[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