Vous êtes sur la page 1sur 2

Federal Register / Vol. 73, No.

53 / Tuesday, March 18, 2008 / Rules and Regulations 14385

Drug labeler DEPARTMENT OF HEALTH AND regulations in 21 CFR 558.665 are


Firm name and address code HUMAN SERVICES amended to reflect the approval.
In accordance with the freedom of
Pharmacosmos, Inc., 776 042552 Food and Drug Administration information provisions of 21 CFR part
Mountain 20 and 21 CFR 514.11(e)(2)(ii), a
Blvd.,Watchung, NJ 21 CFR Part 558
07069.
summary of safety and effectiveness
* * * * *
data and information submitted to
New Animal Drugs for Use in Animal support approval of this application
Feed; Zilpaterol may be seen in the Division of Dockets
(2) * * * AGENCY: Food and Drug Administration, Management (HFA–305), Food and Drug
HHS. Administration, 5630 Fishers Lane, rm.
Drug labeler 1061, Rockville, MD 20852, between 9
Firm name and address ACTION: Final rule.
code
a.m. and 4 p.m., Monday through
SUMMARY: The Food and Drug Friday.
* * * * *
042552 Pharmacosmos, Inc., 776
Administration (FDA) is amending the The agency has determined under 21
Mountain animal drug regulations to reflect CFR 25.33(a)(2) that this action is of a
Blvd.,Watchung, NJ approval of a new animal drug type that does not individually or
07069 application (NADA) filed by Intervet, cumulatively have a significant effect on
* * * * * Inc. The NADA provides for use of the human environment. Therefore,
approved, single-ingredient zilpaterol neither an environmental assessment
hydrochloride and monensin U.S.P. nor environmental impact statement is
PART 522—IMPLANTATION OR Type A medicated articles to make two-
INJECTABLE DOSAGE FORM NEW required.
way combination Type B and Type C This rule does not meet the definition
ANIMAL DRUGS medicated feeds for cattle fed in of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
confinement for slaughter. it is a rule of ‘‘particular applicability.’’
■ 3. The authority citation for 21 CFR DATES: This rule is effective March 18, Therefore, it is not subject to the
part 522 continues to read as follows: 2008. congressional review requirements in 5
Authority: 21 U.S.C. 360b. FOR FURTHER INFORMATION CONTACT: U.S.C. 801–808.
Gerald L. Rushin, Center for Veterinary
§ 522.1182 [Amended] List of Subjects in 21 CFR Part 558
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl., Animal drugs, Animal feeds.
■ 4. In § 522.1182, in paragraphs (b)(1)
Rockville, MD 20855, 240–276–8103, e- ■ Therefore, under the Federal Food,
and (b)(7) remove ‘‘059130 and 068718’’
mail: gerald.rushin@fda.hhs.gov. Drug, and Cosmetic Act and under the
and add in its place ‘‘042552 and
SUPPLEMENTARY INFORMATION: Intervet, authority delegated to the Commissioner
059130’’.
Inc., P.O. Box 318, 29160 Intervet Lane, of Food and Drugs and redelegated to
Dated: March 6, 2008. Millsboro, DE 19966, filed NADA 141– the Center for Veterinary Medicine, 21
Bernadette Dunham, 278 that provides for use of ZILMAX CFR part 558 is amended as follows:
Director, Center for Veterinary Medicine. (zilpaterol hydrochloride) and
RUMENSIN (monensin U.S.P.) Type A PART 558—NEW ANIMAL DRUGS FOR
[FR Doc. E8–5452 Filed 3–17–08; 8:45 am]
medicated articles to make dry and USE IN ANIMAL FEEDS
BILLING CODE 4160–01–S
liquid, two-way combination Type B
and Type C medicated feeds used for ■ 1. The authority citation for 21 CFR
increased rate of weight gain, improved part 558 continues to read as follows:
feed efficiency, and increased carcass Authority: 21 U.S.C. 360b, 371.
leanness; and for prevention and control ■ 2. In § 558.665, add paragraph (e)(3) to
of coccidiosis due to Eimeria bovis and read as follows:
E. zuernii in cattle fed in confinement
for slaughter during the last 20 to 40 § 558.665 Zilpaterol.
days on feed. The NADA is approved as * * * * *
of February 15, 2008, and the (e) * * *

Zilpaterol in Combination in Indications for use Limitations Sponsor


grams/ton grams/ton

* * * * * * *

(3) 6.8 to provide Monensin 10 to Cattle fed in confinement for slaughter: As As in paragraph (e)(1) of this section; see 057926
60 to 90 mg/ 40 in paragraph (e)(1) of this section; and paragraph § 558.355(d) of this chapter.
head/day for prevention and control of coccidiosis Monensin as provided by No. 000986 in
due to Eimeria bovis and E. zuernii. § 510.600(c) of this chapter.

* * * * * * *
rwilkins on PROD1PC63 with PROPOSALS

VerDate Aug<31>2005 16:03 Mar 17, 2008 Jkt 214001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\18MRR1.SGM 18MRR1
14386 Federal Register / Vol. 73, No. 53 / Tuesday, March 18, 2008 / Rules and Regulations

Dated: March 6, 2008. ‘‘§§ 1.338–11 and 1.338–11T(d)’’ and PART 1—INCOME TAXES
Bernadette Dunham, adding the language ‘‘§ 1.338–11’’ in its
Director, Center for Veterinary Medicine. place. ■ Paragraph 1. The authority citation
[FR Doc. E8–5450 Filed 3–17–08; 8:45 am] Cynthia Grigsby,
for part 1 continues to read, in part, as
BILLING CODE 4160–01–S follows:
Senior Federal Register Liaison Officer,
Publications and Regulations Branch, Legal Authority: 26 U.S.C. 7805. * * *
Processing Division, Office of Associate Chief
DEPARTMENT OF THE TREASURY Counsel, (Procedure and Administration). ■ Par. 2. Section 1.367(b)–6 is amended
[FR Doc. E8–5333 Filed 3–17–08; 8:45 am] by revising paragraph (a)(1) to read as
Internal Revenue Service BILLING CODE 4830–01–P follows:
26 CFR Part 1 § 1.367(b)–6 Effective dates and
DEPARTMENT OF THE TREASURY coordination rules.
[TD 9377]
(a) Effective date. (1) In general.
RIN 1545–BF02 Internal Revenue Service
Except as otherwise provided in this
Application of Section 338 to 26 CFR Part 1 paragraph (a)(1), §§ 1.367(b)–1 through
Insurance Companies; Correction 1.367(b)–5, and this section, apply to
section 367(b) exchanges that occur on
AGENCY: Internal Revenue Service (IRS), [TD 9273]
or after February 23, 2000. The rules of
Treasury. §§ 1.367(b)–3 and 1.367(b)–4, as they
ACTION: Correcting amendment. RIN 1545–AX65
apply to reorganizations described in
SUMMARY: This document contains a Stock Transfer Rules: Carryover of section 368(a)(1)(A) (including
correction to final regulations (TD 9377) Earnings and Taxes reorganizations described in section
that were published in the Federal 368(a)(2)(D) or (E)) involving a foreign
Register on Wednesday, January 23, AGENCY: Internal Revenue Service (IRS), acquiring or foreign acquired
2008 (73 FR 3868), that apply to a Treasury. corporation, apply only to transfers
section 197 intangible resulting from an ACTION: Correction to final regulations. occurring on or after January 23, 2006.
assumption reinsurance transaction, and Section 1.367(b)–4(b)(1)(ii) applies to all
SUMMARY: This document contains a
under section 338 that apply to reserve triangular reorganizations and
correction to final regulations (TD 9273)
increases after a deemed asset sale. reorganizations described in section
that were published in the Federal
DATES: This correction is effective on 368(a)(1)(G) and (a)(2)(D) occurring on
Register on Tuesday, August 8, 2006 (71
March 18, 2008. or after January 23, 2006, although
FR 44887) addressing the carryover of
FOR FURTHER INFORMATION CONTACT: certain tax attributes, such as earnings taxpayers may apply § 1.367(b)–
William T. Sullivan (202) 622–7052 (not and profits and foreign income tax 4(b)(1)(ii) to triangular B reorganizations
toll-free number). accounts, when two corporations occurring on or after February 23, 2000,
SUPPLEMENTARY INFORMATION: combine in a corporate reorganization or in a taxable year that is not closed by
liquidation that is described in both the period of limitations if done
Background consistently with respect to all such
sections 367(b) and 381 of the Internal
The final regulations (TD 9377) that is Revenue Code. triangular B reorganizations. The second
the subject of this correction is under DATES: This correction is effective sentence of paragraph (a) in § 1.367(b)–
section 197 of the Internal Revenue March 18, 2008. 4 shall apply to section 304(a)(1)
Code. transactions occurring on or after
FOR FURTHER INFORMATION CONTACT:
Need for Correction Jeffrey L. Parry at (202) 622–3050 (not February 23, 2006; however, taxpayers
a toll-free number). may rely on this sentence for all section
As published, TD 9377 contains an 304(a)(1) transactions occurring in open
error that may prove to be misleading SUPPLEMENTARY INFORMATION:
taxable years. Section 1.367(b)–
and is in need of clarification. Background 1(c)(2)(v), (c)(3)(ii)(A), (c)(4)(iv),
List of Subjects 26 CFR Part 1 The final regulations (TD 9273) that (c)(4)(v), 1.367(b)–2(j)(1)(i), (l), and
Income taxes, Reporting and are the subject of this correction are 1.367(b)–3(e) and (f), apply to section
recordkeeping requirements. under section 367(b) of the Internal 367(b) exchanges that occur on or after
Revenue Code. November 6, 2006. For guidance with
Correction of Publication respect to § 1.367(b)–1(c)(3)(ii)(A) and
Need for Correction (c)(4)(iv) and (v) and § 1.367(b)–2(j)(1)(i)
■ Accordingly, 26 CFR part 1 is
corrected by making the following As published, final regulations (TD for exchanges that occur before
correcting amendment: 9273) contain errors that may prove to November 6, 2006, see 26 CFR part 1
be misleading and are in need of revised as of April 1, 2006.
PART 1—INCOME TAXES clarification. * * * * *
■ Paragraph 1. The authority citation List of Subjects in 26 CFR Part 1
La Nita VanDyke,
for part 1 continues to read as follows: Income taxes, Reporting and Branch Chief, Publications and Regulations
rwilkins on PROD1PC63 with PROPOSALS

Authority: 26 U.S.C. 7805. * * * recordkeeping requirements. Branch, Legal Processing Division, Associate
Correction of Publication Chief Counsel (Procedure and
§ 1.1060–1 [Corrected] Administration).
■ Par. 2. Section 1.1060–1(a)(2)(iii) ■ Accordingly, 26 CFR part 1 is [FR Doc. E8–5334 Filed 3–17–08; 8:45 am]
introductory text, last sentence is corrected by making the following BILLING CODE 4830–01–P
amended by removing the language correcting amendment:

VerDate Aug<31>2005 16:03 Mar 17, 2008 Jkt 214001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\18MRR1.SGM 18MRR1

Vous aimerez peut-être aussi