23632 Federal Register / Vol. 66, No. 90 / Wednesday, May 9, 2001 / Proposed Rules

6. Section 104.14 would be amended

by revising paragraph (a) to read as

follows:

§ 104.14 Formal requirements regarding

reports and statements.

(a) Each individual having the

responsibility to file a designation,

report or statement required under this

subchapter shall sign the original

designation, report or statement except

that:

(1) Reports or statements of

independent expenditures filed by

facsimile machine or electronic mail

under 11 CFR 104.4(b) or 11 CFR 109.2

must be verified in accordance with

those sections; and

(2) Reports, designations, or

statements filed electronically under 11

CFR 104.18 must follow the signature

requirements of 11 CFR 104.18(g).

* * * * *

7. Section 104.18 would be amended

by revising paragraph (h) to read as

follows:

§ 104.18 Electronic filing of reports (2

U.S.C. 432(d) and 434(a)(11)).

* * * * *

(h) Schedules and forms with special

requirements. (1) The following are

schedules and forms that require the

filing of additional documents and that

have special signature requirements:

(i) Schedules C–1 and C–P–1, Loans

and Lines of Credit From Lending

Institutions (see 11 CFR 104.3(d)); and

(ii) Form 8, Debt Settlement Plan (see

11 CFR 116.7(e)).

(2) If a person files a report

electronically by submitting a diskette

to the Commission and is required to

file any of the schedules or forms listed

in paragraph (h)(1) of this section, the

person shall file a paper copy of the

required schedule or form with the

electronic submission, or a digitized

version as a separate file in the

electronic submission, by the close of

business on the prescribed filing date.

(3) If a person files a report

electronically by uploading the data to

the Commission’s electronic filing

system and is required to file any

schedules or forms listed in paragraph

(h)(1) of this section, the person shall

file a paper copy or a digitized version

of the required schedule or form by the

close of business on the prescribed

filing date.

* * * * *

PART 109—INDEPENDENT

EXPENDITURES (2 U.S.C. 431(17),

434(c))

8. The authority citation for part 109

would continue to read as follows:

Authority: 2 U.S.C. 431(17), 434(a)(11) and

(c), 438(a)(8), and 441d.

9. Section 109.1 would be amended

by adding new paragraph (f) to read as

follows:

§ 109.1 Definitions (2 U.S.C. 431(17)).

* * * * *

(f) An independent expenditure is

made on the earliest of—

(1) The date on which a written

contract, including a media contract,

promise or agreement to make an

independent expenditure is executed;

(2) The first date on which the

communication is printed, broadcast or

otherwise publicly disseminated; or

(3) The date on which the person

making the independent expenditure

pays for it.

10. Section 109.2 would be amended

by revising the introductory text in

paragraphs (a) and (a)(1) by revising

paragraphs (a)(1)(v), (a)(2), and (b) by

redesignating paragraph (a)(1)(vi) as

paragraph (a)(1)(vii) and adding new

paragraphs (a)(1)(vi) and (c) to read as

follows:

§ 109.2 Reporting of independent

expenditures by persons other than a

political committee (2 U.S.C. 434(c)).

(a) Every person other than a political

committee, who makes independent

expenditures aggregating in excess of

$250 in a calendar year shall file a

verified statement or report on FEC

Form 5 with the Commission or

Secretary of the Senate in accordance

with 11 CFR 104.4(c).

(1) If a verified statement is

submitted, the statement shall include:

* * * * *

(v) A verified certification under

penalty of perjury as to whether such

expenditure was made in cooperation,

consultation or concert with, or at the

request or suggestion of any candidate

or any authorized committee or agent

thereof;

(vi) A verified certification under

penalty of perjury as to whether the

expenditure involved the financing,

dissemination, distribution or

republication of any campaign materials

prepared by a candidate or a candidate’s

agent or authorized committee; and

* * * * *

(2) Reports or statements filed under

this section shall be filed at the end of

the reporting period (quarterly, preelection, post-election, semi-annual or

annual) (See 11 CFR 104.5)) during

which any independent expenditure

which aggregates in excess of $250 is

made and in any reporting period

thereafter in which additional

independent expenditures are made.

(b) Reports of independent

expenditures aggregating $1,000 or more

made by any person after the twentieth

day, but more than 24 hours before

12:01 a.m of the day of an election must

be received by the appropriate officers

as listed in paragraph (c) of this section

within 24 hours after such independent

expenditure is made. Such report or

statement shall contain the information

required by paragraph (a) of this section

indicating whether the independent

expenditure is made in support of, or in

opposition to, a particular candidate.

(c) Verification of independent

expenditure statements and reports: For

reports filed on paper (e.g., by hand

delivery, U.S. Mail or facsimile

machine), the certification required by

paragraphs (a)(1)(v) and (a)(1)(vi) of this

section must be immediately followed

by the handwritten signature of the

person who made the independent

expenditure and who certifies, under

penalty of perjury, its independence.

For reports filed by electronic mail, the

certification required by paragraphs

(a)(1)(v) and (a)(1)(vi) of this section

must be immediately followed by the

typewritten name of the person who

made the independent expenditure and

who certifies, under penalty of perjury,

its independence.

Dated: May 3, 2001.

Danny L. McDonald,

Chairman, Federal Election Commission.

[FR Doc. 01–11587 Filed 5–8–01; 8:45 am]

BILLING CODE 6715–01–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 2001–SW–03–AD]

RIN 2120–AA64

Airworthiness Directives; Eurocopter

France Model AS–365N3 Helicopters

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This document proposes

adopting a new airworthiness directive

(AD) for Eurocopter France Model AS–

365N3 helicopters. This proposal would

require modifying the Full Authority

Digital Engine Control (FADEC)

software within 90 days after the

effective date of this AD. This proposal

is prompted by a design problem in the

FADEC ‘‘power loss printed circuit

board’’ software found during laboratory

Federal Register / Vol. 66, No. 90 / Wednesday, May 9, 2001 / Proposed Rules 23633

testing. The actions specified by the

proposed AD are intended to prevent

loss of the FADEC one-engineinoperative (OEI) power and subsequent

loss of control of the helicopter.

DATES: The FAA must receive any

comments on this proposal by July 9,

2001.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Office of the

Regional Counsel, Southwest Region,

Attention: Rules Docket No. 2001–SW–

03–AD, 2601 Meacham Blvd., Room

663, Fort Worth, Texas 76137. You may

also send comments electronically to

the Rules Docket at the following

address: 9-asw-adcomments@faa.gov.

Comments may be inspected at the

Office of the Regional Counsel between

9 a.m. and 3 p.m., Monday through

Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT:

Carroll Wright, Aviation Safety

Engineer, FAA, Rotorcraft Directorate,

Regulations Group, Fort Worth, Texas

76193–0111, telephone (817) 222–5120,

fax (817) 222–5961.

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

should 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 will be

considered before taking action on the

proposed rule. The proposals contained

in this document 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 mailed

comments submitted in response to this

proposal must submit a self-addressed,

stamped postcard on which the

following statement is made:

‘‘Comments to Docket No. 2001–SW–

03–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, Office of the Regional Counsel,

Southwest Region, Attention: Rules

Docket No. 2001–SW–03–AD, 2601

Meacham Blvd., Room 663, Fort Worth,

Texas 76137.

Discussion

The Direction Generale De L’Aviation

Civile (DGAC), the airworthiness

authority for France, notified us that an

unsafe condition may exist on

Eurocopter France Model AS–365N3

helicopters. The DGAC advises that the

engine FADEC software and the

associated existing wiring for the engine

indicating system for the FADEC should

be modified. The main purpose of these

modifications is to transfer the ‘‘OEI

torque limit setting’’ and the ‘‘NG

difference indicating’’ function from the

‘‘power loss’’ card to the main

computer. This modification should

eliminate hung starts and loss of access

to the maximum allowable emergency

OEI power from the remaining engine

after one engine has failed.

Eurocopter France has issued

Eurocopter France Service Bulletin (SB)

71.00.13, Revision 1, dated October 17,

2000. This SB specifies modifying the

engine FADEC computer software and

the associated existing wiring. The

DGAC classified this SB as mandatory

and issued AD No. 2000–517–051(A),

dated December 13, 2000, to ensure the

continued airworthiness of these

helicopters in France. Incorporation of

the SB provides terminating action for

DGAC AD Nos. 1998–517–048(A) R2,

dated December 13, 2000; 1998–517–

048(A) R1, dated April 5, 2000; and

1998–517–048(A), dated January 13,

1999.

This helicopter model is

manufactured in France and is type

certificated for operation in the United

States under the provisions 14 CFR

21.29 and the applicable bilateral

airworthiness agreement. Pursuant to

this bilateral airworthiness agreement,

the DGAC has kept the FAA informed

of the situation described above. The

FAA has examined the findings of the

DGAC, reviewed all available

information, and determined that AD

action is necessary for products of this

type design that are certificated for

operation in the United States.

We have identified an unsafe

condition that is likely to exist or

develop on other Eurocopter France

Model AS–365N helicopters of this

same type design registered in the

United States. The proposed AD would

require modifying the FADEC software

and wiring within 90 days after the

effective date of this AD. The actions

would be required to be accomplished

in accordance with the SB’s described

previously.

Regulatory Impact

We estimate that 1 helicopter of U.S.

registry would be affected by this

proposed AD and that it would take

approximately 17 work hours per

helicopter to modify the wiring. The

average labor rate is $60 per work hour.

The FADEC software modification will

have an estimated turbomeca labor

charge of $1200. The manufacturer has

stated that the wiring kits will be

furnished at no cost. Based on these

figures, the total cost impact of the

proposed AD on U.S. operators is

estimated to be $2220.

The regulations proposed herein

would not have a substantial direct

effect 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,

it is determined that this proposal

would not have federalism implications

under Executive Order 13132.

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. You can get a copy of

the draft regulatory evaluation prepared

for this action from the Rules Docket. A

copy of it may be obtained by contacting

the Rules Docket at the mailing address

listed under the caption ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Safety.

The Proposed Amendment

Accordingly, under 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.

23634 Federal Register / Vol. 66, No. 90 / Wednesday, May 9, 2001 / Proposed Rules

§ 39.13 [Amended]

2. The FAA amends § 39.13 by adding

the following new airworthiness

directive:

Eurocopter France: Docket No. 2001–SW–

03–AD.

Applicability: Model AS–365N3

helicopters, certificated in any category.

Note 1: This AD applies to each helicopter

identified in the preceding applicability

provision, regardless of whether it has been

otherwise modified, altered, or repaired in

the area subject to the requirements of this

AD. For helicopters 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: Within 90 days after the

effective date of this AD, unless previously

accomplished.

To prevent loss of the Full Authority

Digital Engine Control (FADEC) one-engineinoperative power and subsequent loss of

control of the helicopter, accomplish the

following:

(a) Modify the FADEC software in

accordance with the Accomplishment

Instructions of Eurocopter France Service

Bulletin 71.00.13, Revision 1, dated October

17, 2000 (except this AD does not require

contact with the manufacturer as specified in

the caution statement in paragraph 2.B. and

the Note I in paragraph 2.B.2.).

(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, Regulations

Group, Rotorcraft Directorate, FAA.

Operators shall submit their requests through

an FAA Principal Maintenance Inspector,

who may concur or comment and then send

it to the Manager, Regulations Group.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Regulations Group.

(c) Special flight permits may be issued in

accordance with 14 CFR 21.197 and 21.199

to operate the helicopter to a location where

the requirements of this AD can be

accomplished.

Note 3: The subject of this AD is addressed

in Direction Generale De L’Aviation Civile

(France) AD Nos. 2000–517–051(A) and

1998–517–048(A) R2, both dated December

13, 2000; 1998–517–048(A) R1, dated April 5,

2000; and 1998–517–048(A), dated January

13, 1999.

Issued in Fort Worth, Texas, on April 26,

2001.

Mark R. Schilling,

Acting Manager, Rotorcraft Directorate,,

Aircraft Certification Service.

[FR Doc. 01–11585 Filed 5–8–01; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 864

[Docket No. 95P–0351]

Hematology and Pathology Devices;

Reclassification of Automated

Differential Cell Counters

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

reclassify from class III (premarket

approval) to class II (special controls)

the automated differential cell counter

(ADCC). The ADCC is a device intended

to identify and classify one or more of

the formed elements of the blood, or to

flag, count, or classify immature or

abnormal hematopoietic cells of the

blood, bone marrow, or other body

fluids. FDA is basing this

reclassification on new information

submitted in a reclassification petition

from the International Society for

Laboratory Hematology (ISLH). The

agency is taking this action under the

Federal Food, Drug, and Cosmetic Act

(the act), as amended by the Medical

Device Amendments of 1976 (the 1976

amendments), the Safe Medical Devices

Act of 1990 (the SMDA), and the Food

and Drug Administration Modernization

Act of 1997 (FDAMA).

DATES: Submit written comments by

August 7, 2001.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Larry J. Brindza, Center for Devices and

Radiological Health (HFZ–440), Food

and Drug Administration, 2098 Gaither

Rd., Rockville, MD 20850, 301–594–

1293.

SUPPLEMENTARY INFORMATION:

I. Background (Regulatory Authorities)

The act, as amended by the 1976

amendments (Public Law 94–295), the

SMDA (Public Law 101–629), and

FDAMA (Public Law 105–115),

established a comprehensive system for

the regulation of medical devices

intended for human use. Section 513 of

the act (21 U.S.C. 360c) established

three categories (classes) of devices,

depending on the regulatory controls

needed to provide reasonable assurance

of their safety and effectiveness. The

three categories of devices are class I

(general controls), class II (special

controls), and class III (premarket

approval).

Under section 513 of the act, devices

that were in commercial distribution

before May 28, 1976 (the date of

enactment of the 1976 amendments),

generally referred to as preamendments

devices, are classified after FDA has: (1)

Received a recommendation from a

device classification panel (an FDA

advisory committee); (2) published the

panel’s recommendation for comment,

along with a proposed regulation

classifying the device; and (3) published

a final regulation classifying the device.

FDA has classified most

preamendments devices under these

procedures.

Devices that were not in commercial

distribution prior to May 28, 1976,

generally referred to as postamendments

devices, are classified automatically by

statute (section 513(f) of the act) into

class III without any FDA rulemaking

process. Those devices remain in class

III and require premarket approval,

unless and until: (1) The device is

reclassified into class I or II; (2) FDA

issues an order classifying the device

into class I or II in accordance with

section 513(f)(2) of the act, as amended

by FDAMA; or (3) FDA issues an order

finding the device to be substantially

equivalent, under section 513(i) of the

act, to a predicate device that does not

require premarket approval. The agency

determines whether new devices are

substantially equivalent to previously

offered devices by means of premarket

notification procedures in section 510(k)

of the act (21 U.S.C. 360(k)) and part 807

of the regulations (21 CFR part 807).

A preamendments device that has

been classified into class III may be

marketed, by means of premarket

notification procedures, without

submission of a premarket approval

application (PMA) until FDA issues a

final regulation under section 515(b) of

the act (21 U.S.C. 360e(b)) requiring

premarket approval.

Reclassification of classified

preamendments devices is governed by

section 513(e) of the act. This section

provides that FDA may, by rulemaking,

reclassify a device (in a proceeding that

parallels the initial classification

proceeding) based upon ‘‘new

information.’’ The reclassification can

be initiated by FDA or by the petition

of an interested person. The term ‘‘new

information,’’ as used in section 513(e)

of the act, includes information

developed as a result of a reevaluation

of the data before the agency when the

device was originally classified, as well

as information not presented, not