Federal Register / Vol. 61, No. 95 / Wednesday, May 15, 1996 / Rules and Regulations 24441

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1644.

SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health, Schering-Plough

Corp., P.O. Box 529, Kenilworth, NJ

07033, has requested that NADA 47–486

Garasol Injection (5 milligrams

gentamicin per milliliter (mg/mL) for

turkeys) be included in NADA 101–862

Garasol Injection (50 and 100 mg/mL

for chickens). The NADA’s are

combined as NADA 101–862. NADA

47–486 is withdrawn. Schering-Plough

also filed supplemental NADA 101–862

providing for the use of 50 and 100 mg/

mL gentamicin sulfate injection for

turkeys at the same dosage and for the

same indications as currently approved.

The supplement is approved as of

March 28, 1996. In addition,

supplemental NADA 101–862 was

approved on July 27, 1983, for the use

of a 100 mg/mL injection in day-old

chickens. However, this approval was

not codified. At this time the regulation

in § 522.1044 (21 CFR 522.1044) is

amended to codify use of the 100 mg/

mL injection in day-old chickens.

Although the use was approved in

chickens as well as turkeys, the

regulations were not amended to

provide for a tolerance for gentamicin

residues in chickens. The regulations in

21 CFR 556.300 are amended to provide

for tolerances for gentamicin residues in

chickens as well as turkeys.

The approved, combined, and

supplemented NADA 101-862 provides

for use of Garasol Injection (50 and

100 mg/mL gentamicin sulfate injection)

in day-old chickens for the prevention

of early mortality caused by Escherichia

coli, Salmonella typhimurium, and

Pseudomonas aeruginosa susceptible to

gentamicin, and for use of Garasol

Injection (5, 50, and 100 mg/mL

gentamicin sulfate injection) in 1- to 3-

day-old turkeys for the prevention of

early mortality due to Arizona

paracolon infections susceptible to

gentamicin.

In § 522.1044(d)(2)(i), the regulation is

editorially amended to reflect the

language used in § 522.1044(d)(3)(i).

Also, American Scientific

Laboratories, A Division of Schering

Corp., has been incorporated into

Schering-Plough Animal Health,

Schering-Plough Corp. Therefore, 21

CFR 510.600(c) is amended to remove

the entries for American Scientific

Laboratories, drug label code 000138.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 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.

The agency has determined under 21

CFR 25.24(d)(1)(iii) 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 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 522

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 510, 522, and 556 are

amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 503,

512, 701, 721 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e).

§ 510.600 [Amended]

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) by

removing the entry for ‘‘American

Scientific Laboratories’’ and in the table

in paragraph (c)(2) by removing the

entry for ‘‘000138’’.

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

3. The authority citation for 21 CFR

part 522 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

4. Section 522.1044 is amended by

revising paragraphs (b), (d)(2)(i), and

(d)(3)(i) to read as follows:

§ 522.1044 Gentamicin sulfate injection.

(b) Sponsors. (1) See No. 000061 in

§ 510.600(c) of this chapter for use of: 5-

milligrams-per-milliliter solution in

swine as in paragraph (d)(4) of this

section, 50-milligrams-per-milliliter

solution in dogs and cats as in

paragraph (d)(1) of this section, 50- and

100-milligrams-per-milliliter solution in

chickens and turkeys as in paragraphs

(d)(2) and (d)(3) of this section.

(2) [Reserved]

* * * * *

(d) * * *

(2) Turkeys—(i) Amount. One

milligram of gentamicin per 0.2

milliliter dose, using the 50- or 100-

milligrams-per-milliliter product

diluted with sterile saline to a

concentration of 5 milligrams-permilliliter.

* * * * *

(3) Chickens—(i) Amount. 0.2

milligram of gentamicin per 0.2

milliliter dose, using the 50- or 100-

milligrams-per-milliliter product

diluted with sterile saline to a

concentration of 1.0 milligram-permilliliter.

* * * * *

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

5. 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).

§ 556.300 [Amended]

6. Section 556.300 Gentamicin sulfate

is amended in paragraph (a) by adding

the phrase ‘‘chickens and’’ after ‘‘tissues

of’’.

Dated: April 26, 1996.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 96–12154 Filed 5–14–96; 8:45 am]

BILLING CODE 4160–01–F

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.

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
24442 Federal Register / Vol. 61, No. 95 / Wednesday, May 15, 1996 / Rules and Regulations

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 § 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

§ 520.2325a. On that basis, the subject

supplemental NADA was approved as of

March 6, 1996, and § 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 § 556.685.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 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)
Federal Register / Vol. 61, No. 95 / Wednesday, May 15, 1996 / Rules and Regulations 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:

§ 520.2325a Sulfaquinoxaline drinking

water.

(a) Sponsor. See § 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 § 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 § 556.685 is added to subpart

B read as follows:

§ 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

21 CFR Parts 520 and 558

Animal Drugs, Feeds, and Related

Products; Monensin

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 supplemental new animal

drug applications (NADA’s) filed by

Elanco Animal Health, Division of Eli

Lilly and Co., Moorman Manufacturing

Co., and Farmland Industries, Inc.

Elanco’s supplemental NADA provides

for use of monensin Type C medicated

feeds fed to pasture cattle weighing less

than 400 pounds (lb) for increased rate

of weight gain. Moorman’s and

Farmland’s supplemental NADA’s

provide for use of monensin blocks for

pasture cattle weighing less than 400 lb

for increased rate of weight gain.

EFFECTIVE DATE: May 15, 1996.

FOR FURTHER INFORMATION CONTACT: Jack

Caldwell, Center for Veterinary

Medicine (HFV–126), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1638.

SUPPLEMENTARY INFORMATION: Elanco

Animal Health, Division of Eli Lilly and

Co., Lilly Corporate Center,

Indianapolis, IN 46285, filed

supplemental NADA 95–735, which

provides for use of monensin Type A

medicated articles to make monensin

Type C medicated feeds containing 25

to 400 grams per ton monensin as

monensin sodium to be fed at 50 to 200

milligrams per head per day to pasture

cattle (slaughter, stocker, feeder, and

dairy and beef replacement heifers)

weighing less than 400 lb for increased

rate of weight gain. Moorman

Manufacturing Co., Quincy, IL 62301,

filed supplemental NADA 115–581, and

Farmland Industries, Inc., Kansas City,

MO 64116, filed supplemental NADA

118–509, providing for free-choice

feeding of monensin blocks, all to

pasture cattle weighing less than 400 lb

for increased rate of weight gain.

The supplemental NADA’s provide

for removal of the restriction concerning

feeding of the products to animals

weighing less than 400 lb body weight

as currently approved. The

supplemental NADA’s are approved as

of March 15, 1996, and the regulations

are amended in 21 CFR 520.1448a(c)

and 558.355(f)(3)(iii) and (f)(3)(v) to

reflect the approvals. The basis for

approval is discussed in the freedom of

information summary for Elanco’s

supplemental NADA 95–735.

Under section 512(c)(2)(F)(iii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(iii)), approval of

Elanco Animal Health’s supplemental

NADA 95–735 qualifies for 3 years of

marketing exclusivity beginning March

15, 1996, because the supplement

contains reports of new clinical or field

investigations (other than

bioequivalence or residue studies)

essential to the approval and conducted

or sponsored by the applicant.

Marketing exclusivity applies only to

the new use of the product.

Under section 512(c)(2)(F)(iii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(iii)), approval of

Moorman’s supplemental NADA 115–

581 and Farmland’s supplemental

NADA 118–509 do not qualify for

marketing exclusivity because the

supplements do not contain reports of

new clinical or field investigations

(other than bioequivalence or residue

studies) or new human food safety

studies (other than bioequivalence or

residue studies) essential to the

approval and conducted or sponsored

by the applicant.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 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.

The basis of approval of Moorman’s

and Farmland’s supplemental NADA’s

are by authorization to reference data

and information in Elanco’s

supplemental NADA 95–735. Therefore,

a freedom of information summary of

the data and information required for

approval of these NADA’s is available

under Elanco’s supplemental NADA 95–

735.

The agency has determined under 21

CFR 25.24(d)(1)(i) 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 520

Animal drugs.

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 520 and 558 are amended as

follows: