New Animal Drugs for Use in Animal Feed; Zilpaterol, 14385-14386 [E8-5450]
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14385
Federal Register / Vol. 73, No. 53 / Tuesday, March 18, 2008 / Rules and Regulations
Drug labeler
code
Firm name and address
Pharmacosmos, Inc., 776
Mountain
Blvd.,Watchung, NJ
07069.
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*
*
042552
Food and Drug Administration
21 CFR Part 558
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*
New Animal Drugs for Use in Animal
Feed; Zilpaterol
(2) * * *
AGENCY:
Firm name and address
*
*
ACTION:
*
*
*
Pharmacosmos, Inc., 776
Mountain
Blvd.,Watchung, NJ
07069
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
§ 522.1182
[Amended]
4. In § 522.1182, in paragraphs (b)(1)
and (b)(7) remove ‘‘059130 and 068718’’
and add in its place ‘‘042552 and
059130’’.
I
Dated: March 6, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–5452 Filed 3–17–08; 8:45 am]
BILLING CODE 4160–01–S
Zilpaterol in
grams/ton
*
rwilkins on PROD1PC63 with PROPOSALS
VerDate Aug<31>2005
Indications for use
*
*
Jkt 214001
PO 00000
*
Frm 00015
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 558 is amended as follows:
I
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
2. In § 558.665, add paragraph (e)(3) to
read as follows:
I
§ 558.665
*
Zilpaterol.
*
*
(e) * * *
*
Cattle fed in confinement for slaughter: As
in paragraph (e)(1) of this section; and
for prevention and control of coccidiosis
due to Eimeria bovis and E. zuernii.
*
regulations in 21 CFR 558.665 are
amended to reflect the approval.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
The agency has determined under 21
CFR 25.33(a)(2) 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 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.
*
*
Limitations
*
Monensin 10 to
40
16:03 Mar 17, 2008
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a new animal drug
application (NADA) filed by Intervet,
Inc. The NADA provides for use of
approved, single-ingredient zilpaterol
hydrochloride and monensin U.S.P.
Type A medicated articles to make twoway combination Type B and Type C
medicated feeds for cattle fed in
confinement for slaughter.
DATES: This rule is effective March 18,
2008.
FOR FURTHER INFORMATION CONTACT:
Gerald L. Rushin, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8103, email: gerald.rushin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet,
Inc., P.O. Box 318, 29160 Intervet Lane,
Millsboro, DE 19966, filed NADA 141–
278 that provides for use of ZILMAX
(zilpaterol hydrochloride) and
RUMENSIN (monensin U.S.P.) Type A
medicated articles to make dry and
liquid, two-way combination Type B
and Type C medicated feeds used for
increased rate of weight gain, improved
feed efficiency, and increased carcass
leanness; and for prevention and control
of coccidiosis due to Eimeria bovis and
E. zuernii in cattle fed in confinement
for slaughter during the last 20 to 40
days on feed. The NADA is approved as
of February 15, 2008, and the
Combination in
grams/ton
*
(3) 6.8 to provide
60 to 90 mg/
head/day
*
Food and Drug Administration,
HHS.
Drug labeler
code
*
042552
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Fmt 4700
*
*
As in paragraph (e)(1) of this section; see
paragraph § 558.355(d) of this chapter.
Monensin as provided by No. 000986 in
§ 510.600(c) of this chapter.
*
Sfmt 4700
Sponsor
E:\FR\FM\18MRR1.SGM
*
18MRR1
057926
*
14386
Federal Register / Vol. 73, No. 53 / Tuesday, March 18, 2008 / Rules and Regulations
Dated: March 6, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–5450 Filed 3–17–08; 8:45 am]
‘‘§§ 1.338–11 and 1.338–11T(d)’’ and
adding the language ‘‘§ 1.338–11’’ in its
place.
Cynthia Grigsby,
Senior Federal Register Liaison Officer,
Publications and Regulations Branch, Legal
Processing Division, Office of Associate Chief
Counsel, (Procedure and Administration).
[FR Doc. E8–5333 Filed 3–17–08; 8:45 am]
BILLING CODE 4160–01–S
PART 1—INCOME TAXES
Paragraph 1. The authority citation
for part 1 continues to read, in part, as
follows:
I
Authority: 26 U.S.C. 7805. * * *
BILLING CODE 4830–01–P
Par. 2. Section 1.367(b)–6 is amended
by revising paragraph (a)(1) to read as
follows:
[TD 9377]
DEPARTMENT OF THE TREASURY
§ 1.367(b)–6 Effective dates and
coordination rules.
RIN 1545–BF02
Internal Revenue Service
Application of Section 338 to
Insurance Companies; Correction
26 CFR Part 1
Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting amendment.
[TD 9273]
SUMMARY: This document contains a
correction to final regulations (TD 9377)
that were published in the Federal
Register on Wednesday, January 23,
2008 (73 FR 3868), that apply to a
section 197 intangible resulting from an
assumption reinsurance transaction, and
under section 338 that apply to reserve
increases after a deemed asset sale.
DATES: This correction is effective on
March 18, 2008.
FOR FURTHER INFORMATION CONTACT:
William T. Sullivan (202) 622–7052 (not
toll-free number).
SUPPLEMENTARY INFORMATION:
Stock Transfer Rules: Carryover of
Earnings and Taxes
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
AGENCY:
Background
The final regulations (TD 9377) that is
the subject of this correction is under
section 197 of the Internal Revenue
Code.
Need for Correction
As published, TD 9377 contains an
error that may prove to be misleading
and is in need of clarification.
Correction of Publication
Need for Correction
Accordingly, 26 CFR part 1 is
corrected by making the following
correcting amendment:
I
As published, final regulations (TD
9273) contain errors that may prove to
be misleading and are in need of
clarification.
PART 1—INCOME TAXES
Paragraph 1. The authority citation
for part 1 continues to read as follows:
rwilkins on PROD1PC63 with PROPOSALS
§ 1.1060–1
16:03 Mar 17, 2008
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
Correction of Publication
[Corrected]
I Par. 2. Section 1.1060–1(a)(2)(iii)
introductory text, last sentence is
amended by removing the language
VerDate Aug<31>2005
SUMMARY: This document contains a
correction to final regulations (TD 9273)
that were published in the Federal
Register on Tuesday, August 8, 2006 (71
FR 44887) addressing the carryover of
certain tax attributes, such as earnings
and profits and foreign income tax
accounts, when two corporations
combine in a corporate reorganization or
liquidation that is described in both
sections 367(b) and 381 of the Internal
Revenue Code.
DATES: This correction is effective
March 18, 2008.
FOR FURTHER INFORMATION CONTACT:
Jeffrey L. Parry at (202) 622–3050 (not
a toll-free number).
SUPPLEMENTARY INFORMATION:
The final regulations (TD 9273) that
are the subject of this correction are
under section 367(b) of the Internal
Revenue Code.
Income taxes, Reporting and
recordkeeping requirements.
Authority: 26 U.S.C. 7805. * * *
Internal Revenue Service (IRS),
Treasury.
ACTION: Correction to final regulations.
AGENCY:
Background
List of Subjects 26 CFR Part 1
I
RIN 1545–AX65
Jkt 214001
Accordingly, 26 CFR part 1 is
corrected by making the following
correcting amendment:
I
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
I
(a) Effective date. (1) In general.
Except as otherwise provided in this
paragraph (a)(1), §§ 1.367(b)–1 through
1.367(b)–5, and this section, apply to
section 367(b) exchanges that occur on
or after February 23, 2000. The rules of
§§ 1.367(b)–3 and 1.367(b)–4, as they
apply to reorganizations described in
section 368(a)(1)(A) (including
reorganizations described in section
368(a)(2)(D) or (E)) involving a foreign
acquiring or foreign acquired
corporation, apply only to transfers
occurring on or after January 23, 2006.
Section 1.367(b)–4(b)(1)(ii) applies to all
triangular reorganizations and
reorganizations described in section
368(a)(1)(G) and (a)(2)(D) occurring on
or after January 23, 2006, although
taxpayers may apply § 1.367(b)–
4(b)(1)(ii) to triangular B reorganizations
occurring on or after February 23, 2000,
in a taxable year that is not closed by
the period of limitations if done
consistently with respect to all such
triangular B reorganizations. The second
sentence of paragraph (a) in § 1.367(b)–
4 shall apply to section 304(a)(1)
transactions occurring on or after
February 23, 2006; however, taxpayers
may rely on this sentence for all section
304(a)(1) transactions occurring in open
taxable years. Section 1.367(b)–
1(c)(2)(v), (c)(3)(ii)(A), (c)(4)(iv),
(c)(4)(v), 1.367(b)–2(j)(1)(i), (l), and
1.367(b)–3(e) and (f), apply to section
367(b) exchanges that occur on or after
November 6, 2006. For guidance with
respect to § 1.367(b)–1(c)(3)(ii)(A) and
(c)(4)(iv) and (v) and § 1.367(b)–2(j)(1)(i)
for exchanges that occur before
November 6, 2006, see 26 CFR part 1
revised as of April 1, 2006.
*
*
*
*
*
La Nita VanDyke,
Branch Chief, Publications and Regulations
Branch, Legal Processing Division, Associate
Chief Counsel (Procedure and
Administration).
[FR Doc. E8–5334 Filed 3–17–08; 8:45 am]
BILLING CODE 4830–01–P
E:\FR\FM\18MRR1.SGM
18MRR1
]]>Agencies
[Federal Register Volume 73, Number 53 (Tuesday, March 18, 2008)]
[Rules and Regulations]
[Pages 14385-14386]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-5450]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal Feed; Zilpaterol
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 new animal drug application
(NADA) filed by Intervet, Inc. The NADA provides for use of approved,
single-ingredient zilpaterol hydrochloride and monensin U.S.P. Type A
medicated articles to make two-way combination Type B and Type C
medicated feeds for cattle fed in confinement for slaughter.
DATES: This rule is effective March 18, 2008.
FOR FURTHER INFORMATION CONTACT: Gerald L. Rushin, Center for
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8103, e-mail:
gerald.rushin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet
Lane, Millsboro, DE 19966, filed NADA 141-278 that provides for use of
ZILMAX (zilpaterol hydrochloride) and RUMENSIN (monensin U.S.P.) Type A
medicated articles to make dry and liquid, two-way combination Type B
and Type C medicated feeds used for increased rate of weight gain,
improved feed efficiency, and increased carcass leanness; and for
prevention and control of coccidiosis due to Eimeria bovis and E.
zuernii in cattle fed in confinement for slaughter during the last 20
to 40 days on feed. The NADA is approved as of February 15, 2008, and
the regulations in 21 CFR 558.665 are amended to reflect the approval.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(2) 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 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 558
Animal drugs, Animal feeds.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
2. In Sec. 558.665, add paragraph (e)(3) to read as follows:
Sec. 558.665 Zilpaterol.
* * * * *
(e) * * *
----------------------------------------------------------------------------------------------------------------
Zilpaterol in Combination in
grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(3) 6.8 to Monensin 10 to 40 Cattle fed in confinement for As in paragraph (e)(1) of this 057926
provide 60 to slaughter: As in paragraph section; see paragraph Sec.
90 mg/head/day (e)(1) of this section; and 558.355(d) of this chapter.
for prevention and control of Monensin as provided by No.
coccidiosis due to Eimeria 000986 in Sec. 510.600(c)
bovis and E. zuernii. of this chapter.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
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[[Page 14386]]
Dated: March 6, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-5450 Filed 3-17-08; 8:45 am]
BILLING CODE 4160-01-S
