57748 Federal Register / Vol. 70, No. 191 / Tuesday, October 4, 2005 / Rules and Regulations 

FDC date State City Airport FDC No. Subject 

09/19/05 ...... ID Idaho Falls ..................... Idaho Falls Regional ......................... 5/8505 NDB Rwy 20, Amdt 10B 

09/19/05 ...... ID Idaho Falls ..................... Idaho Falls Regional ......................... 5/8520 ILS Rwy 20, Amdt 11C 

09/19/05 ...... UT Cedar City ..................... Cedar City Regional .......................... 5/8521 ILS OR LOC Rwy 20, Amdt 3C 

09/19/05 ...... UT Provo ............................. Provo Muni ........................................ 5/8522 ILS OR LOC/DME Rwy 13, Orig-A 

09/19/05 ...... UT Roosevelt ....................... Roosevelt Muni .................................. 5/8523 RNAV (GPS) Rwy 25, Orig-A 

09/19/05 ...... UT Roosevelt ....................... Roosevelt Muni .................................. 5/8524 VOR/DME RNAV Rwy 25, Amdt 2A 

09/19/05 ...... UT Provo ............................. Provo Muni ........................................ 5/8526 VOR/DME Rwy 13, Amdt 1A 

09/19/05 ...... UT Provo ............................. Provo Muni ........................................ 5/8527 VOR Rwy 13, Amdt 3A

09/19/05 ...... UT Moab .............................. Canyon Lands Field .......................... 5/8528 VOR–A, Amdt 10A 

[FR Doc. 05–19745 Filed 10–3–05; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. 2005N–0341] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

AFP-L3% Immunological Test Systems 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying 

AFP-L3% (alpha-fetoprotein L3 

subfraction) immunological test systems 

into class II (special controls). The 

special control that will apply to the 

device is the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: AFP-L3% 

Immunological Test Systems.’’ The 

agency is classifying the device into 

class II (special controls) in order to 

provide a reasonable assurance of safety 

and effectiveness of the device. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of a guidance document that 

will serve as the special control for the 

device. 

DATES: This rule is effective November 

3, 2005. The classification was effective 

May 19, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Maria Chan, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 240–276–

0496. 

SUPPLEMENTARY INFORMATION: 

I. What is the Background of this 

Rulemaking? 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 360c(f)(1)), 

devices that were not in commercial 

distribution before May 28, 1976, the 

date of enactment of the Medical Device 

Amendments of 1976 (the amendments), 

generally referred to as postamendments 

devices, are classified automatically by 

statute into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or reclassified 

into class I or II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the act, to a predicate device 

that does not require premarket 

approval. The agency determines 

whether new devices are substantially 

equivalent to predicate devices by 

means of premarket notification 

procedures in section 510(k) of the act 

(21 U.S.C. 360(k)) and 21 CFR part 807 

of FDA’s regulations. 

Section 513(f)(2) of the act provides 

that any person who submits a 

premarket notification under section 

510(k) of the act for a device that has not 

previously been classified may, within 

30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1) of the act, request FDA 

to classify the device under the criteria 

set forth in section 513(a)(1) of the act. 

FDA shall, within 60 days of receiving 

such a request, classify the device by 

written order. This classification shall 

be the initial classification of the device. 

Within 30 days after the issuance of an 

order classifying the device, FDA must 

publish a notice in the Federal Register 

announcing such classification (section 

513(f)(2) of the act). 

In accordance with section 513(f)(1) of 

the act, FDA issued an order on April 

1, 2005, classifying the Wako LBA 

(liquid-phase binding assay) AFP-L3 in 

class III, because it was not substantially 

equivalent to a device that was 

introduced or delivered for introduction 

into interstate commerce for commercial 

distribution before May 28, 1976, or a 

device that was subsequently 

reclassified into class I or class II. On 

April 6, 2005, Wako Chemical USA, 

Inc., submitted a petition requesting 

classification of the Wako AFP-L3 Test 

System under section 513(f)(2) of the 

act. The manufacturer recommended 

that the device be classified into class II. 

In accordance with 513(f)(2) of the 

act, FDA reviewed the petition in order 

to classify the device under the criteria 

for classification set forth in 513(a)(1) of 

the act. Devices are to be classified into 

class II if general controls, by 

themselves, are insufficient to provide 

reasonable assurance of safety and 

effectiveness, but there is sufficient 

information to establish special controls 

to provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use. After review of the 

information submitted in the petition, 

FDA determined that the Wako LBA 

AFP-L3 Test System can be classified 

into class II with the establishment of 

special controls. FDA believes these 

special controls will provide reasonable 

assurance of the safety and effectiveness 

of the device. 

The device is assigned the generic 

name AFP-L3% immunological test 

system and it is identified as an in vitro 

device that consists of reagents and an 

automated instrument used to 

quantitatively measure, by 

immunochemical techniques, AFP and 

AFP-L3 subfraction in human serum. 

The device is intended for in vitro 

diagnostic use as an aid in the risk 

assessment of patients with chronic 

liver disease for development of 

hepatocellular carcinoma, in 

conjunction with other laboratory 

findings, imaging studies, and clinical 

assessment. 

FDA has identified the risks to health 

associated with this type of device as 

inappropriate risk assessment and 

improper patient management. Failure 

of the system to perform as indicated, or 

error in interpretation of results, could 

lead to inappropriate risk assessment 

and improper management of patients 

with chronic liver diseases. Specifically, 

a falsely low AFP-L3% could result in 

a determination that the patient is at a 

lower risk of developing hepatocellular 

carcinoma, which could delay 

appropriate monitoring and treatment. 

A falsely high AFP-L3% could result in 

a determination that the patient is at a 

Federal Register / Vol. 70, No. 191 / Tuesday, October 4, 2005 / Rules and Regulations 57749 

higher risk for hepatocellular 

carcinoma, which could lead to 

unnecessary evaluation and testing, or 

inappropriate treatment decisions. Use 

of assay results without consideration of 

other laboratory findings, imaging 

studies, and clinical assessment could 

also pose a risk. 

The class II special controls guidance 

document aids in mitigating potential 

risks by providing recommendations on 

validation of performance 

characteristics, including software 

validation, control methods, 

reproducibility, and clinical studies. 

The guidance document also provides 

information on how to meet premarket 

(510(k)) submission requirements for the 

device. FDA believes that following the 

recommendations in the class II special 

controls guidance document generally 

addresses the risks to health identified 

in the previous paragraph. 

Following the effective date of this 

final classification rule, any firm 

submitting a 510(k) premarket 

notification for an AFP-L3% 

immunological test system will need to 

address the issues covered in the special 

controls guidance. However, the firm 

need only show that its device meets the 

recommendations of the guidance, or in 

some other way provides equivalent 

assurance of safety and effectiveness. 

Section 510(m) of the act provides 

that FDA may exempt a class II device 

from the premarket notification 

requirements under 510(k) of the act if 

FDA determines that premarket 

notification is not necessary to provide 

reasonable assurance of the safety and 

effectiveness of the device. For this type 

of device, FDA has determined that 

premarket notification is necessary to 

provide reasonable assurance of the 

safety and effectiveness of the device 

and, therefore, the type of device is not 

exempt from premarket notification 

requirements. Persons who intend to 

market this type of device must submit 

to FDA a premarket notification, prior to 

marketing the device, which contains 

information about the AFP-L3% 

immunological test system they intend 

to market. 

II. What is the Environmental Impact of 

This Rule? 

The agency has determined under 21 

CFR 25.34(b) that this action is of type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

III. What is the Economic Impact of 

This Rule? 

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

the Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Public Law 104–4). 

Executive Order 12866 directs agencies 

to assess all costs and benefits of 

available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

agency believes that this final rule is not 

a significant regulatory action as defined 

by the Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because classification of this 

device into class II will relieve 

manufacturers of the device of the cost 

of complying with the premarket 

approval requirements of section 515 of 

the act (21 U.S.C. 360e), and may permit 

small potential competitors to enter the 

marketplace by lowering their costs, the 

agency certifies that the final rule will 

not have a significant economic impact 

on a substantial number of small 

entities. 

Section 202 (a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $115 

million, using the most current (2003) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

IV. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

V. How Does This Rule Comply with 

the Paperwork Reduction Act of 1995? 

FDA tentatively concludes that this 

proposed rule contains no collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (the PRA) (44 U.S.C. 3501- 

3502) is not required. 

FDA also tentatively concludes that 

the special controls guidance document 

identified by this rule contains 

information collection provisions that 

are subject to review and clearance by 

OMB under the PRA. Elsewhere in this 

issue of the Federal Register, FDA is 

publishing a notice announcing the 

availability of the draft guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: AFP-L3% 

Immunological Test Systems.’’

VI. What References Are on Display? 

The following reference has been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Petition from Wako Chemical USA, Inc., 

received April 7, 2005. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, Medical 

devices. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for 21 CFR 

part 866 continues to read as follows: 

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

360j, 371. 

■ 2. Section 866.6030 is added to 

subpart G to read as follows: 

§ 866.6030 AFP-L3% immunological test 

system. 

(a) Identification. An AFP-L3% 

immunological test system is an in vitro 

device that consists of reagents and an 

automated instrument used to 

quantitatively measure, by 

immunochemical techniques, AFP and 

AFP-L3 subfraction in human serum. 

The device is intended for in vitro 

57750 Federal Register / Vol. 70, No. 191 / Tuesday, October 4, 2005 / Rules and Regulations 

diagnostic use as an aid in the risk 

assessment of patients with chronic 

liver disease for development of 

hepatocellular carcinoma, in 

conjunction with other laboratory 

findings, imaging studies, and clinical 

assessment. 

(b) Classification. Class II (special 

controls). The special control is FDA’s 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

AFP-L3% Immunological Test 

Systems.’’ See § 866.1(e) for the 

availability of this guidance document. 

Dated: September 9, 2005. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. 05–19863 Filed 10–3–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9223] 

RIN 1545–BC20 

Value of Life Insurance Contracts 

When Distributed From a Qualified 

Retirement Plan; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correction to final regulations. 

SUMMARY: This document contains a 

correction to final regulations that were 

published in the Federal Register on 

Monday, August 29, 2005 (70 FR 50967) 

regarding the amount includible in a 

distributee’s income when life 

insurance contracts are distributed by a 

qualified retirement plan and regarding 

the treatment of property sold by a 

qualified retirement plan to a plan 

participant or beneficiary for less than 

fair market value. 

FOR FURTHER INFORMATION CONTACT: 

Concerning the section 79 regulations, 

Betty Clary at (202) 622–6080; 

concerning the section 83 regulations, 

Robert Misner at (202) 622–6030; 

concerning the section 402 regulations, 

Bruce Perlin or Linda Marshall at (202) 

622–6090 (not toll-free numbers). 

SUPPLEMENTARY INFORMATION: 

Background 

The final regulations (TD 9223) that 

are the subject of this correction are 

under sections 402(a), 79 and 83 of the 

Internal Revenue Code. 

Need for Correction 

As published, TD 9223 contains an 

error that may prove to be misleading 

and is in need of clarification. 

Correction of Publication 

Accordingly, the publication of the 

final regulations (TD 9223) which was 

the subject of FR Doc. 05–17046, is 

corrected as follows: 

On page 50969, column 2, in the 

preamble, under the paragraph heading 

‘‘B. The 2004 Proposed Regulations’’, 

line 2 from the top of the column, the 

language ‘‘§ 1.79-(d) to replace the term 

‘‘cash’’ is corrected read ‘‘§ 1.79–1(d) to 

replace the term ‘‘cash’’. 

Cynthia Grigsby, 

Acting Chief, Publications and Regulations 

Branch, Legal Processing Division, Associate 

Chief Counsel (Procedure and 

Administration). 

[FR Doc. 05–19776 Filed 10–3–05; 8:45 am] 

BILLING CODE 4830–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[R04–OAR–2004–KY–0003–200529; FRL–

7979–7A] 

Approval and Promulgation of 

Implementation Plans for Kentucky: 

Inspection and Maintenance Program 

Removal for Northern Kentucky; New 

Solvent Metal Cleaning Equipment; 

Commercial Motor Vehicle and Mobile 

Equipment Refinishing Operations 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is approving four related 

revisions to the Kentucky State 

Implementation Plan (SIP) submitted by 

the Commonwealth of Kentucky on 

February 9, 2005. These revisions affect 

the Northern Kentucky area, which is 

comprised of the Kentucky Counties of 

Boone, Campbell, and Kenton, and is 

part of the Cincinnati-Hamilton 

Metropolitan Statistical Area. EPA is 

approving the movement of the 

regulation underlying the Northern 

Kentucky inspection and maintenance 

(I/M) program from the regulatory 

portion of the Kentucky SIP to the 

contingency measures section of the 

Northern Kentucky 1-Hour Ozone 

Maintenance Plan. EPA is also 

approving revisions to a Kentucky rule 

which provides for the control of 

volatile organic compounds (VOCs) 

from new solvent metal cleaning 

equipment. Further, EPA is approving a 

new rule into the Kentucky SIP affecting 

commercial motor vehicle and mobile 

equipment refinishing operations in 

Northern Kentucky. Finally, EPA is 

approving updated mobile source 

category emissions projections with 

updated, state motor vehicle emission 

budgets (MVEBs) for the year 2010. This 

final rule addresses comments made on 

EPA’s proposed rulemaking previously 

published for this action. 

EFFECTIVE DATE: This rule will be 

effective November 3, 2005. 

ADDRESSES: EPA has established a 

docket for this action under Regional 

Material in EDocket (RME) ID No. R04–

OAR–2004–KY–0003. All documents in 

the docket are listed in the RME index 

at http://docket.epa.gov/rmepub/. Once 

in the system, select ‘‘quick search,’’

then key in the appropriate RME Docket 

identification number. Although listed 

in the index, some information is not 

publicly available, i.e., Confidential 

Business Information or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in RME or in hard copy at 

the Regulatory Development Section, 

Air Planning Branch, Air, Pesticides and 

Toxics Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street, SW., 

Atlanta, Georgia 30303–8960. EPA 

requests that if at all possible, you 

contact the contact listed in the FOR

FURTHER INFORMATION CONTACT section to 

schedule your inspection. The Regional 

Office’s official hours of business are 

Monday through Friday, 8:30 to 4:30, 

excluding federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Michele Notarianni, Regulatory 

Development Section, Air Planning 

Branch, Air, Pesticides and Toxics 

Management Division, Region 4, U.S. 

Environmental Protection Agency, 61 

Forsyth Street, SW., Atlanta, Georgia 

30303–8960. Ms. Notarianni can be 

reached via telephone number at (404) 

562–9031 or electronic mail at 

notarianni.michele@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

II. Today’s Action 

III. Clarifications Made in the Final SIP 

Submittal 

IV. Responses to Comments 

V. Final Action 

VI. Statutory and Executive Order Reviews