[Federal Register Volume 64, Number 171 (Friday, September 3, 1999)]
[Rules and Regulations]
[Pages 48295-48297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22997]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558


New Animal Drugs For Use In Animal Feeds; Semduramicin and 
Virginiamycin

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 a new animal drug application 
(NADA) filed by Pfizer, Inc. The NADA provides for using approved 
single ingredient semduramicin and virginiamycin Type A medicated 
articles to make combination drug Type C medicated broiler chicken 
feeds. Approval of the NADA also provides for tolerances for 
semduramicin residues and an acceptable daily intake (ADI) for 
semduramicin and for virginiamycin.

EFFECTIVE DATE:  September 3, 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:  Pfizer, Inc., 235 East 42d St., New York, 
NY 10017, filed NADA 141-114 that provides for combining approved 
Aviax (22.7 grams per pound (g/lb) semduramicin) and 
Stafac (20 or 227 g/lb virginiamycin) Type A medicated 
articles to make combination drug Type C medicated broiler chicken 
feeds. The Type C medicated broiler feeds containing 25 parts per 
million (ppm) (22.7 g/ton (t)) semduramicin and 5 to 15 g/t 
virginiamycin are used for the prevention of coccidiosis caused by 
Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, 
and E. mivati/mitis, and for increased rate of weight gain. The Type C 
medicated broiler feeds containing 25 ppm semduramicin and 5 g/t 
virginiamycin are used for the prevention of coccidiosis caused by E. 
tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, and E. 
mivati/mitis, and for increased rate of weight gain and improved feed 
efficiency. The Type C medicated broiler feeds containing 25 ppm 
semduramicin and 20 g/t virginiamycin are used for the prevention of 
coccidiosis caused by E. tenella, E. acervulina, E. maxima, E. 
brunetti, E. necatrix, and E. mivati/mitis, and for prevention of 
necrotic enteritis caused by Clostridium

[[Page 48296]]

perfringens susceptible to virginiamycin.
    The NADA is approved as of July 27, 1999. The regulations are 
amended in 21 CFR 558.555 by redesignating paragraph (b) as paragraph 
(d), by adding new paragraph (b) and adding and reserving paragraph 
(c), by revising the heading of newly redesignated paragraph (d), by 
removing the introductory text of newly redesignated paragraph (d)(1), 
and by adding paragraphs (d)(5), (d)(6), and (d)(7) to reflect the 
approval. Also, the regulations are amended in 21 CFR 558.635 by 
removing paragraphs (a), (c), (e)(3), and (e)(4), by redesignating 
paragraphs (b), (d), (e), and (f) as paragraphs (a), (b), (c), and (d), 
by correcting the cross-references in newly redesignated paragraph (a) 
from paragraph (f) to paragraph (d), by correcting a typographical 
error in newly redesignated paragraph (d)(2)(i), and by adding 
paragraph (d)(4)(vii) to also reflect the approval. The basis for 
approval is discussed in the freedom of information summary.
    Furthermore, neither an ADI for semduramicin or for virginiamycin 
nor a tolerance for semduramicin residues have been previously 
established. At this time, 21 CFR 556.597 is added to establish an ADI 
and a tolerance for semduramicin. Also, 21 CFR 556.750 is amended to 
remove language referring to negligible residues in swine, broiler 
chicken, and cattle tissues to provide for an ADI for virginiamycin, 
and to reflect a revised format.
    In accordance with the freedom of information provisions of 21 CFR 
part 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.
    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

21 CFR Part 556

    Animal drugs, Foods.

21 CFR Part 558

    Animal drugs, Animal feeds.
    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 parts 556 and 
558 are amended as follows:

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

    1. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority:  21 U.S.C. 342, 360b, 371.

    2. Section 556.597 is added to read as follows:


Sec. 556.597  Semduramicin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
semduramicin is 180 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Broiler chickens. Tolerances are established 
for residues of parent semduramicin in uncooked edible tissues of 400 
parts per billion (ppb) in liver and 130 ppb in muscle.
    (2) [Reserved]
    3. Section 556.750 is revised to read as follows:


Sec. 556.750   Virginiamycin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
virginiamycin is 250 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Swine. Tolerances are established for residues 
of virginiamycin in uncooked edible tissues of 0.4 part per million 
(ppm) in kidney, skin, and fat, 0.3 ppm in liver, and 0.1 ppm in 
muscle.
    (2)  Broiler chickens and cattle. A tolerance for residues of 
virginiamycin is not required.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    4. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

    5. Section 558.555 is amended by redesignating paragraph (b) as 
paragraph (d), by adding new paragraph (b) and adding and reserving 
paragraph (c), by revising the heading of newly redesignated paragraph 
(d), by removing the introductory text of newly redesignated paragraph 
(d)(1), and by adding paragraphs (d)(5), (d)(6), and (d)(7) to read as 
follows:


Sec. 558.555   Semduramicin.

* * * * *
    (b) Related tolerances. See Sec. 556.597 of this chapter.
    (c) [Reserved]
    (d) Conditions of use in broiler chickens. * * *
    (5) Amount. Semduramicin 22.7 grams with virginiamycin 20 grams per 
ton.
    (i) Indications for use. For the prevention of coccidiosis caused 
by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, 
and E. mivati/mitis, and for prevention of necrotic enteritis caused by 
Clostridium perfringens susceptible to virginiamycin.
    (ii)  Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not feed to laying hens. Semduramicin and virginiamycin 
as provided by 000069 in Sec. 510.600(c) of this chapter.
    (6)  Amount. Semduramicin 22.7 grams with virginiamycin 5 to 15 
grams per ton.
    (i)  Indications for use. For the prevention of coccidiosis caused 
by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, 
and E. mivati/mitis, and for increased rate of weight gain.
    (ii)  Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not feed to laying hens. Semduramicin and virginiamycin 
as provided by 000069 in Sec. 510.600(c) of this chapter.
    (7)  Amount. Semduramicin 22.7 grams with virginiamycin 5 grams per 
ton.
    (i) Indications for use. For the prevention of coccidiosis caused 
by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, 
and E. mivati/mitis, and for increased rate of weight gain and improved 
feed efficiency.
    (ii)  Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not feed to laying hens. Semduramicin and virginiamycin 
as provided by 000069 in Sec. 510.600(c) of this chapter.
    6. Section 558.635 is amended by removing paragraphs (a), (c), 
(e)(3), and (e)(4), by redesignating paragraphs (b), (d), (e), and (f) 
as paragraphs (a), (b), (c), and (d), respectively, by removing ``(f)'' 
and ``(f)(3)'' in newly redesignated paragraph (a)(1) and adding in 
their places ``(d)'' and ``(d)(3)'', by removing ``(f)(1)(iv)'' and 
``(f)(1)(v)'' in newly redesignated paragraph (a)(2) and adding in 
their places ``(d)(1)(iv)'' and ``(d)(1)(v)'', by removing 
``chiickens'' in newly redesignated paragraph (d)(2)(i) and adding in 
its place ``chickens'', and

[[Page 48297]]

by adding paragraph (d)(4)(vii) to read as follows:


Sec. 558.635   Virginiamycin.

* * * * *
    (d) * * *
    (4) * * *
    (vii) Semduramicin as in Sec. 558.555 of this chapter.

    Dated: August 24, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-22997 Filed 9-3-99; 8:45 am]
BILLING CODE 4160-01-F