174 Federal Register / Vol. 63, No. 2 / Monday, January 5, 1998 / Proposed Rules

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:

De Havilland Inc.: Docket 97-NM–

269-AD.

Applicability: Model DHC–8–100 series

airplanes; serial numbers 191, and 225

through 307 inclusive; certificated in any

category.

Note 1: This AD applies to each airplane

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

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 (b) 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 smoke contamination in the

passenger and crew cabins, in the event of

fire or smoke in the baggage compartment,

due to a direct smoke path between the

baggage compartment and the cabins,

accomplish the following:

(a) Within 4 months after the effective date

of this AD, perform a one-time visual

inspection to determine the presence of block

seals on the upper portions of the right-and

left-hand cabin/baggage compartment

bulkheads; and, prior to further flight, for any

missing block seal, install a new or

serviceable block seal; in accordance with de

Havilland Service Bulletin S.B. 8–25–80,

Revision ‘A,’ dated July 5, 1993.

(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, New York

Aircraft Certification Office (ACO), FAA,

Engine and Propeller Directorate. Operators

shall submit their requests through an

appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, New York ACO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the New York ACO.

(c) Special flight permits may be issued in

accordance with sections 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.

Note 3: The subject of this AD is addressed

in Canadian airworthiness directive

CF–92–16, dated June 26, 1992.

Issued in Renton, Washington, on

December 29, 1997.

Darrell M. Pederson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–116 Filed 1–2–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 97–NM–105–AD]

RIN 2120–AA64

Airworthiness Directives; McDonnell

Douglas Model DC–9, DC–9–80, and C–

9 (Military) Series Airplanes, and Model

MD–88 Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This document proposes the

supersedure of an existing airworthiness

directive (AD), applicable to certain

McDonnell Douglas Model DC–9, DC–9–

80, and C–9 (military) series airplanes,

and Model MD–88 airplanes, that

currently requires an inspection to

detect chafing on the FIREX pipe

assembly of the number one engine; and

either repair of chafed pipe assemblies

or replacement of the chafed pipe

assemblies with new pipe assemblies;

and modification of the FIREX and the

pneumatic sense pipe assembly clamp

marriage. That AD was prompted by

reports of incidents in which the

pneumatic sense pipe chafed against the

FIREX supply pipe of the number one

engine. This action would revise the

applicability of the existing AD to

include additional airplanes and remove

others. The actions specified by the

proposed AD are intended to prevent

chafing of the FIREX supply pipe,

which could result in a hole in the pipe

and consequently prevent the proper

distribution of the fire extinguishing

agent within the nacelle in the event of

a fire.

DATES: Comments must be received by

February 19, 1998.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Transport

Airplane Directorate, ANM–114,

Attention: Rules Docket No. 97–NM–

105–AD, 1601 Lind Avenue, SW.,

Renton, Washington 98055–4056.

Comments may be inspected at this

location between 9:00 a.m. and 3:00

p.m., Monday through Friday, except

Federal holidays.

The service information referenced in

the proposed rule may be obtained from

The Boeing Company, Douglas Products

Division, 3855 Lakewood Boulevard,

Long Beach, California 90846,

Attention: Technical Publications

Business Administration, Dept. C1–L51

(2–60). This information may be

examined at the FAA, Transport

Airplane Directorate, 1601 Lind

Avenue, SW., Renton, Washington; or at

the FAA, Transport Airplane

Directorate, Los Angeles Aircraft

Certification Office, 3960 Paramount

Boulevard, Lakewood, California.

FOR FURTHER INFORMATION CONTACT:

Robert Baitoo, Aerospace Engineer,

Propulsion Branch, ANM–140L, FAA,

Los Angeles Aircraft Certification

Office, 3960 Paramount Boulevard,

Lakewood, California 90712; telephone

(562) 627–5245; fax (562) 627–5210.

SUPPLEMENTARY INFORMATION:

Comments Invited

Interested persons are invited to

participate in the making of the

proposed rule by submitting such

written data, views, or arguments as

they may desire. Communications shall

identify the Rules Docket number and

be submitted in triplicate to the address

specified above. All communications

received on or before the closing date

for comments, specified above, will be

considered before taking action on the

proposed rule. The proposals contained

in this notice may be changed in light

of the comments received.

Comments are specifically invited on

the overall regulatory, economic,

environmental, and energy aspects of

the proposed 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

summarizing each FAA-public contact

concerned with the substance of this

proposal will be filed in the Rules

Docket.

Commenters wishing the FAA to

acknowledge receipt of their comments

submitted in response to this notice

must submit a self-addressed, stamped

postcard on which the following

statement is made: ‘‘Comments to

Docket Number 97–NM–105–AD.’’ The

postcard will be date stamped and

returned to the commenter.

Availability of NPRMs

Any person may obtain a copy of this

NPRM by submitting a request to the

FAA, Transport Airplane Directorate,

ANM–114, Attention: Rules Docket No.

97–NM–105–AD, 1601 Lind Avenue,

SW., Renton, Washington 98055–4056.
Federal Register / Vol. 63, No. 2 / Monday, January 5, 1998 / Proposed Rules 175

Discussion

On June 9, 1995, the FAA issued AD

95–12–25, amendment 39–9278 (60 FR

32579, June 23, 1995), applicable to

certain McDonnell Douglas Model DC–

9, DC–9–80, and C–9 (military) series

airplanes, and Model MD–88 airplanes,

to require an inspection to detect

chafing on the FIREX pipe assembly of

the number one engine; and either

repair of chafed pipe assemblies or

replacement of the chafed pipe

assemblies with new pipe assemblies;

and modification of the FIREX and the

pneumatic sense pipe assembly clamp

marriage. That action was prompted by

reports of incidents in which the

pneumatic sense pipe chafed against the

FIREX supply pipe of the number one

engine. The requirements of that AD are

intended to prevent chafing of the

FIREX supply pipe, which could result

in a hole in the pipe and consequently

prevent the proper distribution of the

fire extinguishing agent within the

nacelle in the event of a fire.

Actions Since Issuance of Previous Rule

Since the issuance of that AD, the

FAA has reviewed and approved

McDonnell Douglas DC–9 Service

Bulletin 26–25, dated May 25, 1994;

McDonnell Douglas Service Bulletin

DC9–26–025, Revision 03, dated July 25,

1996; and McDonnell Douglas Service

Bulletin DC9–26–025, Revision 04,

dated April 30, 1997. The inspection

procedures described in the original

version, Revision 03, and Revision 04

are identical to those described in

Revision 1 and Revision 2 of the service

bulletin (which were referenced in AD

95–12–25 as the appropriate sources of

service information). Revision 04 of the

service bulletin expands the effectivity

listing to include additional airplanes

that are subject to the addressed unsafe

condition and removes other airplanes

from the effectivity listing.

Explanation of Requirements of

Proposed Rule

Since an unsafe condition has been

identified that is likely to exist or

develop on other products of this same

type design, the proposed AD would

supersede AD 95–12–25 to continue to

require an inspection to detect chafing

on the FIREX pipe assembly of the

number one engine; and either repair of

chafed pipe assemblies or replacement

of the chafed pipe assemblies with new

pipe assemblies; and modification of the

FIREX and the pneumatic sense pipe

assembly clamp marriage. The proposed

AD would revise the applicability of the

existing AD to include additional

airplanes and remove others. The

actions would be required to be

accomplished in accordance with the

service bulletin described previously.

Cost Impact

There are approximately 1,691

McDonnell Douglas Model DC–9, DC–9–

80, and C–9 (military) series airplanes,

and Model MD–88 airplanes of the

affected design in the worldwide fleet.

The FAA estimates that 834 airplanes of

U.S. registry would be affected by this

proposed AD.

The actions that are currently

required by AD 95–12–25, and retained

in this proposed AD, take approximately

1 work hour per airplane to accomplish,

at an average labor rate of $60 per work

hour. The cost of required parts will be

nominal. Based on these figures, the

cost impact of the currently required

actions on U.S. operators is estimated to

be $50,040, or $60 per airplane.

The cost impact figure discussed

above is based on assumptions that no

operator has yet accomplished any of

the current or proposed requirements of

this AD action, and that no operator

would accomplish those actions in the

future if this AD were not adopted.

Regulatory Impact

The regulations proposed herein

would 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

proposal would not have sufficient

federalism implications to warrant the

preparation of a Federalism Assessment.

For the reasons discussed above, I

certify that this proposed regulation (1)

is not a ‘‘significant regulatory action’’

under Executive Order 12866; (2) is not

a ‘‘significant rule’’ under the DOT

Regulatory Policies and Procedures (44

FR 11034, February 26, 1979); and (3) if

promulgated, 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 copy of the draft

regulatory evaluation prepared for this

action is contained in the Rules Docket.

A copy of it may be obtained by

contacting 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.

The Proposed Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration proposes to amend 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

removing amendment 39–9278 (60 FR

32579, June 23, 1995), and by adding a

new airworthiness directive (AD), to

read as follows:

McDonnell Douglas: Docket 97–NM–105–

AD. Supersedes AD 95–12–25,

Amendment 39–9278.

Applicability: Model DC–9–30, -40, and -50

series airplanes; Model DC–9–81 (MD–81),

DC–9–82 (MD–82), DC–9–83 (MD–83), and

DC–9–87 (MD–87) series airplanes; Model

MD–88 airplanes; and C–9 (military) series

airplanes; as listed in McDonnell Douglas

Service Bulletin DC9–26–025, Revision 04,

dated April 30, 1997; certificated in any

category.

Note 1: This AD applies to each airplane

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

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 (b) 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 chafing of the FIREX supply

pipe, which could result in a hole in the pipe

and consequently prevent the proper

distribution of the fire extinguishing agent

within the nacelle in the event of a fire,

accomplish the following:

(a) Within 8 months after the effective date

of this AD, perform an inspection to detect

chafing of the FIREX pipe assembly of the

number one engine, in accordance with

McDonnell Douglas DC–9 Service Bulletin

26–25, dated May 25, 1994; McDonnell

Douglas DC–9 Service Bulletin 26–25,

Revision 1, dated September 30, 1994;

McDonnell Douglas DC–9 Service Bulletin

26–25, Revision 2, dated April 18, 1995;

McDonnell Douglas Service Bulletin DC9–

26–025, Revision 03, dated July 25, 1996; or

McDonnell Douglas Service Bulletin DC9–

26–025, Revision 04, dated April 30, 1997.

(1) If any chafing is detected, prior to

further flight, accomplish paragraphs (a)(1)(i)
176 Federal Register / Vol. 63, No. 2 / Monday, January 5, 1998 / Proposed Rules

and (a)(1)(ii) of this AD in accordance with

the service bulletin. Where there are

differences between the requirements of this

AD and the procedures specified in the

service bulletin, the AD prevails.

(i) Either repair chafed pipe assemblies or

replace chafed pipe assemblies with new or

serviceable pipe assemblies. And

(ii) Modify the FIREX and the pneumatic

sense pipe assembly clamp marriage.

(2) If no chafing is detected, prior to further

flight, modify the FIREX and the pneumatic

sense pipe assembly clamp marriage in

accordance with the service bulletin.

(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, Los

Angeles Aircraft Certification Office (ACO),

FAA, Transport Airplane Directorate.

Operators shall submit their requests through

an appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, Los Angeles ACO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Los Angeles ACO.

(c) Special flight permits may be issued in

accordance with sections 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.

Issued in Renton, Washington, on

December 29, 1997.

Darrell M. Pederson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–124 Filed 1–2–98; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket No. 90N–0056]

Aluminum in Large and Small Volume

Parenterals Used in Total Parenteral

Nutrition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its regulations to add certain

labeling requirements concerning

aluminum in large volume parenterals

(LVP’s) and small volume parenterals

(SVP’s) used in total parenteral nutrition

(TPN). FDA is also proposing to specify

an upper limit of aluminum permitted

in LVP’s and to require applicants to

develop and to submit to FDA for

approval validated assay methods for

determining aluminum content in

parenteral drug products. The agency is

proposing these requirements because of

evidence linking the use of parenteral

drug products containing aluminum to

morbidity and mortality among patients

on TPN therapy, especially premature

infants and patients with impaired

kidney function.

DATES: Submit written comments by

April 6, 1998. Submit written comments

on the information collection

requirements by February 4, 1998.

ADDRESSES: Submit written comments

on this proposed rule to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Submit written comments on the

information collection requirements to

the Office of Information and Regulatory

Affairs, Office of Management and

Budget (OMB), New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, ATTN: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Leanne Cusumano, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Background

Aluminum in ionic form is naturally

present in all plant and animal tissues

and in natural bodies of water, although

it has no known biological function.

Human exposure to aluminum also

occurs through aluminum-containing

medications, aluminum cans and

cooking utensils, drinking water, baking

powder, and deodorants (Ref. 1).

Aluminum is found in public water

supplies treated with various clarifiers

and in food and drink, including infant

formulas (Refs. 2, 3, and 4).

Aluminum is commonly found in dye

lakes (coloring agents) and sometimes

found as an excipient in certain drug

products. It is usually found in

parenteral drugs as a contaminant in the

protein source, calcium and phosphate

salts, albumin, and heparin (Refs. 5 and

6). Aluminum also leaches from glass

containers and closures during

autoclaving and storage.

Changes in the processing and

screening of raw materials may reduce

aluminum contamination of drug

products. Aluminum toxicity in adults

has been reduced by replacing casein

hydrolysate with crystalline amino

acids in TPN solutions (Ref. 7). In

addition, the use of deionized water in

dialysis and the substitution of calcium

for aluminum-containing oral phosphate

binders have reduced dialysis

osteomalacia and encephalopathy.

FDA has become increasingly

concerned about the aluminum content

in parenteral drug products, which

could result in a toxic accumulation of

aluminum in the tissues of individuals

receiving TPN therapy. Research

indicates that neonates and patient

populations with impaired kidney

function may be at high risk of exposure

to unsafe amounts of aluminum (Refs. 2,

5, 6, and 8 through 13). Studies show

that aluminum may accumulate in the

bone, urine, and plasma of infants

receiving TPN (Refs. 5, 8, and 9). Many

drug products used routinely in

parenteral therapy may contain levels of

aluminum sufficiently high to cause

clinical manifestations. Generally, when

medication and nutrition are

administered orally, the gastrointestinal

tract acts as an efficient barrier to the

absorption of aluminum, and relatively

little ingested aluminum actually

reaches body tissues. However,

parenterally administered drug products

containing aluminum bypass the

protective mechanism of the

gastrointestinal tract and aluminum

circulates and is deposited in human

tissues (Refs. 1, 3, 14, and 15).

Aluminum toxicity is difficult to

identify in infants because few reliable

techniques are available to evaluate

bone metabolism in premature infants.

Techniques used to evaluate the effects

of aluminum on bone in adults cannot

be used in premature infants. Although

aluminum toxicity is not commonly

detected clinically, it can be serious in

selected patient populations, such as

neonates, and may be more common

than is recognized. One study indicated

that premature infants who received

parenteral therapy had higher than

normal plasma and urinary aluminum

concentrations. The study also indicated

that aluminum concentration in bone

marrow was 10 times higher in infants

who had received at least 3 weeks of

parenteral therapy than in those who

had received limited parenteral therapy:

20.16±13.4 milligrams (mg) versus

1.98±1.44 mg per kilogram (kg) of dry

weight (p < 0.0001) (Ref. 2).

Furthermore, there has been at least one

credible report of measurable aluminum

in the brain of a premature infant (Ref.

16).

Classic manifestations of aluminum

intoxication in patients with impaired

kidney function include fracturing

osteomalacia, encephalopathy, and

microcytic hypochromic anemia.

Aluminum may prevent calcium

absorption in premature infants

receiving TPN therapy (Ref. 9). In

addition, aluminum loading may be a