[Federal Register Volume 61, Number 95 (Wednesday, May 15, 1996)]
[Rules and Regulations]
[Pages 24441-24443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11927]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 520 and 556
Animal Drugs, Feeds, and Related Products; Liquid Sul-Q-Nox
(Sodium Sulfaquinoxaline Solution)
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 I. D. Russell Co. Laboratories. The
supplemental NADA provides for safe and effective use of a sodium
[[Page 24442]]
sulfaquinoxaline solution in medicating the drinking water of chickens,
turkeys, calves, and cattle for either control or control and treatment
of certain coccidial or bacterial diseases susceptible to
sulfaquinoxaline. The approval reflects compliance with results of the
National Academy of Sciences/ National Research Council (NAS/NRC), Drug
Efficacy Study Group's (DESI) evaluation of the drug's effectiveness
and FDA's conclusions concerning that evaluation. FDA is also amending
the regulations to codify a tolerance for sulfaquinoxaline residues in
edible tissues of chickens, turkeys, calves, and cattle.
EFFECTIVE DATE: May 15, 1996.
FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1623.
SUPPLEMENTARY INFORMATION: I. D. Russell Co. Laboratories, 1301 Iowa
Ave., Longmont, CO 80501, is the sponsor of NADA 6-891 which provides
for the use of 34-percent Liquid Sul-Q-Nox (sodium sulfaquinoxaline
solution). The drug product is used to medicate the drinking water of:
(1) Chickens as an aid in the control of outbreaks of coccidiosis
caused by Eimeria tenella, ---E. necatrix, E. acervulina, E. maxima,
and E. brunetti; (2) turkeys as an aid in the control of outbreaks of
coccidiosis caused by E. meleagrimitis and E. adenoeides; (3) chickens
and turkeys as an aid in the control of acute fowl cholera caused by
Pasteurella multocida susceptible to sulfaquinoxaline and fowl typhoid
caused by Salmonella gallinarum susceptible to sulfaquinoxaline; and
(4) calves and cattle for the control and treatment of outbreaks of
coccidiosis caused by E. bovis or E. zurnii. The NADA was originally
approved as safe on April 28, 1949.
In the Federal Register of July 9, 1970 (35 FR 11069), FDA
published the results of a NAS/NRC DESI evaluation of several
sulfaquinoxaline-containing veterinary drug products. The list of drug
products included solutions which are similar to the subject solution.
In that document, NAS/NRC evaluated the products as ``Probably
effective as an aid in prevention and control of outbreaks of
coccidiosis in chickens, turkeys, pheasants (and other game birds),
cattle, and sheep (provided the specie of coccidia for the respective
hosts are shown) * * *.'' Additionally, although it was inadvertently
omitted from that document, NAS/NRC also evaluated such products as
effective for control of acute fowl cholera in chickens, turkeys,
pheasants, and other game birds and as effective for the control of
fowl typhoid in chickens and turkeys. FDA concurred with the NAS/NRC
findings.
The NAS/NRC evaluation was concerned only with the drugs'
effectiveness and safety to the treated animal. It did not take into
account the safety for human food use of food derived from drug-treated
animals.
Subsequently, in the Federal Register of January 28, 1983 (48 FR
3962 at 3964), FDA established several sections for sulfaquinoxaline-
containing drugs, including Sec. 520.2325a (21 CFR 520.2325a), which
specify those conditions of use found to be effective by NAS/NRC and
FDA.
I. D. Russell Co. Laboratories has submitted information to comply
with the NAS/NRC and FDA findings and has revised its labeling to
conform to the currently approved conditions of use in Sec. 520.2325a.
On that basis, the subject supplemental NADA was approved as of March
6, 1996, and Sec. 520.2325a is now amended to reflect the approval. The
basis for this approval is discussed in the freedom of information
summary.
Also, the section is amended to remove reserved paragraphs (a) and
(b), to add a ``related tolerances'' paragraph, and to add a warning
against use of sulfaquinoxaline-medicated drinking water in veal
calves. The latter is part of a general effort to distinguish between
ruminating and preruminating calves based on information indicating
that withdrawal periods established in ruminating calves may not be
adequate for preruminating calves.
Furthermore, the regulation contains an outdated paragraph citing
the NAS/NRC status of these products. The Generic Animal Drug and
Patent Term Restoration Act of 1988 changed that status. Therefore, the
NAS/NRC paragraph is removed at this time.
Finally, the animal drug regulations are amended because FDA has
noted that a tolerance for sulfaquinoxaline residues in edible tissues
has not been codified. The tolerance for sulfaquinoxaline residues in
all edible tissues from chickens, turkeys, calves, and cattle is 0.1
part per million (ppm). When sulfaquinoxaline was approved, a
negligible tolerance of 0.1 ppm in all edible tissues was applied to
animal drug residues based on subchronic (90-day) toxicological
studies. This ``negligible tolerance'' concept is based on two
precepts: (1) The residues are present at a level of insignificance and
(2) the safety of the residues is supported by limited toxicological
data. The toxicological data available for sulfaquinoxaline (90-day dog
study) permit a tolerance for sulfaquinoxaline residues in edible
tissues of 0.1 ppm. Therefore, this tolerance is being codified in new
Sec. 556.685.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for food-
producing animals does not qualify for marketing exclusivity because
the supplemental application does not contain reports of new clinical
or field investigations (other than bioequivalence or residue studies)
and new human food safety studies (other than bioequivalence or residue
studies) essential to the approval and conducted or sponsored by the
applicant.-
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
List of Subjects
21 CFR Part 520
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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 parts 520 and
556 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. Section 520.2325a is amended by removing paragraph (d); by
redesignating paragraphs (c), (e), and (f)
[[Page 24443]]
as paragraphs (a), (c), and (d), respectively; by revising newly
redesignated paragraph (a); by amending newly redesignated paragraph
(d) by adding two new sentences after the fifth sentence; and by adding
a new paragraph (b) to read as follows:
Sec. 520.2325a Sulfaquinoxaline drinking water.
(a) Sponsor. See Sec. 510.600(c) of this chapter for identification
of the sponsors.
(1) No. 050749 for use of a 25-percent soluble powder and a 20-
percent solution as provided for in paragraph (c) of this section.
(2) No. 060594 for use of 3.44- and 12.85-percent solutions as
provided for in paragraphs (c)(1), (c)(2), (c)(3), (c)(4)(i), and
(c)(4)(ii) of this section.
(3) No. 017144 for use of a 34-percent solution as provided for in
paragraphs (c)(1), (c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) of this
section.
(b) Related tolerances. See Sec. 556.685 of this chapter.
* * * * *
(d) Limitations. * * * A withdrawal period has not been established
for sulfaquinoxaline in preruminating calves. Do not use in calves to
be processed for veal. * * *
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
3. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: Secs. 402, 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342, 360b, 371).
-4. New Sec. 556.685 is added to subpart B read as follows:
Sec. 556.685 Sulfaquinoxaline.
A tolerance of 0.1 part per million is established for negligible
residues of sulfaquinoxaline in the uncooked edible tissues of
chickens, turkeys, calves, and cattle.
Dated: April 15, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-11927 Filed 5-14-96; 8:45 am]
BILLING CODE 4160-01-F