29364 Federal Register / Vol. 63, No. 103 / Friday, May 29, 1998 / Proposed Rules

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Safety.

The Proposed Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration proposes to amend part

39 of the Federal Aviation Regulations

(14 CFR part 39) as follows:

PART 39—AIRWORTHINESS

DIRECTIVES

1. The authority citation for part 39

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding a new airworthiness directive

(AD) to read as follows:

British Aerospace (Operations) Limited:

Docket No. 98–CE–03–AD.

Applicability: Model B.121 Series 1, 2, and

3 airplanes, all serial numbers, certificated in

any category.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

modified, altered, or repaired in the area

subject to the requirements of this AD. For

airplanes that have been modified, altered, or

repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (f) of this AD. The

request should include an assessment of the

effect of the modification, alteration, or repair

on the unsafe condition addressed by this

AD; and, if the unsafe condition has not been

eliminated, the request should include

specific proposed actions to address it.

Compliance: Required as indicated in the

body of this AD, unless already

accomplished.

To prevent structural failure of the main

spar web area caused by fatigue cracking or

separation of the wing caused by loose nuts

at the wing to fuselage main-spar attachment

fittings, which could result in loss of control

of the airplane, accomplish the following:

(a) Within the next 100 hours time-inservice (TIS) after the effective date of this

AD, replace the nuts (with improved design

nuts) at the wing to fuselage main-spar

attachment fittings in accordance with

British Aerospace PUP Mandatory Service

Bulletin No. B121/106, dated January 12,

1998.

(b) Upon accumulating 2,000 hours TIS on

the main spar or within the next 50 hours

TIS, whichever occurs later, install an

inspection opening and inspect, using eddy

current methods, the area at the main spar

web for cracks in accordance with the

ACCOMPLISHMENT INSTRUCTIONS

section of British Aerospace PUP Mandatory

Service Bulletin No. B121/105, dated January

12, 1998.

Note 2: Accomplishing the installation

inspection opening and initial eddy current

inspection required by this AD in accordance

with British Aerospace PUP Mandatory

Service Bulletin No. B121/102, Revision No.

1, Issued April 16, 1997, is considered

‘‘already accomplished’’ for the requirements

of paragraph (b) of this AD.

(c) Within 800 hours TIS after the initial

inspection required by paragraph (b) of this

AD, and thereafter at intervals not to exceed

800 hours TIS, reinspect the area of the main

spar web as specified in paragraph (b) of this

AD.

(d) If any cracks are found during any

inspection required by this AD, prior to

further flight, accomplish the following:

(1) Obtain a repair or replacement scheme

from the manufacturer through the FAA,

Small Airplane Directorate, at the address

specified in paragraph (e) of this AD; and

(2) Incorporate this scheme and continue to

repetitively inspect as required by paragraph

(c) of this AD, unless specified differently in

the instructions to the repair or replacement

scheme.

(e) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(f) An alternative method of compliance or

adjustment of the initial or repetitive

compliance times that provides an equivalent

level of safety may be approved by the

Manager, Small Airplane Directorate, Aircraft

Certification Service, 1201 Walnut, suite 900,

Kansas City, Missouri 64106. The request

shall be forwarded through an appropriate

FAA Maintenance Inspector, who may add

comments and then send it to the Manager,

Small Airplane Directorate.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Small Airplane

Directorate.

(g) Questions or technical information

related to the service information referenced

in this document should be directed to

British Aerospace (Operations) Limited,

British Aerospace Regional Aircraft,

Prestwick International Airport, Ayrshire,

KA9 2RW, Scotland; telephone: (01292)

479888; facsimile: (01292) 479703. This

service information may be examined at the

FAA, Central Region, Office of the Regional

Counsel, Room 1558, 601 E. 12th Street,

Kansas City, Missouri 64106.

Note 4: The subject of this AD is addressed

in British AD 005–01–98, not dated.

Issued in Kansas City, Missouri, on May

21, 1998.

Michael Gallagher,

Manager, Small Airplane Directorate, Aircraft

Certification Service.

[FR Doc. 98–14189 Filed 5–28–98; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 820

Quality System Inspection Technique

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

following public meeting: ‘‘Quality

System Inspection Technique.’’ The goal

of the meeting is to obtain views and

opinions from interested parties

concerning a proposed new technique

for conducting quality system

inspections. This proposed technique

could eventually replace the technique

presently used when FDA conducts

quality systems (good manufacturing

practices) inspections of medical device

manufacturers. The proposed ‘‘Quality

System Inspection Technique’’ was

developed by a group composed of the

Center for Devices and Radiological

Health (CDRH) and Office of Regulatory

Affairs staff, familiar with the Quality

Systems Regulation and present

inspectional processes, with input from

the medical device industry. This

meeting is part of the CDRH’s ongoing

reengineering effort to develop an

inspection program covering the Quality

System Regulation that results in more

focused and efficient inspections.

DATES: The public meeting will be held

on Thursday, June 18, 1998, from 8:30

a.m. to 5 p.m.

ADDRESSES: The public meeting will be

held at 5600 Fishers Lane, conference

rooms D and E, third floor, Rockville,

MD 20857.

FOR FURTHER INFORMATION CONTACT:

For information regarding the

meeting: Timothy R. Wells, Center

for Devices and Radiological Health

(HFZ–332), 2094 Gaither Rd.,

Rockville, MD 20859, 301–594–

4616, FAX 301–594–4638, e-mail

trw@cdrh.fda.gov.

For information regarding registration

or requests for oral presentations:

Georgia A. Layloff, Food and Drug

Administration, St. Louis Branch

Office, 12 Sunnen Dr., suite 122, St.

Louis, MO 63143, 314–645–1167,

ext. 121, FAX 314–645–2969, e-mail

glayloff@ora.fda.gov.

SUPPLEMENTARY INFORMATION: The draft

entitled ‘‘Quality System Inspection

Technique’’ is posted for comment on

the CDRH’s World Wide Web (www)

home page. The draft document may be
Federal Register / Vol. 63, No. 103 / Friday, May 29, 1998 / Proposed Rules 29365

accessed at http://www.fda.gov/cdrh/

gmp/gmp.html.

Send registration information

(including name, title, firm name,

address, telephone, and fax number),

and written material and requests to

make oral presentations, to the contact

person by June 11, 1998. No telephone

requests will be accepted. You will be

notified by fax to tell whether your

presentation will be included and your

time limitation. If you cannot be

reached by fax, please note that in your

request.

Due to space limitations, interested

parties are encouraged to register early.

Depending on the number of requests,

registration may be limited to one

representative per firm or organization.

If special accommodations are needed

due to a disability, please contact

Timothy R. Wells, at least 7 days in

advance.

Dated: May 19, 1998.

Linda S. Kahan,

Acting Deputy Director for Regulations Policy,

Center for Devices and Radiological Health.

[FR Doc. 98–14049 Filed 5–28–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 914

[SPATS No. IN–144–FOR]

Indiana Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Proposed rule; public comment

period and opportunity for public

hearing.

SUMMARY: OSM is announcing receipt of

a proposed amendment to the Indiana

regulatory program (hereinafter the

‘‘Indiana program’’) under the Surface

Mining Control and Reclamation Act of

1977 (SMCRA). The proposed

amendment consists of revisions to and

additions of statutes pertaining to

definitions, permit conditions, and

permit revisions. The amendment is

intended to revise the Indiana program

to improve operational efficiency.

This document sets forth the times

and locations that the Indiana program

and proposed amendment to that

program are available for public

inspection, the comment period during

which interested persons may submit

written comments on the proposed

amendment, and the procedures that

will be followed regarding the public

hearing, if one is requested.

DATES: Written comments must be

received by 4:00 p.m., e.s.t., June 29,

1998. If requested, a public hearing on

the proposed amendment will be held

on June 23, 1998. Requests to speak at

the hearing must be received by 4:00

p.m., e.s.t. on June 15, 1998.

ADDRESSES: Written comments and

requests to speak at the hearing should

be mailed or hand delivered to Andrew

R. Gilmore, Director, Indianapolis Field

Office, at the address listed below

Copies of the Indiana program, the

proposed amendment, a listing of any

scheduled public hearings, and all

written comments received in response

to this document will be available for

public review at the addresses listed

below during normal business hours,

Monday through Friday, excluding

holidays. Each requester may receive

one free copy of the proposed

amendment by contacting OSM’s

Indianapolis Field Office.

Andrew R. Gilmore, Director,

Indianapolis Field Office, Office of

Surface Mining Reclamation and

Enforcement, Minton-Capehart Federal

Building, 575 North Pennsylvania

Street, Room 301, Indianapolis, IN

46204, Telephone: (317) 226–6700.

Indiana Department of Natural

Resources, 402 West Washington Street,

Room C256, Indianapolis, Indiana

46204, Telephone: (317) 232–1547.

FOR FURTHER INFORMATION CONTACT:

Andrew R. Gilmore, Director,

Indianapolis Field Office, Telephone:

(317) 226–6700.

SUPPLEMENTARY INFORMATION:

I. Background on the Indiana Program

On July 29, 1982, the Secretary of the

Interior conditionally approved the

Indiana program. Background

information on the Indiana program,

including the Secretary’s findings, the

disposition of comments, and the

conditions of approval can be found in

the July 26, 1982, Federal Register (47

FR 32107). Subsequent actions

concerning the conditions of approval

and program amendments can be found

at 30 CFR 914.10, 194.15, and 194.15.

II. Description of the Proposed

Amendment

By letter dated May 14, 1998

(Administrative Record No. IND–1606),

Indiana submitted a proposed

amendment to its program pursuant to

SMCRA. Indiana submitted the

proposed amendment at its own

initiative. The amendment pertains to

revisions of and additions to the Indiana

Code (IC) made by House Enrolled Act

(HEA) No. 1074. HEA No. 1074 was

passed through the Indiana Legislature

and signed by the Governor of Indiana

on March 12, 1998. Only those portions

of HEA No. 1074 that pertain to Articles

14–8 and 14–34 are being considered in

this document. The full text of the

proposed program amendment

submitted by Indiana is available for

public inspection at the locations listed

above under ADDRESSES. A discussion of

the proposed amendment is presented

below.

1. IC 14–8–2–117.3, Definition for

‘‘Governmental Entity’’

Indiana proposes the following

definition: ‘‘Governmental entity, for the

purposes of IC 14–22–10–2 and IC 14–

22–10.2.5, has the meaning set forth in

IC 14–22–10–2(a).’’

2. IC 14–34–4–18, Permit Conditions

Indiana identified the existing

provision as subsection (a) and added

the following new provision at

subsection (b):

The director may issue a permit subject to

the condition that the permittee obtain or

maintain in force other licenses or permits

required for the surface coal mining and

reclamation operation. However, the

imposition of a condition under this

subsection does not authorize or require the

director to administer or enforce the

requirements of any federal law or of any

state law other than this article.

3. IC 14–34–5–7, Permit Revisions

The existing provisions in subsections

(a) and (b) were removed and the

following new provisions were added:

(a) A change in mining or reclamation

operations from the approved mining and

reclamation plans that would adversely affect

the permittee’s compliance with this article

is a permit revision subject to review and

approval as provided in this section and

sections 8 through 8.4 of this chapter.

(b) A permit revision is either: (1) A

significant revision subject to sections 8 and

8.1 of this chapter; (2) a nonsignificant

revision subject to sections 8.2 and 8.3 of this

chapter; or (3) a minor field revision subject

to section 8.4 of this chapter.

(c) Permit revisions may be approved by:

(1) The director; or (2) the director’s

designated representative.

(d) A permit revision may not be approved

unless the permittee demonstrates and the

director or the director’s designated

representative finds the following:

(1) That reclamation as required by this

article and by the rules adopted by the

commission under IC 14–34–2–1 can be

accomplished.

(2) That applicable requirements of IC 14–

34–4–7 that are pertinent to the permit

revision are met.

(3) That the permit revision complies with

all applicable requirements of this article and

the rules adopted by the commission under

IC 14–34–2–1.