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Federal Register / Vol. 62, No.

117 / Wednesday, June 18, 1997 / Proposed Rules 33043

Rib 8, in accordance with Airbus Industrie or (d) of this AD: Prior to further flight, DEPARTMENT OF LABOR
Service Bulletin No. A300–57–6027, dated replace the pair of sealing angles on the
October 8, 1991, or Revision 2, dated affected wing and cold work the attachment Employment Standards Administration
September 13, 1994. Thereafter, repeat this holes, in accordance with Airbus Repair
inspection at intervals not to exceed 6,000 Drawing R571–40589 or R571–40942; and 20 CFR Parts 718, 722, 725, 726 and
landings until the inspection required by 727
perform the repetitive inspections required
paragraph (d) of this AD is accomplished.
by paragraph (c) or (d) of this AD, as RIN 1215–AA99
New Requirements of this AD applicable.
(c) For those airplanes on which Airbus (f) If any sealing angle is found to be Regulations Implementing the Federal
modification 08609H5276 (Airbus Service cracked through entirely during the Coal Mine Health and Safety Act of
Bulletin A300–57–6033), or the modification inspections required by paragraph (a), (b), (c), 1969, as Amended; Notice of Public
specified in Airbus Repair Drawing R571– or (d) of this AD: Prior to further flight, Hearing
40588 or R571–40942, has not been perform additional inspections to detect
accomplished: Perform HFEC inspections to cracks in the adjacent butt strap and skin AGENCY: Employment standards
detect cracks in the center spar sealing angles panel, in accordance with paragraph 2.B.(5) Administration, Labor.
adjacent to Rib 8, in accordance with Airbus ACTION: Proposed rule; notice of public
of Airbus Service Bulletin A300–57–6027,
Service Bulletin A300–57–6027, Revision 2, hearing.
Revision 2, dated September 13, 1994. If any
dated September 13, 1994, at the later of the
times specified in paragraph (a)(1) and (a)(2) crack is found in the adjacent butt strap and
SUMMARY: This notice schedules a
of this AD, as applicable. Repeat the skin panel, prior to further flight, repair in
accordance with Airbus Repair Drawing
second public hearing on the proposed
inspection thereafter at intervals not to regulations implementing the Black
exceed 2,625 landings. Accomplishment of R571–40611.
these inspections terminates the (g)(1) An alternative method of compliance
Lung Benefits Act which the
requirements of paragraph (a) of this AD. or adjustment of the compliance time that
Employment Standards Administration
(1) For airplanes on which HFEC provides an acceptable level of safety may be
(ESA) issued on January 22, 1997 (62 FR
inspections have not been accomplished in used if approved by the Manager, 3338–3435). The first public hearing is
accordance with AD 93–23–07: Prior to the Standardization Branch, ANM–113, FAA, scheduled for June 19, 1997 in
accumulation of 4,638 total landings; or Transport Airplane Directorate. Operators Charleston, West Virginia (62 FR 27562;
within 500 landings after the effective date of 62 FR 28760).
shall submit their requests through an
this AD, whichever occurs later. The proposed regulations reflect the
(2) For airplanes on which HFEC appropriate FAA Principal Maintenance
Inspector, who may add comments and then program’s suggestions for change in the
inspections have been accomplished in processing and adjudication of
accordance with AD 93–23–07: Within 2,625 send it to the Manager, Standardization
landings after accomplishment of the last Branch, ANM–113. individual claims for black lung
inspection performed in accordance with the (2) Operators may request an extension of benefits. The proposal also revises the
requirements of paragraph (a) of this AD, or the compliance times of this AD in criteria governing the responsibility of
within 500 landings after the effective date of accordance with the adjustment for range coal mine operators to secure the
this AD, whichever occurs later. formula found in paragraph 1(d) of Airbus payment of benefits to their employees
(d) For those airplanes on which Airbus Service Bulletin A300–57–6027, Revision 2, and reflects many decisions issued by
Modification 08609H5276 (Airbus Service dated September 13, 1994. The average flight the Benefits Review Board and U.S.
Bulletin A300–57–6033) or the modification courts of appeals over the past thirteen
time per flight cycle in hours used in this
specified in Airbus Repair Drawing R571– years. ESA proposed these regulations
40588 or R571–40942 has been formula should be for an individual airplane.
accomplished: Perform a HFEC inspection to Average flight time for a group of airplanes with the goal of improving services,
detect cracks in the center spar sealing angles may be used if all airplanes in the group have streamlining the adjudication process
adjacent to Rib 8, in accordance with Airbus flight times differing by no more than 10 and updating the regulations’ content.
Service Bulletin No. A300–57–6027, Revision percent. If compliance times are based on the The purpose of the hearings is to receive
2, dated September 13, 1994, at the later of average flight time for a group of airplanes, comments on the proposed changes.
the times specified in paragraphs (d)(1) and the individual airplane flight times of the DATES: The second hearing will be held
(d)(2) of this AD, as applicable. Repeat the group must be submitted to the Manager, in Washington, D.C. on Tuesday, July
inspection thereafter at intervals not to Standardization Branch, ANM–113, for 22, 1997 beginning at 9:00 a.m. Persons
exceed 2,625 landings. Accomplishment of review.
this inspection terminates the requirements
seeking to testify at the public hearing
of paragraph (b) of this AD. Note 3: Information concerning the based on medical, scientific, economic
(1) For airplanes on which HFEC existence of approved alternative methods of or other technical evidence must file a
inspections have not been accomplished in compliance with this AD, if any, may be notice of intent to appear accompanied
accordance with AD 93–23–07: Prior to the obtained from the Standardization Branch, by three copies of the evidence upon
accumulation of 5,775 landings after ANM–113. which their testimony will be based.
accomplishing the modification, or within (h) Special flight permits may be issued in The notice and evidence must be
500 landings after the effective date of this received by Tuesday, July 8, 1997. Any
accordance with sections 21.197 and 21.199
AD. other party desiring to participate must
of the Federal Aviation Regulations (14 CFR
(2) For airplanes on which HFEC
inspections have been accomplished in 21.197 and 21.199) to operate the airplane to file a notice of intent to appear by
accordance with AD 93–23–07: Within 2,625 a location where the requirements of this AD Tuesday, July 15, 1997. Any party who
landings after accomplishment of the last can be accomplished. has not filed a notice of intent to appear
inspection performed in accordance with the Issued in Renton, Washington, on July 11, may be allowed to testify, at the
requirements of paragraph (b) of this AD, or 1997. discretion of the Administrative Law
within 500 landings after the effective date of Judge, as time permits at the end of the
Darrell M. Pederson,
this AD, whichever occurs later. hearing.
Acting Manager, Transport Airplane
Corrective Action ADDRESSES: The second hearing will be
Directorate, Aircraft Certification Service.
(e) If any crack is found in the center spar held in the auditorium of the Frances
[FR Doc. 97–15887 Filed 6–17–97; 8:45 am]
sealing angles, including cracking entirely Perkins Building, U.S. Department of
BILLING CODE 4910–13–U
through the sealing angle, during the Labor, 3rd Street and Constitution
inspections required by paragraph (a), (b), (c), Avenue, N.W., Washington, D.C. 20210.
33044 Federal Register / Vol. 62, No. 117 / Wednesday, June 18, 1997 / Proposed Rules

Notices of intent to appear and generally will be decided so as to favor DEPARTMENT OF HEALTH AND
accompanying evidence, if any, must be development of the record. HUMAN SERVICES
sent to James L. DeMarce, Director, The order of appearance of persons
Division of Coal Mine Workers’ Food and Drug Administration
who have filed notices of intent to
Compensation, Room C–3520, Frances appear will be determined by ESA. Only
Perkins Building, 200 Constitution 21 CFR Parts 868, 884, and 890
the Department may ask questions of
Avenue, N.W., Washington, D.C. 20210; [Docket No. 94N–0418]
witnesses. The presiding officer will
FAX Number 202–219–8568.
make no decision or recommendation Retaining Certain Preamendment
FOR FURTHER INFORMATION CONTACT:
on the merits of ESA’s proposal, but Class III Devices in Class III
James L. DeMarce, Director, Division of
rather will be responsible for ensuring
Coal Mine Workers’ Compensation,
that the hearing proceeds at a reasonable AGENCY: Food and Drug Administration,
(202) 219–6692.
pace and in an orderly manner. The HHS.
SUPPLEMENTARY INFORMATION: presiding officer, therefore, will have all ACTION: Proposed rule.
Filing of Notices of Intent To Appear the powers necessary and appropriate to
and Evidence Before the Hearing conduct a full and fair informal hearing, SUMMARY: The Food and Drug
including the powers: Administration (FDA) is proposing to
The notice of intent to appear must retain the following preamendment
contain the following information: 1. To regulate the course of the
class III devices in class III: Lung water
1. The name, address, organization, proceedings;
monitor, powered vaginal muscle
and telephone number of each person to 2. To dispose of procedural requests, stimulator for therapeutic use, and stair-
appear; objections and comparable matters; climbing wheelchair. Manufacturers of
2. The capacity in which the person these referenced preamendment class III
3. To confine the presentations to
will appear; devices were requested, by an order
3. The approximate amount of time pertinent and relevant matters; and
published in the Federal Register, to
required for the presentation; 4. To regulate the conduct of those submit a summary of, and a citation to,
4. A brief statement of the position present at the hearing by appropriate all information known or otherwise
that will be taken with respect to the means. available to them respecting their
proposed regulations; Individuals with disabilities, who devices, including adverse safety or
5. Whether the party intends to testify need special accommodations, should effectiveness information concerning
based on medical, scientific, economic contact James L. DeMarce by Tuesday, the devices that had not been submitted
or technical evidence. If so, three copies under the Federal Food, Drug, and
July 8 at the address indicated in this
of that evidence must be attached to the Cosmetic Act (the act). FDA believes
notice.
notice of intent to appear. that these devices should remain in
ESA will review each notice of intent Contents of the Rulemaking Record class III because insufficient information
to appear in light of the amount of time exists to determine that special controls
requested. In those instances when the This rulemaking record will remain
would provide reasonable assurance of
requested amount of time exceeds 20 open through August 21, 1997 (62 FR
their safety and effectiveness, and/or
minutes, ESA will determine, in its sole 27000). A verbatim transcript of the
these devices present a potential
discretion, whether the amount of time hearing will be prepared and made a unreasonable risk of illness or injury.
requested is supported by the part of the record. It will be available for DATES: Submit written comments by
accompanying documentation. If not, public inspection at the Office of the September 16, 1997. FDA proposes that
the participant will be notified of that Solicitor, Division of Black Lung any final rule that may issue based on
fact prior to the hearing. Benefits, 200 Constitution Avenue, NW., this proposal become effective 30 days
Conduct and Nature of the Hearing Suite N–2605, Washington, DC 20210. after the date of publication of the final
Members of the public may also arrange rule.
The hearing will commence at 9:00 with the court reporter to purchase their
a.m. on July 22, 1997. At that time, the ADDRESSES: Submit written comments
own copies. All notices of intent to to the Dockets Management Branch
presiding officer, an Administrative Law appear at the hearing and accompanying
Judge, will resolve any procedural (HFA–305), Food and Drug
evidence, if any, will also be made a Administration, 12420 Parklawn Dr.,
matters relating to the hearing which are
part of the record and will be available rm. 1–23, Rockville, MD 20857.
delegated to his discretion in this
for public inspection at the above FOR FURTHER INFORMATION CONTACT: Lisa
notice. It is ESA’s intent to provide
interested members of the public with address. ESA will also accept additional A. Rooney, Center for Devices and
an opportunity to make effective oral written comments and other appropriate Radiological Health (HFZ–403), Food
presentations and to insure that these data from any interested party, and Drug Administration, 9200
presentations proceed expeditiously, including those not presenting oral Corporate Blvd., Rockville, MD 20850,
without procedural restraints which testimony, until expiration of the 301–594–1190.
might impede or protract the comment period. SUPPLEMENTARY INFORMATION:
rulemaking process. The hearing is Signed at Washington, DC, this 12th day of
primarily for the purpose of information I. Background
June, 1997.
gathering and therefore will be an Gene Karp, The act (21 U.S.C. 321 et seq.), as
informal administrative proceeding amended by the Medical Device
Deputy Assistant Secretary for Employment
rather than an adjudicative one. The Standards.
Amendments of 1976 (the 1976
formal rules of evidence will not apply. amendments) (Pub. L. 94–295) and the
[FR Doc. 97–15942 Filed 6–17–97; 8:45 am]
The hearing is also intended to facilitate Safe Medical Devices Act of 1990 (the
the development of a clear, accurate and BILLING CODE 4510–27–M SMDA) (Pub. L. 101–629), established a
complete record. Thus, questions of comprehensive system for the regulation
relevance, procedure and participation of medical devices intended for human

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