61912 Federal Register / Vol. 62, No. 224 / Thursday, November 20, 1997 / Rules and Regulations

Poulenc, Inc.’s NADA 49–934. The

ANADA is approved as of November 20,

1997 and the regulations are amended

in § 558.175 (21 CFR 558.175) to reflect

the approval. The basis for approval is

discussed in the freedom of information

summary.

In addition, § 558.175 is amended to

reflect the approval by redesignating

paragraph (c) as paragraph (d), by

reserving paragraph (c), and by

amending newly redesignated paragraph

(d)(1)(iv)(b).

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 20857, between

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

Friday.

The agency has determined under 21

CFR 25.33(a)(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 in 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 part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

The authority citation for 21 CFR part

558 continues to read as follows:

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

§ 558.175 [Amended]

2. Section 558.175 Clopidol is

amended by redesignating paragraph (c)

as paragraph (d), by reserving paragraph

(c), and in newly redesignated

paragraph (d)(1)(iv)(b) by removing ‘‘No.

000061’’ and adding in its place ‘‘Nos.

000061 and 046573’’.

Dated: October 30, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–30408 Filed 11–19–97; 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; Monensin and Bacitracin Zinc

With Roxarsone

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

Alpharma Inc. The ANADA provides for

using approved monensin, bacitracin

zinc, and roxarsone Type A medicated

articles to make Type C medicated

broiler chicken feeds used for

prevention of coccidiosis and increased

rate of weight gain, or for prevention of

coccidiosis and improved feed

efficiency and improved pigmentation.

EFFECTIVE DATE: November 20, 1997.

FOR FURTHER INFORMATION CONTACT:

Jeffrey M. Gilbert, Center for Veterinary

Medicine (HFV–128), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1602.

SUPPLEMENTARY INFORMATION: Alpharma

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

Fort Lee, NJ 07024, is sponsor of

ANADA 200–211 that provides for

combining approved monensin,

bacitracin zinc, and roxarsone Type A

medicated articles to make Type C

medicated broiler feeds containing:

Monensin 90 to 110 grams per ton (g/

t) and bacitracin zinc 10 g/t with

roxarsone 15 g/t for prevention of

coccidiosis caused by Eimeria tenella, E.

necatrix, E. acervulina, E. brunetti, E.

mivati, and E. maxima, and for

increased rate of weight gain, or;

monensin 90 to 110 g/t and bacitracin

zinc 4 to 50 g/t with roxarsone 15 to

45.4 g/t for prevention of coccidiosis

caused by E. tenella, E. necatrix, E.

acervulina, E. brunetti, E. mivati, and E.

maxima, and for improved feed

efficiency and improved pigmentation

by enhancing carotenoid and

xanthophyll utilization.

ANADA 200–211, sponsored by

Alpharma Inc., is approved as a generic

copy of Hoffmann-La Roche’s NADA

123–154. The ANADA is approved as of

November 20, 1997 and the regulations

are amended in 21 CFR 558.355(f)(1) 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 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 20857, between

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

Friday.

The agency has determined under 21

CFR 25.33(a)(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 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.

§ 558.355 [Amended]

2. Section 558.355 Monensin is

amended in paragraphs (f)(1)(xv)(b) and

(f)(1)(xvi)(b) by removing ‘‘No. 000004’’

and adding in its place ‘‘Nos. 000004

and 046573’’.

Dated: November 7, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–30483 Filed 11–19–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Fiscal Service

31 CFR Part 357

[Department of the Treasury Circular, Public

Debt Series, No. 2–86]

Regulations Governing Book-Entry

Treasury Bonds, Notes, and Bills;

Determination Regarding State

Statutes

AGENCY: Bureau of the Public Debt,

Fiscal Service, Treasury.

ACTION: Determination of substantially

identical state statutes.
Federal Register / Vol. 62, No. 224 / Thursday, November 20, 1997 / Rules and Regulations 61913

SUMMARY: The Department of the

Treasury is announcing that it has

reviewed the statutes of 13 states which

have recently enacted laws adopting

Revised Article 8 of the Uniform

Commercial Code—Investment

Securities (‘‘Revised Article 8’’) and

determined that they are substantially

identical to the uniform version of

Revised Article 8 for purposes of

interpreting the rules in 31 CFR Part

357, Subpart B (the ‘‘TRADES’’

regulations). Therefore, that portion of

the TRADES rule requiring application

of Revised Article 8 if a state has not

adopted Revised Article 8 will no longer

be applicable for those 13 states.

EFFECTIVE DATE: November 20, 1997.

FOR FURTHER INFORMATION CONTACT:

Sandy Dyson, Attorney-Advisory, (202)

219–3320, or Cynthia E. Reese, Deputy

Chief Counsel, (202) 219–3320.

SUPPLEMENTARY INFORMATION: On August

23, 1996, the Department published a

final rule to govern securities held in

the commercial book-entry system, now

referred to as the Treasury/Reserve

Automated Debt Entry System

(‘‘TRADES’’) (61 FR 43626).

In the commentary to the final

regulations, Treasury stated that for the

28 states that had by then adopted

Revised Article 8, the versions enacted

were ‘‘substantially identical’’ to the

uniform version for purposes of the rule.

Therefore, for those states, that portion

of the TRADES rule requiring

application of Revised Article 8 was not

invoked. Treasury also indicated in the

commentary that as additional states

adopt Revised Article 8, notice would

be provided in the Federal Register as

to whether the enactments are

substantially identical to the uniform

version so that the federal application of

Revised Article 8 would no longer be in

effect for those states. Treasury adopted

this approach in an attempt to provide

certainty in application of the rule in

response to public comments. Treasury

published such notices with respect to

California (62 FR 26, January 2, 1997)

and the District of Columbia (62 FR

34010, June 18, 1997). 31 CFR Part 357,

Appendix B, the TRADES Commentary

also was amended by final rule (62 FR

43283, August 13, 1997) to update the

list of states that have enacted Revised

Article 8 statutes which Treasury

determined to be substantially identical

to the uniform version.

This notice addresses the recent

adoption of Article 8 by the following

13 states: Delaware, Hawaii, Maine,

Missouri, Montana, Nevada, New Jersey,

New York, North Carolina, North

Dakota, Ohio, Tennessee and Puerto

Rico. A ‘‘state’’ is defined in the

regulations as including Puerto Rico.

Treasury has reviewed the 13 state

enactments and has concluded all of

them are substantially identical to the

uniform version of Revised Article 8.

Accordingly, if either § 357.10(b) or

§ 357.11(b) directs a person to Delaware,

Hawaii, Maine, Missouri, Montana,

Nevada, New Jersey, New York, North

Carolina, North Dakota, Ohio,

Tennessee and Puerto Rico, the

provisions of §§ 357.10(c) and 357.11(d)

of the TRADES rule are not applicable.

This means that a total of 43 states

(including D.C. and Puerto Rico) have

enacted Revised Article 8 that have been

either: (1) the subject of notices by

Treasury stating that the laws are

‘‘substantially identical’’ to the uniform

version for purposes of the TRADES

regulations; or (2) included in the list of

states appearing in a footnote to the

Commentary section in Appendix B of

the TRADES regulations.

In addition, Treasury has reviewed

the recent enactment of Revised Article

8 by Connecticut. Because we

understand that Connecticut will likely

be acting within the next year to amend

the statute that was passed, we make no

determination at this time with respect

whether the statute passed is

‘‘substantially identical’’ to the uniform

version for purposes of the rule.

Dated: November 12, 1997.

Richard L. Gregg,

Commissioner of the Public Debt.

[FR Doc. 97–30432 Filed 11–19–97; 8:45 am]

BILLING CODE 4810–39–M

DEPARTMENT OF DEFENSE

Department of the Navy

32 CFR Part 701

[Secretary of the Navy Instruction 5211.5]

Department of the Navy Privacy

Program

AGENCY: Department of the Navy, DOD.

ACTION: Final rule.

SUMMARY: The Department of the Navy

is amending a system of records notice

identifier for an exempt system of

records at 32 CFR part 701, subpart G.

This action is needed because the

system identifier for the notice was

previously amended on July 22, 1997, at

62 FR 39225. The amendment changed

the system of records notice identifier

from N01000–4 to N01000–5. This rule

ensures that the system identifier for the

rule and the notice are the same.

EFFECTIVE DATE: November 20, 1997.

FOR FURTHER INFORMATION CONTACT: Mrs.

Doris Lama at (202) 685–6545 or DSN

325–6545.

SUPPLEMENTARY INFORMATION:

Executive Order 12866. It has been

determined that this Privacy Act rule for

the Department of Defense does not

constitute ‘significant regulatory action’.

Analysis of the rule indicates that it

does not have an annual effect on the

economy of $100 million or more; does

not create a serious inconsistency or

otherwise interfere with an action taken

or planned by another agency; does not

materially alter the budgetary impact of

entitlements, grants, user fees, or loan

programs or the rights and obligations of

recipients thereof; does not raise novel

legal or policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in Executive

Order 12866 (1993).

Regulatory Flexibility Act. It has been

determined that this Privacy Act rule for

the Department of Defense does not

have significant economic impact on a

substantial number of small entities

because it is concerned only with the

administration of Privacy Act systems of

records within the Department of

Defense.

Paperwork Reduction Act. It has been

determined that this Privacy Act rule for

the Department of Defense imposes no

information requirements beyond the

Department of Defense and that the

information collected within the

Department of Defense is necessary and

consistent with 5 U.S.C. 552a, known as

the Privacy Act of 1974.

The Department of the Navy is

amending a system of records notice

identifier for an exempt system of

records at 32 CFR part 701, subpart G.

This action is needed because the

system identifier for the notice was

previously amended on July 22, 1997, at

62 FR 39225. The amendment changed

the system of records notice identifier

from N01000–4 to N01000–5. This rule

ensures that the system identifier for the

rule and the notice are the same.

List of Subjects in 32 CFR Part 701,

Subpart G

Privacy.

1. The authority citation for 32 CFR

part 701, Subpart G continues to read as

follows:

Authority: Pub. L. 93–579, 88 Stat.

1896 (5 U.S.C. 552a).

2. Section 701.118, is amended by

revising paragraph (r) introductory text

as follows:

§ 701.118 Exemptions for specific Navy

record systems.

* * * * *