Federal Register / Vol. 65, No. 216 / Tuesday, November 7, 2000 / Rules and Regulations 66619

7 47 FR 18619–1820.

8 48 FR 35248, 35275–78 (August 3, 1983).

that registered FCMs are not small

entities for the purposes of the RFA.7

With respect to IBIs, the Commission

stated that it is appropriate to evaluate

within the context of a particular rule

whether some or all introducing broker

should be considered to be small

entities and, if so, to analyze the

economic impact on such entities at that

time.8 The amendments to Rule

1.17(c)(5)(xiii) expanding the amount of

funds that may be excluded from the

foreign brokers receivable capital charge

do not impose additional requirements

on an IBI. Therefore, the Chairman, on

behalf of the Commission, certifies that

these regulations will not have a

significant economic impact on a

substantial number of small entities.

B. Paperwork Reduction Act

The Paperwork Reduction Act of

1995, 44 U.S.C. 3501 et seq. (Supp. I

1995), imposes certain requirements on

federal agencies (including the

Commission) to review rules and rule

amendments to evaluate the information

collection burden that they impose on

the public. The Commission believes

that the amendments to Rule

1.17(c)(5)(xiii) will impose a minimal

information collection burden on the

public, namely those FCMs and IBIs

who wish to take advantage of the

exemption will be required to maintain

a record of the margins required to be

on deposit with a foreign broker over

the preceding six month period.

However, this burden is believed to be

minimal when compared to the capital

savings to be generated by the exclusion

of increased amounts from the capital

charge.

List of Subjects in 17 CFR Part 1

Brokers, Commodity futures.

In consideration of the foregoing and

pursuant to the authority contained in

the Commodity Exchange Act and, in

particular, Sections 4(b), 4f, 4g, and

8a(5) thereof, 7 U.S.C. 6(b), 6d, 6g, and

12a(5), the Commission hereby amends

Chapter I of Title 17 of the Code of

Federal Regulations as follows:

PART 1—GENERAL REGULATIONS

UNDER THE COMMODITY EXCHANGE

ACT

1. The authority citation for Part 1

continues to read as follows:

Authority. 7 U.S.C. 1a, 2, 2a, 4, 4a, 6, 6a,

6b, 6c, 6d, 6e, 6f, 6g, 6h, 6i, 6j, 6k,6l, 6m, 6n,

6o, 6p, 7, 7a, 7b, 8, 9, 12, 12a 12c, 13a, 13a–

1, 16, 16a, 19, 21, 23, and 24.

2. Section 1.17 is amended by revising

paragraph (c)(5)(xiii) to read as follows:

§1.17 Minimum financial requirements for

futures commission merchants and

introducing brokers.

* * * * *

(c) * * *

(5) * * *

(xiii) Five percent of all unsecured

receivables includable under paragraph

(c)(2)(ii)(D) of this section used by the

applicant or registrant in computing

‘‘net capital’’ and which are not due

from:

(A) A registered futures commission

merchant;

(B) A broker or dealer that is

registered as such with the Securities

and Exchange Commission; or

(C) A foreign broker that has been

granted comparability relief pursuant to

§30.10 of this chapter, Provided,

however, that the amount of the

unsecured receivable not subject to the

five percent capital charge is no greater

than 150 percent of the current amount

required to maintain futures and option

positions in accounts with the foreign

broker, or 100 percent of such greater

amount required to maintain futures

and option positions in the accounts at

any time during the previous six-month

period, and Provided, that, in the case

of customer funds, such account is

treated in accordance with the special

requirements of the applicable

Commission order issued under §30.10

of this chapter.

* * * * *

Issued in Washington, DC, on November 1,

2000, by the Commission.

Jean A. Webb,

Secretary of the Commission.

[FR Doc. 00–28492 Filed 11–6–00; 8:45 am]

BILLING CODE 6351–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

Ophthalmic and Topical Dosage Form

New Animal Drugs; Enrofloxacin,

Silver Sulfadiazine Emulsion

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 new animal drug

application (NADA) filed by Bayer

Corp., Agriculture Division, Animal

Health. The NADA provides for

veterinary prescription use of an

enrofloxacin/silver sulfadiazine otic

emulsion to treat otitis externa in dogs.

DATES: This rule is effective November

7, 2000.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–110), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–7540.

SUPPLEMENTARY INFORMATION: Bayer

Corp., Agriculture Division, Animal

Health, P.O. Box 390, Shawnee Mission,

KS 66201, filed NADA 141–176 that

provides for veterinary prescription use

of BAYTRIL (0.5 % enrofloxacin/1.0%

silver sulfadiazine) Otic Emulsion for

the treatment of otitis externa in dogs.

The NADA is approved as of September

29, 2000, and the regulations are

amended in 21 CFR part 524 by adding

new section 524.802 to reflect the

approval. The basis of approval is

discussed in the freedom of information

summary.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

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

Friday.

Under section 512(c)(2)(F)(ii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(ii)), this

approval qualifies for 3 years of

marketing exclusivity beginning

September 29, 2000, because the

application contains substantial

evidence of effectiveness of the drug

involved, or any studies of animal

safety, required for approval of the

application and conducted or sponsored

by the applicant.

The agency has determined under 21

CFR 25.33(d)(1) 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.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.

List of Subjects in 21 CFR Part 524

Animal drugs.

66620 Federal Register / Vol. 65, No. 216 / Tuesday, November 7, 2000 / Rules and Regulations

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 524 is amended as follows:

PART 524—OPHTHALMIC AND

TOPICAL DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 524 continues to read as follows:

Authority: 21 U.S.C. 360b.

2. Section 524.802 is added to read as

follows:

§ 524.802 Enrofloxacin, silver sulfadiazine

emulsion.

(a) Specifications. Each milliliter

contains 5 milligrams (mg) enrofloxacin

and 10 mg silver sulfadiazine.

(b) Sponsor. See No. 000859 in

§ 510.600(c) of this chapter.

(c) Conditions of use—Dogs—(1)

Amount. 5 to 10 drops for dogs

weighing 35 pounds (lb) or less and 10

to 15 drops for dogs weighing more than

35 lb; applied twice daily for up to 14

days.

(2) Indications for use. For the

treatment of otitis externa in dogs.

(3) Limitations. Federal law restricts

this drug to use by or on the order of

a licensed veterinarian. Federal law

prohibits the extra-label use of this drug

in food-producing animals.

Dated: October 26, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 00–28520 Filed 11–6–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Decoquinate and

Chlortetracycline

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 new animal drug

application (NADA) filed by Alpharma,

Inc. The NADA provides for use of

approved decoquinate and

chlortetracycline (CTC) Type A

medicated articles to make two-way

combination Type B and Type C

medicated feeds for calves, beef and

nonlactating dairy cattle used for

prevention of coccidiosis, treatment of

bacterial enteritis, and treatment of

bacterial pneumonia.

DATES: This rule is effective November

7, 2000.

FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for

Veterinary Medicine (HFV–135), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

7578.

SUPPLEMENTARY INFORMATION: Alpharma

Inc., One Executive Dr., P.O. Box 1399,

Fort Lee, NJ 07024, filed NADA 141–147

that provides for use of Deccox (27.2

grams per pound g/lb) and ChlorMaxTM

(50, 65, or 70 g/lb CTC) Type A

medicated articles to make combination

drug Type B and Type C medicated

feeds for calves, beef and nonlactating

dairy cattle. The combination Type C

feeds are for prevention of coccidiosis

caused by Eimeria bovis and E. zuernii,

for treatment of bacterial enteritis

caused by Escherichia coli, and for

treatment of bacterial pneumonia

caused by Pasteurella multocida

organisms susceptible to CTC. The

NADA is approved as of September 29,

2000, and the regulations are amended

in the table in 21 CFR 558.195(d) to

reflect the approval. The basis of

approval is discussed in the freedom of

information summary.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

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

Friday.

The agency has determined under 21

CFR 25.33(a)(2) 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.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.

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:

Authority: 21 U.S.C. 360b, 371.

2. Section 558.195 is amended in the

table in paragraph (d) by adding an

entry following the indication for

‘‘Cattle’’ at the 13.6 to 27.2 grams per

ton decoquinate dose level and before

the entry for ‘‘Cattle’’ at the 13.6 to

535.7 grams per ton dose level, to read

as follows:

§ 558.195 Decoquinate.

* * * * *

(d) * * *