[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]
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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.
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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 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
