Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Proposed Rules 7503 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Web site transitioned to the 

Federal Dockets Management System 

(FDMS). FDMS is a Government-wide, 

electronic docket management system. 

Electronic submissions will be accepted 

by FDA through FDMS only. 

List of Subjects in 21 CFR Part 880 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, FDA proposes to 

amend 21 CFR part 880 as follows: 

PART 880—GENERAL HOSPITAL AND 

PERSONAL USE DEVICES 

1. The authority citation for 21 CFR 

part 880 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

2. Part 880 is amended in subpart G 

by adding § 880.6310 to read as follows: 

§ 880.6310 Medical Device Data System. 

(a) Identification. (1) A medical 

device data system (MDDS) is a device 

intended to provide one or more of the 

following uses: 

(i) The electronic transfer or exchange 

of medical device data from a medical 

device, without altering the function or 

parameters of any connected devices. 

(ii) The electronic storage and 

retrieval of medical device data from a 

medical device, without altering the 

function or parameters of connected 

devices. 

(iii) The electronic display of medical 

device data from a medical device, 

without altering the function or 

parameters of connected devices. 

(iv) The electronic conversion of 

medical device data from one format to 

another format in accordance with a 

preset specification. 

(2) Medical device data consists of 

numerical or other information available 

from a medical device in a form suitable 

for processing by computer. Medical 

device data can represent any type of 

information or knowledge, e.g., clinical 

values, alarm conditions, error 

messages. This identification does not 

include a device that creates diagnostic, 

decision support, or alarm functions. It 

also does not include the report-writing 

functions of a data system that allows 

for the manual input of data by 

practitioners. This identification does 

not include devices with any real time, 

active, or online patient monitoring. 

(b) Classification. Class I (general 

controls). When the device is indicated 

for use only by a healthcare professional 

and does not perform irreversible data 

compression, it is exempt from the 

premarket notification procedures in 

subpart E of part 807, subject to the 

limitations in § 880.9. When the device 

is indicated to be prescribed by a 

healthcare professional for use by a lay 

user, or performs irreversible data 

compression, or for over-the-counter use 

by a lay user, the device requires the 

submission and clearance of a 

premarket notification. 

Dated: January 25, 2008. 

Daniel G. Schultz, 

Director, Center for Devices and Radiological 

Health. 

[FR Doc. E8–2325 Filed 2–7–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–153589–06] 

RIN 1545–BG34 

Time and Manner for Electing Capital 

Asset Treatment for Certain SelfCreated Musical Works 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Notice of proposed rulemaking 

by cross-reference to temporary 

regulation. 

SUMMARY: In the Rules and Regulations 

section of this issue of the Federal 

Register, the IRS is issuing 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 temporary 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 

temporary 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 the temporary regulation 

also serves as the text of this proposed 

regulation. 

DATES: Written or electronic comments 

and requests for a public hearing must 

be received by May 8, 2008. 

ADDRESSES: Send submissions to: 

CC:PA:LPD:PR (REG–153589–06), room 

5203, Internal Revenue Service, PO Box 

7604, Ben Franklin Station, Washington, 

DC 20044. Submissions may be hand 

delivered Monday through Friday 

between the hours of 8 a.m. and 4 p.m. 

to: CC:PA:LPD:PR (REG–153589–06), 

Courier’s Desk, Internal Revenue 

Service, 1111 Constitution Avenue, 

NW., Washington, DC, or sent 

electronically via the Federal 

eRulemaking Portal at 

www.regulations.gov (IRS REG–

153589–06). 

FOR FURTHER INFORMATION CONTACT: 

Concerning the proposed regulation, 

Jamie Kim, (202) 622–4950; concerning 

submission of comments or requesting a 

hearing, Richard.A.Hurst@irscounsel. 

treas.gov, (202) 622–7180 (not toll-free 

numbers). 

SUPPLEMENTARY INFORMATION: 

Background and Explanation of 

Provisions 

Temporary regulation in the Rules 

and Regulations section of this issue of 

the Federal Register amends the Income 

Tax Regulations (26 CFR part 1) relating 

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

Revenue Code (Code). The temporary 

regulation provides rules regarding the 

time and manner for making an election 

under section 1221(b)(3) to treat the sale 

or exchange of certain musical 

compositions or copyrights in musical 

works as the sale or exchange of a 

capital asset. The text of the temporary 

regulation also serves as the text of this 

proposed regulation. The preamble to 

the temporary regulation explains the 

amendments. 

Special Analyses 

It has been determined that this notice 

of proposed rulemaking 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, and because the 

regulation does not impose a collection 

of information on small entities, the 

Regulatory Flexibility Act (5 U.S.C. 

chapter 6) does not apply. Pursuant to 

section 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. 

Comments and Requests for a Public 

Hearing 

Before this proposed regulation is 

adopted as a final regulation, 

consideration will be given to any 


ebenthall on PRODPC61 with PROPOSALS
7504 Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Proposed Rules 

written comments (a signed original and 

eight (8) copies) or electronic comments 

that are submitted timely to the IRS. The 

IRS and Treasury Department request 

comments on the clarity of the proposed 

rules and how they can be made easier 

to understand. All comments will be 

available for public inspection and 

copying. A public hearing will be 

scheduled if requested in writing by any 

person that timely submits written 

comments. If a public hearing is 

scheduled, notice of the date, time, and 

place for the public hearing will be 

published in the Federal Register. 

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. 

Proposed Amendments to the 

Regulations 

Accordingly, 26 CFR part 1 is 

proposed to be 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 1.1221–3 is added to 

read as follows: 

§ 1.1221–3 Time and manner for electing 

capital asset treatment for certain selfcreated musical works. 

[The text of proposed § 1.1221–3 is 

the same as the text of § 1.1221–3T(a) 

through (d)(1) published elsewhere in 

this issue of the Federal Register.] 

Linda E. Stiff, 

Deputy Commissioner for Services and 

Enforcement. 

[FR Doc. E8–2307 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–

8524–8] 

Approval and Promulgation of Air 

Quality Implementation Plans; Maine; 

Transportation Conformity 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The EPA is proposing to 

approve 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 transportation-related 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: Written comments must be 

received on or before March 10, 2008. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R01–

OAR–2007–1054 by one of the following 

methods: 

1. http://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: ‘‘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. 

Please see the direct final rule which 

is located in the Rules section of this 

Federal Register for detailed 

instructions on how to submit 

comments. 

FOR FURTHER INFORMATION CONTACT: 

Donald O. Cooke, Air Quality Unit, U.S. 

Environmental Protection Agency, EPA 

New England Regional Office, One 

Congress Street, Suite 1100 (CAQ), 

Boston, MA 02114–2023, telephone 

number (617) 918–1668, fax number 

(617) 918–0668, e-mail 

cooke.donald@epa.gov. 

SUPPLEMENTARY INFORMATION: In the 

Final Rules section of this Federal 

Register, EPA is approving the State’s 

SIP submittal as a direct final rule 

without prior proposal because the 

Agency views this as a noncontroversial 

submittal and anticipates no adverse 

comments. A detailed rationale for the 

approval is set forth in the direct final 

rule. If no adverse comments are 

received in response to this action rule, 

no further activity is contemplated. If 

EPA receives adverse comments, the 

direct final rule will be withdrawn and 

all public comments received will be 

addressed in a subsequent final rule 

based on this proposed rule. EPA will 

not institute a second comment period. 

Any parties interested in commenting 

on this action should do so at this time. 

Please note that if EPA receives adverse 

comment on an amendment, paragraph, 

or section of this rule and if that 

provision may be severed from the 

remainder of the rule, EPA may adopt 

as final those provisions of the rule that 

are not the subject of an adverse 

comment. 

For additional information, see the 

direct final rule which is located in the 

Rules section of this Federal Register. 

Dated: January 24, 2008. 

Ira W. Leighton, 

Acting Regional Administrator, EPA New 

England. 

[FR Doc. E8–2248 Filed 2–7–08; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 52 and 70 

[EPA–R07–OAR–2007–0829; FRL–8526–1] 

Approval and Promulgation of 

Implementation Plans and Operating 

Permits Program; State of Kansas 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to approve 

a revision to the Kansas State 

Implementation Plan (SIP) for the 

purpose of revoking the Sulfur 

Compound Emissions rule and for the 

purpose of approving revisions to a 

Class I major source operating permit 

annual emissions inventory rule and 

several Class II minor source operating 

permits rules. EPA is also proposing to 

approve additional amendments 

adopted by KDHE on February 20, 1998 

which pertain to the Class II operating 

permit rules. The rules were primarily 

revised to align the annual emission 

inventory reporting date deadline with 

the June 1 payment of applicable 

emissions fees. EPA’s proposed 

approval of these amendments would 

ensure consistency between the state 

and the Federally-approved rules. 


ebenthall on PRODPC61 with PROPOSALS