Federal Register / Vol. 60, No. 99 / Tuesday, May 23, 1995 / Rules and Regulations 27223

the labeling. Transfer an accurately

measured representative portion of the

suspension equivalent to one dose into

a 200-milliliter volumetric flask. Add 10

milliliters of methanol and disperse the

sample. Dilute to volume with

methanol. Dilute 20.0 milliliters of this

solution to volume in a 50-milliliter

volumetric flask with deionized water,

swirl to mix, and allow to stand for 10

minutes. (Note: A white turbidity is

formed.) Filter this solution via a

suitable disposable filter unit,

discarding the first 5 milliliters. Store

for no more than 8 hours under

refrigeration and protect from light.

(iii) Calculations. Calculate the

milligrams of cefuroxime per dose (5

milliliters) as follows:

Milligrams of

cefuroxime per

5 milliliters

of sample

= × ×

×

A P d

A

U S

S 1 000 ,

where:

AU = Sum of the areas of the cefuroxime

axetil sample isomer A and isomer B

peaks;

AS = Sum of the peak areas of the cefuroxime

axetil working standard isomer A and

isomer B peaks;

PS = Cefuroxime activity in the cefuroxime

axetil working standard solution in

micrograms per milliliter; and

d = Dilution factor of the sample.

(2) Dissolution. Proceed as directed in

§ 436.215 of this chapter. The quantity

Q (the amount of cefuroxime activity

dissolved) is 60 percent at 30 minutes.

(3) Moisture. Proceed as directed in

§ 436.201 of this chapter.

(4) pH. Reconstitute as directed in the

labeling and proceed as directed in

§ 436.202 of this chapter.

(5) Identity. The high-performance

liquid chromatogram of the sample

determined as directed in paragraph

(b)(1) of this section compares

qualitatively to that of the cefuroxime

axetil working standard.

Dated: May 9, 1995.

Murray M. Lumpkin,

Deputy Director, Center for Drug Evaluation

and Research.

[FR Doc. 95–12604 Filed 5–22–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 522

[Docket No. 95N–0096]

Implantation or Injectable Dosage

Form New Animal Drugs; Guaifenesin

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect the

change of the animal drug name from

glyceryl guaiacolate to guaifenesin. This

amendment is an administrative change

to redesignate glyceryl guaiacolate

products as guaifenesin products.

EFFECTIVE DATE: May 23, 1995.

FOR FURTHER INFORMATION CONTACT:

Mohammad I. Sharar, Center for

Veterinary Medicine (HFV–216), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1722.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 30, 1972 (37 FR

12936) and November 5, 1976 (41 FR

48732), FDA published final rules

which reflected approval of injectable

glyceryl guaiacolate products. In the

Federal Register of December 10, 1984

(49 FR 48038), FDA published a final

rule which reflected approval of a

guaifenesin powder for injection.

Guaifenesin is the newer chemical name

for glyceryl guaiacolate. At the time of

the December 10, 1984, approval, the

prior approvals were not amended to

reflect the newer chemical name. FDA

is amending the regulations in part 522

(21 CFR part 522) to reflect the newer

chemical name by removing

§§ 522.1060, 522.1060a, and 522.1060b;

by adding a new sponsor to § 522.1085;

and by adding new § 522.1086

Guaifenesin injection.

FDA has determined under 21 CFR

25.24(a)(9) 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 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).

§ 522.1060 [Removed]

2. Section 522.1060 Glyceryl

guaiacolate implantation or injectable

dosage forms is removed.

§ 522.1060a [Removed]

3. Section 522.1060a Glyceryl

guaiacolate sterile powder is removed.

§ 522.1060b [Removed]

4. Section 522.1060b Glyceryl

guaiacolate injection is removed.

§ 522.1085 [Amended]

5. Section 522.1085 Guaifenesin

sterile powder is amended in paragraph

(b) by removing ‘‘000031’’ and adding in

its place the phrase ‘‘000031 and

037990’’.

6. New § 522.1086 is added to read as

follows:

§ 522.1086 Guaifenesin injection.

(a) Specifications. Each milliliter of

sterile aqueous solution contains 50

milligrams of guaifenesin and 50

milligrams of dextrose.

(b) Sponsor. See No. 037990 in

§ 510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is

used intravenously in horses as a

skeletal muscle relaxant.

(2) Administer rapidly at a dosage of

1 milliliter per pound of body weight.

(3) No to be used in horses intended

for food.

(4) Federal law restricts this drug to

use by or on the order of a licensed

veterinarian.

Dated: May 5, 1995.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 95–12506 Filed 5–22–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF EDUCATION

34 CFR Parts 78, 208, 215, 230, 232,

233, 234, 236, 238, 241, 245, 246, 247,

250, 251, 252, 253, 254, 255, 256, 257,

258, 282, 298, 346, 347, 354, 362, 372,

374, 405, 407, 408, 409, 414, 416, 417,

418, 419, 422, 423, 424, 445, 462, 463,

471, 473, 474, 475, 476, 500, 501, 520,

524, 525, 526, 537, 538, 548, 555, 561,

573, 574, 581, 629, 665, 671, 673, 691,

698, 700, 706, 707, 708, 722, 750, 755,

757, 758, 760, 761, 762, 763, 768, 773,

778, 779, and 790

Removal of Regulations

AGENCY: Department of Education.

ACTION: Final regulations.

SUMMARY: The Secretary amends the

Code of Federal Regulations (CFR) to

remove unnecessary and obsolete

regulations. As a result of new

legislation, absence of funding, and

review in accordance with the

President’s regulatory reinvention

initiative, the Secretary has determined