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Federal Register / Vol. 71, No.

129 / Thursday, July 6, 2006 / Rules and Regulations 38261

million; freight forwarding firms are Done in Washington, DC, this 29th day of data and information submitted to
small if their annual receipts are less June 2006. support approval of this application
than $6 million, and deep sea freight Kevin Shea, may be seen in the Division of Dockets
transport firms are small if they have Acting Administrator, Animal and Plant Management (HFA–305), Food and Drug
not more than 500 workers. According Health Inspection Service. Administration, 5630 Fishers Lane, rm.
to the 2002 Economic Census, there [FR Doc. E6–10555 Filed 7–5–06; 8:45 am] 1061, Rockville, MD 20852, between 9
were 9,177 trucking firms, 5,840 freight BILLING CODE 3410–34–P a.m. and 4 p.m., Monday through
forwarders, and 383 deep sea freight Friday.
transport companies. Over 99 percent of The agency has determined under 21
trucking firms, 90 percent freight DEPARTMENT OF HEALTH AND CFR 25.33(a)(1) that this action is of a
forwarders, and 70 percent of deep sea HUMAN SERVICES type that does not individually or
freight transport firms are considered to cumulatively have a significant effect on
be small. Although the majority of these Food and Drug Administration the human environment. Therefore,
establishments are small entities, the neither an environmental assessment
effect of this rule will be negligible. 21 CFR Part 524 nor an environmental impact statement
Under these circumstances, the is required.
Administrator of the Animal and Plant Ophthalmic and Topical Dosage Form This rule does not meet the definition
Health Inspection Service has New Animal Drugs; Gentamicin of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
Sulfate, Betamethasone Valerate, it is a rule of ‘‘particular applicability.’’
determined that this action will not
Clotrimazole Ointment Therefore, it is not subject to the
have a significant economic impact on
congressional review requirements in 5
a substantial number of small entities. AGENCY: Food and Drug Administration, U.S.C. 801–808.
Executive Order 12988 HHS.
List of Subjects in 21 CFR Part 524
ACTION: Final rule.
This final rule has been reviewed Animal drugs.
under Executive Order 12988, Civil SUMMARY: The Food and Drug ■ Therefore, under the Federal Food,
Justice Reform. This rule: (1) Preempts Administration (FDA) is amending the Drug, and Cosmetic Act and under
all State and local laws and regulations animal drug regulations to reflect authority delegated to the Commissioner
that are inconsistent with this rule; (2) approval of an abbreviated new animal of Food and Drugs and redelegated to
has no retroactive effect; and (3) does drug application (ANADA) filed by the Center for Veterinary Medicine, 21
not require administrative proceedings Altana Inc. The ANADA provides for CFR part 524 is amended as follows:
before parties may file suit in court veterinary prescription use of
challenging this rule. gentamicin sulfate, betamethasone PART 524—OPHTHALMIC AND
Paperwork Reduction Act valerate, clotrimazole ointment for the TOPICAL DOSAGE FORM NEW
treatment of canine otitis externa. ANIMAL DRUGS
This rule contains no information DATES: This rule is effective July 6,
collection or recordkeeping ■ 1. The authority citation for 21 CFR
2006.
requirements under the Paperwork part 524 continues to read as follows:
Reduction Act of 1995 (44 U.S.C. 3501 FOR FURTHER INFORMATION CONTACT: Authority: 21 U.S.C. 360b.
et seq.). Daniel A. Benz, Center for Veterinary
■ 2. In § 524.1044g, add paragraph (b)(4)
Medicine (HFV–104), Food and Drug
List of Subjects in 9 CFR Part 94 to read as follows:
Administration, 7500 Standish Pl.,
Animal diseases, Imports, Livestock, Rockville, MD 20855, 301–827–0223, e- § 524.1044g Gentamicin sulfate,
Meat and meat products, Milk, Poultry mail: daniel.benz@fda.hhs.gov. betamethasone valerate, clotrimazole
and poultry products, Reporting and SUPPLEMENTARY INFORMATION: Altana ointment.
recordkeeping requirements. Inc., 60 Baylis Rd., Melville, NY 11747, * * * * *
filed ANADA 200–283 that provides for (b) * * *
■ Accordingly, we are amending 9 CFR (4) No. 025463 for use of 7.5- or 15-
part 94 as follows: veterinary prescription use of VETRO–
MAX (gentamicin sulfate, USP; g tubes, or 215-g bottles.
PART 94—RINDERPEST, FOOT-AND- betamethasone valerate, USP; and * * * * *
MOUTH DISEASE, FOWL PEST (FOWL clotrimazole, USP, ointment) for the Dated: June 22, 2006.
PLAGUE), EXOTIC NEWCASTLE treatment of canine otitis externa Stephen F. Sundlof,
DISEASE, AFRICAN SWINE FEVER, associated with yeast (Malassezia Director, Center for Veterinary Medicine.
CLASSICAL SWINE FEVER, AND pachydermatis, formerly Pityrosporum [FR Doc. E6–10496 Filed 7–5–06; 8:45 am]
BOVINE SPONGIFORM canis) and/or bacteria susceptible to
BILLING CODE 4160–01–S
ENCEPHALOPATHY: PROHIBITED gentamicin. Altana Inc.’s VETRO–MAX
AND RESTRICTED IMPORTATIONS Otic Ointment is approved as a generic
copy of Schering-Plough Animal Health
■ 1. The authority citation for part 94 Corp.’s OTOMAX Ointment approved DEPARTMENT OF THE TREASURY
continues to read as follows: under NADA 140–896. The ANADA is Internal Revenue Service
Authority: 7 U.S.C. 450, 7701–7772, 7781– approved as of June 1, 2006, and the
7786, and 8301–8317; 21 U.S.C. 136 and regulations are amended in 21 CFR 26 CFR Part 1
136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 524.1044g to reflect the approval. The
371.4. basis of approval is discussed in the Corporate Distributions and
freedom of information summary.
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§ 94.6 [Amended] Adjustments


In accordance with the freedom of
■ 2. In § 94.6, paragraph (a)(2) is information provisions of 21 CFR part CFR Correction
amended by adding the word 20 and 21 CFR 514.11(e)(2)(ii), a In Title 26 of the Code of Federal
‘‘Denmark,’’ before the word ‘‘Fiji.’’ summary of safety and effectiveness Regulations, part 1 (§§ 1.301 to 1.400),

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38262 Federal Register / Vol. 71, No. 129 / Thursday, July 6, 2006 / Rules and Regulations

revised as of April 1, 2006, on page 10, FOR FURTHER INFORMATION CONTACT: Paul well as from the sale to customers of P’s
§ 1.301–1 is corrected by adding Handleman or Lauren RossTaylor, (202) substantially identical tax preparation
paragraph (g) to read as follows: 622–3040 (not a toll-free number). computer software that customers have
downloaded from the Internet. Under
SUPPLEMENTARY INFORMATION: paragraph (i)(6)(iii)(B) of this section, O’s
§ 1.301–1 Rules applicable with respect to
distributions of money and other property. Background gross receipts derived from providing its tax
* * * * * preparation computer software to customers
The correction notice that is the over the Internet will be treated as derived
(g) Reduction for liabilities—(1) subject of this document is under from the lease, rental, license, sale, exchange,
General rule. For the purpose of section section 199 of the Internal Revenue or other disposition of computer software
301, no reduction shall be made for the and are DPGR (assuming all the other
Code.
amount of any liability, unless the requirements of § 1.199–3 are met).
liability is assumed by the shareholder Need for Correction
* * * * *
within the meaning of section 357(d). As published, the correction notice
(2) No reduction below zero. Any (TD 9262) contains errors that may § 1.199–8T [Corrected]
reduction pursuant to paragraph (g)(1) prove to be misleading and are in need
of this section shall not cause the ■ Par. 3. Section 1.199–8T is amended
of clarification. by revising paragraph (i)(4) to read as
amount of the distribution to be reduced
below zero. List of Subjects in 26 CFR Part 1 follows:
(3) Effective dates—(i) In general. This Income taxes, Reporting and § 1.199–8T Other rules (temporary).
paragraph (g) applies to distributions recordkeeping requirements. (i) * * *
occurring after January 4, 2001.
(ii) Retroactive application. This Correction of Publication (4) Computer software. Section 1.199–
paragraph (g) also applies to 3T(i)(6)(ii) through (v) are applicable for
■ Accordingly, 26 CFR part 1 is taxable years beginning on or after June
distributions made on or before January
corrected by making the following 1, 2006. Taxpayers may apply these
4, 2001, if the distribution is made as
correcting amendments: temporary regulations to taxable years
part of a transaction described in, or
substantially similar to, the transaction beginning after December 31, 2004, and
PART 1—INCOME TAXES before June 1, 2006. The applicability of
in Notice 99-59 (1999-2 C.B. 761),
including transactions designed to ■ Paragraph 1. The authority citation § 1.199–3T(i)(6)(ii) through (v) expires
reduce gain (see § 601.601(d)(2) of this for part 1 continues to read in part as on or before May 22, 2009.
chapter). For rules for distributions on follows: Guy R. Traynor,
or before January 4, 2001 (other than Authority: 26 U.S.C. 7805 * * * Chief, Publications and Regulations Branch,
distributions on or before that date to Legal Processing Division, Associate Chief
which this paragraph (g) applies), see § 1.199–3T [Corrected] Counsel (Procedure and Administration).
rules in effect on January 4, 2001 (see ■ Par. 2. Section 1.199–3T is amended [FR Doc. E6–10245 Filed 7–5–06; 8:45 am]
§ 1.301-1(g) as contained in 26 CFR part by revising paragraphs (i)(6)(iii) BILLING CODE 4830–01–P
1 revised April 1, 2001). introductory text and Example 5 to read
[FR Doc. 06–55522 Filed 7–5–06; 8:45 am] as follows:
BILLING CODE 1505–01–D
DEPARTMENT OF THE TREASURY
§ 1.199–3T Domestic production gross
receipts (temporary). Internal Revenue Service
DEPARTMENT OF THE TREASURY * * * * *
(i) * * * 26 CFR Part 301
Internal Revenue Service (6) * * *
(iii) Exceptions. Notwithstanding [TD 9267]
26 CFR Part 1 paragraph (i)(6)(ii) of this section, if a
taxpayer derives gross receipts from RIN 1545–BE02
[TD 9262] providing to customers computer
software MPGE in whole or in Disclosure of Return Information to the
RIN 1545–BF57
significant part by the taxpayer within Bureau of Economic Analysis
Computer Software Under Section the United States for the customers’ AGENCY: Internal Revenue Service (IRS),
199(c)(5)(B); Correction direct use while connected to the Treasury.
Internet (online software), then such
AGENCY: Internal Revenue Service (IRS), ACTION: Temporary regulations.
gross receipts will be treated as being
Treasury.
derived from the lease, rental, license, SUMMARY: This document contains
ACTION: Correcting amendments. sale, exchange, or other disposition of temporary regulations regarding
SUMMARY: This document contains a computer software only if— additional items of return information
correction to temporary regulations (TD * * * * * disclosable to the Bureau of Economic
9262) that were published in the Example 5. The facts are the same as in Analysis (Bureau) of the Department of
Federal Register on Thursday, June 1, Example 4, except that O does not sell the Commerce. The text of these temporary
2006 (71 FR 31074) concerning the tax preparation computer software to regulations serves as the text of the
application of section 199 of the Internal customers affixed to a compact disc or by proposed regulations set forth in the
Revenue Code, which provides a download and O’s only method of providing notice of proposed rulemaking on this
deduction for income attributable to the tax preparation computer software to subject in the Proposed Rules section of
domestic production activities, to customers is over the Internet. P, an this issue of the Federal Register.
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unrelated person, derives, on a regular and


certain transactions involving computer ongoing basis in its business, gross receipts DATES: Effective Date: These temporary
software. from the sale to customers of P’s substantially regulations are effective July 6, 2006.
DATES: These corrections are effective identical tax preparation computer software Applicability Date: For dates of
June 1, 2006. that has been affixed to a compact disc as applicability, see § 301.6103(j)(1)–1T(f).

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