Federal Register / Vol. 62, No. 224 / Thursday, November 20, 1997 / Rules and Regulations 61911

those actions in the future if this AD

were not adopted.

Regulatory Impact

The regulations adopted herein will

not have substantial direct effects on the

States, on the relationship between the

national government and the States, or

on the distribution of power and

responsibilities among the various

levels of government. Therefore, in

accordance with Executive Order 12612,

it is determined that this final rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

For the reasons discussed above, I

certify that this action (1) is not a

‘‘significant regulatory action’’ under

Executive Order 12866; (2) is not a

‘‘significant rule’’ under DOT

Regulatory Policies and Procedures (44

FR 11034, February 26, 1979); and (3)

will not have a significant economic

impact, positive or negative, on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act. A final evaluation has

been prepared for this action and it is

contained in the Rules Docket. A copy

of it may be obtained from the Rules

Docket at the location provided under

the caption ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Incorporation by reference,

Safety.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration amends part 39 of the

Federal Aviation Regulations (14 CFR

part 39) as follows:

PART 39—AIRWORTHINESS

DIRECTIVES

1. The authority citation for part 39

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding the following new airworthiness

directive:

97–24–03 Dassault Aviation: Amendment

39–10210. Docket 97–NM–198–AD.

Applicability: Model Falcon 2000

airplanes, serial numbers 2 through 31

inclusive; certificated in any category.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

otherwise modified, altered, or repaired in

the area subject to the requirements of this

AD. For airplanes that have been modified,

altered, or repaired so that the performance

of the requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (c) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or

repair on the unsafe condition addressed by

this AD; and, if the unsafe condition has not

been eliminated, the request should include

specific proposed actions to address it.

Compliance: Required as indicated, unless

accomplished previously.

To prevent injury to passengers as a result

of inadequate breaking strength of the

baggage net, accomplish the following:

(a) Within 60 days after the effective date

of this AD, revise the Limitations section of

the FAA-approved Airplane Flight Manual

(AFM) by inserting into the AFM a copy of

Falcon 2000 AFM Temporary Change No. 31

(undated).

Note 2: The revision of the AFM required

by this paragraph may be accomplished by

inserting a copy of Falcon 2000 AFM

Temporary Change No. 31 in the AFM. When

this temporary change has been incorporated

into general revisions of the AFM, the general

revisions may be inserted in the AFM,

provided that the information contained in

the general revisions is identical to that

specified in Falcon 2000 AFM Temporary

Change No. 31.

(b) Within 6 months after the effective date

of this AD, replace the center baggage net in

the baggage compartment with a net having

reinforced straps, in accordance with

Dassault Service Bulletin F2000–76 (F2000–

25–2), dated December 11, 1996. After this

replacement is accomplished, the AFM

revision required by paragraph (a) of this AD

may be removed from the AFM.

(c) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager,

International Branch, ANM–116, FAA,

Transport Airplane Directorate. Operators

shall submit their requests through an

appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, International Branch,

ANM–116.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the International Branch,

ANM–116.

(d) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(e) The actions shall be done in accordance

with Falcon 2000 Airplane Flight Manual

Temporary Change No. 31 (undated), and

Dassault Service Bulletin F2000–76 (F2000–

25–2), dated December 11, 1996. This

incorporation by reference was approved by

the Director of the Federal Register in

accordance with 5 U.S.C. 552(a) and 1 CFR

part 51. Copies may be obtained from

Dassault Falcon Jet Corporation, Teterboro

Airport, P.O. Box 2000, South Hackensack,

New Jersey 07606. Copies may be inspected

at the FAA, Transport Airplane Directorate,

1601 Lind Avenue, SW., Renton,

Washington; or at the Office of the Federal

Register, 800 North Capitol Street, NW., suite

700, Washington, DC.

Note 4: The subject of this AD is addressed

French airworthiness directive 96–291–

002(B), dated December 4, 1996.

(f) This amendment becomes effective on

December 26, 1997.

Issued in Renton, Washington, on

November 10, 1997.

Darrell M. Pederson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–30301 Filed 11–19–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Clopidol and Bacitracin Zinc

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 clopidol and bacitracin

zinc Type A medicated articles to make

Type C medicated broiler chicken feeds

used for prevention of coccidiosis,

improved feed efficiency, and increased

rate of weight gain.

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 200–218 that provides for

combining approved clopidol and

bacitracin zinc Type A medicated

articles to make Type C medicated feeds

for broilers containing clopidol 113.5

grams per ton (g/t) and bacitracin zinc

5 to 25 g/t. The Type C medicated feed

is used as an aid in the 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 and

improved feed efficiency.

Alpharma Inc.’s ANADA 200–218 is

approved as a generic copy of Rhone-
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.