7464 Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Rules and Regulations 

The rationale for requiring blood and 

blood components, including fresh 

frozen plasma collected by an apheresis 

procedure, to be collected by a single 

uninterrupted venipuncture is to help 

ensure minimal tissue damage which 

could activate the coagulation cascade. 

This is also a requirement for Platelet 

collection. Under 21 CFR 640.22(d), the 

regulation states that Platelet 

phlebotomy shall be performed by a 

single uninterrupted venipuncture with 

minimal damage to, and minimal 

manipulation of, the donor’s tissue. 

FDA does not anticipate, in the near 

future, any change in the policy for 

using a sterile connecting device to 

attach a sterile needle to a collection set 

in the event of a blood flow 

interruption. 

List of Subjects 

21 CFR Part 640 

Blood, Labeling, Reporting and 

recordkeeping requirements. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and the Public 

Health Service Act, and under authority 

delegated by the Commissioner of Food 

and Drugs, 21 CFR part 640 is amended 

as follows: 

PART 640—ADDITIONAL STANDARDS 

FOR HUMAN BLOOD AND BLOOD 

PRODUCTS 

■ 1. The authority citation for 21 CFR 

part 640 continues to read as follows: 

Authority: 21 U.S.C. 321, 351, 352, 353, 

355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 

264. 

■ 2. Section 640.4 is amended by 

revising paragraph (h) to read as 

follows: 

§ 640.4 Collection of the blood. 

* * * * * 

(h) Storage. Whole Blood must be 

placed in storage at a temperature 

between 1 and 6 °C immediately after 

collection unless the blood is to be 

further processed into another 

component or the blood must be 

transported from the donor center to the 

processing laboratory. If transported, the 

blood must be placed in temporary 

storage having sufficient refrigeration 

capacity to cool the blood continuously 

toward a temperature range between 1 

and 10 °C until arrival at the processing 

laboratory. At the processing laboratory, 

the blood must be stored at a 

temperature between 1 and 6 °C. Blood 

from which a component is to be 

prepared must be held in an 

environment maintained at a 

temperature range specified for that 

component in the directions for use for 

the blood collecting, processing, and 

storage system approved for such use by 

the Director, CBER. 

§ 640.24 [Amended] 

■ 3. Section 640.24 is amended in the 

first sentence of paragraph (d) by 

removing ‘‘6.0’’ and adding in its place 

‘‘6.2’’. 

Dated: February 1, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E8–2322 Filed 2–7–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9379] 

RIN 1545–BG35 

Time and Manner for Electing Capital 

Asset Treatment for Certain SelfCreated Musical Works 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Temporary regulation. 

SUMMARY: This document contains a 

temporary regulation that provides the 

time and manner for making an election 

to treat the sale or exchange of musical 

compositions or copyrights in musical 

works created by the taxpayer (or 

received by the taxpayer from the 

works’ creator in a transferred basis 

transaction) as the sale or exchange of 

a capital asset. The regulation reflects 

changes to the law made by the Tax 

Increase Prevention and Reconciliation 

Act of 2005 and the Tax Relief and 

Health Care Act of 2006. The regulation 

affects taxpayers making the election 

under section 1221(b)(3) of the Internal 

Revenue Code (Code) to treat gain or 

loss from such a sale or exchange as 

capital gain or loss. The text of this 

temporary regulation also serves as the 

text of the proposed regulation (REG–

153589–06) set forth in the Proposed 

Rules section of this issue of the Federal 

Register. 

DATES: Effective Date: This regulation is 

effective on February 8, 2008. 

Applicability Dates: For dates of 

applicability, see § 1.1221–3T(d). 

FOR FURTHER INFORMATION CONTACT: 

Jamie Kim, (202) 622–4950 (not a tollfree number). 

SUPPLEMENTARY INFORMATION: 

Background 

Section 1221(a) of the Internal 

Revenue Code (Code) generally provides 

that capital assets include all property 

held by a taxpayer with certain 

specified exclusions. Section 1221(a)(1) 

excludes from the definition of a capital 

asset inventory property or property 

held by a taxpayer primarily for sale to 

customers in the ordinary course of the 

taxpayer’s trade or business. Section 

1221(a)(3) excludes from the definition 

of a capital asset copyrights, literary, 

musical, or artistic compositions, letters 

or memoranda, or similar property held 

by a taxpayer whose personal efforts 

created the property (or held by a 

taxpayer whose basis in the property is 

determined by reference to the basis of 

such property in the hands of the 

taxpayer whose personal efforts created 

the property). 

Section 1221(b)(3) of the Code, added 

by section 204 of the Tax Increase 

Prevention and Reconciliation Act of 

2005 (Public Law 109–222, 120 Stat. 

345) and amended by section 412 of the 

Tax Relief and Health Care Act of 2006 

(Public Law 109–432, 120 Stat. 2922), 

provides that, at the election of a 

taxpayer, the section 1221(a)(1) and 

(a)(3) exclusions from capital asset 

status do not apply to musical 

compositions or copyrights in musical 

works sold or exchanged by a taxpayer 

described in section 1221(a)(3). Thus, if 

a taxpayer who owns a musical 

composition or copyright in a musical 

work created by the taxpayer (or 

transferred to the taxpayer by the work’s 

creator in a section 1221(a)(3)(C) 

transferred basis transaction) elects the 

application of this provision, gain or 

loss from the sale or exchange of the 

musical composition or copyright is 

treated as capital gain or loss. 

Explanation of Provisions 

This temporary regulation provides 

rules regarding the time and manner for 

making an election under section 

1221(b)(3) to treat gain or loss from the 

sale or exchange of certain musical 

compositions or copyrights in musical 

works as gain or loss from the sale or 

exchange of a capital asset. 

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 

also has been determined that section 

553(b) of the Administrative Procedure 

Act (5 U.S.C. chapter 5) does not apply 

to this regulation. For application of the 

Regulatory Flexibility Act (5 U.S.C. 

Chapter 6) please refer to the cross 

reference notice of proposed rulemaking 

published elsewhere in this issue of the 

Federal Register. Pursuant to section 


jlentini on PROD1PC65 with RULES
Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Rules and Regulations 7465 

7805(f) of the Internal Revenue Code, 

this regulation has been 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 these 

regulations is Jamie Kim of the Office of 

Associate Chief Counsel (Income Tax & 

Accounting). 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. 

Amendments 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 1.1221–3T is added to 

read as follows: 

§ 1.1221–3T Time and manner for electing 

capital asset treatment for certain selfcreated musical works (temporary). 

(a) Description. Section 1221(b)(3) 

allows an electing taxpayer to treat the 

sale or exchange of a musical 

composition or copyright in a musical 

work created by the taxpayer’s personal 

efforts (or having a basis determined by 

reference to the basis of such property 

in the hands of a taxpayer whose 

personal efforts created such property) 

as the sale or exchange of a capital asset. 

As a consequence, gain or loss from the 

sale or exchange is treated as capital 

gain or loss. An election may be made 

for sales and exchanges in taxable years 

beginning after May 17, 2006. 

(b) Time and manner for making the 

election. An election described in this 

section is made separately for each 

musical composition (or copyright in a 

musical work) sold or exchanged during 

the taxable year. An election must be 

made on or before the due date 

(including extensions) of the income tax 

return for the taxable year of the sale or 

exchange. An election is to be made on 

Schedule D, ‘‘Capital Gains and Losses,’’

of the appropriate income tax form (for 

example, Form 1040, ‘‘U.S. Individual 

Income Tax Return;’’ Form 1065, ‘‘U.S. 

Return of Partnership Income;’’ Form 

1120, ‘‘U.S. Corporation Income Tax 

Return’’) by treating the sale or 

exchange as the sale or exchange of a 

capital asset, in accordance with the 

form and its instructions. 

(c) Revocability of election. An 

election described in this section is 

revocable with the consent of the 

Commissioner. To seek consent to 

revoke an election, a taxpayer must 

submit a request for a letter ruling under 

the appropriate revenue procedure. See, 

for example, Rev. Proc. 2007–1, 2007–1 

CB 1 (updated annually). Alternatively, 

an automatic extension of 6 months 

from the due date of the taxpayer’s 

income tax return (excluding 

extensions) is granted to revoke an 

election, provided the taxpayer timely 

filed the taxpayer’s income tax return 

and, within this 6-month extension 

period, the taxpayer files an amended 

income tax return that treats the sale or 

exchange as the sale or exchange of 

property that is not a capital asset. See 

§ 601.601(d)(2)(ii)(b) of this Chapter. 

(d) Effective/applicability date. (1) 

The rules of this section apply to sales 

and exchanges in taxable years 

beginning after May 17, 2006. 

(2) Expiration date. This section 

expires on February 7, 2011. 

Linda E. Stiff, 

Deputy Commissioner for Services and 

Enforcement. 

Approved: January 28, 2008. 

Eric Solomon, 

Assistant Secretary of the Treasury (Tax 

Policy). 

[FR Doc. E8–2309 Filed 2–7–08; 8:45 am] 

BILLING CODE 4830–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R01–OAR–2007–1054; A–1–FRL–

8524–9] 

Approval and Promulgation of Air 

Quality Implementation Plans; Maine; 

Transportation Conformity 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is approving a State 

Implementation Plan (SIP) revision 

submitted by the State of Maine. This 

revision establishes transportation 

conformity criteria and procedures 

related to interagency consultation and 

enforceability of certain transportationrelated control measures and mitigation 

measures. The intended effect of this 

action is to approve State criteria and 

procedures to govern transportation 

conformity determinations. This action 

is being taken in accordance with the 

Clean Air Act. 

DATES: This direct final rule will be 

effective April 8, 2008, unless EPA 

receives adverse comments by March 

10, 2008. If adverse comments are 

received, EPA will publish a timely 

withdrawal of the direct final rule in the 

Federal Register informing the public 

that the rule will not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID Number EPA–

R01–OAR–2007–1054 by one of the 

following methods: 

1. www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

2. E-mail: arnold.anne@epa.gov. 

3. Fax: (617) 918–0047. 

4. Mail: ‘‘Docket Identification 

Number EPA–R01–OAR–2007–1054’’, 

Anne Arnold, U.S. Environmental 

Protection Agency, EPA New England 

Regional Office, One Congress Street, 

Suite 1100 (mail code CAQ), Boston, 

MA 02114–2023. 

5. Hand Delivery or Courier. Deliver 

your comments to: Anne Arnold, 

Manager, Air Quality Planning Unit, 

Office of Ecosystem Protection, U.S. 

Environmental Protection Agency, EPA 

New England Regional Office, One 

Congress Street, 11th floor, (CAQ), 

Boston, MA 02114–2023. Such 

deliveries are only accepted during the 

Regional Office’s normal hours of 

operation. The Regional Office’s official 

hours of business are Monday through 

Friday, 8:30 to 4:30, excluding legal 

holidays. 

Instructions: Direct your comments to 

Docket ID No. EPA–R01–OAR–2007–

1054. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit through 

www.regulations.gov, or e-mail, 

information that you consider to be CBI 

or otherwise protected. The 

www.regulations.gov Web site is an 

‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

www.regulations.gov your e-mail 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 


jlentini on PROD1PC65 with RULES