Federal Register / Vol. 60, No. 51 / Thursday, March 16, 1995 / Rules and Regulations 14217

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 520.1263c is amended by

revising paragraph (a) to read as follows:

§ 520.1263c Lincomycin hydrochloride

soluble powder.

(a) Specifications. Each 40-gram

packet (1.41 ounce) contains lincomycin

hydrochloride equivalent to 16 grams of

lincomycin. Each 80-gram packet (2.82

ounces) contains lincomycin

hydrochloride equivalent to 32 grams of

lincomycin.

* * * * *

Dated: March 8, 1995.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 95–6531 Filed 3–15–95; 8:45 am]

BILLING CODE 4160–01–F

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

Sanofi Animal Health, Inc. The ANADA

provides for the use of a generic

neomycin sulfate soluble powder

administered orally in drinking water or

in milk for the treatment and control of

colibacillosis in cattle (excluding veal

calves), swine, sheep, and goats.

EFFECTIVE DATE: March 16, 1995.

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: Sanofi

Animal Health, Inc., 7101 College Blvd.,

suite 610, Overland Park, KS 66210,

filed ANADA 200–050, which provides

for the oral use of neomycin sulfate

soluble powder in drinking water or

milk for cattle (excluding veal calves),

swine, sheep, and goats for the

treatment and control of colibacillosis

(bacterial scours) caused by Escherichia

coli susceptible to neomycin sulfate.

Approval of ANADA 200–050 is as a

generic copy of The Upjohn’s approved

NADA 11–315 for Neomix 325 soluble

powder. The ANADA is approved as of

February 15, 1995, and the regulations

are amended by revising § 520.1484(b)

(21 CFR 520.1484(b)) 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, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857,

between 9 a.m. and 4 p.m., Monday

through Friday.

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 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) to read as follows:

§ 520.1484 Neomycin sulfate soluble

powder.

* * * * *

(b) Sponsors. See Nos. 000009,

000069, 050604, and 059130 in

§ 510.600(c) of this chapter.

* * * * *

Dated: March 8, 1995.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 95–6530 Filed 3–15–95; 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

Phoenix Scientific, Inc. The ANADA

provides for the use of oxytetracycline

injection in cattle and swine for the

treatment of diseases caused by

oxytetracycline susceptible organisms.

EFFECTIVE DATE: March 16, 1995.

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: Phoenix

Scientific, Inc., 3915 South 48th Street

Terrace, P.O. Box 6457, St. Joseph, MO

64506–0457, has filed ANADA 200–123

which provides for use of

oxytetracycline injection as follows: (1)

Intramuscular or intravenous use in beef

and nonlactating dairy cattle for the

treatment of pneumonia and shipping

fever 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

acute metritis caused by strains of

staphylococci and streptococci

organisms sensitive to oxytetracycline;

(2) intramuscular use in swine for

treatment of bacterial enteritis (scours,

colibacillosis) caused by E. coli;

pneumonia caused by P. multocida; and

leptospirosis caused by L. pomona; and

(3) intramuscular use in sows for control

of infectious enteritis (baby pig scours,

colibacillosis) in suckling pigs caused

by E. coli.

Phoenix Scientific’s ANADA 200–123

for oxytetracycline injection (Maxim

200) is approved as a generic copy of

Pfizer’s NADA 113–232 for

oxytetracycline injection (Liquamycin
14218 Federal Register / Vol. 60, No. 51 / Thursday, March 16, 1995 / Rules and Regulations

LA–200). The ANADA is approved as of

February 10, 1995, and the regulations

are amended in 21 CFR 522.1660(b) and

(c)(2)(iii) 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, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857,

between 9 a.m. and 4 p.m., Monday

through Friday.

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 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).

2. Section 522.1660 is amended in

paragraph (b) by removing the phrase

‘‘000010 and 000069’’ and adding in its

place ‘‘000010, 000069, and 059130’’,

and in paragraph (c)(2)(iii) by revising

the last sentence to read as follows:

§ 522.1660 Oxytetracycline injection.

* * * * *

(c) * * *

(2) * * *

(iii) * * * Discontinue treatment at

least 42 days prior to slaughter when

provided by 000010 and 28 days prior

to slaughter when provided by 000069

or 059130.

Dated: March 8, 1995.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 95–6527 Filed 3–15–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF LABOR

Occupational Safety and Health

Administration

29 CFR Part 1915

[Docket No. S–050]

Confined and Enclosed Spaces and

Other Dangerous Atmospheres in

Shipyard Employment

AGENCY: Occupational Safety and Health

Administration (OSHA), Department of

Labor.

ACTION: Final rule; correction.

SUMMARY: In the July 25, 1994, Federal

Register OSHA published a revised

standard for Shipyard Employment,

subpart B of 29 CFR part 1915,

extending the previous requirements for

work in explosive and other dangerous

atmospheres on ships to cover all work

involving confined or enclosed spaces

or other dangerous atmospheres

throughout shipyard employment (59

FR 37816). With the present document,

OSHA is making corrections to the rule

which include: clarifying the order of

testing before employees may enter a

confined or enclosed space or other

dangerous atmosphere; clarifying when

flammable atmospheres must be

maintained above the upper explosive

limit during installation of ventilation

or rescue; and clarifying the limited

locations and conditions where hot

work may be performed without first

being certified by a Marine Chemist.

Several typographical errors are also

being corrected.

EFFECTIVE DATE: The final rule published

on July 25, 1994, became effective on

October 24, 1994. These corrections are

effective March 16, 1995.

FOR FURTHER INFORMATION CONTACT:

Richard Liblong, Director, Office of

Information and Consumer Affairs,

Occupational Safety and Health

Administration, Room N3647, U.S.

Department of Labor, 200 Constitution

Ave., N.W., Washington, D.C. 20210

(202–219–8148).

SUPPLEMENTARY INFORMATION:

I. Correction to § 1915.12—Precautions

Before Entering Confined and Enclosed

Spaces and Other Dangerous

Atmospheres

OSHA is correcting the section

heading to § 1915.12 to make clearer the

requirement that atmospheric testing

must be done in the order set forth in

the standard (i.e., oxygen content, then

flammability, and then toxicity).

In the preamble to the final rule

OSHA explained how the section was

being reformatted to address the order of

atmospheric testing to be conducted

when determining hazards within

confined and enclosed spaces and other

dangerous atmospheres prior to entry

(59 FR 37830). The Agency stated

explicitly in the preamble to paragraphs

(a), (b), and (c) of § 1915.12 that

atmospheres must be tested for oxygen

content first, flammability second, and

toxicity third (59 FR 37831). However,

the section heading did not include the

sequence of testing, and the specific

introductory statement requiring

atmospheric testing to be conducted in

the proper sequence was inadvertently

omitted from the regulatory text. The

insertion of the sequence of testing into

the section heading and the addition of

the introductory text to § 1915.12 brings

the section into conformance with the

rulemaking record, the preamble

explanation, and OSHA’s intent.

II. Correction to § 1915.12(b)—

Flammable Atmospheres

In the previous standard covering

entry into spaces containing flammable

atmospheres, § 1915.12(d), employees

were allowed to perform work of brief

duration in atmospheres containing

concentrations of flammable

contaminants as long as the

concentrations remained above the

upper explosive limit (UEL) and the

requirements of § 1915.152(a) and (b),

Respiratory protection, were followed.

That allowance was continued in the

proposed revision to subpart B,

§ 1915.12(d), Work of brief duration (53

FR 48108). In the final standard, which

permits such entry only to set up

ventilation or for rescue, OSHA carried

over the condition that the flammable

contaminant(s) be maintained above the

UEL (59 FR 37858). Unfortunately, the

wording of this condition could be

construed to require that levels of

atmospheric contaminants in a space

actually be increased to a level above

the UEL prior to ventilation start-up or

rescue so that they may be maintained

above the UEL. OSHA did not intend

the rule to require this. When the

atmosphere is below the UEL (but above