Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 15043 

and standard temperature, and the type 

of surface for which it is valid; 

(4) The effect on landing distances of 

operation on other than smooth hard 

surfaces, when dry, determined under 

SC 23.45(g); and 

(5) The effect on landing distances of 

runway slope and 50 percent of the 

headwind component and 150 percent 

of the tailwind component. 

(b) Not applicable. 

(c) Not applicable. 

(d) In addition to paragraph (a) of this 

section the following information must 

be furnished—

(1) The accelerate-stop distance 

determined under SC 23.55; 

(2) The takeoff distance determined 

under SC 23.59(a); 

(3) At the option of the applicant, the 

takeoff run determined under SC 

23.59(b); 

(4) The effect on accelerate-stop 

distance, takeoff distance and, if 

determined, takeoff run, of operation on 

other than smooth hard surfaces, when 

dry, determined under SC 23.45(g); 

(5) The effect on accelerate-stop 

distance, takeoff distance, and if 

determined, takeoff run, of runway 

slope and 50 percent of the headwind 

component and 150 percent of the 

tailwind component; 

(6) The net takeoff flight path 

determined under SC 23.61(b); 

(7) The enroute gradient of climb/ 

descent with one engine inoperative, 

determined under § 23.69(b); 

(8) The effect, on the net takeoff flight 

path and on the enroute gradient of 

climb/descent with one engine 

inoperative, of 50 percent of the 

headwind component and 150 percent 

of the tailwind component; 

(9) Overweight landing performance 

information (determined by 

extrapolation and computed for the 

range of weights between the maximum 

landing and maximum takeoff weights) 

as follows—

(i) The maximum weight for each 

airport altitude and ambient 

temperature at which the airplane 

complies with the climb requirements of 

SC 23.63(d)(2); and 

(ii) The landing distance determined 

under § 23.75 for each airport altitude 

and standard temperature. 

(10) The relationship between IAS 

and CAS determined in accordance with 

§ 23.1323 (b) and (c). 

(11) The altimeter system calibration 

required by § 23.1325(e). 

Issued in Kansas City, Missouri on March 

23, 2007. 

Kim Smith, 

Manager, Small Airplane Directorate, Aircraft 

Certification Service. 

[FR Doc. E7–5951 Filed 3–29–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 310 

[Docket No. 2007N–0099] 

New Drugs Exempted From 

Prescription-Dispensing 

Requirements; Technical Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: Amendments to the Federal 

Food, Drug, and Cosmetic Act (the act) 

necessitate several changes to the 

citations used in Food and Drug 

Administration (FDA) regulations 

regarding the prescription-exemption 

procedure and the list of new drugs that 

are exempted from the prescriptiondispensing requirements. These changes 

are editorial, pertaining only to 

citations, and do not constitute a change 

in FDA regulation. 

DATES: This rule is effective March 30, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

Gerald M. Rachanow, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 5496, 

Silver Spring, MD 20993, 301–796–

2090. 

SUPPLEMENTARY INFORMATION: Section 

126 of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Public Law 105–115) 

amended section 503(b)(1) of the act (21 

U.S.C. 353(b)(1)). Specifically, the 

previous paragraph (b)(1)(A) of the act 

was stricken from the act and 

paragraphs (b)(1)(B) and (b)(1)(C) were 

redesignated as paragraphs (b)(1)(A) and 

(b)(1)(B), respectively. This amendment 

to the act necessitates that FDA revise 

the corresponding citations in its 

regulations. FDA is making this change 

in 21 CFR part 310 (§§ 310.200 and 

310.201). These changes are editorial, 

pertaining only to citations, and do not 

constitute a change in FDA regulation. 

Publication of this document 

constitutes final action on this change 

under the Administrative Procedure Act 

(5 U.S.C. 553). Notice and public 

procedures are unnecessary because 

FDA is merely implementing a change 

in citation to a section of the act as a 

result of amendment of the act. 

List of Subjects in 21 CFR Part 310 

Administrative practice and 

procedure, Drugs, Labeling, Medical 

devices, Reporting and recordkeeping 

requirements. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 310 is 

amended as follows: 

PART 310—NEW DRUGS 

■ 1. The authority citation for 21 CFR 

part 310 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 360b–360f, 360j, 361(a), 371, 374, 

375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 

263b–263n. 

§ 310.200 [Amended] 

■ 2. In § 310.200(a), (b), and (e) remove 

‘‘503(b)(1)(C)’’ wherever it appears and 

add in its place ‘‘503(b)(1)(B)’’. 

§ 310.201 [Amended] 

■ 3. In § 310.201(a) remove 

‘‘503(b)(1)(C)’’ and add in its place 

‘‘503(b)(1)(B)’’. 

Dated: March 22, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–5895 Filed 3–29–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9320] 

RIN 1545-BF67 

United States Dollar Approximate 

Separate Transactions Method 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulation. 

SUMMARY: This document contains final 

regulations which provide the 

translation rates that must be used when 

translating into dollars certain items and 

amounts transferred by a qualified 

business unit (QBU) to its home office 

or parent corporation for purposes of 

computing dollar approximate separate 

transactions method (DASTM) gain or 

loss. This regulation is necessary to 

provide guidance under section 985 


cprice-sewell on PROD1PC66 with RULES
15044 Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 

regarding the proper translation rates 

that must be used under the DASTM 

method. Taxpayers affected by these 

regulations are taxpayers with QBUs 

required to use the DASTM method of 

accounting described in § 1.985–3. 

DATES: Effective Date: This regulation is 

effective March 30, 2007. 

Applicability Date: This regulation is 

applicable to any transfer, dividend, or 

distribution that is a return of capital 

that is made after March 8, 2005, and 

that gives rise to an adjustment under 

§ 1.985–3(d)(3). 

FOR FURTHER INFORMATION CONTACT: 

Sheila Ramaswamy, at (202) 622–3870. 

SUPPLEMENTARY INFORMATION: 

Background 

On July 13, 2006, a notice of proposed 

rulemaking (REG–118897–06), United 

States Dollar Approximate Separate 

Transactions Method, was published in 

the Federal Register (71 FR 39604). The 

notice of proposed rulemaking proposed 

to amend § 1.985–3(d)(3). No requests 

for a public hearing were received, and 

no public hearing was held. The IRS 

received no comments in response to 

the notice of proposed rulemaking. The 

proposed regulation is adopted without 

change by this Treasury decision. 

Explanation of Provisions 

For taxable years beginning after 

August 24, 1994, a U.S. taxpayer’s QBU 

that would otherwise be required to use 

a hyperinflationary currency as its 

functional currency generally must use 

the dollar as its functional currency and 

must compute income or loss under the 

DASTM method of accounting 

described in § 1.985–3. See § 1.985–

1(b)(2)(ii). Under the DASTM method of 

accounting, a QBU’s income or loss for 

a taxable year is computed in U.S. 

dollars and adjusted to account for its 

DASTM gain or loss. See § 1.985–3(b). A 

QBU’s DASTM gain or loss for a taxable 

year is determined under § 1.985–3(d) 

by first computing the QBU’s change in 

net worth from the prior year. In 

computing the QBU’s change in net 

worth, items whose dollar value 

fluctuates with changes in exchange 

rates are translated using the year-end 

exchange rate while items whose dollar 

value does not change with exchange 

rate fluctuations are translated using the 

exchange rate for the translation period 

in which the cost of the item was 

incurred. Specified adjustments are 

made to the QBU’s change in net worth. 

Under § 1.985–3(d)(3), one of the 

adjustments requires adding back to the 

change in net worth transactions that 

decrease the QBU’s net worth without 

affecting the QBU’s income or loss 

including dividend distributions, 

certain transfers, and returns of capital 

from the QBU to its home office or 

parent corporation. This final regulation 

provides the translation rate to be used 

in translating these items into dollars for 

purposes of computing DASTM gain or 

loss. 

Under § 1.985–3(d)(3), the applicable 

translation rate to be used generally 

depends upon whether the dollar value 

of the item transferred changes with 

fluctuations in exchange rates. 

Accordingly, the regulation provides 

that if the item giving rise to the 

adjustment is an asset which would be 

translated under § 1.985–3(d)(5) at the 

exchange rate for the last translation 

period of the taxable year if it were on 

the QBU’s year-end balance sheet, the 

item will be translated at the exchange 

rate on the date the item is transferred. 

However, if the item giving rise to the 

adjustment is an asset which would be 

translated under § 1.985–3(d)(5) at the 

exchange rate for the translation period 

in which the cost of the item was 

incurred if it were on the QBU’s yearend balance sheet, the item will be 

translated at the same historical rate. 

Special Analyses 

It has been determined that this 

Treasury decision is not a significant 

regulatory action as defined in 

Executive Order 12866. Therefore, a 

regulatory assessment is not required. It 

has been determined that sections 553 

(b) and (d) of the Administrative 

Procedure Act (5 U.S.C. chapter 5) do 

not apply to this regulation, and because 

this regulation does not impose a 

collection of information on small 

entities, the provisions of the Regulatory 

Flexibility Act (5 U.S.C. chapter 6) does 

not apply. Pursuant to section 7805(f) of 

the Internal Revenue Code, the notice of 

proposed rulemaking preceding this 

regulation was submitted to the Chief 

Counsel for Advocacy of the Small 

Business Administration for comment 

on its impact on small business. 

Drafting Information 

The principal author of this regulation 

is Sheila Ramaswamy, Office of 

Associate Chief Counsel (International). 

However, other personnel from the IRS 

and Treasury Department participated 

in their development. 

List of Subjects in 26 CFR Part 1 

Income taxes, Reporting and 

recordkeeping requirements. 

Adoption of Amendment to the 

Regulations 

■ Accordingly, 26 CFR part 1 is 

amended as follows: 

PART 1—INCOME TAXES 

■ Paragraph 1. The authority citation 

for part 1 continues to read in part as 

follows: 

Authority: 26 U.S.C. 7805 * * * 

■ Par. 2. Section 1.985–3 is amended by 

revising paragraph (d)(3) to read as 

follows: 

§ 1.985–3 United States dollar approximate 

separate transactions method. 

* * * * * 

(d) * * * 

(3) Positive adjustments—(i) In 

general. The items described in this 

paragraph (d)(3) are dividend 

distributions for the taxable year and 

any items that decrease net worth for 

the taxable year but that generally do 

not affect income or loss or earnings and 

profits (or a deficit in earnings and 

profits). Such items include a transfer to 

the home office of a QBU branch and a 

return of capital. 

(ii) Translation. Except as provided by 

ruling or administrative 

pronouncement, items described in 

paragraph (d)(3)(i) of this section shall 

be translated into dollars as follows: 

(A) If the item giving rise to the 

adjustment would be translated under 

paragraph (d)(5) of this section at the 

exchange rate for the last translation 

period of the taxable year if it were 

shown on the QBU’s year-end balance 

sheet, such item shall be translated at 

the exchange rate on the date the item 

is transferred. 

(B) If the item giving rise to the 

adjustment would be translated under 

paragraph (d)(5) of this section at the 

exchange rate for the translation period 

in which the cost of the item was 

incurred if it were shown on the QBU’s 

year-end balance sheet, such item shall 

be translated at the same historical rate. 

(iii) Effective date. Paragraph (d)(3)(ii) 

of this section is applicable for any 

transfer, dividend, or distribution that is 

a return of capital that is made after 

March 8, 2005, and that gives rise to an 

adjustment under this paragraph (d)(3). 

* * * * * 

Kevin M. Brown, 

Deputy Commissioner for Services and 

Enforcement. 

Approved: March 20, 2007. 

Eric Solomon, 

Assistant Secretary for Tax Policy. 

[FR Doc. E7–5857 Filed 3–29–07; 8:45 am] 

BILLING CODE 4830–01–P 


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