[Federal Register Volume 69, Number 50 (Monday, March 15, 2004)]
[Rules and Regulations]
[Pages 12067-12069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5755]


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

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 and monensin Type A medicated articles to make 
dry and liquid two-way combination Type B and Type C medicated feeds 
for cattle fed in confinement for slaughter. The other NADA provides 
for use of ractopamine, monensin, and tylosin Type A

[[Page 12068]]

medicated articles to make dry and liquid three-way combination Type B 
and Type C medicated feeds for cattle fed in confinement for slaughter.

DATES: This rule is effective March 15, 2004.

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 and Co., Lilly Corporate Center, Indianapolis, IN 46285, filed 
NADA 141-225 that provides for use of OPTAFLEXX (ractopamine 
hydrochloride) and RUMENSIN (monensin sodium) Type A medicated articles 
to make dry and liquid two-way combination Type B and Type C medicated 
feeds used for increased rate of weight gain, improved feed efficiency, 
and increased carcass leanness; and for prevention and control of 
coccidiosis due to Eimeria bovis and E. zuernii in cattle fed in 
confinement for slaughter during the last 28 to 42 days on feed. Elanco 
Animal Health also filed NADA 141-224 that provides for use of 
OPTAFLEXX, RUMENSIN, and TYLAN (tylosin phosphate) Type A medicated 
articles to make dry and liquid three-way combination Type B and 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; and for reduction of 
incidence of liver abscesses caused by Fusobacterium necrophorum and 
Actinomyces (Corynebacterium) pyogenes in cattle fed in confinement for 
slaughter during the last 28 to 42 days on feed. The NADAs are approved 
as of January 27, 2004, and the regulations are amended in 21 CFR 
558.355, 558.500, and 558.625 are 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 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 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 558.355 is amended by adding paragraph (f)(7)(iii) to read 
as follows:


Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (7) * * *
    (iii) Ractopamine alone or with tylosin as in Sec.  558.500.
0
3. Section 558.500 is amended in paragraph (d)(3) after ``7.5'' by 
adding ``or, if in combination with monensin and/or tylosin, at a pH of 
4.5 to 6.0''; and by revising the table in paragraph (e)(2) to read as 
follows:


Sec.  558.500  Ractopamine.

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

------------------------------------------------------------------------
 Ractopame  Combination
 in grams/   in grams/    Indications for use     Limitations    Sponsor
    ton         ton
------------------------------------------------------------------------
(i) 8.2 to  ...........  Cattle fed in         Feed              000986
 24.6                     confinement for       continuously as
                          slaughter: For        sole ration
                          increased rate of     during the last
                          weight gain and       28 to 42 days
                          improved feed         on feed. Not
                          efficiency during     for animals
                          the last 28 to 42     intended for
                          days on feed          breeding
------------------------------------------------------------------------
(ii) 8.2    Monensin 10  Cattle fed in         As in paragraph   000986
 to 24.6     to 30        confinement for       (e)(2)(i) of
                          slaughter: As in      this section;
                          paragraph (e)(2)(i)   see Sec.
                          of this section;      558.355(d) of
                          and for prevention    this chapter
                          and control of
                          coccidiosis due to
                          Eimeria bovis and
                          E. zuernii
------------------------------------------------------------------------
(iii)       ...........  ....................  ................  .......
 [Reserved
 ]
------------------------------------------------------------------------
(iv) 8.2    Monensin 10  Cattle fed in         As in paragraph   000986
 to 24.6     to 30,       confinement for       (e)(2)(i) of
             plus         slaughter: As in      this section;
             tylosin 8    paragraph (e)(2)(i)   see Sec.  Sec.
             to 10        of this section;       558.355(d) and
                          for prevention and    558.625(c) of
                          control of            this chapter
                          coccidiosis due to
                          E. bovis and E.
                          zuernii; and for
                          reduction of
                          incidence of liver
                          abscesses caused by
                          Fusobacterium
                          necrophorum and
                          Actinomyces
                          (Corynebacterium)
                          pyogenes
------------------------------------------------------------------------
(v)         ...........  ....................  ................  .......
 [Reserved
 ]
------------------------------------------------------------------------
(vi) 9.8    ...........  Cattle fed in         Feed              000986
 to 24.6                  confinement for       continuously as
                          slaughter: For        sole ration
                          increased rate of     during the last
                          weight gain,          28 to 42 days
                          improved feed         on feed. Not
                          efficiency, and       for animals
                          increased carcass     intended for
                          leanness during the   breeding
                          last 28 to 42 days
                          on feed
------------------------------------------------------------------------

[[Page 12069]]

 
(vii) 9.8   Monensin 10  Cattle fed in         As in paragraph   000986
 to 24.6     to 30        confinement for       (e)(2)(vi) of
                          slaughter: As in      this section;
                          paragraph             see Sec.
                          (e)(2)(vi) of this    558.355(d) of
                          section; and for      this chapter
                          prevention and
                          control of
                          coccidiosis due to
                          E. bovis and E.
                          zuernii
------------------------------------------------------------------------
(viii)      ...........  ....................  ................  .......
 [Reserved
 ]
------------------------------------------------------------------------
(ix) 9.8    Monensin 10  Cattle fed in         As in paragraph   000986
 to 24.6     to 30,       confinement for       (e)(2)(vi) of
             plus         slaughter: As in      this section;
             tylosin 8    paragraph             see Sec.  Sec.
             to 10        (e)(2)(vi) of this     558.355(d) and
                          section; for          558.625(c) of
                          prevention and        this chapter
                          control of
                          coccidiosis due to
                          E. bovis and E.
                          zuernii; and for
                          reduction of
                          incidence of liver
                          abscesses caused by
                          Fusobacterium
                          necrophorum and
                          Actinomyces
                          (Corynebacterium)
                          pyogenes
------------------------------------------------------------------------
(x)         ...........  ....................  ................  .......
 [Reserved
 ]
------------------------------------------------------------------------

0
4. Section 558.625 is amended by revising paragraph (f)(2)(vii) to read 
as follows:


Sec.  558.625  Tylosin.

* * * * *
    (f) * * *
    (2) * * *
    (vii) Ractopamine alone or with monensin as in Sec.  558.500.
* * * * *

    Dated: March 3, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-5755 Filed 3-12-04; 8:45 am]
BILLING CODE 4160-01-S