[Federal Register Volume 64, Number 176 (Monday, September 13, 1999)]
[Rules and Regulations]
[Pages 49383-49385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23665]


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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; Nicarbazin and 
Bambermycins

AGENCY: Food and Drug Administration, HHS.


[[Page 49384]]


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 new animal drug application 
(NADA) filed by Hoechst Roussel Vet. The NADA provides for combining 
approved single ingredient nicarbazin and bambermycins Type A medicated 
articles to make Type C medicated broiler chicken feeds to be used as 
an aid in preventing outbreaks of cecal and intestinal forms of 
coccidiosis, and for increased rate of weight gain and improved feed 
efficiency.

EFFECTIVE DATE: September 13, 1999

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-1600.

SUPPLEMENTARY INFORMATION: Hoechst Roussel Vet, 30 Independence Blvd., 
P.O. Box 4915, Warren, NJ 07059, filed NADA 140-339 that provides for 
combining approved single ingredient Nicarb (nicarbazin) and 
Flavomycin (bambermycins) Type A medicated articles to make 
Type C medicated broiler chicken feeds containing 113.5 grams per ton 
(g/t) nicarbazin and 1 to 2 g/t bambermycins. The Type C medicated 
broiler chicken feeds are used as an aid in preventing outbreaks of 
cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. 
necatrix, and E. brunetti) coccidiosis, and for increased rate of 
weight gain and improved feed efficiency in broiler chickens. The NADA 
is approved as of August 6, 1999, and the regulations are amended in 
Sec. 558.95 (21 CFR 558.95) by adding paragraph (d)(5)(iv), and in 21 
CFR 558.366 in the table in paragraph (c) by adding an entry, to 
reflect the approval. Also, the introductory text of Sec. 558.95(d)(5) 
is revised to better reflect the combination approvals.
    In accordance with the freedom of information provisions of 21 CFR 
parts 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 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.
    This approval is for use of single ingredient Type A medicated 
articles to make combination drug Type C medicated feeds. One 
ingredient, nicarbazin, is a Category II drug as defined in 21 CFR 
558.3(b)(1)(ii). As provided in 21 CFR 558.4(b), an approved form FDA 
1900 is required to make Type C medicated feed from a Category II drug. 
Under section 512(m) of the act (21 U.S.C. 360b(m)), as amended by the 
Animal Drug Availability Act of 1996 (Public Law 104-250), medicated 
feed applications have been replaced by a requirement for feed mill 
licenses. Therefore, use of Type A medicated articles to make Type C 
medicated feeds as provided in NADA 140-339 is limited to manufacture 
in a licensed feed mill.
    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 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.
    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 558.95 is amended by revising the introductory text of 
paragraph (d)(5) and by adding paragraph (d)(5)(iv) to read as follows:


Sec. 558.95  Bambermycins.

* * * * *
    (d) * * *
    (5) Bambermycins may be used in chickens as in paragraph (d)(1) of 
this section in combination with:
* * * * *
    (iv) Nicarbazin as in Sec. 558.366.
    3. Section 558.366 is amended in the table in paragraph (c) under 
the entry for ``113.5 (0.0125 pct)'' by alphabetically adding an item 
for ``Bambermycins 1 to 2'' and revising the item for ``Lincomycin 2'' 
to read as follows:


Sec. 558.366   Nicarbazin.

* * * * *
    (c) * * *

 
----------------------------------------------------------------------------------------------------------------
 Nicarbazin in grams    Combination in grams
       per ton                per ton          Indications for use        Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *
                                                             *
113.5 (0.0125 pct)                            * * *                  * * *                  * * *
  *                    *                    *                    *                    *                    *
                                                             *
                       Bambermycins 1 to 2    Broiler chickens; aid  Feed continuously as   012799
                                               in preventing          sole ration from
                                               outbreaks of cecal     time chicks are
                                               (Eimeria tenella)      placed on litter
                                               and intestinal (E.     until past the time
                                               acervulina, E.         when coccidiosis is
                                               maxima, E. necatrix,   ordinarily a hazard;
                                               and E. brunetti)       do not use as a
                                               coccidiosis, for       treatment for
                                               increased rate of      coccidiosis; do not
                                               weight gain and        use in flushing
                                               improved feed          mashes; do not feed
                                               efficiency.            to laying hens;
                                                                      withdraw 4 days
                                                                      before slaughter.
                                                                      Nicarbazin as
                                                                      provided by 063271.

[[Page 49385]]

 
                       Lincomycin 2 (0.00044  Broiler chickens; aid  Feed continuously as   060728 063271
                        pct)                   in preventing          sole ration from
                                               outbreaks of secal     time chicks are
                                               (Eimeria tenella)      placed on litter
                                               and intestinal (E.     until past the time
                                               acervulina, E.         when coccidiosis is
                                               maxima, E. necatrix,   ordinarily a hazard;
                                               and E. brunetti)       do not use as a
                                               coccidiosis; for       treatment for
                                               increased rate of      coccidiosis; do not
                                               weight gain.           use in flushing
                                                                      mashes; do not feed
                                                                      to laying hens;
                                                                      withdraw 4 days
                                                                      before slaughter.
  *                    *                    *                    *                    *                    *
                                                             *
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    Dated: August 30, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-23665 Filed 9-10-99; 8:45 am]
BILLING CODE 4160-01-F