Federal Register / Vol. 66, No. 116 / Friday, June 15, 2001 / Rules and Regulations 32539

2 5 U.S.C. 553(b)(3)(B).

3For similar reasons, the amendments do not

require analysis under the Regulatory Flexibility

Act or analysis of major rule status under the Small

Business Regulatory Enforcement Fairness Act. See

5 U.S.C. 601(2) (for purposes of Regulatory

Flexibility Act analyses, the term ‘‘rule’’ means any

rule for which the agency publishes a general notice

of proposed rulemaking); 5 U.S.C. 804(3)(C) (for

purposes of congressional review of agency

rulemaking, the term ‘‘rule’’ does not include any

rule of agency organization, procedure, or practice

that does not substantially affect the rights or

obligations of non-agency parties).

4See U.S.C. 553(d)(3).

express reference to this requirement in

the instruction to Item 3.A was not

intended to signal a change in policy.

Finally, the amendment corrects various

cross-references in Forms F–2 and F–3

under the Securities Act of 1933.

Certain Findings

Under the Administrative Procedure

Act (‘‘APA’’), notice of proposed

rulemaking is not required when an

agency, for good cause, finds ‘‘that

notice and public procedure thereon are

impracticable, unnecessary, or contrary

to the public interest.’’ 2 The correcting

amendments to Form 20–F and Forms

F–2 and F–3 are technical changes that

(1) clarify that there is no change in the

long-standing requirement for full

period, audited financial statements; (2)

incorporate the long-standing practice of

accepting two years income statement

and cash flow information for filers

presenting financial information in

accordance with U.S. GAAP; (3)

reconcile the instructions to Item 3.A

and Item 8 of Form 20–F; and (4) correct

cross-references in the forms. For these

reasons, the Commission finds that

there is no need to publish notice of

these amendments.3

The APA also requires publication of

a rule at least 30 days before its effective

date unless the agency finds otherwise

for good cause.4 For the same reasons

described with respect to opportunity

for notice and comment, the

Commission finds there is good cause

for the amendments to take effect

immediately.

List of Subjects in 17 CFR Parts 239 and

249

Reporting and recordkeeping

requirements, Securities.

Text of the Amendments

In accordance with the foregoing, the

Commission amends Title 17, chapter II

of the Code of Federal Regulations as

follows:

PART 239—FORMS PRESCRIBED

UNDER THE SECURITIES ACT OF 1933

1. The authority citation for part 239

continues to read in part as follows:

Authority: 15 U.S.C. 77f, 77g, 77h, 77j, 77s,

77z–2, 77sss, 78c, 78l, 78m, 78n, 78o(d),

78u–5, 78w(a), 78ll(d), 79e, 79f, 79g, 79j, 79l,

79m, 79n, 79q, 79t, 80a–8, 80a–24, 80a–29,

80a–30 and 80a–37, unless otherwise noted.

* * * * *

2. Amend Form F–2 (referenced in

§ 239.32) Item 4 by removing the words

‘‘Item 10 (The Offer and Listing)’’ and

adding in their place the words ‘‘Item 9

(Offer and Listing), Item 10 (Additional

Information)’’.

Note: The text of Form F–2 does not and

this amendment will not appear in the Code

of Federal Regulations.

3. Amend Form F–3 (referenced in

§ 239.33) Item 4 by removing the words

‘‘Item 10 (The Offer and Listing)’’ and

adding in their place the words ‘‘Item 9

(Offer and Listing), Item 10 (Additional

Information)’’.

Note: The text of Form F–3 does not and

this amendment will not appear in the Code

of Federal Regulations.

PART 249—FORMS, SECURITIES

EXCHANGE ACT OF 1934

4. The authority citation for part 249

continues to read, in part, as follows:

Authority: 15 U.S.C. 78a, et seq., unless

otherwise noted.

* * * * *

5. Amend Form 20–F (referenced in

§ 249.220f) by:

a. In Item 3, designate the current text

of Instructions to Item 3.A as Instruction

2 and add new Instruction 1;

b. In Item 8, paragraph 1 to

Instructions to Item 8.A.4, remove the

last sentence; and

c. In Item 8, add Instruction 3 to

Instructions to Item 8.A.2 to read as

follows:

Note: The text of Form 20-F does not and

this amendment will not appear in the Code

of Federal Regulations.

Securities and Exchange Commission

OMB Approval

OMB Number: 3235–0288

Expires: June 20, 2002

Estimated average burden hours per

response—1991.00

Form 20–F—Registration Statement

Pursuant to Section 12(b) or (g) of the

Securities Exchange Act of 1934

* * * * *

Instructions to Item 3.A

1. This item refers to the company, but

note that in some cases, you may have to

provide selected financial data for a

predecessor. See the definition of

predecessor in Exchange Act Rule 12b–2 and

Securities Act Rule 405.

2. * * *

* * * * *

Instructions to Item 8.A.2

1. * * *

3. In initial registration statements, if the

financial statements presented pursuant to

Item 8.A.2 are prepared in accordance with

U.S. generally accepted accounting

principles, the earliest of the three years may

be omitted if that information has not

previously been included in a filing made

under the Securities Act of 1933 or the

Securities Exchange Act of 1934. Selected

financial data presented pursuant to Item 3.A

of Form 20–F for the full five fiscal years is

still required.

* * * * *

June 11, 2001.

By the Commission.

Margaret H. McFarland,

Deputy Secretary.

[FR Doc. 01–15137 Filed 6–14–01; 8:45 am]

BILLING CODE 8010–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Ceftiofur

Sterile Powder for Injection

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 a supplemental new animal

drug application (NADA) filed by

Pharmacia and Upjohn Co. The

supplemental NADA provides for

subcutaneous injection of a solution of

reconstituted ceftiofur sodium powder

in cattle.

DATES: This rule is effective June 15,

2001.

FOR FURTHER INFORMATION CONTACT:

Naba K. Das, Center for Veterinary

Medicine (HFV–130), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–7569.

SUPPLEMENTARY INFORMATION: Pharmacia

and Upjohn Co., 7000 Portage Rd.,

Kalamazoo, MI 49001–0199, filed

supplemental NADA 140–338 that

provides for use of Naxcel (ceftiofur

sodium) sterile powder for injection by

subcutaneous injection of a solution of

reconstituted ceftiofur sodium powder

in cattle for the treatment of several

bacterial diseases.

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.