Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Rules and Regulations 7463 

Riverton, WY, Riverton Regional, ILS OR 

LOC RWY 28, Amdt 1B 

Martinsburg, WV, Eastern WV Regional/ 

Shepherd, LOC/DME BC RWY 8, Amdt 6, 

CANCELLED 

The FAA published an Amendment in 

Docket No. 30587, Amdt No. 3251 to Part 97 

of the Federal Aviation Regulations (Vol. 73, 

FR No. 16, Page 4073 dated Thursday, 

January 24, 2008) under section 97.29 

effective March 13, 2008, which is hereby 

corrected to read as follows: 

Waterville, ME, ILS OR LOC RWY 5, Amdt 

2B 

The FAA published an Amendment in 

Docket No. 30587, Amdt No. 3251 to Part 97 

of the Federal Aviation Regulations (Vol. 73, 

FR No. 16, Page 4073 dated Thursday, 

January 24, 2008) under section 97.29 

effective April 10, 2008, which is hereby 

rescinded: 

Burlington, VT, Burlington Intl, ILS OR LOC/ 

DME RWY 33, Amdt 1 

The FAA published an Amendment in 

Docket No. 30587, Amdt No. 3251 to Part 97 

of the Federal Aviation Regulations (Vol. 73, 

FR No. 16, Page 4073 dated Thursday, 

January 24, 2008) under section 97.29 

effective February 14, 2008, which is hereby 

corrected to read as follows: 

Omaha, NE, Epply Airfield, ILS OR LOC 

RWY 32L, Amdt 1 

Omaha, NE, Epply Airfield, ILS OR LOC/ 

DME RWY 14L, Amdt 1 

Omaha, NE, Epply Airfield, ILS OR LOC/ 

DME RWY 14R, ILS RWY 14R (CAT II), ILS 

RWY 14R (CAT III), Amdt 4 

Omaha, NE, Epply Airfield, RNAV (GPS) 

RWY 14L, Amdt 1 

Omaha, NE, Epply Airfield, Takeoff 

Minimums and Obstacle DP, Amdt 5 

[FR Doc. 08–535 Filed 2–7–08; 8:45 am] 

BILLING CODE 4910–13–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 606, 607, 610, and 640 

[Docket No. FDA–2008–N–0067] 

Revisions to the Requirements 

Applicable to Blood, Blood 

Components and Source Plasma; 

Confirmation of Effective Date and 

Technical Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule; confirmation of 

effective date and technical amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is confirming the 

effective date of February 19, 2008, for 

the direct final rule that appeared in the 

Federal Register of August 16, 2007 (72 

FR 45883). The direct final rule amends 

the biologics regulations by removing, 

revising, or updating specific 

regulations applicable to blood, blood 

components and Source Plasma to be 

more consistent with current practices 

in the blood industry and to remove 

unnecessary or outdated requirements. 

In addition, FDA is making technical 

amendments to the biologics regulations 

in response to comments received on 

the direct final rule. 

DATES: The effective date for the 

regulation is confirmed as February 19, 

2008. The effective date of the technical 

amendment is also February 19, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of August 16, 2007 (72 

FR 45883), FDA solicited comments 

concerning the direct final rule for a 75- 

day period ending October 30, 2007. 

FDA stated that the effective date of the 

direct final rule would be on February 

19, 2008, 6 months after the end of the 

comment period, unless any significant 

adverse comment was submitted to FDA 

during the comment period. FDA 

received several letters of comment on 

the direct final rule; however, FDA did 

not receive any significant adverse 

comments. Therefore, FDA is 

confirming the effective date of the 

direct final rule and making two 

technical amendments in response to 

comments received. Comments were 

received from private industry, an 

individual, organizations representing 

the blood industry, and an employee of 

the Food and Drug Administration. The 

comments received and FDA’s 

responses to the comments are 

discussed below as follows: 

Two comments stated that under 

paragraph (c) of 21 CFR 610.53, there 

was an error in a temperature listed in 

the table under Red Blood Cells 

Deglycerolized and Red Blood Cells 

Frozen. 

FDA agrees. In the Federal Register of 

September 24, 2007 (72 FR 54208), FDA 

issued a notice to correct a 

typographical error in the codified 

section of the direct final rule. The table 

in paragraph (c) of section 610.53 was 

corrected by replacing 65°C with -65°C. 

One comment requested clarification 

of the proposed change in wording from 

‘‘toward’’ to ‘‘at’’ concerning the 

specified temperature range under 21 

CFR 640.4(h) because coolers do not 

have the capacity to maintain a 

temperature range between 1 and 10°C. 

FDA agrees with the comment and 

therefore, is revising the regulation to 

use ‘‘toward’’ rather than ‘‘at’’. 

One comment requested that under 21 

CFR 640.24(d) the pH be revised from 

‘‘not less than 6.0’’ to ‘‘not less than 6.2’’

to be consistent with the change in 21 

CFR 640.25(b)(2) (§ 640.25(b)(2)) and 

with industry practice. 

Because both of these provisions refer 

to the same pH requirement, FDA agrees 

and is revising 21 CFR 640.24(d) as 

requested. 

One comment agreed with the change 

in pH under § 640.25(b)(2) but stated 

that there was no mention of the 

number of units that must meet this 

requirement and therefore the 

assumption is that 100 percent of the 

units must meet the requirement which 

they believe is unachievable. 

We believe that the four units we 

require to be tested for quality control 

purposes under § 640.25(b) must meet 

the criteria listed under this regulation. 

However, FDA recently issued a 

document entitled ‘‘Guidance for 

Industry and FDA Review Staff: 

Collection of Platelets by Automated 

Methods,’’ dated December 2007 

(December 17, 2007; 72 FR 71418). In 

this guidance, we provide 

recommendations on quality control 

monitoring. Therefore, no additional 

changes are warranted. 

Two comments requested that FDA 

revise the definition under 21 CFR 

640.30(a) to include ‘‘for intravenous or 

further manufacturing use’’ to facilitate 

use of plasma for further manufacturing 

use that has been collected concurrently 

with the collection of another blood 

component by apheresis. In addition, 

the comments requested that 21 CFR 

640.34 and other provisions in the 

regulations be revised and harmonized 

to allow interchangeability of the 

plasma from intravenous use to 

manufacturing use after blood 

collection. 

FDA presently has this issue under 

consideration and may address this in 

future rulemaking, if warranted. This 

comment is beyond the scope of this 

rulemaking. 

One comment requested that FDA 

provide the rationale for the revision to 

21 CFR 640.34(b) requiring fresh frozen 

plasma collected by an apheresis 

procedure to be prepared from blood 

collected by single uninterrupted 

venipuncture, and why it was 

differentiated from other components 

collected by apheresis. The comment 

also questioned whether the current 

practice of using a sterile connecting 

device to attach a sterile needle in the 

event of blood flow interruption would 

be prohibited in the future. 


jlentini on PROD1PC65 with RULES
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