Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Rules and Regulations 34727

clarithromycin used conforms to the

standards prescribed by § 452.50(a)(1).

(2) Labeling. It shall be labeled in

accordance with the requirements of

§ 432.5 of this chapter.

(3) Requests for certification; samples.

In addition to complying with the

requirements of § 431.1 of this chapter,

each such request shall contain:

(i) Results of tests and assays on:

(A) The clarithromycin used in

making the batch for potency, moisture,

pH, residue on ignition, heavy metals,

specific rotation, identity, and

crystallinity.

(B) The batch for content, loss on

drying, pH, and identity.

(ii) Samples, if required by the

Director, Center for Drug Evaluation and

Research:

(A) The clarithromycin used in

making the batch: 10 packages, each

containing approximately 500

milligrams.

(B) The batch: A minimum of six

immediate containers.

(b) Tests and methods of assay—(1)

Clarithromycin content. Proceed as

directed in § 452.50(b)(1), except use a

known injection volume between 10

and 60 microliters. Also, prepare the

mobile phase, working standard

solution, and sample solution, and use

system suitability requirements and

calculation as follows:

(i) Mobile phase. Add 600 milliliters

of methanol and 400 milliliters of

0.067M potassium phosphate,

monobasic, to a suitable container, mix

well, and adjust the pH to 3.5 with

phosphoric acid. Filter through a

suitable filter capable of removing

particulate matter to 0.5 micron in

diameter. Degas the mobile phase just

before its introduction into the

chromatographic system.

(ii) Preparation of standard solution.

Dissolve an accurately weighed portion

of the clarithromycin working standard

in sufficient methanol to obtain a

solution having a known concentration

of approximately 2.1 milligrams per

milliliter of clarithromycin.

Quantitatively transfer and dilute an

aliquot of this solution with mobile

phase and mix to obtain a solution of

known concentration of approximately

415 micrograms of clarithromycin per

milliliter.

(iii) Preparation of sample solution.

Constitute as directed in the labeling.

Accurately measure a representative

portion of the suspension that contains

about 1 to 2 grams of clarithromycin

activity and, using approximately 330

milliliters of 0.067M potassium

phosphate, dibasic, quantitatively

transfer into a 1,000 milliliter

volumetric flask containing

approximately 50 milliliters of 0.067M

potassium phosphate, dibasic. Shake for

30 minutes. Dilute to volume with

methanol. Mix well and place in an

ultrasonic bath for 30 minutes. Cool to

room temperature and adjust to volume

with methanol. Add a magnetic stirring

bar and stir for 60 minutes. Allow

excipients to settle and dilute an

appropriate aliquot of the solution with

mobile phase to obtain a solution

containing 500 micrograms of

clarithromycin activity per milliliter

and mix well. Filter through a suitable

filter capable of removing particulate

matter 0.5 micron in diameter.

(iv) System suitability requirements—

(A) Tailing factor. The tailing factor (T)

is satisfactory if it is not less than 1.0

and not greater than 1.7 for the

clarithromycin peak.

(B) Efficiency of the column. The

efficiency (n) is satisfactory if it is

greater than 2,100 theoretical plates for

the clarithromycin peak.

(C) Capacity factor. The capacity

factor (k′) is satisfactory if it is between

2.5 and 6 for the clarithromycin peak.

(D) Coefficient of variation (relative

standard deviation). The coefficient of

variation (SR in percent of three

replicate injections) is satisfactory if it is

not more than 2.0 percent.

(v) Calculations. Calculate the

clarithromycin content as follows:

Milligrams of

clarithromycin

per milliliter

=

AU X PS X D

AS X V

where:

AU = Area of the clarithromycin peak in the

chromatogram of the sample;

AS = Area of the clarithromycin peak in the

chromatogram of the clarithromycin

working standard;

PS = Clarithromycin activity in the

clarithromycin working standard

solution in micrograms per milliliter;

D = Dilution factor of the sample test

solution; and

V = Volume, in milliliters, of the portion of

suspension taken.

(2) Loss on drying. Proceed as directed

in § 436.200(a) of this chapter, using a

sample weight of approximately 1 gram,

weighing in a normal laboratory

atmosphere.

(3) pH. Proceed as directed in

§ 436.202 of this chapter, using the

suspension prepared as directed in the

labeling. Stir the suspension for 10

minutes with the electrode immersed

and record the pH.

(4) Identity. Using the highperformance liquid chromatographic

procedure described in paragraph (b)(1)

of this section, the retention times for

the clarithromycin peak must be within

2 percent of the retention time for the

peak of the reference standard.

Dated: June 20, 1996.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 96–16977 Filed 7–2–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 520, 522, 529, and 558

Animal Drugs, Feeds, and Related

Products; 29 Various New Animal Drug

Products and Type A Medicated

Articles

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 reflecting approval of 29 new

animal drug applications (NADA’s) held

by Bayer Corp., Agriculture Division,

Animal Health (formerly Miles, Inc.,

Agriculture Division, Animal Health

Products), Hubbard Milling Co.,

Hoffmann-LaRoche, Inc., and Ohmeda,

Inc. The NADA’s provide for the use of

29 various new animal drug products

and Type A medicated articles used to

manufacture finished medicated animal

feeds. In a notice published elsewhere

in this issue of the Federal Register,

FDA is withdrawing approval of the

NADA’s.

EFFECTIVE DATE: July 15, 1996.

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:
34728 Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Rules and Regulations

NADA No. Drug name Sponsor name and address

6–462 ....................................... Diethylcarbamazine tablets ................................................ Bayer Corp., Agriculture Division, Animal Health,

P.O. Box 390, Shawnee Mission, KS 66201.

10–540 ..................................... Calcium disodium edetate injection ................................... Do.

11–380 ..................................... Diethylcarbamazine powder ............................................... Do.

12–054 ..................................... Protokylol hydrochloride tablets and injection ................... Do.

12–103 ..................................... Triamcinolone tablets ......................................................... Do.

12–392 ..................................... Triamcinolone injection ...................................................... Do.

12–598 ..................................... Disophenol sodium injection .............................................. Do.

15–161 ..................................... Trichlorfon powder ............................................................. Do.

15–965 ..................................... Coumaphos Type A medicated article ............................... Do.

30–045 ..................................... Triamcinolone/neomycin sulfate ointment .......................... Do.

34–394 ..................................... Niclosamide tablets ............................................................ Do.

35–263 ..................................... Styrylpyridinium chloride, diethylcarbamazine (as base)

oral liquid.

Do.

45–287 ..................................... Coumaphos crumbles ........................................................ Do.

48–645 ..................................... Tylosin Type A medicated articles (5, 10, 20, and 40

grams per pound).

Hubbard Milling Co., 424 North Riverfront Dr., P.O.

Box 8500, Mankato, MN 56002–8500.

49–555 ..................................... Styrylpyridinium chloride, diethylcarbamazine control diet

HRH/MSD.

Bayer Corp.

91–628 ..................................... Diethylcarbamazine citrate syrup ....................................... Do.

93–372 ..................................... Chlortetracycline calcium complex Type A medicated articles.Hoffmann-LaRoche, Inc., Nutley, NJ 07110.

94–402 ..................................... Tylosin and sulfamethazine Type A medicated articles .... Hubbard Milling Co.

95–078 ..................................... Trichlorfon oral liquid .......................................................... Bayer Corp.

96–031 ..................................... Styrylpyridinium chloride, diethylcarbamazine citrate tablets.Do.

100–201 ................................... Trichlorfon paste ................................................................ Do.

100–356 ................................... Styrylpyridinium chloride, diethylcarbamazine control diet

HRH.

Do.

100–670 ................................... Niclosamide Type A medicated article .............................. Do.

101–078 ................................... Dichlorophene and toluene capsules ................................. Do.

120–327 ................................... Diethylcarbamazine chewable tablets ................................ Do.

120–670 ................................... Styrylpyridinium, diethylcarbamazine edible tablets .......... Do.

121–291 ................................... Enflurane liquid (anesthetic) .............................................. Ohmeda, Inc., Pharmaceutical Products Division,

P.O. Box 804, Liberty Corner, NJ 07938–0804.

121–813 ................................... Styrylpyridinium, diethylcarbamazine film-coated tablets Bayer Corp.

133–509 ................................... Pyrantel tartrate Type A medicated articles ...................... Hubbard Milling Co.

The sponsors requested withdrawal of

approval of the NADA’s. This final rule

removes 21 CFR 520.500, 520.620a,

520.620b, 520.1520, 520.2022,

520.2160a, 520.2160b, 520.2160c,

520.2160d, 520.2480, 520.2520c,

520.2520d, 522.281, 522.740, 522.2022,

522.2480, 529.810, 558.367, and

558.565, and amends 21 CFR 520.580,

520.622a, 520.622b, 520.2520a, 558.185,

558.485, 558.625, and 558.630.

List of Subjects

21 CFR Parts 520, 522, and 529

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, 522, 529, 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).

§ 520.500 [Removed]

2. Section 520.500 Coumaphos

crumbles is removed.

§ 520.580 [Amended]

3. Section 520.580 Dichlorophene and

toluene capsules is amended in

paragraph (b)(2) by removing ‘‘000859,’’.

§ 520.620a [Removed]

4. Section 520.620a

Diethylcarbamazine is removed.

§ 520.620b [Removed]

5. Section 520.620b

Diethylcarbamazine chewable tablets is

removed.

§ 520.622a [Amended]

6. Section 520.622a

Diethylcarbamazine citrate tablets is

amended in paragraph (a) by removing

‘‘000859 and’’.

7. Section 520.622b is amended by

revising paragraph (b)(2) to read as

follows:

§ 520.622b Diethylcarbamazine citrate

syrup.

* * * * *

(b)(1) * * *

(2) Sponsors. See No. 017030 for use

as in paragraphs (b)(3)(ii)(a) and

(b)(3)(ii)(c) of this section.

* * * * *

§ 520.1520 [Removed]

8. Section 520.1520 Niclosamide

tablets is removed.

§ 520.2022 [Removed]

9. Section 520.2022 Protokylol

hydrochloride tablets is removed.

§ 520.2160a [Removed]

10. Section 520.2160a

Styrylpyridinium, diethylcarbamazine

tablets is removed.
Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Rules and Regulations 34729

§ 520.2160b [Removed]

11. Section 520.2160b

Styrylpyridinium chloride,

diethylcarbamazine (as base) is

removed.

§ 520.2160c [Removed]

12. Section 520.2160c

Styrylpyridinium, diethylcarbamazine

edible tablets is removed.

§ 520.2160d [Removed]

13. Section 520.2160d

Styrylpyridinium, diethylcarbamazine

film-coated tablets is removed.

§ 520.2480 [Removed]

14. Section 520.2480 Triamcinolone

tablets is removed.

§ 520.2520a [Amended]

15. Section 520.2520a Trichlorfon oral

is amended in paragraph (b) by

removing the phrase ‘‘Nos. 017800 and

000859’’ and adding in its place ‘‘No.

017800’’.

§ 520.2520c [Removed]

16. Section 520.2520c Trichlorfon oral

liquid is removed.

§ 520.2520d [Removed]

17. Section 520.2520d Trichlorfon

paste is removed.

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

18. 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).

§ 522.281 [Removed]

19. Section 522.281 Calcium

disodium edetate injection is removed.

§ 522.740 [Removed]

20. Section 522.740 Disophenol

sodium injection is removed.

§ 522.2022 [Removed]

21. Section 522.2022 Protokylol

hydrochloride injection is removed.

§ 522.2480 [Removed]

22. Section 522.2480 Triamcinolone

injection is removed.

PART 529—CERTAIN OTHER DOSAGE

FORM NEW ANIMAL DRUGS

23. 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).

§ 529.810 [Removed]

24. Section 529.810 Enflurane is

removed.

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

25. 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).

§ 558.185 [Amended]

26. Section 558.185 Coumaphos is

amended by removing and reserving

paragraph (a)(1).

§ 558.367 [Removed]

27. Section 558.367 Niclosamide is

removed.

§ 558.485 [Amended]

28. Section 558.485 Pyrantel tartrate

is amended by removing and reserving

paragraph (a)(16).

§ 558.565 [Removed]

29. Section 558.565 Styrylpyridinium

chloride, diethylcarbamazine is

removed.

§ 558.625 [Amended]

30. Section 558.625 Tylosin is

amended by removing and reserving

paragraph (b)(72).

§ 558.630 [Amended]

31. Section 558.630 Tylosin and

sulfamethazine is amended in

paragraph (b)(10) by removing

‘‘012190,’’.

Dated: June 3, 1996.

Michael J. Blackwell,

Acting Director, Center for Veterinary

Medicine.

[FR Doc. 96–16886 Filed 7–2–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

28 CFR Part 42

[A.G. Order No. 2037–96]

Equal Employment Opportunity

AGENCY: Department of Justice

ACTION: Final Rule

SUMMARY: This document revises the

Department of Justice policy with regard

to the nondiscrimination in

employment to include sexual

orientation as a prohibited basis for

discrimination. This revised rule also

makes clear that retaliation for opposing

a prohibited practice or participating in

a related proceeding is prohibited. This

action promotes the equitable treatment

of employees and applicants for

employment

EFFECTIVE DATE: June 26, 1996.

FOR FURTHER INFORMATION CONTACT:

Ted McBurrows, Director, Equal

Employment Opportunity Staff, Room

1246, 10th & Pennsylvania Ave., NW,

Washington, DC 20530, (202) 616–4800.

SUPPLEMENTARY INFORMATION: In 1994,

pursuant to 5 U.S.C. 301, the Attorney

General issued several policy statements

prohibiting discrimination on the basis

of sexual orientation and affirmatively

promoting the principles of equal

employment opportunity. The Attorney

General is revising 28 CFR 42.1 to

reflect this policy. This policy affects

agency operation and procedures, and

therefore is exempt from the notice

requirement of 5 U.S.C. 553(b) and is

effective upon issuance.

This rule has been drafted and

reviewed in accordance with section

1(b) of Executive Order 12866. This rule

is not a ‘‘significant regulatory action’’

under section 3(f) of Executive Order

12866. Accordingly, this rule has not

been reviewed by the Office of

Management and Budget. In accordance

with the Regulatory Flexibility Act (5

U.S.C. 605(b)), the Attorney General

certifies that this rule will not have a

significant economic impact on a

substantial number of small entities.

This rule will not have a substantial

direct impact upon the states, on the

relationships between the national

government and the states, or on

distribution of power and

responsibilities among the various

levels of government. Therefore, this

rule does not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment in

accordance with Executive order 12612.

List of Subjects in 28 CFR Part 42

Administrative practice and

procedure, Aged, Civil rights, Equal

employment opportunity, Grant

programs, Individuals with disabilities,

Reporting and recordkeeping, Sex

discrimination.

Accordingly, for reasons set out in the

preamble, 28 CFR Part 42 is amended as

set forth below.

PART 42—EQUAL EMPLOYMENT

OPPORTUNITY WITHIN THE

DEPARTMENT OF JUSTICE

1. The authority citation for Part 42

Subpart A is revised to read as follows:

Authority: 5 U.S.C. 301, 28 U.S.C. 509,

510; E.O. 11246, 3 CFR 1964–1965 Comp., p.

339; E.O. 11478, 3 CFR 1966–1970 Comp., p.

803.

2. Section 42.1 is revised to read as

follows: