Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Rules and Regulations 20401

4. Section 405.5 is added to read as

follows:

§ 405.5 Risk assessment reporting

requirements for registered government

securities brokers and dealers.

(a) Every registered government

securities broker or dealer shall comply

with the requirements of § 240.17h–2T

of this title (SEC Rule 17h–2T), with the

following modifications:

(1) For the purposes of this section,

references to ‘‘broker or dealer’’ and

‘‘broker or dealer registered with the

Commission pursuant to Section 15 of

the Act’’ mean registered government

securities brokers or dealers.

(2) For the purposes of this section,

references to §§ 240.17h–1T and

240.17h–2T of this title mean those

sections as modified by §§ 404.2(b) and

405.5, respectively.

(3) For the purposes of this section,

‘‘associated person’’ has the meaning set

out in Section 3(a)(18) of the Act (15

U.S.C. 78c(a)(18)), except that natural

persons are excluded.

(4) Paragraph 240.17h–2T(b) of this

title is modified to read as follows:

‘‘(b) Exemptions. (1) The provisions of

this section shall not apply to any

registered government securities broker

or dealer:

‘‘(i) Which is exempt from the

provisions of § 240.15c3–3 of this title,

as made applicable by § 403.4, pursuant

to paragraph (k)(2) of § 240.15c3–3 of

this title; or

‘‘(ii) If the registered government

securities broker or dealer does not

qualify for exemption from the

provisions of § 240.15c3–3 of this title,

as made applicable by § 403.4, and such

registered government securities broker

or dealer does not hold funds or

securities for, or owe money or

securities to, customers and does not

carry the accounts of, or for, customers;

unless

‘‘(iii) In the case of paragraphs (b)(1)

(i) or (ii) of this section, the registered

government securities broker or dealer

maintains capital of at least

$20,000,000, including debt

subordinated in accordance with

Appendix D of § 240.15c3–1 of this title,

as modified by Appendix D of § 402.2.

‘‘(2) The provisions of this section

shall not apply to any registered

government securities broker or dealer

which maintains capital of less than

$250,000, including debt subordinated

in accordance with Appendix D of

§ 240.15c3–1 of this title, as modified by

Appendix D of § 402.2, even if the

registered government securities broker

or dealer holds funds or securities for,

or owes money or securities to,

customers or carries the accounts of, or

for, customers.

‘‘(3) The provisions of this section

shall not apply to any registered

government securities broker or dealer

which has an associated person that is

a registered broker or dealer, provided

that:

‘‘(i) The registered broker or dealer is

subject to, and in compliance with, the

provisions of § 240.17h–1T and

§ 240.17h–2T of this title, and

‘‘(ii) All of the Material Associated

Persons of the registered government

securities broker or dealer are Material

Associated Persons of the registered

broker or dealer subject to § 240.17h–1T

and § 240.17h–2T of this title.

‘‘(4) In calculating capital for the

purposes of this paragraph, a registered

government securities broker or dealer

shall include with its equity capital and

subordinated debt the equity capital and

subordinated debt of any other

registered government securities brokers

or dealers or registered brokers or

dealers that are associated persons of

such registered government securities

broker or dealer, except that the equity

capital and subordinated debt of

registered brokers and dealers that are

exempt from the provisions of

§ 240.15c3–3 of this title, pursuant to

paragraph (k)(1) of § 240.15c3–3, shall

not be included in the capital

computation.

‘‘(5) The Secretary may, upon written

application by a Reporting Registered

Government Securities Broker or Dealer,

exempt from the provisions of this

section, either unconditionally or on

specified terms and conditions, any

registered government securities brokers

or dealers that are associated persons of

such Reporting Registered Government

Securities Broker or Dealer. The term

‘‘Reporting Registered Government

Securities Broker or Dealer’’ shall mean

any registered government securities

broker or dealer that submits such

application to the Secretary on behalf of

its associated registered government

securities brokers or dealers.’’

(5) Paragraph 240.17h–2T(c) of this

title is modified to read as follows:

‘‘(c) Special provisions with respect to

Material Associated Persons subject to

the supervision of certain domestic

regulators. A registered government

securities broker or dealer shall be

deemed to be in compliance with the

reporting requirements of paragraph (a)

of this section with respect to a Material

Associated Person if such registered

government securities broker or dealer

files Items 1, 2, and 3 (in Part I) of Form

17–H in accordance with paragraph (a)

of this section, provided that:

‘‘(1) Such Material Associated Person

is subject to examination by or the

reporting requirements of a Federal

banking agency and the registered

government securities broker or dealer

or such Material Associated Person

furnishes in accordance with paragraph

(a) of this section copies of reports filed

by the Material Associated Person with

the Federal banking agency pursuant to

section 5211 of the Revised Statutes,

section 9 of the Federal Reserve Act,

section 7(a) of the Federal Deposit

Insurance Act, section 10(b) of the

Home Owners’ Loan Act, or section 5 of

the Bank Holding Company Act of 1956;

or’’

* * * * *

(6) Paragraph 240.17h–2T(d) of this

title is modified to read as follows:

‘‘(d) Special provisions with respect to

Material Associated Persons subject to

the supervision of a foreign financial

regulatory authority. A registered

government securities broker or dealer

shall be deemed to be in compliance

with the reporting requirements of

paragraph (a) of this section with

respect to a Material Associated Person

if such registered government securities

broker or dealer furnishes, in

accordance with the provisions of

paragraph (a) of this section, Items 1, 2,

and 3 (in Part I) of Form 17–H and

copies of the reports filed by such

Material Associated Person with a

Foreign Financial Regulatory Authority.

The registered government securities

broker or dealer shall file a copy of the

original Foreign Financial Regulatory

report and a copy translated into the

English language. For the purposes of

this section, the term Foreign Financial

Regulatory Authority shall have the

meaning set forth in section 3(a)(52) of

the Act.’’

(7) Paragraph 240.17h–2T(f) of this

title is modified to read as follows:

‘‘(f) Implementation schedule. Every

registered government securities broker

or dealer subject to the requirements of

this section shall file the information

required by Items 1, 2 and 3 (in Part I)

of Form 17–H by July 31, 1995.

Commencing September 30, 1995, the

provisions of this section shall apply in

their entirety.’’

(Approved by the Office of Management and

Budget under control number 1535–0089)

Dated: April 18, 1995.

Frank N. Newman,

Deputy Secretary.

[FR Doc. 95–10219 Filed 4–25–95; 8:45 am]

BILLING CODE 4810–39–W
20402 Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Lufenuron Suspension

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 Ciba

Animal Health, Ciba-Geigy Corp. The

NADA provides for oral administration

of lufenuron suspension to cats for the

control of flea populations.

EFFECTIVE DATE: April 26, 1995.

FOR FURTHER INFORMATION CONTACT:

Marcia K. Larkins, Center for Veterinary

Medicine (HFV–112), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–0614.

SUPPLEMENTARY INFORMATION: Ciba

Animal Health, Ciba-Geigy Corp., P.O.

Box 18300, Greensboro, NC 27419–

8300, filed NADA 141–026, which

provides for oral administration of

Program (Lufenuron) Suspension to

cats 6 weeks of age or older. The drug

is provided once a month, mixed in

food, for the control of flea populations.

The product contains six individual

dose packs of 135 or 270 milligrams

lufenuron. Lufenuron has no deleterious

effect on adult fleas, but it prevents

most flea eggs from hatching or

maturing into adults. The NADA is

approved as of March 28, 1995, and the

regulations are amended in part 520 (21

CFR 520) by adding new § 520.1289 to

reflect the approval. The basis for

approval is discussed in the freedom of

information summary.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 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, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857,

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 March

28, 1995, because it contains reports of

new clinical or field investigations,

other than bioequivalence or residue

studies, essential to the approval and

conducted or sponsored by the

applicant.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

List of Subjects in 21 CFR Part 520

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 520 is 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).

2. New § 520.1289 is added to read as

follows:

§ 520.1289 Lufenuron suspension.

(a) Specifications. Each individual

dose pack contains either 135 or 270

milligrams of lufenuron.

(b) Sponsor. See No. 058198 in

§ 510.600(c) of this chapter.

(c) Conditions of use in cats—(1)

Amount. Minimum of 13.6 milligrams

per pound of body weight (30

milligrams per kilogram).

Recommended dose of 135 milligrams

for up to 10 pounds of body weight or

270 milligrams for 11 to 20 pounds. Cats

over 20 pounds are provided the

appropriate combination of packs.

(2) Indications for use. For control of

flea populations.

(3) Limitations. For oral use in cats 6

weeks of age or older, once a month,

mixed with food. Administer in

conjunction with a full meal to ensure

adequate absorption. Treat all cats in the

household to ensure maximum benefits.

Because the drug has no affect on adult

fleas, the concurrent use of insecticides

that kill adults may be necessary

depending on the severity of the

infestation. Federal law restricts this

drug to use by or on the order of a

licensed veterinarian.

Dated: April 19, 1995.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 95–10273 Filed 4–25–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Bureau of Alcohol, Tobacco and

Firearms

27 CFR Parts 6, 8, 10 and 11

[T.D. ATF–364, Re: Notice No. 794 and

Notice No. 796]

RIN 1512–AB10

Unfair Trade Practices Under the

Federal Alcohol Administration Act

(93F–003P)

AGENCY: Bureau of Alcohol, Tobacco

and Firearms (ATF), Treasury.

ACTION: Final rule, Treasury decision.

SUMMARY: The Bureau of Alcohol,

Tobacco and Firearms (ATF) is

amending trade practice regulations

under the Federal Alcohol

Administration (FAA) Act on tiedhouse, exclusive outlets, commercial

bribery, and consignment sales by

adding standards for enforcing the

‘‘exclusion’’ element where appropriate.

Under the FAA Act, ‘‘exclusion, in

whole or in part, of distilled spirits,

wine, or malt beverages, sold or offered

for sale by other persons’’ is a necessary

element of a violation of the tied-house,

exclusive outlets or commercial bribery

provisions. In this final rule, ATF

promulgates a framework for

establishing ‘‘exclusion,’’ identifies

promotional practices which result in

control of a retailer or in exclusion

under the Act, identifies factors which

will apply in evaluating exclusion, and

identifies those practices for which

there is no likelihood that exclusion

will result and for which the Bureau

will not take action (safe harbors). Other

regulatory amendments are also made as

a result of an ATF review of the

regulations and an industry petition

submitted in 1992.

EFFECTIVE DATE: May 26, 1995.

FOR FURTHER INFORMATION CONTACT:

James R. Crandall, Coordinator, Market

Compliance Branch, 650 Massachusetts

Avenue, NW, Washington, DC 20226;

telephone (202) 927–8100.

SUPPLEMENTARY INFORMATION:

Background

The Federal Alcohol Administration Act

The Federal Alcohol Administration

Act (hereinafter referred to as FAA Act