[Federal Register Volume 67, Number 140 (Monday, July 22, 2002)]
[Rules and Regulations]
[Pages 47687-47691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18367]


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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; Melengestrol

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 several supplemental 
applications filed by Pharmacia and Upjohn Co. to their new animal drug 
applications (NADAs) for the use of single-ingredient Type A medicated

[[Page 47688]]

articles containing melengestrol acetate, monensin, and tylosin to make 
two-way and (with tylosin) three-way, dry and liquid, combination drug 
Type C medicated feeds for heifers fed in confinement for slaughter. 
Some of the supplemental NADAs add the single-ingredient monensin claim 
for prevention and control of coccidiosis in feedlot heifers to the 
indications for combinations of melengestrol acetate and monensin with 
and without tylosin. Other supplemental NADAs extend the dose of 
tylosin to the single-ingredient range of 60 to 90 milligrams (mg) per 
head per day to reduce the incidence of liver abscesses in feedlot 
heifers and provide for use of liquid Type C medicated feeds containing 
melengestrol acetate and tylosin with and without monensin.

DATES: This rule is effective July 22, 2002.

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, [email protected].

SUPPLEMENTARY INFORMATION: Pharmacia and Upjohn Co., 7000 Portage Rd., 
Kalamazoo, MI 49001-0199, filed supplemental applications to NADAs 124-
309 and 125-476 that provide for use of MGA (melengestrol acetate) 
Premixes and RUMENSIN (monensin sodium) Premixes to make two-way, dry 
and liquid, combination drug Type C medicated feeds and to NADAs 138-
792 and 138-870 that provide for use of MGA Premixes, RUMENSIN 
Premixes, and TYLAN (tylosin phosphate) Premixes to make three-way, dry 
and liquid, combination drug Type C medicated feeds for heifers fed in 
confinement for slaughter. These supplemental NADAs add the claim for 
use of 50 to 360 mg of monensin per head per day for prevention and 
control of coccidiosis due to Eimeria bovis and E. zuernii. Pharmacia 
and Upjohn Co. also filed supplemental applications to NADAs 138-995 
and 139-192 that provide for combination use of MGA Premixes and TYLAN 
Premixes, and to NADAs 138-792 and 138-870, described previously. These 
supplemental NADAs extend the dose of tylosin to a range of 60 to 90 mg 
per head per day to reduce the incidence of liver abscesses caused by 
Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes 
and provide for use of liquid Type C medicated feeds in combinations of 
melengestrol acetate and tylosin with and without monensin in heifers 
fed in confinement for slaughter. The supplemental applications are 
approved as of February 26, 2002, and the regulations are amended in 
Sec. 558.342 (21 CFR 558.342) to reflect the approvals. Where 
appropriate, the basis of approval is discussed in freedom of 
information summaries.
    Section 558.342 is also being revised to include a table format and 
to correct drug labeler codes to reflect recent changes of sponsorship 
for single-ingredient lasalocid (66 FR 46705, September 7, 2001) and 
oxytetracycline (66 FR 47962, September 17, 2001) Type A medicated 
articles. Section 558.355 is also being revised to delete a redundant 
entry and to add a cross-reference.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 Dockets Management Branch (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) and (a)(6) that 
these actions are of a type that do not individually or cumulatively 
have a significant effect on the human environment. Therefore, neither 
environmental assessments nor environmental impact statements are 
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 
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:

    Authority: 21 U.S.C. 360b, 371.

    2. Section 558.342 is amended by revising the section heading and 
paragraph (a); by redesignating paragraphs (b), (c), and (d) as 
paragraphs (c), (d), and (e), respectively; by adding a new paragraph 
(b) and paragraphs (d)(3) through (d)(8); and by revising newly 
redesignated paragraph (e) to read as follows:


Sec. 558.342  Melengestrol.

    (a) Specifications. (1) Dry Type A medicated articles containing 
100 or 200 milligrams (mg) melengestrol acetate per pound.
    (2) Liquid Type A medicated article containing 500 mg melengestrol 
acetate per pound.
    (b) Approvals. See No. 000009 in Sec. 510.600(c) of this chapter.
* * * * *
    (d) * * * 
    (3) Combination Type B or C medicated feeds containing lasalocid 
must be labeled in accordance with Sec. 558.311(d)(5) of this chapter.
    (4) Liquid combination Type B or C medicated feeds containing 
melengestrol acetate and lasalocid must be manufactured in accordance 
with Sec. 558.311(d) of this chapter.
    (5) Combination Type B or C medicated feeds containing monensin 
must be labeled in accordance with Sec. 558.355(d) of this chapter.
    (6) Liquid combination Type B or C medicated feeds containing 
melengestrol acetate and monensin must be manufactured in accordance 
with Sec. 558.355(f)(3)(i) of this chapter.
    (7) Liquid combination Type B or C medicated feeds containing 
melengestrol acetate and tylosin must be manufactured in accordance 
with Sec. 558.625(c) of this chapter.
    (8) Liquid melengestrol acetate may not be mixed with 
oxytetracycline in a common liquid feed supplement.
    (e) Conditions of use--(1) Cattle.

------------------------------------------------------------------------
 Melengestrol   Combination
acetate in mg/  in mg/head/   Indications for     Limitations    Sponsor
   head/day         day             use
------------------------------------------------------------------------
(i) 0.25 to                  Heifers fed in    Administer 0.5    000009
 0.5                          confinement for   to 2.0 pounds
                              slaughter: For    (lb)/head/day
                              increased rate    of medicated
                              of weight gain,   feed containing
                              improved feed     0.125 to 1.0 mg
                              efficiency, and   melengestrol
                              suppression of    acetate/lb to
                              estrus (heat).    provide 0.25 to
                                                0.5 mg
                                                melengestrol
                                                acetate/head/
                                                day.

[[Page 47689]]

 
(ii) 0.5                     Heifers intended  Administer 0.5    000009
                              for breeding:     to 2.0 lb/head/
                              For suppression   day of Type C
                              of estrus         feed containing
                              (heat).           0.25 to 1.0 mg
                                                melengestrol
                                                acetate/lb to
                                                provide 0.5 mg
                                                melengestrol
                                                acetate/head/
                                                day. Do not
                                                exceed 24 days
                                                of feeding.
(iii) 0.25 to  Lasalocid     Heifers fed in    Add at the rate   000009
 0.5            100 to 360    confinement for   of 0.5 to 2.0
                              slaughter: As     lb/head/day a
                              in paragraph      medicated feed
                              (e)(1)(i) of      (liquid or dry)
                              this section.     containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate/lb to a
                                                feed containing
                                                10 to 30 grams
                                                (g) of
                                                lasalocid per
                                                ton; or add at
                                                the rate of 0.5
                                                to 2.0 lb/head/
                                                day a medicated
                                                feed (liquid or
                                                dry) containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate plus 50
                                                to 720 mg
                                                lasalocid/lb to
                                                a ration of
                                                nonmedicated
                                                feed to provide
                                                0.25 to 0.5 mg
                                                melengestrol
                                                acetate and 100
                                                to 360 mg
                                                lasalocid/head/
                                                day.
                                               Lasalocid
                                                provided by No.
                                                046573 in Sec.
                                                510.600(c) of
                                                this chapter.
(iv) 0.25 to   Lasalocid     Heifers fed in    To administer     000009
 0.5            100 to 360    confinement for   0.25 to 0.5 mg
                plus          slaughter: As     melengestrol
                tylosin 90    in paragraph      acetate plus
                              (e)(1)(i) of      100 to 360 mg
                              this section;     lasalocid plus
                              and for reduced   90 mg tylosin/
                              incidence of      head/day:
                              liver            1. Add 0.5 to
                              abscesses.        2.0 lb/head/day
                                                of a liquid or
                                                dry medicated
                                                feed containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate/lb to a
                                                medicated feed
                                                containing 10
                                                to 30 g
                                                lasalocid and 8
                                                to 10 g tylosin
                                                per ton; or
                                               2. Add 0.5 to
                                                2.0 lb/head/day
                                                of a liquid or
                                                dry medicated
                                                feed containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate plus 50
                                                to 720 mg
                                                lasalocid/lb to
                                                4.5 to 18 lb of
                                                a dry medicated
                                                feed containing
                                                10 to 40 g
                                                tylosin per
                                                ton; or
                                               3. Add 0.5 to
                                                2.0 lb/head/day
                                                of a dry
                                                pelleted
                                                medicated feed
                                                containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate (from a
                                                dry Type A
                                                article), 50 to
                                                720 mg
                                                lasalocid, and
                                                45 to 180 mg
                                                tylosin/lb to a
                                                ration of
                                                nonmedicated
                                                feed.
                                               Lasalocid
                                                provided by No.
                                                046573 and
                                                tylosin as
                                                tylosin
                                                phosphate by
                                                No. 000986 in
                                                Sec.  510.600(c
                                                ) of this
                                                chapter.
(v) 0.25 to    Monensin 50   Heifers fed in    ................  000009
 0.4            to 360        confinement for  Add at the rate
                              slaughter: As     of 0.5 to 2.0
                              in paragraph      lb/head/day a
                              (e)(1)(i) of      medicated feed
                              this section.     (liquid or dry)
                                                containing
                                                0.125 to 0.80
                                                mg melengestrol
                                                acetate/lb to a
                                                feed containing
                                                5 to 30 g
                                                monensin per
                                                ton; or add at
                                                the rate of 0.5
                                                to 2.0 lb/head/
                                                day a medicated
                                                feed (liquid or
                                                dry) containing
                                                0.125 to 0.80
                                                mg melengestrol
                                                acetate plus 25
                                                to 720 mg
                                                monensin/lb to
                                                a nonmedicated
                                                feed to provide
                                                0.25 to 0.40 mg
                                                melengestrol
                                                acetate and 50
                                                to 360 mg
                                                monensin/head/
                                                day.
                                               Monensin
                                                provided by No.
                                                000986 in Sec.
                                                510.600(c) of
                                                this chapter.

[[Page 47690]]

 
 (vi) 0.25 to  Monensin 50   Heifers fed in    ................  000009
 0.4            to 360        confinement for  Add at the rate
                              slaughter: As     of 0.5 to 2.0
                              in item           lb/head/day a
                              paragraph         medicated feed
                              (e)(1)(i) of      (liquid or dry)
                              this section;     containing
                              and for the       0.125 to 0.80
                              prevention and    mg melengestrol
                              control of        acetate/lb to a
                              coccidiosis due   feed containing
                              to Eimeria        10 to 30 g
                              bovis and E.      monensin per
                              zuernii.          ton; or add at
                                                the rate of 0.5
                                                to 2.0 lb/head/
                                                day a medicated
                                                feed (liquid or
                                                dry) containing
                                                0.125 to 0.80
                                                mg melengestrol
                                                acetate plus 25
                                                to 720 mg
                                                monensin/lb to
                                                a nonmedicated
                                                feed to provide
                                                0.25 to 0.40 mg
                                                melengestrol
                                                acetate and
                                                0.14 to 0.42 mg
                                                monensin/lb
                                                body weight, up
                                                to 360 mg
                                                monensin/head/
                                                day.
                                               Monensin
                                                provided by No.
                                                000986 in Sec.
                                                510.600(c) of
                                                this chapter.
(vii) 0.25 to  Monensin 50   Heifers fed in    To administer     000009
 0.5            to 360 plus   confinement for   0.25 to 0.50 mg
                tylosin 60    slaughter: As     melengestrol
                to 90         in paragraph      acetate to 50
                              (e)(1)(i) of      to 360 mg
                              this section;     monensin plus
                              for the           60 to 90 mg
                              prevention and    tylosin/head/
                              control of        day:
                              coccidiosis due  1. Add 0.5 to
                              to E. bovis and   2.0 lb/head/day
                              E. zuernii; and   of a liquid or
                              for reduced       dry medicated
                              incidence of      feed containing
                              liver abscesses   0.125 to 1.0 mg
                              caused by         melengestrol
                              Fusobacterium     acetate/lb to a
                              necrophorum and   medicated feed
                              Actinomyces       containing 5 to
                              (Corynebacteriu   30 g monensin
                              m) pyogenes.      and 8 to 10 g
                                                tylosin per
                                                ton; or
                                               2. Add 0.5 to
                                                2.0 lb/head/day
                                                of a liquid or
                                                dry medicated
                                                feed containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate plus 25
                                                to 720 mg
                                                monensin per
                                                pound to 4.5 to
                                                18 lb of a dry
                                                medicated feed
                                                containing 10
                                                to 40 g tylosin
                                                per ton; or
                                               3. Add 0.5 to
                                                2.0 lb/head/day
                                                of a liquid or
                                                dry medicated
                                                feed containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate (from a
                                                dry Type A
                                                article), 25 to
                                                600 mg
                                                monensin, and
                                                45 to 180 mg
                                                tylosin/lb to a
                                                ration of
                                                nonmedicated
                                                feed.
                                               Monensin and
                                                tylosin as
                                                tylosin
                                                phosphate
                                                provided by No.
                                                000986 in Sec.
                                                510.600(c) of
                                                this chapter.
(viii) 0.25    Oxytetracycl  Heifers fed in    Add at the rate   000009
 to 0.5         ine 75        confinement for   of 0.5 to 2.0
                              slaughter: As     lb/head/day a
                              in paragraph      medicated feed
                              (e)(1)(i) of      (liquid or dry)
                              this section;     containing
                              and for           0.125 to 1.0 mg
                              reduction of      melengestrol
                              liver             acetate/lb per
                              condemnation      pound to a feed
                              due to liver      containing 6 to
                              abscesses.        10 g
                                                oxytetracycline
                                                per ton; or add
                                                at the rate of
                                                0.5 to 2.0 lb/
                                                head/day a dry
                                                medicated feed
                                                containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate plus
                                                37.5 to 150 mg
                                                oxytetracycline/
                                                lb to provide
                                                0.25 to 0.5 mg
                                                melengestrol
                                                acetate and 75
                                                mg
                                                oxytetracycline/
                                                head/day.
                                               Oxytetracycline
                                                as provided by
                                                No. 066104 in
                                                Sec.  510.600(c
                                                ) of this
                                                chapter.

[[Page 47691]]

 
(ix) 0.25 to   Tylosin 60    Heifers fed in    To administer     000009
 0.5            to 90         confinement for   0.25 to 0.5 mg
                              slaughter: As     melengestrol
                              in paragraph      acetate with 60
                              (e)(1)(i) of      to 90 mg
                              this section;     tylosin/head/
                              and for reduced   day:
                              incidence of     1. Add 0.5 to
                              liver abscesses   2.0 lb/head/day
                              caused by F.      of a liquid or
                              necrophorum and   dry medicated
                              Actinomyces       feed containing
                              (Corynebacteriu   0.125 to 1.0 mg
                              m) pyogenes.      melengestrol
                                                acetate/lb to a
                                                medicated feed
                                                containing 8 to
                                                10 g tylosin
                                                per ton; or
                                               2. Add 0.5 to
                                                2.0 lb/head/day
                                                of a liquid or
                                                dry medicated
                                                feed containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate/lb to
                                                4.5 to 18
                                                pounds of a dry
                                                medicated feed
                                                containing 10
                                                to 40 g tylosin
                                                per ton; or
                                               3. Add 0.5 to
                                                2.0 lb/head/day
                                                of a liquid or
                                                dry medicated
                                                feed containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate (from a
                                                dry Type A
                                                article) plus
                                                45 to 180 mg
                                                tylosin/lb to a
                                                ration of
                                                nonmedicated
                                                feed.
                                               Tylosin as
                                                tylosin
                                                phosphate
                                                provided by No.
                                                000986 in Sec.
                                                510.600(c) of
                                                this chapter.
------------------------------------------------------------------------

    (2) [Reserved]
    3. Section 558.355 is amended by removing and reserving paragraph 
(f)(3)(iv) and by revising paragraph (f)(7) to read as follows:


Sec. 558.355  Monensin.

* * * * *
    (f) * * * 
    (7) Monensin may also be used in combination with:
    (i) Decoquinate alone or with tylosin as in Sec.  558.195.
    (ii) Melengestrol acetate alone or with tylosin as in Sec.  
558.342.

    Dated: July 8, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 02-18367 Filed 7-19-02; 8:45 am]
BILLING CODE 4160-01-S