Federal Register / Vol. 63, No. 147 / Friday, July 31, 1998 /Rules and Regulations 40825

Bacitracin methylene disalicylate in grams per tonCombination in grams per

ton Indications for use Limitations Sponsor

* * * * * * *

(vi) * * *.

............................................... ............................................... Replacement chickens; as an

aid in the prevention of necrotic enteritis caused or

complicated by Clostridium

spp. or other organisms

susceptible to bacitracin.

Feed continuously as sole

ration..

046573

* * * * * * *

(ix) * * *.

............................................... ............................................... Replacement chickens; as an

aid in the control of necrotic enteritis caused or complicated by Clostridium

spp. or other organisms

susceptible to bacitracin.

Feed continuously as sole

ration. Start at first clinical

signs of disease, vary dosage based on severity of

infection, administer continuously for 5 to 7 days or

as long as clinical signs

persist, then reduce medication to prevention level

(50 g/t).

046573

* * * * * * *

* * * * *

Dated: July 10, 1998.

Margaret Ann Miller,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–20466 Filed 7–30–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. 98N–0171]

Medical Devices; Humanitarian Use of

Devices

AGENCY: Food and Drug Administration,

HHS.

ACTION: Direct final rule; withdrawal.

SUMMARY: The Food and Drug

Administration (FDA) published, in the

Federal Register of April 17, 1998 (63

FR 19185), a direct final rule to

implement the amendments to the

humanitarian use devices provision of

the Federal Food, Drug, and Cosmetic

Act (the act), as amended by the Food

and Drug Administration Modernization

Act of 1997 (FDAMA). The comment

period closed July 1, 1998. FDA is

withdrawing the direct final rule

because the agency received significant

adverse comment.

DATES: The direct final rule published at

63 FR 19185, April 17, 1998, is

withdrawn effective July 31, 1998.

FOR FURTHER INFORMATION CONTACT:

Joanne R. Less, Center for Devices and

Radiological Health (HFZ–403), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20857,

301–594–1190.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, and under

authority delegated to the Commissioner

of Food and Drugs, the direct final rule

published on April 17, 1998, at 63 FR

19185 is withdrawn.

Dated: July 29, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20594 Filed 7–30–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 917

[KY–217–FOR]

Kentucky Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Final rule; approval of

amendment.

SUMMARY: OSM is approving a proposed

amendment to the Kentucky regulatory

program (hereinafter referred to as the

‘‘Kentucky program’’) under the Surface

Mining Control and Reclamation Act of

1977 (SMCRA). Kentucky requested the

removal of 30 CFR 917.17(a) which

disapproved Kentucky’s proposed

revision to its staffing and budget levels

(49 FR 50718, December 31, 1984). The

amendment is intended to revise the

Kentucky program to be consistent with

the Federal regulations and SMCRA.

EFFECTIVE DATE: July 31, 1998.

FOR FURTHER INFORMATION CONTACT:

William J, Kovacic, Director, Lexington

Field Office, 2675 Regency Road,

Lexington, Kentucky 40502. Telephone:

(606) 233–2494.

SUPPLEMENTARY INFORMATION:

I. Background on the Kentucky Program

II. Submission of the Proposed Amendment

III. Director’s Findings

IV. Summary and Disposition of Comments

V. Director’s Decision

VI. Procedural Determinations

I. Background on the Kentucky

Program

On May 18, 1982, the Secretary of the

Interior conditionally approved the

Kentucky program. Background

information on the Kentucky program,

including the Secretary’s findings, the

disposition of comments, and the

conditions of approval can be found in

the May 18, 1982 Federal Register (47

FR 21404). Subsequent actions

concerning conditions of approval and

program amendments can be found at
40826 Federal Register / Vol. 63, No. 147 / Friday, July 31, 1998 /Rules and Regulations

30 CFR 917.11, 917.13, 917.15, 917.16,

and 917.17.

II. Submission of the Proposed

Amendment

By letter dated November 3, 1997

(Administrative Record No. KY–1418),

Kentucky submitted a proposed

amendment to its program pursuant to

SMCRA requesting the removal of 30

CFR 917.17(a), which disapproved

revisions to its approved staffing and

budget levels.

Specifically, Kentucky requested

removal of the requirement that the

Kentucky Department for Surface

Mining Reclamation and Enforcement

(DSMRE) maintain a staffing level of 156

field inspectors. This specific

requirement is codified at 30 CFR

917.16(b)(2).

OSM announced receipt of the

proposed amendment in the December

10, 1997, Federal Register (62 FR

65044), and in the same document

opened the public comment period and

provided an opportunity for a public

hearing on the adequacy of the proposed

amendment. The public comment

period closed on January 9, 1998. OSM

reopened the comment period on April

27, 1998 (63 FR 20561), because OSM

requested and Kentucky subsequently

provided certain documents containing

evidence that it has sufficient inspection

and enforcement staffing levels to

regulate mining in accordance with

SMCRA. Those documents are:

‘‘Historical Information on Kentucky’s

Surface Mining Primacy Program,’’

compiled by Kentucky, July 1997

(Administrative Record No. KY–1424);

‘‘Review of Current Staffing and

Funding Levels,’’ prepared by the OSM

Lexington Field Office (LFO), December

1997 (Administrative Record No. KY–

1420); and ‘‘Inspection Resources

Study,’’ prepared by OSM and

Kentucky, August 1989 (Administrative

Record No. KY–1418). The comment

period closed on May 12, 1998. OSM

reopened the comment period a second

time on May 18, 1998 (63 FR 27229).

III. Director’s Findings

Set forth below, pursuant to SMCRA

and the Federal regulations at 30 CFR

732.15 and 732.17, are the Director’s

findings concerning the proposed

amendment.

Kentucky is requesting the removal of

30 CFR 917.17(a) which disapproved a

revision to its approved staffing and

budget levels. One effect of the

disapproval was that Kentucky was

required to maintain a staffing level of

156 field inspectors (49 FR 50718,

December 31, 1984). In its submission

letter dated November 3, 1997,

Kentucky provided the following

information:

—field inspector staffing levels are no

longer based on 1984 inspection

numbers and budgetary needs,

—a study pursuant to the settlement

agreement between Kentucky and the

National Wildlife Federation

[National Wildlife Federation v.

Miller, No. 86–99 (E.D. Ky. 1986)]

determined that a cap of 24

inspectable units per field inspector

should be established. See August

1989, ‘‘Inspection Resources Study’’

which concluded that 176 inspectors

were needed to adequately conduct

the monthly and quarterly inspections

needed for 4,260 permanent program

sites (Administrative Record No. KY–

1418),

—OSM has accepted the limits set by

the study in determining inspection

staff levels as indicated by the

approval of Title V administrative and

enforcement grants,

—OSM’s annual reports indicate that

Kentucky’s Title V regulatory program

meets high inspection frequency

levels. See July 1997, document

‘‘Historical Information on Kentucky’s

Surface Mining Primacy Program,’’

prepared by the Kentucky Natural

Resources and Environmental

Protection cabinet, DSMRE

(Administrative Record No. KY–

1424).

Kentucky also asserts that using a

fixed number of field inspectors fails to

provide the latitude necessary to adapt

its inspection force to changing

conditions in the coal industry. Further,

the number of inspectors Kentucky

maintains is based on the current and

ever-changing number of inspectable

units.

In December 1997, OSM’s LFO

prepared a summary of current staffing

and funding levels at the DSMRE

(Administrative Record No. KY–1420).

That summary reported that the number

of inspectable units in Kentucky had

been steadily declining for several years.

Specifically, since the 1993 evaluation

period, the total number of inspectable

units had declined from 3,799 to 2,832.

During that same period, the number of

inspection and enforcement staff

dropped from 156 to 123. However,

even with 123 inspectors, the ratio of

inspectable units to inspectors stood at

23 units per inspector, as of December

1997. This ratio is actually slightly

better than the ratio of 24 units per

inspector agreed upon in the settlement

in National Wildlife Federation, supra.

In 1984, when the Director

disapproved Kentucky’s proposal to

reduce its inspection staff below the

mandated number of 156, he cited the

lack of thorough complete inspections

and the failure to consistently cite all

violations as the grounds for

disapproval (49 FR 50720). However, in

its December 1997, ‘‘Review of Staffing

and Funding Levels,’’ LFO reported the

DSMRE inspectors had made at least 97

percent of all required inspections over

the last five evaluation periods,

averaging 98.3 percent over that same

period. Moreover, LFO found that 76

percent of all mines were in complete

compliance with applicable

performance standards over the last five

years, and that over half of the mines

not in full compliance had only one

violation per year. Finally, over the last

two evaluation periods, only 4 percent

and 8 percent of mines, respectively,

had violations which caused off site

impacts. Thus, LFO concluded, not only

are DSMRE’s 123 inspectors making an

adequate number of inspections, the

inspections are also serving as a

deterrent to violations (Administrative

Record No. KY–1420).

LFO also noted that, while permitting

staff had dropped from 52 to 38 over the

five year period prior to December,

1997, the permitting workload had

dropped even faster. Since the 1993

evaluation period, new permit

approvals had dropped from 142 per

year to 99.

Therefore, based on the new evidence

discussed in the preceding paragraphs,

the Director finds that Kentucky has

demonstrated that it has sufficient

staffing levels to regulate mining in

accordance with SMCRA. He finds that

the Kentucky program is consistent with

the provisions of section 503(a)(3) of

SMCRA and is therefore removing the

required amendment at 30 CFR

917.16(b), which requires Kentucky to

maintain a minimum permanent

program staff of 408, including a

minimum of 156 inspection and

enforcement personnel. The disapproval

codified at 30 CFR 917.17(a) is also

being removed, since Kentucky will no

longer be required to maintain a

permanent program staff of 408.

IV. Summary and Disposition of

Comments

Public Comments

The Director solicited public

comments and provided an opportunity

for a public hearing on the proposed

amendment submitted on November 3,

1997. One comment was received in

support of the amendment. The

commentor stated that the coal industry

has witnessed a dramatic decline in the

number of coal mines in Kentucky. To

support this statement, the commentor
Federal Register / Vol. 63, No. 147 / Friday, July 31, 1998 /Rules and Regulations 40827

also submitted a ‘‘Survey of Active Coal

Mining Operations in Kentucky (June 1–

July 31, 1997)’’ reflecting a total of 353

active mines in the State. By

comparison, the number of licensed

mines in 1984 was 2,063.

Federal Agency Comments

Pursuant to 30 CFR 732.17(h)(11)(i),

the Director solicited comments on the

proposed amendment submitted on

November 3, 1997, from various Federal

agencies with an actual or potential

interest in the Kentucky program. No

comments were received.

Environmental Protection Agency (EPA)

Pursuant to 30 CFR 732.17(h)(11)(ii),

OSM is required to obtain the written

concurrence of the EPA with respect to

those provisions of the proposed

program amendment that relate to air or

water quality standards promulgated

under the authority of the Clean Water

Act (33 U.S.C. 1251 et seq.) or the Clean

Air Act (42 U.S.C. 7401 et seq.).

None of the revisions that Kentucky

proposed to make in its amendment

pertains to air or water quality

standards. Therefore, OSM did not

request EPA’s concurrence.

V. Director’s Decision

Based on the above findings, the

Director approves the proposed

amendment as submitted by Kentucky

on November 3, 1997.

The Federal regulations at 30 CFR

Part 917, codifying decisions concerning

the Kentucky program, are being

amended to implement this decision.

This final rule is being made effective

immediately to expedite the State

program amendment process and to

encourage States to bring their programs

into conformity with the Federal

standards without undue delay.

Consistency of State and Federal

standards is required by SMCRA.

VI. Procedural Determinations

Executive Order 12866

This rule is exempted from review by

the Office of Management and Budget

(OMB) under Executive Order 12866

(Regulatory Planning and Review).

Executive Order 12988

The Department of the Interior has

conducted the reviews required by

section 3 of Executive Order 12988

(Civil Justice Reform) and has

determined that, to the extent allowed

by law, this rule meets the applicable

standards of subsections (a) and (b) of

that section. However, these standards

are not applicable to the actual language

of State regulatory programs and

program amendments since each such

program is drafted and promulgated by

a specific State, not by OSM. Under

sections 503 and 505 of SMCRA (30

U.S.C. 1253 and 1255) and 30 CFR

730.11, 732.15, and 732.17(h)(10),

decisions on proposed State regulatory

programs and program amendments

submitted by the States must be based

solely on a determination of whether the

submittal is consistent with SMCRA and

its implementing Federal regulations

and whether the other requirements of

30 CFR Parts 730, 731, and 732 have

been met.

National Environmental Policy Act

No environmental impact statement is

required for this rule since section

702(d) of SMCRA (30 U.S.C. 1292(d))

provides that agency decisions on

proposed State regulatory program

provisions do not constitute major

Federal actions within the meaning of

section 102(2)(C) of the National

Environmental Policy Act (42 U.S.C.

4332(2)(C)).

Paperwork Reduction Act

This rule does not contain

information collection requirements that

require approval by OMB under the

Paperwork Reduction Act (44 U.S.C.

3507 et seq.).

Regulatory Flexibility Act

The Department of the Interior has

determined that this rule will not have

a significant economic impact on a

substantial number of small entities

under the Regulatory Flexibility Act (5

U.S.C. 6501 et seq.) The State submittal

which is the subject of this rule is based

upon corresponding Federal regulations

for which an economic analysis was

prepared and certification made that

such regulations would not have a

significant economic effect upon a

substantial number of small entities.

Accordingly, this rule will ensure that

existing requirements previously

promulgated by OSM will be

implemented by the State. In making the

determination as to whether this rule

would have a significant economic

impact, the Department relied upon the

data and assumptions for the

corresponding Federal regulations.

Unfunded Mandates

This rule will not impose a cost of

$100 million or more in any given year

on any governmental entity or the

private sector.

List of Subjects in 30 CFR Part 917

Intergovernmental relations, Surface

mining, Underground mining.

Dated: July 16, 1998.

Allen D. Klein,

Regional Director, Appalachian Regional

Coordinating Center.

For the reasons set out in the

preamble,Title 30, Chapter VII,

Subchapter T of the Code of Federal

Regulations is amended as set forth

below:

PART 917—KENTUCKY

1. The authority citation for part 917

continues to read as follows:

Authority: 30 U.S.C. 1201 et seq.

2. Section 917.15 is amended in the

table by adding a new entry in

chronological order by ‘‘Date of Final

Publication’’ to read as follows:

§ 917.15 Approval of Kentucky regulatory

program amendments.

* * * * *

Original

amendment

submission

date

Date of final

publication

Citation/description

* * * * *

November 3,

1997.

July 31, 1998 Staffing and

budget levels.

§ 917.16 [Amended]

3. Section 917.16 is amended by

removing and reserving paragraph (b).

§ 917.17 [Amended]

4. Section 917.16 is amended by

removing and reserving paragraph (a).

[FR Doc. 98–20468 Filed 7–30–98; 8:45 am]

BILLING CODE 4310–05–M

POSTAL SERVICE

39 CFR Part 111

Elimination of Mixed BMC/ADC Pallets

of Packages of Flats

AGENCY: Postal Service.

ACTION: Final rule; correction.

SUMMARY: The Postal Service published

a document in the Federal Register of

July 10, 1998, concerning revisions to

Domestic Mail Manual (DMM) sections

M020, M041, and M045, eliminating

options for mailers to place packages

and bundles of Standard Mail (A) and

Standard Mail (B) on mixed BMC

pallets. The document contained an

incorrect date.

FOR FURTHER INFORMATION CONTACT:

Cheryl Beller, (202) 268–5166.