[Federal Register Volume 61, Number 200 (Tuesday, October 15, 1996)]
[Notices]
[Pages 53762-53766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-26321]


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DEPARTMENT OF JUSTICE
[Docket No. 954-15]


Michael J. Septer, D.O., Grant of Request To Modify Continuation 
of Registration With Restrictions

    On November 4, 1993, the then-Director, Office of Diversion 
Control, Drug Enforcement Administration (DEA), issued an Order to Show 
Cause to Michael James Septer, D.O. (Respondent) at two locations in 
Tucson, Arizona and one location in Sierra Vista, Arizona, notifying 
him of an opportunity to show cause as to why DEA should not revoke his 
DEA Certificates of Registration (BS0321454, BS0321430 and BS0321442) 
under 21 U.S.C. 824(a)(4), and deny any request to modify such 
registrations by changing the registered address, and deny any pending 
applications for renewal of such registrations as a practitioner under 
21 U.S.C. 823(f), as being inconsistent with the public interest.
    By letter dated December 2, 1993, the Respondent filed a timely 
request for a hearing, and following prehearing procedures, a hearing 
was held in Grand Rapids, Michigan on February 28, 1995, before 
Administrative Law Judge Paul A. Tenney. At the hearing, the parties 
agreed that two of the DEA registrations that were the subject of the 
proceedings (BS0321454 and BS0321442) had terminated as a matter of law 
pursuant to 21 CFR 1301.62. Consequently, the scope of the proceedings 
was narrowed to determine whether the Respondent's DEA Certificate of 
Registration (BS0321430) should be modified or transferred from Arizona 
to Michigan, or whether such action should be denied for reasons that 
the Respondent's continued registration with DEA as a practitioner is 
inconsistent with the public interest as determined pursuant to 21 
U.S.C. 823(f) and 825(a)(4). Both parties called witnesses to testify 
and introduced documentary evidence. After the hearing, both sides 
submitted proposed findings of fact, conclusions of law and argument. 
On May 30, 1995, Judge Tenney issued his Findings of Fact, Conclusions 
of Law, and Recommended Ruling, recommending that the Deputy 
Administrator grant the Respondent's request to modify his DEA 
Certificate of Registration (BS0321430) so that it may be transferred 
from Arizona to Michigan, and to impose certain conditions on the 
registration. Judge Tenney's recommended conditions for the 
registration contemplated that the Respondent would continue to be 
employed at Hackley Occupational Health Clinic (HOHC), his place of 
employment at the time of the hearing, or at another facility approved 
by DEA that would provide a structured environment similar to HOHC. 
Neither party filed exceptions to the Administrative Law Judge's 
decision, and on June 29, 1995, Judge Tenney transmitted the record of 
these proceedings to the Deputy Administrator.
    By letter dated October 23, 1995, an attorney representing HOHC 
notified the Deputy Administrator that the HOHC Vice President, who 
testified at the hearing on behalf of the Respondent and who was in 
charge of monitoring the Respondent at HOHC, was no longer employed by 
HOHC. In addition, the letter indicated that Respondent and HOHC have 
voluntarily terminated their employment agreement. On November 1, 1995, 
the Deputy Administrator returned the record to the Administrative Law 
Judge, along with a copy of the October 23, 1995 letter from the HOHC 
attorney, and requested that Judge Tenney reopen the record to add this 
letter and to take whatever other actions he deemed necessary to 
consider the information contained in the letter. By order dated 
November 1, 1995, Judge Tenney included the letter in the record and 
allowed the parties to notify him of their recommendations on how to 
proceed in light of the HOHC's letter. Respondent was the only party to 
file a response and submitted a letter requesting that he be allowed to 
continue his DEA registration until the necessary monitors are 
available at his new employment. On December 6, 1995, the 
Administrative Law Judge issued an Addendum to his Recommended Ruling 
dated May 30, 1995, recommending that Respondent be allowed to continue 
his DEA registration provided that the nearest DEA office approve the 
monitoring conditions at any new place of employment. No exceptions 
were filed to the Addendum and the record was again transmitted to the 
Deputy Administrator on May 16, 1996.
    The Acting Deputy Administrator has considered the record in its 
entirety, and pursuant to 21 CFR 1316.67, hereby issues his final order 
based upon findings of fact and conclusions of law as hereinafter set 
forth. The Acting Deputy Administrator adopts, with noted exceptions, 
the opinion and recommended ruling of the Administrative Law Judge, and 
his adoption is in no manner diminished by any recitation of facts, 
issues and conclusions herein, or of any failure to mention a matter of 
fact or law.
    The Acting Deputy Administrator finds that on November 25, 1980, a 
ten-count indictment was filed against the Respondent in the United 
States District Court for the District of Arizona. Six of the ten 
counts alleged mail fraud in violation of 18 U.S.C. 1341 with respect 
to certain Medicare claims filed by the Respondent. The remaining 
counts alleged insurance fraud in violation of 42 U.S.C. Sec. 1395nn, 
in that Respondent attempted to secure payment for ``medical services 
never performed and medical supplies never placed, rented or purchased 
. . . .'' On May 4, 1981, following a jury trial, the Respondent was 
convicted of the six mail fraud counts. The court suspended imposition 
of sentence for a period of three years, placed the Respondent on 
probation during that time, and ordered that he spend one day per week 
for one year furnishing community service without compensation. There 
is little evidence in the record as to the underlying facts that led to 
Respondent's convictions. The Respondent however, testified at the 
hearing that the convictions were the result of his making up permanent 
placement dates for transcutaneous electrical nerve stimulators (TENS) 
to assure prospectively that he was reimbursed when the TENS were 
actually placed on his patients.
    As a result of his mail fraud convictions, on October 21, 1981, the 
Board of Osteopathic Examiners of the State of Arizona placed the 
Respondent's license to practice osteopathic medicine on probation for 
three years to run concurrently with the criminal probation. Also as a 
result of

[[Page 53763]]

his convictions, on December 9, 1981, the Respondent was suspended from 
participation in the Medicare program by the United States Department 
of Health and Human Services (HHS). Recognizing that the offenses were 
not of long duration and there were no adverse impacts on program 
patients, Respondent's Medicare privileges were restored.
    On July 1, 1981, the United States of America filed a civil 
complaint against the Respondent in the United States District Court 
for the District of Arizona seeking a judgment in excess of $44,000 
based upon Respondent's filing of fourteen false, fictitious, and 
fraudulent Medicare claims. On January 11, 1982, the court approved a 
consent judgment whereby the Respondent agreed to pay a civil fine of 
$8,265.60.
    In 1987, based upon reports that Respondent was excessively 
purchasing anorectic controlled substances, DEA and the Board of 
Osteopathic Examiners of the State of Arizona (BOE) initiated an 
investigation of Respondent. On September 28, 1988, pursuant to an 
administrative inspection warrant, DEA and BOE investigators conducted 
an accountability audit at Respondent's office located at 344 West Ajo, 
Tucson, Arizona, covering the period February 1, 1987 through September 
28, 1988. The audit revealed a shortage of approximately 190,000 to 
203,000 dosage units of Schedule III and IV controlled substances, 
recordkeeping deficiencies and security violations. As a result of the 
audit, on April 11, 1989, a civil complaint was filed against 
Respondent, doing business as Tucson Family Practice Clinic, in the 
United States District Court for the District of Arizona, seeking civil 
penalties in excess of $375,000 for violations of the Controlled 
Substances Act. A consent judgment was approved on December 18, 1989, 
in which the Respondent admitted various allegations in the complaint 
and the United States agreed to dismiss the other counts with 
prejudice. Subsequently, on March 13, 1990, the court ordered that 
Respondent pay a civil penalty of $40,000.
    After completion of the civil proceedings, on May 4, 1990, DEA 
issued an Order to Show Cause proposing to revoke Respondent's DEA 
Certificate of Registration. A hearing was held before an 
Administrative Law Judge in September 1991. No decision was rendered by 
the Administrative Law Judge, since the parties entered into a 
Memorandum of Agreement in early 1992. The agreement permitted the 
Respondent to retain his DEA registration subject to certain terms and 
conditions for a period of two years. For instance, the Respondent was 
prohibited from prescribing, administering, dispensing, or possessing 
any Schedule II controlled substances for purposes of weight reduction 
or control of obesity. The Respondent further agreed that when 
prescribing, administering and/or dispensing Schedule III, IV and V 
controlled substances for purposes of weight reduction or control of 
obesity, he would be limited to periods of time as recommended in the 
current Physicians' Desk Reference (PDR), and that the phrase ``short 
term'' as used in the PDR will mean up to eight weeks. In addition, 
Respondent agreed to conduct accountability audits on a daily basis, 
and to notify the DEA investigator of any change in his business 
addresses.
    Following execution of the Memorandum of Agreement, in September 
1992, Respondent moved to Mississippi and commuted to his practice in 
Arizona. On October 8, 1992, Respondent sought medical licensure in the 
State of Mississippi. On the licensure questionnaire, Respondent denied 
ever having his DEA Certificate of Registration revoked or restricted 
even though his DEA registration was restricted approximately eight 
months earlier when the Memorandum of Agreement was executed. As a 
result of his responses, the Mississippi State Board of Medical 
Licensure (Mississippi Board) issued a letter to Respondent dated 
December 18, 1992, advising him that if he wished to pursue his 
application for licensure in Mississippi an ``Order to Show Cause'' 
would be issued. Respondent testified at the hearing that he attempted 
to honestly complete the Mississippi licensure questionnaire, however, 
in light of the Mississippi Board's letter, he decided to move to 
Michigan rather than pursue medical licensure in Mississippi.
    On October 20, 1992, Respondent contacted DEA and expressed concern 
that one of his employees at his Arizona office may have diverted 
controlled substances. Consequently, DEA investigators went to 
Respondent's Arizona clinic on October 26, 1992, to conduct an 
accountability audit. The employee present during the audit indicated 
that she had been instructed by Respondent to cooperate fully in the 
investigation. The audit covered an approximate 10 month period in 1992 
and revealed a shortage of 56 dosage units. At the hearing in this 
matter, the DEA investigator described the shortage as ``very good for 
that length of time with the quantity that he was dispensing; very 
good.'' The investigator also indicated that he was ``very satisfied'', 
and felt no further action was necessary.
    By November of 1992, the Respondent decided not to return to 
Arizona, since a bench warrant had been issued for spousal maintenance 
and child support arrearages. Respondent testified at the hearing 
before Judge Tenney that all attempts to obtain physician coverage for 
his Arizona practice were unsuccessful. He then contacted the Arizona 
Nursing Board (Nursing Board) and based upon information from the 
Nursing Board, Respondent believed that it was permissible for a nurse 
practitioner to dispense controlled substances without a physician 
present. According to the Respondent the Nursing Board stated that: (1) 
a nurse practitioner, duly licensed in the State of Arizona, is 
permitted to prescribe and dispense controlled substances; (2) the 
presence of a physician on site would not be required; and (3) nurse 
practitioners are able to conduct their own practices without the 
supervision of a physician. Respondent then hired a nurse practitioner, 
who was left in charge of his Arizona office, and controlled substances 
were dispensed without the direct supervision of the Respondent.
    On December 7, 1992, investigators of DEA and BOE went to 
Respondent's Arizona office to investigate whether controlled 
substances were being dispensed without a physician on the premises. An 
individual, identified as Respondent's advisor, was present and the 
investigators provided him with a copy of Arizona Revised Statutes 
Sec. 32-1871(D) which states that a physician ``shall provide direct 
supervision of a nurse or attendant involved in the dispensing 
process.'' The section further provides that the term `` `direct 
supervision' means that a physician is present and makes the 
determination as to the legitimacy or the advisability of the drugs . . 
. to be dispensed.'' The investigators advised the individual that 
Respondent's office should be shut down since controlled substances 
were being dispensed without a physician present. The individual stated 
that he and Respondent had done extensive research and did not believe 
that there was any violation of the law.
    Based upon conversations with Respondent's advisor, members of 
Respondent's staff, and a review of the records maintained at 
Respondent's office, the investigators discovered that controlled 
substances had in fact been dispensed from Respondent's Arizona office 
without a physician present; that anorectics had been dispensed for 
periods longer than eight weeks in violation of the Memorandum of

[[Page 53764]]

Agreement; and that audits were not consistently taken on a daily basis 
also in violation of the Memorandum of Agreement. In addition, the 
investigators discovered that in Respondent's absence, employees were 
dispensing controlled substances to each other and to family members.
    During the course of the investigation, it was also revealed that 
between March 1, 1993, and August 26, 1993, while in Michigan, the 
Respondent wrote or authorized 96 prescriptions for controlled 
substances using DEA Certificate of Registration BS0321430 issued to 
him in Arizona. Respondent failed to notify DEA of his change of 
address to Michigan in violation of the Memorandum of Agreement and 
failed to obtain a modification of his registration to change the 
address to Michigan before writing or authorizing these prescriptions. 
Respondent testified at the hearing in this matter that he thought 
``that all of his credentials were in place for practicing medicine and 
prescribing'' in Michigan, and that he ``would never have written any 
of those prescriptions at Sparta Health Center [in Michigan] had I 
known my control [sic] substance number was not yet valid.''
    Subsequently, in August 1993, the DEA investigators contacted the 
Respondent and advised him of the violations of the Memorandum of 
Agreement. During the conversation, Respondent denied responsibility 
for what had occurred at the Arizona clinic when he was not present. At 
the hearing before Judge Tenney however, Respondent partly blamed 
incorrect advice of counsel for his actions, but also admitted failing 
to focus on his responsibilities, and that he ``should have kept a 
closer look over . . . the control logs.'' Almost immediately after 
being contacted by DEA, the Respondent requested modification of his 
DEA registrations to Michigan.
    During the hearing, the DEA investigator acknowledged that he and 
the Respondent have always had a good working relationship, and have 
exhibited a spirit of cooperation and forthrightness in their dealings 
with one another. He further indicated that they have ``always tried to 
accommodate each other.''
    On the day of the hearing, the Arizona Board of Osteopathic 
Examiners served a complaint upon the Respondent. The complaint was 
based, in part, on the Respondent's failure to directly supervise his 
employees in late 1992. However, there is nothing in the record to 
indicate the disposition of this complaint.
    At the time of the hearing before Judge Tenney, Respondent was 
working at HOHC. The Vice President of Operations for HOHC (Vice 
President) testified on behalf of Respondent at the hearing, and 
candidly stated that ``[the Respondent] has made a lot of glaring 
mistakes * * *. I would even go so far as to say they've been real 
dumb.'' Nonetheless, the Vice President testified that he was impressed 
with Respondent's abilities; that Respondent ``does occupational 
medicine very well''; that Respondent is a ``quality physician''; that 
Respondent ``relates to people [and h]e knows what he's doing''; and 
that his diagnoses are ``fine''.
    The Vice President testified that Respondent's lack of a DEA 
registration is ``somewhat limiting'', and if Respondent's request for 
modification were granted, HOHC would be willing to comply with any 
type of auditing or monitoring systems that would enable Respondent to 
handle controlled substances at HOHC. Respondent, when testifying about 
his past and current employment, stated that he was not interested in 
dispensing controlled substances anymore and he will ``never again'' 
take on that degree of responsibility that was associated with his 
former position as medical director of a multi-location facility. 
However, subsequent to the hearing, an attorney representing HOHC 
informed DEA in a letter dated October 23, 1995, that the Respondent 
and the Vice President were no longer employed by HOHC.
    Documentary evidence is in the record that indicates that 
Respondent falsified two of his applications filed with DEA. On his 
December 18, 1990 application for registration, and his February 13, 
1992 renewal application, Respondent answered ``No'' to the question 
which asks whether his State professional license was ever ``revoked, 
suspended, denied, restricted or placed on probation,'' when in fact 
his license to practice osteopathic medicine had been placed on 
probation for three years in 1981. In addition, on his February 13, 
1992 renewal application, Respondent answered ``No'' to the question 
which asks whether his Federal controlled substance registration was 
``revoked, suspended, restricted or denied''. Technically, there was no 
falsification regarding this answer since the Memorandum of Agreement 
which imposed restrictions on Respondent's DEA registration, while 
signed by Respondent on January 7, 1992, was not actually fully 
executed until February 24, 1992, after the renewal application was 
submitted.
    Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy 
Administrator may revoke a DEA Certificate of Registration and deny any 
pending applications, if he determines that the continued registration 
would be inconsistent with the public interest. Section 823(f) requires 
that the following factors be considered:
    (1) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (2) The applicant's experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The applicant's conviction record under Federal or State laws 
relating to the manufacture, distribution, or dispensing of controlled 
substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health or 
safety. These factors are to be considered in the disjunctive; the 
Deputy Administrator may rely on any one or a combination of factors 
and may give each factor the weight he deems appropriate in determining 
whether a registration should be revoked or an application for 
registration be denied. See Henry J. Schwarz, Jr., M.D., Docket No. 88-
42, 54 FR 16,422 (1989).
    In this case, factors one, two, four and five are relevant in 
determining whether the Respondent's continued registration would be 
inconsistent with the public interest. As to factor one, 
``recommendation of the appropriate licensing board * * *,'' in 1981, 
the Arizona Board of Osteopathic Examiners placed Respondent's license 
on probation for three years, based upon his mail fraud convictions. 
However, the Acting Deputy Administrator attaches very little 
significance to this action since it occurred approximately 15 years 
ago and did not involve his handling of controlled substances. The 
State of Arizona did file a complaint against the Respondent in 1995, 
however, there is no evidence in the record as to the disposition. In 
addition, there is no evidence in the record that the State of Michigan 
has taken any action against Respondent's license to practice 
osteopathic medicine in that state. Thus the Acting Deputy 
Administrator concludes that factor one is of little relevance in 
determining the public interest in this case.
    As to factor two, the Respondent's ``experience in dispensing * * * 
controlled substances,'' the Acting Deputy Administrator agrees with 
Judge Tenney's conclusion that ``[i]t is readily apparent from the 
evidence that the Respondent has demonstrated an

[[Page 53765]]

inability to dispense controlled substances as part of his medical 
practice.'' The 1988 audit revealed significant overages and shortages 
of various Schedule III and IV substances, as well as other 
recordkeeping and security violations, resulting in Respondent's 
payment of a $40,000 civil penalty. Although, a subsequent audit in 
1992 revealed a shortage of 56 dosage units over a 10 month period, 
which according to the DEA investigator, who testified at the hearing, 
was ``very good for that length of time with the quantity [Respondent] 
was dispensing,'' Respondent continued to have other problems with his 
dispensing of controlled substances. He violated the Memorandum of 
Agreement by failing to conduct daily audits of the dispensing of 
controlled substances from his Arizona office, and by dispensing 
controlled substances to individuals for weight reduction or control of 
obesity for longer than eight weeks. Additionally, he allowed the 
employees at his Arizona office to dispense controlled substances 
without adequate supervision. Respondent testified at the hearing that 
based upon advice he received from the Arizona Nursing Board he did not 
think that he needed to be present when controlled substances were 
dispensed and thought that it was permissible to leave a nurse 
practitioner in charge of his Arizona practice. This however does not 
justify his cavalier behavior. In fact, the Respondent himself readily 
concedes that he ``should have kept a closer look over * * * the 
control logs.'' Thus, factor three is significant in evaluating the 
public interest in this case.
    As to factor four, the Respondent's ``[c]ompliance with applicable 
State, Federal, or local laws relating to controlled substances'', the 
Respondent violated Arizona Revised Statutes Sec. 32-1871, by failing 
to provide direct supervision to his employees that dispensed 
controlled substances. In addition, the Acting Deputy Administrator 
finds that Respondent violated 21 CFR 1301.71 by failing to ``provide 
effective controls and procedures to guard against theft and diversion 
of controlled substances.'' In evaluating a registrant's practice, a 
consideration is ``[t]he adequacy of supervision over employees having 
access to * * * storage areas.'' 21 CFR 1301.71(b)(11). Consequently, 
factor four is relevant in determining whether Respondent's continued 
registration is inconsistent with the public interest.
    As to factor five, the Government argues that Respondent has ``not 
demonstrated an ability to accept the responsibilities of a DEA 
registration,'' and that he ``has attempted to shift the blame to 
[others] for his predicament.'' However, as Judge Tenney noted in his 
opinion, ``[a]lthough the Respondent partly blamed improper advice of 
counsel for his decisions, he also admitted failing to focus on his 
responsibilities, and that he `should have kept a closer look over * * 
* the control logs.' '' In addition, the Respondent's testimony at the 
hearing indicated that he recognizes that he had problems with 
dispensing controlled substances, and consequently is not interested in 
dispensing controlled substances in the future. The Acting Deputy 
Administrator concludes that the evidence does not support the 
Government's contentions regarding factor five.
    The Acting Deputy Administrator agrees with Judge Tenney's 
conclusion that factors one and five are of little significance, but 
that the Government has established a prima facie case regarding the 
relevance of factors two and four in determining the public interest. 
Therefore, grounds exist to revoke or suspend the Respondent's 
registration as inconsistent with the public interest. In addition, 
based upon Respondent's material falsification of his December 18, 1990 
and February 13, 1992 applications for DEA registration, grounds exist 
to revoke his registration pursuant to 21 U.S.C. 824(a)(1).
    The Acting Deputy Administrator concludes that neither complete 
revocation nor any unrestricted registration is in the public interest 
at this time. Respondent has clearly had problems with the handling of 
controlled substances in the past, however, most, if not all of those 
problems stemmed from his significant responsibilities at his prior 
private practice or from his dispensing of controlled substances. Judge 
Tenney recommended that Respondent's registration not be revoked, but 
instead be restricted, inter alia, to the closely monitored prescribing 
of Schedule III, IV and V controlled substances at HOHC, or at another 
DEA approved facility. As the letter HOHC attorney indicated, the 
Respondent is no longer employed at HOHC. The Acting Deputy 
Administrator agrees that strict controls must be imposed upon the 
Respondent's registration. This ``will allow the Respondent to 
demonstrate that he can responsibly handle controlled substances in his 
medical practice, yet simultaneously protect the public by providing a 
mechanism for rapid detection of any improper activity related to 
controlled substances.'' Steven M. Gardner, M.D., Docket No. 85-26, 51 
Fed. Reg. 12,576 (1986). However, the Acting Deputy Administrator 
concludes that with these restrictions in place, it is unnecessary for 
the Respondent to obtain DEA's prior approval regarding the specific 
setting in which he handles controlled substances as was recommended by 
Judge Tenney.
    The Acting Deputy Administrator concludes that the modification of 
Respondent's DEA Certificate of Registration (BS0321430) from Arizona 
to Michigan is in the public interest with the following limitations 
placed upon the registration:
    (1) The Respondent's controlled substance handling authority shall 
be limited to the writing of prescriptions for Schedule III, IV and V 
controlled substances only. He shall not dispense, administer, possess, 
or store any controlled substances. The only exception to this 
limitation is that the Respondent may possess controlled substances 
which are medically necessary for his own use and which he has obtained 
lawfully from another duly authorized physician.
    (2) The Respondent shall maintain a log of all prescriptions that 
he issues. At a minimum, the log shall indicate the date that the 
prescription was written, the name of the patient for whom it was 
written, and the name and dosage of the controlled substance(s) 
prescribed. The Respondent shall maintain this log for a period of 
three years from the effective date of this final order. Upon request 
by the Special Agent in Charge of the DEA Detroit Field Division, or 
his designee, the Respondent shall submit or otherwise make available 
his prescription log for inspection.
    (3) By the effective date of this final order, the Respondent shall 
notify the Special Agent in Charge of the DEA Detroit Field Division, 
or his designee, of his place of employment at that time. Thereafter, 
the Respondent shall immediately notify the Special Agent in Charge of 
the DEA Detroit Field Division, or his designee, of any changes in his 
employment.
    (4) These restrictions shall remain in effect for three years from 
the effective date of this final order.
    Accordingly, the Acting Deputy Administrator of the Drug 
Enforcement Administration, pursuant to the authority vested in him by 
21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that 
DEA Certificate of Registration BS0321430, issued to Michael J. Septer, 
D.O., be modified by transferring it to Michigan, and any pending 
applications be granted, with the above restrictions. This order is 
effective November 14, 1996.


[[Page 53766]]


    Dated: October 8, 1996.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 96-26321 Filed 10-11-96; 8:45 am]
BILLING CODE 4410-09-M