Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Justice

###### Drug Enforcement Administration

          - [Docket No. 08-1]

                    On August 30, 2007, I, the Deputy Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to Elmer P. Manalo, M.D. (Respondent), of Greensburg, Indiana. The immediate suspension of Respondent's registration was based on my preliminary finding that Respondent posed an “imminent danger to public health or safety” because he prescribed schedule II and IV controlled substances to undercover law enforcement personnel on numerous occasions without a legitimate medical purpose and outside the scope of his professional practice. Show Cause Order at 1. The Show Cause Order further alleged that Respondent continued to prescribe controlled substances to certain persons notwithstanding that he had been specifically informed that these persons “were illegitimate drug seekers and addicts,” and that several of his patients had “died due to mixed drug intoxication or accidental drug overdose.”                     *Id.*                     at 2.                

Following service of the Show Cause Order, Respondent, through his attorney, requested a hearing on the allegations and the ALJ proceeded to conduct pre-hearing procedures. Meanwhile, on October 2, 2007, the Medical Licensing Board of Indiana summarily suspended Respondent's registration for ninety days effective September 27, 2007. The State Board subsequently extended the suspension an additional ninety days.

Thereafter, the Government moved for summary disposition on the ground that because Respondent lacked authority under state law to handle controlled substances, he was not entitled to maintain his DEA registration. Gov. Mot. for Summ. Disp. at 1 (citing 21 U.S.C. 801(21); 823(f); & 824(a)(3)). Responding to the Government's motion, Respondent did not dispute that his state license had been suspended. Respondent's Reply to DEA's Motion, at 1. Respondent, however, sought a stay of the issuance of the final order in this matter pending the resolution of the state proceedings.

Based on the undisputed fact that Respondent lacked authority to practice medicine in Indiana, and that it was reasonable to infer that he was also without authority to handle controlled substances under state law, the ALJ granted the Government's motion, noting the settled rule that “DEA does not have statutory authority under the [CSA] to maintain a registration if the registrant is without state authority to dispense controlled substances in the State in which he practices medicine.” ALJ Dec. at 3 (citing 21 U.S.C. 823(f) & 824(a)(3)). The ALJ further denied Respondent's request to stay the proceeding. The ALJ then ordered that the hearing be cancelled, recommended that Respondent's registration be revoked and any pending renewal applications be denied, and forwarded the record to me for final agency action.

                    In reviewing the record, I noted that neither the Show Cause Order nor any other document establishes the status of Respondent's registration or whether Respondent has filed a timely renewal application. I therefore took official notice of the Agency's record pertaining to Respondent's registration. That record indicated that Respondent's registration expired on January 31, 2008, and that Respondent had not filed a renewal application.                     *See*5 U.S.C. 558(c). Accordingly, I found that Respondent is not currently registered with the Agency.                

                    Under DEA precedent, “if a registrant has not submitted a timely renewal application prior to the expiration date, then the registration expires and there is nothing to revoke.”                     *Ronald J. Riegel*, 63 FR 67132, 67133 (1998). In other words, under ordinary circumstances the case is moot.                

                    This case commenced, however, with the issuance of an Order of Immediate Suspension, and this Order was based on allegations that Respondent committed acts which rendered “his registration * * * inconsistent with the public interest.” 21 U.S.C. 824(a)(4);                     *see also*                     Show Cause Order at 1-2. DEA has recognized a limited exception to the mootness rule in cases which commence with the issuance of an immediate suspension order because of the collateral consequences which may attach with the issuance of such a suspension.                     *See William R. Lockridge*, 71 FR 77791, 77797 (2006).                

                    I also noted that in moving for summary disposition, the Government did not seek to litigate the allegations of the Order to Show Cause and Immediate Suspension. Rather, it relied on the different ground that Respondent no longer had authority under state law to handle controlled substances and thus was not entitled to be registered.                     *See*21 U.S.C. 824(a)(3). I further observed that because Respondent did not file a renewal application, it is unclear whether he intended to remain in professional practice.                

                    Accordingly, on May 6, 2008, I ordered that the parties brief the issue of whether this proceeding remains a live controversy. The Order further directed that if Respondent contended                           ( print page 50354)                        that the case was not moot, he should specifically address why he failed to file a renewal application and what collateral consequences attach as a result of the suspension order.                

                    On June 5, the Government filed its brief. As relevant here, the Government maintains that this proceeding is now moot and that the matter should now be dismissed.                     *See*                     Brief in Response to the Order of the Deputy Administrator at 10. As of this date, Respondent has not filed a brief.                

In light of Respondent's failure to comply with the briefing order, his failure to file a renewal application, and his failure to provide any evidence of his intent to remain in professional practice or of other collateral consequences that attached with the issuance of the suspension order, I conclude that this case is now moot. Accordingly, the Order to Show Cause will be dismissed.

## Order

Pursuant to the authority vested in me by 21 U.S.C. 824, as well as 21 CFR 0.100(b) and 0.104, I hereby order that the Order to Show Cause issued to Elmer P. Manalo, M.D., be, and it hereby is, dismissed. This Order is effective immediately.

Dated: August 18, 2008.

Michele M. Leonhart,

Deputy Administrator.

 [FR Doc. E8-19773 Filed 8-25-08; 8:45 am]

BILLING CODE 4410-09-P