Federal Register / Vol. 63, No. 84 / Friday, May 1, 1998 /Rules and Regulations 24105

and (l) as paragraphs (g), (h), (i), (j), and

(k).

3. Section 703.50 is amended by

revising paragraph (b)(2) to read as

follows:

§ 703.50 What rules govern my dealings

with entities I use to purchase and sell

investments (‘‘broker-dealers’’)?

* * * * *

(b) * * *

(2) Information available from state or

federal securities regulators and

securities industry self-regulatory

organizations, such as the National

Association of Securities Dealers and

the North American Securities

Administrators Association, about any

enforcement actions against the brokerdealer, its affiliates, or associated

personnel.

* * * * *

4. Section 703.100 is amended by

revising paragraph (e) to read as follows:

§ 703.100 What investments and

investment activities are permissible for

me?

* * * * *

(e) You may invest in fixed or variable

rate CMOs/REMICs.

* * * * *

5. Section 703.130 is revised to read

as follows:

§ 703.130 May I continue to hold

investments purchased before January 1,

1998, that will be impermissible after that

date?

(a) Subject to safety and soundness

considerations, you may hold a CMO/

REMIC residual, SMBS, or zero coupon

security with a maturity greater than 10

years, if you purchased the investment:

(1) Before December 2, 1991; or

(2) On or after December 2, 1991, but

before January 1, 1998, if for the

purpose of reducing interest rate risk

and you meet the following:

(i) You have a monitoring and

reporting system in place that provides

the documentation necessary to evaluate

the expected and actual performance of

the investment under different interest

rate scenarios;

(ii) You use the monitoring and

reporting system to conduct and

document an analysis that shows, before

purchase, that the proposed investment

will reduce your interest rate risk;

(iii) After purchase, you evaluate the

investment at least quarterly to

determine whether or not it actually has

reduced your interest rate risk; and

(iv) You classify the investment as

either trading or available-for-sale.

(b) All grandfathered investments are

subject to the valuation and monitoring

requirements of §§ 703.70, 703.80, and

703.90.

PART 704—CORPORATE CREDIT

UNIONS

6. The authority citation for part 704

continues to read as follows:

Authority: 12 U.S.C. 1757(7), 1757(8),

1757(15).

7. Section 704.5 is amended by

revising paragraph (c)(6) to read as

follows:

§ 704.5 Investments.

* * * * *

(c) * * *

(6) CMOs/REMICs.

* * * * *

Appendix B to Part 704—[Amended]

8. Appendix B to part 704 is amended

as follows:

a. A heading is added to the beginning

of the Appendix; and

b. In Part I paragraph (c)(6) is removed

and paragraphs (c)(7) through (c)(9) are

redesignated as paragraphs (c)(6)

through (c)(8); and

c. In Part II paragraph (c)(6) is

removed and paragraphs (c)(7) and (c)(8)

are redesignated as paragraphs (c)(6)

and (c)(7).

The addition reads as follows:

Appendix B to Part 704—Expanded

Authorities and Requirements

Part I

* * * * *

[FR Doc. 98–11450 Filed 4–30–98; 8:45 am]

BILLING CODE 7535–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 529

Certain Other Dosage Form New

Animal Drugs; Isoflurane

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 an abbreviated new animal

drug application (ANADA) filed by

Marsam Pharmaceuticals, Inc. The

ANADA provides for inhalational use of

isoflurane USP for induction and

maintenance of general anesthesia in

horses and dogs.

EFFECTIVE DATE: May 1, 1998.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0209.

SUPPLEMENTARY INFORMATION: Marsam

Pharmaceuticals, Inc., Bldg. 31, 24

Olney Ave., Cherry Hill, NJ 08034, filed

ANADA 200–187 that provides for

inhalational use of isoflurane USP for

induction and maintenance of general

anesthesia in horses and dogs. The drug

is limited to use by or on the order of

a licensed veterinarian.

Approval of ANADA 200–187 for

Marsam Pharmaceuticals, Inc.’s,

isoflurane is as a generic copy of

Ohmeda Pharmaceutical Product’s

NADA 135–773 AErrane (isoflurane,

USP). The ANADA is approved as of

February 11, 1998, and the regulations

are amended in 21 CFR 529.1186(b) to

reflect the approval. The basis of

approval is discussed in the freedom of

information summary.

In addition, Marsam Pharmaceuticals,

Inc., has not been previously listed in

§ 510.600 (21 CFR 510.600) as sponsor

of an approved application. The

regulations are amended in

§ 510.600(c)(1) and (c)(2) to reflect the

new sponsor.

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, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20855, between

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

Friday.

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.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 529

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 parts 510 and 529 are amended as

follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:
24106 Federal Register / Vol. 63, No. 84 / Friday, May 1, 1998 /Rules and Regulations

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e.

2. Section 510.600 is amended in the

table in paragraph (c)(1) by

alphabetically adding an entry for

‘‘Marsam Pharmaceuticals, Inc.,’’ and in

the table in paragraph (c)(2) by

numerically adding an entry for

‘‘000209’’ to read as follows:

§ 510.600 Names, addresses, and drug

labeler codes of sponsors of approved

applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address Drug labeler code

* * * * * * *

Marsam Pharmaceuticals, Inc., Bldg. 31,

24 Olney Ave., Cherry Hill, NJ 08034.

000209

* * * * * * *

(2) * * *

Drug labeler code Firm name and address

* * * * * * *

000209 Marsam Pharmaceuticals, Inc., Bldg. 31, 24 Olney Ave., Cherry Hill, NJ 08034.

* * * * * * *

PART 529—CERTAIN OTHER DOSAGE

FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 529 continues to read as follows:

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

2. Section 529.1186 is amended by

revising paragraph (b) to read as follows:

§ 529.1186 Isoflurane.

* * * * *

(b) Sponsors. See Nos. 000074,

000209, 010019, 012164, and 059258 in

§ 510.600(c) of this chapter.

* * * * *

Dated: April 22, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–11685 Filed 4–30–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556

Implantation or Injectable Dosage

Form New Animal Drugs;

Spectinomycin 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 new animal drug

application (NADA) filed by Pharmacia

& Upjohn Co. The NADA provides for

veterinary prescription use of

spectinomycin solution as a

subcutaneous injection in cattle for

treatment of bovine respiratory disease.

EFFECTIVE DATE: May 1, 1998.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1644.

SUPPLEMENTARY INFORMATION: Pharmacia

& Upjohn Co., 7000 Portage Rd.,

Kalamazoo, MI 49001–0199, filed

NADA 141–077 that provides for

veterinary prescription use of AdspecTM

(spectinomycin) sterile solution for

cattle, by subcutaneous injection in the

neck, for treatment of bovine respiratory

disease (pneumonia) associated with

Pasteurella haemolytica, P. multocida,

and Haemophilus somnus. The NADA

is approved as of January 28, 1998, and

the regulations are amended by adding

§ 522.2121 (21 CFR 522.2121) to reflect

the approval.

A tolerance for residues of

spectinomycin in edible tissues of cattle

has not been previously established.

The regulations are amended in 21 CFR

556.600 to provide a tolerance for

spectinomycin residues in cattle kidney

(target tissue) and in cattle muscle.

FDA is also amending the regulations

to provide for the acceptable daily

intake (ADI) for total residues of

spectinomycin. The ADI is the amount

of total drug residue that can be

consumed by humans every day.

Previously, FDA had provided for safe

concentrations, which represent the ADI

corrected for consumption. The safe

concentrations were confusing because

few individuals understood the

relationship between safe concentration,

a value representing total residues, and

tolerance, the part of the drug residue in

a given tissue that is detected by an

analytical method. To eliminate this

confusion, FDA is codifying the ADI.

Also, the heading of § 522.2120

Spectinomycin injection (21 CFR

522.2120) is revised to ‘‘§ 522.2120

Spectinomycin dihydrochloride

injection’’ to clarify the difference

between § 522.2120 and § 522.2121

Spectinomycin sulfate solution.

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.