Erwin E. Feldman, D.O.; Revocation of Registration, 16835-16838 [2011-7047]
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clear, Respondent is not entitled to ‘‘an
opportunity to demonstrate that he can
responsibly handle controlled
substances’’ through the issuance of
even a restricted registration unless and
until he accepts responsibility for his
misconduct.18
It is acknowledged that fifteen years
have passed since the first Agency
Order. See ALJ at 20–21, 28. However,
way * * * using (his son’s problems) as an excuse
for bad behavior or to try to rationalize it away
* * * as being justified.’’ Id. Moreover, in
discussing the public interest factors and whether
the respondent had rebutted the Government’s
prima facie case, the decision made no reference to
the medical issues of his son. See 63 FR at 11909–
10. It is thus inaccurate to say that the Agency
‘‘considered the effect a relative’s medical issues
can have on a practitioner and recognized that
when those stresses are taken out of the picture, it
is less likely that the circumstances will ever be
repeated.’’ ALJ at 23.
Most significantly, the Agency’s decision in
Oakes noted in at least three different places that
the respondent had expressed remorse and accepted
responsibility for his misconduct. See 63 FR at
11909 (noting that ‘‘the evidence in favor of denial
of Respondent’s application is overcome by * * *
his expressions of remorse and acceptance of
responsibility for his actions’’); id. at 11910 (noting
that while the respondent’s misrepresentation on a
state application ‘‘is troublesome, it does not
warrant the denial of Respondent’s application in
light of his expressions of remorse and acceptance
of responsibility for his actions’’).
Thus, contrary to the ALJ’s reasoning, Oakes
provides no comfort to Respondent. Moreover, even
giving weight to Respondent’s testimony that he is
not likely to again invite a patient to live with him,
his testimony does not address his misconduct with
respect to Patients #2 and 3.
18 The ALJ also noted that since the revocation of
his registration, ‘‘Respondent has had no further
problems related to his practice of medicine.’’ ALJ
at 20. Given that DEA does not regulate the practice
of medicine, it is an open question whether such
evidence is even relevant in assessing whether an
applicant’s registration would be consistent with
the public interest. See Edmund Chein, 72 FR 6580,
6590 (2007) (declining to decide ‘‘whether a
registrant’s unwillingness to comply with State
rules that are unrelated to controlled substances can
be considered [in a revocation proceeding] when
the registrant maintains a valid State license’’).
What is noteworthy, however, are the State ALJ’s
extensive findings regarding Respondent’s
dispensing of controlled substances to Patient #1,
not only during the period following the issuance
of the first Order to Show Cause on July 29, 1993,
but also after the DEA ALJ’s issuance of his
recommended decision on January 12, 1995. While
the DEA ALJ’s decision was not a final decision of
the Agency, it found that Respondent dispensed
controlled substances to Patient #1 ‘‘on demand,’’
‘‘virtually upon request,’’ with ‘‘virtually no
scrutiny,’’ that his ‘‘prescribing and dispensing to
[Patient #1] was outside of the context of the
Respondent’s usual professional practice’’ and thus
violated 21 CFR 1306.04(a), and that the
Government had ‘‘established a prima facie case
under factor (2).’’ GX 6, at 20. Yet thereafter,
Respondent continued to engage in what the State
ALJ ‘‘characterized as irrational polypharmacy’’; the
State ALJ further noted that ‘‘[t]otally absent from
his care and treatment of [Patient #1] was control,
monitoring and periodic assessment’’ and that
‘‘[f]rom 1990 to 1996, almost all of respondent’s
prescribing to [Patient #1] took place in the absence
of a legitimate physical examination.’’ GX 8, at 15–
16.
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DEA has long held that ‘‘[t]he paramount
issue is not how much time has elapsed
since [his] unlawful conduct, but rather,
whether during that time. * * *
Respondent has learned from past
mistakes and has demonstrated that he
would handle controlled substances
properly if entrusted with a new
registration. Leonardo v. Lopez, 54 FR
36915 (1989); see also Leslie, 68 FR at
15227 (revoking registration issued
through administrative error on ground
that practitioner still refused to
acknowledge misconduct which he
committed seventeen years earlier
notwithstanding that there was no
evidence that he had mishandled
controlled substances under the
erroneously issued registration).
Moreover, it should be noted that
neither the 1995 Order, nor any Agency
rule, barred Respondent from reapplying at an earlier date. What does
bar his obtaining of a new registration
is his failure to fully acknowledge his
misconduct. Absent Respondent’s
acknowledgment of the full scope of his
misconduct, I am compelled to
conclude that issuing him a new
registration would be ‘‘inconsistent with
the public interest.’’ 21 U.S.C. 823(f).
Accordingly, I reject the ALJ’s
recommended ruling and will deny
Respondent’s application.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f), as well as 28 CFR
0.100(b) and 0.104, I order that the
pending application of Robert L.
Dougherty, M.D., for a DEA Certificate
of Registration as a practitioner, be, and
it hereby is, denied. This Order is
effective immediately.
Dated: March 11, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–7014 Filed 3–24–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Erwin E. Feldman, D.O.; Revocation of
Registration
On May 29, 2009, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Erwin E. Feldman, D.O.
(Respondent), of Madison Heights,
Michigan. The Show Cause Order
proposed the revocation of
Respondent’s DEA Certificate of
Registration, AF9086415, which
authorizes him to dispense controlled
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16835
substances as a practitioner, and the
denial of any pending applications to
renew his registration, on the ground
that his ‘‘continued registration is
inconsistent with the public interest.’’
Show Cause Order at 1 (citing 21 U.S.C.
823(f) and 824(a)).
More specifically, the Show Cause
Order alleged that on January 18, 2005,
DEA issued an Order to Show Cause to
Respondent, which alleged, inter alia,
that between December 2001 and July
2004, he had prescribed controlled
substances on ten occasions to
undercover agents without performing a
medical examination, and that he had
issued prescriptions for Suboxone ‘‘to
treat opiate addiction without having
obtained’’ certification from the
Michigan Center for Substance Abuse
Treatment and a separate DEA
registration to prescribe controlled
substances for ‘‘maintenance and
detoxification treatment of opiate
addiction as required by 21 U.S.C.
823(g).’’ Id. at 1–2.
Next, the Show Cause Order alleged
that on April 4, 2007, Respondent
entered into a Memorandum of
Agreement (MOA) with the Agency to
resolve the allegations of the 2005 Show
Cause Order, which was to remain in
force through May 2010. Id. at 2. The
Show Cause Order then alleged that
under the MOA, Respondent agreed that
he would prescribe controlled
substances for only a thirty-day supply
with one refill; that he would not
prescribe controlled substances to
persons who were not residents of the
State of Michigan; that he would not
prescribe controlled substances to
family members; that he would
maintain a log of all controlled
substance prescriptions he issued; that
he would maintain in patient charts,
reports from the Michigan Automated
Prescriptions System (MAPS) for all
patients who received controlled
substances from him for ‘‘in excess of six
months’’; and that he would notify DEA
‘‘in writing, within twenty days of the
initiation of any proceedings which
impacted [his] ability to handle
controlled substances, including the
initiation of any action by a state entity
to restrict, deny, rescind, suspend,
revoke or otherwise limit [his] authority
to handle controlled substances.’’ Id.
Finally, the Show Cause Order alleged
that Respondent had violated the MOA.
Id. The Order specifically alleged that
‘‘on several occasions,’’ Respondent had
issued controlled substance
prescriptions ‘‘with as many as seven
refills’’; that he had prescribed
controlled substances to residents of
Florida and Colorado; that he had
prescribed Phenobarbital, a schedule IV
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controlled substance, to his wife; that he
had failed to maintain an accurate log of
his controlled substance prescriptions;
that he had failed to maintain MAPS
reports for those patients he prescribed
controlled substances to for more than
six months; and that he had ‘‘failed to
notify DEA in writing’’ that on
November 3, 2008, the Michigan Board
of Osteopathic Medicine and Surgery
had filed an administrative complaint
against his medical license. Id.
Respondent requested a hearing on
the allegations, and the matter was
placed on the docket of the Agency’s
Administrative Law Judges (ALJs).
Thereafter, the ALJ ordered the parties
to file pre-hearing statements. Ex. 6. On
July 27, 2009, the Government filed its
pre-hearing statement; on August 17,
Respondent’s counsel filed a notice of
appearance and requested a two-week
extension to file Respondent’s prehearing statement. Id. The record does
not disclose what action the ALJ took in
response to Respondent’s request for an
extension. However, on September 4,
the ALJ issued a ‘‘Notice to Show Cause
Why the Proceeding Should Not Be
Terminated’’ and gave Respondent
‘‘until September 18 to respond.’’ Id. On
September 21, Respondent’s counsel
faxed a document which bore the
caption of Respondent’s Pre-Hearing
Statement. Id. However, when several
pages appeared to be missing, the ALJ’s
office left telephone messages on
September 21, 22 and 23 with
Respondent’s counsel, notifying him
that the entire document had not been
received. Id.
On September 28, the ALJ issued
another ‘‘Notice to Show Cause Why the
Proceeding Should Not Be Terminated’’
and gave Respondent until October 1 to
file a response. Id. However, on October
20, 2009, the ALJ ordered that the
proceeding be terminated, noting that
Respondent had not filed a response to
the order. Id. The ALJ further
‘‘conclude[d] that Respondent has
waived his right to a hearing.’’ Order
Terminating Proceedings, at 1.
Thereafter, the Investigative Record
was forwarded to this Office for final
agency action. Having reviewed the
entire record in this matter, I adopt the
ALJ’s finding that Respondent has
waived his right to a hearing. See 21
CFR 1301.43(d). I make the following
findings of fact.
Findings
Respondent is the holder of DEA
Certificate of Registration, AF9086415,
which authorizes him to dispense
controlled substances in schedules II
through V as a practitioner.
Respondent’s registration was due to
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expire on September 30, 2008; however,
on September 22, 2008, Respondent
submitted a renewal application.
Because Respondent’s renewal
application was timely submitted, I find
that Respondent’s registration remains
in effect pending the issuance of this
Decision and Final Order. See 5 U.S.C.
558(c). Moreover, on March 17, 2010,
Respondent submitted a further
application for registration as a
practitioner. See GX 2.
On January 18, 2005, the Deputy
Assistant Administrator, Office of
Diversion Control, issued an Order to
Show Cause to Respondent, which
proposed the revocation of his
registration. GX 3. The 2005 Show
Cause Order alleged that Respondent
had ‘‘issued numerous prescriptions for
controlled substances to’’ an addict, and
that he had continued to prescribe
controlled substances to patient P.H.
even after he became aware that P.H.
had been admitted to a hospital
following an overdose. Id. at 2–3. This
Show Cause Order further alleged that
between December 2001 and July 2004,
four DEA Agents made undercover
visits to Respondent and that on at least
ten occasions, the Agents had obtained
prescriptions ‘‘without having received
any type of medical exam.’’ Id. at 3.
The 2005 Show Cause Order also
alleged that Respondent was engaged in
family practice, that he issued a
substantially greater number of
controlled-substance prescriptions than
four other family practice physicians
who practiced at the same medical
office building, and that he had issued
approximately 59% of the controlled
substance prescriptions which were
dispensed by the Oakland Medical
Pharmacy, which was located in the
same building. Id. at 1, 4–5. Finally, the
Show Cause Order alleged that
Respondent had prescribed Suboxone to
three patients even though he did not
possess a certification issued by the
Michigan Center for Substance Abuse
Treatment or a DEA registration to
prescribe controlled substances for
maintenance and detoxification
treatment; the Order also alleged that he
had prescribed Suboxone to three
patients simultaneously with other
controlled substances which were
contraindicated. Id. at 5–6.
Respondent requested a hearing on
the allegations of the 2005 Show Cause
Order. Thereafter, the parties settled the
matter and entered into a Memorandum
of Agreement (MOA), under which the
Agency agreed to renew Respondent’s
registration subject to various terms as
set forth in the MOA. The MOA, which
became effective on May 21, 2007, was
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to remain in force for a period of three
years. GX 5, at 2 & 5.
More specifically, Respondent agreed
to limit his controlled substance
activities ‘‘to prescribing only,’’ that he
would prescribe a controlled substance
for only a thirty-day supply with one
refill, and that he would issue a new
controlled-substance prescription only
after a patient visited with him. Id. at 2.
Respondent also agreed that he would
not prescribe controlled substances to
persons who were not residents of the
State of Michigan; that he would not
prescribe controlled substances ‘‘to
members of his immediate family’’; that
he would maintain a quarterly log of all
controlled-substance prescriptions he
issued which would be available to DEA
personnel on request; and that in his
patient charts, he would maintain
reports from the Michigan Automated
Prescriptions System (MAPS) for all
patients who received controlled
substances from him for ‘‘in excess of six
months.’’ Id. at 2–3.
Respondent also agreed that he would
not ‘‘delegate to any pharmacist
authorization to dispense’’ a new
controlled-substance prescription ‘‘or
refill an existing prescription * * *
prior to speaking with [him] or his
designated representative * * * unless
such prescription is pursuant to a lawful
prescription order by [him].’’ Id. at 3.
Respondent further agreed to notify
DEA ‘‘in writing, within twenty days of
the initiation of any proceedings which
impacted [his] ability to handle
controlled substances, including the
initiation of any action by a state entity
to restrict, deny, rescind, suspend,
revoke or otherwise limit [his] authority
to handle controlled substances.’’ Id. at
4. Finally, Respondent agreed that ‘‘if he
violate[d] any term or condition of [the
MOA], such violation could result in
[the] initiation of proceedings to revoke
his’’ DEA registration. Id. at 4–5.
According to the affidavit of a DEA
Diversion Investigator (DI), following
Respondent’s submission of his renewal
application, DIs obtained from both
local pharmacies and MAPS,
information pertaining to the
prescriptions issued by Respondent; the
DIs also met with Respondent on
February 11, 2009 to review his
compliance with the MOA. GX 22, at 4–
5.
During the February 11, 2009 meeting,
Respondent provided the DIs with his
controlled-substance prescription log.
Id. at 5. The log showed that
Respondent had issued prescriptions to
several patients with ‘‘as many as five
refills’’ for Androgel, a schedule III
controlled substance, as well as that he
had issued prescriptions with between
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three and seven refills, to multiple
patients for Testim, another schedule III
controlled substance. Id.; see also GXs 7,
9–11, 13. The evidence also showed that
Respondent had issued a prescription
for Ativan (lorazepam), a schedule IV
controlled substance, with three refills,
to two different patients. See GX 7.
Based on their review of MAPS data
and medical records, the DIs further
determined that on December 21, 2007,
Respondent had issued a prescription
for hydrocodone/acetaminophen, a
schedule III controlled substance to
M.L.G., a resident of Florida; that on
January 8, 2008, he had issued a
prescription for propoxyphene/
acetaminophen, a schedule IV
controlled substance, to M.S.E., a
resident of Colorado; and that on July 25
and August 18, 2008, he had issued
prescriptions for 60 and 90 tablets of
alprazolam, a schedule IV controlled
substance, to B.P., a resident of Port
Orange, Florida. GX 22, at 6. The DIs
further determined that on September
24, 2007, Respondent prescribed 160
tablets of phenobarbital, a schedule IV
controlled substance, to his wife, by
calling in a prescription to a local
pharmacy. Id. at 7; see also GX 16.
Moreover, during the February 11, 2009
meeting with the DIs, Respondent
denied calling in the prescription for his
wife and maintained ‘‘that he called in
a refill of an earlier phenobarbital
prescription issued by’’ another
physician (Dr. C.) on September 21,
2007. GX 22, at 7. However, the
prescription issued by Dr. C. was for
only sixteen tablets with two refills. Id.
In addition, the DIs compared the
MAPS report showing Respondent’s
prescribing with the controlledsubstance log he was required to
maintain. Id. at 8. This review showed
that Respondent had failed to document
fourteen prescriptions in the log. Id.
Upon reviewing the patient charts, the
DIs also found various instances in
which Respondent had prescribed
controlled substances to a patient for
more than six months and had not
maintained a MAPS report in the
patient’s chart. Id. at 9.
Finally, on November 3, 2008, the
Michigan Board of Ostheopathic
Medicine and Surgery issued an
administrative complaint to Respondent
charging him with eight counts of
violating state law, including five
counts of ‘‘prescribing drugs without a
lawful diagnostic or therapeutic
purpose.’’ GX 18, at 5–12; 19 (citing
Mich. Comp. Laws § 16221(c)(iv)). The
Board also charged Respondent with
negligence and incompetence based on
his prescribing of Suboxone to treat
opioid dependence without having
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‘‘obtain[ed] the necessary certification.’’
Id. at 18–19 (citing Mich. Comp. Laws
§§ 16221(a) and 16221(b)(i)). While the
Board sought to impose sanctions on
Respondent’s medical license,1 see id. at
1–3, Respondent did not notify DEA of
the proceeding.2 GX 22, at 10.
Discussion
Section 304(a) of the CSA provides
that a ‘‘registration pursuant to section
823 of this title to * * * dispense a
controlled substance * * * may be
suspended or revoked by the Attorney
General upon a finding that the
registrant * * * has committed such
acts as would render his registration
under section 823 of this title
inconsistent with the public interest as
determined under such section.’’ 21
U.S.C. 824(a)(4). In determining the
public interest, Congress directed 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 * * * 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 and safety.
21 U.S.C. 823(f).
‘‘[T]hese factors are considered in the
disjunctive.’’ Robert A. Leslie, 68 FR
15227, 15230 (2003). I may rely on any
one or a combination of factors and may
give each factor the weight I deem
appropriate in determining whether to
revoke an existing registration or to
deny an application for a registration.
Id. Moreover, I am ‘‘not required to make
findings as to all of the factors.’’ Hoxie
v. DEA, 419 F.3d 477, 482 (6th Cir.
2005); see also Morall v. DEA, 412 F.3d
165, 173–74 (D.C. Cir. 2005).3
1 Respondent
received the complaint on
November 8, 2008. See GX 19 (letter from
Respondent to Michigan Bureau of Health
Professions).
2 In its Request for Final Agency Action, the
Government also contends that Respondent altered
the expiration date of his registration when he
submitted his credentials to a health insurance
company. The Government did not, however,
establish that it provided notice to Respondent of
its intent to rely on this conduct in this proceeding.
3 The Government has ‘‘the burden of proving that
the requirements for * * * revocation or
suspension pursuant to section 304(a) * * * are
satisfied.’’ 21 CFR 1301.44(e); see also 21 CFR
1301.44(d) (Government has ‘‘the burden of proving
that the requirement for [a] registration pursuant to
section 303 * * * are not satisfied’’). In a contested
hearing, where the Government satisfies its prima
facie burden, the burden then shifts to the registrant
to demonstrate why he can be entrusted with a new
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16837
In this matter, I conclude that the
record establishes that Respondent has
violated multiple provisions of the
MOA and that these violations are
relevant under factors two and five. The
record also establishes that Respondent
made a false statement to DEA
Investigators when he denied having
issued a controlled substance
prescription to his wife. This conduct is
also relevant under factor five. I
therefore conclude that Respondent has
committed acts which render his
registration inconsistent with the public
interest and that these acts are
sufficiently egregious to warrant the
revocation of his registration.4
Factors Two and Five—Respondent’s
Experience in Dispensing Controlled
Substances and Such Other Conduct
Which May Threaten Public Health and
Safety
In May of 2007, DEA exercised
forbearance and allowed Respondent to
settle a previous Show Cause
proceeding by entering into an MOA.
However, as found above, Respondent
promptly proceeded to violate multiple
provisions of the MOA.
First, Respondent violated the MOA’s
restriction that he could only prescribe
a thirty-day supply of a controlled
substance with one refill, and that he
could issue a new prescription only
after the patient visited him. More
specifically, the record shows that
Respondent issued prescriptions which
authorized multiple refills to multiple
patients for both schedule III anabolic
steroids (Androgel and Testim) and a
schedule IV depressant (lorazepam).
Second, Respondent violated the
MOA’s provision that he could not
prescribe a controlled substance to a
non-resident of Michigan. More
specifically, Respondent prescribed
hydrocodone/acetaminophen, a
schedule III controlled substance, to
registration. Medicine Shoppe-Jonesborough, 73 FR
363, 380 (2008).
4 With respect to factor one, while the
Investigative Record contains a copy of the
Administrative Complaint filed by the Michigan
Board, there is no evidence establishing the
outcome of this proceeding. However, even
assuming that Respondent retains his state
authority, DEA has long held that while the
possession of state authority is an essential
condition for holding a Practitioner’s registration,
see 21 U.S.C. 823(f), this factor is not dispositive in
the public interest inquiry. Patrick Stodola, 74 FR
20727, 20730 n.16 (2009).
Likewise, there is no evidence that Respondent
has been convicted of a criminal offense under
either Federal or State law related to the
distribution or dispensing of a controlled substance
(factor three). However, because there are multiple
reasons why a person may not even be charged, let
alone be convicted of such an offense, DEA has long
held that this factor is not dispositive. See Edmund
Chein, 72 FR 6580, 6593 n.22 (2007).
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M.L.G., a resident of Florida; he
prescribed propoxyphene and
acetaminophen, a schedule IV
controlled substance, to M.S.E., a
resident of Colorado; and on two
occasions, he prescribed alprazolam, a
schedule IV controlled substance to
B.P., a resident of Florida.
Third, Respondent violated the
MOA’s prohibition against his
prescribing to a member of his
immediate family. More specifically, on
September 24, 2007, Respondent
prescribed 160 tablets of phenobarbital,
a schedule IV controlled substance, to
his wife. Moreover, when questioned by
the DIs regarding the prescription,
Respondent denied having called in the
prescription and asserted that he had
only called in a refill of an earlier
prescription which had been written by
another physician. Respondent’s
statement was false because the other
physician had authorized refills for only
sixteen tablets, and it was materially
false because the MOA prohibited him
from prescribing to a family member
and was thus capable of influencing the
decision of the Agency as to whether to
seek the revocation of his registration.
See David A. Hoxie, M.D., 69 FR 51477,
51479 (2004) (considering false
statements to investigators under factor
five).
Fourth, Respondent violated the
MOA’s requirement that he maintain a
log of all controlled-substance
prescriptions he issued. More
specifically, Respondent failed to
document fourteen controlled-substance
prescriptions in the log.
Finally, Respondent violated the
MOA’s requirement that he notify DEA,
in writing, within twenty days, of ‘‘the
initiation of any action by a state entity
to * * * suspend, revoke, or otherwise
limit [his] authority to handle controlled
substances.’’ Notwithstanding that the
State filed an Administrative Complaint
against him, which sought to impose
sanctions on his medical license and his
authority to handle controlled
substances, see Mich. Comp. Laws
§ 333.7311(6), Respondent failed to
notify DEA that the proceeding had
been brought.
DEA has long held that a registrant’s
failure to comply with the terms of an
MOA can constitute acts which render
his registration inconsistent with the
public interest. See Fredal Pharmacy, 55
FR 53592, 53593 (1990) (holding that
pharmacy which violated MOA ‘‘ha[d]
engaged in conduct which threatens the
public health and safety’’). This is so
even if the violation of the MOA does
not establish a violation of the CSA or
its implementing regulations. Moreover,
Respondent’s various violations of the
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MOA, as well as his having made a false
statement to the Investigators, show that
he cannot be trusted to faithfully
comply with the obligations of a
registrant. I therefore conclude that
Respondent’s registration should be
revoked and his pending application
should be denied.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) & 824(a)(4), as well
as by 28 CFR 0.100(b) & 0.104, I order
that DEA Certificate of Registration,
AF9086415, issued to Erwin E.
Feldman, D.O., be, and it hereby is,
revoked. I further order that any
application of Erwin E. Feldman, D.O.,
to renew or modify such registration, be,
and it hereby is, denied. This Order is
effective April 25, 2011.
Dated: March 10, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–7047 Filed 3–24–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Federal Bureau of Prisons
Finding of No Significant Impact;
Notice of Availability of the Finding of
No Significant Impact (FONSI)
Concerning a Proposal To Award a
Contract for New Low Security Beds to
One Private Contractor To House
Approximately 1,000 Federal, LowSecurity, Adult Male, Non-US Citizen,
Criminal Aliens at a Contractor-Owned,
Contractor-Operated Correctional
Facility
U.S. Department of Justice,
Federal Bureau of Prisons.
ACTION: Finding of No Significant
Impact.
AGENCY:
The U.S. Department of
Justice, Federal Bureau of Prisons (BOP)
announces the availability of the
Finding of No Significant Impact
(FONSI) concerning the Environmental
Assessment (EA) for the proposal to
award one or more contracts to house
approximately, 1,000 federal, lowsecurity, adult males, criminal aliens
within one existing contractor owned,
contractor operated facility.
SUMMARY:
Background Information
Growth of the federal inmate
population has been substantial over the
last two decades. Currently, the
increased federal inmate population
exceeds the combined rated capacities
of the 116 BOP facilities. It is projected
that this growth will continue as a result
PO 00000
Frm 00115
Fmt 4703
Sfmt 4703
of actions and programs implemented
by the U.S. Department of Justice and
the U.S. Department of Homeland
Security regarding sentenced and
unsentenced criminal aliens.
In response, the BOP is seeking
flexibility in managing its current
shortage of beds by contracting for those
services with non-federal facilities to
house federal inmates. This approach
provides the BOP with flexibility to
meet population capacity needs in a
timely fashion, conform to federal law,
and maintain fiscal responsibility, while
successfully attaining the mission of the
BOP.
The BOP proposed action is to award
one contract to house approximately
1,000 federal low-security, adult male,
non-U.S. citizen, criminal aliens at an
existing privately owned and privately
operated correctional facility. Under the
Proposed Action, the selected contractor
would be required to operate the facility
in a manner consistent with the mission
and requirements of the BOP. All
inmate services would be developed in
a manner that complies with the BOP’s
contract requirements, as well as
applicable federal, state, and local laws
and regulations. The contract also
requires that no new construction or
expansion of the existing facility occur.
In addition, the facility will be within
proximity, and have access to,
ambulatory, fire and police protection
services. The federal inmates assigned
to this facility would consist primarily
of inmates with sentences of 90 months
or less remaining to be served. As
described previously these inmates are
anticipated to be low-security, adult
male, non-U.S. citizen, criminal aliens,
however the BOP may designate any
inmate within its custody to serve their
sentence in this facility. The contract
awarded for this action would have one
four-year base period and three, twoyear option periods, for a maximum
term of ten years.
Five existing privately owned and
operated correctional facilities in
Kentucky, Louisiana, and Texas have
been offered in response to the BOP’s
nationwide solicitation from which the
BOP will award one contract to one of
the five facilities offered. Each of the
following existing facilities has been
evaluated in this EA. In addition, the No
Action Alternative is evaluated, to
determine baseline conditions and
comply with the provisions of NEPA.
• Lee Adjustment Center. Located on
an approximately 90 acre parcel in
Beattyville, Kentucky.
• Limestone County Detention
Center. Located on a 293 acre parcel in
Groesbeck, Texas.
E:\FR\FM\25MRN1.SGM
25MRN1
]]>Agencies
[Federal Register Volume 76, Number 58 (Friday, March 25, 2011)]
[Notices]
[Pages 16835-16838]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7047]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Erwin E. Feldman, D.O.; Revocation of Registration
On May 29, 2009, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Erwin E. Feldman, D.O. (Respondent), of Madison Heights,
Michigan. The Show Cause Order proposed the revocation of Respondent's
DEA Certificate of Registration, AF9086415, which authorizes him to
dispense controlled substances as a practitioner, and the denial of any
pending applications to renew his registration, on the ground that his
``continued registration is inconsistent with the public interest.''
Show Cause Order at 1 (citing 21 U.S.C. 823(f) and 824(a)).
More specifically, the Show Cause Order alleged that on January 18,
2005, DEA issued an Order to Show Cause to Respondent, which alleged,
inter alia, that between December 2001 and July 2004, he had prescribed
controlled substances on ten occasions to undercover agents without
performing a medical examination, and that he had issued prescriptions
for Suboxone ``to treat opiate addiction without having obtained''
certification from the Michigan Center for Substance Abuse Treatment
and a separate DEA registration to prescribe controlled substances for
``maintenance and detoxification treatment of opiate addiction as
required by 21 U.S.C. 823(g).'' Id. at 1-2.
Next, the Show Cause Order alleged that on April 4, 2007,
Respondent entered into a Memorandum of Agreement (MOA) with the Agency
to resolve the allegations of the 2005 Show Cause Order, which was to
remain in force through May 2010. Id. at 2. The Show Cause Order then
alleged that under the MOA, Respondent agreed that he would prescribe
controlled substances for only a thirty-day supply with one refill;
that he would not prescribe controlled substances to persons who were
not residents of the State of Michigan; that he would not prescribe
controlled substances to family members; that he would maintain a log
of all controlled substance prescriptions he issued; that he would
maintain in patient charts, reports from the Michigan Automated
Prescriptions System (MAPS) for all patients who received controlled
substances from him for ``in excess of six months''; and that he would
notify DEA ``in writing, within twenty days of the initiation of any
proceedings which impacted [his] ability to handle controlled
substances, including the initiation of any action by a state entity to
restrict, deny, rescind, suspend, revoke or otherwise limit [his]
authority to handle controlled substances.'' Id.
Finally, the Show Cause Order alleged that Respondent had violated
the MOA. Id. The Order specifically alleged that ``on several
occasions,'' Respondent had issued controlled substance prescriptions
``with as many as seven refills''; that he had prescribed controlled
substances to residents of Florida and Colorado; that he had prescribed
Phenobarbital, a schedule IV
[[Page 16836]]
controlled substance, to his wife; that he had failed to maintain an
accurate log of his controlled substance prescriptions; that he had
failed to maintain MAPS reports for those patients he prescribed
controlled substances to for more than six months; and that he had
``failed to notify DEA in writing'' that on November 3, 2008, the
Michigan Board of Osteopathic Medicine and Surgery had filed an
administrative complaint against his medical license. Id.
Respondent requested a hearing on the allegations, and the matter
was placed on the docket of the Agency's Administrative Law Judges
(ALJs). Thereafter, the ALJ ordered the parties to file pre-hearing
statements. Ex. 6. On July 27, 2009, the Government filed its pre-
hearing statement; on August 17, Respondent's counsel filed a notice of
appearance and requested a two-week extension to file Respondent's pre-
hearing statement. Id. The record does not disclose what action the ALJ
took in response to Respondent's request for an extension. However, on
September 4, the ALJ issued a ``Notice to Show Cause Why the Proceeding
Should Not Be Terminated'' and gave Respondent ``until September 18 to
respond.'' Id. On September 21, Respondent's counsel faxed a document
which bore the caption of Respondent's Pre-Hearing Statement. Id.
However, when several pages appeared to be missing, the ALJ's office
left telephone messages on September 21, 22 and 23 with Respondent's
counsel, notifying him that the entire document had not been received.
Id.
On September 28, the ALJ issued another ``Notice to Show Cause Why
the Proceeding Should Not Be Terminated'' and gave Respondent until
October 1 to file a response. Id. However, on October 20, 2009, the ALJ
ordered that the proceeding be terminated, noting that Respondent had
not filed a response to the order. Id. The ALJ further ``conclude[d]
that Respondent has waived his right to a hearing.'' Order Terminating
Proceedings, at 1.
Thereafter, the Investigative Record was forwarded to this Office
for final agency action. Having reviewed the entire record in this
matter, I adopt the ALJ's finding that Respondent has waived his right
to a hearing. See 21 CFR 1301.43(d). I make the following findings of
fact.
Findings
Respondent is the holder of DEA Certificate of Registration,
AF9086415, which authorizes him to dispense controlled substances in
schedules II through V as a practitioner. Respondent's registration was
due to expire on September 30, 2008; however, on September 22, 2008,
Respondent submitted a renewal application. Because Respondent's
renewal application was timely submitted, I find that Respondent's
registration remains in effect pending the issuance of this Decision
and Final Order. See 5 U.S.C. 558(c). Moreover, on March 17, 2010,
Respondent submitted a further application for registration as a
practitioner. See GX 2.
On January 18, 2005, the Deputy Assistant Administrator, Office of
Diversion Control, issued an Order to Show Cause to Respondent, which
proposed the revocation of his registration. GX 3. The 2005 Show Cause
Order alleged that Respondent had ``issued numerous prescriptions for
controlled substances to'' an addict, and that he had continued to
prescribe controlled substances to patient P.H. even after he became
aware that P.H. had been admitted to a hospital following an overdose.
Id. at 2-3. This Show Cause Order further alleged that between December
2001 and July 2004, four DEA Agents made undercover visits to
Respondent and that on at least ten occasions, the Agents had obtained
prescriptions ``without having received any type of medical exam.'' Id.
at 3.
The 2005 Show Cause Order also alleged that Respondent was engaged
in family practice, that he issued a substantially greater number of
controlled-substance prescriptions than four other family practice
physicians who practiced at the same medical office building, and that
he had issued approximately 59% of the controlled substance
prescriptions which were dispensed by the Oakland Medical Pharmacy,
which was located in the same building. Id. at 1, 4-5. Finally, the
Show Cause Order alleged that Respondent had prescribed Suboxone to
three patients even though he did not possess a certification issued by
the Michigan Center for Substance Abuse Treatment or a DEA registration
to prescribe controlled substances for maintenance and detoxification
treatment; the Order also alleged that he had prescribed Suboxone to
three patients simultaneously with other controlled substances which
were contraindicated. Id. at 5-6.
Respondent requested a hearing on the allegations of the 2005 Show
Cause Order. Thereafter, the parties settled the matter and entered
into a Memorandum of Agreement (MOA), under which the Agency agreed to
renew Respondent's registration subject to various terms as set forth
in the MOA. The MOA, which became effective on May 21, 2007, was to
remain in force for a period of three years. GX 5, at 2 & 5.
More specifically, Respondent agreed to limit his controlled
substance activities ``to prescribing only,'' that he would prescribe a
controlled substance for only a thirty-day supply with one refill, and
that he would issue a new controlled-substance prescription only after
a patient visited with him. Id. at 2. Respondent also agreed that he
would not prescribe controlled substances to persons who were not
residents of the State of Michigan; that he would not prescribe
controlled substances ``to members of his immediate family''; that he
would maintain a quarterly log of all controlled-substance
prescriptions he issued which would be available to DEA personnel on
request; and that in his patient charts, he would maintain reports from
the Michigan Automated Prescriptions System (MAPS) for all patients who
received controlled substances from him for ``in excess of six
months.'' Id. at 2-3.
Respondent also agreed that he would not ``delegate to any
pharmacist authorization to dispense'' a new controlled-substance
prescription ``or refill an existing prescription * * * prior to
speaking with [him] or his designated representative * * * unless such
prescription is pursuant to a lawful prescription order by [him].'' Id.
at 3. Respondent further agreed to notify DEA ``in writing, within
twenty days of the initiation of any proceedings which impacted [his]
ability to handle controlled substances, including the initiation of
any action by a state entity to restrict, deny, rescind, suspend,
revoke or otherwise limit [his] authority to handle controlled
substances.'' Id. at 4. Finally, Respondent agreed that ``if he
violate[d] any term or condition of [the MOA], such violation could
result in [the] initiation of proceedings to revoke his'' DEA
registration. Id. at 4-5.
According to the affidavit of a DEA Diversion Investigator (DI),
following Respondent's submission of his renewal application, DIs
obtained from both local pharmacies and MAPS, information pertaining to
the prescriptions issued by Respondent; the DIs also met with
Respondent on February 11, 2009 to review his compliance with the MOA.
GX 22, at 4-5.
During the February 11, 2009 meeting, Respondent provided the DIs
with his controlled-substance prescription log. Id. at 5. The log
showed that Respondent had issued prescriptions to several patients
with ``as many as five refills'' for Androgel, a schedule III
controlled substance, as well as that he had issued prescriptions with
between
[[Page 16837]]
three and seven refills, to multiple patients for Testim, another
schedule III controlled substance. Id.; see also GXs 7, 9-11, 13. The
evidence also showed that Respondent had issued a prescription for
Ativan (lorazepam), a schedule IV controlled substance, with three
refills, to two different patients. See GX 7.
Based on their review of MAPS data and medical records, the DIs
further determined that on December 21, 2007, Respondent had issued a
prescription for hydrocodone/acetaminophen, a schedule III controlled
substance to M.L.G., a resident of Florida; that on January 8, 2008, he
had issued a prescription for propoxyphene/acetaminophen, a schedule IV
controlled substance, to M.S.E., a resident of Colorado; and that on
July 25 and August 18, 2008, he had issued prescriptions for 60 and 90
tablets of alprazolam, a schedule IV controlled substance, to B.P., a
resident of Port Orange, Florida. GX 22, at 6. The DIs further
determined that on September 24, 2007, Respondent prescribed 160
tablets of phenobarbital, a schedule IV controlled substance, to his
wife, by calling in a prescription to a local pharmacy. Id. at 7; see
also GX 16. Moreover, during the February 11, 2009 meeting with the
DIs, Respondent denied calling in the prescription for his wife and
maintained ``that he called in a refill of an earlier phenobarbital
prescription issued by'' another physician (Dr. C.) on September 21,
2007. GX 22, at 7. However, the prescription issued by Dr. C. was for
only sixteen tablets with two refills. Id.
In addition, the DIs compared the MAPS report showing Respondent's
prescribing with the controlled-substance log he was required to
maintain. Id. at 8. This review showed that Respondent had failed to
document fourteen prescriptions in the log. Id. Upon reviewing the
patient charts, the DIs also found various instances in which
Respondent had prescribed controlled substances to a patient for more
than six months and had not maintained a MAPS report in the patient's
chart. Id. at 9.
Finally, on November 3, 2008, the Michigan Board of Ostheopathic
Medicine and Surgery issued an administrative complaint to Respondent
charging him with eight counts of violating state law, including five
counts of ``prescribing drugs without a lawful diagnostic or
therapeutic purpose.'' GX 18, at 5-12; 19 (citing Mich. Comp. Laws
Sec. 16221(c)(iv)). The Board also charged Respondent with negligence
and incompetence based on his prescribing of Suboxone to treat opioid
dependence without having ``obtain[ed] the necessary certification.''
Id. at 18-19 (citing Mich. Comp. Laws Sec. Sec. 16221(a) and
16221(b)(i)). While the Board sought to impose sanctions on
Respondent's medical license,\1\ see id. at 1-3, Respondent did not
notify DEA of the proceeding.\2\ GX 22, at 10.
---------------------------------------------------------------------------
\1\ Respondent received the complaint on November 8, 2008. See
GX 19 (letter from Respondent to Michigan Bureau of Health
Professions).
\2\ In its Request for Final Agency Action, the Government also
contends that Respondent altered the expiration date of his
registration when he submitted his credentials to a health insurance
company. The Government did not, however, establish that it provided
notice to Respondent of its intent to rely on this conduct in this
proceeding.
---------------------------------------------------------------------------
Discussion
Section 304(a) of the CSA provides that a ``registration pursuant
to section 823 of this title to * * * dispense a controlled substance *
* * may be suspended or revoked by the Attorney General upon a finding
that the registrant * * * has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21 U.S.C.
824(a)(4). In determining the public interest, Congress directed 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 * * * 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 and
safety.
21 U.S.C. 823(f).
``[T]hese factors are considered in the disjunctive.'' Robert A.
Leslie, 68 FR 15227, 15230 (2003). I may rely on any one or a
combination of factors and may give each factor the weight I deem
appropriate in determining whether to revoke an existing registration
or to deny an application for a registration. Id. Moreover, I am ``not
required to make findings as to all of the factors.'' Hoxie v. DEA, 419
F.3d 477, 482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165,
173-74 (D.C. Cir. 2005).\3\
---------------------------------------------------------------------------
\3\ The Government has ``the burden of proving that the
requirements for * * * revocation or suspension pursuant to section
304(a) * * * are satisfied.'' 21 CFR 1301.44(e); see also 21 CFR
1301.44(d) (Government has ``the burden of proving that the
requirement for [a] registration pursuant to section 303 * * * are
not satisfied''). In a contested hearing, where the Government
satisfies its prima facie burden, the burden then shifts to the
registrant to demonstrate why he can be entrusted with a new
registration. Medicine Shoppe-Jonesborough, 73 FR 363, 380 (2008).
---------------------------------------------------------------------------
In this matter, I conclude that the record establishes that
Respondent has violated multiple provisions of the MOA and that these
violations are relevant under factors two and five. The record also
establishes that Respondent made a false statement to DEA Investigators
when he denied having issued a controlled substance prescription to his
wife. This conduct is also relevant under factor five. I therefore
conclude that Respondent has committed acts which render his
registration inconsistent with the public interest and that these acts
are sufficiently egregious to warrant the revocation of his
registration.\4\
---------------------------------------------------------------------------
\4\ With respect to factor one, while the Investigative Record
contains a copy of the Administrative Complaint filed by the
Michigan Board, there is no evidence establishing the outcome of
this proceeding. However, even assuming that Respondent retains his
state authority, DEA has long held that while the possession of
state authority is an essential condition for holding a
Practitioner's registration, see 21 U.S.C. 823(f), this factor is
not dispositive in the public interest inquiry. Patrick Stodola, 74
FR 20727, 20730 n.16 (2009).
Likewise, there is no evidence that Respondent has been
convicted of a criminal offense under either Federal or State law
related to the distribution or dispensing of a controlled substance
(factor three). However, because there are multiple reasons why a
person may not even be charged, let alone be convicted of such an
offense, DEA has long held that this factor is not dispositive. See
Edmund Chein, 72 FR 6580, 6593 n.22 (2007).
---------------------------------------------------------------------------
Factors Two and Five--Respondent's Experience in Dispensing Controlled
Substances and Such Other Conduct Which May Threaten Public Health and
Safety
In May of 2007, DEA exercised forbearance and allowed Respondent to
settle a previous Show Cause proceeding by entering into an MOA.
However, as found above, Respondent promptly proceeded to violate
multiple provisions of the MOA.
First, Respondent violated the MOA's restriction that he could only
prescribe a thirty-day supply of a controlled substance with one
refill, and that he could issue a new prescription only after the
patient visited him. More specifically, the record shows that
Respondent issued prescriptions which authorized multiple refills to
multiple patients for both schedule III anabolic steroids (Androgel and
Testim) and a schedule IV depressant (lorazepam).
Second, Respondent violated the MOA's provision that he could not
prescribe a controlled substance to a non-resident of Michigan. More
specifically, Respondent prescribed hydrocodone/acetaminophen, a
schedule III controlled substance, to
[[Page 16838]]
M.L.G., a resident of Florida; he prescribed propoxyphene and
acetaminophen, a schedule IV controlled substance, to M.S.E., a
resident of Colorado; and on two occasions, he prescribed alprazolam, a
schedule IV controlled substance to B.P., a resident of Florida.
Third, Respondent violated the MOA's prohibition against his
prescribing to a member of his immediate family. More specifically, on
September 24, 2007, Respondent prescribed 160 tablets of phenobarbital,
a schedule IV controlled substance, to his wife. Moreover, when
questioned by the DIs regarding the prescription, Respondent denied
having called in the prescription and asserted that he had only called
in a refill of an earlier prescription which had been written by
another physician. Respondent's statement was false because the other
physician had authorized refills for only sixteen tablets, and it was
materially false because the MOA prohibited him from prescribing to a
family member and was thus capable of influencing the decision of the
Agency as to whether to seek the revocation of his registration. See
David A. Hoxie, M.D., 69 FR 51477, 51479 (2004) (considering false
statements to investigators under factor five).
Fourth, Respondent violated the MOA's requirement that he maintain
a log of all controlled-substance prescriptions he issued. More
specifically, Respondent failed to document fourteen controlled-
substance prescriptions in the log.
Finally, Respondent violated the MOA's requirement that he notify
DEA, in writing, within twenty days, of ``the initiation of any action
by a state entity to * * * suspend, revoke, or otherwise limit [his]
authority to handle controlled substances.'' Notwithstanding that the
State filed an Administrative Complaint against him, which sought to
impose sanctions on his medical license and his authority to handle
controlled substances, see Mich. Comp. Laws Sec. 333.7311(6),
Respondent failed to notify DEA that the proceeding had been brought.
DEA has long held that a registrant's failure to comply with the
terms of an MOA can constitute acts which render his registration
inconsistent with the public interest. See Fredal Pharmacy, 55 FR
53592, 53593 (1990) (holding that pharmacy which violated MOA ``ha[d]
engaged in conduct which threatens the public health and safety'').
This is so even if the violation of the MOA does not establish a
violation of the CSA or its implementing regulations. Moreover,
Respondent's various violations of the MOA, as well as his having made
a false statement to the Investigators, show that he cannot be trusted
to faithfully comply with the obligations of a registrant. I therefore
conclude that Respondent's registration should be revoked and his
pending application should be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a)(4), as well as by 28 CFR 0.100(b) & 0.104, I order that DEA
Certificate of Registration, AF9086415, issued to Erwin E. Feldman,
D.O., be, and it hereby is, revoked. I further order that any
application of Erwin E. Feldman, D.O., to renew or modify such
registration, be, and it hereby is, denied. This Order is effective
April 25, 2011.
Dated: March 10, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-7047 Filed 3-24-11; 8:45 am]
BILLING CODE 4410-09-P
