[Federal Register Volume 74, Number 204 (Friday, October 23, 2009)]
[Notices]
[Pages 54851-54853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25480]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 07-6]


Samuel H. Albert, M.D.; Dismissal of Proceeding

    On October 25, 2006, the Deputy Assistant Administrator, Office of 
Diversion Control, issued an Order to Show Cause to Samuel H. Albert, 
M.D. (Respondent), of Fountain Valley, California. ALJ Ex. 1, at 1. The 
Show Cause Order proposed the denial of Respondent's ``pending 
application for a DEA Certificate of Registration'' as a practitioner 
on the grounds that on this application, which he submitted on March 
24, 2006, as well as on multiple previous applications for renewal of 
his previous registration, Respondent had materially falsified his 
applications by failing to indicate that the Medical Board of 
California had imposed disciplinary sanctions on his state medical 
license, which included a revocation which was stayed, a thirty-day 
suspension, and the imposition of probationary terms. Id. at 1-2 
(citing 21 U.S.C. 824(a)(1)). The Show Cause Order further alleged that 
Respondent's previous registration had expired on June 5, 2005, and 
that thereafter, Respondent had issued approximately 200 controlled 
substance prescriptions without being registered. Id. at 1-2. (citing 
21 U.S.C. 822(a)(2), 841(a)(1), 843(a)(2)).
    Respondent requested a hearing on the allegations and the matter 
was assigned to an Administrative Law Judge (ALJ), who conducted a 
hearing in Los Angeles, California. ALJ Dec. at 3. At the hearing, both 
parties elicited testimonial evidence and introduced documentary 
evidence. Id. at 3. Following the hearing, both parties filed briefs 
containing their proposed findings of fact, conclusion of law, and 
argument.
    Thereafter, the ALJ issued her recommended decision. Neither party 
filed exceptions. The record was then forwarded to me for final agency 
action.
    Upon reviewing the record, I noted that on May 16, 2006, more than 
five months prior to the issuance of the Order to Show Cause, 
Respondent submitted a letter to a DEA Field Office in which he 
requested to withdraw his application to renew his registration. See RX 
C. Under an Agency regulation, ``[a]n application may be amended or 
withdrawn without permission of the Administrator at any time before 
the date on which the applicant receives an order to show cause.'' 21 
CFR 1301.16(a) (emphasis added). Because this regulation plainly did 
not require that Respondent obtain permission from the Agency for the 
withdrawal of his application to be effective and it thus appeared that 
Respondent did not have an application currently pending before the 
Agency, I ordered the parties to address whether this proceeding is 
ripe for adjudication.
    Thereafter, only the Government filed a brief. Having considered 
the Government's arguments, I conclude that there is no application 
currently pending before the Agency and that this case is not ripe for 
adjudication. Accordingly, the Order to Show Cause must be dismissed.

Findings

    Prior to its expiration on June 30, 2005, Respondent held DEA 
Certificate of Registration, AA0017473, which authorized him to 
dispense controlled substances in schedules II through V as a 
practitioner. GX 7. Respondent did not file a renewal application prior 
to the expiration of his registration. Rather, on or about March 24, 
2006, Respondent filed an application. GX 6. The actual application 
form is not, however, part of the record.\1\
---------------------------------------------------------------------------

    \1\ It appears that Respondent filed the form for a renewal 
application and not the form for a new application.
---------------------------------------------------------------------------

    On May 16, 2006, apparently after a conversation with a DEA 
Diversion Investigator (DI) regarding the application, Respondent 
submitted a letter to the DI. RX C. The letter's opening paragraph 
stated: ``The purpose of this letter is to request withdrawal of my 
recent attempt to obtain an extension and renewal of [my] DEA 
certificate.'' Id. at 1. Later in the letter, Respondent further wrote: 
``I request that you permit me to withdraw the current application for 
renewal, so that I may in the future submit [a] new application for a 
different DEA certificate number.'' Id. at 2.
    On October 25, 2006, the Deputy Assistant Administrator, Office of 
Diversion Control, issued an Order to Show Cause which proposed the 
denial of Respondent's ``pending application.'' ALJ Ex. 1. On some date 
not later than November 22, 2006, Respondent received the Order to Show 
Cause. ALJ Ex. 2.

Discussion

    Under a DEA regulation, ``[a]n application may be amended or 
withdrawn without permission of the Administrator at any time before 
the date on which the applicant receives an order to show cause 
pursuant to Sec.  1301.37.'' 21 CFR 1301.16(a) (emphasis added). The 
same regulation further provides that ``[a]n application may be amended 
or withdrawn with permission of the Administrator at any time where 
good cause is shown by the applicant or where the amendment or 
withdrawal is in the public interest.'' Id.
    As the regulation makes plain, an applicant's receipt of an Order 
to Show Cause is the operative event in determining whether he must 
obtain the Agency's permission to withdraw his application. When an 
applicant seeks to withdraw an application prior to his receipt of the 
Order to Show Cause, he is entitled to do so as a matter of right.
    Respondent's May 2006 letter provides a clear and manifest 
expression of his intent to withdraw his application. Indeed, it is 
hard to imagine how Respondent could have made his intent to withdraw 
any clearer. See RX C, at 1 (``The purpose of this letter is to request 
withdrawal''); id. at 2 (``I request that you permit me to withdraw the 
current application for renewal''). Moreover, because at the time he 
requested to withdraw, Respondent had not been served with

[[Page 54852]]

the Show Cause Order (and would not be served with the Order for at 
least another five months), he did not need the Agency's permission to 
do so. That he erroneously believed he needed the Agency's permission 
to withdraw does not make his intent to do so any less clear.
    The Government nonetheless attempts to create ambiguity out of 
clarity. In its brief, the Government contends that ``[f]rom the 
context of [his] letter and the testimony, it is clear that Respondent 
did not intend his letter to be a withdrawal of his new application.'' 
Gov. Br. at 3. The Government maintains that this is so because ``[t]he 
letter was written in response to a request from [the] DI to explain 
the answers in [Respondent's] past renewal application and his new 
application.'' Id. The Government further contends that Respondent 
prepared the letter ``under the mistaken belief that the new 
application was a renewal application and that he needed to file a new 
application in place of the `renewal' application.'' Id.
    The Government also argues that because his counsel requested a 
hearing on the allegations of the Show Cause Order, ``Respondent has 
constructively acknowledged that the letter was not a withdrawal of his 
pending new application for a DEA registration.'' Id. The Government 
further contends that Respondent should ``have moved to clarify his 
position by clearly asking to withdraw his application.'' Id.
    The Government's arguments are not persuasive. As for its 
contention that Respondent testified that he submitted the letter in 
the mistaken belief that he had submitted the wrong application form, 
thus implying that Respondent would not have submitted the letter if he 
had only recognized that he had submitted the correct form, the 
argument misreads the evidence. Respondent's May 2006 letter made clear 
enough that the reason he sought to withdraw the application (whether 
it was filed on the correct form or not) was not because it was filed 
on the wrong form, but because it contained an ``inadvertent error'' 
which he sought to correct. RX C, at 1-2. Moreover, even in his 
testimony on cross-examination, Respondent never asserted that he did 
not intend to withdraw.\2\
---------------------------------------------------------------------------

    \2\ During cross-examination, the following colloquy occurred:
    Q. * * * When you wrote the letter, weren't you aware that you 
were not dealing with a renewal, you're dealing with a new 
application; is that correct?
    A. Well, yes. That's why part of the text of the letter was that 
[I] realized that what I should do is cancel any application I had, 
and then make an application for a brand new number, and I thought 
that the wisest course would be to request permission from the DEA.
    Q. But the March 06 was a new application; correct?
    A. Well, as it turns out, it was at the time. But I was not 
thinking quite clearly then.
    Q. * * * But by the time you wrote this letter, was your 
thinking more clear?
    A. Well, if you read the last paragraph, you'll see what my 
thinking was at the time. What I requested was that I wanted to 
withdraw the application that I wrote down [in the letter] was an 
application for renewal, although in fact it was an application for 
a new DEA number. And then I wanted to submit a new application, 
which shows you that I was not completely aware of what I had done, 
even when I wrote this letter.
    Q. * * * So now you realize that * * * the letter * * * should 
not have referred to a request for renewal because the March 
application was a new application?
    A. I understand that now.
    Tr. 244-45.
     Moreover, the Government ignores Respondent's answers to two of 
the ALJ's questions. When asked ``what is it you think you have 
pending before the DEA?,'' Respondent answered: ``I believe that 
what's pending is the DEA's letter to me, which is called an order 
to show cause, and this I believe is my response to that letter.'' 
Tr. 269. Noting that her ``question was not very artfully asked,'' 
the ALJ then asked Respondent: ``[i]n terms of your registration, do 
you believe you have an application for a new registration pending 
before the DEA?'' Id. Respondent answered:
    I do not, and the reason is that I've never received any 
confirmation from the DEA, that I have any sort of application 
pending, new or old, or renewal, and therefore I think at the 
moment, that I do not have a valid DEA number, and I will be trying 
to obtain one in accordance with whatever techniques there are to 
obtain them.
    Id. at 269-70.
    To the extent it is even necessary or appropriate to go beyond 
the unambiguous text of Respondent's letter in assessing his intent, 
Respondent's testimony on cross examination fails to establish the 
Government's contention that he did not intend to withdraw. 
Moreover, the Government does not explain why Respondent should be 
deemed to have ``constructively acknowledged'' that his application 
is still pending when he expressly testified as to his belief that 
he does not have an application pending before the Agency.
---------------------------------------------------------------------------

    No more persuasive is the Government's contention that because 
Respondent requested a hearing on the allegations, he constructively 
acknowledged that the letter was not a withdrawal. The Government 
ignores that this act occurred approximately six months after 
Respondent submitted his letter and is hardly indicative of his intent 
in sending the letter. Moreover, the Government fails to acknowledge 
that it was the party that filed the Show Cause Order, which proposed 
to deny what it asserted was his ``pending application'' before the 
Agency. ALJ 1, at 1. Having been notified by the Government that it was 
proceeding to adjudicate his still ``pending application,'' and that he 
had a right to be heard on the allegations, it was reasonable for 
Respondent to have requested a hearing to defend himself. Respondent's 
act in requesting a hearing therefore does not negate the clear intent 
of his letter.
    It is true, of course, that Respondent is charged with knowledge of 
the Agency's regulation. See Federal Crop. Ins. Corp. v. Merrill, 332 
U.S. 380, 384-85 (1947). But so, too, are the Government's personnel 
including its Investigator (who received the letter), its Counsel, and 
the ALJ. Moreover, Respondent's withdrawal of his application goes to 
the subject matter jurisdiction of the Agency, an issue which can and 
should be raised sua sponte. In short, because Respondent withdrew his 
application, there is nothing to adjudicate. See, e.g., Ronald J. 
Riegel, 63 FR 67132, 67133 (1998).
    Finally, the Government contends that it would ``be a futile act to 
treat [Respondent's letter] as a withdrawal, only to have [him] re-
submit the application and have the matter re-litigated.'' Gov. Br. 4. 
The Government may, of course, choose to relitigate whether Respondent 
is entitled to be registered in the event he files a new application. 
But the Government's predicament is entirely of its own making. Having 
promulgated the regulation, the Government must abide by it.
    Moreover, contrary to the Government's understanding, the relevant 
judicial authority suggests that the issuance of a final order would 
also ``be a futile act.'' Id. It is well settled that where the federal 
courts cannot review an agency order because of intervening mootness, 
the court vacates the agency's order. See A.L. Mechling Barge Lines, 
Inc. v. United States, 368 U.S. 324, 329 (1961) (vacating 
administrative orders which had become unreviewable in federal court); 
American Family Life Assurance Co. v. FCC, 129 F.3d 625, 630 (D.C. Cir. 
1997) (``Since Mechling, we have, as a matter of course, vacated agency 
orders in cases that have become moot by the time of judicial 
review.'').
    This case does not raise a question of mootness, but rather, one of 
ripeness (as there is no application before the Agency, and indeed, 
there was no application at the time the case was commenced). 
Nonetheless, were Respondent to file a petition for review, because of 
the Article III limits on the judicial power, the court of appeals 
would likely hold that the case is not justiciable. See Ohio Forestry 
Ass'n, Inc. v. Sierra Club, 523 U.S. 726, 732-33 (1998); see also 
DaimlerChrysler Corp. v. Cuno, 547 U.S. 332, 352 (2006) (noting that 
ripeness doctrine ``originate[s] in Article III's `case' or 
`controversy' language''). Having concluded that the case was not

[[Page 54853]]

justiciable, the court of appeals would simply vacate the Agency's 
order. Cf. Mechling, 368 U.S. at 329 (applying to unreviewed 
administrative orders the principle ``that a party should not be 
concluded in subsequent litigation by a District Court's resolution of 
issues, when appellate review of the judgment incorporating that 
resolution, otherwise available as of right, fails because of 
intervening mootness * * * [T]hat principle should be implemented by 
the reviewing court's vacating the unreviewed judgment below.''). Thus, 
contrary to the Government's understanding, it would be pointless to 
issue a final order which in all likelihood would be vacated by the 
court of appeals and which would therefore have no preclusive effect.
    In conclusion, because Respondent's May 2006 letter clearly 
manifested his intent to withdraw his application, and the Agency's 
regulation does not require that he obtain its permission to do so, I 
hold that there is no application currently before the Agency. 
Accordingly, the Order to Show Cause must be dismissed.
    It is so ordered.

    Dated: October 15, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-25480 Filed 10-22-09; 8:45 am]
BILLING CODE 4410-09-P