[Federal Register Volume 64, Number 94 (Monday, May 17, 1999)]
[Rules and Regulations]
[Pages 26671-26672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12285]
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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; Sulfadimethoxine with
Ormetoprim
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 supplemental new animal drug
application (NADA) filed by Roche Vitamins, Inc. The supplemental NADA
provides for use of sulfadimethoxine/ormetoprim type A medicated
articles to make type C medicated chukar partridge feeds used for the
prevention of coccidiosis. Also, FDA is amending the regulations to
reflect tolerances for residues of sulfadimethoxine and for ormetoprim
in edible chukar partridge tissues.
EFFECTIVE DATE: May 17, 1999.
FOR FURTHER INFORMATION CONTACT: Naba K. Das, Center for Veterinary
Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-7569.
SUPPLEMENTARY INFORMATION: Roche Vitamins, Inc., 45 Waterview Blvd.,
Parsippany, NJ 07054-1298, filed supplemental NADA 40-209 that provides
for use of Rofenaid 40 (113.5 grams per pound (g/lb) (25
percent) sulfadimethoxine with 68.1 g/lb (15 percent) ormetoprim) type
A medicated articles to make type C chukar partridge feeds containing
113.5 grams per ton (g/t) sulfadimethoxine and 68.1 g/t ormetoprim. The
type C chukar partridge feeds are fed continuously to young birds up to
8 weeks of age for the prevention of coccidiosis caused by Eimeria
kofoidi and E. legionensis. The supplemental NADA is approved as of
April 1, 1999. The regulations are amended in 21 CFR 558.575 to
redesignate paragraph (c) as paragraph (d), to reserve paragraph (c),
to amend paragraph (a) to reflect the redesignation and to reflect the
approval, and to add paragraph (d)(7) to further reflect the approval.
The basis of approval is discussed in the freedom of information
summary.
Also, tolerances are established for sulfadimethoxine and for
ormetoprim residues in edible chukar partridge tissues. The regulations
are amended in 21 CFR 556.490 and 556.640, accordingly.
[[Page 26672]]
Approval of this supplement is based on data and information in
Public Master File (PMF) 5157. The notice of availability of a summary
of the data and information in PMF 5157 and of permission to use it to
support approval of a NADA or supplemental NADA was published in the
Federal Register of July 19, 1996 (61 FR 37753).
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.
FDA has determined under 21 CFR 25.33(d)(4) 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.
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 556.490 is revised to read as follows:
Sec. 556.490 Ormetoprim.
(a) [Reserved]
(b) Tolerances. A tolerance of 0.1 part per million (ppm) is
established for negligible residues of ormetoprim in uncooked edible
tissues of chickens, turkeys, ducks, salmonids, catfish, and chukar
partridges.
3. Section 556.640 is revised to read as follows:
Sec. 556.640 Sulfadimethoxine.
(a) [Reserved]
(b) Tolerances. (1) A tolerance of 0.1 part per million (ppm) is
established for negligible residues of sulfadimethoxine in uncooked
edible tissues of chickens, turkeys, cattle, ducks, salmonids, catfish,
and chukar partridges.
(2) A tolerance of 0.01 ppm is established for negligible residues
of sulfadimethoxine in milk.
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 558.575 is amended by revising paragraph (a),
redesignating paragraph (c) as paragraph (d), reserving paragraph (c),
and adding paragraph (d)(7) to read as follows:
Sec. 558.575 Sulfadimethoxine, ormetoprim.
(a) Approvals. Type A medicated articles to sponsors as identified
in Sec. 510.600(c) of this chapter for uses as in paragraph (d) of this
section as follows:
(1) 25 percent sufadimethoxine and 15 percent ormetoprim to 000004
for use for poultry as in paragraphs (d)(1), (d)(2), (d)(3), (d)(4),
and (d)(7) of this section.
(2) 25 percent sulfadimethoxine and 5 percent ormetoprim to 000004
for use for fish as in paragraphs (d)(5) and (d)(6) of this section.
* * * * *
(c) [Reserved]
(d) * * *
(7) Chukar partridges--(i) Amount per ton. Sulfadimethoxine 113.5
grams (0.0125 percent) plus ormetoprim 68.1 grams (0.0075 percent).
(ii) Indications for use. For prevention of coccidiosis caused by
Eimeria kofoidi and E. legionensis.
(iii) Limitations. Feed continuously to young birds up to 8 weeks
of age as sole ration.
Dated: April 30, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-12285 Filed 5-14-99; 8:45 am]
BILLING CODE 4160-01-F
