48948 Federal Register / Vol. 62, No. 181 / Thursday, September 18, 1997 / Rules and Regulations

certification that no investigator will be

added to the treatment IDE before the

agreement is signed; and

(x) If the device is to be sold, the price

to be charged and a statement indicating

that the price is based on manufacturing

and handling costs only.

(2) A licensed practitioner who

receives an investigational device for

treatment use under a treatment IDE is

an ‘‘investigator’’ under the IDE and is

responsible for meeting all applicable

investigator responsibilities under this

part and parts 50 and 56 of this chapter.

(d) FDA action on treatment IDE

applications. (1) Approval of treatment

IDE’s. Treatment use may begin 30 days

after FDA receives the treatment IDE

submission at the address specified in

§ 812.19, unless FDA notifies the

sponsor in writing earlier than the 30

days that the treatment use may or may

not begin. FDA may approve the

treatment use as proposed or approve it

with modifications.

(2) Disapproval or withdrawal of

approval of treatment IDE’s. FDA may

disapprove or withdraw approval of a

treatment IDE if:

(i) The criteria specified in § 812.36(b)

are not met or the treatment IDE does

not contain the information required in

§ 812.36(c);

(ii) FDA determines that any of the

grounds for disapproval or withdrawal

of approval listed in § 812.30(b)(1)

through (b)(5) apply;

(iii) The device is intended for a

serious disease or condition and there is

insufficient evidence of safety and

effectiveness to support such use;

(iv) The device is intended for an

immediately life-threatening disease or

condition and the available scientific

evidence, taken as a whole, fails to

provide a reasonable basis for

concluding that the device:

(A) May be effective for its intended

use in its intended population; or

(B) Would not expose the patients to

whom the device is to be administered

to an unreasonable and significant

additional risk of illness or injury;

(v) There is reasonable evidence that

the treatment use is impeding

enrollment in, or otherwise interfering

with the conduct or completion of, a

controlled investigation of the same or

another investigational device;

(vi) The device has received

marketing approval/clearance or a

comparable device or therapy becomes

available to treat or diagnose the same

indication in the same patient

population for which the investigational

device is being used;

(vii) The sponsor of the controlled

clinical trial is not pursuing marketing

approval/clearance with due diligence;

(viii) Approval of the IDE for the

controlled clinical investigation of the

device has been withdrawn; or

(ix) The clinical investigator(s) named

in the treatment IDE are not qualified by

reason of their scientific training and/or

experience to use the investigational

device for the intended treatment use.

(3) Notice of disapproval or

withdrawal. If FDA disapproves or

proposes to withdraw approval of a

treatment IDE, FDA will follow the

procedures set forth in § 812.30(c).

(e) Safeguards. Treatment use of an

investigational device is conditioned

upon the sponsor and investigators

complying with the safeguards of the

IDE process and the regulations

governing informed consent (part 50 of

this chapter) and institutional review

boards (part 56 of this chapter).

(f) Reporting requirements. The

sponsor of a treatment IDE shall submit

progress reports on a semi-annual basis

to all reviewing IRB’s and FDA until the

filing of a marketing application. These

reports shall be based on the period of

time since initial approval of the

treatment IDE and shall include the

number of patients treated with the

device under the treatment IDE, the

names of the investigators participating

in the treatment IDE, and a brief

description of the sponsor’s efforts to

pursue marketing approval/clearance of

the device. Upon filing of a marketing

application, progress reports shall be

submitted annually in accordance with

§ 812.150(b)(5). The sponsor of a

treatment IDE is responsible for

submitting all other reports required

under § 812.150.

3. Section 812.150 is amended by

revising paragraph (b)(5) to read as

follows:

§ 812.150 Reports.

* * * * *

(b) * * *

(5) Progress reports. At regular

intervals, and at least yearly, a sponsor

shall submit progress reports to all

reviewing IRB’s. In the case of a

significant risk device, a sponsor shall

also submit progress reports to FDA. A

sponsor of a treatment IDE shall submit

semi-annual progress reports to all

reviewing IRB’s and FDA in accordance

with § 812.36(f) and annual reports in

accordance with this section.

* * * * *

Dated: August 20, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–24735 Filed 9–17–97; 8:45 am]

BILLING CODE 4160–01–F

FEDERAL MEDIATION AND

CONCILIATION SERVICE

29 CFR Part 1404

Expedited Arbitration

AGENCY: Federal Mediation and

Conciliation Service.

ACTION: Final rule.

SUMMARY: This addition to the

arbitration regulations is intended to

create a new service know as ‘‘expedited

arbitration.’’ This service will provide a

streamlined arbitration process for nonprecedential and non-complex

grievance arbitration cases while

encouraging the parties to select new

arbitrators in order to enhance their

career development. This new service is

the result of specific recommendations

of the Arbitration Focus Group by FMCS

on March 27, 1997.

EFFECTIVE DATE: This regulation is

effective October 1, 1997.

FOR FURTHER INFORMATION CONTACT:

Peter Regner, 202–606–8181.

SUPPLEMENTARY INFORMATION: The

Federal Mediation and Conciliation

Service, in an effort to receive public

input on its proposed new service of

expedited arbitration, published the

draft version of its proposed rule in the

June 30, 1997 issue of the Federal

Register (62 FR 35112). Nine arbitrators

responded in writing to the proposed

rule. In general, all individuals

supported the new service. Almost all of

them, however, objected to limiting

eligibility to deliver this service to those

arbitrators listed on the FMCS Roster of

Arbitrators for five (5) years or less.

More specific information about the

public response is contained in the

following section-by-section analysis.

Subpart D—Expedited Arbitration

Section 1404.17 Policy

The first section was further clarified

by adding the ‘‘unique’’ issues would

also be inappropriate for expedited

arbitration, as would complex or

precedential issues.

Section 1404.18 Procedures for

Requesting Expedited Panels

Subsection (d). The procedures for

requesting expedited arbitrators were

modified slightly by allowing the parties

to select a second arbitrator from the

panel submitted to them in the event

their first choice was not available to

serve. This was in response to one

comment opposing a direct appointment

by FMCS in the event the original

arbitrator selected by the parties was not

able to serve. The parties now have an

additional option.
Federal Register / Vol. 62, No. 181 / Thursday, September 18, 1997 / Rules and Regulations 48949

Section 1404.19 Arbitration Process

Subsection (c). The language has been

clarified to state that ‘‘post hearing’’ will

not be allowed. This permits the parties

to present pre-hearing summaries or

briefs of their positions. One comment

expressed concern that the ‘‘no

transcript’’ provision of the rule might

be interpreted to mean that the

arbitrator could not tape the hearing for

his/her own use. This is not the

intention of the rule. Arbitrators may

tape the proceedings, if both parties

agree, as a supplement to his/her notes.

Section 1404.20 Arbitrator Eligibility

Eight of the nine individuals

submitting comments about the

proposed rule objected to the policy of

having only arbitrators with five (5)

years or less experience on the FMCS

Roster automatically placed on the

expedited arbitration panels. Some

argued fairness, others stated that in

order to be able to render quick

decisions, more arbitration experience

was required. FMCS has modified its

policy to that at lease two more senior

arbitrators will be listed on every

expedited panel. Given the number of

arbitrators with five (5) years of less

listing on the Roster, it is possible that

many, if not most, expedited arbitration

panels will contain more than two more

senior arbitrators. The parties continue

to have the right to jointly request any

special qualifications that they feel

necessary.

The Federal Mediation and

Consiliation Service amends 29 CFR

part 1404 as follows:

PART 1404—ARBITRATION SERVICES

1. The authority citation for part 1404

continues to read as follows:

Authority: 29 U.S.C. 172 and 29 U.S.C. 173

et seq.

2. By adding Subpart D to read as

follows:

Subpart D—Expedited Arbitration

Sec.

1404.17 Policy.

1404.18 Prcedures for requesting expedited

panels.

1404.19 Arbitration process.

1404.20 Arbitrator eligibility.

1404.21 Proper use of expedited arbitration.

Subpart D—Expedited Arbitration

§ 1404.17 Policy

In an effort to reduce the time and

expense of some grievance arbitrators,

FMCS is offering expedited procedures

that may be appropriate in certain nonprecedential cases or those that do not

involve complex or unique issues.

Expedited Arbitrator is intended to be a

mutually agreed upon process whereby

arbitrator appointments, hearings and

awards are acted upon quickly by the

parties, FMCS, and the arbitrators. The

process is streamlined by mandating

short deadlines and eliminating

requirements for transcripts, briefs and

lengthy opinions.

§ 1404.18 Procedures for requesting

expedited panels.

(a) With the excepting of the specific

changes noted in this Subpart, all FMCS

rules and regulations governing its

arbitration services shall apply to

Expedited Arbitration.

(b) Upon receipt of a joint Request for

Arbitration Panel (Form R–43)

indicating that expedited services are

desired by both parties, the OAS will

require a panel of arbitrators.

(c) A panel of arbitrators submitted by

the OAS in expedited cases shall be

valid for up to 30 days. Only one panel

will be submitted per case. If the parties

are unable to mutually agree upon an

arbitrator or if prioritized selections are

not received from both parties within 30

days, the OAS will make a direct

appointment of an arbitrator not on the

original panel.

(d) If the parties mutually select an

arbitrator, but the arbitrator is not

available, the parties may select a

second name from the same panel or the

OAS will make a direct appointment of

another arbitrator not listed on the

original panel.

§ 1404.19 Arbitration process.

(a) Once notified of the expedited case

appointment by the OAS, the arbitrator

must contact the parties within seven

(7) calendar days.

(b) The parties and the arbitrator must

attempt to schedule a hearing within 30

days of the appointment date.

(c) Absent mutual agreement, all

hearings will be concluded within one

day. No transcripts of the proceedings

will be made and the filing of posthearing briefs will not be allowed.

(d) All awards must be completed

within seven (7) working days from the

hearing. These awards are expected to

be brief, concise, and not required

extensive written opinion or research

time.

§ 1404.20 Arbitrator eligibility.

In an effort to increase exposure for

new arbitrators, those arbitrators who

have been listed on the Roster of

Arbitrators for a period of five (5) years

or less will be automatically placed on

expedited panels submitted to the

parties. However, all panels will also

contain the names of at least two more

senior arbitrators. In addition, the

parties may jointly request a larger pool

of arbitrators or a direct appointment of

their choice who is listed on the Roster.

§ 1404.21 Proper use of expedited

arbitration.

(a) FMCS reserves the right to cease

honoring request for Expedited

Arbitration if a pattern of misuse of this

becomes apparent. Misuse may be

indicated by the parties’ frequent delay

of the process or referral of

inappropriate cases.

(b) Arbitrators who exhibit a pattern

of unavailability of appointments or

who are repeatedly unable to schedule

hearings or render awards within

established deadlines will be considered

ineligible for appointment for this

service.

John Calhoun Wells,

Director.

[FR Doc. 97–24727 Filed 9–17–97; 8:45 am]

BILLING CODE 6732–01–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 62

[OR–1–0001; FRL–5891–5]

Approval and Promulgation of State

Plans for Designated Facilities and

Pollutants: Oregon; Correction

AGENCY: Environmental Protection

Agency.

ACTION: Direct final rule; correction.

SUMMARY: On December 19, 1995,

pursuant to sections 111 and 129 of the

Clean Air Act (Act), the EPA

promulgated new source performance

standards (NSPS) applicable to new

Municipal Waste Combustors (MWCs)

and Emission Guidelines applicable to

existing MWCs. On April 8, 1997, the

United States Court of Appeals for the

District of Columbia Circuit vacated 40

CFR part 60, subparts Cb and Eb, as they

apply to MWC units with capacity to

combust less than or equal to 250 tons/

day of municipal solid waste (small

MWCs), consistent with the opinion in

Davis County Solid Waste Management

and Recovery District v. EPA, 101 F.3d

1395 (D.C. Cir. 1996), as amended, 108

F.3d 1454 (D.C. Cir. 1997). As a result,

40 CFR part 60, subparts Eb and Cb,

apply only to large MWC units which

are defined as units with individual

capacity to combust more than 250 tons/

day of municipal solid waste.

In a July 10, 1997, Federal Register

document (62 FR 36995), the EPA

approved the State Plan submitted by

Oregon to implement and enforce