Federal Register / Vol. 62, No. 218 / Wednesday, November 12, 1997 / Rules and Regulations 60653

Greenville, MS, Mid Delta Regl, GPS RWY

18R, Orig

Greenville, MS, Mid Delta Regl, GPS RWY

36L, Orig

Greenville, MS, Mid Delta Regl. GPS RWY

36R, Orig

Chapel Hill, NC, Horace Williams, GPS RWY

27, Orig

Smithfield, NC, Johnston County, NDB RWY

3, Orig

Smithfield, NC, Johnston County, ILS RWY 3,

Orig

Smithfield, NC, Johnston County, LOC/DME

RWY 3, AMDT 1, CANCELLED

Smithfield, NC, Johnston County, NDB OR

GPS RWY 21, Amdt 6

Crete, NE, Crete Muni, VOR/DME OR GPS

RWY 17, Amdt 3

Crete, NE, Crete Muni, VOR/DME RWY 35,

Amdt 3

Crete, NE, Crete Muni, NDB RWY 17, Amdt

2

Crete, NE, Crete Muni, NDB RWY 35, Amdt

2

Crete, NE, Crete Muni, GPS RWY 35, Orig

Lumberton, NJ, Flying W, VOR OR GPS–A,

Amdt 2

Lumberton, NJ, Flying W, GPS RWY 1, Orig

Lumberton, NJ, Flying W, GPS RWY 19, Orig

Syracuse, NY, Syracuse Hancock Intl, VOR

RWY 14, Amdt 22

Syracuse, NY, Syracuse Hancock Intl, GPS

RWY 10, Orig

Syracuse, NY, Syracuse Hancock Intl, GPS

RWY 14 Orig

Syracuse, NY, Syracuse Hancock Intl, GPS

RWY 28, Orig

Syracuse, NY, Syracuse Hancock Intl, GPS

RWY 32, Orig

Wilmington, OH, Clinton Field, GPS RWY

21, Orig

Tulsa, OK, Tulsa Intl, GPS RWY 26 Orig

Tullahoma, TN, Tullahoma Regional Airport/

WM Northern Field, VOR OR GPS–A,

AMDT 3A, CANCELLED

Tullahoma, TN, Tullahoma Regional Airport/

WM Northern Field, VOR/DME–A, Orig

Amarillo, TX, Amarillo Intl, GPS RWY 22,

CANCELLED

Fort Worth, TX, Bourland Field, GPS RWY

17, Orig

Gillette, WY, Gillette-Campbell County, LOC/

DME BC RWY 16, Amdt 3

Manassas, VA, Manassas Regional/Harry P

Davis Field, ILS RWY 16L, Amdt 4

Manassas, VA, Manassas Regional/Harry P

Davis Field, GPS RWY 16L, Orig

Manassas, VA, Manassas Regional/Harry P

Davis Field GPS RWY 34R, Orig

Osceola, WI, L O Simenstad Muni, NDB RWY

28, Amdt 10

Oscecola, WI, L O Simenstad Muni, GPS

RWY 28, Orig

Elkins, WV, Elkins-Randolph Co-Jennings

Randolph Field, VOR/DME–B Amdt 3A,

CANCELLED

Elkins, WV, Elins-Randolph Co-Jennings

Randolph Fld, GPS RWY 5, Orig

Elkins, WV, Elkins-Randolph Co-Jennings

Randolph Fld. NDB–A, Orig

Pineville, WV, Kee Field, GPS RWY 25, Orig

[FR Doc. 97–29727 Filed 11–10–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 29053; Amdt. No. 1832]

RIN 2120–AA65

Miscellaneous Amendments

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule.

SUMMARY: This amendment establishes,

amends, suspends, or revokes Standard

Instrument Approach Procedures

(SIAPs) for operations at certain

airports. These regulatory actions are

needed because of the adoption of new

or revised criteria, or because of changes

occurring in the National Airspace

System, such as the commissioning of

new navigational facilities, addition of

new obstacles, or changes in air traffic

requirements. These changes are

designed to provide safe and efficient

use of the navigable airspace and to

promote safe flight operations under

instrument flight rules at the affected

airports.

DATES: An effective date for each SIAP

is specified in the amendatory

provisions.

Incorporation by reference-approved

by the Director of the Federal Register

on December 31, 1980, and reapproved

as of January 1, 1982.

ADDRESSES: Availability of matters

incorporated by reference in the

amendment is as follows:

For Examination

1. FAA Rules Docket, FAA

Headquarters Building, 800

Independence Avenue, SW.,

Washington, DC 20591;

2. The FAA Regional Office of the

region in which the affected airport is

located; or

3. The Flight Inspection Area Office

which originated the SIAP.

For Purchase

Individual SIAP copies may be

obtained from:

1. FAA Public Inquiry Center (APA–

200), FAA Headquarters Building, 800

Independence Avenue, SW.,

Washington, DC 20591; or

2. The FAA Regional Office of the

region in which the affected airport is

located.

By Subscription

Copies of all SIAPs, mailed once

every 2 weeks, are for sale by the

Superintendent of Documents, U.S.

Government Printing Office,

Washington, DC 20402.

FOR FURTHER INFORMATION CONTACT: Paul

J. Best, Flight Procedures Standards

Branch (AFS–420), Technical Programs

Division, Flight Standards Service,

Federal Aviation Administration, 800

Independence Avenue, SW.,

Washington, DC 20591; telephone (202)

267–8277.

SUPPLEMENTARY INFORMATION: This

amendment to part 97 of the Federal

Aviation Regulations (14 CFR part 97)

establishes, amends, suspends, or

revokes Standard Instrument Approach

Procedures (SIAPs). The complete

regulatory description of each SIAP is

contained in official FAA form

documents which are incorporated by

reference in this amendment under 5

U.S.C. 552(a), 1 CFR part 51, and § 97.20

of the Federal Aviation Regulations

(FAR). The applicable FAA Forms are

identified as FAA Forms 8260–3, 8260–

4, and 8260–5. Materials incorporated

by reference are available for

examination or purchase as stated

above.

The large number of SIAPs, their

complex nature, and the need for a

special format make their verbatim

publication in the Federal Register

expensive and impractical. Further,

airmen do not use the regulatory text of

the SIAPs, but refer to their graphic

depiction on charts printed by

publishers of aeronautical materials.

Thus, the advantages of incorporation

by reference are realized and

publication of the complete description

of each SIAP contained in FAA form

documents is unnecessary. The

provisions of this amendment state the

affected CFR (and FAR) sections, with

the types and effective dates of the

SIAPs. This amendment also identifies

the airport, its location, the procedure

identification and the amendment

number.

The Rule

This amendment to part 97 is effective

upon publication of each separate SIAP

as contained in the transmittal. Some

SIAP amendments may have been

previously issued by the FAA in a

National Flight Data Center (FDC)

Notice to Airmen (NOTAM) as an

emergency action of immediate flight

safety relating directly to published

aeronautical charts. The circumstances

which created the need for some SIAP

amendments may require making them

effective in less than 30 days. For the

remaining SIAPs, an effective date at

least 30 days after publication is

provided.
60654 Federal Register / Vol. 62, No. 218 / Wednesday, November 12, 1997 / Rules and Regulations

Further, the SIAPs contained in this

amendment are based on the criteria

contained in the U.S. Standard for

Terminal Instrument Approach

Procedures (TERPS). In developing

these SIAPs, the TERPS criteria were

applied to the conditions existing or

anticipated at the affected airports.

Because of the close and immediate

relationship between these SIAPs and

safety in air commerce, I find that notice

and public procedure before adopting

these SIAPs are impracticable and

contrary to the public interest and,

where applicable, that good cause exists

for making some SIAPs effective in less

than 30 days.

The FAA has determined that this

regulation only involves an established

body of technical regulations for which

frequent and routine amendments are

necessary to keep them operationally

current. It, therefore—(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)

does not warrant preparation of a

regulatory evaluation as the anticipated

impact is so minimal. For the same

reason, the FAA certifies that this

amendment will not have a significant

economic impact on a substantial

number of small entities under the

criteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

Air Traffic Control, Airports,

Navigation (Air).

Issued in Washington, DC on October 31,

1997.

Richard O. Gordon,

Deputy Director, Flight Standards Service.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me, part 97 of the

Federal Aviation Regulations (14 CFR

part 97) is amended by establishing,

amending, suspending, or revoking

Standard Instrument Approach

Procedures, effective at 0901 UTC on

the dates specified, as follows:

PART 97—STANDARD INSTRUMENT

APPROACH PROCEDURES

1. The authority citation for part 97 is

revised to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120, 44701; and 14 CFR 11.49(b)(2).

2. Part 97 is amended to read as

follows:

§§ 97.23, 97.25, 97.27, 97.29, 97.31, 97.33,

97.35 [Amended]

By amending: § 97.23 VOR, VOR/

DME, VOR or TACAN, and VOR/DME

or TACAN; § 97.25 LOC, LOC/DME,

LDA, LDA/DME, SDF, SDF/DME;

§ 97.27 NDB, NDB/DME; § 97.29 ILS,

ILS/DME, ISMLS, MLS, MLS/DME,

MLS/RNAV; § 97.31 RADAR SIAPs;

§ 97.33 RNAV SIAPs; and § 97.35

COPTER SIAPs, identified as follows:

* * * Effective Upon Publication

FDC date State City Airport FDC No. SIAP

10/16/97 ...... IL CHICAGO/AURORA ............ AURORA MUNI ............................... 7/6782 VOR OR GPS RWY 36, AMDT

1A...

10/20/97 ...... MS PASCAGOULA .................... TRENT LOTT INTL .......................... 7/6828 ILS RWY 17, ORIG–1A...

10/20/97 ...... MS PASCAGOULA .................... TRENT LOTT INTL .......................... 7/6829 GPS RWY 17, ORIG...

10/20/97 ...... MS PASCAGOULA .................... TRENT LOTT INTL .......................... 7/6830 VOR OR GPS–A, ORIG...

10/21/97 ...... KS COFFEYVILLE .................... COFFEYVILLE MUNI ...................... 7/6854 VOR/DME OR GPS–A, AMDT

6A...

10/22/97 ...... GA JEFFERSON ....................... JACKSON COUNTY ........................ 7/6883 NDB RWY 34, ORIG...

10/22/97 ...... MN MINNEAPOLIS .................... CRYSTAL ......................................... 7/6864 GPS RWY 13L, ORIG...

10/22/97 ...... MN MINNEAPOLIS .................... CRYSTAL ......................................... 7/6865 VOR OR GPS–A, AMDT 9B...

10/22/97 ...... MN MINNEAPOLIS .................... FLYING CLOUD .............................. 7/6860 VOR OR GPS RWY 36, AMDT

11A...

10/22/97 ...... MN MINN3APOLIS ..................... FLYING CLOUD .............................. 7/6861 VOR OR GPS RWY 9R, AMDT

7A...

10/22/97 ...... MN MINNEAPOLIS .................... FLYING CLOUD .............................. 7/6863 ILS RWY 9R, AMDT 1A...

10/22/97 ...... MN MORRIS .............................. MORRIS MUNI ................................ 7/6857 VOR OR GPS RWY 32, AMDT

4A...

10/23/97 ...... TX LUBBOCK ............................ LUBBOCK INTL ............................... 7/6908 VOR/DME OR TACAN RWY 26,

AMDT 10...

10/28/97 ...... LA ALEXANDRIA ...................... ALEXANDRIA INTL ......................... 7/6989 VOR OR GPS RWY 32, ORIG–

A...

10/28/97 ...... LA ALEXANDRIA ...................... ALEXANDRIA INTL ......................... 7/6990 VOR OR GPS RWY 14, ORIG–

B...

10/28/97 ...... LA ALEXANDRIA ...................... ALEXANDRIA INTL ......................... 7/6991 GPS RWY 18, ORIG–A...

10/28/97 ...... MI GRAND RAPIDS ................. KENT COUNTY INTL ...................... 7/6972 RADAR–1, AMDT 10...

10/29/97 ...... LA ALEXANDRIA ...................... ALEXANDRIA INTL ......................... 7/7006 ILS/DME RWY 14, AMDT 1...

Jefferson

JACKSON COUNTY

Georgia

NDB RWY 34, ORIG...

FDC Date: 10/22/97

FDC 7/FDC 7/6883 /19A/ FI/P JACKSON

COUNTY, JEFFERSON, GA. NDB RWY 34,

ORIG...TERMINAL ROUTE WOMAC INT TO

COMMERCE NDB MIN ALT 3700. THIS IS

NDB RWY 34 ORIG–A.

Chicago/Aurora

AURORA MUNI

Illinois

VOR OR GPS RWY 36, AMDT 1A...

FDC Date: 10/16/97

FDC 7/6782 /ARR/FI/P AURORA MUNI,

CHICAGO/AURORA, IL. VOR OR GPS RWY

36, AMDT 1A...CHANGE NOTE TO READ...

WHEN CONTROL TOWER CLOSED USE

DUPAGE ALTIMETER SETTING. CHANGE

ALTERNATE MINIMUMS TO READ...

STANDARD, EXCEPT NA WHEN CONTROL

TOWER CLOSED. THIS IS VOR OR GPS

RWY 36, AMDT 1B.

Coffeyville

COFFEYVILLE MUNI

Kansas

VOR/DME OR GPS–A, ADMT 6A...

FDC Date: 10/21/97

FDC 7/6854 /CFV/ FI/P COFFEYVILLE

MUNI, COFFEYVILLE, KS. VOR/DME OR

GPS–A, AMDT 6A...CIRCLING MDA 1200/

HAA 466 CAT A. THIS IS VOR/DME OR

GPS–A, AMDT 6B.

Alexandria

ALEXANDRIA INTL

Louisiana

VOR OR GPS RWY 32, ORIG–A...

FDC Date: 10/28/97

FDC 7/6989 /AEX/ FI/P ALEXANDIRA

INTL, ALEXANDRIA, LA. VOR OR GPS RWY

32, ORIG–A...CIRCLING CAT A MDA 520/
Federal Register / Vol. 62, No. 218 / Wednesday, November 12, 1997 / Rules and Regulations 60655

HAA CAT A 431. CAT B/C HAA 451. CAT

D HAA 551. NOTE...RADAR REQUIRED.

THIS IS VOR OR GPS RWY 32, ORIG–B.

Alexandria

ALEXANDRIA INTL

Louisiana

VOR OR GPS RWY 14, ORIG–B...

FDC Date: 10/28/97

FDC 7/6990 /AEX/ FI/P ALEXANDRIA

INTL, ALEXANDRIA, LA. VOR OR GPS RWY

14, ORIG–B...CIRCLING CAT A MDA 520/

HAA CAT A 431. CAT B/C HAA 451, CAT

D HAA 551. NOTE...WHEN R–3801 B

ACTIVE, RADAR REQUIRED. NOTE...FOR

INOPERATIVE ALSF INCREASE S–14 CAT

D VISIBILITY TO 11⁄4. THIS IS VOR OR GPS

RWY 14, ORIG–C.

Alexandria

ALEXANDRIA INTL

Louisiana

VOR OR GPS RWY 18, ORIG–A...

FDC Date: 10/28/97

FDC 7/6991 /AEX/ FI/P ALEXANDRIA

INTL, ALEXANDRIA, LA GPS RWY 18,

ORIG–A...NOTE... WHEN R–3801 A OR B

ACTIVE, RADAR REQUIRED. THIS IS GPS

RWY 18, ORIG–B.

Alexandria

ALEXANDRIA INTL

Louisiana

ILS/DME RWY 14, AMDT 1...

FDC Date: 10/29/97

FDC 7/7006 /AEX/ FI/P ALEXANDRIA

INTL, ALEXANDRIA, LA. ILS/DME RWY 14,

AMDT 1...CIRCLING CAT A MDA 520/HAT

CAT A 431. CAT B/C/ HAT 451. CAT D HAT

551. NOTE... WHEN R–3801 B ACTIVE,

RADAR REQUIRED. THIS IS ILS/DME RWY

14, AMDT 1A.

Grand Rapids

KENT COUNTY INTL

MICHIGAN

RADAR–1, AMDT 10...

FDC Date: 10/28/97

FDC 7/6972/GRR/ FI/P KENT COUNTY

INTL, GRAND RAPIDS, MI. RADAR–1,

AMDT 10...S–26R MDA 1160/HAT 373 ALL

CATS. THIS IS RADAR–1, AMDT 10A.

Morris

MORRIS MUNI

Minnesota

VOR OR GPS RWY 32, AMDT 4A...

FDC Date: 10/28/97

FDC 7/6857 /MOX/ FI/P MORRIS MUNI,

MORRIS, MN. VOR OR GPS RWY 32, AMDT

4A...CHANGE DME MNMS...S–32... MDA

1500/HAT 370, ALL CATS. THIS IS VOR OR

GPS RWY 32, AMDT 4B.

Minneapolis

FLYING CLOUD

Minnesota

VOR OR GPS RWY 36, AMDT 11A...

FDC Date: 10/22/97

FDC 7/6860 /FCM/ FI/P FLYING CLOUD,

MINNEAPOLIS, MN. VOR OR GPS RWY 36,

AMDT 11A...DELETE NOTE...WHEN

CONTROL TOWER CLOSED, USE

MINNEAPOLIS ST. PAUL INTL ALTIMETER

SETTING AND INCREASE ALL MDA’S 40

FEET DELETE PROFILE NOTE...ASTERISK

1460 WHEN USING MINNEAPOLIS

ALTIMETER SETTING. ALTERNATE MNMS

STANDARD. ADD...CHART ASOS. THIS IS

VOR OR GPS RWY 36, AMDT 11B.

Minneapolis

FLYING CLOUD

Minnesota

VOR OR GPS RWY 9R, AMDT 71A...

FDC Date: 10/22/97

FDC 7/6861 /FCM/ FI/P FLYING CLOUD,

MINNEAPOLIS, MN. VOR OR GPS RWY 9R,

AMDT 7A...DELETE NOTE...WHEN

CONTROL TOWER CLOSED, USE

MINNEAPOLIS ST. PAUL INTL ALTIMETER

SETTING AND INCREASE ALL MDA’S 40

FEET AND INCREASE CAT C S–9R DME VIS

TO 3⁄4 MILE. DELETE PROFILE NOTE...

ASTERISK 1400 WHEN USING

MINNEAPOLIS ALTIMETER SETTING.

ALTERNATE MNMS STANDARD. ADD...

CHART ASOS. THIS IS VOR OR GPS RWY

9R, AMDT 7B.

Minneapolis

FLYING CLOUD

Minnesota

ILS RWY 9R, AMDT 1A...

FDC Date: 10/22/97

FDC 7/6863/FCM/FI/P FLYING

CLOUD, MINNEAPOLIS, MN. ILS RWY

9R, AMDT 1A...DELETE NOTE... WHEN

CONTROL TOWER CLOSED, USE

MINNEAPOLIS ST. PAUL INTL

ALTIMETER SETTING AND INCREASE

ALL DH/MDA’S 40 FEET, AND

INCREASE CAT C S–LOC 9R DME VIS

TO 3⁄4 MILE. DELETE PROFILE

NOTE...ASTERISK 1380 WHEN USING

MINNEAPOLIS ALTIMETER SETTING.

ALTERNATE MNMS STANDARD.

ADD...CHART ASOS. THIS IS ILS RWY

9R, AMDT 1B.

Minneapolis

CRYSTAL

Minneasota

GPS RWY 13L, ORIG...

FDC Date: 10/22/97

FDC 7/6864 /MIC/ FI/P CRYSTAL,

MINNEAPOLIS, MN. GPS RWY 13L,

ORIG...DELETE...MINNEAPOLIS

ALTIMETER SETTING MNMS. DELETE

NOTE... WHEN CONTROL TOWER

CLOSED, USE MINNEAPOLIS

ALTIMETER SETTING. ADD... CHART

ASOS. THIS IS GPS RWY 13L, AMDT

ORIG–A.

Minneapolis

CRYSTAL

Minnesota

VOR OR GPS–A, AMDT 9B...

FDC Date: 10/22/97

FDC 7/6865 /MIC/FI/P CRYSTAL,

MINNEAPOLIS, MN. VOR OR GPS–A,

AMDT 9B...DELETE... MINNEAPOLIS

ALTIMETER SETTING MNMS. DELETE

NOTE... WHEN CONTROL TOWER

CLOSED, USE MINNEAPOLIS

ALTIMETER SETTING. ALTERNATE

MNMS STANDARD. ADD... CHART

ASOS. THIS IS VOR OR GPS–A, AMDT

9C.

Pascagoula

TRENT LOTT INTL

Mississippi

ILS RWY 17, ORIG–A

FDC Date: 10/20/97...

FDC 7/6828 /PQL/ FI/P TRENT LOTT

INTL, PASCAGOULA, MS. ILS RWY 17,

ORIG–A...DELETE NOTE... OBTAIN

LOCAL ALTIMETER SETTING ON

CTAF, WHEN NOT RECEIVED USE

MOBILE ALTIMETER SETTING.

MOBILE ALTIMETER SETTING

MINIMUMS FOR INOPERATIVE

MALSR, INCREASE S–ILS RWY 17

VISIBILITY TO 1 ALL CATS. DELETE...

MOBILE ALTIMETER SETTING

MINIMUMS. THIS IS ILS RWY 17,

ORIG–B.

Pascogoula

TRENT LOTT INTL

Mississippi

GPS RWY 17, ORIG...

FDC Date: 10/20/97

FDC 7/6829 /PQL/ FI/P TRENT LOTT

INTL, PASCAGOULA, MS. GPS RWY

17, ORIG...DELETE MOBILE, AL.

ALTIMETER MINIMUMS. DELETE

NOTE... OBTAIN LOCAL ALTIMETER

SETTING ON CTAF, WHEN NOT

RECEIVED USE MOBILE ALTIMETER

SETTING. THIS IS GPS RWY 17, ORIG–

A.

Pascagoula

TRENT LOTT INTL

Mississippi

VOR OR GPS–A, ORIG...

FDC Date: 10/20/97

FDC 7/6830 /PQL/FI/P TRENT LOTT

INTL, PASCAGOULA, MS. VOR OR

GPS–A, ORIG...DELETE MOBILE

ALTIMETER SETTING MINIMUMS.

DELETE NOTE... OBTAIN LOCAL

ALTIMETER SETTING ON CTAF, IF

NOT RECEIVED USE MOBILE

ALTIMETER SETTING. ALTERNATE

MINIMUMS... CATS A/B/C

STANDARD, CAT D 800–21⁄4. THIS IS

VOR OR GPS–A, ORIG–A.

Lubbock

LUBBOCK INTL

Texas

VOR/DME OR TACAN RWY 26, AMDT

10...

FDC Date: 10/23/97

FDC 7/6908/LBB/FI/P LUBBOCK

INTL, LUBBOCK, TX. VOR/DME OR

TACAN RWY 26, AMDT 10...S–26

VSBY CAT A/B 1.CHANGE

INOPERATIVE TABLE NOTE TO

READ... INOPERATIVE TABLE DOES
60656 Federal Register / Vol. 62, No. 218 / Wednesday, November 12, 1997 / Rules and Regulations

NOT APPLY. THIS IS VOR/DME OR

TACAN RWY 26, AMDT 10A.

[FR Doc. 97–29726 Filed 11–10–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Chlortetracycline Powder

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

Phoenix Scientific, Inc. The ANADA

provides for oral use of chlortetracycline

hydrochloride soluble powder in the

drinking water of swine for control and

treatment of certain diseases caused by

pathogens susceptible to

chlortetracycline and chickens and

turkeys for control of certain diseases

caused by pathogens susceptible to

chlortetracycline.

EFFECTIVE DATE: November 12, 1997.

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: Phoenix

Scientific, Inc., 3915 South 48th Street

Terrace, P.O. Box 6457, St. Joseph, MO

64506–0457, filed ANADA 200–236 that

provides for oral use of chlortetracycline

hydrochloride soluble powder in animal

drinking water as follows: (1) Swine:

Control and treatment of bacterial

enteritis (scours) caused by Escherichia

coli and Salmonella spp., and bacterial

pneumonia associated with Pasteurella

spp., Actinobacillus pleuropneumoniae

(Haemophilus spp.) and Klebsiella spp.;

(2) Chickens: Control of infectious

synovitis caused by Mycoplasma

synoviae, and chronic respiratory

disease (CRD) and air-sac infections

caused by M. gallisepticum and E. coli;

and (3) Turkeys: Control of infectious

synovitis caused by M. synoviae and

complicating bacterial organisms

associated with bluecomb (transmissible

enteritis, coronaviral enteritis).

Approval of Phoenix Scientific Inc.’s

ANADA 200–236 chlortetracycline

hydrochloride soluble powder is as a

generic copy of ADM Animal Health &

Nutrition Div.’s NADA 65–256

ChlortetTM-Soluble-O chlortetracycline

hydrochloride soluble powder. ANADA

200–236 is approved as of September

24, 1997, and the regulations are

amended in 21 CFR 520.445b(b) 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 520

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 part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

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

§ 520.445b [Amended]

2. Section 520.445b Chlortetracycline

powder (chlortetracycline hydrochloride

or chlortetracycline bisulfite) is

amended in paragraph (b) by removing

‘‘No. 017519’’ and adding in its place

‘‘Nos. 017519 and 059130.’’

Dated: October 22, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–29650 Filed 11-10-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Neomycin Sulfate Oral 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 abbreviated

new animal drug application (ANADA)

filed by Pharmacia & Upjohn Co. The

supplemental ANADA provides for a

shorter withdrawal period following use

of neomycin sulfate oral solution in the

drinking water or in milk for cattle

(excluding veal calves), swine, sheep,

and goats for the treatment and control

of colibacillosis.

EFFECTIVE DATE: November 12, 1997.

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: Pharmacia

& Upjohn Co., 7000 Portage Rd.,

Kalamazoo, MI 49001–0199, filed

supplemental ANADA 200–113 that

provides for a shorter withdrawal period

following use of neomycin sulfate oral

solution in the drinking water or in milk

for cattle (excluding veal calves), swine,

sheep, and goats for the treatment and

control of colibacillosis (bacterial

enteritis) caused by Escherichia coli

susceptible to neomycin sulfate.

Approval of supplemental ANADA

200–113 is as a generic copy of the

sponsor’s approved supplemental

NADA 11–315. The supplemental

ANADA is approved as of February 7,

1997, and the regulations are amended

in § 520.1485(d)(3) (21 CFR

520.1485(d)(3)) to reflect the approval.

The previously approved supplement

to NADA 11–315 included data to

support revised tolerances for residues

of neomycin in the edible tissues of

cattle, swine, sheep, and goats. Based on

evaluation of the data as provided in the

‘‘General Principles for Evaluating the

Safety of Compounds Used in FoodProducing Animals Guidelines,’’

tolerances of 1.2 parts per million (ppm)

in muscle, 3.6 ppm in liver, and 7.2

ppm in kidney and fat, and withdrawal

times of 1 day for cattle, 2 days for

sheep, and 3 days for swine and goats

were established. The revised

withdrawal times were established in 21