32540 Federal Register / Vol. 66, No. 116 / Friday, June 15, 2001 / Rules and Regulations

Supplemental NADA is approved as

of May 29, 2001, and the regulations are

amended in 21 CFR 522.313 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 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this supplemental

application may be seen in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852,

between 9 a.m. and 4 p.m., Monday

through Friday.

Under section 512(c)(2)(F)(iii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(iii)), this

supplemental approval qualifies for 3

years of marketing exclusivity beginning

May 29, 2001, because the supplement

application contains substantial

evidence of the effectiveness of the drug

involved, any studies of animal safety

or, in the case of food-producing

animals, human food safety studies

(other than bioequivalence or residue

studies) required for approval of the

supplemental application and

conducted or sponsored by the

applicant.

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.

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 522

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 522 is amended as follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

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

§ 522.313 [Amended]

2. Section 522.313 Ceftiofur sodium

powder for injection is amended in

paragraph (d)(1)(i) by adding after

‘‘intramuscularly’’ the phrase ‘‘or

subcutaneously’’.

Dated: June 7, 2001.

Claire M. Lathers,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 01–15083 Filed 6–14–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF STATE

22 CFR Part 41

[Public Notice 3697]

Documentation of Nonimmigrants

Under the Immigration and Nationality

Act, as Amended: Aliens Ineligible To

Transit Without Visas (TWOV)—Russia

AGENCY: Bureau of Consular Affairs,

Department of State.

ACTION: Interim rule with request for

comments.

SUMMARY: Section 212(d)(4)(A) of the

Immigration and Nationality Act (INA)

permits the Secretary of State, acting

jointly with the Attorney General, to

waive the visa and passport requirement

of INA 212(a)(7)(B) for certain aliens in

direct transit through the United States.

This waiver allows an alien to transit

the United States without a passport

and visa provided the alien is traveling

on a carrier signatory to an agreement

with the Immigration and Naturalization

Service (INS) in accordance with INA

233(c) and bears documentation

establishing identity and nationality

which permits the alien’s entry into

another country. This rule removes

Russia from the list of countries that are

ineligible to transit without visa

(TWOV) that was published on January

5, 2001 at 66 FR 1033.

DATES: Effective Date: This interim rule

is effective June 15, 2001.

Comment Date: Written comments

may be submitted sixty days from

August 14, 2001.

ADDRESSES: Submit comments, in

duplicate, to the H. Edward Odom,

Chief, Legislation and Regulations

Division, Visa Services, Department of

State, Washington, DC 20522–0106; or

e-mail: odomhe@state.gov.

FOR FURTHER INFORMATION CONTACT: H.

Edward Odom, Chief, Legislation and

Regulations Division, Visa Office, Room

L603–C, SA–1, Department of State,

Washington, DC 20520–0106, or phone

(202) 663–1204; or e-mail:

odomhe@state.gov.

SUPPLEMENTARY INFORMATION:

What Is the Authority for Allowing or

Prohibiting Transit Without Visa?

Section 212(d)(4)(C) of the

Immigration and Nationality Act (INA)

provides the authority for the Secretary

of State, acting jointly with the Attorney

General, to waive the passport and/or

visa requirement for a nonimmigrant

who is in immediate and continuous

transit through the United States and is

using a carrier that has entered into a

Transit Without Visa (TWOV)

Agreement as provided in INA 233(c).

Who Determines Which Countries Can

Transit Without a Visa?

Since TWOV does not involve the

issuance of a visa, the Department’s role

in the day-to-day administration of the

TWOV program is minimal. Therefore,

the Department’s regulation at 22 CFR

41.2(i), for the most part, is merely a

restatement of the INS regulation on the

same subject. The Department does

become involved, however, in the

designation of those countries whose

citizens are ineligible to utilize the

TWOV. The current regulation provides

a list of ineligible countries.

Which Countries Are Removed From

the List of Countries Whose Citizens

Cannot TWOV?

This rule removes Russia from the list

of countries whose citizens cannot

TWOV.

Why Is Russia Being Removed From the

List of Countries Whose Citizens Cannot

TWOV?

The Department and the INS have

reviewed again the current list of

ineligible countries and have

determined that Russia can be removed

from the list. In making the decision to

remove Russia from the list the agencies

took into consideration, in addition to

the criteria specified in the regulation,

comments received which expressed

concern about the commercial impact

caused by placing Russia on the list.

Specifically, the withdrawal of TWOV

privileges for Russia would discourage

travel by Russian nationals and thus

would have a serious negative impact

on airline and port-of-entry revenues.

What Other Amendments Are Being

Made?

In the interim regulation the entry for

‘‘Serbia’’ is amended to read ‘‘Federal

Republic of Yugoslavia’’. On November

17, 2000, the United States recognized

the Federal Republic of Yugoslavia as an

independent state. Therefore, the former

reference to Serbia and Montenegro is

now listed as the Federal Republic of

Yugoslavia.

Federal Register / Vol. 66, No. 116 / Friday, June 15, 2001 / Rules and Regulations 32541

Interim Rule

How Will the Department of State

Amend Its Regulations?

This rule and the INS rule published

elsewhere in this issue amend the list of

countries found at 22 CFR 41.2(i) whose

citizens the Department and the INS

have determined are not eligible for the

transit without visa (TWOV) program.

Administrative Procedure Act

The Department is implementing this

rule as an interim rule, with a 60-day

provision for post-promulgation public

comments, based on the ‘‘good cause’’

exceptions found at 5 U.S.C. 553(b)(B)

and 553(d)(3). Since this rule bestows a

benefit for Russian nationals traveling to

the U.S., the Department is

implementing this rule immediately.

Regulatory Flexibility Act

The Department of State, in

accordance with the Regulatory

Flexibility Act (5 U.S.C. 605(b)), has

reviewed this regulation and, by

approving it, certifies that this rule will

not have a significant economic impact

on a substantial number of small

entities.

Unfunded Mandates Reform Act of 1995

This rule will not result in the

expenditure by State, local and tribal

governments, in the aggregate, or by the

private sector, of $100 million or more

in any year and it will not significantly

or uniquely affect small governments.

Therefore, no actions were deemed

necessary under the provisions of the

Unfunded Mandates Reform Act of

1995.

Small Business Regulatory Enforcement

Fairness Act of 1996

This rule is not a major rule as

defined by section 804 of the Small

Business Regulatory Enforcement Act of

1996. This rule will not result in an

annual effect on the economy of $100

million or more; a major increase in

costs or prices; or significant adverse

effects on competition, employment,

investment, productivity, innovation, or

on the ability of United States-based

companies to compete with foreignbased companies in domestic and

export markets.

Executive Order 12866

Although this rule is promulgated in

conjunction with the Immigration and

Naturalization Service, a domestic

agency, the Department of State does

not consider this rule to be a

‘‘significant regulatory action’’ under

Executive Order 12866, section 3(f)

Regulatory Planning and Review.

Therefore, in accordance with the letter

to the Department of State of February

4, 1994 from the Director of

Management and Budget, it does not

require review by the Office of

Management and Budget.

Executive Order 13132

This regulation will not have

substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government. Therefore, in

accordance with section 6 of Executive

Order 13132, it is determined that this

rule does not have sufficient federalism

implications to warrant the preparation

of a federalism summary impact

statement.

Paperwork Reduction Act

This rule does not impose any new

reporting or record-keeping

requirements. The information

collection requirement (Form OF–156)

contained by reference in this rule was

previously approved for use by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act.

List of Subjects in 22 CFR Part 41

Aliens, Foreign officials, Passports

and visas.

In view of the foregoing, the

Department amends 22 CFR as follows:

PART 41—[AMENDED]

1. The authority citation for 22 CFR

part 41 continues to read as follows:

Authority: 8 U.S.C. 1104; Pub. L. 105–277,

112 Stat. 2681 et. seq.

2. Amend § 41.2 by revising paragraph

(i)(2) to read as follows:

§ 41.2 Waiver by Secretary of State and

Attorney General of passport and/or visa

requirements for certain categories of

nonimmigrants.

* * * * *

(i) * * *

(2) Notwithstanding the provisions of

paragraph (i)(1) of this section, this

waiver is not available to an alien who

is a citizen of: Afghanistan, Angola,

Bangladesh, Belarus, BosniaHerzegovina, Burma, Burundi, Central

African Republic, People’s Republic of

China, Colombia, Congo (Brazzaville),

India, Iran, Iraq, Libya, Nigeria, North

Korea, Pakistan,Sierra Leone, Somalia,

Sri Lanka, Sudan, or the Federal

Republic of Yugoslavia.

* * * * *

Dated: June 6, 2001.

Mary A. Ryan,

Assistant Secretary for Consular Affairs,

Department of State.

[FR Doc. 01–15051 Filed 6–14–01; 8:45 am]

BILLING CODE 4710–06–P

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 1, 31, 301, and 602

[TD 8947]

RIN 1545–AY79

Penalties for Underpayments of

Deposits and Overstated Deposit

Claims

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Final regulations and removal of

final regulations.

SUMMARY: This document makes

conforming amendments to certain final

regulations to reflect the removal of

final regulations relating to the penalty

for underpayment of deposits of taxes

and the penalty for overstated deposit

claims. These regulations are obsolete

due to amendments to section 6656 of

the Internal Revenue Code. The removal

of these regulations will not affect

taxpayers.

DATES: The amendments and removals

are effective June 15, 2001.

FOR FURTHER INFORMATION CONTACT:

Robin M. Tuczak, (202) 622–4940 (not a

toll-free number).

SUPPLEMENTARY INFORMATION:

Background and Explanation of

Provisions

This document removes two sections

from the Procedure and Administration

Regulations (26 CFR part 301) relating to

penalties for underpayment of Federal

tax deposits and overstated deposit

claims under section 6656 of the

Internal Revenue Code. The Omnibus

Budget Reconciliation Act of 1989,

Public Law 101–239 (103 Stat. 2106,

1989) amended section 6656, modifying

the penalty rates relating to a failure to

make a Federal tax deposit and

removing the penalty relating to

overstatement of Federal tax deposits.

These changes have rendered

§§ 301.6656–1 and 301.6656–2 obsolete.

Section 301.6656–1 was revised and

§ 301.6656–2 was added by TD 7925,

published in the Federal Register for

December 13, 1983 (LR–311–81, 48 FR

5453). Section 301.6656–2 was added to

implement changes made by the