15110 Federal Register / Vol. 62, No. 61 / Monday, March 31, 1997 / Rules and Regulations

considered the sponsor of the program

under this section.

By the Commission.

Dated: March 24, 1997.

Margaret H. McFarland,

Deputy Secretary.

[FR Doc. 97–8075 Filed 3–28–97; 8:45 am]

BILLING CODE 8010–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 5, 184, 529, and 610

Food and Drugs; Technical

Amendments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; technical

amendments.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations to correct certain

typographical and other inadvertent

errors. This action is being taken to

clarify and improve the accuracy of the

regulations.

EFFECTIVE DATE: April 1, 1997.

FOR FURTHER INFORMATION CONTACT:

LaJuana D. Caldwell, Office of Policy

(HF–27), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–2994.

SUPPLEMENTARY INFORMATION: FDA has

discovered certain nonsubstantive errors

that have been incorporated into the

agency’s codified regulations. FDA is

correcting these errors. The errors in the

regulations are as follows:

1. In 21 CFR 5.89(b)(1) ‘‘x-reay’’ is

corrected to read ‘‘x-ray’’.

2. In 21 CFR 184.1(a) the phrase ‘‘of

this chapter of’’ in the third sentence is

corrected to read ‘‘of this chapter or’’.

3. In 21 CFR 529.50(c)(2) ‘‘Klebsiella

ssp.’’ is corrected to read ‘‘Klebsiella

spp.’’.

4. In 21 CFR 610.53(c), in the table,

in the entry for ‘‘Rubella Virus Vaccine

Live,’’ in the third column, under the

heading ‘‘Manufacturer’s storage period

0 °C or colder (unless otherwise

stated),’’ ‘‘°C’’ is corrected to read ‘‘do’’.

Publication of this document

constitutes final action on these changes

under the Administrative Procedure Act

(5 U.S.C. 553). Notice and public

procedure are unnecessary because FDA

is merely correcting nonsubstantive

errors.

List of Subjects

21 CFR Part 5

Authority delegations (Government

agencies), Imports, Organization and

functions (Government agencies).

21 CFR Part 184

Food ingredients.

21 CFR Part 529

Animal drugs.

21 CFR Part 610

Biologics, Labeling, Reporting and

recordkeeping requirements. Therefore, under the Federal Food,

Drug, and Cosmetic Act, and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR parts 5, 184,

529, and 610 are amended as follows:

PART 5—DELEGATIONS OF

AUTHORITY AND ORGANIZATION

1. The authority citation for 21 CFR

part 5 continues to read as follows:

Authority: 5 U.S.C. 504, 552, App. 2; 7

U.S.C. 138a, 2271; 15 U.S.C. 638, 1261–1282,

3701–3711a; secs. 2–12 of the Fair Packaging

and Labeling Act (15 U.S.C. 1451–1461); 21

U.S.C. 41–50, 61–63, 141–149, 467f, 679(b),

801–886, 1031–1309; secs. 201–903 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321–394); 35 U.S.C. 156; secs. 301,

302, 303, 307, 310, 311, 351, 352, 361, 362,

1701–1706, 2101 of the Public Health Service

Act (42 U.S.C. 241, 242, 242a, 242l, 242n,

243, 262, 263, 264, 265, 300u–300u–5,

300aa–1); 42 U.S.C. 1395y, 3246b, 4332,

4831(a), 10007–10008; E.O. 11490, 11921,

and 12591.

§ 5.89 [Amended]

2. Section 5.89 Notification of defects

in, and repair or replacement of,

electronic products is amended in

paragraph (b)(1) by removing ‘‘x-reay’’

and adding in its place ‘‘x-ray’’.

PART 184—DIRECT FOOD

SUBSTANCES AFFIRMED AS

GENERALLY RECOGNIZED AS SAFE

3. The authority citation for 21 CFR

part 184 continues to read as follows:

Authority: Secs. 201, 402, 409, 701 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348, 371).

§ 184.1 [Amended]

4. Section 184.1 Substances added

directly to human food affirmed as

generally recognized as safe (GRAS) is

amended in the third sentence in

paragraph (a) by removing the phrase

‘‘of this chapter of’’ and adding in its

place the phrase ‘‘of this chapter or’’.

PART 529—CERTAIN OTHER DOSAGE

FORM NEW ANIMAL DRUGS

5. The authority citation for 21 CFR

part 529 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

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

§ 529.50 [Amended]

6. Section 529.50 Amikacin sulfate

intrauterine solution is amended in

paragraph (c)(2) by removing ‘‘Klebsiella

ssp.’’ and adding in its place ‘‘Klebsiella

spp.’’

PART 610—GENERAL BIOLOGICAL

PRODUCTS STANDARDS

7. The authority citation for 21 CFR

part 610 continues to read as follows:

Authority: Secs. 201, 501, 502, 503, 505,

510, 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 351, 352, 353,

355, 360, 371); secs. 215, 351, 352, 353, 361

of the Public Health Service Act (42 U.S.C.

216, 262, 263, 263a, 264).

§ 610.53 [Amended]

8. § 610.53 Dating periods for licensed

biological products is amended in the

table in paragraph (c), in the entry for

‘‘Rubella Virus Vaccine Live,’’ in the

third column, under the heading

‘‘Manufacturer’s storage period 0 °C or

colder (unless otherwise stated),’’ by

removing ‘‘°C’’ and adding in its place

‘‘do’’.

Dated: March 25, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–7971 Filed 3–28–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 310

[Docket Nos. 91P–0186 and 93P–0306]

Iron-Containing Supplements and

Drugs: Label Warning Statements and

Unit-Dose Packaging Requirements;

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 January 15, 1997 (62 FR

2218). The final rule amended the

regulations to require label warning

statements on products taken in solid

oral dosage form to supplement the

dietary intake of iron or to provide iron

for therapeutic purposes and to require

unit dose packaging for iron-containing

products that contain 30 milligrams or

more of iron per dosage unit. The final

rule was published with some

typographical errors. This document

corrects those errors.

DATES: Effective July 15, 1997.

FOR FURTHER INFORMATION CONTACT:

Linda S. Kahl, Center for Food Safety

and Applied Nutrition (HFS–206), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3101.

SUPPLEMENTARY INFORMATION:
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