Federal Register / Vol. 66, No. 117 / Monday, June 18, 2001 / Rules and Regulations 32739

Three-year

average actual

costs

Three-year

percentage of

volume

Average

year 2001 fee

New York Board of Trade ............................................................................................................ 120,068 3.5220 73,730

Kansas City Board of Trade ........................................................................................................ 24,582 .4019 13,854

Minneapolis Grain Exchange ....................................................................................................... 5,102 .1845 3,269

Philadelphia Board of Trade ........................................................................................................ 0 .0004 0

Subtotal ................................................................................................................................. 777,760 100.0000 676,317

National Futures Association ....................................................................................................... 213,421 N/A 213,421

Total ...................................................................................................................................... 991,184 100.0000 889,738

An example of how the fee is

calculated for one exchange, the

Minneapolis Grain Exchange, is set forth

here:

a. Actual three-year average costs

equal $5,102.

b. The alternative computation is:

(.5)($5,102) + (.5)(.001845)($777,760) =

$3,269.

c. The fee is the lesser of a or b; in this

case $3,269.

As noted above, the alternative

calculation based on contracts traded, is

not applicable to the NFA because it is

not a contract market and has no

contracts traded. The Commission’s

average annual cost for conducting

oversight review of the NFA rule

enforcement program during fiscal years

1998 through 2000 was $213,421 (onethird of $640,263). The fee to be paid by

the NFA for the current fiscal year is

$213,421.

IV. Regulatory Flexibility Act

The Regulatory Flexibility Act, 5

U.S.C. 601, et seq., requires agencies to

consider the impact of rules on small

business. The fees implemented in this

release affect contract markets (also

referred to as exchanges) and registered

futures associations. The Commission

has previously determined that contract

markets and registered futures

associations are not ‘‘small entities’’ for

purposes of the Regulatory Flexibility

Act. Accordingly, the Acting Chairman

on behalf of the Commission, certifies

pursuant to 5 U.S.C. 605(b), that the fees

implemented here will not have a

significant economic impact on a

substantial number of small entities.

Issued in Washington, DC on June 6, 2001

by the Commission.

Catherine D. Dixon,

Assistant Secretary of the Commission.

[FR Doc. 01–15272 Filed 6–15–01; 8:45 am]

BILLING CODE 6351–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558

New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect the

change of sponsor for three approved

new animal drug applications (NADAs)

for oxytetracycline premixes from

Pfizer, Inc., to Phibro Animal Health,

Inc. The drug labeler code for Phibro

Animal Health, Inc., is also being listed.

DATES: This rule is effective June 18,

2001.

FOR FURTHER INFORMATION CONTACT:

Norman J. Turner, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0214.

SUPPLEMENTARY INFORMATION: Pfizer,

Inc., 235 East 42d St., New York, NY

10017–5755, has informed FDA that it

has transferred ownership of, and all

rights and interests in, NADA 8–804 for

Terramycin (oxytetracycline) Type A

medicated articles, NADA 38–439 for

Terramycin (oxytetracycline) for fish,

and NADA 95–143 for OXTC

(oxytetracycline) Type A medicated

articles to Phibro Animal Health, Inc.,

One Parker Plaza, Fort Lee, NJ 07024.

Accordingly, the agency is amending

the regulations in 21 CFR 558.450 to

reflect the transfer of ownership.

In addition, Phibro Animal Health,

Inc., has not been previously listed in

the animal drug regulations as a sponsor

of an approved application. At this time,

21 CFR 510.600(c)(1) and (c)(2) is being

amended to add entries for the firm.

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

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 558

Animal drugs, Animal feeds.

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 parts 510 and 558 are 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

alphabetically adding an entry for

‘‘Phibro Animal Health, Inc.’’ and in the

table in paragraph (c)(2) by numerically

adding an 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, Inc., One Parker Plaza, Fort Lee, NJ 07024 066104

32740 Federal Register / Vol. 66, No. 117 / Monday, June 18, 2001 / Rules and Regulations

Firm name and address Drug labeler code

*******

(2) * * *

Drug labeler code Firm name and address

*******

066104 Phibro Animal Health, Inc., One Parker Plaza, Fort Lee, NJ 07024

*******

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

3. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

§ 558.450 [Amended]

4. Section 558.450 Oxytetracycline is

amended in paragraph (a)(1) by

removing ‘‘000069’’ and by adding in its

place ‘‘066104’’; and in table 1 in

paragraphs (d)(1)(i), (d)(1)(v), (d)(1)(vii),

and (d)(1)(viii), under the ‘‘Sponsor’’

column, and in table 2 in paragraphs

(d)(2)(i) through (d)(2)(iii), under the

‘‘Sponsor’’ column, by removing

‘‘000069’’ and by adding in its place

‘‘066104’’.

Dated: June 8, 2001.

Claire M. Lathers,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 01–15273 Filed 6–15–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF STATE

Bureau of Consular Affairs

22 CFR Parts 41 and 42

[Public Notice 3654]

Visas: Documentation of Immigrants

and Nonimmigrants—Visa

Classification Symbols

AGENCY: Bureau of Consular Affairs,

Department of State.

ACTION: Final rule.

SUMMARY: The Department is amending

its regulations to add new immigrant

and nonimmigrant symbols to the

classification tables. The amendments

are necessary to implement recently

enacted legislation. The legislation

created a new immigrant category for

certain international broadcasters (BC1,

BC2, and BC3) and new nonimmigrant

categories for victims of trafficking for

illicit sexual purposes and slavery (T1

and T2), aliens who have suffered abuse

such as battering and other forms of

violence (U1 and U2), spouses and

children of lawful permanent residents

for whom petitions were filed before

December 21, 2000 and who have been

waiting for an immigrant visa for three

years or more (V1, V2, and V3), and

spouses of U.S. citizens (K3) and

children of the K3 (K4) who are

awaiting the issuance of an immigrant

visa (K3, K4). This rule removes the

immigrant classification for diversity

transition natives (AA1, AA2 and AA3).

This program ended September 30,

1995. The Department is also taking this

opportunity to amend the classification

symbols for retired NATO–6 employees,

their spouses and their unmarried sons

and daughters. In the Department’s

publication on April 19, 2000 [65 FR

20903], the Department erroneously

classified these aliens as SK special

immigrants. These aliens should be

classified as SN1, SN2, SN3 and SN4.

DATES: This rule takes effect on June 18,

2001.

FOR FURTHER INFORMATION CONTACT: Pam

Chavez, Legislation and Regulations

Division, Visa Services, Department of

State, Washington, DC 20520–0106,

(202) 663–1204.

SUPPLEMENTARY INFORMATION:

What Legislation Created These New

Visa Categories?

Pub. L. 106–386, The Victims of

Trafficking and Violence Protection Act

of 2000 (VTVPA)

The VTVPA is actually two separate

laws, the ‘‘Trafficking Victims

Protection Act of 2000’’ (TVPA) and the

‘‘Violence Against Women Act of 2000’’

(VAWA2).

How Does an Alien Qualify for T Visa

Status Under the TVPA?

Section 107 of Division A of the

TVPA created a new nonimmigrant

category under INA 101(a)(15)(T) for

aliens who the Attorney General has

determined are victims of a ‘‘severe

form of trafficking in persons.’’ Section

103 of the TVPA defines a ‘‘severe form

of trafficking in persons’’ as either:

(1) sex trafficking in which a commercial

sex act is induced by force, fraud or coercion

or in which the person induced to perform

such act has not attained 18 years of age, or

(2) the recruitment, harboring,

transportation, provision, or obtaining of a

person for labor or services, through the use

of force, fraud, or coercion for the purpose of

subjection to involuntary servitude, peonage,

debt bondage, or slavery.

To qualify for the ‘‘T’’ category, the

person must

(1) Be physically present in the

United States, American Samoa, the

Commonwealth of the Northern Mariana

Islands, or a U.S. port of entry because

of such trafficking;

(2) Have complied with any

reasonable request for assistance to law

enforcement in the investigation or

prosecution of acts of trafficking, or be

under the age of 15; and

(3) Be likely to suffer extreme

hardship involving unusual and severe

harm upon removal.

The Attorney General may, in order to

avoid extreme hardship, permit the

spouse, children and parents of an alien

under age 21 and the spouse and

children of an alien over age 21 to

accompany or follow to join the

principal alien.

How Does an Alien Qualify for U Visa

Status Under the VAWA2?

Section 1513 of Division B of the

VAWA2 created a new category under

INA 101(a)(15)(U) for victims of

physical or mental abuse. To qualify

under the U category the alien must file

a petition with the Attorney General and

establish therein:

(1) The alien has suffered substantial

physical or mental abuse as a result of

having been a victim of any one of an

extensive list of 26 criminal activities,