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Federal Register / Vol. 72, No.

61 / Friday, March 30, 2007 / Rules and Regulations 15043

and standard temperature, and the type Issued in Kansas City, Missouri on March (5 U.S.C. 553). Notice and public
of surface for which it is valid; 23, 2007. procedures are unnecessary because
(4) The effect on landing distances of Kim Smith, FDA is merely implementing a change
operation on other than smooth hard Manager, Small Airplane Directorate, Aircraft in citation to a section of the act as a
surfaces, when dry, determined under Certification Service. result of amendment of the act.
SC 23.45(g); and [FR Doc. E7–5951 Filed 3–29–07; 8:45 am]
List of Subjects in 21 CFR Part 310
BILLING CODE 4910–13–P
(5) The effect on landing distances of Administrative practice and
runway slope and 50 percent of the procedure, Drugs, Labeling, Medical
headwind component and 150 percent devices, Reporting and recordkeeping
of the tailwind component. DEPARTMENT OF HEALTH AND
HUMAN SERVICES requirements.
(b) Not applicable. ■ Therefore, under the Federal Food,
(c) Not applicable. Food and Drug Administration Drug, and Cosmetic Act and under
(d) In addition to paragraph (a) of this authority delegated to the Commissioner
21 CFR Part 310 of Food and Drugs, 21 CFR part 310 is
section the following information must
be furnished— [Docket No. 2007N–0099]
amended as follows:
(1) The accelerate-stop distance PART 310—NEW DRUGS
New Drugs Exempted From
determined under SC 23.55;
Prescription-Dispensing ■ 1. The authority citation for 21 CFR
(2) The takeoff distance determined Requirements; Technical Amendment
under SC 23.59(a); part 310 continues to read as follows:
AGENCY: Food and Drug Administration, Authority: 21 U.S.C. 321, 331, 351, 352,
(3) At the option of the applicant, the
HHS. 353, 355, 360b–360f, 360j, 361(a), 371, 374,
takeoff run determined under SC 375, 379e; 42 U.S.C. 216, 241, 242(a), 262,
23.59(b); Final rule; technical
ACTION:
amendment. 263b–263n.
(4) The effect on accelerate-stop
§ 310.200 [Amended]
distance, takeoff distance and, if SUMMARY: Amendments to the Federal
determined, takeoff run, of operation on Food, Drug, and Cosmetic Act (the act) ■ 2. In § 310.200(a), (b), and (e) remove
other than smooth hard surfaces, when necessitate several changes to the ‘‘503(b)(1)(C)’’ wherever it appears and
dry, determined under SC 23.45(g); citations used in Food and Drug add in its place ‘‘503(b)(1)(B)’’.
(5) The effect on accelerate-stop Administration (FDA) regulations
§ 310.201 [Amended]
distance, takeoff distance, and if regarding the prescription-exemption
determined, takeoff run, of runway procedure and the list of new drugs that ■ 3. In § 310.201(a) remove
slope and 50 percent of the headwind are exempted from the prescription- ‘‘503(b)(1)(C)’’ and add in its place
component and 150 percent of the dispensing requirements. These changes ‘‘503(b)(1)(B)’’.
tailwind component; are editorial, pertaining only to Dated: March 22, 2007.
citations, and do not constitute a change Jeffrey Shuren,
(6) The net takeoff flight path in FDA regulation.
determined under SC 23.61(b); Assistant Commissioner for Policy.
DATES: This rule is effective March 30, [FR Doc. E7–5895 Filed 3–29–07; 8:45 am]
(7) The enroute gradient of climb/ 2007.
descent with one engine inoperative, BILLING CODE 4160–01–S
FOR FURTHER INFORMATION CONTACT:
determined under § 23.69(b); Gerald M. Rachanow, Center for Drug
(8) The effect, on the net takeoff flight Evaluation and Research, Food and DEPARTMENT OF THE TREASURY
path and on the enroute gradient of Drug Administration, 10903 New
climb/descent with one engine Hampshire Ave., Bldg. 22, rm. 5496, Internal Revenue Service
inoperative, of 50 percent of the Silver Spring, MD 20993, 301–796–
headwind component and 150 percent 2090. 26 CFR Part 1
of the tailwind component;
SUPPLEMENTARY INFORMATION: Section [TD 9320]
(9) Overweight landing performance 126 of the Food and Drug
information (determined by Administration Modernization Act of RIN 1545-BF67
extrapolation and computed for the 1997 (FDAMA) (Public Law 105–115)
range of weights between the maximum United States Dollar Approximate
amended section 503(b)(1) of the act (21
landing and maximum takeoff weights) Separate Transactions Method
U.S.C. 353(b)(1)). Specifically, the
as follows— previous paragraph (b)(1)(A) of the act AGENCY: Internal Revenue Service (IRS),
(i) The maximum weight for each was stricken from the act and Treasury.
airport altitude and ambient paragraphs (b)(1)(B) and (b)(1)(C) were ACTION: Final regulation.
temperature at which the airplane redesignated as paragraphs (b)(1)(A) and
complies with the climb requirements of (b)(1)(B), respectively. This amendment SUMMARY: This document contains final
SC 23.63(d)(2); and to the act necessitates that FDA revise regulations which provide the
(ii) The landing distance determined the corresponding citations in its translation rates that must be used when
under § 23.75 for each airport altitude regulations. FDA is making this change translating into dollars certain items and
and standard temperature. in 21 CFR part 310 (§§ 310.200 and amounts transferred by a qualified
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310.201). These changes are editorial, business unit (QBU) to its home office
(10) The relationship between IAS pertaining only to citations, and do not or parent corporation for purposes of
and CAS determined in accordance with constitute a change in FDA regulation. computing dollar approximate separate
§ 23.1323 (b) and (c). Publication of this document transactions method (DASTM) gain or
(11) The altimeter system calibration constitutes final action on this change loss. This regulation is necessary to
required by § 23.1325(e). under the Administrative Procedure Act provide guidance under section 985

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15044 Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations

regarding the proper translation rates including dividend distributions, PART 1—INCOME TAXES
that must be used under the DASTM certain transfers, and returns of capital
method. Taxpayers affected by these from the QBU to its home office or ■ Paragraph 1. The authority citation
regulations are taxpayers with QBUs parent corporation. This final regulation for part 1 continues to read in part as
required to use the DASTM method of provides the translation rate to be used follows:
accounting described in § 1.985–3. in translating these items into dollars for
Authority: 26 U.S.C. 7805 * * *
DATES: Effective Date: This regulation is purposes of computing DASTM gain or
effective March 30, 2007. loss.
Under § 1.985–3(d)(3), the applicable ■ Par. 2. Section 1.985–3 is amended by
Applicability Date: This regulation is revising paragraph (d)(3) to read as
applicable to any transfer, dividend, or translation rate to be used generally
depends upon whether the dollar value follows:
distribution that is a return of capital
that is made after March 8, 2005, and of the item transferred changes with § 1.985–3 United States dollar approximate
fluctuations in exchange rates. separate transactions method.
that gives rise to an adjustment under
Accordingly, the regulation provides
§ 1.985–3(d)(3). * * * * *
that if the item giving rise to the
FOR FURTHER INFORMATION CONTACT: (d) * * *
adjustment is an asset which would be
Sheila Ramaswamy, at (202) 622–3870. translated under § 1.985–3(d)(5) at the (3) Positive adjustments—(i) In
SUPPLEMENTARY INFORMATION: exchange rate for the last translation general. The items described in this
Background period of the taxable year if it were on paragraph (d)(3) are dividend
the QBU’s year-end balance sheet, the distributions for the taxable year and
On July 13, 2006, a notice of proposed item will be translated at the exchange
rulemaking (REG–118897–06), United any items that decrease net worth for
rate on the date the item is transferred. the taxable year but that generally do
States Dollar Approximate Separate However, if the item giving rise to the
Transactions Method, was published in not affect income or loss or earnings and
adjustment is an asset which would be
the Federal Register (71 FR 39604). The profits (or a deficit in earnings and
translated under § 1.985–3(d)(5) at the
notice of proposed rulemaking proposed profits). Such items include a transfer to
exchange rate for the translation period
to amend § 1.985–3(d)(3). No requests in which the cost of the item was the home office of a QBU branch and a
for a public hearing were received, and incurred if it were on the QBU’s year- return of capital.
no public hearing was held. The IRS end balance sheet, the item will be (ii) Translation. Except as provided by
received no comments in response to translated at the same historical rate. ruling or administrative
the notice of proposed rulemaking. The pronouncement, items described in
proposed regulation is adopted without Special Analyses
paragraph (d)(3)(i) of this section shall
change by this Treasury decision. It has been determined that this be translated into dollars as follows:
Explanation of Provisions Treasury decision is not a significant
regulatory action as defined in (A) If the item giving rise to the
For taxable years beginning after Executive Order 12866. Therefore, a adjustment would be translated under
August 24, 1994, a U.S. taxpayer’s QBU regulatory assessment is not required. It paragraph (d)(5) of this section at the
that would otherwise be required to use has been determined that sections 553 exchange rate for the last translation
a hyperinflationary currency as its (b) and (d) of the Administrative period of the taxable year if it were
functional currency generally must use Procedure Act (5 U.S.C. chapter 5) do shown on the QBU’s year-end balance
the dollar as its functional currency and not apply to this regulation, and because sheet, such item shall be translated at
must compute income or loss under the this regulation does not impose a the exchange rate on the date the item
DASTM method of accounting collection of information on small is transferred.
described in § 1.985–3. See § 1.985– entities, the provisions of the Regulatory (B) If the item giving rise to the
1(b)(2)(ii). Under the DASTM method of Flexibility Act (5 U.S.C. chapter 6) does
accounting, a QBU’s income or loss for adjustment would be translated under
not apply. Pursuant to section 7805(f) of paragraph (d)(5) of this section at the
a taxable year is computed in U.S. the Internal Revenue Code, the notice of
dollars and adjusted to account for its exchange rate for the translation period
proposed rulemaking preceding this in which the cost of the item was
DASTM gain or loss. See § 1.985–3(b). A regulation was submitted to the Chief
QBU’s DASTM gain or loss for a taxable incurred if it were shown on the QBU’s
Counsel for Advocacy of the Small year-end balance sheet, such item shall
year is determined under § 1.985–3(d) Business Administration for comment
by first computing the QBU’s change in be translated at the same historical rate.
on its impact on small business.
net worth from the prior year. In (iii) Effective date. Paragraph (d)(3)(ii)
computing the QBU’s change in net Drafting Information of this section is applicable for any
worth, items whose dollar value The principal author of this regulation transfer, dividend, or distribution that is
fluctuates with changes in exchange is Sheila Ramaswamy, Office of a return of capital that is made after
rates are translated using the year-end Associate Chief Counsel (International). March 8, 2005, and that gives rise to an
exchange rate while items whose dollar However, other personnel from the IRS adjustment under this paragraph (d)(3).
value does not change with exchange and Treasury Department participated * * * * *
rate fluctuations are translated using the in their development.
exchange rate for the translation period Kevin M. Brown,
in which the cost of the item was List of Subjects in 26 CFR Part 1
Deputy Commissioner for Services and
incurred. Specified adjustments are Income taxes, Reporting and Enforcement.
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made to the QBU’s change in net worth. recordkeeping requirements. Approved: March 20, 2007.
Under § 1.985–3(d)(3), one of the
Adoption of Amendment to the Eric Solomon,
adjustments requires adding back to the
Regulations Assistant Secretary for Tax Policy.
change in net worth transactions that
decrease the QBU’s net worth without ■Accordingly, 26 CFR part 1 is [FR Doc. E7–5857 Filed 3–29–07; 8:45 am]
affecting the QBU’s income or loss amended as follows: BILLING CODE 4830–01–P

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