[Federal Register Volume 68, Number 243 (Thursday, December 18, 2003)]
[Notices]
[Pages 70534-70538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-31218]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Larry E. Davenport, M.D.: Denial of Application for DEA 
Registration

I. Background

    On September 21, 2001, the Deputy Assistant Administrator, Office 
of Diversion Control, Drug Enforcement Administration (DEA) issued an 
Order to Show Cause (OTSC) to Larry E. Davenport, M.D., (Respondent), 
proposing to deny his application for a DEA Certificate of 
Registration. The basis for the Order to Show Cause was that 
Respondent's registration would be inconsistent with the public 
interest as that term is used 21 U.S.C. 823(f). More specifically, the 
OTSC alleged that the Tennessee Department of Health found that in 1998 
and 1999, Respondent obtained Schedule II and III controlled substances 
for the personal use of Respondent and his wife. Respondent obtained 
the drugs by telephoning in prescriptions using the DEA registration 
numbers of several different physicians. Sometimes he had his employees 
do the calling. The OTSC also alleged that Respondent removed 
controlled substances from the clinic where he was employed, including 
Emerol, a Schedule II controlled substance.
    By letter dated December 10, 2001, Respondent,through his legal 
counsel, requested a hearing on the issues raised in the OTSC. The 
matter was placed on the docket of Administrative Law Judge Gail A. 
Randall. (The ALJ).
    The following prehearing procedures, testimony was presented before 
the ALJ on June 5 and 6, 2002, in Knoxville, Tennessee. The Government 
presented testimony from three witnesses and had admitted into evidence 
several exhibits.

[[Page 70535]]

Respondent testified on his behalf and also had several exhibits 
admitted into evidence. After the hearing, both parties submitted 
Proposed Findings of Fact, conclusions of Law and Argument.
    On August 6, 2003, the ALJ certified and transmitted the record to 
the Acting Deputy Administrator of DEA. The record included, among 
other thing, the Recommended Rulings, Findings of Fact, Conclusions of 
Law and Decision of the Administrative Law Judge, the findings of act 
and conclusions of law proposed by all parties, all of the exhibits and 
affidavits, and the tr4anscript of the hearing sessions.

II. Final Order

    The Acting Deputy Administrator does not adopt the Findings of 
Fact, Conclusions of Law, and Decision of the Administrative Law Judge. 
The Acting Deputy Administrator has carefully reviewed the entire 
record in this matter, as defined above, and hereby issues this final 
rule and final order prescribed by 21 CFR 1316.67 and 21 CFR 1301.46, 
based upon the following findings of fact and conclusions of law.
    The Government adduced substantial evidence at the hearing that in 
1998 and 1999, Respondent was diverting Demerol, a Schedule II 
controlled substance, for his own use. At the hearing, Pam Runyon-Dean 
(Ms. Runyon-Dean) testified on behalf of the Government. Ms. Runyon-
Dean was a medical assistant at Respondent's clinic, the MediCenter, in 
Pigeon Forge, Tennessee form May 1995 until January 1999. After 
completing training to become a medical assistant, she did her 
externship at the MediCenter.
    Ms. Runyon-Dean testified about her observations of the 
Respondent's diversion of Demerol. As the result of a complaint, the 
Tennessee Health Related Board (HRB) initiated an investigation of 
Respondent. Marianne Cheaves, an HRB investigator, met with Ms. Runyon-
Dean and another employee of the MediCenter, and suggested that Ms. 
Runyon-Dean maintain notes of events occuring there. Since Ms. Runyon-
Dean already utilized a daily planner, she used it to write her notes, 
which she then transferred on to lined notebook pages. The notes were 
later faxed to Investigator Cheaves. Entries were written on the date 
when incidents occurred.
    Ms. Runyon-Dean testified that Demerol and other controlled 
substances at the MediCenter were stored in a safe in a closet. The 
dispensing of controlled substances was recorded on a drug log, usually 
by a medical assistant. There were no other procedure to keep track of 
controlled substances at the MediCenter.
    On September 22, 1998, and again on September 29, 1998, Ms. Runyon-
Dean recorded in her log Respondent's requests for tuberculin syringes, 
which he claimed were necessary to give his daughter allergy shots at 
home. On October 6, 1998, Ms. Runyon-Dean observed that Respondent's 
speech ``became more slurred, his eyes were glassy and droopy, he was 
real groggy and sleepy.'' Ms. Runyon-Dean also wrote that Respondent 
went to the Pigeon Forge Drugstore and picked up a bottle of Demerol, 
and later spent ``a lot of time in the restroom.'' On the same day, Ms. 
Runyon-Dean, who was solely responsible for keeping the employees' 
restroom clean, noticed several Kleenex tissues in the employee's 
restroom trash can that had small spots of blood on them.
    On the same day, Ms. Runyon-Dean recorded in her log a conversation 
with another employee, Sherry Linsey. After Ms. Lindsey learned that 
Ms. Runyon-Dean provided syringes to Respondent, she stated that 
Respondent's daughter did not receive allergy injections. Ms. Runyon-
Dean never witnessed Respondent's daughter receive an allergy shot at 
the MediCenter and the medical record at the MediCenter for 
Respondent's daughter did not corroborate any recommendations for 
allergy shots. At the hearing, Respondent testified that his daughter 
suffers from allergies and that Ms. Lindsey should not have made the 
above statements because she doesn't know his daughter's condition. 
However, Respondents presented no documentary evidence of his 
daughter's condition.
    On October 9, 1998, Ms. Runyon-Dean reported in her log that she 
went into the employee's restroom after Respondent came out and found 
blood spots on the commode seat. She had to wipe the spots before she 
could use the commode. When she threw away her paper towel, Ms. Runyon-
Dean saw a wrapper in the trash can from one of the MediCenter's 3cc 
syringes. It was the only thing she saw in the trash can. Ms. Runyon-
Dean testified that the trash can was empty prior to Respondent's use 
of the restroom that day because she had cleaned the facility that 
morning. Ms. Runyon-Dean did not notice blood spots prior to Respondent 
going into the restroom. She also thought it odd to find a 3cc syringe 
in the employee's restroom because there was no medication in the room 
and the room was not used to give injections.
    On October 11, 1998, Ms. Runyon-Dean again observed that Respondent 
spent a lot of time in the restroom, and again noticed throughout the 
day blood spots on Kleenex in the trash can along with blood spots on 
the commode and sink in the employees' restroom. At the end of the day, 
she saw Respondent emerge from the employee's restroom and drop a 
bloody Kleenex into a trash can next to the drug closet.
    Respondent testified that the bloody tissues could have been from 
anybody, including staff or patients. However, Ms. Runyon-Dean 
testified that aside from these occasions, she never saw blood on the 
lid of the commode of the employees' restroom and on the occasions 
where she saw blood, she knew no one had used the restroom other than 
Respondent. Ms. Runyon-Dean further testified that initially, she would 
clean the employees' restroom once or twice a day; however, after the 
change in Respondent's behavior, she would sometimes have to clean the 
restroom five or six times per day as other employees alerted her that 
there was blood in the restroom that needed to be cleaned up.
    On October 13, 1998, Ms. Runyon-Dean also noted in her log a 
meeting between Sheri Linsey and Respondent about Demerol that was 
missing from the drug safe. Respondent told the staff that if the drug 
was missing, then the drug would no longer be kept in the office. This 
account was corroborated by Respondent's testimony. Ms. Runyon-Dean 
noted that the staff agreed with the Respondent's decision to keep the 
drug out of the office. Ms. Runyon-Dean further noted, however, that 
the reason the drug was missing was that Ms. Lindsey (unbeknownst to 
Respondent) had taken the drug out of the safe the previous Friday 
afternoon and hid it in the front office to keep it from Respondent. 
Ms. Runyon-Dean testified that Ms. Lindsey told her that she hid the 
bottle of Demerol from Respondent because she felt that he was taking 
it for personal use. Ms. Runyon-Dean also noted that after a few days, 
a bottle of Demerol was back in the drug safe.
    On October 19, 1998, Ms. Runyon-Dean noted in her log that 
Respondent called her in the morning, and his speech was slurred and he 
would lose his train of thought in the middle of a sentence. Respondent 
came into the MediCenter later that day, and Ms. Runyon-Dean again 
noted that Respondent's speech was slurred. Ms. Runyon-Dean also noted 
that as the day progressed, Respondent became more and more sleepy, 
groggy and glassy eyed, and his speech became more slurred, to a point 
where his words were very drawn out.

[[Page 70536]]

    During his testimony, Respondent disagreed and attributed his 
demeanor to the lack of sleep. Respondent also testified that he 
doubted his speech was slurred.
    On that same date, Ms. Edna Kimble, a patient of the MediCenter, 
told Ms. Runyon-Dean that she observed Respondent take a syringe into 
the employees' restroom, and later return with a bloody Band-Aid on his 
right arm, holding a bloody Kleenex on it. When Ms. Kimble asked the 
Respondent why he was bleeding, he informed her that Terry Sutton, an 
employee of the MediCenter, had drawn Respondent's blood to measure his 
cholesterol. Ms. Runyon-Dean testified that when she asked Mr. Sutton 
that day if he had drawn any blood, or tried to draw blood from the 
Respondent that day, Mr. Sutton stated that he had been too busy and 
had not drawn Respondent's or anyone else's blood on that day. Later 
that day, Ms. Runyon-Dean emptied the trash can in the employees' 
restroom and found several bloodied Kleenex along with two empty 
packages of generic Halcion. Ms. Runyon-Dean also saw a Band Aid on 
Respondent's arm.
    During his testimony, the Respondent again attributed the blood on 
his arm to the ``one time'' that his employee, Terry Sutton, attempted 
to draw Respondent's blood. Respondent claimed that Mr. Sutton got a 
``flashback'' (``pierced the vein''). Respondent failed to explain, 
however, why Mr. Sutton denied drawing Respondent's blood, and did not 
continue the blood drawing procedure at another location on the vein or 
on another vein after he had gotten the flashback. When Ms. Runyon-Dean 
asked Mr. Sutton whether he had drawn blood that day from Respondent, 
Mr. Sutton did not mention to Ms. Runyon-Dean that there had been any 
``flashback'' in an attempt to draw blood from Respondent.
    Ms. Runyon-Dean further testified that anytime MediCenter staff 
drew blood from someone, requisitions for the lab are filled out. On 
October 19, 1998, there were no requisitions for lab worked filled out 
on the Respondent. At the hearing, Respondent contested Ms. Runyon-
Dean's account, stating that she never asked Terry Sutton about drawing 
blood, and that in any event ``* * * it's none of her business when I 
draw blood and when I don't draw blood.''
    In her log entry for October 20, 1998, Ms. Runyon-Dean noted her 
observations of Respondent entering the MediClinic that morning and 
proceeding straight to the drug closet. She then realized that he had 
gone into the drug safe where the Demerol and other controlled 
substances were kept, because she heard the bottles jingling. She then 
observed Respondent go into the employees' restroom. Ms. Runyon-Dean 
immediately asked Julie Bowman, an office employee, to check the drug 
safe. Upon inspection, the Demerol was missing. Ms. Runyon-Dean 
testified that she, along with Ms. Bowman and another office employee, 
noted that the Demerol was present in the safe prior to Respondent 
going into the safe. About 20 minutes later, after Respondent had 
emerged from the restroom, the MediCenter staff noticed that the bottle 
of Demerol had been returned to the drug safe. Ms. Runyon-Dean 
testified that periodically during that day, the bottle of Demerol was 
missing and those times corresponded to Respondent's visits to the 
employees' restroom. By the end of the day, the bottle of Demerol had 
disappeared and was never returned to the safe.
    In addition to testifying that blood spots on his shirt were 
attributed to a ``flashback'' brought about as a result of blood being 
drawn by an employee, Respondent further testified that blood would 
also ``spray back'' on him from lancing wounds and the like. Respondent 
also testified that blood found in the employees' restroom was form 
employees going there to wash off blood if it got splattered.
    Ms. Runyon-Dean noted in her log that on October 20, 1998, 
Respondent's shirt sleeves were rolled up to the elbows, and there were 
blood spots on his ``left arm sleeve.'' She further testified during 
the hearing that Respondent had blood stains on his t-shirt underneath 
his scrubs. On one occasion, Respondent was observed with a syringe 
sticking out of the top of his left back pocket. On that same date, 
MediCenter staff witnessed Ms. Runyon-Dean empty the trash in the 
employees' restroom. The contents of the trash revealed several wads of 
wet paper towels with blood on them along with two ``very bloody'' Band 
Aids.
    On October 2, 1998, Respondent was not in the MediCenter and the 
Demerol was missing from the drug safe. Respondent called later and 
told Ms. Lindsey that he had taken the Demerol and emptied it out 
because he did not want to keep it in the office anymore. He then told 
Ms. Lindsey that he had changed his mind and asked her to get a new 
bottle of Demerol from the pharmacy.
    HRB Inspector Cheaves also testified about the MediCenter's 
handling of Demerol. She first performed an audit of the Demerol 
purchased by the clinic for a period of approximately one year. It 
showed that the clinic had received 14,000 milligrams of Demerol during 
the period. She then calculated how much Demerol had been dispensed to 
the clinic's patients during that time. The audit showed that 10,100 
milligrams were not accounted for.
    Thus, there is substantial evidence to conclude that Respondent 
abused Demerol in 1998 and 1999, and at the hearing, Respondent 
provided very little evidence to rebut this conclusion. The large 
amount of Demerol unaccounted for in Ms. Cheave's audit, Respondent's 
seemingly drugged behavior on certain days, his frequent forays into 
the employees' restroom, leaving behind syringes, bloody band aids, 
tissues and blood on the commode, the disappearance and reappearance of 
the Demerol bottle in the drug safe corresponding to Respondent's 
visits to the restroom, Respondent's untruths about having his blood 
drawn and the prescription for Demerol syrup (see infra) together 
constitute ample evidence that Respondent diverted a substantial amount 
of Demerol for his own use.
    The Government also adduced plentiful evidence that from 1995 until 
1998, Respondent was calling in prescriptions, or having his employees 
call in prescriptions, for Respondent and his family, using the names 
of other doctors at the MediCenter. The Government produced a copy of 
an Agreed Order entered into by Respondent and the Tennessee Department 
of Health (the Department) in January 2001. In the Agreed Order, 
Respondent agreed that he had issued 41 prescriptions for controlled 
substances for his wife and himself under the names of other 
physicians. The Agreed Order was signed by Respondent on January 21, 
2001. The controlled substances included Halcion, Ambien, Hydrocodone 
and Lorcet. The Department suspended Respondent's medical license for 
three months and levied a fine, followed by a two-year period of 
probation.
    The evidence presented by the Government at the hearing confirmed 
Respondent's misconduct. Ms. Runyon-Dean testified that she had heard 
Respondent call in prescriptions for himself and his family members, 
requesting that the prescriptions be issued under the names of other 
doctors at the MediCenter. Two pharmacists told the HRB investigator 
that Respondent had called in prescriptions for himself and his wife 
and had asked that the prescriptions be issued in another physician's 
name. The pharmacists knew that Respondent was on the phone because 
they recognized his voice. Ms. Runyon-Dean testified that when some of 
the physicians at the

[[Page 70537]]

MediCenter found out that their names had been used on prescriptions 
that they had not issued, became upset about it.
    From October 13, 1998, through the middle of the year 2000, HRB 
investigators conducted interviews of past and present employees of the 
MediCenter, including nine physicians. The physicians interviewed were 
shown pharmacy printouts and original prescriptions for controlled 
substances purportedly issued in their names for Respondent and his 
wife. The physicians were asked to review and verify the prescriptions 
in question. All but two of the physicians confirmed that they had not 
authorized the prescriptions attributed to them. One physician was 
unsure whether he had authorized the prescriptions. One of the 
physicians told the investigator that when he later confronted 
Respondent about the prescriptions issued in his name (to which 
Respondent admitted), the Respondent replied ``that's what partners 
do.''
    One physician, Dr. Underwood, confirmed that he had approved a 
prescription for Respondent's wife. The doctor explained that he issued 
a prescription for Lorcet, a Schedule III controlled substance, to 
Respondent's wife, because Respondent had told him that his wife was 
experiencing painful periods. The physician admitted, however, that he 
had never seen Respondent's wife.
    In a later interview, Dr. Underwood further explained that on or 
about February 5, 1999, he received a telephone call from the 
Respondent and was advised that the Respondent had called in another 
prescription for his wife, apparently using Dr. Underwood's name and 
DEA registration number. In a February 17, 1999, written statement, Dr. 
Underwood stated: ``Without my knowledge or permission, neither express 
or implied, [Respondent] apparently, called in a prescription of a pain 
medicine, as well as, anaprox ds and a sedative for insomnia using my 
name and DEA number * * * [h]e did not tell me the date that he called 
in the prescription, nor the pharmacy that he called.''
    At the hearing, Respondent denied that he had ever called in a 
prescription using another doctor's name without first obtaining the 
physician's permission. He contended that he, or one of his employees, 
had asked the doctors to call in the prescriptions for him, and that 
this was run of the mill practice at the clinic. Respondent claimed 
that the doctors must have forgotten to annotate the patient charts, 
and were now lying to protect themselves.
    The Government also presented the testimony of DEA Diversion 
Investigator (D/I) Rhonda Phillips. Investigator Phillips has been a 
Diversion Investigator with the DEA Nashville Office for fourteen 
years. She testified that Respondent came to the attention of DEA in 
1999, when the HRB requested assistance in its investigation of 
Respondent. In the course of its investigation, DEA received a copy of 
a report prepared by the Federal Bureau of Investigation (FBI). The 
initial target of the FBI investigation was a chiropractor, however, 
Dr. Underwood was interviewed as part of that investigation. Dr. 
Underwood stated in the report that Respondent posed as him in calling 
in a Vicodin prescription for Respondent's wife around January 1999. 
According to Dr. Underwood, Respondent apparently became concerned 
about being caught, and told Dr. Underwood, in effect, that ``We have 
to do something.'' Respondent then requested that Dr. Underwood 
postdate a patient chart for his wife to make it appear that the 
earlier prescription was medically necessary. Dr. Underwood refused to 
take such action. At the hearing, Respondent denied asking Dr. 
Underwood to cover up the prescription, claiming that Dr. Underwood was 
lying in order to protect himself.
    There was also evidence that Respondent issued prescriptions in his 
own name for his own use. On March 22, 2001, DEA personnel interviewed 
Clark M. Kent, former registered pharmacist for Drugs For Less 
2121 in Halls, Tennessee. Mr. Kent stated that Respondent 
would come into the pharmacy and write hydrocodone prescriptions in the 
names of other individuals and take the controlled substances with him. 
Mr. Kent further recalled a conversation where Respondent asked Mr. 
Kent if he would fill a call-in prescription that was issued under Dr. 
O'Shaughnessy's name. Mr. Kent stated that he declined Respondent's 
request because it violated federal and state regulations. Mr. Kent 
also informed investigators that Respondent called in a prescription 
for Demerol syrup for the latter's son. Mr. Kent found the prescription 
unusual since that type of medication was not ordinary for a young 
individual. During the hearing, Respondent denied that he had called in 
a prescription for Demerol syrup for his son.
    The Government also presented evidence concerning Respondent's 
issuance of controlled substance prescriptions after his DEA 
registration expired in July 1998. In the Agreed Order, Respondent 
agreed that he had issued prescriptions for controlled substances after 
the expiration of his DEA registration.
    At the hearing, Respondent admitted that he had issued 
prescriptions for controlled substances after his DEA registration had 
expired, blaming it on his own negligence. He claimed that he wrote the 
prescriptions not realizing that his registration had expired. The 
Government presented evidence, however, that Respondent continued to 
issue several prescriptions for controlled substances after he learned 
of the expiration of his registration. The evidence showed that 
Respondent learned about the expiration of his registration in late 
1998. Respondent testified that he stopped writing prescriptions after 
he learned of the expiration of his DEA registration and instructed his 
staff not to refill or call in any prescriptions using his name. 
Nevertheless, Investigator Cheaves obtained a prescription profile from 
the Medicine Shoppe in Knoxville, Tennessee showing that on January 7, 
1999, after Respondent learned that his DEA registration had expired, a 
prescription for Valium was filled for patient Hugh Ray Wilson under 
Respondent's expired DEA registration number, and two prescriptions for 
Ambien for Mr. Wilson were refilled under that registration number on 
January 26 and April 7, 1999.
    On January 23, 1999, a prescription was filed for Clorazepate 
Dipotassium (a Schedule IV controlled substance); on February 10, 1999, 
a prescription was filled for Guaituss DAC Syrup (a Schedule V 
controlled substance); on May 26, 2000,\1\ a prescription was filled 
for Lomitil liquid (diphenoxylate hydrochloride and atropine sulfate (a 
Schedule V controlled substance). With respect to the Lomitil 
prescription, Respondent admitted calling it in, but added that he 
didn't know the drug was a controlled substance. Respondent later added 
that someone from his staff may have called in the prescription.
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    \1\ This prescription was also authorized following Respondent's 
submission of his January 3, 2000 application for DEA registration.
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    Based upon the above, the Acting Deputy Administrator finds that 
Respondent diverted substantial amounts of Demerol for his own use; 
failed to comply with DEA regulations to account for controlled 
substances at his place of business; called in or caused to be called 
in controlled substance prescriptions for himself and his wife using 
other physicians' names; and negligently issued prescriptions for

[[Page 70538]]

controlled substances after his DEA registration had expired.
    The Acting Deputy Administrator will now consider the factors used 
by DEA to determine the public interest. Under 21 U.S.C. 823(f), the 
Attorney General shall register a practitioner to handle controlled 
substances unless the Attorney General determines that the registration 
of the applicant is inconsistent with public interest.\2\ In 
determining the public interest, the Acting Deputy Administrator shall 
consider:
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    \2\ This function has been redelegated to the Acting Deputy 
Administrator of DEA.
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    1. Maintenance by the applicant of effective controls against 
diversion of listed chemicals into other than legitimate channels;
    2. Compliance by the applicant with applicable Federal, State, and 
local laws;
    3. Any prior conviction record of the applicant under Federal or 
State laws relating to controlled substances or the chemicals 
controlled under Federal or State law;
    4. Any past experience of the applicant in the manufacture and 
distribution of chemicals, and
    5. Such other factors as are relevant to and consistent with the 
public health and safety.
    Consideration of the first factor weights heavily against 
Respondent. Respondent could not account for a large amount of Demerol 
that had been purchased by the MediCenter. Respondent never audited his 
supplies of controlled substances and at the hearing testified that he 
was not even aware of the existence of the Code of Federal Regulations.
    With regard to the second factor, there was substantial evidence 
that Respondent failed to comply with Federal, State and local law. His 
diversion of Demerol for his own use violated 21 U.S.C. 841(a). His 
failure to conduct audits of the controlled substances in his place of 
business violated 21 U.S.C. 827. Respondent's issuance of prescriptions 
to himself and his wife under other doctors' names violated 21 U.S.C. 
841(a) and 21 CFR 1306.04 and 1306.05.
    As for the third factor, there is no evidence that Respondent had 
any prior convictions related to controlled substances. The fourth 
factor is not relevant to these proceedings.
    With regard to the fifth factor, many considerations weigh heavily 
against providing Respondent with a DEA Certificate of Registration. 
Respondent's misconduct is extremely alarming. The diversion of Demerol 
for his own use and his long-term issuance of prescriptions for 
controlled substances in other physicians' names are particularly 
disturbing. Moreover, even in the face of overwhelming evidence of his 
misconduct, Respondent has failed to admit to any intentional 
misconduct whatsoever. Respondent's appalling misconduct and his 
continued denials about his misuse of controlled substances show that 
he has failed to recognize the gravity of his actions and that it would 
not be in the public interest to permit him to handle controlled 
substances. Accordingly, the Acting Deputy Administrator of the Drug 
Enforcement Administration, pursuant to the authority vested in her by 
21 U.S.C. 823 and 824 and 28 CFR 0.100 and 0.104, hereby finds that the 
performance of the evidence establishes that the registration of 
Respondent as a practitioner would be inconsistent with the public 
interest.
    Therefore the Acting Deputy Administrator hereby orders that 
Respondent's application for a DEA Certificate of Registration and any 
requests for renewal or modification submitted by Respondent be, and 
hereby are, denied.

    Dated: November 26, 2003.
Michele M. Leonhart,
Acting Deputy Administrator.
[FR Doc. 03-31218 Filed 12-17-03; 8:45 am]
BILLING CODE 4410-09-M