65750 Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Rules and Regulations

additional rulemaking action would be

needed.

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 No. 97–SW–44–AD.’’ The

postcard will be date stamped and

returned to the commenter.

The regulations adopted herein will

not have substantial direct effects 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, in

accordance with Executive Order 12612,

it is determined that this final rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

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

adding a new airworthiness directive to

read as follows:

97–26–02 Eurocopter Deutschland GmbH

(ECD) and Eurocopter Canada LTD.:

Amendment 39–10245. Docket No. 97–

SW–44–AD.

Applicability: Eurocopter Deutschland

GmbH Model BO–105A, BO–105C, BO–105S,

BO–105LS A–1, and BO–105LS A–3

helicopters and Eurocopter Canada Ltd. BO–

105LS A–3 helicopters, certificated in any

category.

Note 1: This AD applies to each helicopter

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

helicopters that have been modified, altered,

or repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must use the authority

provided in paragraph (c) to request approval

from the FAA. This approval may address

either no action, if the current configuration

eliminates the unsafe condition, or different

actions necessary to address the unsafe

condition described in this AD. Such a

request should include an assessment of the

effect of the changed configuration on the

unsafe condition addressed by this AD. In no

case does the presence of any modification,

alteration, or repair remove any helicopter

from the applicability of this AD.

Compliance: Required as indicated, unless

accomplished previously.

To detect cracks in the main rotor mast

flange (flange), which, if not detected, could

result in failure of the flange and subsequent

loss of control of the helicopter, accomplish

the following:

(a) Before further flight and thereafter at

intervals not to exceed 100 hours time-inservice, visually inspect the flange in the

ribbed area for cracks using a 5-power or

higher magnifying glass in accordance with

paragraphs 2.A.1. and 2.A.2. of the

Accomplishment Instructions of Eurocopter

Deutschland GmbH Alert Service Bulletin

No. ASB–BO 105–10–110, dated August 27,

1997, or Eurocopter Canada Alert Service

Bulletin No. ASB–BO 105 LS–10–9, dated

September 11, 1997, as applicable.

(b) If a crack is found, remove the cracked

main rotor mast and replace it with an

airworthy main rotor mast.

(c) 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, Rotorcraft

Standards Staff, Rotorcraft Directorate, FAA.

Operators shall submit their requests through

an FAA Principal Maintenance Inspector,

who may concur or comment and then send

it to the Manager, Rotorcraft Standards Staff.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Rotorcraft Standards Staff.

(d) Special flight permits will not be

issued.

(e) The inspection shall be done in

accordance with Eurocopter Deutschland

GmbH Alert Service Bulletin No. ASB–BO

105–10–110, dated August 27, 1997, or

Eurocopter Canada Alert Service Bulletin No.

ASB–BO 105 LS–10–9, dated September 11,

1997, as applicable. These incorporations by

reference were approved by the Director of

the Federal Register in accordance with 5

U.S.C. 552(a) and 1 CFR part 51. Copies may

be obtained from American Eurocopter

Corporation, 2701 Forum Drive, Grand

Prairie, Texas 75053–4005, telephone (972)

641–3460, fax (972) 641–3527. Copies may be

inspected at the FAA, Office of Regional

Counsel, Southwest Region, 2601 Meacham

Blvd., Room 663, Fort Worth, Texas 76137;

or at the Office of the Federal Register, 800

North Capitol Street, NW., suite 700,

Washington, DC.

(f) This amendment becomes effective on

December 31, 1997.

Note 3: The subject of this AD is addressed

in Luftfahrt-Bundesamt (Germany) AD 97–

275, dated September 25, 1997, and in

Transport Canada AD CF–97–18, dated

September 30, 1997.

Issued in Fort Worth, Texas, on December

5, 1997.

Eric Bries,

Acting Manager, Rotorcraft Directorate,

Aircraft Certification Service.

[FR Doc. 97–32720 Filed 12–15–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 97–SW–45–AD; Amendment

39–10246; AD 97–26–03]

RIN 2120–AA64

Airworthiness Directives; Eurocopter

Deutschland GmbH (ECD) (Eurocopter

Deutschland) Model MBB–BK 117 A–1,

A–3, A–4, B–1, B–2, and C–1

Helicopters

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Final rule; request for

comments.

SUMMARY: This amendment adopts a

new airworthiness directive (AD) that is

applicable to Eurocopter Deutschland

Model MBB–BK 117 A–1, A–3, A–4, B–

1, B–2, and C–1 helicopters. This action

requires visual inspections for cracks in

the ribbed area of the main rotor mast

flange (flange). This amendment is

prompted by one report of cracks in a

flange. The actions specified in this AD

are intended to detect cracks in the
Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Rules and Regulations 65751

flange, which, if not detected, could

result in failure of the flange and

subsequent loss of control of the

helicopter.

DATES: Effective December 31, 1997.

The incorporation by reference of

certain publications listed in the

regulations is approved by the Director

of the Federal Register as of December

31, 1997.

Comments for inclusion in the Rules

Docket must be received on or before

February 17, 1998.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Office of

Regional Counsel, Southwest Region,

Attention: Rules Docket No. 97–SW–45–

AD, 2601 Meacham Blvd., Room 663,

Fort Worth, Texas 76137.

The service information referenced in

this AD may be obtained from American

Eurocopter Corporation, 2701 Forum

Drive, Grand Prairie, Texas 75053–4005,

telephone (972) 641–3460, fax (972)

641–3527. This information may be

examined at the FAA, Office of Regional

Counsel, Southwest Region, 2601

Meacham Blvd., Room 663, Fort Worth,

Texas; or at the Office of the Federal

Register, 800 North Capitol Street, NW.,

suite 700, Washington, DC.

FOR FURTHER INFORMATION CONTACT: Mr.

Richard Monschke, Aerospace Engineer,

FAA, Rotorcraft Directorate, Rotorcraft

Standards Staff, 2601 Meacham Blvd.,

Fort Worth, Texas 76137, telephone

(817) 222–5116, (817) 222–5961.

SUPPLEMENTARY INFORMATION: The

Luftfahrt-Bundesamt (LBA), which is

the airworthiness authority for the

Federal Republic of Germany recently

notified the FAA that an unsafe

condition may exist on Eurocopter

Deutschland Model MBB–BK 117 A–1,

A–3, A–4, B–1, B–2, and C–1

helicopters. The LBA advises that a

main rotor mast was found to have

cracks of critical magnitude in the area

of the flange. The cause of the cracks is

under investigation. Until the cause of

the cracks has been determined, the

flange must be subjected to immediate

and repetitive visual crack inspections

until further notice.

Eurocopter Deutschland has issued

Eurocopter Deutschland GmbH Alert

Service Bulletin MBB–BK 117 No. ASB–

MBB–BK 117–10–114, dated August 27,

1997, which specifies visually

inspecting the area of the holes on the

underside of the flange for cracks,

especially in the ribbed area between

the holes, and if cracks are found,

contacting Eurocopter Deutschland

before further flight for advice on how

to proceed. The LBA classified this

service bulletin as mandatory and

issued LBA AD 97–276, effective

September 25, 1997, in order to assure

the continued airworthiness of these

helicopters in the Federal Republic of

Germany.

This helicopter model is

manufactured in the Federal Republic of

Germany 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 LBA has kept the FAA informed of

the situation described above. The FAA

has examined the findings of the LBA,

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.

Since an unsafe condition has been

identified that is likely to exist or

develop on other Eurocopter

Deutschland Model MBB–BK 117 A–1,

A–3, A–4, B–1, B–2, and C–1

helicopters of the same type design

registered in the United States, this AD

is being issued to detect cracks in the

flange, which, if not detected could

result in failure of the flange and

subsequent loss of control of the

helicopter. This AD requires, before

further flight, a visual inspection of the

ribbed area of the flange for cracks using

a 5-power or higher magnifying glass,

and thereafter, repeated visual

inspections at intervals not to exceed

100 hours time-in-service. The actions

are required to be accomplished in

accordance with the service bulletin

described previously. This flange is a

part of the main rotor mast assembly

and therefore a critical component of

the flight control system. Due to the

criticality of the flange to the continued

safe flight of the affected helicopters,

and the required inspection before

further flight, this rule must be issued

immediately to correct an unsafe

condition in the affected helicopters.

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 should 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.

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 No. 97–SW–45–AD.’’ The

postcard will be date stamped and

returned to the commenter.

The regulations adopted herein will

not have substantial direct effects 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, in

accordance with Executive Order 12612,

it is determined that this final rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

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.
65752 Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Rules and Regulations

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

adding a new airworthiness directive to

read as follows:

97–26–03 Eurocopter Deutschland:

Amendment 39–10246. Docket No. 97–

SW–45–AD.

Applicability: Model MBB–BK 117 A–1, A–

3, A–4, B–1, B–2, and C–1 helicopters,

certificated in any category.

Note 1: This AD applies to each helicopter

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

helicopters that have been modified, altered,

or repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must use the authority

provided in paragraph (c) to request approval

from the FAA. This approval may address

either no action, if the current configuration

eliminates the unsafe condition, or different

actions necessary to address the unsafe

condition described in this AD. Such a

request should include an assessment of the

effect of the changed configuration on the

unsafe condition addressed by this AD. In no

case does the presence of any modification,

alteration, or repair remove any helicopter

from the applicability of this AD.

Compliance: Required as indicated, unless

accomplished previously.

To detects cracks in the main rotor mast

flange (flange), which, if not detected, could

result in failure of the flange and subsequent

loss of control of the helicopter, accomplish

the following:

(a) Before further flight, and thereafter at

intervals not to exceed 100 hours time-inservice, visually inspect the flange in the

ribbed area for cracks using a 5-power or

higher magnifying glass in accordance with

paragraphs 2.A.1. and 2.A.2. of the

Accomplishment Instructions in Eurocopter

Deutschland GmbH Alert Service Bulletin

MBB–BK 117 No. ASB–MBB–BK 117–10–

114, dated August 27, 1997.

(b) If a crack is found as a result of the

inspections specified in paragraph (a) of this

AD, remove the cracked main rotor mast and

replace it with an airworthy main rotor mast.

(c) 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, Rotorcraft

Standards Staff, Rotorcraft Directorate, FAA.

Operators shall submit their requests through

an FAA Principal Maintenance Inspector,

who may concur or comment and then send

it to the Manager, Rotorcraft Standards Staff.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Rotorcraft Standards Staff.

(d) Special flight permits will not be

issued.

(e) The inspection shall be done in

accordance with Eurocopter Deutschland

GmbH Alert Service Bulletin MBB–BK 117

No. ASB–MBB–BK 117–10–114, dated

August 27, 1997. This incorporation by

reference was approved by the Director of the

Federal Register in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. Copies may be

obtained from American Eurocopter

Corporation, 2701 Forum Drive, Grand

Prairie, Texas 75053–4005, telephone (972)

641–3460, fax (972) 641–3527. Copies may be

inspected at the FAA, Office of Regional

Counsel, Southwest Region, 2601 Meacham

Blvd., Room 663, Fort Worth, Texas 76137;

or at the Office of the Federal Register, 800

North Capitol Street, NW., suite 700,

Washington, DC.

(f) This amendment becomes effective on

December 31, 1997.

Note 3: The subject of this AD is addressed

in Luftahrt-Bundesamt (Germany) AD 97–

276, effective September 25, 1997.

Issued in Fort Worth, Texas, on December

5, 1997.

Eric Bries,

Acting Manager, Rotorcraft Directorate,

Aircraft Certification Service.

[FR Doc. 97–32721 Filed 12–15–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

Ophthalmic and Topical Dosage Form

New Animal Drugs; Doramectin

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a new animal drug

application (NADA) filed by Pfizer, Inc.

The NADA provides for topical use of

doramectin for treatment and control of

certain worm, grub, lice, and mite

infections of cattle.

EFFECTIVE DATE: December 16, 1997.

FOR FURTHER INFORMATION CONTACT:

Estella Z. Jones, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: Pfizer,

Inc., 235 East 42d St., New York, NY

10017–5755, is sponsor of NADA 141–

095 that provides for the use of

Dectomax (doramectin) 0.5 percent

pour-on solution for beef cattle and

female dairy cattle less than 20 months

of age for treatment and control of

gastrointestinal roundworms,

lungworms, eyeworms, grubs, biting and

sucking lice, and mange mites, to

control infections and protect from

reinfection with Cooperia oncophora

and Dictyocaulus viviparus for 21 days,

and Ostertagia ostertagia, C. punctata,

and Oesophagostomum radiatum for 28

days after treatment. The NADA is

approved as of September 16, 1997, and

the regulations are amended by adding

new § 524.770 to reflect the approval.

The basis of approval is discussed in the

freedom of information summary.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

9 a.m. and 4 p.m., Monday through

Friday.

Under section 512(c)(2)(F)(ii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(ii)), this

approval for food-producing animals

qualifies for 3 years of marketing

exclusivity beginning September 16,

1997, because the NADA contains

substantial evidence of the effectiveness

of the drug involved, studies of animal

safety or, in the case of food-producing

animals, human food safety studies

(other than bioequivalence or residue

studies) required for approval and

conducted or sponsored by the

applicant.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

List of Subjects in 21 CFR Part 524

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under