36638 Federal Register / Vol. 60, No. 137 / Tuesday, July 18, 1995 / Rules and Regulations

EFFECTIVE DATE: 0901 UTC, July 20,

1995.

FOR FURTHER INFORMATION CONTACT:

Paul J. Best, Flight Procedures

Standards Branch (AFS–420), Technical

Programs Division, Flight Standards

Service Federal Aviation

Administration, 800 Independence

Avenue, SW., Washington, D.C. 20591;

telephone: (202) 267–8277.

SUPPLEMENTARY INFORMATION: This

amendment to part 95 of the Federal

Aviation Regulations (14 CFR part 95)

amends, suspends, or revokes IFR

altitudes governing the operation of all

aircraft in flight over a specified route

or any portion of that route, as well as

the changeover points (COPs) for

Federal airways, jet routes, or direct

routes as prescribed in part 95.

The Rule

The specified IFR altitudes, when

used in conjunction with the prescribed

changeover points for those routes,

ensure navigation aid coverage that is

adequate for safe flight operations and

free of frequency interference. The

reasons and circumstances that create

the need for this amendment involve

matters of flight safety and operational

efficiency in the National Airspace

System, are related to published

aeronautical charts that are essential to

the user, and provide for the safe and

efficient use of the navigable airspace.

In addition, those various reasons or

circumstances require making this

amendment effective before the next

scheduled charting and publication date

of the flight information to assure its

timely availability to the user. The

effective date of this amendment reflects

those considerations. In view of the

close and immediate relationship

between these regulatory changes and

safety in air commerce, I find that notice

and public procedure before adopting

this amendment are impracticable and

contrary to the public interest and that

good cause exists for making the

amendment effective in less than 30

days. The FAA has determined that this

regulation only involves an established

body of technical regulations for which

frequent and routine amendments are

necessary to keep them operationally

current.

It, therefore—(1) is not a ‘‘significant

regulatory action’’ under Executive

Order 12866; (2) is not a ‘‘significant

rule’’ under DOT Regulatory Policies

and Procedures (44 FR 11034; February

26, 1979); and (3) does not warrant

preparation of a regulatory evaluation as

the anticipated impact is so minimal.

For the same reason, the FAA certifies

that this amendment will not have a

significant economic impact on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act.

List of Subjects in 14 CFR Part 95

Airspace, Navigation (air).

Issued in Washington, D.C. on June 2,

1995.

Thomas C. Accardi,

Director, Flight Standards Service.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, part 95 of the Federal

Aviation Regulations (14 CFR part 95) is

amended as follows:

PART 95—[AMENDED]

1. The authority citation for part 95 is

revised to read as follows:

Authority: 49 U.S.C. 40103, 40113, and

40120; 49 U.S.C. 106(g) (Revised Pub. L. 97–

449, January 12, 1983); and 14 CFR 11.49

(b)(2).

2. Part 95 is amended to read as

follows:

REVISIONS TO MINIMUM ENROUTE IFR ALTITUDES AND CHANGEOVER POINTS

[Amendment 390 effective date, July 20, 1995]

From To MEA

§ 95.6225 VOR Federal Airway 225 Is Amended to Read in Part

La Belle, FL VORTAC *1400—MOCA .......................................... Diddy, FL FIX ............................................................................... *2000

§ 95.6381 VOR Federal Airway 381 Is Amended to Read in Part

Bishop, CA VOR/DME *13000—MCA Nicol FIX, SE BND

**12300—MOCA.

*Nicol, CA FIX .............................................................................. **13000

Airway segment Changeover points

From To Distance From

§ 95.8003 VOR Federal Airways Changeover Points

V–97 Is Amended by Adding

Miami, FL VORTAC .......................................................... La Belle, FL VORTAC ...................................................... 25 Miami.

V–521 Is Amended by Adding

Miami, FL VORTAC .......................................................... La Belle, FL VORTAC ...................................................... 25 Miami.

[FR Doc. 95–17595 Filed 7–17–95; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF COMMERCE

Bureau of Export Administration

15 CFR Part 799

General Technology and Software

Notes

CFR Correction

In title 15 of the Code of Federal

Regulations, parts 300 to 799, revised as

of January 1, 1995, on page 661,

Supplement No. 2 to § 799.1 was

removed and reserved in error. The

correct text of the supplement as

published in title 15, revised as of

January 1, 1994, reads as follows:

§ 799.1 [Corrected]

Supplement No. 2 to § 799.1—General

Technology and Software Notes

1. General Technology Note. The export of

‘‘technology’’ that is ‘‘required’’ for the

‘‘development,’’ ‘‘production,’’ or ‘‘use’’ of
Federal Register / Vol. 60, No. 137 / Tuesday, July 18, 1995 / Rules and Regulations 36639

1The phrase ‘‘without restriction’’ clarifies that

software is not ‘‘generally available to the public’’

if it is to be sold only with bundled hardware

generally available to the public. Software that is

both bundled with hardware and ‘‘generally

available to the public’’ does qualify for General

License GDTR, without written assurance.

products on the Commerce Control List is

controlled according to the provisions in

each Category.

‘‘Technology’’ ‘‘required’’ for the

‘‘development,’’ ‘‘production,’’ or ‘‘use’’ of a

controlled product remains controlled even

when applicable to a product controlled at a

lower level.

General License GTDR, without written

assurance, is available for ‘‘technology’’ that

is the minimum necessary for the

installation, operation, maintenance

(checking), and repair of those products that

are eligible for General Licenses or that are

exported under a validated export license.

N.B.: This does not allow release under a

general license of the repair ‘‘technology’’

controlled by 1E02.e, 1E02.f, 7E03, or 8E02.a.

N.B.: The ‘minimum necessary’ excludes

‘‘development’’ or ‘‘production’’ technology

and permits ‘‘use’’ technology only to the

extent ‘‘required’’ to ensure safe and efficient

use of the product. Individual ECCNs may

further restrict export of ‘minimum

necessary’ information.

General License GTDA is available for

‘‘technology’’ that is publicly available or

technology arising during or resulting from

fundamental research. See section 779.3 of

this subchapter for details on General License

GTDA.)

2. General Software Note. General License

GTDR, without written assurance, is

available for release of software that is

generally available to the public by being:

a. Sold from stock at retail selling points,

without restriction,1 by means of:

1. Over the counter transactions;

2. Mail order transactions; or

3. Telephone call transactions; and

b. Designed for installation by the user

without further substantial support by the

supplier.

General License GTDA is available for

software that is publicly available.

N.B.; The General Software Note does not

apply to exports of ‘‘software’’ controlled by

other agencies of the U.S. Government (see

§ 770.10 of this subchapter).

BILLING CODE 1505–01–D

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 892

[Docket No. 94N–0345]

Medical Devices; Classification of

Transilluminators (Diaphanoscopes or

Lightscanners) for Breast Evaluation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a final

rule to classify the transilluminator

(diaphanoscope or lightscanner) for

breast evaluation into class III

(premarket approval). This action is

necessary to require manufacturers of

transilluminators to submit a premarket

approval application that includes

information concerning safety and

effectiveness tests for the device. This

action is being taken under the Federal

Food, Drug, and Cosmetic Act as

amended by the Medical Device

Amendments of 1976 and the Safe

Medical Devices Act of 1990.

EFFECTIVE DATE: August 17, 1995.

FOR FURTHER INFORMATION CONTACT:

Robert A. Phillips, Center for Devices

and Radiological Health (HFZ–470),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1212.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 13, 1995 (60

FR 3168), FDA issued a proposed rule

to classify transilluminators

(diaphanoscopes or lightscanners) for

breast evaluation into class III. The

effect of classifying a device into class

III is to require each manufacturer of the

device to submit to FDA a premarket

approval application that includes

information concerning safety and

effectiveness tests for the device. A

period of 90 days was provided for

interested persons to submit written

comments to FDA. FDA did not receive

any comments on the proposal.

Accordingly, the proposed rule is being

adopted without change.

Environmental Impact

The agency has determined under 21

CFR 25.24(e)(2) 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.

Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (Pub.

L. 96–354). 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.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because the agency believes

only a small number of firms will be

affected by this rule, the agency certifies

that the final rule will not have a

significant economic impact on a

substantial number of small entities.

Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

List of Subjects in 21 CFR Part 892

Medical devices, Radiation

protection, X-rays.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 892 is

amended as follows:

PART 892—RADIOLOGY DEVICES

1. The authority citation for 21 CFR

part 892 continues to read as follows:

Authority: Secs. 501, 510, 513, 520, 701 of

the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 351, 360, 360c, 360e, 360j, 371).

2. New § 892.1990 is added to subpart

B to read as follows:

§ 892.1990 Transilluminator for breast

evaluation.

(a) Identification. A transilluminator,

also known as a diaphanoscope or

lightscanner, is an electrically powered

device that uses low intensity emissions

of visible light and near-infrared

radiation (approximately 700–1050

nanometers (nm)), transmitted through

the breast, to visualize translucent tissue

for the diagnosis of cancer, other

conditions, diseases, or abnormalities.

(b) Classification. Class III (premarket

approval).

(c) Date premarket approval (PMA) or

notice of completion of a product

development protocol (PDP) is required.

The effective date of the requirement for

premarket approval has not been

established. See § 892.3.

Dated: July 10, 1995.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 95–17640 Filed 7–17–95; 8:45 am]

BILLING CODE 4160–01–F