Document ID: FDA-2008-N-0039-0055
Agency: fda
Document Type: Rule
Title: New Animal Drugs For Use in Animal Feeds; Tylosin
Posted Date: 2008-06-17T04:00Z

[Federal Register: June 17, 2008 (Volume 73, Number 117)]
[Rules and Regulations]               
[Page 34184-34185]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17jn08-3]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

 
New Animal Drugs For Use in Animal Feeds; Tylosin

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 revision of an 
effectiveness claim and pathogen nomenclature for a tylosin phosphate 
and sulfamethazine Type A medicated article used to manufacture 
medicated swine feeds.

DATES: This rule is effective June 17, 2008.

FOR FURTHER INFORMATION CONTACT: Timothy Schell, Center for Veterinary 
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8116, e-mail: timothy.schell@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 41-275 that provides for use of TYLAN 40 SULFA-G 
(tylosin phosphate and sulfamethazine) Elliptical Pellets, a Type A 
medicated article. The

[[Page 34185]]

supplement provides for revision of an effectiveness claim and pathogen 
nomenclature. The supplemental NADA is approved as of May 8, 2008, and 
the regulations in 21 CFR 558.630 are amended to reflect the approval.
    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.
    FDA 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.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

0
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.

0
2. Revise Sec.  558.630 to read as follows:

Sec.  558.630  Tylosin and sulfamethazine.

    (a) Specifications. Type A medicated articles containing equal 
amounts of tylosin phosphate and sulfamethazine, available in 
concentrations of 4, 5, 10, 20, or 40 grams each, per pound.
    (b) Approvals. See sponsor numbers in Sec.  510.600(c) of this 
chapter for use as in paragraph (e) of this section.
    (1) No. 000986: 10 or 40 grams per pound each for use as in 
paragraph (e)(2)(i) of this section.
    (2) No. 021930: 2 grams per pound each for use as in paragraph 
(e)(2)(i) of this section.
    (3) No. 051311: 40 grams per pound each for use as in paragraph 
(e)(2)(ii) of this section.
    (4) No. 017139: 4, 10, or 20 grams per pound each for use as in 
paragraph (e)(2)(ii) of this section.
    (5) Nos. 000986, 010439, 016968, 021930, 024174, 030841, 034936, 
035098, 046573, 046987, and 051359: 5, 10, 20, or 40 grams per pound 
each for use as in paragraph (e)(2)(ii) of this section.
    (6) No. 000986: 40 grams per pound each for use as in paragraph 
(e)(2)(iii) of this section.
    (c) Special considerations. Labeling shall bear the statement: ``Do 
not use in medicated feeds containing in excess of 2% bentonite.''
    (d) Related tolerances. See Sec. Sec.  556.670 and 556.740 of this 
chapter.
    (e) Conditions of use. It is used in feed for swine as follows:
    (1) Amount per ton. 100 grams tylosin and 100 grams sulfamethazine.
    (2) Indications for use-(i) Maintaining weight gains and feed 
efficiency in the presence of atrophic rhinitis; lowering the incidence 
and severity of Bordetella bronchiseptica rhinitis; prevention of swine 
dysentery (vibrionic); control of swine pneumonias caused by bacterial 
pathogens (Pasteurella multocida and/or Corynebacterium pyogenes); for 
reducing the incidence of cervical lymphadenitis (jowl abscesses) 
caused by Group E Streptococci. Only the sulfamethazine portion of this 
combination is active in controlling jowl abscesses.
    (ii) Maintaining weight gains and feed efficiency in the presence 
of atrophic rhinitis; lowering the incidence and severity of Bordetella 
bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); 
control of swine pneumonias caused by bacterial pathogens (Pasteurella 
multocida and/or Corynebacterium pyogenes).
    (iii) For maintaining weight gains and feed efficiency in the 
presence of atrophic rhinitis; lowering the incidence and severity of 
Bordetella bronchiseptica rhinitis; prevention of swine dysentery 
associated with Brachyspira hyodysenteriae; and control of swine 
pneumonias caused by bacterial pathogens (Pasteurella multocida and/or 
Arcanobacterium pyogenes).
    (3) Limitations. Withdraw 15 days before swine are slaughtered.

    Dated: June 9, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-13606 Filed 6-16-08; 8:45 am]

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