38128 Federal Register / Vol. 63, No. 135 /Wednesday, July 15, 1998 / Proposed Rules

Issued in Kansas City, Missouri, on July 8,

1998.

Michael Gallagher,

Manager, Small Airplane Directorate, Aircraft

Certification Service.

[FR Doc. 98–18869 Filed 7–14–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

14 CFR Parts 234, 241, 250, 298, and

374a

[Docket No. OST–98–4043; Notice No. 98–

18]

RIN 2105–AC71

Aviation Data Requirements Review

and Modernization Program

AGENCY: Office of the Secretary, DOT.

ACTION: Advance notice of proposed

rulemaking.

SUMMARY: The Department on its own

initiative is requesting public comments

from reporting carriers and aviation data

users on the nature, scope, source, and

means for collecting, processing, and

distributing airline traffic, fare, and

financial data. Specifically, the

Department is inviting comments on

whether existing airline traffic, fare, and

financial data should be amended,

supplemented, or replaced; whether

selected forms and reports should be

retained, modified, or eliminated;

whether the Department should require

all aviation data to be filed

electronically; and how the aviation

data system should be reengineered to

enhance efficiency and to reduce costs

for both the Department and the airline

industry.

It is the Department’s preliminary

position that its current aviation data

systems may not provide sufficiently

reliable data in some areas to ensure

that the Department can fully meet its

regulatory and statutory responsibilities,

and that its aviation data requirements

should be reviewed and modernized.

The Department may engage one or

more contractors to assist it in its

aviation data requirements assessment

and in the reengineering of the

Department’s aviation data systems.

DATES: Comments must be submitted on

or before September 14, 1998. Reply

comments must be submitted on or

before October 13, 1998.

ADDRESSES: Comments are to be filed in

Room PL–401, Docket OST–98–4043,

U.S. Department of Transportation, 400

7th Street, S.W., Washington, D.C.

20590. Late filed comments will be

considered to the extent practical. To

facilitate consideration of comments,

each respondent should file six copies

of its comments.

FOR FURTHER INFORMATION CONTACT:

Regis P. Milan, Office of Aviation

Analysis, (202) 366–2344, or David B.

Richards, Office of International

Aviation, (202) 366–2432; 400 7th

Street, S.W., Washington, D.C. 20590.

SUPPLEMENTARY INFORMATION:

Background

Public Law 98–443 requires the

Department of Transportation, under the

authority of the Secretary of

Transportation (49 U.S.C. 329(b)(1)), to

collect and disseminate information on

civil aeronautics, other than that

collected and disseminated by the

National Transportation Safety Board. In

meeting this responsibility, the

Department collects traffic and financial

data submitted under 14 CFR Part 241

(Uniform System of Accounts for Large

Certificated Air Carriers) and traffic data

submitted under 14 CFR Part 298

(Exemptions for Air Taxi and Commuter

Air Carriers). The Department also

collects certain traffic data from foreign

air carriers for flights to or from the U.S.

under 14 CFR Part 217 and Section 25

of 14 CFR Part 241. The Department

collects service quality data from U.S.

carriers submitted under 14 CFR Part

234 (Airline Service Quality

Performance Reports), and under 14

CFR 250 it collects information on

passengers denied boarding. In addition,

under Part 374a, airlines are required to

report information on any extensions of

credit for air transportation services

provided to federal political candidates.

The Department uses these data in a

variety of ways, including monitoring

the fitness of individual carriers and the

economic health of the airline industry,

assessing the competitiveness of

aviation markets, providing consumers

with data to make decisions on air

travel, providing data for forecasting

traffic and for airport funding and traffic

control purposes, and providing the

basis for policy decisions on aviation

matters, including international aviation

negotiations.

The Department maintains two large

traffic data bases, one for domestic and

international passenger origindestination movements, including ticket

price and itinerary, which are submitted

by U.S. carriers only (Section 19–7 of

Part 241, the Passenger OriginDestination Survey), and another for

aircraft flight data submitted by U.S.

and foreign air carriers (Section 25 of

Part 241 and Part 217, the T–100 and T–

100(f) segment and on-flight market

reports).

The Department collects Form 41

data, which consist of comprehensive

financial and traffic data reported by

large and small air carriers. Form 41

also includes fuel cost and consumption

and aircraft fleet inventory data.

The Department requires air taxi and

commuter carriers to report limited

traffic and market data on Form 298C.

The Department also collects data on

oversales/denied boardings, air service

quality performance, and extensions of

credit by airlines to federal political

candidates.

The Department’s aviation databases

are used by a number of federal

departments and agencies, Congress,

state and local authorities, airlines,

airports, manufacturers, industry

associations, consultants, academics,

researchers, financial analysts,

investors, and the general public.

For the most part, the data collected

by the Department are based upon

regulatory requirements designed for an

economic environment that has evolved

significantly since enactment of the

Airline Deregulation Act in 1978. Many

changes in the airline industry have

taken place since these data reporting

systems were established. Nearly all

domestic air carriers now operate huband-spoke systems, have extensive

code-sharing and other marketing

agreements with other carriers, offer

frequent flyer programs, provide

ticketless travel, and use integrated

computer reservation systems. This

environment represents a marked

change from the linear, point-to-point

systems in place 20 years ago, when the

domestic airline industry was

deregulated. Internationally, the last few

years have seen the development of

global, multi-national carrier alliances

and an increasing number of open-skies

and liberalized-entry agreements with

other nations.

Along with these changes, the needs

of the Department and other aviation

data users have evolved and expanded,

while the collected data and associated

processing systems have changed

slowly. However, the Department has

significantly reduced the reporting

burden on the industry by eliminating

some Form 41 schedules and line items

over the last 20 years. Nonetheless, the

Department intends to reexamine

whether all data items that we now

collect remain relevant to today’s

economic and regulatory environment.

Request for Comments

We are issuing this advance notice of

proposed rulemaking to invite

comments on whether traffic, fare, and
Federal Register / Vol. 63, No. 135 /Wednesday, July 15, 1998 / Proposed Rules 38129

financial data reporting systems should

be retained, amended, supplemented, or

replaced; whether other selected forms

and reports which are less utilized by

the Department and other government

users should be retained, compressed,

or deleted; and finally, whether the

Department should require all data to be

filed by electronic communication

means (e.g., Internet, direct-wire) or on

magnetic media (e.g., tape, disk,

cassette).

The Department now collects data

from over 400 U.S. and foreign airlines

for certain data collections. These data

must be processed, validated, and

edited. We are seeking comments on

alternative data and collection methods

to address deficiencies in the structure

of these data systems.

We request comments on whether

there are alternate, more reliable sources

of these data, and whether changes to

data items may make these data more

useful.

Note: We welcome comments on all

aspects of our data systems. However, for

identification, reference, and administrative

convenience, we have specifically numbered

particular requests for comments by section,

with an identification number placed after

each request. Please use these identifiers in

your response.

A. The T–100 System—Report of Traffic,

Capacity, and Statistics

This database provides airport pair

traffic and capacity data by non-stop

segment by aircraft type and on-flight

market. Schedule T–100 reports are

filed by all large certificated air carriers,

where large certificated air carriers are

defined as those that conduct operations

using ‘‘large’’ aircraft (aircraft with more

than 60 seats or 18,000 pounds of

payload capacity, 14 CFR Parts 217.3

and 241.25). However, carriers

conducting only domestic charter or allcargo operations are not required to file

Schedule T–100, with the exception of

intra-Alaska cargo operations (Part 241,

Section 19–1(a)). The T–100 system

does not require U.S. and foreign

carriers who exclusively operate aircraft

with 60 or fewer seats to report T–100

data. Foreign air carriers serving the

U.S. generally have the same reporting

requirements as U.S. carriers, except

that they instead file Schedule T–100(f).

The Department last year reviewed its

Schedule T–100 and T–100(f) traffic

data systems and determined that the

data-confidentiality restrictions for

international service should be

shortened to no earlier than six months

after the submission date for the data;

reporting of available seats and payload

weight should be added to the reporting

requirements for foreign carriers, similar

to that required for U.S. carriers; and the

requirement to report passenger data by

cabin configuration should be

eliminated (62 FR 6715–6719, February

13, 1997).

We request that respondents provide

specific comments on the following

matters:

[A–1] Is there a continuing need to

collect T–100/T–100(f) data? Explain

the usefulness of these data in satisfying

your requirements.

[A–2] Is there a way to modify or

restructure T–100/T–100(f) data to make

them more functional?

[A3] Are there alternate sources of

and/or more efficient modes for delivery

of these data to the Department?

[A–4] Should the Department

require T–100/T–100(f) data from

carriers who exclusively operate aircraft

with fewer than 60 seats?

[A–5] Should the Department

require T–100 data from domestic allcargo carriers?

[A–6] If yes to A–4 and/or A–5, what

criteria should be used in setting the

data reporting threshold (e.g., aircraft

size, air carrier operations, annual

operating revenues, revenue passenger

enplanements, number of flights, some

combination of these specified criteria,

or other unspecified criteria)?

[A–7] Are there alternate sources of

comparable data available for smaller

carriers or domestic all-cargo carriers?

[A–8] Should the Department amend

T–100 and T–100(f) to require that

international data include summary

citizenship data (e.g., U.S. or non-U.S.)?

B. The Origin and Destination Survey of

Airline Passenger Traffic

The O&D Survey (Survey) provides

U.S. air carrier traffic using a ten

percent sample of ticketed passengers.

These data are reported for the

scheduled operations only of large U.S.

carriers, except where certain foreign

carriers provide data similar to those

required of U.S. carriers as a condition

for approval of, and antitrust immunity

for, carrier alliances (See e.g., Order 96–

11–1, November 1, 1996). U.S. carriers

who exclusively operate aircraft with 60

or fewer seats do not report Survey data

for their operations and such data are

included in the Survey only if

incidentally reported as part of an

itinerary reported by a large carrier.

The Survey was originally designed in

the early 1960s, with fare data (from the

ticket) added in 1979. As with other

regulatory reporting requirements, time

and technology have rendered this data

collection methodology virtually

obsolete. Nearly all carriers now rely on

computer reservation systems for

reservation/ticketing procedures, and a

significant and growing percentage of

passengers are traveling using

‘‘ticketless or electronic’’ procedures.

Carrier use of the physical ticket for

revenue accounting and control

purposes is rapidly declining.

The processing of the current Survey

data is costly both for the reporting

carriers and the Department. Moreover,

the Department’s quarterly release of the

domestic Survey data has been

unacceptably delayed because of

significant carrier submission errors and

omissions. While imposing economic

sanctions for filing such poor quality

data may improve their accuracy and

timeliness, the fundamental problem is

that this O&D Survey data system is

hampered by outmoded and inefficient

transmission, collection, and processing

procedures that rely extensively on

paper tickets.

[B–1] Is there a continuing need to

collect O&D data? Explain the

usefulness of these data in satisfying

your requirements.

[B–2] Is there a way to modify or

restructure O&D data to make them

more functional?

[B–3] Are there alternate sources of

and/or more efficient modes for delivery

of these data to the Department?

[B–4] Should the Department

require O&D data from carriers who

exclusively operate aircraft with fewer

than 60 seats?

[B–5] If yes to B–4, what criteria

should be used in setting the data

reporting threshold (e.g., aircraft size,

air carrier operations, annual operating

revenues, revenue passenger

enplanements, number of flights, some

combination of these specified criteria,

or other unspecified criteria)?

[B–6] Should O&D data be collected

for U.S. domestic services and

international services of U.S. air carriers

only, as is the procedure under the

current Survey, or should foreign air

carrier international O&D data,

involving a U.S. point in the flight

itinerary, be required and processed in

the Survey?

[B–7] If it is determined that foreign

air carrier international O&D data

should be required and processed in the

Survey, should those carriers be

required to submit information on the

full flight itineraries or only on those

flight segments to/from the U.S., or

some combination thereof?

[B–8] Should there be

confidentiality restrictions imposed for

access to international data included in

the Survey, and if so, what should be

the degree and duration of such access

restrictions?
38130 Federal Register / Vol. 63, No. 135 /Wednesday, July 15, 1998 / Proposed Rules

[B–9] What should be the time-frame

for submission to the Department—

weekly, monthly, or quarterly?

Other Automated Sources of O&D Data

The Department wishes to consider

whether there are alternatives to the

current ticket-based O&D System,

especially ones that could be based on

existing internal automated data

systems maintained by airlines and/or

computer reservation systems (CRSs).

As an example, there is a CRS-based

data file called the Transaction Control

Number (TCN) files. In the process of

ticketing airline passengers, airlines and

related computer reservation systems

electronically record the majority of

transactions in the standard TCN

formats for various accounting,

reconciliation, and seat inventory

control purposes. Under a current

industry data interchange program,

many airlines and CRSs routinely

exchange the TCN data through the

Airline Tariff Publishing Company

(ATPCO) electronically on a daily basis.

The Department believes that these TCN

data could provide an alternative, less

expensive source of traffic and fare data.

We request that respondents provide

specific comments on the following

matters:

[B–10] List and describe alternative

data sources, such as TCN, that could

provide the types of comprehensive

passenger O&D itinerary and fare data

we are seeking, and the potential

advantages and disadvantages of each

source.

[B–11] If the Department decides to

use TCN or alternative data as the basis

of a new O&D Survey, should carriers

continue to submit data independently

to the Department, or should such data

be submitted via a common exchange

(such as a CRS or common exchange

point like ATPCO)?

[B–12] Under a new system, should

the replacement O&D data be submitted

for ticketed or booked passengers only,

or should such data be held until

reconciliation, e.g. until the reservation

is actually used (as evidenced by a

coupon lifted at the time of flight) or is

canceled?

[B–13] What are carriers’ best cost

estimates for the submission of domestic

and international TCN data to the

Department via CRS or ATPCO?

[B–14] What are carriers’ best cost

estimates for the submission of data

from other potential sources?

[B–15] What are the best cost

estimates of carriers who do not use

CRS services or ATPCO for

reconciliation or control purposes to file

independent submissions of this type of

data to the Department directly or via an

intermediary?

C. Form 41, Uniform System of

Accounts and Reports of Financial and

Operating Statistics for Large

Certificated Air Carriers

This database provides U.S. air carrier

financial data, predicated on a uniform

system of accounts, and selected traffic

statistics, generally termed the Form 41

schedules. A list of such schedules is

shown in 14 CFR Part 241, Section 22.

These schedules include the balance

sheet, profit and loss statement, various

operating expense schedules, and

summary traffic and capacity schedules.

We request that respondents provide

specific comments on the following

matters:

[C–1] Is there a continuing need to

collect Form 41 data? Explain the

usefulness of these data in satisfying

your requirements.

[C–2] Is there a way to modify

restructure Form 41 data to make them

more functional?

[C–3] Are there alternate sources of

and/or more efficient modes for delivery

of these data to the Department?

D. Commuter, Part 298, Exemptions for

Air Taxi and Commuter Air Carrier

Operations

This rule provides air taxi and

commuter air carriers certain

exemptions from traffic and financial

data reporting required of large

certificated air carriers. However, less

detailed reporting schedules (Form 298–

C) are required, including, for example,

the full reporting of on-line origindestination passengers instead of the

Department’s standard O&D Survey,

expense reporting by general category,

rather than by detailed sub-account, and

simplified quarterly reporting of traffic

rather than the monthly T–100

schedule.

We request that respondents provide

specific comments on the following

matters:

[D–1] Is there a continuing need to

collect Form 298–C data? Explain the

usefulness of these data in satisfying

your requirements.

[D–2] Is there a way to modify or

restructure Form 298–C data to make

them more functional?

[D–3] Are there alternate sources of

and/or more efficient modes for delivery

of these data to the Department?

[D–4] Should the Department retain,

modify, or eliminate the 60-seat

exemption under Part 298?

[D–5] Air taxi and commuter carriers

are asked to indicate their use of

computer reservation systems, with

specific attention to the possible use of

TCN data derived from CRS records to

replace the Survey.

E. Part 234, Airline Service Quality

Performance Reports

These data are collected from air

carriers accounting for at least one

percent of domestic scheduled

passenger revenues. This monthly

report includes flight delays, on-time

flight performance, enplaned

passengers, and the number of

mishandled-baggage reports filed with

air carriers.

We request that respondents provide

specific comments on the following

matters:

[E–1] Is there a continuing need to

collect Part 234 data? Explain the

usefulness of these data in satisfying

your requirements.

[E–2] Is there a way to modify Part

234 data to make them more functional?

[E–3] Are there alternate sources of

and/or more efficient modes for delivery

of these data to the Department?

F. Part 250, Oversales, requires that

U.S. and foreign air carriers report

various data on the number of

passengers that are denied boarding,

and the total number of boardings, each

quarter. Our reporting requirements

were last reviewed in 1995.

We request that respondents provide

specific comments on the following

matters:

[F–1] Is there a continuing need to

collect Part 250 data? Explain the

usefulness of these data in satisfying

your requirements.

[F–2] Is there a way to modify Part

250 data to make them more functional?

[F–3] Are there alternate sources of

and/or more efficient modes for delivery

of these data to the Department?

G. Part 374a, Extension of Credit by

Airlines to Federal Political Candidates,

requires air carriers to make monthly

reports with respect to credit for

transportation furnished to political

candidates, or persons acting on behalf

of candidates, during the period from

six months before nomination or

election, until the date of election.

Continuing reports are to be made until

a filing indicates that no debt is owed

the carrier.

We request that respondents provide

specific comments on the following

matters:

[G–1] Is there a continuing need to

collect Part 374a reports? Explain the

usefulness of these data in satisfying

your requirements.

[G–2] Is there a way to modify or

restructure Part 374a reports to make

them more functional?

[G–3] Are there alternate sources of

and/or superior submission techniques

for these reports?
Federal Register / Vol. 63, No. 135 /Wednesday, July 15, 1998 / Proposed Rules 38131

H. Electronic Filing of Data

The Department currently accepts

data submissions either in paper form or

on magnetic disk or tape. Most large

carriers submit the bulk of their data on

magnetic media, with large data

submissions, such as the Passenger

Origin-Destination Survey and T–100

market reports nearly universally

submitted on tape or cassette. Electronic

submission of data can be processed

more quickly, and at lower cost, than

similar data submitted in paper form.

The Department now accepts the

official filing of international fare and

fare rules tariffs electronically (See 14

CFR Part 221 and 61 FR 18070–18075,

April 24, 1996). Given the Department’s

limited resources, it would be

impossible to process the volume of

tariff data received if these data were

filed in a wholly paper environment.

Similarly, the Department is

increasingly burdened by the filing of

required financial and traffic data in

paper form.

We request that respondents provide

specific comments on the following

matters:

[H–1] All air carriers who supply

aviation data to the Department are

requested to comment on their ability to

file data electronically or on magnetic

media, i.e., via tape or disk, or over the

Internet.

[H–2] If certain large database

material now accepted by the

Department in electronic form (e.g., the

T–100/T–100(f), Origin-Destination

Survey, and 298–C reports) are

submitted on paper, relevant carrier

respondents are requested to indicate

why magnetic media are not employed

for their submissions.

Contact Persons

We recognize that formal comments

submitted to the Department on

rulemaking matters are usually

submitted by corporate counsel.

However, we are seeking comments

regarding complex technical issues in

anticipation of a formal rulemaking, in

areas which are generally outside the

area of expertise of legal counsel. It

would aid in our evaluation of any

technical comments to be able to contact

persons with direct knowledge of

technical issues being commented upon.

Respondents are urged to supply the

names, telephone numbers, and

addresses of knowledgeable individuals

who can be contacted for a more

detailed discussion of any technical

matters that the respondent counsel

cannot answer directly. There may be

multiple contact persons for any

particular item, or in total. These

contact persons should be listed on the

last page of any submitted filing, along

with their area(s) of expertise.

Regulatory Process Matters

Executive Orders 12612 and 12866

The Department has determined that

the proposed notice of proposed

rulemaking is not a significant

regulatory action under Executive Order

12866. However, the proposed rule may

be significant under the Department’s

Regulatory Policies and Procedures (44

CFR 11304), because of substantial

industry interest and because it may

result in a reduction in paperwork and

filing burden for U.S. carriers. The

Department has also analyzed the

proposal in accordance with the

principles and criteria contained in

Executive Order 12612 (‘‘Federalism’’),

and has determined that the rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment. This rule

would not impose unfunded mandates

as defined by the Unfunded Mandates

Reform Act of 1995.

Regulatory Flexibility Act

The Regulatory Flexibility Act of

1980, 5 U.S.C. 601 et seq., was enacted

by Congress to ensure that small entities

are not unnecessarily and

disproportionately burdened by

government regulations. The Act

requires agencies to review proposed

regulations that may have a significant

economic impact on a substantial

number of small entities. For purposes

of this notice, small entities include air

taxis, commuter air carriers, and smaller

U.S. and foreign airlines.

Although we do not believe the

existing rule imposes a significant

economic impact on a substantial

number of small entities, it does affect

many small entities. For that reason, we

specifically seek public comment on

what steps we can take to lessen or

eliminate any burdens it imposes on

small entities.

Paperwork Reduction Act

Our current rules contain significant

collection-of-information requirements.

Changes we may propose will be subject

to the Paperwork Reduction Act, Public

Law No. 96–411, 44 U.S.C. Chapter 35.

The revised rules are expected to result

in a net paperwork reduction for the

industry.

Regulation Identifier Number

A regulation identifier number (RIN)

is assigned to each regulatory action

listed in the Unified Agenda of Federal

Regulations. The Regulatory Information

Service Center publishes the Unified

Agenda in April and October of each

year. The RIN number contained in the

heading of this document can be used

to cross reference this action with the

Unified Agenda.

Patrick V. Murphy,

Deputy Assistant Secretary for Aviation

International Affairs.

Robert A. Knisely,

Acting Director, Bureau of Transportation

Statistics.

[FR Doc. 98–18855 Filed 7–14–98; 8:45 am]

BILLING CODE 4910–62–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 812

[Docket No. 98N–0394]

RIN 0910–ZA14

Medical Devices; Investigational

Device Exemptions

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend the Investigational Device

Exemptions (IDE) regulation. The

proposed regulatory changes are

intended to reflect amendments to the

Federal Food, Drug, and Cosmetic Act

(the act) by the FDA Modernization Act

of 1997 (FDAMA). These amendments

provide that the sponsor of an IDE may

modify the device and/or clinical

protocol, without approval of a new

application or supplemental

application, if the modifications meet

certain criteria and if notice is provided

to FDA within 5 days of making the

change. The proposed rule also defines

the credible information to be used by

sponsors to determine if the criteria are

met.

DATES: Submit written comments on or

before September 28, 1998. Written

comments on the information collection

provisions should be submitted by

August 14, 1998.

ADDRESSES: Submit written comments

on the proposed rule to the Documents

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Submit written comments on the

information collection requirements to

the Office of Information and Regulatory

Affairs, OMB, New Executive Office

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

Washington, DC 20503, Attn: Desk

Officer for FDA.