Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Ferric Oxide Injection; Gleptoferron Injection; Iron Dextran Complex Injection; Iron Hydrogenated Dextran Injection, 12634-12635 [E8-4603]
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12634
Federal Register / Vol. 73, No. 47 / Monday, March 10, 2008 / Rules and Regulations
Burlington, WI, Burlington Muni, RNAV
(GPS) RWY 29, Orig
Burlington, WI, Burlington Muni, VOR
RWY 29, Amdt 8
The FAA published an Amendment
in Docket No. 30591, Amdt No. 3254 to
Part 97 of the Federal Aviation
Regulations (Vol 73, FR No. 27, Page
7462 dated Friday, February 08, 2008)
under section 97.33, effective March 13,
2008 which is hereby rescinded:
Las Cruces, NM, Las Cruces Intl, ILS OR
LOC RWY 30, Amdt 2A
[FR Doc. 08–933 Filed 3–7–08; 8:45 am]
BILLING CODE 4910–13–M
DEPARTMENT OF HOMELAND
SECURITY
Bureau of Customs and Border
Protection
19 CFR Part 4
[CBP Dec. 08–02]
Addition of Lithuania to the List of
Nations Entitled to Special Tonnage
Tax Exemption
Customs and Border Protection,
Department of Homeland Security.
ACTION: Final rule.
AGENCY:
Pursuant to information
provided by the Department of State,
Customs and Border Protection has
found that no discriminating or
countervailing duties are imposed by
the government of Lithuania on vessels
owned by citizens of the United States.
Accordingly, vessels of Lithuania are
exempt from special tonnage taxes and
light money in ports of the United
States. This document amends title 19
of the Code of Federal Regulations by
adding Lithuania to the list of nations
whose vessels are exempt from payment
of any higher tonnage duties than are
applicable to vessels of the United
States and from the payment of light
money.
SUMMARY:
Glen
Vereb, Regulations and Rulings, Office
of International Trade, (202) 572–8724.
SUPPLEMENTARY INFORMATION:
ebenthall on PRODPC61 with RULES
FOR FURTHER INFORMATION CONTACT:
Background
Generally, the United States imposes
regular and special tonnage taxes, and a
duty of a specified amount per ton,
15:37 Mar 07, 2008
Jkt 214001
Regulatory Flexibility Act and
Executive Order 12866
Because no notice of proposed
rulemaking is required, the provisions
of the Regulatory Flexibility Act (5
U.S.C. 601 et seq.) do not apply. This
amendment does not meet the criteria
for a ‘‘significant regulatory action’’ as
specified in Executive Order 12866.
Signing Authority
This document is being issued by CBP
in accordance with § 0.1(b)(1) of the
CBP regulations (19 CFR 0.1(b)(1)).
List of Subjects in 19 CFR Part 4
Cargo vessels, Customs duties and
inspection, Maritime carriers, Vessels.
Amendment to the CBP Regulations
For the reasons set forth above, part 4
of title of the Code of Federal
Regulations (19 CFR part 4) is amended
as set forth below.
I
PART 4—VESSELS IN FOREIGN AND
DOMESTIC TRADES
1. The general authority citation for
part 4 and the specific authority for
§ 4.22 are revised to read as follows:
I
Authority: 5 U.S.C. 301; 19 U.S.C. 66,
1431, 1433, 1434, 1624, 2071 note; 46 U.S.C.
501, 60105.
*
*
*
*
*
Section 4.22 also issued under 46 U.S.C.
60301, 60302, 60303, 60304, 60305, 60306,
60312, 60503;
*
*
*
*
*
Finding
§ 4.22
On the basis of the above-mentioned
information from the Department of
State regarding the absence of
discriminating or countervailing duties
imposed by the government of Lithuania
on vessels owned by citizens of the
United States, CBP has determined that
vessels of Lithuania are exempt from the
payment of special tonnage tax and light
money, effective February 13, 2002. The
CBP regulations are amended
accordingly.
2. Section 4.22 is amended by adding
‘‘Lithuania’’ in appropriate alphabetical
order.
Inapplicability of Notice and Delayed
Effective Date
This amendment is effective
March 10, 2008. The exemption from
special tonnage taxes and light money
for vessels registered in Lithuania
became applicable on February 13,
2002.
DATES:
VerDate Aug<31>2005
called ‘‘light money,’’ on all foreign
vessels which enter U.S. ports (46
U.S.C. 60301–60303). However, vessels
of a foreign country may be exempted
from the payment of special tonnage
taxes and light money upon
presentation of satisfactory proof that
the government of that foreign country
does not impose discriminatory or
countervailing duties to the
disadvantage of the United States (46
U.S.C. 60304).
Section 4.22, Customs and Border
Protection (CBP) regulations (19 CFR
4.22), lists those countries whose
vessels have been found to be exempt
from the payment of any higher tonnage
duties than are applicable to vessels of
the United States and from the payment
of light money. The authority to amend
this section of the CBP regulations has
been delegated to the Chief, Trade and
Commercial Regulations Branch,
Regulations and Rulings, Office of
International Trade.
By letter dated April 13, 2007, the
Department of State informed CBP that
the government of Lithuania does not
impose discriminating or countervailing
duties on vessels owned by citizens of
the United States. Accordingly, the
Department of State recommended that
Lithuania be added to the list of
countries whose vessels are exempt
from special tonnage taxes and light
money in ports of the United States,
effective February 13, 2002.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Because this amendment merely
implements a statutory requirement and
confers a benefit upon the public, CBP
has determined that notice and public
procedure are unnecessary pursuant to
section 553(b)(B) of the Administrative
Procedure Act (APA) (5 U.S.C.
553(b)(B)). Further, for the same
reasons, good cause exists for
dispensing with a delayed effective date
under section 553(d)(3) of the APA (5
U.S.C. 553(d)(3)).
Food and Drug Administration
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
[Amended]
I
Dated: March 5, 2008.
Craig A. Walker
Acting Chief, Trade and Commercial
Regulations Branch, Regulations and Rulings,
Office of International Trade.
[FR Doc. E8–4641 Filed 3–7–08; 8:45 am]
BILLING CODE 9111–14–P
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Change of
Sponsor; Ferric Oxide Injection;
Gleptoferron Injection; Iron Dextran
Complex Injection; Iron Hydrogenated
Dextran Injection
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\10MRR1.SGM
10MRR1
Federal Register / Vol. 73, No. 47 / Monday, March 10, 2008 / Rules and Regulations
Final rule; technical
amendment.
§ 522.940
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for two new animal
drug applications (NADAs) for
injectable iron supplements used in
baby pigs from Boehringer Ingelheim
Vetmedica, Inc., to Animal Health
Pharmaceuticals, LLC. In addition, FDA
is taking this opportunity to consolidate
injectable iron supplements in a single
section of the Code of Federal
Regulations (CFR). This is being done to
simplify and clarify the regulations.
DATES: This rule is effective March 10,
2008.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Boehringer Ingelheim Vetmedica, Inc.,
2621 North Belt Highway, St. Joseph,
MO 64506–2002, has informed FDA that
it has transferred ownership of, and all
rights and interest in, NADA 106–772
for Iron-GARD Injection 100 milligrams/
milliliter (mg/mL) and NADA 134–708
for Iron-GARD Injection 200 mg/mL to
Animal Health Pharmaceuticals, LLC,
1805 Oak Ridge Circle, suite 101, St.
Joseph, MO 64506. Accordingly, the
regulations are amended in 21 CFR
522.1182 to reflect these changes of
sponsorship.
In addition, FDA is taking this
opportunity to consolidate such
injectable iron supplements in a single
section of the CFR. This is being done
to simplify and clarify the regulations.
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.
§ 522.1055
ACTION:
I
List of Subjects in 21 CFR Part 522
ebenthall on PRODPC61 with RULES
Animal drugs.
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 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:
I
Authority: 21 U.S.C. 360b.
VerDate Aug<31>2005
15:37 Mar 07, 2008
Jkt 214001
[Removed]
2. Remove § 522.940.
[Removed]
3. Remove § 522.1055.
4. Revise § 522.1182 to read as
follows:
I
I
§ 522.1182
Iron injection.
(a) Specifications. See § 510.440 of
this chapter. Each milliliter (mL) of
solution contains the equivalent of:
(1) 100 milligrams (mg) of elemental
iron derived from:
(i) Ferric hydroxide;
(ii) Ferric oxide; or
(iii) Elemental iron.
(2) 200 mg of elemental iron derived
from ferric hydroxide.
(b) Sponsors and conditions of use. It
is used in baby pigs by sponsors in
§ 510.600(c) of this chapter as follows:
(1) Nos. 059130 and 068718 for use of
product described in paragraph (a)(1)(i)
of this section as follows:
(i) For prevention of iron deficiency
anemia, inject 100 mg (1 mL) by
intramuscular injection at 2 to 4 days of
age.
(ii) For treatment of iron deficiency
anemia, inject 100 mg (1 mL) by
intramuscular injection. Dosage may be
repeated in approximately 10 days.
(2) No. 000856 for use of product
described in paragraph (a)(1)(i) of this
section as follows:
(i) For the prevention of anemia due
to iron deficiency, administer an initial
intramuscular injection of 100 mg at 2
to 4 days of age. Dosage may be repeated
in 14 to 21 days.
(ii) For the treatment of anemia due to
iron deficiency, administer an
intramuscular injection of 200 mg.
(3) Nos. 000061 and 062408 for use of
product described in paragraph (a)(1)(i)
of this section as follows:
(i) For the prevention of iron
deficiency anemia, administer
intramuscularly an amount of drug
containing 100 to 150 mg of elemental
iron to animals from 1 to 3 days of age.
(ii) For the treatment of iron
deficiency anemia, administer
intramuscularly an amount of drug
containing 100 to 200 mg of elemental
iron per animal. Dosage may be repeated
in 10 days to 2 weeks.
(4) Nos. 051311 and 053501 for use of
product described in paragraph (a)(1)(ii)
of this section as follows:
(i) For prevention of iron deficiency
anemia, administer 1 mL by
intramuscular injection at 2 to 5 days of
age. Dosage may be repeated at 2 weeks
of age.
(ii) For treatment of iron deficiency
anemia, administer 1 to 2 mL by
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
12635
intramuscular injection at 5 to 28 days
of age.
(5) No. 053501 for use of product
described in paragraph (a)(1)(iii) of this
section as follows:
(i) For prevention of anemia due to
iron deficiency, administer 100 mg by
intramuscular or subcutaneous injection
at 2 to 4 days of age.
(ii) For treatment of anemia due to
iron deficiency, administer 100 mg by
intramuscular or subcutaneous injection
up to 4 weeks of age.
(6) Nos. 058005 and 059130 for use of
product described in paragraph
(a)(1)(iii) of this section as follows:
(i) For prevention of anemia due to
iron deficiency, administer 100 mg by
intramuscular injection at 2 to 4 days of
age.
(ii) For treatment of anemia due to
iron deficiency, administer 100 mg by
intramuscular injection. Treatment may
be repeated in 10 days.
(7) Nos. 059130 and 068718 for use of
product described in paragraph (a)(2) of
this section as follows:
(i) For prevention of baby pig anemia
due to iron deficiency, intramuscularly
inject 200 mg of elemental iron (1 mL)
at 1 to 3 days of age.
(ii) For treatment of baby pig anemia
due to iron deficiency, intramuscularly
inject 200 mg of elemental iron at the
first sign of anemia.
(8) No. 062408 for use of product
described in paragraph (a)(2) of this
section as follows:
(i) For prevention of iron deficiency
anemia, administer 200 mg
intramuscularly on or before 3 days of
age.
(ii) For treatment of iron deficiency
anemia, administer 200 mg
intramuscularly.
§ 522.1183
I
[Removed]
5. Remove § 522.1183.
Dated: February 27, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–4603 Filed 3–7–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF JUSTICE
United States Parole Commission
28 CFR Part 2
Paroling, Recommitting, and
Supervising Federal Prisoners:
Prisoners Serving Sentences Under
the United States and District of
Columbia Codes
United States Parole
Commission, Justice.
AGENCY:
E:\FR\FM\10MRR1.SGM
10MRR1
]]>Agencies
[Federal Register Volume 73, Number 47 (Monday, March 10, 2008)]
[Rules and Regulations]
[Pages 12634-12635]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-4603]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs; Change
of Sponsor; Ferric Oxide Injection; Gleptoferron Injection; Iron
Dextran Complex Injection; Iron Hydrogenated Dextran Injection
AGENCY: Food and Drug Administration, HHS.
[[Page 12635]]
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for two new animal drug
applications (NADAs) for injectable iron supplements used in baby pigs
from Boehringer Ingelheim Vetmedica, Inc., to Animal Health
Pharmaceuticals, LLC. In addition, FDA is taking this opportunity to
consolidate injectable iron supplements in a single section of the Code
of Federal Regulations (CFR). This is being done to simplify and
clarify the regulations.
DATES: This rule is effective March 10, 2008.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621
North Belt Highway, St. Joseph, MO 64506-2002, has informed FDA that it
has transferred ownership of, and all rights and interest in, NADA 106-
772 for Iron-GARD Injection 100 milligrams/milliliter (mg/mL) and NADA
134-708 for Iron-GARD Injection 200 mg/mL to Animal Health
Pharmaceuticals, LLC, 1805 Oak Ridge Circle, suite 101, St. Joseph, MO
64506. Accordingly, the regulations are amended in 21 CFR 522.1182 to
reflect these changes of sponsorship.
In addition, FDA is taking this opportunity to consolidate such
injectable iron supplements in a single section of the CFR. This is
being done to simplify and clarify the regulations.
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.
Sec. 522.940 [Removed]
0
2. Remove Sec. 522.940.
Sec. 522.1055 [Removed]
0
3. Remove Sec. 522.1055.
0
4. Revise Sec. 522.1182 to read as follows:
Sec. 522.1182 Iron injection.
(a) Specifications. See Sec. 510.440 of this chapter. Each
milliliter (mL) of solution contains the equivalent of:
(1) 100 milligrams (mg) of elemental iron derived from:
(i) Ferric hydroxide;
(ii) Ferric oxide; or
(iii) Elemental iron.
(2) 200 mg of elemental iron derived from ferric hydroxide.
(b) Sponsors and conditions of use. It is used in baby pigs by
sponsors in Sec. 510.600(c) of this chapter as follows:
(1) Nos. 059130 and 068718 for use of product described in
paragraph (a)(1)(i) of this section as follows:
(i) For prevention of iron deficiency anemia, inject 100 mg (1 mL)
by intramuscular injection at 2 to 4 days of age.
(ii) For treatment of iron deficiency anemia, inject 100 mg (1 mL)
by intramuscular injection. Dosage may be repeated in approximately 10
days.
(2) No. 000856 for use of product described in paragraph (a)(1)(i)
of this section as follows:
(i) For the prevention of anemia due to iron deficiency, administer
an initial intramuscular injection of 100 mg at 2 to 4 days of age.
Dosage may be repeated in 14 to 21 days.
(ii) For the treatment of anemia due to iron deficiency, administer
an intramuscular injection of 200 mg.
(3) Nos. 000061 and 062408 for use of product described in
paragraph (a)(1)(i) of this section as follows:
(i) For the prevention of iron deficiency anemia, administer
intramuscularly an amount of drug containing 100 to 150 mg of elemental
iron to animals from 1 to 3 days of age.
(ii) For the treatment of iron deficiency anemia, administer
intramuscularly an amount of drug containing 100 to 200 mg of elemental
iron per animal. Dosage may be repeated in 10 days to 2 weeks.
(4) Nos. 051311 and 053501 for use of product described in
paragraph (a)(1)(ii) of this section as follows:
(i) For prevention of iron deficiency anemia, administer 1 mL by
intramuscular injection at 2 to 5 days of age. Dosage may be repeated
at 2 weeks of age.
(ii) For treatment of iron deficiency anemia, administer 1 to 2 mL
by intramuscular injection at 5 to 28 days of age.
(5) No. 053501 for use of product described in paragraph
(a)(1)(iii) of this section as follows:
(i) For prevention of anemia due to iron deficiency, administer 100
mg by intramuscular or subcutaneous injection at 2 to 4 days of age.
(ii) For treatment of anemia due to iron deficiency, administer 100
mg by intramuscular or subcutaneous injection up to 4 weeks of age.
(6) Nos. 058005 and 059130 for use of product described in
paragraph (a)(1)(iii) of this section as follows:
(i) For prevention of anemia due to iron deficiency, administer 100
mg by intramuscular injection at 2 to 4 days of age.
(ii) For treatment of anemia due to iron deficiency, administer 100
mg by intramuscular injection. Treatment may be repeated in 10 days.
(7) Nos. 059130 and 068718 for use of product described in
paragraph (a)(2) of this section as follows:
(i) For prevention of baby pig anemia due to iron deficiency,
intramuscularly inject 200 mg of elemental iron (1 mL) at 1 to 3 days
of age.
(ii) For treatment of baby pig anemia due to iron deficiency,
intramuscularly inject 200 mg of elemental iron at the first sign of
anemia.
(8) No. 062408 for use of product described in paragraph (a)(2) of
this section as follows:
(i) For prevention of iron deficiency anemia, administer 200 mg
intramuscularly on or before 3 days of age.
(ii) For treatment of iron deficiency anemia, administer 200 mg
intramuscularly.
Sec. 522.1183 [Removed]
0
5. Remove Sec. 522.1183.
Dated: February 27, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-4603 Filed 3-7-08; 8:45 am]
BILLING CODE 4160-01-S
