32980 Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 /Rules and Regulations

determined that this rule is not a

significant regulatory action as defined

by the Executive Order, so is not subject

to review under the Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because the rule would clarify

FDA policy, the agency certifies that the

rule will not have a significant

economic impact on a substantial

number of small entities. Therefore,

under the Regulatory Flexibility Act, no

further analysis is required.

Section 202 of the Unfunded

Mandates Reform Act requires that

agencies prepare an assessment of

anticipated costs and benefits before

proposing any expenditure by State,

local, and tribal governments, in the

aggregate, or by the private sector of

$100 million (adjusted annually for

inflation) in any one year. The final rule

allowing greater flexibility in the

labeling of new animal drugs for use in

milk-producing animals is estimated to

result in insignificant expenditures of

funds by the private sector, and none by

State, local, and tribal governments.

Because the expenditures are estimated

to be insignificant, FDA is not required

to perform a cost/benefit analysis

according to the Unfunded Mandates

Reform Act.

IV. Paperwork Reduction Act of 1995

FDA has determined that this rule

contains no collections of information

under the Paperwork Reduction Act of

1995 (44 U.S.C. 3501–3520). FDA

concludes that the labeling

requirements described in this

document are not subject to review by

the Office of Management and Budget

(OMB) because they do not constitute a

‘‘collection of information’’ but rather

constitute warning statements that are a

‘‘public disclosure of information

originally supplied by the Federal

Government to the recipient for the

purpose of disclosure to the public’’ (5

CFR 1320.3(c)(2)). For that portion of

the labeling statement required by

§ 510.105(c)(2) that is not supplied to

the manufacturer (the number of hours

necessary to avoid residue in milk used

for food), the necessary information is

already required under a separate

regulation (§ 514.1(b)(7)(i)). This

information has already been cleared by

OMB (OMB Control number 0910–

0032).

V. Federalism

FDA has analyzed the final rule in

accordance with the principles set forth

in Executive Order 12612 and has

determined that this final rule does not

warrant the preparation of a Federalism

Assessment.

List of Subjects in 21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 510 is

amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

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

353, 360b, 371, 379e.

2. Section 510.105 is amended by

revising paragraph (c)(2) to read as

follows:

§ 510.105 Labeling of drugs for use in

milk-producing animals.

* * * * *

(c) * * *

(2) The label should bear the

following statement: ‘‘Warning: Milk

that has been taken from animals during

treatment and for llll hours after

the latest treatment must not be used for

food’’, the blank being filled in with the

figure that the manufacturer has

determined by appropriate investigation

is needed to insure that the milk will

not carry violative residues resulting

from use of the preparation. If the use

of the preparation as recommended does

not result in contamination of the milk,

neither of the above warning statements

is required.

3. Section 510.106 is revised to read

as follows:

§ 510.106 Labeling of antibiotic and

antibiotic-containing drugs intended for use

in milk-producing animals.

Whenever the labeling of an antibiotic

drug included in the regulations in this

chapter suggests or recommends its use

in milk-producing animals, the label of

such drugs shall bear either the

statement ‘‘Warning: Not for use in

animals producing milk, since this use

will result in contamination of the

milk’’ or the statement ‘‘Warning: Milk

that has been taken from animals during

treatment and for llll hours after

the latest treatment must not be used for

food’’, the blank being filled in with the

figure that the Commissioner has

authorized the manufacturer of the drug

to use. The Commissioner shall

determine what such figures shall be

from information submitted by the

manufacturer and which the

Commissioner considers is adequate to

prove that period of time after the latest

treatment that the milk from treated

animals will contain no violative

residues from use of the preparation. If

the Commissioner determines from the

information submitted that the use of

the antibiotic drug as recommended

does not result in its appearance in the

milk, the Commissioner may exempt the

drug from bearing either of the above

warning statements.

Dated: June 9, 1998.

William K. Hubbard

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–16063 Filed 6–16–98; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[AR–2–1–7393; FRL–6111–3]

Approval and Promulgation of State

Implementation Plans; Arkansas;

Recodification of Air Quality Control

Regulations and Correction of Sulfur

Dioxide Enforceability Deficiencies

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Removal of direct final rule

amendments.

SUMMARY: On April 10, 1998 (63 FR

17680), EPA published a direct final

approval and a proposed approval (63

FR 17793), of a revision to the Arkansas

State Implementation Plan (SIP) which

added Arkansas Department of

Pollution Control and Ecology

Regulation #19, ‘‘Compilation of

Regulations of the Arkansas State

Implementation Plan for Air Pollution

Control,’’ as adopted by the Arkansas

Commission on Pollution Control and

Ecology on July 24, 1992, and submitted

to EPA on September 14, 1992. The

direct final action was published

without prior proposal because the

Agency anticipated no adverse

comments. The EPA received adverse

comments on the two April 10, 1998,

actions. The commenters asked EPA not

to consider the regulation as a revision

to the Arkansas SIP. In addition, EPA

also received a letter from the Governor

of Arkansas dated May 8, 1998,

requesting that the Federal Register

approval of the 1992 Regulation #19 be

withdrawn and that the 1992 submittal

be returned to the State. Therefore,

Region 6 is withdrawing its direct final

approval action by removing the

amendments made by the direct final

rule and restoring the regulatory text
Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 /Rules and Regulations 32981

that existed prior to the direct final rule,

and returning the 1992 Regulation #19

submittal to the State, thereby mooting

the proposed approval action. No

further action will be taken by EPA on

this September 14, 1992, SIP revision

submittal. The Arkansas regulations

approved by EPA in 1975 and last

approved by EPA at 40 CFR

52.170(c)(27) in 1991 will continue to be

the Arkansas SIP-approved regulations.

EFFECTIVE DATE: June 17, 1998.

FOR FURTHER INFORMATION CONTACT: Bill

Deese, Air Planning Section (6PD–L),

Environmental Protection Agency, 1445

Ross Avenue, Dallas, Texas 75202,

Telephone (214) 665–7253.

SUPPLEMENTARY INFORMATION: See the

information provided in the direct final

rule located in the final rules section

and the short informational document

located in the proposed rules section of

the April 10, 1998, Federal Register.

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Carbon monoxide,

Hydrocarbons, Intergovernmental

relations, Lead, Nitrogen dioxide,

Ozone, Particulate matter, Sulfur oxides,

Volatile organic compounds.

Dated: June 8, 1998.

Gregg A. Cooke,

Regional Administrator, Region 6.

For the reasons set out in the

preamble 40 CFR part 52 is amended as

follows:

PART 52—[AMENDED]

1. The authority citation for part 52

continues to read as follows:

Authority: 42 U.S.C. 7401 et seq.

§ 52.170 [Amended]

2. Section 52.170 is amended by

removing paragraph (c)(29).

3. Section 52.181 is amended by

revising paragraph (a) to read as follows:

§ 52.181 Significant deterioration of air

quality.

(a) The plan submitted by the

Governor of Arkansas on April 23, 1981

[as adopted by the Arkansas

Commission on Pollution Control and

Ecology (ACPCE) on April 10, 1981],

June 3, 1988 (as revised and adopted by

the ACPCE on March 25, 1988), and

June 19, 1990 (as revised and adopted

by the ACPCE on May 25, 1990),

Prevention of Significant Deterioration

(PSD) Supplement Arkansas Plan of

Implementation For Air Pollution

Control, is approved as meeting the

requirements of Part C, Clean Air Act for

preventing significant deterioration of

air quality.

* * * * *

[FR Doc. 98–16080 Filed 6–16–98; 8:45 am]

BILLING CODE 6560–50–U

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 73

Radio Broadcasting Services; Various

Locations

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: The Commission, on its own

motion, editorially amends the Table of

FM Allotments to specify the actual

classes of channels allotted to various

communities. The changes in channel

classifications have been authorized in

response to applications filed by

licensees and permittees operating on

these channels. This action is taken

pursuant to Revision of Section

73.3573(a)(1) of the Commission’s Rules

Concerning the Lower Classification of

an FM Allotment, 4 FCC Rcd 2413

(1989), and the Amendment of the

Commission’s Rules to permit FM

Channel and Class Modifications

[Upgrades] by Applications, 8 FCC Rcd

4735 (1993).

EFFECTIVE DATE: June 17, 1998.

FOR FURTHER INFORMATION CONTACT:

Kathleen Scheuerle, Mass Media

Bureau, (202) 418–2180.

SUPPLEMENTARY INFORMATION: This is a

summary of the Commission’s Report

and Order, adopted May 29, 1998, and

released June 5, 1998. The full text of

this Commission decision is available

for inspection and copying during

normal business hours in the

Commission’s Reference Center (Room

239), 1919 M Street, NW., Washington,

DC. The complete text of this decision

may also be purchased from the

Commission’s copy contractors,

International Transcription Service,

Inc., 1231 20th Street, NW, Washington,

DC. 20036, (202) 857–3800, facsimile

(202) 857–3805.

List of Subjects in 47 CFR Part 73

Radio broadcasting.

Part 73 of title 47 of the Code of

Federal Regulations is amended as

follows:

PART 73—[AMENDED]

1. The authority citation for Part 73

continues to read as follows:

Authority: 47 U.S.C. 154, 303, 334 and 336.

§ 73.202 [Amended]

2. Section 73.202(b), the Table of FM

Allotments under Arizona, is amended

by removing Channel 285C3 and adding

Channel 285C2 at Willcox.

3. Section 73.202(b), the Table of FM

Allotments under Iowa, is amended by

removing Channel 298A and adding

Channel 298C3 at Castana.

4. Section 73.202(b), the Table of FM

Allotments under Missouri, is amended

by removing Channel 260A and adding

Channel 260C3 at Macon.

5. Section 73.202(b), the Table of FM

Allotments under Oklahoma, is

amended by removing Channel 295C1

and adding Channel 294C1 at Clinton.

Federal Communications Commission.

John A. Karousos,

Chief, Allocations Branch, Policy and Rules

Division, Mass Media Bureau.

[FR Doc. 98–16068 Filed 6–16–98; 8:45 am]

BILLING CODE 6712–01–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

50 CFR Part 17

Endangered and Threatened Wildlife

and Plants; Notice of Determination To

Retain Endangered Status for the

Bruneau Hot Springsnail in

Southwestern Idaho Under the

Endangered Species Act

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of determination.

SUMMARY: The U.S. Fish and Wildlife

Service, in a court-ordered

reconsideration of the 1993 final listing

decision, affirms its earlier

determination that listing the Bruneau

Hot Springsnail (Pyrgulopsis

bruneauensis) as endangered is

appropriate. Federal protection

pursuant to the Endangered Species Act

of 1973 (Act), as amended, for the

Bruneau Hot Springsnail is thus

continued. This species occurs only in

a complex of flowing thermal springs

arising from a single source aquifer

along the Bruneau River in Owyhee

County, Idaho. Bruneau Hot

Springsnails are not known to occur

elsewhere and have not been located

outside of the thermal plumes of hot

springs entering the Bruneau River. The

primary threat to this species is the

reduction of thermal spring habitats

from agricultural-related ground water

withdrawal/pumping.

DATES: The effective date of this notice

is June 17, 1998.