Federal Register / Vol. 70, No. 170 / Friday, September 2, 2005 / Rules and Regulations 52291 

Litchfield, IL, Litchfield Muni, GPS RWY 9, 

Orig-A, CANCELLED 

Litchfield, IL, Litchfield Muni, Takeoff 

Minimums and Textual DP, Amdt 3 

Macomb, IL, Macomb Muni, RNAV (GPS) 

RWY 9, Orig 

Macomb, IL, Macomb Muni, RNAV (GPS) 

RWY 27, Orig 

Macomb, IL, Macomb Muni, LOC RWY 27, 

Amdt 3 

Macomb, IL, Macomb Muni, NDB RWY 27, 

Amdt 3 

Macomb, IL, Macomb Muni, VOR/DME-A, 

Amdt 8 

Springfield, IL, Abraham Lincoln Capital, 

RNAV (GPS) RWY 4, Orig 

Springfield, IL, Abraham Lincoln Capital, 

RNAV (GPS) RWY 13, Orig 

Springfield, IL, Abraham Lincoln Capital, 

RNAV (GPS) RWY 22, Orig 

Springfield, IL, Abraham Lincoln Capital, 

RNAV (GPS) RWY 31, Orig 

Springfield, IL, Abraham Lincoln Capital, ILS 

OR LOC RWY 4, Amdt 25 

Springfield, IL, Abraham Lincoln Capital, ILS 

OR LOC RWY 22, Amdt 8 

Springfield, IL, Abraham Lincoln Capital, ILS 

OR LOC RWY 31, Amdt 2 

Springfield, IL, Abraham Lincoln Capital, 

RADAR–1, Amdt 9 

Springfield, IL, Abraham Lincoln Capital, 

NDB RWY 4, Amdt 19 

Springfield, IL, Abraham Lincoln Capital, 

NDB RWY 22, Amdt 1 

Springfield, IL, Abraham Lincoln Capital, 

VOR/DME RWY 22, Orig 

Springfield, IL, Abraham Lincoln Capital, 

VOR RWY 22, Amdt 20A, CANCELLED 

Springfield, IL, Abraham Lincoln Capital, 

Takeoff Minimums and Textual DP, Orig 

Taylorville, IL, Taylorville Muni, RNAV 

(GPS) RWY 18, Orig 

Taylorville, IL, Taylorville Muni, RNAV 

(GPS) RWY 36, Orig 

Taylorville, IL, Taylorville Muni, NDB RWY 

18, Amdt 4 

Taylorville, IL, Taylorville Muni, GPS RWY 

18, Orig, CANCELLED 

Taylorville, IL, Taylorville Muni, Takeoff 

Minimums and Textual DP, Orig 

Abilene, KS, Abilene Muni, RNAV (GPS) 

RWY 17, Orig 

Abilene, KS, Abilene Muni, RNAV (GPS) 

RWY 35, Orig 

Abilene, KS, Abilene Muni, VOR/DME-A, 

Amdt 3 

Abilene, KS, Abilene Muni, GPS RWY 

35,Orig, CANCELLED 

Abilene, KS, Abilene Muni, VOR/DME 

RNAV RWY 35, Amdt 2, CANCELLED 

Dodge City, KS, Dodge City Regional, RNAV 

(GPS) RWY 14, Amdt 1 

Dodge City, KS, Dodge City Regional, RNAV 

(GPS) RWY 32, Amdt 1 

Dodge City, KS, Dodge City Regional, ILS OR 

LOC RWY 14, Amdt 3 

Wichita, KS, Colonel James Jabara, RNAV 

(GPS) RWY 18, Orig-A 

Wichita, KS, Colonel James Jabara, RNAV 

(GPS) RWY 36, Orig-A 

Gaithersburg, MD, Montgomery County 

Airpark, RNAV (GPS) RWY 32, Amdt 1, 

CANCELLED 

Washington, MO, Washington Memorial, 

Takeoff Minimums and Textual DP, Orig 

Santa Fe, NM, Santa Fe Muni, ILS OR LOC 

RWY 2, Amdt 6 

Westhampton Beach, NY, Francis S. 

Gabreski, RNAV (GPS) RWY 6, Amdt 1 

Charlotte, NC, Charlotte/Douglas Intl, VOR 

RWY 36L, Amdt 5, CANCELLED 

Austin, TX, Austin-Bergstrom Intl, ILS OR 

LOC RWY 35L, Amdt 3 

Lubbock, TX, Lubbock Preston Smith Intl, 

ILS OR LOC RWY 26, Amdt 3 

Stephenville, TX, Clark Field Muni, RNAV 

(GPS) RWY 14, Orig 

Stephenville, TX, Clark Field Muni, RNAV 

(GPS) RWY 32, Orig 

Stephenville, TX, Clark Field Muni, VOR/ 

DME-A, Amdt 1 

Stephenville, TX, Clark Field Muni, Takeoff 

Minimums and Textual DP, Orig 

Blacksburg, VA, Virginia Tech/Montgomery 

Executive, LOC/DME RWY 12, Amdt 1 

Bellingham, WA, Bellingham Intl, RNAV 

(GPS) RWY 16, Orig 

Bellingham, WA, Bellingham Intl, RNAV 

(GPS) RWY 34, Orig 

Bellingham, WA, Bellingham Intl, GPS RWY 

16, Orig-B, CANCELLED 

Bellingham, WA, Bellingham Intl, GPS RWY 

34, Orig-B, CANCELLED 

Rice Lake, WI, Rice Lake Regional-Carl’s 

Field, RNAV (GPS) RWY 19, Amdt 1 

* * * Effective 22 December 2005 

Athens (Albany), OH, Ohio University 

Snyder Field, RNAV (GPS) RWY 7, OrigA 

Athens (Albany), OH, Ohio University 

Snyder Field, RNAV (GPS) RWY 25, OrigA 

[FR Doc. 05–17475 Filed 9–1–05; 8:45 am] 

BILLING CODE 4910–13–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 a 

change of sponsor for an approved new 

animal drug application (NADA) from 

Alpharma Inc., to Pharmaq AS. The 

drug labeler code for Pharmaq AS is also 

being listed. 

DATES: This rule is effective September 

2, 2005. 

FOR FURTHER INFORMATION CONTACT: 

David R. Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–6967, 

e-mail: david.newkirk@fda.gov. 

SUPPLEMENTARY INFORMATION: Alpharma 

Inc., One Executive Drive, Fort Lee, NJ 

07024, has informed FDA that it has 

transferred ownership of, and all rights 

and interest in, NADA 125–933 for 

ROMET–30 (sulfadimethoxine/ 

ormetoprim) Type A medicated article 

to Pharmaq AS, Skogmo 

Industriomrade, N–7863 Overhalla, 

Norway. Accordingly, the agency is 

amending the regulations in 21 CFR 

558.575 to reflect the transfer of 

ownership. 

In addition, Pharmaq AS has not been 

previously listed in the animal drug 

regulations as a sponsor of an approved 

application. Accordingly, 21 CFR 

510.600(c) is being amended to add 

entries for Pharmaq AS. 

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 510.60o is amended in the 

table in paragraph (c)(1) by 

alphabetically adding a new entry for 

‘‘Pharmaq AS’’ and in the table in 

paragraph (c)(2) by numerically adding 

a new entry for ‘‘015331’’ 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 

* * * * * 

Pharmaq AS, Skogmo 

Industriomrade, N–7863 

Overhalla, Norway. 

015331 

* * * * * 

52292 Federal Register / Vol. 70, No. 170 / Friday, September 2, 2005 / Rules and Regulations 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

015331 Pharmaq AS, Skogmo 

Industriomrade, N–7863 

Overhalla, Norway. 

* * * * * 

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. 

§ 558.575 [Amended] 

■ 4. Section 558.575 is amended in 

paragraph (a)(2) by removing ‘‘046573’’

and by adding in its place ‘‘No. 

015331’’. 

Dated: August 22, 2005. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 05–17472 Filed 9–1–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF STATE 

22 CFR Part 41 

RIN 1400–AC12 

[Public Notice 5181] 

Visas: Treaty Trader, Treaty Investor, 

or Treaty Alien in a Specialty 

Occupation 

AGENCY: State Department. 

ACTION: Final rule. 

SUMMARY: This rule expands the 

definition of treaty trader and treaty 

investor contained at 22 CFR 41.51 to 

include a new nonimmigrant category 

(E–3) for nonimmigrant treaty aliens 

coming to the United States solely to 

perform services in a specialty 

occupation. It also reorganizes existing 

regulatory language pertaining to treaty 

traders and treaty investors to make this 

information clearer and easier to read. 

DATES: This rule is effective September 

2, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Charles Robertson, Legislation and 

Regulations Division, Visa Services, 

Department of State, 2401 E Street, NW., 

Room L–603D, Washington, DC 20520–

0106; telephone 202–663–1221; e-mail 

robertsonce@state.gov. 

SUPPLEMENTARY INFORMATION: 

Why Is the Department Promulgating 

This Rule? 

Because of the passage of a new law 

amending the Immigration and 

Nationality Act (INA). The Emergency 

Supplemental Appropriations Act for 

Defense, the Global War on Terror, and 

Tsunami Relief, 2005, Public Law 109–

13, 119 Stat. 231 was signed into law by 

the President on May 11, 2005. Division 

B, Title V, Section 501 of the Act adds 

a new nonimmigrant visa classification 

for certain treaty aliens who are coming 

to the United States solely to perform 

services in a specialty occupation. The 

classification will hereafter be 

designated the ‘‘E–3 visa.’’

Who Qualifies for the E–3 Visa? 

The new E–3 visa classification 

currently applies only to nationals of 

Australia as well as their spouses and 

children. E–3 principal nonimmigrant 

aliens must be coming to the United 

States solely to perform services in a 

specialty occupation. 

Are There Other Requirements for 

Qualifying for an E–3 Visa? 

The E–3 visa classification is 

numerically limited, with a maximum 

of 10,500 visas available annually. 

Spouses and children do not count 

against the numerical limitation nor are 

they required to possess the nationality 

of the principal. A Labor Condition 

Application (LCA), containing 

attestations by the sponsoring employer 

related to wages and working 

conditions, must be filed with and 

approved by the Department of Labor 

(DOL). At the time of visa application, 

the visa applicant must present the 

consular officer with the original or 

copy of the approved LCA. However, if 

the applicant cannot provide the 

original, the consular officer, at his/her 

discretion, may accept a certified copy 

of the approval. The approved LCA 

represents DOL’s certification that the 

employer has met the attestation 

requirements of the E–3 statute. 

What Is a Specialty Occupation? 

In general, a specialty occupation is 

one that requires theoretical and 

practical application of a body of 

knowledge in professional fields and at 

least the attainment of a bachelor’s 

degree, or its equivalent, as a minimum 

for entry into the occupation in the 

United States. The Department’s 

regulations governing E–3 visas 

incorporate the definitions contained in 

section 214(i)(1) of the Immigration and 

Nationality Act (INA). In order to 

determine what constitutes a ‘‘specialty 

occupation,’’ consular officers abroad 

will be guided by, and will apply, 

regulatory criteria already developed by 

the Department of Homeland Security 

for the H–1B classification. 

Is It Necessary To File a Petition With 

the Department of Homeland Security 

as a Prerequisite to Visa Issuance? 

No petition to the Department of 

Homeland Security is necessary. 

Instead, in the case of an employee 

seeking a visa, the employee will 

present the necessary evidence for 

classification directly to the consular 

officer at the time of visa application. 

Such evidence will include the original 

or copy of the Labor Condition 

Application signed by the prospective 

employer and approved by the 

Department of Labor. Procedures for the 

E–3 visa are similar to those established 

for obtaining H–1B1 classification under 

the U.S.-Chile and U.S.-Singapore Free 

Trade Agreements. 

May Spouses Work? 

Yes. INA 214(e)(6) permits the spouse 

of a principal E nonimmigrant to engage 

in employment in the United States. As 

is the case for the spouse of a principal 

E–1 and E–2 nonimmigrant, the spouse 

of a qualified E–3 nonimmigrant may, 

upon admission to the United States, 

apply for an employment authorization 

document, which an employer could 

use to verify the spouse’s employment 

eligibility. Such spousal employment 

may be in a position other than a 

specialty occupation. 

Regulatory Findings 

Administrative Procedure Act 

This final rule involves a foreign 

affairs function of the United States and, 

therefore, is not subject to the 

procedures required by 5 U.S.C. 553 and 

554. It is exempt from review under 

Executive Order 12866 but has been 

reviewed internally by the Department 

to ensure consistency with the purposes 

thereof. This rule does not require 

analysis under the Regulatory 

Flexibility Act or the Unfunded 

Mandates Reform Act. It has been found 

not to be a major rule within the 

meaning of the Small Business 

Regulatory Enforcement Fairness Act of 

1996. It will not have substantial direct 

effects on the States, the relationship 

between the National Government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. Therefore, 

it is determined that this rule does not 

have sufficient federalism implications 

to warrant application of consultation 

provisions of Executive Orders 12372 

and 13132. This rule does not impose 

any new reporting or recordkeeping