This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

58219

Vol. 65, No. 189

Thursday, September 28, 2000

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 2000–NM–305–AD; Amendment

39–11911; AD 2000–19–10]

RIN 2120–AA64

Airworthiness Directives; Empresa

Brasileira de Aeronautica S.A.

(EMBRAER) Model EMB–120 Series

Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Final rule; request for

comments.

SUMMARY: This amendment supersedes

an existing airworthiness directive (AD),

applicable to all EMBRAER Model

EMB–120 series airplanes, that currently

requires a one-time inspection of the

movable backstop of the elevator pitch

trim command system to ensure that it

is installed correctly, and corrective

action, if necessary. That AD also

requires installation of a guide to

maintain the movable backstop in its

correct position. This amendment adds

a requirement for an additional one-time

inspection. This amendment is

prompted by issuance of mandatory

continuing airworthiness information by

a foreign civil airworthiness authority.

The actions specified in this AD are

intended to prevent a sudden change in

pitch attitude caused by autopilot

disconnect, which could result in

reduced controllability of the airplane.

DATES: Effective October 13, 2000.

The incorporation by reference of

EMBRAER Service Bulletin S.B. 120–

27–0081, dated September 1, 2000, is

approved by the Director of the Federal

Register as of October 13, 2000.

The incorporation by reference of

EMBRAER Alert Service Bulletin 120–

27–A081, Change 01, dated October 9,

1997, was approved previously by the

Director of the Federal Register as of

January 13, 1998 (62 FR 67552,

December 29, 1997).

Comments for inclusion in the Rules

Docket must be received on or before

October 30, 2000.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Transport

Airplane Directorate, ANM–114,

Attention: Rules Docket No. 2000–NM–

305–AD, 1601 Lind Avenue, SW.,

Renton, Washington 98055–4056.

Comments may be inspected at this

location between 9 a.m. and 3 p.m.,

Monday through Friday, except Federal

holidays. Comments may be submitted

via fax to (425) 227–1232. Comments

may also be sent via the Internet using

the following address: 9-anmiarcomment@faa.gov. Comments sent

via fax or the Internet must contain

‘‘Docket No. 2000–NM–305–AD’’ in the

subject line and need not be submitted

in triplicate. Comments sent via the

Internet as attached electronic files must

be formatted in Microsoft Word 97 for

Windows or ASCII text.

The service information referenced in

this AD may be obtained from Empresa

Brasileira de Aeronautica S.A.

(EMBRAER), P.O. Box 343—CEP 12.225,

Sao Jose dos Campos—SP, Brazil. This

information may be examined at the

FAA, Transport Airplane Directorate,

1601 Lind Avenue, SW., Renton,

Washington; or at the FAA, Atlanta

Aircraft Certification Office, One Crown

Center, 1895 Phoenix Boulevard, suite

450, Atlanta, Georgia; or at the Office of

the Federal Register, 800 North Capitol

Street, NW., suite 700, Washington, DC.

FOR FURTHER INFORMATION CONTACT: Rob

Capezzuto, Aerospace Engineer,

Systems and Flight Test Branch, ACE–

116A, FAA, Atlanta Aircraft

Certification Office, One Crown Center,

1895 Phoenix Boulevard, Suite 450,

Atlanta, Georgia 30349; telephone (770)

703–6071; fax (770) 703–6097.

SUPPLEMENTARY INFORMATION: On

December 19, 1997, the FAA issued AD

97–26–22, amendment 39–10265 (62 FR

67552, December 29, 1997), applicable

to all EMBRAER Model EMB–120 series

airplanes, to require a one-time

inspection of the movable backstop of

the elevator pitch trim command system

to ensure that it is installed correctly,

and corrective action, if necessary. That

AD also requires installation of a guide

to maintain the movable backstop in its

correct position. That action was

prompted by issuance of mandatory

continuing airworthiness information by

a foreign civil airworthiness authority.

The actions required by that AD are

intended to prevent a sudden change in

pitch attitude caused by autopilot

disconnect, which could result in

reduced controllability of the airplane.

Actions Since Issuance of Previous Rule

Since the issuance of AD 97–26–22,

the Departmento de Aviacao Civil

(DAC), which is the airworthiness

authority for Brazil, advises that a recent

incident occurred that was similar to the

event specified in the preamble of AD

97–26–22, which revealed that the

unsafe condition may still exist.

The manufacturer has issued

EMBRAER Service Bulletin S.B. 120–

27–0081, dated September 1, 2000. This

new service information adds a onetime inspection of the movable backstop

of the elevator pitch trim command

system and the rigging of the elevator

trim to verify proper adjustment of the

system and correct rigging of the

elevator trim tab, and corrective actions,

if necessary. The corrective actions

consist of adjusting the system and/or

the rigging in accordance with the

instructions specified in Chapter 27–32–

00 (Flight Controls) of the EMBRAER

Maintenance Manual. The new service

bulletin also describes procedures for

installation of a guide to maintain the

movable backstop in position in the

spiral groove on the pitch trim right

control wheel. That installation was

specified in EMBRAER Alert Service

Bulletin S.B. 120–27–A081, Change 01,

dated October 9, 1997 (referenced as the

appropriate source of service

information for accomplishment of the

actions specified in AD 97–26–22).

The DAC classified this service

bulletin as mandatory in order to assure

the continued airworthiness of these

airplanes in Brazil.

FAA’s Conclusions

This airplane model is manufactured

in Brazil and is type certificated for

operation in the United States under the

provisions of section 21.29 of the

Federal Aviation Regulations (14 CFR

21.29) and the applicable bilateral

airworthiness agreement. Pursuant to

this bilateral airworthiness agreement,

the DAC has kept the FAA informed of

the situation described above. The FAA

58220 Federal Register / Vol. 65, No. 189 / Thursday, September 28, 2000 / Rules and Regulations

has examined the findings of the DAC,

reviewed all available information, and

determined that AD action is necessary

for products of this type design that are

certificated for operation in the United

States.

Explanation of Requirements of Rule

Since an unsafe condition has been

identified that is likely to exist or

develop on other airplanes of the same

type design registered in the United

States, this AD supersedes AD 97–26–22

to continue to require a one-time

inspection of the movable backstop of

the elevator pitch trim command system

to ensure that it is installed correctly,

and corrective action, if necessary. This

AD also continues to require installation

of a guide to maintain the movable

backstop in its correct position. This

amendment adds an additional one-time

inspection. The actions are required to

be accomplished in accordance with the

service bulletin described previously,

except as discussed below.

Differences Between Rule and Related

Service Information

Operators should note that the service

bulletin specifies accomplishment of a

one-time inspection of the movable

backstop of the elevator pitch trim

command system and the rigging of the

elevator trim tab within the next 400

flight hours; however, the FAA finds

that such a compliance time will not

ensure that the inspection is

accomplished in a timely manner. In

developing an appropriate compliance

time for the inspection, the FAA

considered not only the manufacturer’s

recommendation, but the degree of

urgency associated with addressing the

subject unsafe condition, as well as the

compliance time for the actions

required. The FAA finds

accomplishment of the one-time

inspection within 100 flight hours after

the effective date of this AD to be

warranted, in that this represents an

appropriate amount of time allowable

for affected airplanes to continue to

operate without compromising safety.

Operators also should note that, while

the service bulletin does not specify the

type of inspection of the movable

backstop of the elevator pitch trim

command system and the rigging of the

elevator trim tab to detect discrepancies,

this AD would require a general visual

inspection to detect such discrepancies.

A note has been included in this AD to

define that inspection.

Interim Action

This is considered to be interim

action until final action is identified, at

which time the FAA may consider

further rulemaking.

Determination of Rule’s Effective Date

Since a situation exists that requires

the immediate adoption of this

regulation, it is found that notice and

opportunity for prior public comment

hereon are impracticable, and that good

cause exists for making this amendment

effective in less than 30 days.

Comments Invited

Although this action is in the form of

a final rule that involves requirements

affecting flight safety and, thus, was not

preceded by notice and an opportunity

for public comment, comments are

invited on this rule. Interested persons

are invited to comment on this rule by

submitting such written data, views, or

arguments as they may desire.

Communications shall identify the

Rules Docket number and be submitted

in triplicate to the address specified

under the caption ADDRESSES. All

communications received on or before

the closing date for comments will be

considered, and this rule may be

amended in light of the comments

received. Factual information that

supports the commenter’s ideas and

suggestions is extremely helpful in

evaluating the effectiveness of the AD

action and determining whether

additional rulemaking action would be

needed.

Submit comments using the following

format:

• Organize comments issue-by-issue.

For example, discuss a request to

change the compliance time and a

request to change the service bulletin

reference as two separate issues.

• For each issue, state what specific

change to the AD is being requested.

• Include justification (e.g., reasons or

data) for each request.

Comments are specifically invited on

the overall regulatory, economic,

environmental, and energy aspects of

the rule that might suggest a need to

modify the rule. All comments

submitted will be available, both before

and after the closing date for comments,

in the Rules Docket for examination by

interested persons. A report that

summarizes each FAA-public contact

concerned with the substance of this AD

will be filed in the Rules Docket.

Commenters wishing the FAA to

acknowledge receipt of their comments

submitted in response to this rule must

submit a self-addressed, stamped

postcard on which the following

statement is made: ‘‘Comments to

Docket Number 2000–NM–305–AD.’’

The postcard will be date stamped and

returned to the commenter.

Regulatory Impact

The regulations adopted herein will

not have a substantial direct effect 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. Therefore, it is

determined that this final rule does not

have federalism implications under

Executive Order 13132.

The FAA has determined that this

regulation is an emergency regulation

that must be issued immediately to

correct an unsafe condition in aircraft,

and that it is not a ‘‘significant

regulatory action’’ under Executive

Order 12866. It has been determined

further that this action involves an

emergency regulation under DOT

Regulatory Policies and Procedures (44

FR 11034, February 26, 1979). If it is

determined that this emergency

regulation otherwise would be

significant under DOT Regulatory

Policies and Procedures, a final

regulatory evaluation will be prepared

and placed in the Rules Docket. A copy

of it, if filed, may be obtained from the

Rules Docket at the location provided

under the caption ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Incorporation by reference,

Safety.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration amends 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

removing amendment 39–10265 (62 FR

67552, December 29, 1997), and by

adding a new airworthiness directive

(AD), amendment 39–11911, to read as

follows:

2000–19–10 Empresa Brasileira de

Aeronautica S.A. (EMBRAER):

Amendment 39–11911. Docket 2000–

NM–305–AD. Supersedes AD 97–26–22,

Amendment 39–10265.

Applicability: All Model EMB–120 series

airplanes, certificated in any category.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

Federal Register / Vol. 65, No. 189 / Thursday, September 28, 2000 / Rules and Regulations 58221

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 (d) 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, unless

accomplished previously.

To prevent a sudden change in pitch

attitude caused by autopilot disconnect,

which could result in reduced controllability

of the airplane, accomplish the following:

Restatement of Requirements of

AD 97–26–22

One-Time Inspection

(a) Within 20 flight hours after January 13,

1998 (the effective date of AD 97–26–22,

amendment 39–10265), perform a one-time

general visual inspection of the movable

backstop of the elevator pitch trim command

system to ensure that it is installed correctly,

in accordance with Part I of the

Accomplishment Instructions of EMBRAER

Alert Service Bulletin 120–27–A081, Change

01, dated October 9, 1997. If any discrepancy

is found, before further flight, accomplish

follow-on corrective actions, in accordance

with the alert service bulletin.

Modification

(b) Within 75 flight hours after January 13,

1998, install a guide for the movable

backstop of the elevator pitch trim command

system, in accordance with Part II of the

Accomplishment Instructions of EMBRAER

Alert Service Bulletin 120–27–A081, Change

01, dated October 9, 1997, or EMBRAER

Service Bulletin S.B. 120–27–0081, dated

September 1, 2000. As of the effective date

of this AD, only EMBRAER Service Bulletin

S.B. 120–27–0081 may be used for

accomplishment of this paragraph.

New Requirements of This AD

One-Time Inspection

(c) Within 100 flight hours after the

effective date of this AD: Perform a one-time

general visual inspection of the movable

backstop of the elevator pitch trim command

system to verify proper adjustment of the

system and correct rigging of the elevator

trim tab in accordance with the

Accomplishment Instructions of EMBRAER

Service Bulletin S.B. 120–27–0081, dated

September 1, 2000. If any discrepancy is

detected, before further flight, accomplish

follow-on corrective actions in accordance

with the service bulletin.

Note 2: For the purposes of this AD, a

general visual inspection is defined as: ‘‘A

visual examination of an interior or exterior

area, installation, or assembly to detect

obvious damage, failure, or irregularity. This

level of inspection is made under normally

available lighting conditions such as

daylight, hangar lighting, flashlight, or droplight and may require removal or opening of

access panels or doors. Stands, ladders, or

platforms may be required to gain proximity

to the area being checked.’’

Alternative Methods of Compliance

(d)(1) 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, Atlanta

Aircraft Certification Office (ACO), FAA.

Operators shall submit their requests through

an appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, Atlanta ACO.

(2) Alternative methods of compliance,

approved previously in accordance with AD

97–26–22, amendment 39–10265, are

approved as alternative methods of

compliance with this AD.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Atlanta ACO.

Special Flight Permits

(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.

Incorporation by Reference

(f) The actions shall be done in accordance

with EMBRAER Alert Service Bulletin 120–

27–A081, Change 01, dated October 9, 1997;

and EMBRAER Service Bulletin S.B. 120–27–

0081, dated September 1, 2000.

(1) The incorporation by reference of

EMBRAER Service Bulletin S.B. 120–27–

0081, dated September 1, 2000, is approved

by the Director of the Federal Register in

accordance with 5 U.S.C. 552(a) and 1 CFR

part 51.

(2) The incorporation by reference of

EMBRAER Alert Service Bulletin 120–27–

A081, Change 01, dated October 9, 1997 was

approved previously by the Director of the

Federal Register as of January 13, 1998 (62 FR

67552, December 29, 1997).

(3) Copies may be obtained from Empresa

Brasileira de Aeronautica S.A. (EMBRAER),

P.O. Box 343—CEP 12.225, Sao Jose dos

Campos—SP, Brazil. Copies may be

inspected at the FAA, Transport Airplane

Directorate, 1601 Lind Avenue, SW., Renton,

Washington; or at the FAA, Atlanta Aircraft

Certification Office, One Crown Center, 1895

Phoenix Boulevard, suite 450, Atlanta,

Georgia; or at the Office of the Federal

Register, 800 North Capitol Street, NW., suite

700, Washington, DC.

Effective Date

(g) This amendment becomes effective on

October 13, 2000.

Issued in Renton, Washington, on

September 21, 2000.

Donald L. Riggin,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 00–24745 Filed 9–27–00; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. 99C–1455]

Listing of Color Additives for Coloring

Sutures; D&C Violet No. 2;

Confirmation of Effective Date

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; confirmation of

effective date.

SUMMARY: The Food and Drug

Administration (FDA) is confirming the

effective date of August 29, 2000 (65 FR

46342), for the final rule that appeared

in the Federal Register of July 28, 2000,

and that amended the color additive

regulations to provide for the safe use of

D&C Violet No. 2 as a color additive in

absorbable sutures prepared from

homopolymers of glycolide for general

surgery. The agency also revised the

nomenclature ‘‘polyglactin 910

(glycolic-lactic acid polyester)’’ to the

generic nomenclature ‘‘copolymers of 90

percent glycolide and 10 percent Llactide.’’

DATES: Effective date confirmed: August

29, 2000.

FOR FURTHER INFORMATION CONTACT:

Ellen M. Waldron, Center for Food

Safety and Applied Nutrition (HFS–

215), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3089.

SUPPLEMENTARY INFORMATION: In the

Federal Register of July 28, 2000 (65 FR

46342), FDA amended the color additive

regulations in 21 CFR 74.3602 D&C

Violet No. 2 to provide for the safe use

of D&C Violet No. 2 as a color additive

in absorbable sutures prepared from

homopolymers of glycolide for general

surgery. The agency also revised the

nomenclature ‘‘polyglactin 910

(glycolic-lactic acid polyester)’’ to the

generic nomenclature ‘‘copolymers of 90

percent glycolide and 10 percent Llactide.’’

FDA gave interested persons until

August 28, 2000, to file objections or

requests for a hearing. The agency

received no objections or requests for a

hearing on the final rule. Therefore,

FDA finds that the effective date of the

final rule that published in the Federal

Register of July 28, 2000, should be

confirmed.

List of Subjects in 21 CFR Part 74

Color additives, Cosmetics, Drugs,

Foods, Medical devices.