[Federal Register Volume 69, Number 159 (Wednesday, August 18, 2004)]
[Rules and Regulations]
[Pages 51173-51175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18843]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs; Ractopamine

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 two new animal drug 
applications (NADAs) filed by Elanco Animal Health. One NADA provides 
for use of ractopamine, melengestrol, and monensin Type A medicated 
articles to make three-way combination Type C medicated feeds for 
heifers fed in confinement for slaughter. The other NADA provides for 
use of ractopamine, melengestrol, monensin, and tylosin Type A 
medicated articles to make four-way combination Type C medicated feeds 
for heifers fed in confinement for slaughter.

DATES: This rule is effective August 18, 2004.

[[Page 51174]]


FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 
141-234 that provides for use of OPTAFLEXX (ractopamine hydrochloride), 
MGA (melengestrol acetate), and RUMENSIN (monensin sodium) Type A 
medicated articles to make three-way combination Type C medicated feeds 
used for increased rate of weight gain, improved feed efficiency, and 
increased carcass leanness; for prevention and control of coccidiosis 
due to Eimeria bovis and E. zuernii; and for suppression of estrus 
(heat) in heifers fed in confinement for slaughter during the last 28 
to 42 days on feed. Elanco Animal Health also filed NADA 141-233 that 
provides for use of OPTAFLEXX, MGA, RUMENSIN, and TYLAN (tylosin 
phosphate) Type A medicated articles to make four-way combination Type 
C medicated feeds used for increased rate of weight gain, improved feed 
efficiency, and increased carcass leanness; for prevention and control 
of coccidiosis due to E. bovis and E. zuernii; for suppression of 
estrus (heat); and for reduction of incidence of liver abscesses caused 
by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes 
in heifers fed in confinement for slaughter during the last 28 to 42 
days on feed. The NADAs are approved as of July 2, 2004, and the 
regulations in 21 CFR 558.342, 558.355, 558.500, and 558.625 are 
amended to reflect the approvals. The basis of approval is discussed in 
the freedom of information summaries.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), summaries of safety and 
effectiveness data and information submitted to support approval of 
these applications 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 these 
actions are of a type that do not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor environmental impact statement is required 
for either.
    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. Section 558.342 is amended by adding paragraph (e)(2) to read as 
follows:


Sec.  558.342  Melengestrol.

* * * * *
    (e) * * *
    (2) Melengestrol may also be used with ractopamine alone or in 
combination as in Sec.  558.500 of this chapter.


Sec.  558.355  [Amended]

0
3. Section 558.355 is amended in paragraph (f)(7)(iii) by removing 
``with tylosin'' and by adding in its place ``in combination''.

0
4. Section 558.500 is amended by adding paragraphs (e)(2)(viii) and 
(e)(2)(x) to read as follows:


Sec.  558.500  Ractopamine.

* * * * *
    (e) * * *
* * * * *
    (2) Cattle--

------------------------------------------------------------------------
Ractopamine in  Combination in    Indications
   grams/ton       grams/ton        for use      Limitations    Sponsor
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
(viii) 9.8 to   Monensin 10 to  Heifers fed in  As in          000986
 24.6            30, plus        confinement     paragraph
                 melengestrol    for             (e)(2)(vi)
                 acetate to      slaughter: As   of this
                 provide 0.25    in paragraph    section; see
                 to 0.5 mg/      (e)(2)(vi) of   Sec.  Sec.
                 head/day        this section;   558.342(d)
                                 for             and
                                 prevention      558.355(d)
                                 and control     of this
                                 of              chapter.
                                 coccidiosis     Melengestrol
                                 due to          acetate as
                                 Eimeria bovis   provided by
                                 and E.          No. 000009
                                 zuernii; and    in Sec.
                                 for             510.600(c)
                                 suppression     of this
                                 of estrus       chapter.
                                 (heat).
------------------------------------------------------------------------

[[Page 51175]]

 
                              * * * * * * *
------------------------------------------------------------------------
(x) 9.8 to      Monensin 10 to  Heifers fed in  As in          000986
 24.6            30, plus        confinement     paragraph
                 tylosin 8 to    for             (e)(2)(vi)
                 10, plus        slaughter: As   of this
                 melengestrol    in paragraph    section; see
                 acetate to      (e)(2)(vi) of   Sec.  Sec.
                 provide 0.25    this section;   558.342(d),
                 to 0.5 mg/      for             558.355(d),
                 head/day        prevention      and
                                 and control     558.625(c)
                                 of              of this
                                 coccidiosis     chapter.
                                 due to          Melengestrol
                                 Eimeria bovis   acetate as
                                 and E.          provided by
                                 zuernii; for    No. 000009
                                 reduction of    in Sec.
                                 incidence of    510.600(c)
                                 liver           of this
                                 abscesses       chapter.
                                 caused by
                                 Fusobacterium
                                 necrophorum
                                 and
                                 Actinomyces
                                 (Corynebacter
                                 ium)
                                 pyogenes; and
                                 for
                                 suppression
                                 of estrus
                                 (heat).
------------------------------------------------------------------------

Sec.  558.625  [Amended]

0
5. Section 558.625 is amended in paragraph (f)(2)(vii) by removing 
``with monensin'' and by adding in its place ``in combination''.

    Dated: July 27, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-18843 Filed 8-17-04; 8:45 am]
BILLING CODE 4160-01-S