New Animal Drugs; Change of Sponsor, 52291-52292 [05-17472]
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52291
Federal Register / Vol. 70, No. 170 / Friday, September 2, 2005 / Rules and Regulations
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
VerDate Aug<18>2005
14:47 Sep 01, 2005
Jkt 205001
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
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Part 558
Animal drugs, Animal feeds.
I 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:
Food and Drug Administration
PART 510—NEW ANIMAL DRUGS
21 CFR Parts 510 and 558
I
New Animal Drugs; Change of Sponsor
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
[FR Doc. 05–17475 Filed 9–1–05; 8:45 am]
BILLING CODE 4910–13–P
AGENCY:
1. The authority citation for 21 CFR
part 510 continues to read as follows:
Food and Drug Administration,
HHS.
ACTION:
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
PO 00000
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:
I
Final rule.
Frm 00009
Fmt 4700
Sfmt 4700
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*
*
*
Pharmaq AS, Skogmo
Industriomrade, N–7863
Overhalla, Norway.
*
*
*
E:\FR\FM\02SER1.SGM
02SER1
Drug labeler
code
*
*
*
015331
*
52292
Federal Register / Vol. 70, No. 170 / Friday, September 2, 2005 / Rules and Regulations
(2) * * *
Drug labeler
code
*
015331
Firm name and address
*
*
*
*
*
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:
I
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’’.
I
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
State Department.
Final rule.
AGENCY:
ACTION:
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:
VerDate Aug<18>2005
14:47 Sep 01, 2005
Jkt 205001
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,
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
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
E:\FR\FM\02SER1.SGM
02SER1
]]>Agencies
[Federal Register Volume 70, Number 170 (Friday, September 2, 2005)]
[Rules and Regulations]
[Pages 52291-52292]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17472]
=======================================================================
-----------------------------------------------------------------------
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.
0
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
0
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.
0
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:
Sec. 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 015331
Overhalla, Norway.
* * * * *
------------------------------------------------------------------------
[[Page 52292]]
(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
0
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.575 [Amended]
0
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
