyces) pyogenes.
    (b) Limitations. Feed only to cattle being fed in confinement for 
slaughter. Feed continuously as sole ration at the rate of 50 to 480 
milligrams of monensin and 60 to 90 milligrams of tylosin per head per 
day. Combination drug liquid Type B medicated feeds may be used to 
manufacture dry Type C medicated feeds and shall conform to mixing 
instructions as in Sec.  558.625(c) of this chapter.
* * * * *
    (xii) Amount per ton. Monensin, 10 to 40 grams; plus tylosin, 8 to 
10 grams.
    (a) Indications for use. Cattle fed in confinement for slaughter: 
For prevention and control of coccidiosis due to E. bovis and E. 
zuernii; and reduction of incidence of liver abscesses caused by 
Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes.
    (b) Limitations. Feed only to cattle being fed in confinement for 
slaughter. For prevention and control of coccidiosis, feed at a rate of 
0.14 to 0.42 milligrams monensin per pound of body weight per day, 
depending upon the severity of challenge, up to maximum of 480 
milligrams per head per day; and 60 to 90 milligrams of tylosin per 
head per day.
* * * * *

    Dated: November 20, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-23519 Filed 12-4-07; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.