Federal Register / Vol. 62, No. 61 / Monday, March 31, 1997 / Rules and Regulations 15111

In FR Doc. 97–947, beginning on page

2218 in the Federal Register of January

15, 1997, the following corrections are

made in § 310.518 Drug products

containing iron or iron salts:

§ 310.518 [Corrected]

1. On page 2250, in the second

column, in paragraph (b)(2), beginning

in the fourth line, the phrase ‘‘the

provisions of § 111.50(a) of this chapter’’

is corrected to read ‘‘the provisions of

paragraph (a) of this section’’.

2. On page 2250, in the third column,

in paragraph (c)(5), in the second line,

the phrase ‘‘paragraph (b)(1) of this

section’’ is corrected to read ‘‘paragraph

(c)(1) of this section’’.

Dated: March 25, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–7970 Filed 3–28–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 520 and 558

Animal Drugs, Feeds, and Related

Products; Ronnel; Technical

Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; technical

amendment.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to remove that

portion of the regulations reflecting

approval of new animal drug

applications (NADA’s) held by

Moorman Manufacturing Co. and

Pitman-Moore, Inc., that provide for the

use of ronnel oral dosage forms and

ronnel Type A medicated article. The

approval of these NADA’s were

previously withdrawn. This action is

necessary to ensure the accuracy and

consistency of the regulations.

EFFECTIVE DATE: March 31, 1997.

FOR FURTHER INFORMATION CONTACT:

David L. Gordon, Center for Veterinary

Medicine (HFV–238), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1737.

SUPPLEMENTARY INFORMATION: FDA has

discovered that certain errors have been

incorporated into the agency’s codified

regulations on animal drugs. The errors

in the regulations addressed in this

document follow.

In a notice published in the Federal

Register of July 19, 1989 (54 FR 30268),

the agency announced that PitmanMoore, Inc., had requested that FDA

withdraw NADA’s 12–360 and 12–361.

In a final rule published in that same

issue of the Federal Register (54 FR

30205), the agency inadvertently

omitted an amendment to the

regulations to remove § 520.2080 (21

CFR 520.2080).

In a notice published in the Federal

Register of June 18, 1990 (55 FR 24646),

the agency announced that Moorman

Manufacturing Co. had requested that

FDA withdraw NADA 13–450. In a final

rule published in that same issue of the

Federal Register (55 FR 24556), the

agency inadvertently omitted an

amendment to the regulations to remove

§ 558.525 (21 CFR 558.525).

At this time, the agency is correcting

these errors. Accordingly, §§ 520.2080

and 558.525 are removed because the

sections no longer represent approved

products.

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

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:

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).

§ 520.2080 [Removed]

2. Section 520.2080 Ronnel oral

dosage forms is removed.

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).

§ 558.525 [Removed]

4. Section 558.525 Ronnel is removed.

Dated: March 4, 1997.

Linda Tollefson,

Director, Office of Surveillance and

Compliance, Center for Veterinary Medicine.

[FR Doc. 97–8048 Filed 3–28–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs For Use In Animal

Feeds; Tylosin; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

final rule that appeared in the Federal

Register of December 24, 1996 (61 FR

67713). The document amended the

animal drug regulations to reflect

approval of a supplemental new animal

drug application (NADA) filed by

Elanco Animal Health, Division of Eli

Lilly and Co. The approved use level of

tylosin Type C medicated swine feed

was inadvertently omitted from the

document. The document also

contained certain editorial errors. This

document corrects those errors.

EFFECTIVE DATE: December 24, 1996.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1644.

In FR Doc. 96–32549, appearing on

page 67713 in the Federal Register of

Tuesday, December 24, 1996, the

following correction is made:

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).

§ 558.625 [Corrected]

2. On page 67713, in the second

column, § 558.625 is amended by

revising paragraph (f)(1)(vi)(e) to read as

follows:

§ 558.625 Tylosin.

* * * * *

(f) * * *

(1) * * *

(vi) * * *

(e) Amount per ton. Tylosin 100

grams.

(1) Indications for use. Prevention

and/or control of porcine proliferative

enteropathies (ileitis) associated with

Lawsonia intracellularis.

(2) Limitations. As tylosin phosphate,

administer for 21 days.

Dated: February 6, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–8049 Filed 3–28–97; 8:45 am]

BILLING CODE 4160–01–F