66742 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations

ACTION: Final rule; technical

amendment.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations to remove references to

certain room numbers that no longer are

valid because the address of the Center

for Food Safety and Applied Nutrition

(CFSAN) changed to 5100 Paint Branch

Pkwy., College Park, MD, on December

14, 2001. FDA also is amending its

regulations to remove a reference to an

alternate site for submissions of

documents to the Docket Management

Branch. This alternate site is no longer

available effective December 14, 2001.

This action is editorial in nature and is

intended to improve the accuracy and

clarity of the agency’s regulations.

EFFECTIVE DATE: December 14, 2001.

FOR FURTHER INFORMATION CONTACT:

Louis B. Brock, Office of Regulations

and Policy, Center for Food Safety and

Applied Nutrition (HFS–24), 5100 Paint

Branch Pkwy., College Park, MD,

20740–3835, 301–436–2378.

SUPPLEMENTARY INFORMATION: In the

Federal Register of November 6, 2001

(66 FR 56034), FDA amended its

regulations to reflect that on December

14, 2001, CFSAN’s address was changed

to 5100 Paint Branch Pkwy., College

Park, MD 20740. This change of address

will make room numbers cited in

certain regulations invalid. Therefore,

FDA is amending its regulations in 21

CFR parts 73, 101, 172, 173, 177, 178,

and 184 to remove the phrase ‘‘rm.

3321’’ wherever it appears. FDA also is

amending 21 CFR 10.20(f) to add a

period after ‘‘20857’’ and to remove the

following phrase: ‘‘, except that a

submission which is required to be

received by the Branch by a specified

date may be delivered in person to the

FDA building in Washington (Room

6819, 200 C Street, SW., Washington,

DC 20204) and will be considered as

received by the Branch on the date on

which it is delivered.’’ This alternate

site, originally provided for the

convenience of the public, is no longer

available because CFSAN’s address has

changed to College Park.

Publication of this document

constitutes final action on these changes

under the Administrative Procedure Act

(5 U.S.C. 553). Notice and public

procedure are unnecessary because FDA

is merely correcting nonsubstantive

errors.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR chapter I is

amended as follows:

1. Section 10.20(f) is amended by

adding a period after ‘‘20857’’ and by

removing the rest of the sentence.

2. Parts 73, 101, 172, 173, 177, 178,

and 184 are amended by removing the

words ‘‘rm. 3321’’ wherever they

appear.

Dated: December 19, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–31714 Filed 12–26–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

New Animal Drugs; Change of

Sponsor’s Address

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect a

change of sponsor’s address for Phibro

Animal Health.

DATES: This rule is effective December

27, 2001.

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: Phibro

Animal Health, One Parker Plaza, Fort

Lee, NJ 07024, has informed FDA of a

change of sponsor’s address to 710 Rt.

46 East, suite 401, Fairfield, NJ 07004.

Accordingly, the agency is amending

the regulations in 21 CFR 510.600(c)(1)

and (c)(2) to reflect the change.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.

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 and redelegated to

the Center for Veterinary Medicine, 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 510.600 is amended in the

table in paragraph (c)(1) by revising the

entry for ‘‘Phibro Animal Health’’ and in

the table in paragraph (c)(2) by revising

the entry for ‘‘066104’’ to read as

follows:

§ 510.600 Names, addresses, and drug

labeler codes of sponsors of approved

applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address Drug labeler code

*******

Phibro Animal Health, 710 Rt. 46 East, suite 401, Fairfield, NJ 07004 .. 066104

*******

(2) * * *

Drug labeler code Firm name and address

*******

066104 Phibro Animal Health, 710 Rt. 46 East, suite 401, Fairfield, NJ 07004

Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations 66743

Drug labeler code Firm name and address

*******

Dated: November 30, 2001.

Claire M. Lathers,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 01–31715 Filed 12–26–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 915

[IA–012–FOR]

Iowa Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement, Interior.

ACTION: Final rule; approval of

amendment.

SUMMARY: We, the Office of Surface

Mining Reclamation and Enforcement

(OSM), are approving an amendment to

the Iowa regulatory program (Iowa

program) under the Surface Mining

Control and Reclamation Act of 1977

(SMCRA or the Act). The Iowa

Department of Agriculture and Land

Stewardship, Division of Soil

Conservation, Mines and Minerals

Bureau (Division or Iowa) proposed

revisions to its April 1999 revegetation

success guidelines concerning normal

husbandry practices; minimum planting

arrangements and tree and shrub

stocking requirements for recreational,

wildlife, and forested lands; and criteria

for dry weight determinations for corn,

soybean, oat, and wheat crops. Iowa

intends to revise its program to be

consistent with the corresponding

Federal regulations.

EFFECTIVE DATE: December 27, 2001.

FOR FURTHER INFORMATION CONTACT: John

W. Coleman, Office of Surface Mining,

Mid-Continent Regional Coordinating

Center, Alton Federal Building, 501

Belle Street, Alton, Illinois 62002.

Telephone: (618) 463–6460.

SUPPLEMENTARY INFORMATION:

I. Background on the Iowa Program

II. Submission of the Amendment

III. OSM’s Findings

IV. Summary and Disposition of Comments

V. OSM’s Decision

VI. Procedural Determinations

I. Background on the Iowa Program

Section 503(a) of the Act permits a

State to assume primacy for the

regulation of surface coal mining and

reclamation operations on non-Federal

and non-Indian lands within its borders

by demonstrating that its program

includes, among other things, ‘‘ * * * a

State law which provides for the

regulation of surface coal mining and

reclamation operations in accordance

with the requirements of this Act * * *;

and rules and regulations consistent

with regulations issued by the Secretary

pursuant to this Act.’’ See 30 U.S.C.

1253(a)(1) and (7). On the basis of these

criteria, the Secretary of the Interior

conditionally approved the Iowa

program on January 21, 1981. You can

find background information on the

Iowa program, including the Secretary’s

findings, the disposition of comments,

and the conditions of approval in the

January 21, 1981, Federal Register (46

FR 5885). You can find later actions on

the Iowa program at 30 CFR 915.10,

915.15, and 915.16.

II. Submission of the Amendment

By letter dated August 17, 2001

(Administrative Record No. IA–446),

Iowa sent us an amendment to its

program under SMCRA and the Federal

regulations at 30 CFR 732.17(b). Iowa

sent the amendment in response to

required program amendments at 30

CFR 915.16(b), (d), and (e). Iowa

proposed changes to its April 1999

revegetation success guidelines entitled

‘‘Revegetation Success Standards and

Statistically Valid Sampling

Techniques.’’

We announced receipt of the

amendment in the September 24, 2001,

Federal Register (66 FR 48841). In the

same document, we opened the public

comment period and provided an

opportunity for a public hearing or

meeting on the adequacy of the

amendment. The public comment

period closed on October 24, 2001. We

did not receive any comments. Because

no one requested a public hearing or

meeting, we did not hold one.

During our review of the amendment,

we identified concerns about a

typographical error in a provision for

interseeding at Section III.H.4.(c)(ii); the

interpretation of the revegetation

success standards for recreational,

wildlife, and forested lands at Section

IV.E; and the interpretation of the dry

weight determination for grain samples

at Section V.A.2(l). We notified Iowa of

the error at Section III.H.4.(c)(ii) and

explained our interpretation of its

provisions at Sections IV.E and V.A.2(l)

in a letter dated September 12, 2001

(Administrative Record No. IA–446.3A).

By letter dated September 28, 2001

(Administrative Record No. IA–446.5),

Iowa agreed to correct the typographical

error and concurred with our

interpretation of its provisions at

Sections IV.E and V.A.2(l).

III. OSM’s Findings

This section contains our findings

concerning the amendment to the Iowa

program. We are making these findings

in accordance with the criteria and

procedural requirements of the Federal

regulations at 30 CFR 732.15 and

732.17. Any revisions that we do not

discuss below are minor wording

changes or revised cross-references and

paragraph notations to reflect

organizational changes resulting from

this amendment.

A. Normal Husbandry Practices

Section III, Part H of Iowa’s April

1999 revegetation success guidelines

describes normal husbandry practices

that a permittee can use in the repair of

rills and gullies without restarting the

responsibility period for successful

revegetation and bond liability. A

permittee may address rill and gully

erosion within the permit or partial

permit area without restarting the

responsibility period only if repairs are

completed using the normal husbandry

practice guidelines provided in this

section. If the repair work requires

augmented seeding, fertilization, or

irrigation, the period of responsibility

will restart. Normal husbandry practices

do not include any temporary erosion

control structures, such as silt fencing,

straw, or hay bale dikes. This section

includes requirements for terrace repair

and maintenance; riprap repair and

maintenance; land smoothing and

reseeding; and liming, fertilizing, and

interseeding.

The Federal regulations at 30 CFR

816.116(c)(4) for surface mining

operations and 30 CFR 817.116(c)(4) for

underground mining operations allow

the regulatory authority, under specified

conditions, to approve selective

husbandry practices (excluding

augmented seeding, fertilization, or

irrigation) without extending the period

of responsibility for revegetation success

and bond liability. The regulatory

authority must obtain prior approval

from OSM in accordance with 30 CFR

732.17 that the practices are normal