Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58257

worldwide fleet. We estimate that 42 

airplanes of U.S. registry will be affected 

by this AD, that it will take 

approximately 14 work hours per 

airplane to accomplish the required 

replacement and inspections, and that 

the average labor rate is $65 per work 

hour. Based on these figures, the cost 

impact of the AD on U.S. operators is 

estimated to be $38,220, or $910 per 

airplane. 

The cost impact figure discussed 

above is based on assumptions that no 

operator has yet accomplished any of 

the requirements of this AD action, and 

that no operator would accomplish 

those actions in the future if this AD 

were not adopted. The cost impact 

figures discussed in AD rulemaking 

actions represent only the time 

necessary to perform the specific actions 

actually required by the AD. These 

figures typically do not include 

incidental costs, such as the time 

required to gain access and close up, 

planning time, or time necessitated by 

other administrative actions. 

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. 

For the reasons discussed above, I 

certify that this action (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) 

will not have a significant economic 

impact, positive or negative, on a 

substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. A final evaluation has 

been prepared for this action and it is 

contained in the Rules Docket. A copy 

of it 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 

the following new airworthiness 

directive:

2004–20–02 Boeing: Amendment 39–13807. 

Docket 2003–NM–44–AD.

Applicability: All Model 707 and 720 series 

airplanes, certificated in any category. 

Compliance: Required as indicated, unless 

accomplished previously.

To prevent stress corrosion cracking of the 

bolts and wearing of the joint between the 

lock support fitting and the support link, 

which could lead to failure of the joint and 

could cause the collapse of the main landing 

gear (MLG), accomplish the following: 

Service Bulletin References 

(a) The term ‘‘service bulletin,’’ as used in 

this AD, means the Accomplishment 

Instructions of Boeing 707 Alert Service 

Bulletin A3511, dated January 23, 2003. 

Initial Inspection 

(b) Within 12 months or 1,000 flight cycles 

after the effective date of this AD, whichever 

comes first, perform a high frequency eddy 

current (HFEC) inspection of the MLG lock 

support fitting and the support link for cracks 

and corrosion in accordance with the service 

bulletin. 

Corrective Actions 

(c) If any crack or corrosion is found, 

during the HFEC inspection required by 

paragraph (b) of this AD, before further flight, 

rework the lock support fitting or support 

link, in accordance with the service bulletin, 

except as specified in paragraphs (c)(1) and 

(c)(2) of this AD. 

(1) If the service bulletin specifies to 

contact Boeing for rework limits: Before 

further flight, repair or replace the lock 

support fitting or support link per a method 

approved by the Manager, Seattle Aircraft 

Certification Office (ACO), FAA; or per data 

meeting the type certification basis of the 

airplane approved by a Boeing Company 

Designated Engineering Representative who 

has been authorized by the Manager, Seattle 

ACO, to make such findings. For a repair/

replacement method to be approved, the 

approval must specifically reference this AD. 

(2) Where the service bulletin specifies to 

rework the forward and aft lug bore and faces 

common to the lock support fitting of the 

MLG as given in Boeing Service Bulletin 

707–2837, this AD requires rework to be 

accomplished only in accordance with 

Revision 5 of Boeing 707 Service Bulletin 

2837, dated March 31, 1978. 

Replacement of Bolts and Bushings 

(d) Within 12 months or 1,000 flight cycles 

after the effective date of this AD, whichever 

comes first, replace the bolts and bushings at 

the joint between the lock support fitting for 

the MLG and the wing fillet flap with new 

CRES bolts and Cadmium-plated Al-Ni-Br 

bushings in accordance with the service 

bulletin. 

Parts Installation 

(e) As of the effective date of this AD, only 

bolts specified in paragraph (e)(1) of this AD 

and bushings specified in paragraph (e)(2) of 

this AD, may be installed at the joint between 

the MLG lock support fitting and the support 

link, on any airplane. 

(1) CRES bolts, part number (P/N) 

BACB30LR10DK56 or P/N 

BACB30LR10DK62. 

(2) Cadmium-plated aluminum nickel 

bronze bushings as specified in the service 

bulletin. 

Alternative Methods of Compliance 

(f) In accordance with 14 CFR 39.19, the 

Manager, Seattle ACO, FAA, is authorized to 

approve alternative methods of compliance 

for this AD. 

Incorporation by Reference 

(g) Unless otherwise specified in this AD, 

the actions shall be done in accordance with 

Boeing 707 Alert Service Bulletin A3511, 

dated January 23, 2003. 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 Boeing Commercial 

Airplanes, P.O. Box 3707, Seattle, 

Washington 98124–2207. Copies may be 

inspected at the FAA, Transport Airplane 

Directorate, 1601 Lind Avenue, SW., Renton, 

Washington; or at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at NARA, call (202) 741–6030, or go 

to: http://www.archives.gov/federal_register/

code_of_federal_regulations/

ibr_locations.html.

Effective Date 

(h) This amendment becomes effective on 

November 4, 2004.

Issued in Renton, Washington, on 

September 16, 2004. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service.

[FR Doc. 04–21649 Filed 9–29–04; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. 2003–NE–57–AD; Amendment 

39–13798; AD 2004–19–04] 

RIN 2120–AA64 

Airworthiness Directives; Rolls-Royce 

plc RB211–22B, RB211–524, and 

RB211–535 Series Turbofan Engines

AGENCY: Federal Aviation 

Administration, DOT.

ACTION: Final rule; correction.

58258 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

SUMMARY: This document makes a 

correction to Airworthiness Directive 

(AD) 2004–19–04. That AD applies to 

Rolls-Royce plc (RR) RB211–22B, 

RB211–524, and RB211–535 series 

turbofan engines. That AD was 

published in the Federal Register on 

September 22, 2004 (69 FR 56683). In 

the amendatory language, under § 39.13 

[Amended], the amendment number for 

the AD was inadvertently omitted. This 

document corrects that omission. In all 

other respects, the original document 

remains the same.

EFFECTIVE DATE: Effective September 30, 

2004.

FOR FURTHER INFORMATION CONTACT:

Christopher Spinney, Aerospace 

Engineer, Engine Certification Office, 

FAA, Engine and Propeller Directorate, 

12 New England Executive Park, 

Burlington, MA 01803–5299; telephone 

(781) 238–7175, fax (781) 238–7199.

SUPPLEMENTARY INFORMATION: A final 

rule AD, FR Doc. 04–21173 that applies 

to RR RB211–22B, RB211–524, and 

RB211–535 series turbofan engines, was 

published in the Federal Register on 

September 22, 2004 (69 FR 56683). The 

following correction is needed:

§ 39.13 [Corrected]

■ On page 56684, in the second column, 

under § 39.13 [Amended], in the fifth 

line, ‘‘2004–19–04 Rolls-Royce plc: 

Docket No.’’ is corrected to read ‘‘2004–

19–04 Rolls-Royce plc: Amendment 39–

13798. Docket No.’’.

Issued in Burlington, MA, on September 

23, 2004. 

Francis A. Favara, 

Acting Manager, Engine and Propeller 

Directorate, Aircraft Certification Service.

[FR Doc. 04–21912 Filed 9–29–04; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. 2004P–0354]

Medical Devices; Clinical Chemistry 

and Clinical Toxicology Devices; 

Classification of Sirolimus Test 

System Devices

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

sirolimus test system device into class II 

(special controls). The special control 

that will apply to the device is the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Sirolimus Test Systems.’’ The device is 

intended to measure sirolimus levels in 

whole blood as an aid to managing 

therapy for transplant patients receiving 

sirolimus, an immunosuppressive drug. 

The agency is classifying the device into 

class II (special controls) in order to 

provide a reasonable assurance of safety 

and effectiveness of the device. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a notice of 

availability of a guidance document that 

is the special control for this device.

DATES: This rule becomes effective 

November 1, 2004. The classification 

was effective July 28, 2004.

FOR FURTHER INFORMATION CONTACT: Avis 

Danishefsky, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 301–594–

1243, ext. 161.

SUPPLEMENTARY INFORMATION:

I. Background

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 360c(f)(1)), 

devices that were not in commercial 

distribution before May 28, 1976, the 

date of enactment of the Medical Device 

Amendments of 1976 (the amendments), 

generally referred to as postamendments 

devices, are classified automatically by 

statute into class III without any FDA 

rulemaking process. These devices 

remain in class III until the device is 

classified or reclassified into class I or 

II, or FDA issues an order finding the 

device to be substantially equivalent, in 

accordance with section 513(i) of the 

act, to a predicate device. The agency 

determines whether new devices are 

substantially equivalent to previously 

marketed devices by means of 

premarket notification procedures in 

section 510(k) of the act (21 U.S.C. 

360(k)) and part 807 (21 CFR part 807) 

of FDA’s regulations.

Section 513(f)(2) of the act provides 

that any person who submits a 

premarket notification under section 

510(k) of the act for a device that has not 

previously been classified may, within 

30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1) of the act, request FDA 

to classify the device under the criteria 

set forth in section 513(a)(1) of the act. 

FDA shall, within 60 days of receiving 

such a request, classify the device by 

written order. This classification shall 

be the initial classification of the device. 

Within 30 days after the issuance of an 

order classifying the device, FDA must 

publish a document in the Federal 

Register announcing such classification 

(section 513(f)(2) of the act).

In accordance with section 513(f)(1) of 

the act, FDA issued a document on June 

15, 2004, classifying the Microgenics 

CEDIA Sirolimus Assay in class III 

because it was not substantially 

equivalent to a device that was 

introduced or delivered for introduction 

into interstate commerce for commercial 

distribution before May 28, 1976, or a 

device which was subsequently 

reclassified into class I or class II. On 

June 16, 2004, Microgenics Corp. 

submitted a petition requesting 

classification of the Microgenics CEDIA 

Sirolimus Assay under section 513(f)(2) 

of the act. The manufacturer 

recommended that the device be 

classified into class II.

In accordance with 513(f)(2) of the 

act, FDA reviewed the petition in order 

to classify the device under the criteria 

for classification set forth in 513(a)(1) of 

the act. Devices are to be classified into 

class II if general controls, by 

themselves, are insufficient to provide 

reasonable assurance of safety and 

effectiveness, but there is sufficient 

information to establish special controls 

to provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use. After review of the 

information submitted in the petition, 

FDA determined that the Microgenics 

CEDIA Sirolimus Assay can be 

classified in class II with the 

establishment of special controls. FDA 

believes these special controls, in 

addition to general controls, will 

provide reasonable assurance of safety 

and effectiveness of the device.

The device is assigned the generic 

name sirolimus test system and is 

identified as a device intended to 

quantitatively determine sirolimus 

concentrations in whole blood. 

Measurements are used as an aid in 

management of transplant patients 

receiving therapy with sirolimus.

FDA has identified no direct risks to 

health related to use of sirolimus test 

systems. However, FDA has identified 

improper patient management, which 

involves failure of the test to perform as 

indicated or error in interpretation of 

results, as an indirect risk to health 

related to use of this device. For 

example, a falsely low sirolimus 

measurement could contribute to a 

decision to raise the sirolimus dose 

above that which is necessary for 

therapeutic benefit. This could result in 

increased risk in the form of 

thrombocytopenia, leukopenia, anemia, 

or hyperlipidemia. A falsely high 

sirolimus measurement could contribute 

to a decision to decrease the dose below