41330 Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Rules and Regulations

J–25 [Revised]

From the INT of the United States/Mexican

Border and the Brownsville, TX, INT 221°

radial via Brownsville; INT of the

Brownsville 358° and the Corpus Christi, TX,

178° radials; Corpus Christi; INT of the

Corpus Christi 311° and the San Antonio, TX,

174° radials; San Antonio; Centex, TX; Waco,

TX; Ranger, TX; Tulsa, OK; Kansas City, MO;

Des Moines, IA; Mason City, IA; Gopher, MN;

Brainerd, MN; to Winnipeg, MB, Canada. The

airspace within Canada is excluded. The

airspace within Mexico is excluded.

* * * * *

Issued in Washington, DC, on June 27,

2000.

Reginald C. Matthews,

Manager, Airspace and Rules Division

[FR Doc. 00–16915 Filed 7–3–00; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 97–ASO–18]

RIN 2120–AA66

Realignment and Establishment of

VOR Federal Airways; KY and TN

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule; correction.

SUMMARY: This action corrects a final

rule published in the Federal Register

on June 2, 2000. The legal description

of Federal Airway V–384 inadvertently

listed incorrect radials. This action

corrects that error.

EFFECTIVE DATE: July 5, 2000.

FOR FURTHER INFORMATION CONTACT:

Terry Brown, Airspace and Rules

Division, ATA–400, Office of Air Traffic

Airspace Management, Federal Aviation

Administration, 800 Independence

Avenue, SW., Washington, DC 20591;

telephone: (202) 267–8783.

SUPPLEMENTARY INFORMATION: On June 2,

2000, Airspace Docket No. 97–ASO–18,

FR Doc. 00–13750, was published

establishing V–384 between Livingston,

TN, and Volunteer, TN. This rule

included a legal description for V–384,

which inadvertently listed incorrect

radials. This action corrects this

situation by omitting the radials in the

legal description for V–384, thereby

eliminating the error.

Correction to Final Rule

Accordingly, pursuant to the

authority delegated to me, the legal

description for V–384 as published in

the Federal Register on June 2, 2000 (65

FR 35272); FR Doc. 00–13750, and

incorporated by reference in 14 CFR

71.1, is corrected as follows:

§ 71.1 [Corrected]

On page 35273, the legal description

for V–384 is corrected as follows:

Paragraph 6010(a)—Domestic VOR Federal

Airways

* * * * *

V–384—[Revised]

From Livingston, TN; to Volunteer, TN.

* * * * *

Issued in Washington, DC, on June 27,

2000.

Reginald C. Matthews,

Manager, Airspace and Rules Division.

[FR Doc. 00–16914 Filed 7–3–00; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. 95N–0084]

Medical Devices; Effective Date of

Requirement for Premarket Approval

for a Class III Preamendments

Obstetrical and Gynecological Device

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a final

rule to require the filing of a premarket

approval application (PMA) or a notice

of completion of product development

protocol (PDP) for a Group 1

preamendments class III device, the

obstetric data analyzer intended to

analyze data from fetal and maternal

monitors during labor and to warn of

possible fetal distress. The agency has

summarized its findings regarding the

degree of risk of illness or injury

designed to be eliminated or reduced by

requiring the device to meet the statute’s

approval requirements and the benefits

to the public from the use of the

devices.

DATES: This rule is effective July 5,

2000.

FOR FURTHER INFORMATION CONTACT:

Colin M. Pollard, Center for Devices and

Radiological Health (HFZ–470), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1180.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of May 6, 1994

(59 FR 23731), FDA issued a notice of

availability of a preamendments class III

devices strategy document. The strategy

document set forth FDA’s plans for

implementing the provisions of section

515(i) of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C.

360e(i)) for preamendments class III

devices for which FDA had not yet

required premarket approval. FDA

divided this universe of devices into

three groups as referenced in the May 6,

1994, notice.

In the Federal Register of September

7, 1995 (60 FR 46718), FDA published

a proposed rule to require the filing

under section 515(b) of the act of a PMA

or a notice of completion of a PDP for

43 preamendment class III devices,

including the obstetric data analyzer. In

accordance with section 515(b)(A)(2) of

the act, FDA included in the preamble

to the proposal the agency’s tentative

findings with respect to the degree of

risk of illness or injury designed to be

eliminated or reduced by requiring the

device to meet the premarket approval

requirements of the act, and the benefits

to the public from use of the device. The

September 7, 1995, proposed rule also

provided an opportunity for interested

persons to submit comments on the

proposed rule and the agency’s findings.

Under section 515(b)(2)(B) of the act,

FDA provided an opportunity for

interested persons to request a change in

the classification of the device based on

new information relevant to its

classification. Any petition requesting a

change in the classification of the

devices was required to be submitted by

September 22, 1995. The comment

period closed January 5, 1996.

FDA received one citizen petition

requesting a change in the classification

of the obstetrical data analyzer. FDA

reviewed the petition, identified a

deficiency in the petition, and issued a

deficiency letter on March 7, 1996, to

the petitioner. From the petitioner’s

response to the deficiency letter, it was

apparent that the petitioner had

misinterpreted the September 7, 1995,

proposed rule because he believed that

it was about another device and not the

obstetrical data analyzer. In light of this

petition, FDA has amended the

identification of the device in

§ 884.2050(a) by changing the first two

sentences to read as follows: ‘‘An

obstetric data analyzer (fetal status data

analyzer) is a device used during labor

to analyze electronic signal data

obtained from fetal and maternal

monitors. The obstetric data analyzer

provides clinical diagnosis of fetal

Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Rules and Regulations 41331

status and recommendations for labor

management and clinical

interventions.’’ With this clarifying

change, FDA is proceeding to issue a

final rule to require the filing of a PMA

or a PDP for the obstetric data analyzer.

II. Findings With Respect to Risks and

Benefits

Under section 515(b)(3) of the act,

FDA is adopting the findings as

published in the proposed rule of

September 7, 1995. As required by

section by section 515(b) of the act, FDA

published its findings regarding: (1) The

degree of risk of illness or injury

designed to be eliminated or reduced by

requiring that these devices have an

approved PMA or a declared completed

PDP; and (2) the benefits to the public

from the use of the device.

These findings are based on the

reports and recommendations of the

Obstetrical and Gynecological Devices

Panel, an FDA advisory committee for

the classification of the devices, along

with any additional information FDA

discovered. Additional information can

be found in the proposed and final rules

classifying the devices in the Federal

Register of April 3, 1979 (44 FR 19894)

and February 26, 1980 (45 FR 12682),

respectively.

III. The Final Rule

Under section 515(b)(3) of the act,

FDA is adopting the findings as

published in the preamble to the

proposed rule and issuing this final rule

to require premarket approval of the

generic type of device, the obstetric data

analyzer, by revising 21 CFR part 884.

Under the final rule, a PMA or a

notice of completion of a PDP is

required to be filed on or before October

3, 2000, for any obstetric data analyzer

that was in commercial distribution

before May 28, 1976, or that has been

found by FDA to be substantially

equivalent to such a device on or before

October 3, 2000. An approved PMA or

a declared completed PDP is required to

be in effect for any such devices on or

before 180 days after FDA files the

application. Any other obstetric data

analyzer that was not in commercial

distribution before May 28, 1976, is

required to have an approved PMA or a

declared completed PDP in effect before

it may be marketed.

If a PMA or a notice of completion of

a PDP for an obstetric data analyzer is

not filed on or before the 90th day past

the effective date of this regulation, that

device will be deemed adulterated

under section 501(f)(1)(A) of the act (21

U.S.C. 351(f)(1)(A)), and commercial

distribution of the device will be

required to cease immediately. The

device may, however, be distributed for

investigational use, if the requirements

of the investigational device exemption

(IDE) regulations (21 CFR part 812) are

met.

Under § 812.2(d) of the IDE

regulations, FDA hereby stipulates that

the exemptions from the IDE

requirements in § 812.2(c)(1) and (c)(2)

will no longer apply to clinical

investigations of the obstetric data

analyzer. Further, FDA concludes that

investigational obstetric data analyzers

are significant risk devices as defined in

§ 812.3(m) and advises that, as of the

effective date of § 878.3530(c), the

requirements of the IDE regulations

regarding significant risk devices will

apply to any clinical investigation of an

obstetric data analyzer. For any obstetric

data analyzer that is not subject to a

timely filed PMA or PDP, an IDE must

be in effect under § 812.20 on or before

90 days after the effective date of this

regulation or distribution of the device

must cease. FDA advises all persons

presently sponsoring a clinical

investigation involving the obstetric

data analyzer to submit an IDE

application to FDA no later than 60 days

after the effective date of this final rule

to avoid the interruption of ongoing

investigations.

IV. Environmental Impact

The agency has determined under 21

CFR 25.30(h) that this action is of a 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.

V. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act

(Public Law 96–354), as amended by

subtitle D of the Small Business

Regulatory Fairness Act of 1996 (Public

Law 104–121) 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 consistent

with the regulatory philosophy and

principles identified in the Executive

Order. In addition, the final rule is not

a significant regulatory action as defined

by the Executive Order and so is not

subject to review under the Executive

Order.

If a rule has a significant economic

impact on a substantial number of small

entities, the Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because FDA believes that

there is little or no interest in marketing

these devices, the agency certifies that

the final rule, if issued, will not have a

significant impact on a substantial

number of small entities. Therefore,

under the Regulatory Flexibility Act, no

further analysis is required.

Section 202(a) of the Unfunded

Mandates Reform Act of 1995 (Public

Law 104–4) requires that agencies

prepare a written statement of

anticipated costs and benefits before

proposing any rule that may result in an

expenditure by State, local, and tribal

governments, in the aggregate, or by the

private sector, of $100 million in any

one year (adjusted annually for

inflation). The Unfunded Mandates

Reform Act does not require FDA to

prepare a statement of costs and benefits

for the final rule, because the proposed

rule is not expected to result in any 1-

year expenditure that would exceed

$100 million adjusted for inflation.

VI. Paperwork Reduction Act of 1995

FDA concludes that this final rule

contains no new collections of

information. The premarket approval

program information collection is

approved by the Office of Management

and Budget (OMB) under OMB Control

No. 0910–0231. Therefore, clearance by

under the Paperwork Reduction Act of

1995 is not required.

VII. 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 order and, consequently, a

federalism summary impact statement is

not required.

List of Subjects in 21 CFR Part 884

Medical devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

41332 Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Rules and Regulations

of Food and Drugs, 21 CFR part 884 is

amended as follows:

PART 884—OBSTETRICAL AND

GYNECOLOGICAL DEVICES

1. The authority citation for 21 CFR

part 884 continues to read as follows:

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

360j, 371.

2. Section 884.2050 is revised to read

as follows:

§ 884.2050 Obstetric data analyzer.

(a) Identification. An obstetric data

analyzer (fetal status data analyzer) is a

device used during labor to analyze

electronic signal data obtained from

fetal and maternal monitors. The

obstetric data analyzer provides clinical

diagnosis of fetal status and

recommendations for labor management

and clinical interventions. This generic

type of device may include signal

analysis and display equipment,

electronic interfaces for other

equipment, and power supplies and

component parts.

(b) Classification: Class III (premarket

approval).

(c) Date PMA or notice of completion

of PDP is required. A PMA or a notice

of completion of a PDP is required to be

filed with the Food and Drug

Administration on or before October 3,

2000, for any obstetric data analyzer

described in paragraph (a) of this

section that was in commercial

distribution before May 28, 1976, or that

has been found, on or before October 3,

2000, to be substantially equivalent to

an obstetric data analyzer described in

paragraph (a) of this section that was in

commercial distribution before May 28,

1976. Any other obstetric data analyzer

described in paragraph (a) of this

section shall have an approved PMA or

declared completed PDP in effect before

being placed in commercial

distribution.

Dated: June 22, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–16808 Filed 7–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[TD 8890]

RIN 1545–AX25

Definition of Grantor

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Final and temporary

regulations.

SUMMARY: This document contains final

regulations defining the term grantor for

purposes of part I of subchapter J,

chapter 1 of the Internal Revenue Code.

These regulations provide necessary

guidance in determining who is the

grantor of a trust in applying those Code

sections. These regulations affect trusts

and any person creating or funding a

trust.

DATES: Effective Date: These regulations

are effective July 5, 2000.

Applicability Dates: For dates of

applicability of § 1.671–2(e), see

§ 1.671–2(e)(7).

FOR FURTHER INFORMATION CONTACT:

James A. Quinn at (202) 622–3060 (not

a toll-free number).

SUPPLEMENTARY INFORMATION

Background

On June 5, 1997, the Treasury

Department and the IRS published a

notice of proposed rulemaking (REG–

252487–96) under section 671 of the

Internal Revenue Code (Code) in the

Federal Register (62 FR 30785).

Comments responding to the notice

were received and a public hearing was

held on August 27, 1997. After

consideration of the comments, the

proposed regulations under section 671

were re-issued as proposed (64 FR

43323) and temporary regulations (64

FR 43267) on August 10, 1999.

The proposed and temporary

regulations provide a definition of

grantor for purposes of part I of

subchapter J, chapter 1 of the Code. No

comments were received in response to

the Notice of Proposed Rulemaking

published on August 10, 1999, in the

Federal Register, and no one requested

to speak at the public hearing scheduled

for November 2, 1999. Accordingly, the

public hearing was canceled on October

28, 1999 (64 FR 58006). This document

finalizes the proposed regulations and

removes the temporary regulations.

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 these regulations, and, because the

regulations do 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 Code, the notice

of proposed rulemaking preceding these

regulations was submitted to the Small

Business Administration for comment

on the regulations’ impact on small

business.

Drafting Information

The principal author of these

regulations is James A. Quinn of the

Office of the Assistant Chief Counsel

(Passthroughs and Special Industries).

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 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 is amended by removing the entry

for section 1.671–2T and adding an

entry in numerical order to read in part

as follows:

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

Section 1.671–2 also issued under 26

U.S.C. 643(a)(7) and 672(f)(6). * * *

§ 1.643(h)–1 [Amended]

Par. 2. Section 1.643(h)–1 is amended

as follows:

1. In paragraph (a)(2)(i) the language

‘‘§ 1.671–2T(e)(2)’’ is removed, and

‘‘§ 1.671–2(e)(2)’’ is added in its place.

2. In paragraph (b)(1) the language

‘‘§ 1.671–2T(e)(2)’’ is removed, and

‘‘§ 1.671–2(e)(2)’’ is added in its place.

3. In paragraph (b)(2) the language

‘‘§ 1.671–2T(e)’’ is removed, and

‘‘§ 1.671–2(e)’’ is added in its place.

4. In paragraph (g) Example 1 the

language ‘‘§ 1.671–2T(e)(2)’’ is removed,

and ‘‘§ 1.671–2(e)(2)’’ is added in its

place.

Par. 3. Section 1.671–2(e) is revised to

read as follows:

§ 1.671–2 Applicable principles.

* * * * *

(e)(1) For purposes of part I of

subchapter J, chapter 1 of the Internal