11026 Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Rules and Regulations

stated value of capital stock, paid-in

capital in excess of par, retained

earnings or other capital accounts. The

term equity capital does not include

securities in the securities accounts of

partners and balances in limited

partners’ capital accounts in excess of

their stated capital contributions.

(iii) Paragraphs (i)(1) and (i)(2) of this

section shall not preclude a government

securities broker or dealer from making

required tax payments or preclude the

payment to partners of reasonable

compensation, and such payments shall

not be included in the calculation of

withdrawals, advances or loans for

purposes of paragraphs (i)(1) and (i)(2)

of this section.

(iv) For the purposes of this

subsection (i), any transaction between

a government securities broker or dealer

and a stockholder, partner, sole

proprietor, employee or affiliate that

results in a diminution of the

government securities broker’s or

dealer’s liquid capital shall be deemed

to be an advance or loan of liquid

capital.

* * * * *

(Approved by the Office of Management and

Budget under control number 1535–0089)

4. By adding § 402.2e (Appendix E) as

follows:

§ 402.2e Appendix E—Temporary

Minimum Requirements.

(a) A government securities broker or

dealer that falls within the provisions of

paragraph (b)(1) of § 402.2 shall

maintain not less than the greater of:

(1) The amount of liquid capital

required under paragraph (a) of

§ 402.2(a); or

(2) The amount of liquid capital, after

deducting total haircuts, of:

(i) $25,000 through June 30, 1995;

(ii) $100,000 from July 1, 1995

through December 31, 1995;

(iii) $175,000 from January 1, 1996

through June 30, 1996; and

(iv) $250,000 from July 1, 1996 and

thereafter.

(b) A government securities broker or

dealer that falls within the provisions of

paragraph (b)(2) of § 402.2 shall

maintain not less than the greater of:

(1) The amount of liquid capital

required under paragraph (a) of § 402.2;

or

(2) The amount of liquid capital, after

deducting total haircuts, of:

(i) $25,000 through June 30, 1995;

(ii) $50,000 from July 1, 1995 through

December 31, 1995;

(iii) $75,000 from January 1, 1996

through June 30, 1996; and

(iv) $100,000 from July 1, 1996 and

thereafter.

(c) A government securities broker

that falls within the provisions of

paragraph (c)(1) of § 402.2 shall

maintain not less than the greater of:

(1) The amount of liquid capital

required under paragraph (a) of § 402.2;

or

(2) The amount of liquid capital, after

deducting total haircuts, of:

(i) $5,000 through June 30, 1995;

(ii) $20,000 from July 1, 1995 through

December 31, 1995;

(iii) $35,000 from January 1, 1996

through June 30, 1996; and

(iv) $50,000 from July 1, 1996 and

thereafter.

(d) A government securities broker

that falls within the provisions of

paragraph (c)(2) of § 402.2 shall

maintain not less than the greater of:

(1) The amount of liquid capital

required under paragraph (a) of § 402.2;

or

(2) The amount of liquid capital, after

deducting total haircuts, of:

(i) $5,000 through June 30, 1995;

(ii) $11,000 from July 1, 1995 through

December 31, 1995;

(iii) $18,000 from January 1, 1996

through June 30, 1996; and

(iv) $25,000 from July 1, 1996 and

thereafter.

* * * * *

PART 404—RECORDKEEPING AND

PRESERVATION OF RECORDS

5. The authority citation for Part 404

is revised to read as follows:

Authority: 15 U.S.C. 78o–5(b)(1)(B),

(b)(1)(C), (b)(4).

6. Section 404.2 is amended by

revising paragraph (a)(4) to read as

follows:

§ 404.2 Records to be made and kept

current by registered government securities

brokers and dealers; records of nonresident registered government securities

brokers and dealers.

(a) * * *

(4) Paragraph 240.17a–3(b)(1) is

modified to read as follows:

‘‘(1) This section shall not be deemed

to require a government securities

broker or dealer registered pursuant to

Section 15C(a)(1)(A) of the Act (15

U.S.C. 78o–5(a)(1)(A)) to make or keep

such records of transactions cleared for

such government securities broker or

dealer as are customarily made and kept

by a clearing broker or dealer pursuant

to the requirements of §§ 240.17a–3 and

240.17a–4: Provided, that the clearing

broker or dealer has and maintains net

capital of not less than $250,000 (or, in

the case of a clearing broker or dealer

that is a registered government

securities broker or dealer, liquid capital

less total haircuts, determined as

provided in § 402.2 of this title, of not

less than $250,000) and is otherwise in

compliance with § 240.15c3–1, § 402.2

of this title, or the capital rules of the

exchange of which such clearing broker

or dealer is a member if the members of

such exchange are exempt from

§ 240.15c3–1 by paragraph (b)(2)

thereof.’’.

* * * * *

§§ 400.4, 400.5, 401.9, 403.5, 404.2, 404.3,

404.4, 404.5, 405.2, and 450.4 [Amended]

7. For each section indicated in the

list above, remove the Office of

Management and Budget control

number from the parenthetical

statement at the end of each section, and

add in its place ‘‘1535–0089’’:

Dated: February 15, 1995.

Frank N. Newman,

Deputy Secretary.

[FR Doc. 95–4941 Filed 2–28–95; 8:45 am]

BILLING CODE 4810–39–W

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 450

[Docket No. 94N–0302]

Antibiotic Drugs; Bleomycin Sulfate;

Stay of Regulation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; stay of regulation.

SUMMARY: The Food and Drug

Administration (FDA) is staying a

regulation that established standards for

an antibiotic drug, bleomycin sulfate

bulk drug substance. This action is

being taken in response to a petition for

stay of action.

EFFECTIVE DATE: November 9, 1994.

FOR FURTHER INFORMATION CONTACT:

Tamar S. Nordenberg, Center for Drug

Evaluation and Research (HFD–366),

Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301–

594–2041.

SUPPLEMENTARY INFORMATION: In the

Federal Register of October 4, 1994 (59

FR 50484), FDA published, as a final

rule to become effective on November 3,

1994, a new antibiotic regulation setting

forth standards for a bleomycin sulfate

bulk drug substance (21 CFR 450.10).

This new regulation differed from the

monograph standards for sterile

bleomycin sulfate bulk drug, set forth in

21 CFR 450.10a, in two respects: The

new regulation did not require sterility

at the bulk stage, and the new regulation
Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Rules and Regulations 11027

did not require testing for pyrogens at

the bulk stage.

Bristol-Myers Squibb Co., the

manufacturer of the innovator product,

filed a petition for stay of action

pursuant to 21 CFR 10.35, objecting to

FDA’s decision to promulgate the new

regulation without notice and a prior

opportunity for public comment. On

November 9, 1994, FDA agreed to stay

the effective date of the monograph for

bleomycin sulfate bulk drug substance

in order to reconsider the manner in

which the agency promulgated the new

monograph. A copy of FDA’s letter

notifying Bristol-Myers Squibb Co. of

the stay is on file in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 450 is

amended as follows:

List of Subjects in 21 CFR Part 450

Antibiotics.

PART 450—ANTITUMOR ANTIBIOTIC

DRUGS

1. The authority citation for 21 CFR

part 450 continues to read as follows:

Authority: Sec. 507 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 357).

§ 450.10 [Stayed]

2. Section 450.10 Bleomycin sulfate is

stayed effective November 9, 1994.

Dated: February 15, 1995.

Murray M. Lumpkin,

Deputy Director, Center for Drug Evaluation

and Research.

[FR Doc. 95–5058 Filed 2–28–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 510 and 558

Animal Drugs, Feeds, and Related

Products; Change of Sponsor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect a

change of sponsor for nine new animal

drug applications (NADA’s) from AgriBio Corp. to Hoffman-LaRoche, Inc. This

document also corrects an inadvertent

error in the animal drug regulations.

EFFECTIVE DATE: March 1, 1995.

FOR FURTHER INFORMATION CONTACT:

Benjamin A. Puyot, Center for

Veterinary Medicine (HFV–130), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1646.

SUPPLEMENTARY INFORMATION: Agri-Bio

Corp., 966 Dorsey St., Gainesville, GA

30501, has informed FDA that it has

transferred the ownership of, and all

rights and interests in, the following

approved NADA’s to Hoffmann-La

Roche, Inc., 340 Kingsland St., Nutley,

NJ 07110–1199:

NADA No. Ingredient(s) Trade name(s)

128–686 ... Salinomycin ................................................................................... Bio-Cox.

132–447 ... Salinomycin and Roxarsone ......................................................... Bio-Cox and 3-Nitro.

134–284 ... Salinomycin and Bambermycins ................................................... Bio-Cox and Flavomycins.

134–185 ... Salinomycin and Roxarsone and Bambermycins ......................... Bio-Cox and 3-Nitro Flavomycin.

135–321 ... Salinomycin and Roxarsone and Bacitracin-MD .......................... Bio-Cox and 3-Nitro and BMD.

135–746 ... Salinomycin and Bacitracin-MD .................................................... Bio-Cox and BMD.

137–536 ... Salinomycin and Roxarsone and Bacitracin Zn ............................ Bio-Cox and 3-Nitro and Albac.

137–537 ... Salinomycin and Lincomycin ......................................................... Bio-Cox and Lincomix.

140–581 ... Salinomycin and Roxarsone and Lincomycin ............................... Bio-Cox and 3–Nitro and Lincomix.

Accordingly, the agency is amending

the regulations in 21 CFR 510.600(c)(1)

and (c)(2) and 558.95(b)(1)(xi)(b) and

(b)(1)(xii)(b) to reflect the change of

sponsor.

In the Federal Register of January 13,

1995 (60 FR 3079 at 3080), FDA

amended § 558.550; this amendment

inadvertently failed to reflect a previous

amendment published in the Federal

Register of December 29,1994 (59 FR

67185). The December 29, 1994,

document amended § 558.550(a)(1) and

(a)(2) to provide for specific levels of

Type A articles approved for use for the

specified sponsors. The January 13,

1995, document amended

§ 558.550(a)(2) to add approved

referenced uses as stated in § 558.550(b).

This document corrects the inadventent

error made in the final rule of January

13, 1995.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

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 510 and 558 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).

§ 510.600 [Amended]

2. Section 510.600 is amended in the

table in paragraph (c)(1) by removing

the entry for ‘‘Agri–Bio Corp.’’ and in

the table in paragraph (c)(2) by

removing the entry for ‘‘042835’’.

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

3. 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).

§ 558.95 [Amended]

4. Section 558.95 Bambermycins is

amended in paragraphs (b)(1)(xi)(b) and

(b)(1)(xii)(b) by removing ‘‘042835’’ and

adding in its place ‘‘000004’’.

5. Section 558.550 is amended in

paragraph (a)(1) by removing the

number ‘‘042835’’ and adding in its

place ‘‘000004’’, and by revising

paragraph (a)(2) to read as follows:

§ 558.550 Salinomycin.

(a) * * *

(2) To 012799 for use of 30 and 60

grams per pound as in paragraphs

(b)(1)(i), (b)(1)(iii) through (b)(1)(xvi),