Federal Register / Vol. 66, No. 112 / Monday, June 11, 2001 / Rules and Regulations 31145

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:

2001–11–09 Airbus Industrie: Amendment

39–12252. Docket 2001–NM–135–AD.

Applicability: Model A330 and A340 series

airplanes, certificated in any category,

equipped with a trimmable horizontal

stabilizer actuator (THSA) part number

47172, and on which Airbus Modification

45299 has been performed.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

otherwise 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 degraded operation of the

THSA due to the entrance of water into the

ball nut, and consequent reduced

controllability of the airplane, accomplish

the following:

Repetitive Inspections

(a) Within 150 flight hours from the

effective date of this AD, perform a detailed

visual inspection to detect discrepancies in

the THSA (including distortion of the

transfer tubes, disconnection of the tubes,

and distortion of the collar of the ball nut),

in accordance with All Operators Telex

(AOT) A330–27A3088 (for Model A330 series

airplanes) or A340–27A4093 (for Model A340

series airplanes), both dated April 5, 2001, as

applicable. If any discrepancy, as defined in

paragraph 4–2–2/Rejection Criteria of the

applicable AOT, is detected, prior to further

flight, replace the THSA with a serviceable

one, per the applicable AOT.

Note 2: For the purposes of this AD, a

detailed visual inspection is defined as: ‘‘An

intensive visual examination of a specific

structural area, system, installation, or

assembly to detect damage, failure, or

irregularity. Available lighting is normally

supplemented with a direct source of good

lighting at intensity deemed appropriate by

the inspector. Inspection aids such as mirror,

magnifying lenses, etc., may be used. Surface

cleaning and elaborate access procedures

may be required.’’

(b) At intervals not to exceed 150 flight

hours, repeat the inspection mandated in

paragraph (a) of this AD.

Report of Inspection Findings

(c) Submit a report of inspection findings

(both positive and negative) to Airbus; at the

applicable time specified in paragraph (c)(1)

or (c)(2) of this AD. The report must include

the inspection results, a description of any

discrepancies found, the airplane serial

number, and the number of landings and

flight hours on the airplane. Information

collection requirements contained in this

regulation have been approved by the Office

of Management and Budget (OMB) under the

provisions of the Paperwork Reduction Act of

1980 (44 U.S.C. 3501 et seq.) and have been

assigned OMB Control Number 2120–0056.

(1) For airplanes on which the inspection

is accomplished after the effective date of

this AD: Submit the report within 10 days

after performing the inspection required by

paragraph (a) or (b) of this AD.

(2) For airplanes on which the inspection

has been accomplished prior to the effective

date of this AD: Submit the report within 10

days after the effective date of this AD.

Alternative Methods of Compliance

(d) 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,

International Branch, ANM–116, Transport

Airplane Directorate, FAA. Operators shall

submit their requests through an appropriate

FAA Principal Maintenance Inspector, who

may add comments and then send it to the

Manager, International Branch, ANM–116.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the International Branch,

ANM–116.

Special Flight Permits

(e) Special flight permits may be issued in

accordance with §§ 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 inspections and replacement shall

be done in accordance with Airbus All

Operators Telex A330–27A3088, dated April

5, 2001; or Airbus All Operators Telex A340–

27A4093, dated April 5, 2001; as applicable.

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 Airbus Industrie, 1 Rond Point Maurice

Bellonte, 31707 Blagnac Cedex, France.

Copies may be inspected at the FAA,

Transport Airplane Directorate, 1601 Lind

Avenue, SW., Renton, Washington; or at the

Office of the Federal Register, 800 North

Capitol Street, NW., suite 700, Washington,

DC.

Note 4: The subject of this AD is addressed

in French airworthiness directives 2001–

141(B) and 2001–140(B), both dated April 18,

2001.

Effective Date

(g) This amendment becomes effective on

June 26, 2001.

Issued in Renton, Washington, on May 25,

2001.

Vi L. Lipski,

Manager, Transport Airplane Directorate,

Aircraft Certification Service.

[FR Doc. 01–13996 Filed 6–8–01; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 61, 63, 65, 108, 121 and

135

[Docket No. FAA–2000–7497; Amendment

No. 61–107, 63–30, 65–41, 108–18, 121–280

and 135–79]

RIN 2120–AH01

Advanced Qualification Program;

Correction

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule; correction.

SUMMARY: This document contains a

correction to the final rule, published in

the Federal Register on October 10,

2000 (65 FR 60334). That final rule

established a new termination date for

Special Federal Aviation Regulation

(SFAR) No. 58 (55 FR 40275; October 2,

1990), which provided the approval of

an alternate method (known as

‘‘Advanced Qualification Program’’ or

‘‘AQP’’) for qualifying, training and

certifying, and otherwise ensuring the

competeny of crewmembers, aircraft

dispatchers, other operations personnel,

instructors, and evaluators who are

required to be trained or qualified under

14 CFR parts 121 and 135.

FOR FURTHER INFORMATION CONTACT:

Thomas M. Longridge, (703) 661–0260.

Correction of Publication

In the final rule FR Doc. 00–25951,

beginning on page 60334 in the Federal

Register issue of October 10, 2000, make

the following corrections:

1. On page 60334, in column 1, in the

heading section, beginning on line 7,

31146 Federal Register / Vol. 66, No. 112 / Monday, June 11, 2001 / Rules and Regulations

correct ‘‘Amendment No. 61–107, 63–

30, 65–41, 108–18, 121–280 and 135–

78’’ to read ‘‘Amendment Nos. 61–107,

63–30, 65–41, 108–18, 121–280 and

135–79’’.

Issued in Washington, DC on June 6, 2001.

Donald Byrne,

Assistant Chief Counsel, Regulations

Division.

[FR Doc. 01–14656 Filed 6–8–01; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 121 and 135

[Docket No. FAA–2000–7119; Amendment

No. 121–281 and 135–80]

RIN 2120–AG89

Emergency Medical Equipment;

Correction

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule; correction.

SUMMARY: This document contains a

correction to the final rule, published in

the Federal Register on April 12, 2001

(66 FR 19028). That final rule responds

to the Aviation Medical Assistance Act

of 1998 by requiring that air carrier

operators carry automated external

defibrillators on large, passengercarrying aircraft and augment currently

required emergency medical kits.

FOR FURTHER INFORMATION CONTACT: Judi

citrenbaum, (202) 267–9689.

Correction of Publication

In the final rule FR Doc. 01–8923,

beginning on page 19028 in the Federal

Register issue of April 12, 2001, make

the following corrections:

1. On page 19028, in column 1, in the

heading section, beginning on line 5,

correct ‘‘Amendment No. 121–280 and

135–78’’ to read ‘‘Amendment Nos.

121–281 and 135–80’’.

Issued in Washington, DC, on June 6, 2001.

Donald Byrne,

Assistant Chief Counsel, Regulations

Division.

[FR Doc. 01–14657 Filed 6–8–01; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 606, 607, 610, 640, 660,

and 809

[Docket No. 98N–0581]

Requirements for Testing Human

Blood Donors for Evidence of Infection

Due to Communicable Disease Agents

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is revising the

general biological product standards

applicable to human blood and blood

components by updating the hepatitis B

virus (HBV) and human

immunodeficiency virus (HIV) testing

requirements, by adding testing

requirements for hepatitis C virus

(HCV), human T-lymphotropic virus

(HTLV), and by adding requirements for

supplemental (i.e., additional, more

specific) testing approved for such use

by FDA when a donation is found to be

reactive for any of the required

screening tests for evidence of infection

due to communicable disease agents.

The agency also is requiring

manufacturers of certain test kits to use

reference panels, when available, to

verify the acceptable sensitivity and

specificity of each lot. This final rule is

intended to help protect the safety and

ensure the quality of the Nation’s blood

supply, to enhance the safety of medical

devices containing blood or blood

components, to provide FDA with clear

enforcement authority, and to promote

consistency in the industry. Elsewhere

in this issue of the Federal Register,

FDA is publishing a rule requiring blood

and plasma establishments to notify

donors, including autologous donors,

whenever the donor is deferred or

determined not to be suitable for current

or future donations of blood and blood

components.

DATES: This rule is effective December

10, 2001.

FOR FURTHER INFORMATION CONTACT:

Paula S. McKeever, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

Requirements for testing blood donors

for hepatitis B surface antigen (HBsAg)

and antibody to human

immunodeficiency virus (anti-HIV) are

currently codified in part 610 (21 CFR

part 610), and requirements for

performing a serological test for syphilis

are codified in part 640 (21 CFR part

640). The agency has issued various

guidance documents to registered blood

and plasma establishments providing

recommendations for testing for

antibody to hepatitis B core antigen

(anti-HBc), antibody to human Tlymphotropic virus types I and II (antiHTLV I/II), antibody to hepatitis C virus

(anti-HCV), and HIV–1 p 24 antigen.

The purposes of the guidance

documents are to assist blood and

plasma establishments in protecting the

safety of the blood supply and to

establish policies with the intent of

promoting consistency in the industry.

These guidance documents represent

the agency’s current thinking on the

appropriate testing of human blood

donors for evidence of infection due to

various communicable disease agents.

Through inspection, we (FDA)

determined that blood and plasma

establishments generally have been

following these recommendations.

However, there have been instances

where there have been variations in

testing and in the determination of

suitability of the blood based on the

testing results. Accordingly, we

proposed a regulation requiring testing

consistent with our current

recommendations and industry practice.

In the Federal Register of August 19,

1999 (64 FR 45340), we published a

proposed rule to revise the testing

requirements codified in part 610. The

proposed rule would require:

• Each donation of human blood or

blood component, including autologous

donations, to be tested for evidence of

infection due to HIV, types 1 and 2;

HBV; HCV; and HTLV, types I and II;

• Each donation that tests reactive for

any of the required screening tests for

evidence of infection due to

communicable disease agents, to be

further tested using a supplemental

(additional, more specific) test that has

been approved for such use by FDA;

• The required testing to be performed

by a laboratory certified under the

Clinical Laboratory Improvement

Amendments of 1988 (CLIA) or meeting

equivalent requirements as described by

Health Care Financing Administration

(HCFA), and registered with FDA in

accordance with part 607 (21 CFR part

607);

• Deferral from future donations of

donors who test reactive;

• Criteria for release or shipment of

human blood or blood components prior

to completion of testing under limited

circumstances;