46666 Federal Register / Vol. 62, No. 171 / Thursday, September 4, 1997 / Rules and Regulations

administrators of the 4 orders to

ascertain whether at least two-thirds of

the producers marketing their milk

under each of the orders approved the

issuance of the amended orders. The

final decision concluded that amended

orders were needed to effectuate the

declared policy of the Agricultural

Marketing Agreement Act. That Act

requires that at least two-thirds of the

producers voting in a referendum must

vote affirmatively before an order can be

issued.

Less than two-thirds of the producers

whose milk is pooled under the

Tennessee Valley order approved the

issuance of the proposed amended

order. Consequently, on July 3 the

Department issued a notice of proposed

termination of the Tennessee Valley

order. It is now evaluating comments

received in response to that notice.

At the present time, the Tennessee

Valley milk order is being administered

under the interim provisions adopted in

August 1996, whereas the surrounding

orders with transportation credit

provisions are being administered with

revised provisions that became effective

on August 1, 1997.

In July 1997, an extraordinary volume

of supplemental milk was received in

the neighboring Southeast order. As a

result of these receipts, the

transportation credit balancing fund for

that order was virtually depleted in July.

There is now good reason to believe that

shipments of supplemental milk may be

rerouted to handlers under the

Tennessee Valley order in September

since that order still has the interim

provision allowing unlimited payments

for transportation credits even if the

money to pay for the credits must come

from the producer-settlement fund.

Although the Tennessee Valley order

has a viable balance in the TCBF at the

present time, it is likely that funds from

the producer-settlement fund will be

necessary for transportation credit

payments for September’s milk. Were

this to happen, it would reduce blend

prices to producers in the Tennessee

Valley order while their counterparts in

the surrounding markets with

transportation credit provisions would

suffer no such reduction under the

revised August 1997 amendments. This

situation would be inconsistent with the

premises upon which the psf transfer

provision was included in the

Tennessee Valley order.

This suspension is necessary to

ensure that producers’ milk will not be

moved in an uneconomic and inefficient

manner simply to obtain unlimited

transportation credits under the

Tennessee Valley order and to ensure

that producers in the Tennessee Valley

order will be treated in an equitable

manner in relation to producers

supplying the adjacent Southeast,

Carolina, and Louisville-LexingtonEvansville orders.

Accordingly, it is appropriate to

suspend the aforesaid provisions during

the period of consideration of

terminating the Tennessee Valley milk

order.

It is hereby found and determined

that thirty days’ notice of the effective

date hereof is impractical, unnecessary

and contrary to the public interest in

that:

(a) The suspension is necessary to

reflect current marketing conditions and

to assure orderly marketing conditions

in the marketing area, in that such rule

is necessary to permit the continued

pooling of the milk of dairy farmers who

have historically supplied the market

without the need for making costly and

inefficient movements of milk; and

(b) This suspension does not require

of persons affected substantial or

extensive preparation prior to the

effective date.

Therefore, good cause exists for

making this order effective less than 30

days from the date of publication in the

Federal Register.

List of Subjects in 7 CFR Part 1011

Milk marketing orders.

For the reasons set forth in the

preamble, 7 CFR Part 1011 is amended

as follows:

PART 1011—MILK IN THE TENNESSEE

VALLEY MARKETING AREA

1. The authority citation for 7 CFR

Part 1011 continues to read as follows:

Authority: 7 U.S.C. 601–674.

§ 1011.61 [Suspended in part]

2. In § 1011.61, paragraph (a)(4) is

suspended.

§ 1011.81 [Suspended in part]

3. In § 1011.81, paragraph (b) is

suspended.

Dated: August 29, 1997.

Lon Hatamiya,

Administrator.

[FR Doc. 97–23568 Filed 9–3–97; 8:45 am]

BILLING CODE 3410–02–P

CONSUMER PRODUCT SAFETY

COMMISION

16 CFR Parts 1000, 1014, 1021, 1051,

1115, 1211, 1402, 1406, 1500, 1502,

1700, and 1702

Address and Telephone Number

Corrections

AGENCY: Consumer Product Safety

Commission.

ACTION: Final rule.

SUMMARY: The Commission is amending

16 CFR chapter II to correct errors in

addresses and telephone numbers.

EFFECTIVE DATE: September 4, 1997.

FOR FURTHER INFORMATION CONTACT:

Joseph F. Rosenthal, Office of the

General Counsel, Consumer Product

Safety Commission, Washington, D.C.

20207, telephone 301-504-0980.

SUPPLEMENTARY INFORMATION: Some

addresses, office designations, and

telephone numbers in various parts of

16 CFR chapter II are obsolete as a result

of the Consumer Product Safety

Commission’s relocation to new

headquarters in 1994. This rule makes

the necessary corrections. It also revises

some authority citations to conform to

Federal Register recommendations.

Since this rule relates solely to

internal agency management, pursuant

to 5 U.S.C. 553(b), notice and other

public procedures are not required and

it is effective immediately on the

specified effective date. Further, this

action is not a rule as defined in the

Regulatory Flexibility Act, 5 U.S.C. 601-

612 and, thus, is exempt from the

provisions of the Act. This action will

have no effect on the environment.

List of Subjects

16 CFR Part 1000

Organization and functions

(Government agencies).

16 CFR Part 1014

Privacy

16 CFR Part 1021

Environmental impact statements.

16 CFR Part 1051

Administrative practice and

procedure, consumer protection.

16 CFR Part 1115

Administrative practice and

procedure, business and industry,

consumer protection, reporting and

recordkeeping requirements.

16 CFR Part 1211

Consumer protection, imports,

labeling, reporting and recordkeeping

requirements.

16 CFR Part 1402
Federal Register / Vol. 62, No. 171 / Thursday, September 4, 1997 / Rules and Regulations 46667

Consumer protection, labeling, radio,

television.

16 CFR Part 1406

Consumer protection, fire prevention,

flammable materials, heaters, household

appliances, labeling, reporting and

recordkeeping requirements.

16 CFR Part 1500

Consumer protection, hazardous

materials, imports, infants and children,

labeling, law enforcement, reporting and

recordkeeping requirements, toys.

16 CFR Part 1502

Administrative practice and

procedure, consumer protection,

hazardous substances, poison

prevention.

16 CFR Part 1700

Consumer protection, drugs, infants

and children, packaging and containers,

poison prevention, reporting and

recordkeeping requrements.

16 CFR Part 1702

Administrative practice and

procedure, consumer protection, drugs,

infants and children, packaging and

containers, poison prevention.

Accordingly, 16 CFR chapter II is

amended as follows:

PART 1000—[AMENDED]

1. The authority citation for part 1000

continues to read as follows:

Authority: 5 U.S.C. 552(a).

2. In section 1000.8 remove the words

‘‘5401 Westbard Avenue’’ and add, in

their place, ‘‘4330 East West Highway’’.

PART 1014—[AMENDED]

1. The authority citation for part 1014

continues to read as follows:

Authority: 5 U.S.C. 552a.

2. In section 1014.3(a) remove the

words ‘‘5401 Westbard Avenue’’ and

add, in their place ‘‘4330 East West

Highway’’.

3. In section 1014.3(c) remove the

words ‘‘Division of Personnel’s

Processing Unit in Room 337, 5401

Westbard Avenue’’ and add, in their

place, ‘‘Office of Human Resources

Management, Room 523, 4330 East West

Highway’’.

PART 1021—[AMENDED]

1. The authority citation for part 1021

is revised to read as follows:

Authority: 42 U.S.C. 4321-4347; 40 CFR

part 1500 et seq.

2. In section 1021.11 remove the

words ‘‘(301-492-6550)’’ and add, in

their place, ‘‘(301-504-0550)’’.

PART 1051—[AMENDED]

1. The authority citation for part 1051

continues to read as follows:

Authority: 5 U.S.C. 553(e), 5 U.S.C. 555(e).

2. In section 1051.3 remove the words

‘‘either, 5401 Westbard Avene (third

floor) Bethesda, Maryland or 1111 18th

Street, NW, (eighth floor), Washington,

DC’’ and add, in their place ‘‘4330 East

West Highway, Bethesda, Maryland’’.

PART 1115—[AMENDED]

1. The authority citation for part 1115

continues to read as follows:

Authority: 15 U.S.C. 2061, 2064, 2065,

2066(a), 2068, 2069, 2070, 2071, 2073, 2076,

2079, and 2084.

2. In section 1115.10(a) remove the

words ‘‘and Enforcement’’.

3. In section 1115.10(a) remove the

words ‘‘301-492-6608’’and add, in their

place, ‘‘301-504-0608’’.

PART 1211—[AMENDED]

1. The authority citation for part 1211

is revised to read as follows:

Authority: 15 U.S.C. 2063 and 2065.

2. In section 1211.2(c) remove the

words ‘‘5401 Westbard Avenue’’ and

add, in their place ‘‘4330 East West

Highway’’.

3. In section 1211.4(c) remove the

words ‘‘5401 Westbard Avenue’’ and

add, in their place, ‘‘4330 East West

Highway’’.

4. In section 1211.5(b)(3) remove the

words ‘‘5402 Westbard Avenue’’ and

add, in their place, ‘‘4330 East West

Highway’’.

5. In section 1211.10(d) remove the

words ‘‘5401 Westbard Avenue’’ and

add, in their place, ‘‘4330 East West

Highway’’.

6. In section 1211.12(c)(2) remove the

words ‘‘5401 Westbard Avenue’’ and

add, in their place, ‘‘4330 East West

Highway’’.

PART 1402—[AMENDED]

1. The authority citation for part 1402

is revised to read as follows:

Authority: 15 U.S.C. 2051, 2076.

2. In section 1402.4(b)(1) remove the

words ‘‘Associate Executive Director for

Compliance and Enforcement,

Consumer Product Safety Commission,

5401 Westbard Avenue’’ and add, in

their place, ‘‘Assistant Executive

Director for Compliance, Consumer

Product Safety Commission, 4330 East

West Highway’’.

PART 1406—[AMENDED]

1. The authority citation for part 1406

is revised to read as follows:

Authority: 15 U.S.C. 2051, 2076.

2. In section 1406.5(d)(2) remove the

words ‘‘Associate Executive Director for

Compliance and Administrative

Litigation, Consumer Product Safety

Commission, 5401 Westbard Avenue,

Bethesda, Maryland 20207’’ and add, in

their place, ‘‘Assistant Executive

Director for Compliance, Consumer

Product Safety Commission,

Washington, DC 20207’’.

PART 1500—[AMENDED]

1. The authority citation for part 1500

continues to read as follows:

Authority: 15 U.S.C. 1261-1278, 2079.

2. In section 1500.42, footnote 1,

remove the words ‘‘Directorate for

Health Sciences, CPSC, Washington,

D.C. 20207, (301) 492-6957’’and add, in

their place, ‘‘ Directorate for

Epidemiology and Health Sciences,

CPSC, Washington, DC 20207, (301)

504-0957’’.

PART 1502—[AMENDED]

1. The authority citation for part 1502

continues to read as follows:

Authority: 15 U.S.C. 1261(q)(1)(B), 1262(a),

1262(e), 1269(a); 15 U.S.C. 1474(a); 21 U.S.C.

371(e)-(g).’’

2. In section 1502.4(b) remove the

words ‘‘Room 420, 5401 Westbard

Avenue, Bethesda, Maryland 20816’’

and add, in their place ‘‘Room 502, 4330

East West Highway, Bethesda, Maryland

20814’’.

3. In section 1502.4(c) remove the

words ‘‘(301) 492-6800’’ and add, in

their place, ‘‘(301) 504-0800’’.

4. In section 1502.16(a) remove the

words ‘‘Room 420, 5401 Westbard Ave.’’

and add, in their place ‘‘Room 502, 4330

East West Highway’’.

5. In section 1502.17(a) remove the

words ‘‘(301) 492-6800’’ and add, in

their place ‘‘(301) 504-0800’’.

PART 1700—[AMENDED]

1. The authority citation for part 1700

continues to read as follows:

Authority: 15 U.S.C. 1471-1476. Secs.

1700.1 and 1700.14 also issued under 15

U.S.C. 2079(a).

2. In section 1700.14(b) remove the

words ‘‘Attention: Bureau of

Compliance, 5401 Westbard Avenue’’

and add, in their place, ‘‘Office of

Compliance, 4330 East West Highway’’.

PART 1702—[AMENDED]

1. The authority citation for part 1702

is revised to read as follows:

Authority: 15 U.S.C. 1471(4), 1472, 1474,

1269(a), 2079(a); 21 U.S.C. 371(a).

2. Section 1702.2(a)(1) is revised to

read as follows:
46668 Federal Register / Vol. 62, No. 171 / Thursday, September 4, 1997 / Rules and Regulations

§ 1702.2 Procedural requirements and

recommendations.

(a) * * *

(1) Be mailed to the Office of the

Secretary, Consumer Product Safety

Commission, Washington, DC 20207, or

delivered to the Office of the Secretary,

Consumer Product Safety Commission,

4330 East West Highway, Bethesda, MD

20814.

* * * * *

Sadye E. Dunn,

Secretary, Consumer Product Safety

Commission.

[FR Doc. 97–23498 Filed 9–3–97; 8:45 am]

BILLING CODE 6355–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Tetracycline Hydrochloride Soluble

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

Med-Pharmex, Inc. The ANADA

provides for oral use of tetracycline

hydrochloride soluble powder in the

drinking water of swine and calves for

control and treatment of certain diseases

caused by pathogens susceptible to

tetracycline, and of chickens and

turkeys for control of certain diseases

caused by pathogens susceptible to

tetracycline.

EFFECTIVE DATE: September 4, 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: MedPharmex, Inc., 2727 Thompson Creek

Rd., Pomona, CA 91767–1861, filed

ANADA 200–234, which provides for

oral use of tetracycline hydrochloride

soluble powder in the drinking water of

calves, swine, chickens, and turkeys, as

follows: (1) For calves for control and

treatment of bacterial enteritis (scours)

caused by Escherichia coli, and bacterial

pneumonia (shipping fever complex)

associated with Pasteurella spp.,

Actinobacillus pleuropneumoniae

(Hemophilus spp.), and Klebsiella spp.

susceptible to tetracycline; (2) for swine

for control and treatment of bacterial

enteritis (scours) caused by E. coli, and

bacterial pneumonia associated with

Pasteurella spp., Actinobacillus

pleuropneumoniae (Hemophilus spp.),

and Klebsiella spp. susceptible to

tetracycline; (3) for chickens for control

of chronic respiratory disease (CRD or

air-sac disease) caused by Mycoplasma

gallisepticum and E. coli; infectious

synovitis caused by M. synoviae

susceptible to tetracycline; and (4) for

turkeys for control of infectious

synovitis caused by M. synoviae and

bluecomb (transmissible enteritis or

coronaviral enteritis) complicated by

bacterial organisms susceptible to

tetracycline.

Approval of Med-Pharmex’s ANADA

200–234 tetracycline hydrochloride

soluble powder is as a generic copy of

Fermenta’s NADA 65–496 tetracycline

hydrochloride soluble powder. ANADA

200–234 is approved as of July 22, 1997,

and the regulations are amended in 21

CFR 520.2345d(a)(1) to reflect the

approval. The basis of approval is

discussed in the freedom of information

summary.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 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)(i) 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: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

§ 520.2345d [Amended]

2. Section 520.2345d Tetracycline

hydrochloride soluble powder is

amended in paragraph (a)(1) by

removing ‘‘047864, 000010, 057561, and

059130’’ and adding in its place

‘‘047864, 051259, 054273, 057561, and

059130’’.

Dated: August 22, 1997.

Michael J. Blackwell,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 97–23372 Filed 9–3–97; 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;

Clindamycin Hydrochloride Liquid

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 veterinary prescription use

in dogs of clindamycin hydrochloride

liquid for therapy of wounds, abscesses,

and dental infections, and therapy of

osteomyelitis.

EFFECTIVE DATE: September 4, 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 St.

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

64506–0457, filed ANADA 200–193 that

provides for veterinary prescription use

in dogs of clindamycin hydrochloride

liquid for therapy of wounds, abscesses,

and dental infections when

administered orally at 2.5 milligrams

per pound (mg/lb) every 12 hours, and

for therapy of osteomyelitis when

administered orally at 5.0 mg/lb every

12 hours.

Phoenix Scientific, Inc.’s, ANADA

200–193 clindamycin hydrochloride

liquid is approved as a generic copy of

Pharmacia & Upjohn’s NADA 135–940

Antirobe Aquadrops. The ANADA is

approved as of August 1, 1997, and the

regulations are amended in 21 CFR

520.447(b) to reflect the approval. The