Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Solution, 14926 [E8-5598]
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Federal Register / Vol. 73, No. 55 / Thursday, March 20, 2008 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
information. Therefore, a freedom of
information summary is not required.
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.
Food and Drug Administration
List of Subjects in 21 CFR Part 522
Aviation Administration withdraws the
direct final rule published in the
Federal Register February 11, 2008 (73
FR 7667).
*
*
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Issued in Fort Worth, TX, on March 5,
2008.
Donald R. Smith,
Manager, System Support Group, ATO
Central Service Center.
[FR Doc. E8–5164 Filed 3–19–08; 8:45 am]
BILLING CODE 4910–13–M
Animal drugs.
21 CFR Part 522
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
Norbrook Laboratories, Ltd. The
supplemental NADA provides for
changing scientific nomenclature for a
bovine pathogen on labeling for 300
milligrams per milliliter (mg/mL)
strength oxytetracycline injectable
solution.
DATES:
This rule is effective March 20,
2008.
Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8342,
e-mail: joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Norbrook
Laboratories, Ltd., Station Works,
Newry, BT35 6JP, Northern Ireland,
filed a supplement to NADA 141–143
for TETRADURE 300 (oxytetracycline)
Injection used for the treatment of
various bacterial diseases of cattle and
swine. The supplemental NADA
provides for changing a bovine pathogen
genus from Haemophilus to Histophilus
on product labeling. The supplemental
NADA is approved as of February 8,
2008, and the regulations are amended
in 21 CFR 522.1660b to reflect the
approval.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
ebenthall on PRODPC61 with RULES
FOR FURTHER INFORMATION CONTACT:
VerDate Aug<31>2005
13:27 Mar 19, 2008
Jkt 214001
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:
I
Implantation or Injectable Dosage
Form New Animal Drugs;
Oxytetracycline Solution
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. In § 522.1660, revise the section
heading to read as follows:
I
§ 522.1660 Oxytetracycline injectable
dosage forms.
3. In § 522.1660a, revise the section
heading to read as follows:
I
§ 522.1660a Oxytetracycline solution, 200
milligrams/milliliter.
§ 522.1660b
[Amended]
4. In § 522.1660b, in the section
heading, remove ‘‘injection, 300
milligram/milliliter’’ and in its place
add ‘‘solution, 300 milligrams/
milliliter’’; in paragraph (e)(1)(i)(A),
remove ‘‘Haemophilus spp.’’ and in its
place add ‘‘Histophilus spp.’’; and in the
fourth sentence in paragraph (e)(1)(ii),
remove ‘‘in cattle’’.
I
Dated: March 6, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–5598 Filed 3–19–08; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
DEPARTMENT OF STATE
22 CFR Parts 41 and 42
[Public Notice: 6135]
Visas: Documentation of Immigrants
and Nonimmigrants —Visa
Classification Symbols
State Department.
Final rule.
AGENCY:
ACTION:
SUMMARY: The Department is amending
its regulations to add new classification
symbols to the immigrant and
nonimmigrant classification tables. The
amendment is necessary to implement
legislation that has created additional
immigrant and nonimmigrant
classifications as described herein.
Additionally, the Department is
removing immigrant classifications that
have become obsolete as a result of
either their deletion from the
Immigration and Nationality Act ‘‘INA’’
or the expiration of legislative
provisions that had temporarily
authorized them. This rule also corrects
typographical errors noted in the tables.
DATES: This rule is effective March 20,
2008.
FOR FURTHER INFORMATION CONTACT:
Barbara J. Kennedy, Legislation and
Regulations Division, Visa Services,
U.S. Department of State, Washington,
DC 20520–0106, phone (202) 663–1206.
SUPPLEMENTARY INFORMATION:
Which immigrant classifications are
being added?
The new immigrant classification
symbols listed are for children residing
habitually in Hague Adoption
Convention countries who have been or
will be adopted by U.S. citizens who are
habitually residents in the United States
(IH3, IH4), and for two additional
classes of special immigrants: certain
nationals of Afghanistan and Iraq
employed by the U.S. Government in
Afghanistan or Iraq as translators or
interpreters (SI1, SI2, SI3), and certain
Iraqis employed by or on behalf of the
U.S. Government in Iraq (SQ1, SQ2,
SQ3).
Which nonimmigrant classifications are
being added?
Added to the nonimmigrant
classification tables are symbols for
certain nationals of Australia in a
specialty occupation (E3), spouses and
children accompanying or following to
join E3 principal aliens (E3D), E3
principal aliens who are applying for a
new visa when there has been
uninterrupted continuity of
employment (E3R); treaty aliens from
E:\FR\FM\20MRR1.SGM
20MRR1
Agencies
[Federal Register Volume 73, Number 55 (Thursday, March 20, 2008)]
[Rules and Regulations]
[Page 14926]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-5598]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Oxytetracycline Solution
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 Norbrook Laboratories, Ltd. The
supplemental NADA provides for changing scientific nomenclature for a
bovine pathogen on labeling for 300 milligrams per milliliter (mg/mL)
strength oxytetracycline injectable solution.
DATES: This rule is effective March 20, 2008.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8342, e-mail:
joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works,
Newry, BT35 6JP, Northern Ireland, filed a supplement to NADA 141-143
for TETRADURE 300 (oxytetracycline) Injection used for the treatment of
various bacterial diseases of cattle and swine. The supplemental NADA
provides for changing a bovine pathogen genus from Haemophilus to
Histophilus on product labeling. The supplemental NADA is approved as
of February 8, 2008, and the regulations are amended in 21 CFR
522.1660b to reflect the approval.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
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.
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 part 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 522.1660, revise the section heading to read as follows:
Sec. 522.1660 Oxytetracycline injectable dosage forms.
0
3. In Sec. 522.1660a, revise the section heading to read as follows:
Sec. 522.1660a Oxytetracycline solution, 200 milligrams/milliliter.
Sec. 522.1660b [Amended]
0
4. In Sec. 522.1660b, in the section heading, remove ``injection, 300
milligram/milliliter'' and in its place add ``solution, 300 milligrams/
milliliter''; in paragraph (e)(1)(i)(A), remove ``Haemophilus spp.''
and in its place add ``Histophilus spp.''; and in the fourth sentence
in paragraph (e)(1)(ii), remove ``in cattle''.
Dated: March 6, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-5598 Filed 3-19-08; 8:45 am]
BILLING CODE 4160-01-S