Federal Register / Vol. 60, No. 238 / Tuesday, December 12, 1995 / Rules and Regulations 63621

L. 96–354). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this final rule is consistent

with the regulatory philosophy and

principles identified in Executive Order

12866. In addition, the final rule is not

a significant regulatory action as defined

by the Executive Order and so is not

subject to review under the Executive

Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact on small entities.

Because no current activity is prohibited

by this final rule, the compliance cost to

firms is zero. Because no increase in the

health risks faced by consumers will

result from this final rule, total costs are

also zero. Potential benefits include

wider use of this substance because of

reduced uncertainty concerning its

GRAS status, and any resources saved

by eliminating the need to prepare

further petitions to affirm the GRAS

status of this substance for this use. The

agency certifies, therefore, that the final

rule will not have a significant

economic impact on a substantial

number of small entities. Therefore,

under the Regulatory Flexibility Act, no

further analysis is required.

VI. References

The following references have been

placed on display in the Dockets

Management (address above) and may

be seen by interested persons between 9

a.m. and 4 p.m., Monday through

Friday.

1. Gurr, M. I., and A. T. James, Lipid

Biochemistry: An Introduction, John Wiley

and Sons, Inc., New York, 1975.

2. Memorandum dated September 6, 1988,

from M. Dinovi to J. Ziyad, ‘‘GRP 8G0344—

Parexel Int. Corp. (PI) for Gattefosse ́, SA.

Glyceryl Palmitostearate.’’

3. Park, Y. K., and E. A. Yetley ‘‘Trend

Changes in Use and Current Intakes of

Tropical Oils in The United States’’

American Journal of Clinical Nutrition

51:738–748, 1990.

4. Select Committee on GRAS Substances.

‘‘Evaluation of the Health Aspects of Glycerin

and Glycerides as Food Ingredients’’

(SCOGS–30) PB–254 536, 1975.

5. Food and Agriculture Organization of

the United Nations, ‘‘Toxicological

Evaluation of Some Food Additives

Including Anticaking Agents, Antimicrobials,

Antioxidants, Emulsifiers and Thickening

Agents.’’ FAO Nutrition Meetings Report

Series No. 53A, Rome, 1974.

List of Subjects in 21 CFR Part 184

Food additives, Food ingredients.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Director, Center for Food Safety and

Applied Nutrition, 21 CFR part 184 is

amended as follows:

PART 184—DIRECT FOOD

SUBSTANCES AFFIRMED AS

GENERALLY RECOGNIZED AS SAFE

1. 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).

2. New § 184.1329 is added to subpart

B to read as follows:

§ 184.1329 Glyceryl palmitostearate.

(a) Glyceryl palmitostearate is a

mixture of mono-, di-, and triglyceryl

esters of palmitic and stearic acids made

from glycerin, palmitic acid, and stearic

acid.

(b) The ingredient meets the following

specifications:

(1) The substance is a mixture of

mono-, di-, and triglycerides of palmitic

acid and stearic acid.

(2) Heavy metals (as lead): Not more

than 10 parts per million.

(c) In accordance with § 184.1(b)(1),

the ingredient is used in food with no

limitation other than current good

manufacturing practice. The affirmation

of this ingredient as generally

recognized as safe (GRAS) as a direct

human food ingredient is based upon

the following current good

manufacturing practice conditions of

use:

(1) The ingredient is used as a

formulation aid, as defined in §

170.3(o)(14) of this chapter.

(2) The ingredient is used in excipient

formulations for use in tablets at levels

not to exceed good manufacturing

practice.

Dated: November 16, 1995.

Janice F. Oliver,

Deputy Director for Systems and Support,

Center for Food Safety and Applied Nutrition.

[FR Doc. 95–30125 Filed 12–11–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 510, 520, and 522

Animal Drugs, Feeds, and Related

Products; Diphenylhydantoin Sodium

Capsules, et al.

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to remove those

portions of the regulations that reflect

approval of one new animal drug

application (NADA) held by ParkeDavis, Division of Warner-Lambert Co.,

three held by Akorn, Inc., and one held

by Veterinary Research and

Development, Inc. All of the sponsors

submitted written requests that the

agency withdraw approval of the

NADA’s. In a notice published

elsewhere in this issue of the Federal

Register, FDA is withdrawing approval

of the NADA’s.

EFFECTIVE DATE: December 22, 1995.

FOR FURTHER INFORMATION CONTACT:

Mohammad I. Sharar, Center for

Veterinary Medicine (HFV–216), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

0159.

SUPPLEMENTARY INFORMATION: In a notice

published elsewhere in this issue of the

Federal Register, FDA is withdrawing

approval of the following NADA’s:

NADA No. Drug name Sponsor name and address

6–032 ....................................... Diphenylhydantoin sodium capsules ............................. Parke-Davis, Division of Warner-Lambert Co., 201

Tabor Rd., Morris Plains, NJ 07950

12–444 ..................................... Sterile prednisolone suspension ................................... Akorn, Inc., 100 Akorn Dr., Abita Springs, LA 70420

94–978 ..................................... Phenylbutazone injection .............................................. Do.

110–046 ................................... Dexamethasone injection .............................................. Do.

140–904 ................................... Copper disodium edetate injection ................................ Veterinary Research and Development, Inc., P.O. Box

1299, Truckee, CA 95734
63622 Federal Register / Vol. 60, No. 238 / Tuesday, December 12, 1995 / Rules and Regulations

The sponsors requested withdrawal of

approval of the NADA’s because the

drug products are no longer being

marketed. This final rule removes 21

CFR 520.704, 522.514, and 522.1880,

and amends 21 CFR 522.540 and

522.1720 to reflect the withdrawal of

approval of these NADA’s.

In addition, 21 CFR 510.600(c) is

amended to remove the entries for the

three sponsors from the list of approved

drug sponsors because they no longer

hold any approved NADA’s.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Parts 520 and 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 parts 510, 520, and 522 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).

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) by

removing the entries for ‘‘Akorn, Inc.,’’

‘‘Parke-Davis, Division of WarnerLambert Co.,’’ and ‘‘Veterinary Research

and Development, Inc.’’ and in the table

in paragraph (c)(2) by removing the

entries for ‘‘000071,’’ ‘‘017478,’’ and

‘‘057428.’’

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

3. 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).

§ 520.704 [Removed]

4. Section 520.704 Diphenylhydantoin

sodium capsules is removed.

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

5. 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).

§ 522.514 [Removed]

6. Section 522.514 Copper disodium

edetate injection is removed.

§ 522.540 [Amended]

7. Section 522.540 Dexamethasone

injection is amended by removing

paragraph (d)(2)(ii) and by redesignating

paragraph (d)(2)(iii) as paragraph

(d)(2)(ii).

§ 522.1720 [Amended]

8. Section 522.1720 Phenylbutazone

injection is amended in paragraph (b)(1)

by removing the phrase ‘‘000031,

017220, 015579, and 017478’’ and

adding in its place ‘‘000031, 017220,

and 015579’’.

§ 522.1880 [Removed]

9. Section 522.1880 Sterile

prednisolone suspension is removed.

Dated: December 4, 1995.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 95–30123 Filed 12–11–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Monensin

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

Elanco Animal Health, Division of Eli

Lilly and Co. The supplemental NADA

provides for use of an approved

monensin Type A medicated article to

make a revised formulation of a

monensin Type C medicated feed/freechoice mineral granule fed to pasture

cattle for increased rate of weight gain.

EFFECTIVE DATE: December 12, 1995.

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary

Medicine (HFV–142), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–2701.

SUPPLEMENTARY INFORMATION: Elanco

Animal Health, Division of Eli Lilly and

Co., Lilly Corporate Center,

Indianapolis, IN 46285, filed

supplemental NADA 95–735, which

provides for use of 80 grams(g) per

pound monensin Type A articles to

make a monensin Type C medicated

feed/free-choice mineral granule

containing 1,620 g per ton monensin.

The Type C feed/free-choice mineral

granules are fed to pasture cattle

(slaughter, stocker, feeder, and dairy

and beef replacement heifers) for

increased rate of weight gain. The

supplemental NADA provides for a

revised formulation Type C free-choice

mineral granule. The revised

formulation does not affect the safety or

effectiveness data and information upon

which the application is approved. The

supplemental NADA is approved as of

December 12, 1995, and the regulations

are amended in 21 CFR 558.355 by

adding new paragraph (f)(3)(x) to reflect

the approval.

Use of a Type A medicated article to

make a free-choice Type C medicated

feed/ mineral granule requires an

approved Form FDA 1900 as in 21 CFR

510.455.

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

approval does not qualify for marketing

exclusivity because the supplement

does not contain reports of new clinical

or field investigations or new human

food safety studies (other than

bioequivalence or residue studies)

essential to the approval and conducted

or sponsored by the applicant.

A freedom of information summary

for this approval is not required because

it involves approval of a revised

formulation which does not affect the

basis of approval of the product. A

summary of the data and information

submitted to support the original

approval 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 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 the

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: