24440 Federal Register / Vol. 61, No. 95 / Wednesday, May 15, 1996 / Rules and Regulations

System (the Board) requested public

comment on a proposed rule (the

Proposed Rule) that would require

foreign banks with only agencies and

subsidiary commercial lending

companies in the United States to select

a home state, or have a home state

designated by the Board. 60 FR 67100.

The Proposed Rule also would remove

a restriction on the ability of foreign

banks to effect major bank mergers

through U.S. subsidiary banks located

outside the foreign banks’ home states,

and would delete certain outdated rules

governing home state selection.

The comment period ended on

February 5, 1996. The Board received a

single public comment on the Proposed

Rule from a trade association. The Board

has considered the comment and has

made changes to address it in the final

rule. Except as discussed below, the

Board’s final rule remains unchanged

from the Proposed Rule. In addition, the

Board requested and received comments

on other aspects of the Interstate Act as

it applies to foreign banks. The Board

will consider these comments in

connection with future review of the

provisions of Regulation K concerning

the interstate operation of foreign banks.

The commenter generally supported

the provisions of the Proposed Rule,

including its provisions requiring

certain foreign banks to select a home

state as contemplated by the Interstate

Act. The commenter suggested,

however, that the deadline for home

state selection by these banks be 60 days

from the publication of the final rule,

rather than March 31, 1996, as proposed

in the Proposed Rule. The commenter

requested this extension in order to give

these banks adequate time to assess the

consequences of their decision.

Although the Interstate Act removed

the geographic restrictions of the IBA on

the interstate acquisition of banks by

foreign banks, the home state of a

foreign bank continues to affect its

options for establishing additional

branches in the United States under the

IBA. In particular, the location of a

foreign bank’s home state is a factor

determining the ability of the foreign

bank to establish further interstate

branches pursuant to section 5 (a)(1)

and 5 (a)(2) of the IBA, as amended by

the Interstate Act. 12 U.S.C. § 3103

(a)(1), (a)(2).

Accordingly, the final rule allows

additional time for home state selection

by establishing June 30, 1996, as the

deadline for such selection. This

extension affords foreign banks affected

by the rule ample time in which to make

an informed home state selection.

The proposed rule provided that, in

the event a foreign bank required to

select a home state fails to do so, the

Board would exercise its authority to

determine a foreign bank’s home state.

In such cases, the Board generally will

designate as a foreign bank’s home state

the state in which the total assets of all

its offices, net of claims on affiliates or

other offices of the foreign bank, is the

largest, as reflected in the foreign bank’s

most recent report of condition, unless

other circumstances warrant designation

of a different home state.

Paperwork Reduction Act

In accordance with section 3506 of

the Paperwork Reduction Act of 1995

(44 U.S.C. Ch. 35; 5 CFR 1320 Appendix

A.1), the Board reviewed the rule under

the authority delegated to the Board by

the Office of Management and Budget.

No collections of information pursuant

to the Paperwork Reduction Act are

contained in the rule.

Regulatory Flexibility Act Analysis

Pursuant to section 605(b) of the

Regulatory Flexibility Act (Pub. L. 96–

354, 5 U.S.C. 601 et seq.), the Board

certifies that the final rule would not

have a significant economic impact on

a substantial number of small entities

that are subject to its regulation.

List of Subjects in 12 CFR Part 211

Exports, Federal Reserve System,

Foreign banking, Holding companies,

Investments, Reporting and

recordkeeping requirements.

For the reasons set out in the

preamble, the Board amends 12 CFR

Part 211 as set forth below:

PART 211—INTERNATIONAL

BANKING OPERATIONS

(REGULATION K)

1. The authority citation for Part 211

continues to read as follows:

Authority: 12 U.S.C. 221 et seq., 1818,

1841 et seq., 3101 et seq., 3901 et seq.

2. In § 211.22, paragraph (a) is revised;

paragraph (c) is removed; and paragraph

(d) is redesignated as paragraph (c) to

read as follows:

§ 211.22 Interstate banking operations of

foreign banking organizations.

(a) Determination of home state. (1) A

foreign bank (except a foreign bank to

which paragraph (a)(2) of this section

applies) that has any combination of

domestic agencies or subsidiary

commercial lending companies that

were established before September 29,

1994, in more than one state and have

been continuously operated shall select

its home state from those states in

which such offices or subsidiaries are

located. A foreign bank shall do so by

filing with the Board a declaration of

home state by June 30, 1996. In the

absence of such selection, the Board

shall designate the home state for such

foreign banks.

(2) A foreign bank that, as of

September 29, 1994, had declared a

home state or had a home state

determined pursuant to the law and

regulations in effect prior to that date

shall have that state as its home state.

(3) A foreign bank that has any

branches, agencies, subsidiary

commercial lending companies, or

subsidiary banks in one state, and has

no such offices or subsidiaries in any

other states, shall have as its home state

the state in which such offices or

subsidiaries are located.

* * * * *

By order of the Board of Governors of the

Federal Reserve System, May 9, 1996.

William W. Wiles,

Secretary of the Board.

[FR Doc. 96–12134 Filed 5–14–96; 8:45 am]

BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 522, and 556

Animal Drugs, Feeds, and Related

Products; Gentamicin Injection

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

following actions on two new animal

drug applications (NADA’s) held by

Schering-Plough Animal Health: The

combination of two NADA’s into one

and the withdrawal of the other, the

codification of a supplemental NADA

approved by letter, the approval of a

supplemental NADA that provides for

the use of two higher product

concentrations at the same dosage and

for the same indications, and the

addition of a tolerance for residues of

gentamicin in chickens.

The approved, combined, and

supplemented NADA provides for use

of gentamicin sulfate injection for the

prevention of early mortality of day-old

chickens and 1- to 3-day-old turkeys

due to certain infections susceptible to

gentamicin.

EFFECTIVE DATE: May 15, 1996

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary

Medicine (HFV–133), Food and Drug
Federal Register / Vol. 61, No. 95 / Wednesday, May 15, 1996 / Rules and Regulations 24441

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1644.

SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health, Schering-Plough

Corp., P.O. Box 529, Kenilworth, NJ

07033, has requested that NADA 47–486

Garasol Injection (5 milligrams

gentamicin per milliliter (mg/mL) for

turkeys) be included in NADA 101–862

Garasol Injection (50 and 100 mg/mL

for chickens). The NADA’s are

combined as NADA 101–862. NADA

47–486 is withdrawn. Schering-Plough

also filed supplemental NADA 101–862

providing for the use of 50 and 100 mg/

mL gentamicin sulfate injection for

turkeys at the same dosage and for the

same indications as currently approved.

The supplement is approved as of

March 28, 1996. In addition,

supplemental NADA 101–862 was

approved on July 27, 1983, for the use

of a 100 mg/mL injection in day-old

chickens. However, this approval was

not codified. At this time the regulation

in § 522.1044 (21 CFR 522.1044) is

amended to codify use of the 100 mg/

mL injection in day-old chickens.

Although the use was approved in

chickens as well as turkeys, the

regulations were not amended to

provide for a tolerance for gentamicin

residues in chickens. The regulations in

21 CFR 556.300 are amended to provide

for tolerances for gentamicin residues in

chickens as well as turkeys.

The approved, combined, and

supplemented NADA 101-862 provides

for use of Garasol Injection (50 and

100 mg/mL gentamicin sulfate injection)

in day-old chickens for the prevention

of early mortality caused by Escherichia

coli, Salmonella typhimurium, and

Pseudomonas aeruginosa susceptible to

gentamicin, and for use of Garasol

Injection (5, 50, and 100 mg/mL

gentamicin sulfate injection) in 1- to 3-

day-old turkeys for the prevention of

early mortality due to Arizona

paracolon infections susceptible to

gentamicin.

In § 522.1044(d)(2)(i), the regulation is

editorially amended to reflect the

language used in § 522.1044(d)(3)(i).

Also, American Scientific

Laboratories, A Division of Schering

Corp., has been incorporated into

Schering-Plough Animal Health,

Schering-Plough Corp. Therefore, 21

CFR 510.600(c) is amended to remove

the entries for American Scientific

Laboratories, drug label code 000138.

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, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

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

Friday.

The agency has determined under 21

CFR 25.24(d)(1)(iii) 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

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 522

Animal drugs.

21 CFR Part 556

Animal drugs, Foods.

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, 522, and 556 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 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) by

removing the entry for ‘‘American

Scientific Laboratories’’ and in the table

in paragraph (c)(2) by removing the

entry for ‘‘000138’’.

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

3. 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).

4. Section 522.1044 is amended by

revising paragraphs (b), (d)(2)(i), and

(d)(3)(i) to read as follows:

§ 522.1044 Gentamicin sulfate injection.

(b) Sponsors. (1) See No. 000061 in

§ 510.600(c) of this chapter for use of: 5-

milligrams-per-milliliter solution in

swine as in paragraph (d)(4) of this

section, 50-milligrams-per-milliliter

solution in dogs and cats as in

paragraph (d)(1) of this section, 50- and

100-milligrams-per-milliliter solution in

chickens and turkeys as in paragraphs

(d)(2) and (d)(3) of this section.

(2) [Reserved]

* * * * *

(d) * * *

(2) Turkeys—(i) Amount. One

milligram of gentamicin per 0.2

milliliter dose, using the 50- or 100-

milligrams-per-milliliter product

diluted with sterile saline to a

concentration of 5 milligrams-permilliliter.

* * * * *

(3) Chickens—(i) Amount. 0.2

milligram of gentamicin per 0.2

milliliter dose, using the 50- or 100-

milligrams-per-milliliter product

diluted with sterile saline to a

concentration of 1.0 milligram-permilliliter.

* * * * *

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

5. The authority citation for 21 CFR

part 556 continues to read as follows:

Authority: Secs. 402, 512, 701 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 342, 360b, 371).

§ 556.300 [Amended]

6. Section 556.300 Gentamicin sulfate

is amended in paragraph (a) by adding

the phrase ‘‘chickens and’’ after ‘‘tissues

of’’.

Dated: April 26, 1996.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 96–12154 Filed 5–14–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 520 and 556

Animal Drugs, Feeds, and Related

Products; Liquid Sul-Q-Nox (Sodium

Sulfaquinoxaline Solution)

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 supplemental new animal

drug application (NADA) filed by I. D.

Russell Co. Laboratories. The

supplemental NADA provides for safe

and effective use of a sodium