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

40427

Vol. 62, No. 145

Tuesday, July 29, 1997

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 13

RIN 3150–AD71

Program Fraud Civil Remedies;

Technical Amendment

AGENCY: Nuclear Regulatory

Commission.

ACTION: Final rule: technical

amendment.

SUMMARY: This document corrects a

paragraph numbering error contained in

the Nuclear Regulatory Commission

(NRC) regulations implementing the

Program Fraud Civil Remedies Act of

1986.

EFFECTIVE DATE: July 29, 1997.

FOR FURTHER INFORMATION CONTACT:

Susan Fonner, Office of the General

Counsel, U.S. Nuclear Regulatory

Commission, Washington, DC 20555–

0001, telephone (301) 415–1634.

SUPPLEMENTARY INFORMATION: As

published, the NRC’s Program Fraud

Civil Remedies regulations contain a

numbering error in the definition of

‘‘Claim’’ contained in 10 CFR 13.2.

Paragraph (b)(3) of the definition should

have been numbered as paragraph (c).

That this was an inadvertent error is

evident both from the internal wording

of the definition and from the definition

of ‘‘claim’’ in the Act contained at 31

U.S.C. 3801. The definition of ‘‘claim’’

in the regulation is virtually identical to

the definition in the Act, except for this

numbering error.

List of Subjects in 10 CFR Part 13

Claims, Fraud, Organization and

function (government agencies),

Penalties.

Accordingly, 10 CFR part 13 is

amended by making the following

corrective amendment.

PART 13—PROGRAM FRAUD CIVIL

REMEDIES

1. The authority citation for Part 13

continues to read as follows:

Authority: Public Law 99–509, secs. 6101–

6104, 100 Stat. 1874 (31 U.S.C. 3801–3812).

Sections 13.13 (a) and (b) also issued under

section Pub. L. 101–410, 104 Stat. 890, as

amended by section 31001(s), Pub. L. 104–

134, 110 Stat. 1321–373 (28 U.S.C. 2161

note).

§ 13.2 [Amended]

2. In the definition of ‘‘Claim’’ in

§ 13.2, paragraph (b)(3) is redesignated

as paragraph (c).

Dated at Rockville, MD, this 17th day of

July, 1997.

For the Nuclear Regulatory Commission.

L. Joseph Callan,

Executive Director for Operations.

[FR Doc. 97–19929 Filed 7–28–97; 8:45 am]

BILLING CODE 7590–01–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. NM–143; Special Conditions

No. 25–ANM–130]

Special Conditions: International

Aviation Services, Ltd.; Boeing Model

747–SP Airplane; High Intensity

Radiated Fields (HIRF)

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final special conditions, request

for comments.

SUMMARY: These special conditions are

issued for Boeing Model 747–SP

airplanes modified by International

Aviation Services, Ltd. These airplanes

will have novel and unusual design

features when compared to the state of

technology envisioned in the

airworthiness standards for transport

category airplanes. These special

conditions contain the additional safety

standards that the Administrator

considers necessary to establish a level

of safety equivalent to that provided by

the existing airworthiness standards.

DATES: The effective date of these

special conditions is July 17, 1997.

Comments must be received on or

before August 28, 1997.

ADDRESSES: Comments on these special

conditions may be mailed in duplicate

to: Federal Aviation Administration,

Office of the Assistant Chief Counsel,

Attn: Rules Docket (ANM–7), Docket

No. NM–143, 1601 Lind Avenue SW.,

Renton, Washington, 98055–4056; or

delivered in duplicate to the Office of

the Assistant Chief Counsel at the above

address. Comments must be marked:

Docket No. NM–143. Comments may be

inspected in the Rules Docket

weekdays, except Federal holidays,

between 7:30 a.m. and 4:00 p.m.

FOR FURTHER INFORMATION CONTACT: Tom

Groves, FAA, Standardization Branch,

ANM–113, Transport Airplane

Directorate, Aircraft Certification

Service, 1601 Lind Avenue SW.,

Renton, Washington, 98055–4056;

telephone (425) 227–1503; facsimile

(425) 227–1149.

SUPPLEMENTARY INFORMATION:

Comments Invited

The FAA has determined that good

cause exists for making these special

conditions effective upon issuance;

however, interested persons are invited

to submit such written data, views, or

arguments as they may desire.

Communications should identify the

regulatory docket and special condition

number and be submitted in duplicate

to the address specified above. All

communications received on or before

the closing date for comments will be

considered by the Administrator. These

special conditions may be changed in

light of the comments received. All

comments submitted will be available in

the rules docket for examination by

interested persons, both before and after

the closing date for comments. A report

summarizing each substantive public

contact with FAA personnel concerning

this rulemaking will be filed in the

docket. Persons wishing the FAA to

acknowledge receipt of their comments

submitted in response to this request

must submit with those comments a

self-addressed, stamped postcard on

which the following statement is made:

‘‘Comments to Docket No. NM–143.’’

The postcard will be date stamped and

returned to the commenter.

Background

On August 8, 1996, International

Aviation Services, Ltd. applied for a

supplemental type certificate (STC) to

modify Boeing Model 747–SP airplanes
40428 Federal Register / Vol. 62, No. 145 / Tuesday, July 29, 1997 / Rules and Regulations

listed on Type Certificate A20WE. The

modification includes the installation of

a 5-tube electronic flight instrument

system (EFIS) that will replace the

existing electro-mechanical horizontal

situation indicator (HSI) and attitude

director indicator (ADI). These systems,

which display flight critical

information, are vulnerable to highintensity radiated fields (HIRF) external

to the airplane.

Type Certification Basis

Under the provisions of 14 CFR

§ 21.101, International Aviation

Services, Ltd. must show that the

Boeing Model 747–SP, as changed,

continues to meet the applicable

provisions of the regulations

incorporated by reference in Type

Certificate A20WE, or the applicable

regulations in effect on the date of

application for the change. The

regulations incorporated by reference in

the type certificate are commonly

referred to as the ‘‘original type

certification basis.’’ The certification

basis for the modified Model 747–SP

includes 14 CFR part 25, as amended by

Amendments 25–1 through 25–8 and

certain later amendments, special

conditions, exemptions, and optional

requirements listed in the type

certificate data sheet that are not

relevant to these special conditions. In

addition, the certification basis for the

modifications, and for areas affected by

the modifications, will be amended to

include the following sections:

Section Amendment Title

25.779(a) ..... 25–72 Motion and effect of

cockpit controls.

25.1303 ....... 25–38 Flight and navigation instruments.

25.1307 ....... 25–72 Miscellaneous

equipment.

25.1309 ....... 25–41 Equipment, systems, and installations.

25.1316 ....... 25–80 System lightning

protection.

25.1321 ....... 25–41 Arrangement and

visibility.

25.1322 ....... 25–38 Warning, caution,

and advisory

lights.

25.1329 ....... 25–46 Automatic pilot system.

25.1331 ....... 25–41 Instruments using a

power supply.

25.1333 ....... 25–41 Instrument systems.

25.1335 ....... 25–41 Flight director systems.

25.1381 ....... 25–72 Instrument lights.

25.1501 ....... 25–42 General.

25.1529 ....... 25–54 Instructions for Continued Airworthiness.

25.1581 ....... 25–72 General.

Section Amendment Title

25.1583 ....... 25–72 Operating limitations.

If the Administrator finds that the

applicable airworthiness regulations

(i.e., part 25, as amended) do not

contain adequate or appropriate safety

standards for the Boeing Model 747–SP

airplane because of novel or unusual

design features, special conditions are

prescribed under the provisions of

§ 21.16 to establish a level of safety

equivalent to that established in the

regulations.

Special conditions, as appropriate, are

issued in accordance with 14 CFR

§ 11.49 after public notice, as required

by §§ 11.28 and 11.29, and become part

of the type certification basis in

accordance with § 21.101(b)(2).

Special conditions are initially

applicable to the model for which they

are issued. Should International

Aviation Services, Ltd. apply at a later

date for an STC to modify any other

model already included on the same

type certificate to incorporate the same

novel or unusual design feature, the

special conditions would also apply to

the other model under the provisions of

§ 21.101(a)(1).

Novel or Unusual Design Features

The Boeing Model 747–SP will

incorporate a new electronic flight

instrument system that performs critical

functions. This system may be

vulnerable to HIRF external to the

airplane.

Discussion

There is no specific regulation that

addresses protection requirements for

electrical and electronic systems from

HIRF. Increased power levels from

ground-based radio transmitters and the

growing use of sensitive electrical and

electronic systems to command and

control airplanes have made it necessary

to provide adequate protection.

To ensure that a level of safety is

achieved equivalent to that intended by

the regulations incorporated by

reference, special conditions are needed

for the Boeing Model 747–SP, which

require that new electrical and

electronic systems, such as the EFIS,

that perform critical functions be

designed and installed to preclude

component damage and interruption of

function due to both the direct and

indirect effects of HIRF.

High-Intensity Radiated Fields (HIRF)

With the trend toward increased

power levels from ground-based

transmitters, plus the advent of space

and satellite communications, couples

with electronic command and control of

the airplane, the immunity of critical

digital avionics systems to HIRF must be

established.

It is not possible to precisely define

the HIRF to which the airplane will be

exposed in service. There is also

uncertainty concerning the effectiveness

of airframe shielding for HIRF.

Furthermore, coupling of

electromagnetic energy to cockpitinstalled equipment through the cockpit

window apertures is undefined. Based

on surveys and analysis of existing HIRF

emitters, an adequate level of protection

exists when compliance with the HIRF

protection special condition is shown

with either paragraphs 1, or 2 below:

1. A minimum threat of 100 volts per

meter peak electric field strength from

10 KHz to 18 GHz.

a. The threat must be applied to the

system elements and their associated

wiring harnesses without the benefit of

airframe shielding.

b. Demonstration of this level of

protection is established through system

tests and analysis.

2. A threat external to the airframe of

the following field strengths for the

frequency ranges indicated.

Frequency Peak

(V/M)

Average (V/

M)

10 KHz–100 KHz .............. 50 50

100 KHz–500 KHz ............ 60 60

500 KHz–2 MHz ................ 70 70

2 MHz–30 MHz ................. 200 200

30 MHz–100 MHz ............. 30 30

100 MHz–200 MHz ........... 150 33

200 MHz–400 MHz ........... 70 70

400 MHz–700 MHz ........... 4,020 935

700 MHz–1 GHz ............... 1,700 170

1 GHz–2 GHz ................... 5,000 990

2 GHz–4 GHz ................... 6,680 840

4 HGz–6 GHz ................... 6,850 310

6 GHz–8 GHz ................... 3,600 670

8 GHz–12 GHz ................. 3,500 1,270

12 GHz–18 GHz ............... 3,500 360

18 GHz–40 GHz ............... 2,100 750

Applicability

As discussed above, these special

conditions are applicable to Boeing

Model 747–SP airplanes modified by

International Aviation Services, Ltd.

Should International Aviation Services,

Ltd. apply at a later date for a

supplemental type certificate to modify

any other model included on Type

Certificate A20WE to incorporate the

same novel or unusual design feature,

the special conditions would apply to

that model as well under the provisions

of § 21.101(a)(1).
Federal Register / Vol. 62, No. 145 / Tuesday, July 29, 1997 / Rules and Regulations 40429

Conclusion

This action affects only certain design

features on Boeing Model 747–SP

airplanes modified by International

Aviation Services, Ltd. It is not a rule of

general applicability and affects only

the applicant who applied to the FAA

for approval of these features on the

airplane.

The substance of the special

conditions for this airplane has been

subjected to the notice and comment

procedure in several prior instances and

has been derived without substantive

change from those previously issued. It

is unlikely that prior public comment

would result in a significant change

from the substance contained herein.

For this reason, and because a delay

would significantly affect the

certification of the airplane, which is

imminent, the FAA has determined that

prior public notice and comment are

unnecessary and impracticable, and

good cause exists for adopting these

special conditions immediately.

Therefore, these special conditions are

being made effective upon issuance. The

FAA is requesting comments to allow

interested persons to submit views that

may not have been submitted in

response to the prior opportunities for

comment described above.

List of Subjects in 14 CFR Part 25

Aircraft, Aviation safety, Reporting

and recordkeeping requirements.

The authority citation for these

special conditions is as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701,

44702, 44704.

The Special Conditions

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the following special

conditions are issued as part of the type

certification basis for Boeing Model

747–SP airplanes modified by

International Aviation Services, Ltd.

1. Protection from Unwanted Effects

of High-Intensity Radiated Fields

(HIRF). Each electrical and electronic

system that performs critical functions

must be designed and installed to

ensure that the operation and

operational capability of these systems

to perform critical functions are not

adversely affected when the airplane is

exposed to high intensity radiated

fields.

For the purpose of these special

conditions, the following definition

applies:

Critical Functions. Functions whose

failure would contribute to or cause a

failure condition that would prevent the

continued safe flight and landing of the

airplane.

Issued in Renton, Washington, on July 17,

1997.

Gary L. Killion,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–19858 Filed 7–28–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 1270

[Docket No. 93N–0453]

RIN 0910–AA40

Human Tissue Intended for

Transplantation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a final

rule to require certain infectious disease

testing, donor screening, and

recordkeeping to help prevent the

transmission of the human

immunodeficiency virus (HIV), and

hepatitis viruses through human tissue

used in transplantation. In response to

comments received, FDA has clarified

and modified many of the provisions of

the interim rule on human tissue

intended for transplantation which was

published in the Federal Register of

December 14, 1993. The final rule

requires facilities engaged in the

recovery, screening, testing, processing,

storing, or distributing of human tissues

to ensure that specified minimum

required medical screening and

infectious disease testing has been

performed and that records

documenting such screening and testing

for each human tissue are available for

inspection by FDA. The regulations also

contain provisions for the inspection of

such facilities and for retaining,

recalling, or destroying human tissue for

which appropriate documentation is not

available.

DATES: The regulation is effective

January 26, 1998. This effective date is

applicable to all human tissue intended

for transplantation procured on or after

this date. Written comments on the

information collection requirements

should be submitted by September 29,

1997.

ADDRESSES: Submit written comments

on the information collection

requirements to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. All comments should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Paula S. McKeever, Center for Biologics

Evaluation and Research (HFM–630),

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–594–3074.

SUPPLEMENTARY INFORMATION:

I. Introduction

A. Background

In the Federal Register of December

14, 1993 (58 FR 65514), FDA issued an

interim rule on human tissue intended

for transplantation (hereinafter referred

to as the interim rule). These regulations

became effective upon the date of

publication in the Federal Register and

required human tissue in storage as of

that date to be in compliance. The

interim rule was issued because of

evidence indicating an immediate need

to protect the public health from the

transmission of HIV infection and

hepatitis infection through

transplantation of human tissue from

known donors infected with or at risk

for these diseases. The movement

towards regulating human tissue was

accelerated by a hearing on appropriate

oversight for human tissue banking

chaired by Senator (then Representative)

Wyden before the Subcommittee on

Regulation, Business Opportunities and

Technology of the Committee on Small

Business held on October 15, 1993. At

the hearing, representatives of persons

involved in human tissue banking

advocated that legislation setting forth

regulatory requirements for human

tissue banking be passed. There was

testimony that human tissues from

foreign sources were being offered for

sale in the United States with little

documentation as to the source of the

human tissue, the cause of death, the

medical conditions of the donor, or the

results of donor screening and testing.

This raised significant concerns about

the safety and quality of some of the

human tissue available for

transplantation. As a result of a number

of similar allegations, the agency

initiated inquiries into the possibility

that human tissues intended for

transplantation were being supplied

without appropriate infectious disease

testing and medical screening. In a

relatively brief period of time, the

agency was able to confirm the

availability for importation and

distribution to the United States of