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

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new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

62239

Vol. 62, No. 225

Friday, November 21, 1997

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 97–SW–22–AD; Amendment

39–10211; AD 97–24–04]

RIN 2120–AA64

Airworthiness Directives; Eurocopter

France (Eurocopter) Model SE 3130,

SE 313B, SA 3180, SA 318B, and SA

318C 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 Model SE

3130, SE 313B, SA 3180, SA 318B, and

SA 318C helicopters. This action

requires a visual inspection of the main

rotor blade reinforcement strips for

debonding between the reinforcement

strips of the blade; and a visual

inspection of the main rotor blade

(blade) skin for cracks or corrosion, and

replacement of the blade with an

airworthy blade if certain debonding or

a crack or corrosion is found. This

amendment is prompted by an accident

in which a blade separated in flight. The

actions specified in this AD are

intended to detect debonding, cracks, or

corrosion in the affected blades and to

prevent failure of a blade and

subsequent loss of control of the

helicopter.

DATES: Effective December 8, 1997.

Comments for inclusion in the Rules

Docket must be received on or before

January 20, 1998.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Office of

Regional Counsel, Southwest Region,

Attention: Rules Docket No. 97–SW–22–

AD, 2601 Meacham Blvd., Room 663,

Fort Worth, Texas 76137.

FOR FURTHER INFORMATION CONTACT: Mr.

Richard Monschke, Aerospace Engineer,

Rotorcraft Standards Staff, 2601

Meacham Blvd., Fort Worth, Texas

76137, telephone (817) 222–5116, fax

(817) 222–5961.

SUPPLEMENTARY INFORMATION: The

Direction General De L’Aviation Civile

(DGAC), which is the airworthiness

authority for France, recently notified

the FAA that an unsafe condition may

exist on Eurocopter Model SE 3130, SE

313B, SA 3180, SA 318B, and SA 318C

helicopters with part number (P/N)

3130–S–11–10000, 3130–S–11–20000,

or 3130–S–11–30000 main rotor blades

installed. The DGAC advises that fatigue

cracks, initiated by skin debonding or

skin corrosion in the area of the

reinforcement strip, may develop in the

blade skin near the blade root, resulting

in failure of the blade in flight and

subsequent loss of control of the

helicopter.

Eurocopter France has issued

Eurocopter Telex Service 0033/00169/

97, dated June 18, 1997, which specifies

visual inspections of the blade root skin

and reinforcement strip for bonding

separation, and replacement of the blade

with an airworthy blade if bonding

separation is found; and a visual

inspection of the blade root skin for

cracks and corrosion, and replacement

of the blade with an airworthy blade if

cracks or corrosion are found. The

DGAC classified this Telex Service as

mandatory and issued AD 97–135–

055(B) in order to assure the continued

airworthiness of these helicopters in

France.

This helicopter model is

manufactured in France 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 DGAC has

kept the FAA informed of the situation

described above. The FAA has

examined the findings of the DGAC,

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 Model SE

3130, SE 313B, SA 3180, SA 318B, and

SA 318C helicopters of the same type

design registered in the United States,

this AD is being issued to detect

debonding, cracks, or corrosion in the

affected blades and to prevent failure of

a blade and subsequent loss of control

of the helicopter. This AD requires a

visual inspection in the area extending

5 mm (0.200 inch) from the strip

reinforcing the inboard edge of the blade

as shown in Figure 1 for debonding

between the main rotor blade skin and

reinforcement strip, and replacement of

the main rotor blade with an airworthy

blade if debonding is found; a visual

inspection for debonding between the

blade and the reinforcement strip on the

leading edge of the blade that covers the

blade spar, and replacement with an

airworthy blade if debonding is present

for more than 0.750 inch2 (500 mm2);

and a visual inspection of the main rotor

blade skin for cracks and corrosion, and

replacement with an airworthy blade if

any crack or corrosion is found.

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,
62240 Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Rules and Regulations

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–22–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, 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:

97–24–04 Eurocopter France: Amendment

39–10211. Docket No. 97–SW–22–AD.

Applicability: Model SE 3130, SE 313B, SA

3180, SA 318B, and SA 318C helicopters

with part number (P/N) 3130–S–11–10000,

3130–S–11–20000, or 3130–S–11–30000

main rotor blades, installed, 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 (b) 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 debonding, cracks, or corrosion

in the affected blades and to prevent failure

of a main rotor blade (blade) and subsequent

loss of control of the helicopter, accomplish

the following:

(a) Before further flight, and thereafter at

intervals not to exceed 25 hours time-inservice, for part number (P/N) 3130–S–11–

10000, 3130–S–11–20000, or 3130–S–11–

30000, visually inspect:

(1) For debonding in the area extending 5

mm (0.200 inch) from the strip reinforcing

the inboard edge of the blade as shown in

Figure 1. If there is any debonding of the

reinforcement strip, replace the blade with an

airworthy blade.

(2) For debonding between the blade and

the reinforcement strip on the leading edge

of the blade that covers the blade spar. If

debonding is present for more than 0.750

inches 2 (500 mm2) at any point on the blade,

replace the blade with an airworthy blade.

(3) For cracks in the blade skin in the first

12 inches (300 mm) of the blade measured

from the root reinforcement strip using a 3×

or higher magnifying glass. If any crack is

found, replace the blade with an airworthy

blade.

(4) For corrosion in the blade skin in the

first 12 inches (300 mm) of the blade

measured from the root reinforcement strip.

If any corrosion is found, replace the blade

with an airworthy blade.

(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, FAA,

Rotorcraft Directorate, Rotorcraft Standards

Staff. 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.

(c) Special flight permits are prohibited.

(d) This amendment becomes effective on

December 8, 1997.

Note 3: The subject of this AD is addressed

in Direction General De L’Aviation Civile

(France) AD 97–135–055(B), dated June 20,

1997.

BILLING CODE 4910–13–U
Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Rules and Regulations 62241

BILLING CODE 4910–13–C

Issued in Fort Worth, Texas, on November

14, 1997.

Eric Bries,

Acting Manager, Rotorcraft Directorate,

Aircraft Certification Service.

[FR Doc. 97–30603 Filed 11–20–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522

New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect a

change of sponsor for an approved new

animal drug application (NADA) from

Schering-Plough Animal Health Corp. to

Sioux Biochemical, Inc.

EFFECTIVE DATE: November 21, 1997.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 1095

Morris Ave., Union, NJ 07083, has

informed FDA that it has transferred

ownership of, and all rights and

interests in NADA 9–505 (follicle

stimulating hormone) to Sioux

Biochemical, Inc., 204 Third St. NW.,

Sioux Center, IA 51250. Accordingly,

the agency is amending the regulations

in 21 CFR 522.1002 to reflect the

transfer of ownership. The agency is

also amending the regulations in 21 CFR

510.600(c)(1) and (c)(2) by

alphabetically adding a new listing for

Sioux Biochemical, Inc.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 522

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR parts 510 and 522 are amended as

follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 376e.

2. Section 510.600 is amended in the

table in paragraph (c)(1) by

alphabetically adding a new entry for

‘‘Sioux Biochemical, Inc.’’ and in the

table in paragraph (c)(2) by numerically

adding a new entry for ‘‘063112’’ to read

as follows:

§ 510.600 Names, addresses, and drug

labeler codes of sponsors of approved

applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address Drug labeler code

* * * * * * *

Sioux Biochemical, Inc., 204 Third St. NW., Sioux Center, IA 51250 ..... 063112

* * * * * * *

(2) * * *