Federal Register / Vol. 60, No. 246 / Friday, December 22, 1995 / Proposed Rules 66529

mixer valve/main air valve assemblies and

associated hot air ducting; in accordance

with Hawker Service Bulletin SB. 49–45,

dated May 15, 1995.

(1) If no discrepancy is detected, no further

action is required by this AD.

(2) If any overheating or degradation is

detected, prior to further flight, replace the

hose assembly with a new assembly,

ensuring proper clearance and routing exists,

in accordance with the service bulletin.

(3) If any hose assembly is improperly

routed, prior to further flight, re-route the

assembly maintaining proper clearance, in

accordance with the service bulletin.

(4) If the clearance of the hose assembly is

inadequate and the hose assembly is properly

routed, prior to further flight, adjust the hose

assembly to achieve the 0.5-inch clearance,

in accordance with the service bulletin.

(b) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager,

Standardization Branch, ANM–113, FAA,

Transport Airplane Directorate. Operators

shall submit their requests through an

appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, Standardization

Branch, ANM–113.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Standardization Branch,

ANM–113.

(c) 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.

Issued in Renton, Washington, on

December 18, 1995.

Darrell M. Pederson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 95–31189 Filed 12–21–95; 8:45 am]

BILLING CODE 4910–13–U

14 CFR Part 71

[Airspace Docket No. 95–AWP–38]

Proposed Establishment of Class D

and E Airspace Areas; Saipan Island,

CQ

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

SUMMARY: This proposed rule would

establish Class D and E airspace areas at

Saipan Island, CQ. The Class D airspace

area would be established because an

airport traffic control tower (ATCT) at

Saipan International Airport, Saipan

Island, CQ, has been commissioned. The

FAA is proposing to establish the Class

E airspace area to provide adequate

controlled airspace for aircraft executing

instrument approach operations at

Saipan International Airport.

DATES: Comments must be received on

or before February 2, 1996.

ADDRESSES: Send comments on the

proposal in triplicate to: Manager, Air

Traffic Division, AWP–500, Docket No.

95–AWP–38, Federal Aviation

Administration, P. O. Box 92007,

Worldway Postal Center, Los Angeles,

CA 90009.

The official docket may be examined

in the Rules Docket, Office of the Chief

Counsel, Room 916, 800 Independence

Avenue, SW., Washington, DC,

weekdays, except Federal holidays,

between 8:30 a.m. and 5:00 p.m.

An informal docket may also be

examined during normal business hours

at the office of the Regional Air Traffic

Division.

FOR FURTHER INFORMATION CONTACT:

Patricia Crawford, Airspace and

Obstruction Evaluation Branch (ATP–

240), Airspace-Rules and Aeronautical

Information Division, Air Traffic Rules

and Procedures Service, Federal

Aviation Administration, 800

Independence Avenue, SW.,

Washington, DC 20591; telephone: (202)

267–3075.

SUPPLEMENTARY INFORMATION:

Comments Invited

Interested parties are invited to

participate in this proposed rulemaking

by submitting such written data, views,

or arguments as they may desire.

Comments that provide the factual basis

supporting the views and suggestions

presented are particularly helpful in

developing reasoned regulatory

decisions on the proposal. Comments

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. 95–

AWP–38.’’ 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 Rules Docket 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 Federal

Aviation Administration, Office of

Public Affairs, Attention: Public Inquiry

Center, APA–220, 800 Independence

Avenue, SW., Washington, DC 20591, or

by calling (202) 267–3485.

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 is considering an

amendment to part 71 of the Federal

Aviation Regulations (14 CFR part 71) to

establish Class D and E airspace areas at

Saipan Island, CQ. The Class D airspace

area would be established because an

ATCT at Saipan International Airport,

Saipan Island, CQ, has been

commissioned. The FAA is proposing to

establish the Class E airspace area to

provide adequate controlled airspace for

aircraft executing instrument approach

operations at Saipan International

Airport. Class D and E airspace

designations are published in

paragraphs 5000 and 6004, respectively,

of FAA Order 7400.9C dated August 17,

1995, and effective September 16, 1995,

which is incorporated by reference in 14

CFR 71.1. The Class D and E airspace

designations listed in this document

would be published subsequently in

this Order.

The FAA has determined that this

proposed 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.

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.
66530 Federal Register / Vol. 60, No. 246 / Friday, December 22, 1995 / Proposed Rules

ICAO Considerations

As part of this proposal relates to

navigable airspace outside the United

States, this notice is submitted in

accordance with the International Civil

Aviation Organization (ICAO)

International Standards and

Recommended Practices.

Applicability of International

Standards and Recommended Practices

by the Air Traffic Rules and Procedures

Service, FAA, in areas outside domestic

airspace of the United States is governed

by Article 12 of, and Annex 11 to, the

Convention on International Civil

Aviation, which pertains to the

establishment of air navigational

facilities and services necessary to

promote the safe, orderly, and

expeditious flow of civil air traffic.

Their purpose is to ensure that civil

aircraft operations on international air

routes are carried out under uniform

conditions designed to improve the

safety and efficiency of air operations.

The International Standards and

Recommended Practices in Annex 11

apply in those parts of the airspace

under the jurisdiction of a contracting

state, derived from ICAO, wherein air

traffic services are provided and also

whenever a contracting state accepts the

responsibility of providing air traffic

services over high seas or in airspace of

undetermined sovereignty. A

contracting state accepting such

responsibility may apply the

International Standards and

Recommended Practices in a manner

consistent with that adopted for

airspace under its domestic jurisdiction.

In accordance with Article 3 of the

Convention on International Civil

Aviation, Chicago, 1944, state aircraft

are exempt from the provisions of

Annex 11 and its Standards and

Recommended Practices. As a

contracting state, the United States

agreed by Article 3(d) that its state

aircraft will be operated in international

airspace with due regard for the safety

of civil aircraft.

Since this action involves, in part, the

designation of navigable airspace

outside the United States, the

Administrator is consulting with the

Secretary of State and the Secretary of

Defense in accordance with the

provisions of Executive Order 10854.

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—[AMENDED]

1. The authority citation for 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; 14 CFR 11.69.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of the Federal Aviation

Administration Order 7400.9C, Airspace

Designations and Reporting Points,

dated August 17, 1995, and effective

September 16, 1995, is amended as

follows:

Paragraph 5000—Class D Airspace

* * * * *

AWP CQ D Saipan Island, CQ [New]

Saipan International Airport, CQ

(Lat. 15°07′08′′N, long. 145°43′46′′E)

Saipan RBN (lat. 15°06′41′′N, long.

145°42′37′′E)

That airspace extending upward from the

surface to and including 2,500 feet MSL

within a 4.3-mile radius of Saipan

International Airport. This Class D airspace

area is effective during the specific dates and

times established in advanced by a Notice to

Airmen. The effective date and time will

thereafter be continuously published in the

Airport/Facility Directory, Pacific Chart

Supplement.

* * * * *

Paragraph 6004—Class E airspace areas

designated as an extension to a Class D

surface area

* * * * *

AWP CQ E4 Saipan Island, CQ [New]

Saipan International Airport, CQ

(Lat. 15°07′08′′N, long. 145°43′46′′E)

Saipan RBN (lat. 15°06′41′′N, long.

145°42′37′′E)

That airspace extending upward from the

surface within a 4.3-mile radius of Saipan

International Airport and within 2.6 miles

each side of the Saipan RBN 264° bearing,

extending from the 4.3-mile radius to 7.4

miles west of the Saipan RBN and within 1.8

miles each side of the Saipan RBN 248°

radial, extending from the 4.3-mile radius to

7.4 miles west of the Saipan RBN and within

1.8 miles each side of the Saipan RBN 068°

radial, extending from the 4.3-mile radius to

6.5 miles east of the Saipan International

Airport. This Class E airspace area is effective

during the specific dates and times

established in advanced by a Notice to

Airmen. The effective date and time will

thereafter be continuously published in the

Airport/Facility Directory, Pacific Chart

Supplement.

* * * * *

Issued in Washington, DC, on December

12, 1995.

Harold W. Becker,

Manager, Airspace-Rules and Aeronautical

Information Division.

[FR Doc. 95–31202 Filed 12–21–95; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 50 and 312

[Docket No. 95N–0359]

Protection of Human Subjects;

Informed Consent

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its current informed consent

regulations to require that the written

consent form signed by the subject or

the subject’s legally authorized

representative, be dated by the subject

or the subject’s legally authorized

representative at the time consent is

given. FDA is proposing this

requirement because the agency has had

problems on occasion verifying that

informed consent was obtained from a

research subject prior to participation in

a study because the consent document

was not dated. The agency believes that

by explicitly requiring that the consent

form be dated at the time it is signed,

the agency will be able to help ensure

that informed consent was, in fact,

obtained prior to entry into the study as

required by FDA regulations. FDA is

also proposing to amend its regulation

on case histories to clarify what

adequate case histories include.

DATES: Written comments by March 21,

1996.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Glen

D. Drew, Office of Health Affairs (HFY–

20), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–443–1382.

SUPPLEMENTARY INFORMATION:

I. Description of the Proposed Rule

Except as provided in FDA

regulations, no investigator may involve

a human being as a subject in research

covered by part 50 (21 CFR part 50)

unless the investigator has obtained the

legally effective informed consent of the

subject or the subject’s legally

authorized representative. Section 50.20

requires the investigator to seek

informed consent only under

circumstances that provide the

prospective subject or the representative

sufficient opportunity to consider

whether or not to participate and that