Federal Register / Vol. 61, No. 119 / Wednesday, June 19, 1996 / Rules and Regulations 31027

after the first month for which disability

or blindness benefits are suspended

because of such VR refusal.

§ 416.2217 [Amended]

13. Section 416.2217 is amended in

the introductory text of the section by

adding ‘‘and (e)’’ after ‘‘section

1615(d).’’

[FR Doc. 96–15407 Filed 6–18–96; 8:45 am]

BILLING CODE 4190–29–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Neomycin Sulfate Soluble Powder

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 an abbreviated new animal

drug application (ANADA) filed by

Wade Jones Co., Inc. The ANADA

provides for the use of a generic

neomycin sulfate soluble powder in

drinking water and milk for cattle

(excluding veal calves), swine, sheep,

and goats for the treatment and control

of colibacillosis.

EFFECTIVE DATE: June 19, 1996.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: Wade

Jones Co., Inc., Hwy. 71 North, Lowell,

AK 72745, filed ANADA 200–130,

which provides for the use of neomycin

sulfate soluble powder in drinking

water and milk for cattle (excluding veal

calves), swine, sheep, and goats for the

treatment and control of colibacillosis

(bacterial enteritis) caused by

Escherichia coli susceptible to

neomycin sulfate. ANADA 200–130 is

approved as a generic copy of the

Upjohn Co.’s NADA 11–315. The

ANADA is approved as of May 8, 1996,

and the regulations are amended in 21

CFR 520.1484(b) and (c)(3) to reflect the

approval. The basis for approval is

discussed in the freedom of information

summary.

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)(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 in 21 CFR Part 520

Animal drugs.

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 part 520 is 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 520.1484 is amended by

revising paragraph (b) and the last

sentence of paragraph (c)(3) to read as

follows:

§ 520.1484 Neomycin sulfate soluble

powder.

* * * * *

(b) Sponsors. See Nos. 000009,

000069, 047864, 050604, and 059130 in

§ 510.600(c) of this chapter.

(c) * * *

(3) * * * Discontinue treatment prior

to slaughter as follows: For sponsors

000009, 000069, 047864, and 050604—

cattle (not for use in veal calves), 1 day;

sheep, 2 days; swine and goats, 3 days.

Dated: June 10, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–15466 Filed 6–18–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs;

Oxytetracycline Injection

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 an abbreviated new animal

drug application (ANADA) filed by

Pennfield Oil Co. The ANADA provides

for the use of a generic oxytetracycline

injection for beef cattle, non-lactating

dairy cattle, and swine.

EFFECTIVE DATE: June 19, 1996.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: Pennfield

Oil Co., 14040 Industrial Rd., Omaha,

NE 68137, filed ANADA 200–154,

which provides for use of 200 milligram

per milliliter (mg/mL) oxytetracycline

injection for intramuscular and

intravenous use in beef cattle and nonlactating dairy cattle and intramuscular

use in swine for control or treatment of

diseases caused by oxytetracycline

susceptible diseases. The drug is used in

beef cattle and non-lactating dairy cattle

for treatment of pneumonia and

shipping fever complex associated with

Pasteurella spp. and Hemophilus spp.;

infectious bovine keratoconjunctivitis

(pinkeye) caused by Moraxella bovis;

foot rot and diphtheria caused by

Fusobacterium necrophorum; bacterial

enteritis (scours) caused by Escherichia

coli; wooden tongue caused by

Actinobacillus lignieresi; leptospirosis

caused by Leptospira pomona; and

wound infections and metritis caused

by strains of staphylococci and

streptococci organisms sensitive to

oxytetracycline. The drug is used in

swine for the treatment of bacterial

enteritis (scours, colibacillosis) caused

by E. coli; pneumonia caused by P.

multocida; and leptospirosis caused by

L. pomona; and in sows as an aid in the

control of infectious enteritis (baby pig

scours, colibacillosis) in suckling pigs

caused by E. coli.

ANADA 200–154 for Pennfield Oil

Co.’s oxytetracycline injection is

approved as a generic copy of Pfizer’s

NADA 113–232 Liquamycin LA–200

(oxytetracycline) Injection. The ANADA

is approved as of May 8, 1996, and the

regulations are amended in 21 CFR

522.1660 to reflect the approval. The

basis for approval is discussed in the

freedom of information summary.

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.,
31028 Federal Register / Vol. 61, No. 119 / Wednesday, June 19, 1996 / Rules and Regulations

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)(l)(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 in 21 CFR Part 522

Animal drugs.

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 part 522 is amended as follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. 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).

§ 522.1660 [Amended]

2. Section 522.1660 Oxytetracycline

injection is amended in paragraphs (b)

and (c)(2)(iii) by adding ‘‘053389,’’ after

‘‘000069,’’.

Dated: June 10, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–15465 Filed 6–18–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 522 and 556

Animal Drugs, Feeds, and Related

Products; Spectinomycin Injection

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 an abbreviated new animal

drug application (ANADA) filed by The

Upjohn Co. The ANADA provides for

subcutaneous use of a generic

spectinomycin sterile solution in turkey

poults and newly-hatched chicks as an

aid in the control of bacterial respiratory

infections, airsacculitis, and mortality.

The regulations are also amended to add

a tolerance for spectinomycin residues

in turkey tissues.

EFFECTIVE DATE: June 19, 1996.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: The

Upjohn Co., Agricultural Division,

Kalamazoo, MI 49001–0199, is the

sponsor of ANADA 200–127 which

provides for the use of a generic

spectinomycin dihydrochloride

pentahydrate sterile solution (500

milliliter (mL) vial; 100 milligrams of

spectinomycin activity per mL). The

generic drug product is administered

subcutaneously to 1- to 3-day-old turkey

poults as an aid in the control of chronic

respiratory disease (CRD) and

airsacculitis and 1- to 3-day-old chicks

as an aid in the control of mortality and

to lessen the severity of respiratory

infections, caused by certain microbial

species sensitive to spectinomycin.

Approval of ANADA 200–127 for The

Upjohn Co.’s spectinomycin

dihydrochloride pentahydrate sterile

solution is as a generic copy of Rhone

Merieux’s (formerly Sanofi Animal

Health) NADA 040–040 for Spectam

Injectable. The ANADA is approved as

of May 9, 1996, and the regulations are

amended in 21 CFR 522.2120 to reflect

the approval. The basis for approval is

discussed in the freedom of information

summary.

Spectinomycin was originally

approved based on the negligible

tolerance concept. A negligible

tolerance has been applied to animal

drug residues when the supporting

toxicological data are of subchronic (90-

day) duration. The ‘‘negligible

tolerance’’ concept is based on two

precepts: (1) The residue present is at a

level of insignificance and (2) the safety

of the residue is supported by limited

toxicological data. The upper level for a

drug residue to qualify for ‘‘negligible

tolerance’’ is considered customarily to

be 0.1 part per million (ppm) residue in

tissue. Therefore, the tolerance for

spectinomycin residues in edible tissues

is the same for all species in which the

drug is approved. Accordingly, 21 CFR

556.600 is amended to apply the

tolerance of 0.1 ppm to edible turkey

tissues.

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)(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 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 522 and 556 are amended to

read as follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. 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).

2. Section 522.2120 is amended by

revising paragraph (b) and by amending

paragraph (d)(4) by removing ‘‘M.

mileagridis’’ and adding in its place ‘‘M.

meleagridis’’ to read as follows:

§ 522.2120 Spectinomycin injection.

* * * * *

(b) Sponsor. In § 510.600 of this

chapter, see Nos. 000033 and 050604 for

conditions of use as in paragraph (d) of

this section, and see No. 000009 for

conditions of use as in paragraph (d)(2)

and (d)(4) of this section.

* * * * *

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. Section 556.600 is revised to read

as follows:

§ 556.600 Spectinomycin.

A tolerance of 0.1 part per million is

established for negligible residues of

spectinomycin in the uncooked edible

tissues of chickens and turkeys.

Dated: June 10, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–15567 Filed 6–18–96; 8:45 am]

BILLING CODE 4160–01–F