19430 Federal Register / Vol. 63, No. 75 / Monday, April 20, 1998 / Proposed Rules

are specifically invited on the overall

regulatory, aeronautical, economic,

environmental, and energy-related

aspects of the proposal.

Communications should identify the

airspace docket number and be

submitted in triplicate to the address

listed above. Commenters wishing the

FAA to acknowledge receipt of their

comments on this notice must submit

with those comments a self-addressed,

stamped postcard on which the

following statement is made:

‘‘Comments to Airspace Docket No. 98–

AAL–7.’’ The postcard will be date/time

stamped and returned to the

commenter. All communications

received on or before the specified

closing date for comments will be

considered before taking action on the

proposed rule. The proposal contained

in this notice may be changed in light

of comments received. All comments

submitted will be available for

examination in the Operations Branch,

Air Traffic Division, Federal Aviation

Administration, 222 West 7th Avenue,

Box 14, Anchorage, AK, both before and

after the closing date for comments. A

report summarizing each substantive

public contact with FAA personnel

concerned with this rulemaking will be

filed in the docket.

Availability of NPRM’s

Any person may obtain a copy of this

Notice of Proposed Rulemaking (NPRM)

by submitting a request to the

Operations Branch, AAL–530, Federal

Aviation Administration, 222 West 7th

Avenue, Box 14, Anchorage, AK 99513–

7587. Communications must identify

the notice number of this NPRM.

Persons interested in being placed on a

mailing list for future NPRM’s should

also request a copy of Advisory Circular

No. 11–2A which describes the

application procedure.

The Proposal

The FAA proposes to amend 14 CFR

part 71 by revising the Class E airspace

at Barrow, AK, due to the establishment

of GPS instrument approaches to RWY

6 and RWY 24. The area would be

depicted on aeronautical charts for pilot

reference. The intended effect of this

proposal is to provide adequate

controlled airspace for IFR operations at

Wiley Post-Will Rogers Memorial

Airport, Barrow, AK.

The coordinates for this airspace

docket are based on North American

Datum 83. The Class E airspace areas

designated as 700/1200 foot transition

areas are published in paragraph 6005 of

FAA Order 7400.9E, Airspace

Designations and Reporting Points,

dated September 10, 1997, and effective

September 16, 1997, which is

incorporated by reference in 14 CFR

71.1 (62 FR 52491; October 8, 1997).

The Class E airspace designation listed

in this document would be revised and

published subsequently in the Order.

The FAA has determined that these

proposed regulations only involve 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.

Since this is a routine matter that will

only affect air traffic procedures and air

navigation, it is certified that this rule,

when promulgated, 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 71

Airspace, Incorporation by reference,

Navigation (air).

The Proposed Amendment

In consideration of the foregoing, the

Federal Aviation Administration

proposes to amend 14 CFR part 71 as

follows:

PART 71—DESIGNATION OF CLASS A,

CLASS B, CLASS C, CLASS D, AND

CLASS E AIRSPACE AREAS;

AIRWAYS; ROUTES; AND REPORTING

POINTS

1. The authority citation for 14 CFR

part 71 continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of Federal Aviation

Administration Order 7400.9E, Airspace

Designations and Reporting Points,

dated September 10, 1997, and effective

September 16, 1997, is to be amended

as follows:

Paragraph 6005—Class E airspace extending

upward from 700 feet or more above the

surface of the earth.

* * * * *

AAL AK E5 Barrow, AK

Barrow/Wiley Post—Will Rogers Memorial

Airport, AK

(lat. 71° 17′ 08′′ N, long. 156° 45′ 58′′ W)

Point Barrow LRRS Airport

(lat. 71° 20′ 20′′ N, long. 156° 37′ 58′′ W)

Barrow VORTAC

(lat. 71° 16′ 24′′ N, long. 156° 47′ 18′′ W)

Barrow Localizer

(lat. 71° 17′ 08′′ N, long. 156° 44′ 07′′ W)

That airspace extending upward from

700 feet above the surface within a 6.6-

mile radius of Barrow/Wiley Post—Will

Rogers Memorial Airport and within 4

miles each side of the Barrow Localizer

back course extending from the 6.6-mile

radius to 14.6 miles east of the airport

and within a 6.5-mile radius of the Point

Barrow LRRS Airport; and that airspace

extending upward from 1,200 feet above

the surface within a 77-mile radius of

the airport extending clockwise from the

Barrow VORTAC 101° radial to the 240°

radial and within the area bounded by

a line beginning at the Barrow VORTAC

240° radial 20 miles west to 71°13′ N

158° W to 71°23′ N 157° 48′ W to the

intersection of the Barrow VORTAC

345° radial and the 6.5-mile radius of

the Point Barrow LRRS Airport.

* * * * *

Issued in Anchorage, AK, on April 10,

1998.

Willis C. Nelson,

Manager, Air Traffic Division, Alaskan

Region.

[FR Doc. 98–10308 Filed 4–17–98; 8:45 am]

BILLING CODE 4910–13–P

SECURITIES AND EXCHANGE

COMMISSION

17 CFR Part 240

[Release No. 34–39859; File No. S7–8–98]

RIN 3235–AH42

Year 2000 Readiness Reports To Be

Made by Transfer Agents

AGENCY: Securities and Exchange

Commission.

ACTION: Proposed rule; extension of the

comment period.

SUMMARY: The Securities and Exchange

Commission is extending from April 13,

1998, until April 27, 1998, the comment

period for Securities Exchange Act

Release No. 39726 (March 5, 1998), 63

FR 12062 (March 12, 1998). In the

release the Commission proposed a rule

that would require non-bank transfer

agents to provide at least one report to

the Commission regarding its

preparations for Year 2000 problems.

DATES: Comments should be received on

or before April 27, 1998.

ADDRESSES: Comments should be

submitted in triplicate to Jonathan G.

Katz, Secretary, Securities and Exchange

Commission (‘‘Commission’’), 450 Fifth

Street, N.W., Washington, D.C. 20549.
Federal Register / Vol. 63, No. 75 / Monday, April 20, 1998 / Proposed Rules 19431

Comments also may be submitted

electronically at the following E-mail

address: rule-comments@sec.gov.

Comment letters should refer to File No.

S7–8–98; this file number should be

included on the subject line if E-mail is

used. All comments received will be

available for public inspection and

copying at the Commission’s Public

Reference Room, 450 Fifth Street, N.W.,

Washington, D.C. 20549. Electronically

submitted comment letters will be

posted on the Commission’s Internet

web site (http://www.sec.gov).

FOR FURTHER INFORMATION CONTACT: Jerry

W. Carpenter, Assistant Director, 202/

942–4187; Thomas C. Etter, Jr., Special

Counsel, 202/942–0178; or Jeffrey S.

Mooney, Special Counsel, 202/942–

4174, Division of Market Regulation,

Securities and Exchange Commission,

450 Fifth Street, N.W., Mail Stop 10–1,

Washington, D.C. 20549.

SUPPLEMENTARY INFORMATION: On March

5, 1998, the Commission proposed

temporary Rule 17Ad-18 under the

Securities Exchange Act of 1934. Rule

17Ad-18 would require all non-bank

registered transfer agents to file with the

Commission at least one report

regarding its Year 2000 readiness. The

initial report would be due no later than

45 days after the Commission adopts

this rule. The follow-up reports, which

would be due on August 31, 1998, and

on August 31, 1999, would include an

attestation by an independent public

accountant that would give the

independent public accountant’s

opinion whether there is a reasonable

basis for the transfer agent’s assertions

in the reports. Additionally, the release

contains a Commission advisory notice

on its transfer agent record retention

and recordkeeping requirements relating

to the Year 2000.

The Commission has recently

received requests from interested

persons to extend the comment period

for this release. The Commission

believes that extending the comment

period is appropriate in order to give the

public additional time to comment on

the matters the release addresses.

Therefore, the comment period is

extended until April 27, 1998.

By the Commission.

Dated: April 14, 1998.

Margaret H. McFarland,

Deputy Secretary.

[FR Doc. 98–10336 Filed 4–17–98; 8:45 am]

BILLING CODE 8010–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 610

[Docket No. 97N–0449]

RIN 0910–AB51

Revisions to the General Safety

Requirements for Biological Products;

Companion Document to Direct Final

Rule

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend the biologics regulations by

adding cellular therapy products to the

list of products exempted from the

general safety test (GST) and by adding

an administrative procedure for

obtaining exemptions from the GST

requirements. This proposed rule is a

companion document to the direct final

rule published elsewhere in this issue of

the Federal Register. FDA is taking this

action because the GST may not be

relevant or necessary for many types of

biological products, including cellular

therapy products, currently in various

stages of development.

DATES: Comments must be received on

July 6, 1998. Submit written comments

on the information collection provisions

by June 19, 1998.

ADDRESSES: Submit written comments

on the proposed rule to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Dano B. Murphy, Center for Biologics

Evaluation and Research (HFM–630),

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–594–3074.

SUPPLEMENTARY INFORMATION:

I. Background

This proposed rule is a companion to

the direct final rule published in the

final rules section of this issue of the

Federal Register. This companion

proposed rule will provide the

procedural framework to finalize the

rule in the event the direct final rule

receives any significant adverse

comment and is withdrawn. The

comment period for this companion

proposed rule runs concurrently with

the comment period for the direct final

rule. Any comments received under this

companion proposed rule will also be

considered as comments regarding the

direct final rule. FDA is publishing the

direct final rule because the rule

contains noncontroversial changes, and

FDA anticipates that it will receive no

significant adverse comment.

A significant adverse comment is

defined as a comment that explains why

the rule would be inappropriate,

including challenges to the rule’s

underlying premise or approach, or

would be ineffective or unacceptable

without a change. In determining

whether a significant adverse comment

is sufficient to terminate a direct final

rulemaking, FDA will consider whether

the comment raises an issue serious

enough to warrant a substantive

response in a notice-and-comment

process. Comments that are frivolous,

insubstantial, or outside the scope of the

rule will not be considered significant

or adverse under this procedure. For

example, a comment requesting

inclusion of additional product classes

in the exceptions paragraph of the GST

(§ 610.11(g)) will not be considered a

significant adverse comment because it

is outside the scope of this rule. A

comment recommending a rule change

in addition to the rule would not be

considered a significant adverse

comment, unless the comment states

why the rule would be ineffective

without additional change. In addition,

if a significant adverse comment applies

to part of a rule and that part can be

severed form the remainder of the rule,

FDA may adopt as final those parts of

the rule that are not subject of a

significant adverse comment.

A detailed rationale for the rule is set

forth in the preamble to the direct final

rule and in section I of this document.

If no significant adverse comment is

received in response to the direct final

rule, no further action will be taken

related to this proposed rule. Instead,

FDA will publish a confirmation

document within 30 days after the

comment period ends confirming that

the direct final rule will go into effect

on September 2, 1998. Additional

information about FDA’s direct final

rulemaking procedures is set forth in a

guidance published in the Federal

Register of November 21, 1997 (62 FR

62466).

If FDA receives any significant

adverse comment regarding this rule,

FDA will publish a document

withdrawing the direct final rule within

30 days after the comment period ends.

FDA then will proceed to respond to all

of the comments received regarding this

rule and, if appropriate, the rule will be

finalized under this proposed rule using

usual notice-and-comment procedures.