50494 Federal Register / Vol. 62, No. 187 / Friday, September 26, 1997 / Rules and Regulations

provided under the contracts, and to

otherwise enforce the contracts in

accordance with their terms. In no case

will the Administrator settle a debt or

claim for less than the value (after

considering the government’s collection

costs) of the borrower’s system and

other collateral securing the debt or

claim.

(2) RUS may use such methods,

analyses, and assessments as the

Administrator deems appropriate to

determine the value of the borrower’s

system.

(g) Rates. The Administrator will

consider the rates charged for electric

service by the borrower and, in the case

of a power supply borrower, by its

members, taking into account, among

other factors, the practices of the

Federal Energy Regulatory Commission

(FERC), as adapted to the cooperative

structure of borrowers, and, where

applicable, FERC treatment of any

investments by co-owners in projects

jointly owned by the borrower.

(h) Collection action. The

Administrator will consider whether a

settlement is favorable to the

government in comparison with the

amount that can be recovered by

enforced collection procedures.

(i) Regulatory approvals. Before the

Administrator will approve a

settlement, the borrower must provide

satisfactory evidence that it has

obtained all approvals required of

regulatory bodies that the Administrator

determines are needed to implement

rates or other provisions of the

settlement, or that are needed in any

other way for the borrower to fulfill its

obligations under the settlement.

(j) Conditions regarding management

and operations. As a condition of debt

settlement, the borrower, and in the case

of a power supply borrower, its

members, will be required to implement

those changes in structure, management,

operations, and performance deemed

necessary by the Administrator. Those

changes may include, but are not

limited to, the following:

(1) The borrower may be required to

undertake a corporate restructuring and/

or sell a portion of its plant, facilities,

or other assets

(2) The borrower may be required to

replace senior management and/or hire

outside experts acceptable to the

Administrator. Such changes may

include a commitment by the borrower’s

board of directors to restructure and/or

obtain new membership to improve

board oversight and leadership;

(3) The borrower may be required to

agree to:

(i) Controls by RUS on the general

funds of the borrower, as well as on any

investments, loans or guarantees by the

borrower, notwithstanding any

limitations on RUS’ control rights in the

borrower’s loan documents or RUS

regulations; and

(ii) Requirements deemed necessary

by RUS to perfect and protect its lien on

cash deposits, securities, equipment,

vehicles, and other items of real or nonreal property; and

(4) In the case of a power supply

borrower, the borrower may be required

to obtain credit support from its member

systems, as well as pledges and action

plans by the members to change their

operations, management, and

organizational structure (e.g., shared

services, mergers, or consolidations) in

order to reduce operating costs, improve

efficiency, and/or expand markets and

revenues.

(k) Conveyance of assets. As a

condition of a settlement, a borrower

may be required to convey some or all

its assets to the government.

(l) Additional conditions. The

borrower will be required to warrant

and agree that no bonuses or similar

extraordinary compensation has been or

will be provided, for reasons related to

the settlement of government debt, to

any officer or employee of the borrower

or to other persons or entities identified

by RUS. The Administrator may impose

such other terms and conditions of debt

settlement as the Administrator

determines to be in the government’s

interests.

(m) Certification of accuracy. Before

the Administrator will approve a debt

settlement, the manager or other

appropriate official of the borrower

must certify that all information

provided to the government by the

borrower or by any agent of the

borrower, in connection with the debt

settlement, is true, correct, and

complete in all material respects.

§ 1717.1205 Waiver of existing conditions

on borrowers.

Pursuant to section 331(b) of the Con

Act, the Administrator, at his or her sole

discretion, may waive or otherwise

reduce conditions and requirements

imposed on a borrower by its loan

documents if the Administrator

determines that such action will

contribute to enhancement of the

government’s recovery of debt. Such

waivers or reductions in conditions and

requirements under this section shall

not include the exercise of any of the

debt settlement measures set forth in

§ 1717.1204(c), which are subject to all

of the requirements of said § 1717.1204.

§ 1717.1206 Loans subsequent to

settlement.

In considering any future loan

requests from a borrower whose debt

has been settled in whole or in part

(including the surviving entity of

merged or consolidated borrowers,

where at least one of said borrowers had

its debts settled), it will be presumed

that credit support for the full amount

of the requested loan will be required.

Such support may be in a number of

forms, provided that they are acceptable

to the Administrator on a case by case

basis. They may include, but need not

be limited to, equity infusions and

guarantees of debt repayment, either

from the applicant’s members (in the

case of a power supply borrower), or

from a third party.

§ 1717.1207 RUS obligations under loan

guarantees.

Nothing in this subpart affects the

obligations of RUS under loan guarantee

commitments it has made to the Federal

Financing Bank or other lenders.

§ 1717.1208 Government’s rights under

loan documents.

Nothing in this subpart limits,

modifies, or otherwise affects the rights

of the government under loan

documents executed with borrowers, or

under law or equity.

Dated: September 19, 1997.

Jill Long Thompson,

Under Secretary, Rural Development.

[FR Doc. 97–25315 Filed 9–25–97; 8:45 am]

BILLING CODE 3410–15–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. NM–141; Special Conditions

No. 25–ANM–132]

Special Conditions: Boeing Model 737–

600/–700/–800; High Intensity Radiated

Fields (HIRF)/Engine Stoppage

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final special conditions.

SUMMARY: These special conditions are

issued for Boeing Model 737–600/–700/

–800 airplanes. 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
Federal Register / Vol. 62, No. 187 / Friday, September 26, 1997 / Rules and Regulations 50495

of safety equivalent to that provided by

the existing airworthiness standards.

EFFECTIVE DATE: September 17, 1997.

FOR FURTHER INFORMATION CONTACT:

Gregory Dunn, FAA, Standardization

Branch, ANM–113, Transport Airplane

Directorate, Aircraft Certification

Service, 1601 Lind Avenue SW.,

Renton, Washington, 98055–4056;

telephone (425) 227–2799; facsimile

(425) 227–1149.

SUPPLEMENTARY INFORMATION:

Background

On February 4, 1993, Boeing

submitted an application for an

amendment to Type Certificate A16WE

to include the next generation 737

family of airplanes. Two of these

airplanes will have the same length as

the present 737–300 and 737–500. The

third version will be the existing 737–

400, stretched to add two additional

passenger rows. In addition, all models

will have increased wing size, higher

thrust engines, and body structure

modifications due to increased design

weights and higher wing and tail loads.

The maximum operating altitude is to

be increased from 37,000 ft. to 41,000 ft.

The long range cruise speed is increased

to 0.78 Mach or better. The range is

increased to be transcontinental of

approximately 2,950 nmi. There is only

one engine type being offered, which is

a derivative of the existing CFM56

referred to as the CFM56–7.

Type Certification Basis

Under the provisions of 14 CFR

§ 21.101, Boeing must show that the

Model 737–600/–700/–800 airplanes

meet the applicable provisions of the

regulations incorporated by reference in

Type Certificate A16WE, or the

applicable regulations in effect on the

date of application for the change to the

Model 737. The regulations

incorporated by reference in the type

certificate are commonly referred to as

the ‘‘original type certification basis.’’

The certification basis for the Model

737–600/–700/–800 airplanes includes

14 CFR part 25, as amended by

Amendments 25–1 through 25–77,

except as indicated below:

Section No. Title At amdt.

25–

25.365 .......... Pressurized Compartment Loads.0

25.561 .......... Emergency Landing Conditions—General.0

25.562 .......... Emergency Landing Dynamic

Conditions.

* 64

Section No. Title At amdt.

25–

25.571 .......... Damage-tolerance and Fatigue Evaluation of Structure.** 0,77

25.607 .......... Fasteners ............ ** 0,77

25.631 .......... Bird Strike Damage.** 0,77

25.699 .......... Lift and Drag Device Indicator.** 0,77

25.783(f) ....... Doors .................. ** 15,77

25.807(c)(3) Emergency Exits 15

25.813 .......... Emergency Exit

Access.

45

25.832 .......... Cabin Ozone

Concentration.

*** 0,77

25.1309 ........ Equipment, Systems and Installations.** 0,77

25.1419(c) .... Ice Protection ..... ** 23,77

Boeing has also elected to comply with

Amendments 25–78 and 25–80 and portions

of Amendments 25–79, 25–84, and 25–86. * Flight attendants seats will be qualified to

Technical Standard Order C127. Passenger

and flight deck seats will comply with 14 CFR

25.562 (a),(b),((c)(1),(2),(3),(4),(7), and (8)). **Applicable to new and significantly modified structure and systems and portions of the

airplane affected by these changes. Where

two amendment levels are shown for the

same paragraph, the number without the asterisks (*) applies to structures, systems, and

portions of the airplane which are not new or

significantly modified. The structure, systems,

and components which comply with the later

amendment will be identified in Boeing document D010A001, approved by the FAA and

JAA, and referenced on the type certificate

data sheet. ***Boeing provides FAA approved data

(Document number D6–49779) to 737 operators to enable the operators to show ozone

compliance per 14 CFR 121.578 for their specific route structures.

Amendment level ‘‘0’’ is the original

published version of Part 25 (February

1, 1965).

In addition, the certification basis will

be upgraded to include the Part 25

complement to any Part 121

amendments adopted prior to the

certification date and having impact on

transport category airplane type designs,

and these special conditions.

In addition to the applicable

airworthiness regulations and special

conditions, the Model 737–600/–700/–

800 airplanes must comply with the fuel

vent and exhaust emission requirements

of 14 CFR part 34, and the noise

certification requirements of 14 CFR

part 36.

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 737–

600/–700/–800 airplanes because of

novel or unusual design features,

special conditions are prescribed under

the provisions of 14 CFR 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 14

CFR 11.28 and 11.29, and become part

of the type certification basis in

accordance with 14 CFR 21.101(b)(2).

Special conditions are initially

applicable to the model for which they

are issued. Should the type certificate

for that model be amended later to

include any other model that

incorporates the same novel or unusual

design feature, or should any other

model already included on the same

type certificate be modified to

incorporate the same novel or unusual

design feature, the special conditions

would also apply to the other model

under the provisions of 14 CFR

21.101(a)(1).

Novel or Unusual Design Features

The Boeing Model 737–600/–700/–

800 airplanes will incorporate new

avionic/electronic systems, such as the

Air Data Inertial Reference System

(ADIRS) and Common Display System

(CDS), that perform critical functions.

These systems may be vulnerable to

HIRF external to the airplane. In

addition, the CFM56–7B engine

proposed for the Boeing 737–700

airplane is a high-bypass ratio fan jet

engine that will not seize and produce

transient torque loads in the same

manner that is envisioned by current

§ 25.361(b)(1) related to ‘‘sudden engine

stoppage.’’

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, a special condition is needed

for the Boeing Model 737–600/–700/–

800, which requires that new electrical

and electronic systems 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.

For the CFM56–7B engine, the limit

engine torque load imposed by sudden

engine stoppage due to malfunction or

structural failure (such as compressor

jamming) has been a specific

requirement for transport category
50496 Federal Register / Vol. 62, No. 187 / Friday, September 26, 1997 / Rules and Regulations

airplanes since 1957. The size,

configuration, and failure modes of jet

engines has change considerably from

those envisioned in 14 CFR 25.361(b)

when the engine seizure requirement

was first adopted.

Relative to the engine configurations

that existed when the rule was

developed in 1957, the present

generation of engines are sufficiently

different and novel to justify issuance of

a special condition to establish

appropriate design standards.

The FAA is developing a new

regulation and new advisory circular

that will provide more comprehensive

criteria for treating engine loads

resulting from structural failures. In the

meantime, a special condition is needed

to establish appropriate criteria for the

Boeing 737–600/–700/–800 airplanes.

High-Intensity Radiated Fields (HIRF)

With the trend toward increased

power levels from ground-based

transmitters, plus the advent of space

and satellite communications, coupled

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

Frequency Peak (V/

M)

Average

(V/M)

700 MHz–1 GHz ........... 1,700 170

1 GHz–2 GHz ............... 5,000 990

2 GHz–4 GHz ............... 6,680 840

4 GHz–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

Limit Engine Torque Loads for Sudden

Engine Stoppage

In order to maintain the level of safety

envisioned by § 25.361(b), more

comprehensive criteria are needed for

the new generation of high bypass

engines. This special condition

distinguishes between the more

common events and those rare events

resulting from structural failures in the

engine. For these more rare but severe

events, these criteria allow deformation

in the engine supporting structure in

order to absorb the higher energy

associated with the high bypass engines,

while at the same time protecting the

adjacent primary structure in the wing

and fuselage by applying an additional

factor on these loads.

Discussion of Comments

Notice of proposed special conditions

No. SC–97–3–NM for the Boeing 737–

600/–700/–800 airplanes was published

in the Federal Register on May 14, 1997

(62 FR 26453).

Comments were received from an

engine manufacturer who, while

supporting the need for the engine

torque loads requirements, offers the

following comments for consideration.

The commenter recommends that the

words ‘‘* * * and that could cause a

shutdown due to vibrations’’ be

removed from paragraph 2(b)(1)(i) of the

special conditions. The commenter

states that its position is based on a

comparison of the proposed special

condition with similar work currently

underway within the Aviation

Rulemaking Advisory Committee

(ARAC). The commenter notes

differences between these two

proposals. For example, the special

condition adds a provision that the

engine malfunction for limit load

calculation be such that it ‘‘could cause

a shutdown due to engine vibrations,’’

while this provision was removed from

the ARAC proposal, whose intent is to

address engine events beyond maximum

acceleration and other than structural

failures, seizures, jamming, and

unbalance, such as engine surge. The

commenter further notes that the special

condition does not explicitly state that

the limit torque acts simultaneously

with 1g flight loads, although this may

be intended.

The FAA recognizes that the ARAC

working group is studying this issue and

that its final proposal may be different

from what has already been applied as

a special condition on several airplanes.

However, until more definitive criteria

have been accepted by industry and by

the FAA, the special condition will

remain unchanged. The special

condition is based on the assumption

that the airplane will be subjected to 1g

flight loads throughout the engine

torque event.

Applicability

As discussed above, these special

conditions are applicable to the Model

737–600/–700/–800 airplanes. Should

Boeing Commercial Airplane Group

apply at a later date for a change to the

type certificate to include another

model incorporating the same novel or

unusual design feature, the special

conditions would apply to that model as

well under the provisions of 14 CFR

21.101(a)(1).

Under standard practice, the effective

date of final special conditions would

be 30 days after the date of publication

in the Federal Register; however, as the

certification date for the Model 737–

600/–700/–800 airplanes is imminent,

the FAA finds that good cause exists to

make these special conditions effective

upon issuance.

Conclusion

This action affects only certain design

features on the Boeing Model 737–600/

–700/–800 airplanes. 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.

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

737–600/–700/–800 airplanes.

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
Federal Register / Vol. 62, No. 187 / Friday, September 26, 1997 / Rules and Regulations 50497

to perform critical functions are not

adversely affected when the airplane is

exposed to high intensity radiated

fields.

For the purpose of this special

condition, 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.

2. Engine Torque Loads. In lieu of

compliance with § 25.361(b),

compliance with the following must be

shown:

(b) For turbine engine installations,

the mounts and local supporting

structure must be designed to withstand

each of the following:

(1) The maximum torque load,

considered as limit, imposed by:

(i) sudden deceleration of the engine

due to a malfunction that could result

in a temporary loss of power or thrust

capability, and that could cause a

shutdown due to vibrations; and

(ii) the maximum acceleration of the

engine.

(2) The maximum torque load,

considered as ultimate, imposed by

sudden engine stoppage due to a

structural failure, including fan blade

failure.

(3) The load condition defined in

paragraph (b)(2) of this section is also

assumed to act on adjacent airframe

structure, such as the wing and fuselage.

This load condition is multiplied by a

factor of 1.25 to obtain ultimate loads

when the load is applied to the adjacent

wing and fuselage supporting structure.

Issued in Renton, Washington, on

September 17, 1997.

Vi L. Lipski,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–25509 Filed 9–25–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. 95N–0374]

RIN 0910–AA32

Latex Condoms; User Labeling;

Expiration Dating

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a final

rule that requires the labeling of latex

condoms to contain an expiration date

based upon physical and mechanical

testing performed after exposing the

product to varying conditions that age

latex. Studies show that latex condoms

degrade over time. Such degradation has

a significant effect on the product’s

ability to provide a barrier to sexually

transmitted diseases (STD’s), including

human immunodeficiency virus (HIV).

This requirement is established in order

to provide consumers with essential

information regarding the safe use of

these products.

EFFECTIVE DATE: March 25, 1998.

FOR FURTHER INFORMATION CONTACT:

Donald E. Marlowe, Center for Devices

and Radiological Health (HFZ–100),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–2444.

SUPPLEMENTARY INFORMATION:

I. Background

It is estimated that over 1 million

persons in the United States are infected

with HIV (Ref. 1). Although nonsexual

transmission can occur, HIV is

transmitted primarily through sexual

contact. With the prevalence of HIV

infection and the risk of transmission of

other STD’s, the importance of the

quality of an effective barrier to the

transmission of infection is crucial.

Because latex membranes, such as

condoms and medical gloves, are

effective barriers against the spread of

various diseases, including hepatitis,

HIV, and other STD’s (Refs. 2, 4, and 5),

the Centers for Disease Control and

Prevention and the Surgeon General of

the Public Health Service have

recommended that latex condoms be

used according to instructions with

every act of intercourse for maximum

protection against STD’s (Ref. 3). The effectiveness of latex condoms as

a barrier, however, is dependent upon

the integrity of the latex material.

Degradation of latex film products (e.g.,

the embrittlement of the latex film, an

increase in the porosity of the

membrane, or other loss of physical

properties) occurs when latex is

exposed to various types of

environmental conditions (such as

elevated temperature, fluorescent lights,

or ozone) normally experienced in

product use, shipment, or storage

conditions. Exposure to these

environmental conditions degrade the

film progressively over time and may

result in bursts, rips, tears, or seepages

that allow the transmission of disease.

To understand the effects of aging and

other storage conditions on latex

properties, the State of Washington’s

Board of Pharmacy initiated an FDAsponsored study of the material integrity

of latex condoms (the FDA/Washington

study) in July of 1989 (Ref. 6). At the

laboratories of the FDA/Washington

study, packaged and unpackaged latex

condoms were exposed to 20 and 30 °C

(representing room temperature) for up

to 5 years. In order to represent

exposure to the upper extreme of

environmental temperatures, condoms

were exposed for 100 days to a

temperature of 45 °C. Also, to accelerate

the aging process of the latex, condoms

were exposed to temperatures of 70 and

85 °C for up to 100 days (Refs. 7 through

9).

The study revealed that exposed

condoms (i.e., condoms not protected by

packaging) degraded to the point of

being unusable within 1 year at room

temperature, and at higher temperatures

in as little as 10 days. The FDA/

Washington study further shows that

latex condoms stored in intact plastic

packages also degrade over time, though

at a much slower rate. The results of the

FDA/Washington study demonstrate

that aging and other conditions can

significantly affect the integrity,

strength, and quality of latex essential to

maintaining a barrier against the

transmission of disease.

Based upon these findings, using

standards established by the American

Society for Testing and Materials

(ASTM), and following meetings with

condom manufacturers, the agency

published in the Federal Register of

May 24, 1996 (61 FR 26140), a proposed

rule that would require latex condoms

to be labeled with an expiration date.

Specifically, FDA proposed that, to

ensure visibility of the expiration date

by customers, an expiration date must

appear on the primary packaging (i.e.,

the individual package), as well as

higher levels of labeling, such as the

case containing individually packaged

products.

To establish the expiration date, FDA

proposed that a manufacturer, before

performing tests on products that

demonstrate physical and mechanical

integrity of the product, subject

products from three discrete and

random lots to each of the following

conditions: (1) Storage unpackaged for

the maximum amount of time the

manufacturer allows the product to

remain unpackaged after manufacture,

followed by storage of the packaged

product at 70 °C (plus or minus 2 °C)

for 7 days; (2) storage unpackaged for

the maximum amount of time the

manufacturer allows the product to

remain unpackaged after manufacture,

followed by storage of the packaged

product at 40 to 50 °C (plus or minus