Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Rules and Regulations 11027

did not require testing for pyrogens at

the bulk stage.

Bristol-Myers Squibb Co., the

manufacturer of the innovator product,

filed a petition for stay of action

pursuant to 21 CFR 10.35, objecting to

FDA’s decision to promulgate the new

regulation without notice and a prior

opportunity for public comment. On

November 9, 1994, FDA agreed to stay

the effective date of the monograph for

bleomycin sulfate bulk drug substance

in order to reconsider the manner in

which the agency promulgated the new

monograph. A copy of FDA’s letter

notifying Bristol-Myers Squibb Co. of

the stay is on file in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 450 is

amended as follows:

List of Subjects in 21 CFR Part 450

Antibiotics.

PART 450—ANTITUMOR ANTIBIOTIC

DRUGS

1. The authority citation for 21 CFR

part 450 continues to read as follows:

Authority: Sec. 507 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 357).

§ 450.10 [Stayed]

2. Section 450.10 Bleomycin sulfate is

stayed effective November 9, 1994.

Dated: February 15, 1995.

Murray M. Lumpkin,

Deputy Director, Center for Drug Evaluation

and Research.

[FR Doc. 95–5058 Filed 2–28–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 510 and 558

Animal Drugs, Feeds, and Related

Products; Change of Sponsor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect a

change of sponsor for nine new animal

drug applications (NADA’s) from AgriBio Corp. to Hoffman-LaRoche, Inc. This

document also corrects an inadvertent

error in the animal drug regulations.

EFFECTIVE DATE: March 1, 1995.

FOR FURTHER INFORMATION CONTACT:

Benjamin A. Puyot, Center for

Veterinary Medicine (HFV–130), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1646.

SUPPLEMENTARY INFORMATION: Agri-Bio

Corp., 966 Dorsey St., Gainesville, GA

30501, has informed FDA that it has

transferred the ownership of, and all

rights and interests in, the following

approved NADA’s to Hoffmann-La

Roche, Inc., 340 Kingsland St., Nutley,

NJ 07110–1199:

NADA No. Ingredient(s) Trade name(s)

128–686 ... Salinomycin ................................................................................... Bio-Cox.

132–447 ... Salinomycin and Roxarsone ......................................................... Bio-Cox and 3-Nitro.

134–284 ... Salinomycin and Bambermycins ................................................... Bio-Cox and Flavomycins.

134–185 ... Salinomycin and Roxarsone and Bambermycins ......................... Bio-Cox and 3-Nitro Flavomycin.

135–321 ... Salinomycin and Roxarsone and Bacitracin-MD .......................... Bio-Cox and 3-Nitro and BMD.

135–746 ... Salinomycin and Bacitracin-MD .................................................... Bio-Cox and BMD.

137–536 ... Salinomycin and Roxarsone and Bacitracin Zn ............................ Bio-Cox and 3-Nitro and Albac.

137–537 ... Salinomycin and Lincomycin ......................................................... Bio-Cox and Lincomix.

140–581 ... Salinomycin and Roxarsone and Lincomycin ............................... Bio-Cox and 3–Nitro and Lincomix.

Accordingly, the agency is amending

the regulations in 21 CFR 510.600(c)(1)

and (c)(2) and 558.95(b)(1)(xi)(b) and

(b)(1)(xii)(b) to reflect the change of

sponsor.

In the Federal Register of January 13,

1995 (60 FR 3079 at 3080), FDA

amended § 558.550; this amendment

inadvertently failed to reflect a previous

amendment published in the Federal

Register of December 29,1994 (59 FR

67185). The December 29, 1994,

document amended § 558.550(a)(1) and

(a)(2) to provide for specific levels of

Type A articles approved for use for the

specified sponsors. The January 13,

1995, document amended

§ 558.550(a)(2) to add approved

referenced uses as stated in § 558.550(b).

This document corrects the inadventent

error made in the final rule of January

13, 1995.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 558

Animal drugs, Animal feeds.

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 and 558 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 is amended in the

table in paragraph (c)(1) by removing

the entry for ‘‘Agri–Bio Corp.’’ and in

the table in paragraph (c)(2) by

removing the entry for ‘‘042835’’.

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

3. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: Secs. 512, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360b, 371).

§ 558.95 [Amended]

4. Section 558.95 Bambermycins is

amended in paragraphs (b)(1)(xi)(b) and

(b)(1)(xii)(b) by removing ‘‘042835’’ and

adding in its place ‘‘000004’’.

5. Section 558.550 is amended in

paragraph (a)(1) by removing the

number ‘‘042835’’ and adding in its

place ‘‘000004’’, and by revising

paragraph (a)(2) to read as follows:

§ 558.550 Salinomycin.

(a) * * *

(2) To 012799 for use of 30 and 60

grams per pound as in paragraphs

(b)(1)(i), (b)(1)(iii) through (b)(1)(xvi),
11028 Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Rules and Regulations

and (b)(3)(i) through (b)(3)(iii) of this

section.

* * * * *

Dated: February 9, 1995.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 95–4912 Filed 2–28–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

Animal Drugs, Feeds, and Related

Products; Melengestrol Acetate and

Tylosin

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 The

Upjohn Co. The supplemental NADA

provides for use of single ingredient

Type A medicated articles containing

melengestrol acetate (MGA) and tylosin

to manufacture certain combination

drug Type B and Type C medicated

feeds for heifers fed in confinement for

slaughter. The supplement provides for

use of a dry MGA Type A article to

make a dry Type B or Type C medicated

feed.

EFFECTIVE DATE: March 1, 1995.

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: The

Upjohn Co., Kalamazoo, MI 49001, filed

supplemental NADA 138–995, MGA

with Tylan (MGA with tylosin), which

provides for use of approved MGA and

tylosin Type A medicated articles to

make Type B and Type C medicated

feeds for heifers being fed in

confinement for slaughter. The

supplement removes the requirement

for making dry pelleted Type B or C

medicated feed. Therefore, dry MGA

and tylosin Type A articles may be used

to make a dry Type B or C medicated

feed containing MGA and tylosin.

This supplement is approved as of

January 13, 1995. Accordingly, 21 CFR

558.342(c)(4)(ii)(C) is amended by

removing the existing reference to a

pelleted medicated feed to reflect this

approval.

This is a manufacturing supplement

to an approved NADA. Approval of this

supplement does not require added

safety or efficacy data or information.

Therefore, a freedom of information

summary as provided in part 20 (21 CFR

part 20) and § 514.11(e)(2)(ii) (21 CFR

514.11(e)(2)(ii)) is not required.

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

supplement for food-producing animals

does not qualify for marketing

exclusivity because the supplement

does not contain 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 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 in 21 CFR Part 558

Animal drugs, Animal feeds.

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 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: Secs. 512, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360b, 371).

§ 558.342 [Amended]

2. Section 558.342 Melengestrol

acetate is amended in paragraph

(c)(4)(ii)(C) by removing the word

‘‘pelleted’’.

Dated: February 9, 1995.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 95–4913 Filed 2–28–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[TD 8578]

RIN 1545–AP23

Election Out of Subchapter K for

Producers of Natural Gas; Correction

AGENCY: Internal Revenue Service (IRS),

Treasury.

SUMMARY: This document contains a

correction to final regulations [TD 8578]

which was published in the Federal

Register for Friday, December 23, 1994

(59 FR 66181). The final regulations

provide that the co-producers under a

joint operating agreement must use one

of two permissible methods described in

the regulations in reporting income from

gas sales and certain related deductions

and credits.

EFFECTIVE DATE: January 1, 1995.

FOR FURTHER INFORMATION CONTACT:

Grace Kim, (202) 622–3060 (not a tollfree number).

SUPPLEMENTARY INFORMATION:

Background

The final regulations that are the

subject of this correction are under

section 761 of the Internal Revenue

Code.

Need for Correction

As published, TD 8578 contains a

typographical error that is in need of

correction.

Correction of Publication

Accordingly, the publication of the

final regulations which is the subject of

FR Doc. 94–31291, is corrected as

follows:

On page 66183, column 2, § 1.761–2,

paragraph (d)(2)(i), ninth line from the

bottom of the paragraph, regulation

section ‘‘§ 1.4461(e)(3)’’ is corrected to

read ‘‘§ 1.446–1(e)(3)’’.

Cynthia E. Grigsby,

Chief, Regulations Unit, Assistant Chief

Counsel (Corporate).

[FR Doc. 95–4902 Filed 2–28–95; 8:45 am]

BILLING CODE 4830–01–P