Brenton D. Goodman, M.D.; Decision and Order, 17403-17406 [2021-06801]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 86, No. 62 / Friday, April 2, 2021 / Notices Authority: The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in section 210.10 of the Commission’s Rules of Practice and Procedure, 19 CFR 210.10 (2020). Scope of Investigation: Having considered the complaint, the U.S. International Trade Commission, on March 30, 2021, ordered that— (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products identified in paragraph (2) by reason of infringement of one or more of claims 1, 2, 5, and 7 of the ’322 patent; claims 1, 2, 5, 7, 15, 16, 19, and 20 of the ’567 patent; claims 1–3, and 16–18 of the ’983 patent; claims 1, 5–7, 9, 13–15, and 17 of the ’550 patent and claims 1, 2, 5, 7–10, and 13–15 of the ’488 patent; and whether an industry in the United States exists as required by subsection (a)(2) of section 337; (2) Pursuant to section 210.10(b)(1) of the Commission’s Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is ‘‘smart thermostat systems, smart HVAC systems, smart HVAC control systems, and components thereof’’; (3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served: (a) The complainant is: EcoFactor, Inc., 441 California Avenue, Number 2, Palo Alto, CA 94301. (b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served: ecobee Ltd., 25 Dockside Dr., Suite 600, Toronto, ON M5A 0B5, Canada ecobee, Inc., 25 Dockside Dr., Suite 600, Toronto, ON M5A 0B5, Canada Google LLC, 1600 Amphitheatre Parkway, Mountain View, California 94043 Carrier Global Corporation, 13995 Pasteur Boulevard, Palm Beach Gardens, Florida 33418 Emerson Electric Co., 8000 W Florissant Ave., P.O. Box 4100, St. Louis, Missouri 63136 Honeywell International Inc., 300 South Tryon Street, Charlotte, NC 28202 VerDate Sep<11>2014 23:04 Apr 01, 2021 Jkt 253001 Resideo Technologies, Inc., 901 E 6th Street, Austin, Texas 78702 Johnson Controls International, PLC, One Albert Quay, Cork, Ireland, T12 X8N6 Siemens Industry, Inc., 1000 Deerfield Pkwy., Buffalo Grove, IL 60089 Siemens AG, Werner-von-Siemens-Str. 1, 80333 Munich, Germany (3) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge. The Office of Unfair Import Investigations will not participate as a party in this investigation. Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission’s Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), as amended in 85 FR 15798 (March 19, 2020), such responses will be considered by the Commission if received not later than 20 days after the date of service by the complainant of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown. Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent. By order of the Commission. Issued: March 30, 2021. Lisa Barton, Secretary to the Commission. [FR Doc. 2021–06846 Filed 4–1–21; 8:45 am] BILLING CODE 7020–02–P PO 00000 17403 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 20–34] Brenton D. Goodman, M.D.; Decision and Order On August 19, 2020, the Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to Brenton D. Goodman, M.D. (hereinafter, Respondent) of Lafayette, Indiana. OSC, at 1. The OSC proposed the revocation of Respondent’s Certificate of Registration No. FG7707409. It alleged that Respondent is without ‘‘authority to handle controlled substances in the State of Indiana, the state in which [Respondent is] registered with the DEA.’’ OSC, at 2 (citing 21 U.S.C. 824(a)(3)). Specifically, the OSC alleged that Respondent’s Indiana medical license and Indiana controlled substances registration had both expired, leaving Respondent without authority to handle controlled substances in the State of Indiana. Id. The OSC notified Respondent of the right to request a hearing on the allegations or to submit a written statement, while waiving the right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option. Id. (citing 21 CFR 1301.43). The OSC also notified Respondent of the opportunity to submit a corrective action plan. OSC, at 3 (citing 21 U.S.C. 824(c)(2)(C)). By letter dated September 22, 2020, Respondent timely requested a hearing.1 Hearing Request, at 1. According to the Hearing Request, Respondent denied that his Indiana medical license was expired and claimed that his Indiana controlled substance registration was in the administrative process of being renewed. Id. He further requested that the hearing be delayed ‘‘to afford Registrant a reasonable opportunity to be heard before the Indiana Board of Pharmacy’’ regarding the renewal of his Indiana controlled substance registration. Id. The Office of Administrative Law Judges put the matter on the docket and assigned it to Chief Administrative Law Judge John J. Mulrooney (hereinafter, the Chief ALJ). The Chief ALJ issued a Briefing Order, dated September 23, 1 The Hearing Request was filed on September 22, 2020. Order for Supplemental Briefing, at 1. I find that the Government’s service of the OSC was adequate and that the Hearing Request was timely filed on September 22, 2020. Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1 jbell on DSKJLSW7X2PROD with NOTICES 17404 Federal Register / Vol. 86, No. 62 / Friday, April 2, 2021 / Notices 2020, directing the parties to brief the Government’s allegation that the Respondent lacked state authority and denying the Respondent’s request for a stay. Order Granting Summary Disposition and Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision dated January 13, 2021 (hereinafter, Recommended Decision or RD), at 2. The Government timely complied with the Briefing Order by filing a Motion for Summary Disposition (hereinafter, Government MSD) on October 8, 2020. Id. In its motion, the Government presented evidence that demonstrated that Respondent lacks authority to handle controlled substances in Indiana, the state in which he is registered with the DEA and argued that, therefore, DEA must revoke his registration. Government MSD, at 3. Respondent answered the Government MSD in a Response in Opposition to Government’s Motion for Summary Disposition (hereinafter, Respondent’s Response) in which Respondent argued that ‘‘certain procedural and substantive defects’’ of the Government’s argument ‘‘cannot be ignored.’’ Respondent’s Response, at 2–3. Specifically, Respondent argued that in the course of proceedings, the Government’s theory of the case had changed such that Respondent was ‘‘deprived of due process guaranteed to him under the United States Constitution and the applicable statutes, rules and regulations.’’ Id. at 3. Additionally, Respondent objected to the Government’s introduction of what Respondent claimed was ‘‘hearsay evidence that lacks appropriate foundation for authenticity.’’ Id. at 7. Finally, the Respondent argued that the Government had not demonstrated that he had had his medical license and controlled substance registration ‘‘suspended, revoked, or denied by competent State authority,’’ and argued that the limitation on his ‘‘access’’ to controlled substances did not limit his prescribing authority. Id. at 9. On January 7, 2021, Respondent filed a ‘‘Belated Notice of Registrant’s Current Status’’ (hereinafter, Status Update), which stated that the Indiana Board of Pharmacy had issued a Decision regarding Respondent’s Indiana controlled substances registration and argued that the DEA proceeding was now moot. Status Update, at 1. The Status Update included a copy of the Board’s Decision, which stated that it was ‘‘adopt[ing] the June 28, 2019 Medical Board Order.’’ Status Update Exhibit 1, at 1. On January 13, 2021, the ALJ granted the Government MSD finding that because ‘‘the Respondent does not have VerDate Sep<11>2014 23:04 Apr 01, 2021 Jkt 253001 authority as a practitioner in Indiana, there is no other fact of consequence for this tribunal to decide in order to determine whether or not he is entitled to hold a [DEA Certificate of Registration].’’ RD, at 7. The ALJ recommended that Respondent’s DEA Certificate of Registration be revoked based on his lack of state authority. Id. By letter dated February 28, 2021, the ALJ certified and transmitted the record to me for final Agency action. In that letter, the ALJ advised that neither party filed exceptions. I issue this Decision and Order based on the entire record before me. 21 CFR 1301.43(e). I make the following findings of fact. Findings of Fact Respondent’s DEA Registration Respondent is the holder of DEA Certificate of Registration No. FG7707409 at the registered address of 5165 McCarty Lane, Lafayette, IN 47905. Government MSD, Exhibit 1 (Certification of Registration Status), at 1. Pursuant to this registration, Respondent is authorized to dispense controlled substances in schedules II through V as a practitioner. Id. Respondent’s registration expires on September 30, 2021. Id. The Status of Respondent’s State License At the time DEA issued its OSC, Respondent’s Indiana medical license and Indiana controlled substances registration were both expired. MSD, at 3. Respondent has since renewed his state medical license; 2 however, under the terms of a previous order, 2 Respondent notes that the Government added to its foundation for revocation the fact that Respondent’s medical license is currently on probation after the OSC was issued, and argues that the addition of this fact at this stage impeded Respondent’s Constitutional right to due process of law. Respondent’s Response, at 3–6. Although it is noted that the Indiana Medical Board’s Order was in effect at the time of the issuance of the OSC, the status of Respondent’s medical license and controlled substances registration at the time was expired, and it was the intervening act of Respondent on or about September 14, 2020, to renew his controlled substances registration, following the issuance of the OSC, that changed his status. See Respondent’s Response, Exhibit (Respondent’s Affidavit), at 1. The agency has frequently determined that an OSC does not need to be amended to account for loss of state authority grounds. See e.g., Hatem M. Ataya, M.D., 81 FR 8221, 8244 (2016). Furthermore, by virtue of Respondent’s arguments in his response, I find that Respondent has had an opportunity to contest both the legal and factual predicates of the Government’s case. See e.g., Duane v. Dep’t of Defense, 275 F.3d 988, 993–96 (10th Cir. 2002); Abercrombie v. Clarke, 920 F.2d 1351, 1360 (7th Cir. 1990), cert. denied, 502 U.S. 809, 112 S.Ct. 52, 116 L.Ed.2d 29 (1991))(‘‘Absent evidence that a party is misled by an administrative complaint, resulting in ‘prejudicial error,’ we shall not reverse.’’) PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Respondent’s medical license is on indefinite probation. Id. Specifically, the Government submitted as evidence an Order issued by the Indiana Medical Board on June 28, 2019, which placed Respondent’s Indiana medical license on indefinite probation and included a provision that prohibited Respondent from having ‘‘access to Schedules I through V Controlled Substances, except for medications prescribed to him by a treating physician for Respondent’s recovery or medical needs’’ for the first two years of probation. MSD, Exhibit 4 (Indiana Medical Board Order),3 at 3. Respondent further submitted evidence that the Indiana Board of Pharmacy had adopted the Indiana Medical Board Order, which included all of the provisions of his probation, including the same restriction on access to controlled substances. Status Update, Exhibit 1, at 1. According to Indiana’s online records, of which I take official notice, both Respondent’s Indiana medical license and Indiana controlled substances registration are listed as on indefinite probation.4 https:// www.mylicense.in.gov/everification (last visited date of signature of this Order). Accordingly, I find that Respondent is currently restricted from access to controlled substances in Indiana, the state in which Respondent is registered with the DEA. Discussion Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of the Controlled Substances Act (hereinafter, CSA) ‘‘upon a finding that the registrant . . . has had his State license or registration 3 It is noted that, although Respondent challenges some of the Government’s supporting documentation, he does not appear to challenge the legitimacy or text of this Order, which is the primary document in the Government’s evidence on which I am relying in this decision. See Respondent’s Response, at 3 and Respondent’s Affidavit. 4 Under the Administrative Procedure Act, an agency ‘‘may take official notice of facts at any stage in a proceeding—even in the final decision.’’ United States Department of Justice, Attorney General’s Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an agency decision rests on official notice of a material fact not appearing in the evidence in the record, a party is entitled, on timely request, to an opportunity to show the contrary.’’ Accordingly, Respondent may dispute my finding by filing a properly supported motion for reconsideration of findings of fact within fifteen calendar days of the date of this Order. Any such motion and response shall be filed and served by email to the other party and to Office of the Administrator, Drug Enforcement Administration at dea.addo.attorneys@dea.usdoj.gov. E:\FR\FM\02APN1.SGM 02APN1 Federal Register / Vol. 86, No. 62 / Friday, April 2, 2021 / Notices jbell on DSKJLSW7X2PROD with NOTICES suspended . . . [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.’’ With respect to a practitioner, the DEA has also long held that the possession of authority to dispense controlled substances under the laws of the state in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner’s registration. See, e.g., James L. Hooper, M.D., 76 FR 71,371 (2011), pet. for rev. denied, 481 F. App’x 826 (4th Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27,616, 27,617 (1978). This rule derives from the text of two provisions of the CSA. First, Congress defined the term ‘‘practitioner’’ to mean ‘‘a physician . . . or other person licensed, registered, or otherwise permitted, by . . . the jurisdiction in which he practices . . . , to distribute, dispense, . . . [or] administer . . . a controlled substance in the course of professional practice.’’ 21 U.S.C. 802(21). Second, in setting the requirements for obtaining a practitioner’s registration, Congress directed that ‘‘[t]he Attorney General shall register practitioners . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.’’ 21 U.S.C. 823(f). Because Congress has clearly mandated that a practitioner possess state authority in order to be deemed a practitioner under the CSA, the DEA has held repeatedly that revocation of a practitioner’s registration is the appropriate sanction whenever he is no longer authorized to dispense controlled substances under the laws of the state in which he practices.5 See, e.g., James L. Hooper, 76 FR at 71,371– 72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131 (2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby Watts, M.D., 53 FR 11,919, 11,920 5 I reject the Respondent’s arguments related to the distinction between expiration and suspension or revocation of the registrant’s state authority as inconsistent with long-established DEA decisions, including the case to which he cited in support of his argument. See William D. Levitt, 64 FR 49,822, 49,823 (1999) (because ‘‘state authorization was clearly intended to be a prerequisite to DEA registration, Congress could not have intended for DEA to maintain a registration if a registrant is no longer authorized by the state in which he practices to handle controlled substances due to the expiration of his state license.’’) Additionally, Respondent’s argument is irrelevant, because the facts on the record here demonstrate that both the Pharmacy Board and the Medical Board of Indiana placed a restriction on Respondent’s access to controlled substances. VerDate Sep<11>2014 23:04 Apr 01, 2021 Jkt 253001 (1988); Frederick Marsh Blanton, 43 FR at 27,617. Respondent makes two primary arguments related to the Indiana Board of Medicine’s Order: (1) That the Indiana Board of Medicine has no authority to restrict Respondent’s prescribing, Respondent’s Response, at 9–10; and (2) that the term ‘‘access’’ in the Indiana Board of Medicine Order was ‘‘in reference to controlled substances that Affiant would be in possession of for personal use,’’ Respondent’s Response, Respondent’s Affidavit, at 2. In regard to the first argument, Respondent submitted evidence that the Indiana Board of Pharmacy had adopted the same terms of probation; and therefore, I find this argument to be mooted because the entity that Respondent claimed had the appropriate jurisdiction has now acted. See Status Update, Exhibit 1, at 1. Further, I agree with the Chief ALJ’s finding that Respondent’s interpretation of the Indiana Board of Medicine’s restrictions on his ‘‘access’’ to controlled substances as permitting him to continue to prescribe controlled substances contradicts the plain language of such terms. RD, at 5 (citing Respondent’s Response, at 3, 6, 9). The Board’s Order states that Respondent shall not have ‘‘access to Schedules I through V Controlled Substances, except for medications prescribed to him by a treating physician for Respondent’s recovery or medical needs.’’ MSD, Exhibit 4, at 3. The plain language of this provision makes the drafters’ intent crystal clear: the limitations regarding his access to controlled substances do not apply to controlled medications prescribed for his benefit, but apply to any controlled substances he may encounter outside that scenario (to wit, medications that he might have occasion to prescribe or administer). Thus, the Respondent’s position that the [Indiana Medical Board] used the term ‘‘access’’ in that clause only to describe controlled medications that might come ‘‘in[to his] possession [ ] for personal use’’ makes no sense, because the plain language of that clause already addresses drugs prescribed for his treatment. A contrary interpretation would indulge the unlikely supposition that the [Indiana Medical Board] was making a provision designed to regulate controlled substances he possesses without a prescription (i.e., abuse them). RD, at 5.6 6 I find that the Chief ALJ’s reading is further bolstered by the additional terms of the Indiana Medical Board’s Order, which state that once the initial two year probation period has ended and Respondent has met certain conditions, his medical license will be then be subject to a ‘‘subsequent probation,’’ which includes that ‘‘Respondent shall submit Quarterly Reports and Inspect Reports for both himself as a patient and as a prescribing PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 17405 Furthermore, because ‘‘the controlling question’’ in a proceeding brought under 21 U.S.C. 824(a)(3) is whether the holder of a practitioner’s registration ‘‘is currently authorized to handle controlled substances in the state,’’ Hooper, 76 FR at 71,371 (quoting Anne Lazar Thorn, 62 FR 12,847, 12,848 (1997)), the Agency has also long held that revocation is warranted even where a practitioner is still challenging the underlying action or where the state action is temporary. Kambiz Haghighi, M.D., 85 FR 5989 (2020); Bourne Pharmacy, 72 FR 18,273, 18,274 (2007); Wingfield Drugs, 52 FR 27,070, 27,071 (1987). Thus, it is of no consequence that the action is temporary. What is consequential is my finding that Respondent is not currently authorized to dispense controlled substances in Indiana, the state in which he is registered. According to Indiana statute, ‘‘[e]very person who dispenses or proposes to dispense any controlled substance within Indiana must have a registration issued by the [Indiana Board of Pharmacy] in accordance with the board’s rules.’’ Ind. Code § 35–48–3–3(b) (2021). ‘‘Dispense’’ means ‘‘to deliver a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a practitioner and includes the prescribing, administering, packaging, labeling, or compounding necessary to prepare the substance for that delivery.’’ Ind. Code § 35–28–1–12 (2021). Additionally, as discussed herein, there is direct evidence on the record that the terms of Respondent’s probation explicitly prohibit him from access to controlled substances in Indiana. See Status Update, Exhibit 1, at 1; see also MSD, Exhibit 4. Here, the undisputed evidence in the record is that Respondent currently lacks authority to dispense controlled substances in Indiana. As already discussed, a physician must hold a controlled substances registration to dispense a controlled substance in Indiana. Thus, because Respondent lacks authority to handle controlled substances in Indiana, Respondent is not eligible to maintain a DEA registration. Accordingly, I will order physician for this Board’s review.’’ MSD, Exhibit 4, at 6. If the Indiana Medical Board intended for Respondent to be able to prescribe under the restricted access provision in the first two years of his probation, it would make little sense for the terms to have omitted a similar provision requiring such reports on his prescribing. The fact that the reporting provision appears as the probation becomes more lenient, further demonstrates that the Indiana Medical Board did not intend for Respondent to be able to prescribe for the beginning two years of probation. E:\FR\FM\02APN1.SGM 02APN1 17406 Federal Register / Vol. 86, No. 62 / Friday, April 2, 2021 / Notices that Respondent’s DEA registration be revoked. Order Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. FG7707409 issued to Brenton D. Goodman. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby deny any pending application of Brenton D. Goodman to renew or modify this registration, as well as any other application of Brenton D. Goodman, for additional registration in Indiana. This Order is effective May 3, 2021. D. Christopher Evans, Acting Administrator. [FR Doc. 2021–06801 Filed 4–1–21; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration jbell on DSKJLSW7X2PROD with NOTICES Kendrick E. Duldulao, M.D.; Decision and Order On January 29, 2021, the Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, Government), issued an Order to Show Cause (hereinafter, OSC) to Kendrick E. Duldulao, M.D. (hereinafter, Registrant) of Tampa, Florida. OSC, at 1. The OSC proposed the revocation of Registrant’s Certificate of Registration No. FD0005593. It alleged that Registrant is without ‘‘authority to handle controlled substances in Florida, the state in which [Registrant is] registered with DEA.’’ OSC, at 2 (citing 21 U.S.C. 824(a)(3)). Specifically, the OSC alleged that on or about May 23, 2019, the U.S. District Court for the Middle District of Florida found Registrant guilty of one count of Conspiracy to Distribute and Dispense Controlled Substances in violation of 21 U.S.C. 846. OSC, at 1. Following the conviction, the State of Florida Department of Health (hereinafter, the Florida Department of Health) issued an Order of Emergency Suspension of License on November 18, 2019. OSC, at 2. This Order, according to the OSC, immediately restricted Registrant’s Florida medical license based on the Registrant’s conviction. Id. The OSC notified Registrant of the right to request a hearing on the allegations or to submit a written statement, while waiving the right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option. Id. at 2 (citing 21 VerDate Sep<11>2014 23:04 Apr 01, 2021 Jkt 253001 CFR 1301.43). The OSC also notified Registrant of the opportunity to submit a corrective action plan. OSC, at 3 (citing 21 U.S.C. 824(c)(2)(C)). Adequacy of Service In a Declaration dated March 9, 2021, a Diversion Investigator (hereinafter, DI) assigned to the DEA Miami Field Division, Tampa District Office, stated that the first attempt to serve the OSC to Registrant at his registered address was ‘‘returned via USPS as undeliverable as [Registrant] was no longer at the address and he left no forwarding information.’’ Request for Final Agency Action (hereinafter, RFAA), App. 6 (Declaration of DI), at 2; see also App. 5 (Copy of Return to Sender Envelope). The DI further stated that following the first unsuccessful service attempt, he and others from the Tampa District Office attempted to contact and personally serve the OSC on Registrant at ‘‘addresses obtained from queries made of numerous online public databases for [Registrant’s] address.’’ Id. The DI went on to detail the multiple attempts to personally serve the OSC on Registrant at the various addresses on February 1, 2021. Id. On February 1, 2021, the DI and others from the Tampa District Office ‘‘travelled to an address know[n] to be owned and occupied by [Registrant’s] parents’’ and ‘‘despite multiple efforts to knock on the door and placing a phone call to the address, no contact was made with the occupants of the home.’’ Id. Additionally, on February 1, 2021, the DI and another from the Tampa District Office ‘‘travelled to an address identified as [Registrant’s] residence’’ and ‘‘were told [Registrant] no longer lived there.’’ Id. Finally, on February 1, 2021, the DI and others from the Tampa District Office ‘‘travelled to an address 1 identified as [Registrant’s] residence’’ and ‘‘were told that [Registrant] no longer lived there.’’ Id. The DI concluded that ‘‘during [the] attempts to serve [Registrant]’’ he was informed that ‘‘[Registrant’s] registered address was permanently closed.’’ Id. The Government forwarded its RFAA, along with the evidentiary record, to this office on March 10, 2021. In its RFAA, the Government represents that ‘‘more than thirty days have passed since the Order to Show Cause was served on [Registrant] and no request for hearing has been received by DEA.2 RFAA, at 1. The Government requests that Registrant’s ‘‘Certificate of Registration as a practitioner be revoked and his application for renewal denied, based on [Registrant’s] lack of state authority.’’ RFAA, at 5. Based on the DI’s Declaration, the Government’s written representations, and my review of the record, I find the Government’s attempts to serve Registrant were legally sufficient. Due process does not require actual notice. Jones v. Flowers, 547 U.S. 220, 226 (2006). ‘‘[I]t requires only that the Government’s effort be reasonably calculated to apprise a party of the pendency of the action.’’ Dusenbery v. United States, 534 U.S. 161, 170 (2002) (internal quotations omitted). In this case, the Government first attempted to serve Registrant by mail to his registered address. When the OSC was returned as undeliverable because Registrant was no longer at the address and left no forwarding information, the Government attempted to personally serve Registrant at his registered address, his identified residences, and the address known to be owned and occupied by Registrant’s parents, all of which were locations where the Government reasonably believed Registrant would be located. ‘‘[T]he Due Process Clause does not require . . . heroic efforts by the Government’’ to find Registrant. Id. I find, therefore, that under the circumstances, the Government’s efforts to notify Registrant of the OSC were reasonable and satisfied due process. See Frederick Silvers, M.D., 85 FR 45,442, 45,443 (2020). I also find that more than thirty days have now passed since the Government accomplished service of the OSC. Further, based on the Government’s written representations, I find that neither Registrant, nor anyone purporting to represent the Registrant, requested a hearing, submitted a written statement while waiving Registrant’s right to a hearing, or submitted a corrective action plan. Accordingly, I find that Registrant has waived the right to a hearing and the right to submit a written statement and corrective action plan. 21 CFR 1301.43(d) and 21 U.S.C. 824(c)(2)(C). I, therefore, issue this Decision and Order based on the record submitted by the Government, which constitutes the entire record before me. 21 CFR 1301.43(e). Findings of Fact 1 It appears from the language of the Declaration, that the DI attempted service at two separate potential residences of Registrant on February 1, 2021, in addition to Registrant’s parents’ address. 2 The Government also represents that DEA has not received ‘‘any other correspondence of [sic] filing’’ from Registrant. RFAA, at 3. PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 Registrant’s DEA Registration Registrant is the holder of DEA Certificate of Registration No. FD0005593 at the registered address of 14495 University Cove Place, Tampa, FL E:\FR\FM\02APN1.SGM 02APN1

Agencies

[Federal Register Volume 86, Number 62 (Friday, April 2, 2021)]
[Notices]
[Pages 17403-17406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06801]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 20-34]


Brenton D. Goodman, M.D.; Decision and Order

    On August 19, 2020, the Assistant Administrator, Diversion Control 
Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause (hereinafter, OSC) to 
Brenton D. Goodman, M.D. (hereinafter, Respondent) of Lafayette, 
Indiana. OSC, at 1. The OSC proposed the revocation of Respondent's 
Certificate of Registration No. FG7707409. It alleged that Respondent 
is without ``authority to handle controlled substances in the State of 
Indiana, the state in which [Respondent is] registered with the DEA.'' 
OSC, at 2 (citing 21 U.S.C. 824(a)(3)).
    Specifically, the OSC alleged that Respondent's Indiana medical 
license and Indiana controlled substances registration had both 
expired, leaving Respondent without authority to handle controlled 
substances in the State of Indiana. Id.
    The OSC notified Respondent of the right to request a hearing on 
the allegations or to submit a written statement, while waiving the 
right to a hearing, the procedures for electing each option, and the 
consequences for failing to elect either option. Id. (citing 21 CFR 
1301.43). The OSC also notified Respondent of the opportunity to submit 
a corrective action plan. OSC, at 3 (citing 21 U.S.C. 824(c)(2)(C)).
    By letter dated September 22, 2020, Respondent timely requested a 
hearing.\1\ Hearing Request, at 1. According to the Hearing Request, 
Respondent denied that his Indiana medical license was expired and 
claimed that his Indiana controlled substance registration was in the 
administrative process of being renewed. Id. He further requested that 
the hearing be delayed ``to afford Registrant a reasonable opportunity 
to be heard before the Indiana Board of Pharmacy'' regarding the 
renewal of his Indiana controlled substance registration. Id.
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    \1\ The Hearing Request was filed on September 22, 2020. Order 
for Supplemental Briefing, at 1. I find that the Government's 
service of the OSC was adequate and that the Hearing Request was 
timely filed on September 22, 2020.
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    The Office of Administrative Law Judges put the matter on the 
docket and assigned it to Chief Administrative Law Judge John J. 
Mulrooney (hereinafter, the Chief ALJ). The Chief ALJ issued a Briefing 
Order, dated September 23,

[[Page 17404]]

2020, directing the parties to brief the Government's allegation that 
the Respondent lacked state authority and denying the Respondent's 
request for a stay. Order Granting Summary Disposition and Recommended 
Rulings, Findings of Fact, Conclusions of Law, and Decision dated 
January 13, 2021 (hereinafter, Recommended Decision or RD), at 2. The 
Government timely complied with the Briefing Order by filing a Motion 
for Summary Disposition (hereinafter, Government MSD) on October 8, 
2020. Id. In its motion, the Government presented evidence that 
demonstrated that Respondent lacks authority to handle controlled 
substances in Indiana, the state in which he is registered with the DEA 
and argued that, therefore, DEA must revoke his registration. 
Government MSD, at 3. Respondent answered the Government MSD in a 
Response in Opposition to Government's Motion for Summary Disposition 
(hereinafter, Respondent's Response) in which Respondent argued that 
``certain procedural and substantive defects'' of the Government's 
argument ``cannot be ignored.'' Respondent's Response, at 2-3. 
Specifically, Respondent argued that in the course of proceedings, the 
Government's theory of the case had changed such that Respondent was 
``deprived of due process guaranteed to him under the United States 
Constitution and the applicable statutes, rules and regulations.'' Id. 
at 3. Additionally, Respondent objected to the Government's 
introduction of what Respondent claimed was ``hearsay evidence that 
lacks appropriate foundation for authenticity.'' Id. at 7. Finally, the 
Respondent argued that the Government had not demonstrated that he had 
had his medical license and controlled substance registration 
``suspended, revoked, or denied by competent State authority,'' and 
argued that the limitation on his ``access'' to controlled substances 
did not limit his prescribing authority. Id. at 9.
    On January 7, 2021, Respondent filed a ``Belated Notice of 
Registrant's Current Status'' (hereinafter, Status Update), which 
stated that the Indiana Board of Pharmacy had issued a Decision 
regarding Respondent's Indiana controlled substances registration and 
argued that the DEA proceeding was now moot. Status Update, at 1. The 
Status Update included a copy of the Board's Decision, which stated 
that it was ``adopt[ing] the June 28, 2019 Medical Board Order.'' 
Status Update Exhibit 1, at 1.
    On January 13, 2021, the ALJ granted the Government MSD finding 
that because ``the Respondent does not have authority as a practitioner 
in Indiana, there is no other fact of consequence for this tribunal to 
decide in order to determine whether or not he is entitled to hold a 
[DEA Certificate of Registration].'' RD, at 7. The ALJ recommended that 
Respondent's DEA Certificate of Registration be revoked based on his 
lack of state authority. Id. By letter dated February 28, 2021, the ALJ 
certified and transmitted the record to me for final Agency action. In 
that letter, the ALJ advised that neither party filed exceptions.
    I issue this Decision and Order based on the entire record before 
me. 21 CFR 1301.43(e). I make the following findings of fact.

Findings of Fact

Respondent's DEA Registration

    Respondent is the holder of DEA Certificate of Registration No. 
FG7707409 at the registered address of 5165 McCarty Lane, Lafayette, IN 
47905. Government MSD, Exhibit 1 (Certification of Registration 
Status), at 1. Pursuant to this registration, Respondent is authorized 
to dispense controlled substances in schedules II through V as a 
practitioner. Id. Respondent's registration expires on September 30, 
2021. Id.

The Status of Respondent's State License

    At the time DEA issued its OSC, Respondent's Indiana medical 
license and Indiana controlled substances registration were both 
expired. MSD, at 3. Respondent has since renewed his state medical 
license; \2\ however, under the terms of a previous order, Respondent's 
medical license is on indefinite probation. Id. Specifically, the 
Government submitted as evidence an Order issued by the Indiana Medical 
Board on June 28, 2019, which placed Respondent's Indiana medical 
license on indefinite probation and included a provision that 
prohibited Respondent from having ``access to Schedules I through V 
Controlled Substances, except for medications prescribed to him by a 
treating physician for Respondent's recovery or medical needs'' for the 
first two years of probation. MSD, Exhibit 4 (Indiana Medical Board 
Order),\3\ at 3. Respondent further submitted evidence that the Indiana 
Board of Pharmacy had adopted the Indiana Medical Board Order, which 
included all of the provisions of his probation, including the same 
restriction on access to controlled substances. Status Update, Exhibit 
1, at 1.
---------------------------------------------------------------------------

    \2\ Respondent notes that the Government added to its foundation 
for revocation the fact that Respondent's medical license is 
currently on probation after the OSC was issued, and argues that the 
addition of this fact at this stage impeded Respondent's 
Constitutional right to due process of law. Respondent's Response, 
at 3-6. Although it is noted that the Indiana Medical Board's Order 
was in effect at the time of the issuance of the OSC, the status of 
Respondent's medical license and controlled substances registration 
at the time was expired, and it was the intervening act of 
Respondent on or about September 14, 2020, to renew his controlled 
substances registration, following the issuance of the OSC, that 
changed his status. See Respondent's Response, Exhibit (Respondent's 
Affidavit), at 1. The agency has frequently determined that an OSC 
does not need to be amended to account for loss of state authority 
grounds. See e.g., Hatem M. Ataya, M.D., 81 FR 8221, 8244 (2016). 
Furthermore, by virtue of Respondent's arguments in his response, I 
find that Respondent has had an opportunity to contest both the 
legal and factual predicates of the Government's case. See e.g., 
Duane v. Dep't of Defense, 275 F.3d 988, 993-96 (10th Cir. 2002); 
Abercrombie v. Clarke, 920 F.2d 1351, 1360 (7th Cir. 1990), cert. 
denied, 502 U.S. 809, 112 S.Ct. 52, 116 L.Ed.2d 29 (1991))(``Absent 
evidence that a party is misled by an administrative complaint, 
resulting in `prejudicial error,' we shall not reverse.'')
    \3\ It is noted that, although Respondent challenges some of the 
Government's supporting documentation, he does not appear to 
challenge the legitimacy or text of this Order, which is the primary 
document in the Government's evidence on which I am relying in this 
decision. See Respondent's Response, at 3 and Respondent's 
Affidavit.
---------------------------------------------------------------------------

    According to Indiana's online records, of which I take official 
notice, both Respondent's Indiana medical license and Indiana 
controlled substances registration are listed as on indefinite 
probation.\4\ https://www.mylicense.in.gov/everification (last visited 
date of signature of this Order).
---------------------------------------------------------------------------

    \4\ Under the Administrative Procedure Act, an agency ``may take 
official notice of facts at any stage in a proceeding--even in the 
final decision.'' United States Department of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), 
``[w]hen an agency decision rests on official notice of a material 
fact not appearing in the evidence in the record, a party is 
entitled, on timely request, to an opportunity to show the 
contrary.'' Accordingly, Respondent may dispute my finding by filing 
a properly supported motion for reconsideration of findings of fact 
within fifteen calendar days of the date of this Order. Any such 
motion and response shall be filed and served by email to the other 
party and to Office of the Administrator, Drug Enforcement 
Administration at [email protected].
---------------------------------------------------------------------------

    Accordingly, I find that Respondent is currently restricted from 
access to controlled substances in Indiana, the state in which 
Respondent is registered with the DEA.

Discussion

    Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized 
to suspend or revoke a registration issued under section 823 of the 
Controlled Substances Act (hereinafter, CSA) ``upon a finding that the 
registrant . . . has had his State license or registration

[[Page 17405]]

suspended . . . [or] revoked . . . by competent State authority and is 
no longer authorized by State law to engage in the . . . dispensing of 
controlled substances.'' With respect to a practitioner, the DEA has 
also long held that the possession of authority to dispense controlled 
substances under the laws of the state in which a practitioner engages 
in professional practice is a fundamental condition for obtaining and 
maintaining a practitioner's registration. See, e.g., James L. Hooper, 
M.D., 76 FR 71,371 (2011), pet. for rev. denied, 481 F. App'x 826 (4th 
Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27,616, 27,617 (1978).
    This rule derives from the text of two provisions of the CSA. 
First, Congress defined the term ``practitioner'' to mean ``a physician 
. . . or other person licensed, registered, or otherwise permitted, by 
. . . the jurisdiction in which he practices . . . , to distribute, 
dispense, . . . [or] administer . . . a controlled substance in the 
course of professional practice.'' 21 U.S.C. 802(21). Second, in 
setting the requirements for obtaining a practitioner's registration, 
Congress directed that ``[t]he Attorney General shall register 
practitioners . . . if the applicant is authorized to dispense . . . 
controlled substances under the laws of the State in which he 
practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated 
that a practitioner possess state authority in order to be deemed a 
practitioner under the CSA, the DEA has held repeatedly that revocation 
of a practitioner's registration is the appropriate sanction whenever 
he is no longer authorized to dispense controlled substances under the 
laws of the state in which he practices.\5\ See, e.g., James L. Hooper, 
76 FR at 71,371-72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131 
(2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby 
Watts, M.D., 53 FR 11,919, 11,920 (1988); Frederick Marsh Blanton, 43 
FR at 27,617.
---------------------------------------------------------------------------

    \5\ I reject the Respondent's arguments related to the 
distinction between expiration and suspension or revocation of the 
registrant's state authority as inconsistent with long-established 
DEA decisions, including the case to which he cited in support of 
his argument. See William D. Levitt, 64 FR 49,822, 49,823 (1999) 
(because ``state authorization was clearly intended to be a 
prerequisite to DEA registration, Congress could not have intended 
for DEA to maintain a registration if a registrant is no longer 
authorized by the state in which he practices to handle controlled 
substances due to the expiration of his state license.'') 
Additionally, Respondent's argument is irrelevant, because the facts 
on the record here demonstrate that both the Pharmacy Board and the 
Medical Board of Indiana placed a restriction on Respondent's access 
to controlled substances.
---------------------------------------------------------------------------

    Respondent makes two primary arguments related to the Indiana Board 
of Medicine's Order: (1) That the Indiana Board of Medicine has no 
authority to restrict Respondent's prescribing, Respondent's Response, 
at 9-10; and (2) that the term ``access'' in the Indiana Board of 
Medicine Order was ``in reference to controlled substances that Affiant 
would be in possession of for personal use,'' Respondent's Response, 
Respondent's Affidavit, at 2. In regard to the first argument, 
Respondent submitted evidence that the Indiana Board of Pharmacy had 
adopted the same terms of probation; and therefore, I find this 
argument to be mooted because the entity that Respondent claimed had 
the appropriate jurisdiction has now acted. See Status Update, Exhibit 
1, at 1. Further, I agree with the Chief ALJ's finding that 
Respondent's interpretation of the Indiana Board of Medicine's 
restrictions on his ``access'' to controlled substances as permitting 
him to continue to prescribe controlled substances contradicts the 
plain language of such terms. RD, at 5 (citing Respondent's Response, 
at 3, 6, 9). The Board's Order states that Respondent shall not have 
``access to Schedules I through V Controlled Substances, except for 
medications prescribed to him by a treating physician for Respondent's 
recovery or medical needs.'' MSD, Exhibit 4, at 3.

    The plain language of this provision makes the drafters' intent 
crystal clear: the limitations regarding his access to controlled 
substances do not apply to controlled medications prescribed for his 
benefit, but apply to any controlled substances he may encounter 
outside that scenario (to wit, medications that he might have 
occasion to prescribe or administer). Thus, the Respondent's 
position that the [Indiana Medical Board] used the term ``access'' 
in that clause only to describe controlled medications that might 
come ``in[to his] possession [ ] for personal use'' makes no sense, 
because the plain language of that clause already addresses drugs 
prescribed for his treatment. A contrary interpretation would 
indulge the unlikely supposition that the [Indiana Medical Board] 
was making a provision designed to regulate controlled substances he 
possesses without a prescription (i.e., abuse them).
    RD, at 5.\6\
---------------------------------------------------------------------------

    \6\ I find that the Chief ALJ's reading is further bolstered by 
the additional terms of the Indiana Medical Board's Order, which 
state that once the initial two year probation period has ended and 
Respondent has met certain conditions, his medical license will be 
then be subject to a ``subsequent probation,'' which includes that 
``Respondent shall submit Quarterly Reports and Inspect Reports for 
both himself as a patient and as a prescribing physician for this 
Board's review.'' MSD, Exhibit 4, at 6. If the Indiana Medical Board 
intended for Respondent to be able to prescribe under the restricted 
access provision in the first two years of his probation, it would 
make little sense for the terms to have omitted a similar provision 
requiring such reports on his prescribing. The fact that the 
reporting provision appears as the probation becomes more lenient, 
further demonstrates that the Indiana Medical Board did not intend 
for Respondent to be able to prescribe for the beginning two years 
of probation.

    Furthermore, because ``the controlling question'' in a proceeding 
brought under 21 U.S.C. 824(a)(3) is whether the holder of a 
practitioner's registration ``is currently authorized to handle 
controlled substances in the state,'' Hooper, 76 FR at 71,371 (quoting 
Anne Lazar Thorn, 62 FR 12,847, 12,848 (1997)), the Agency has also 
long held that revocation is warranted even where a practitioner is 
still challenging the underlying action or where the state action is 
temporary. Kambiz Haghighi, M.D., 85 FR 5989 (2020); Bourne Pharmacy, 
72 FR 18,273, 18,274 (2007); Wingfield Drugs, 52 FR 27,070, 27,071 
(1987). Thus, it is of no consequence that the action is temporary. 
What is consequential is my finding that Respondent is not currently 
authorized to dispense controlled substances in Indiana, the state in 
which he is registered.
    According to Indiana statute, ``[e]very person who dispenses or 
proposes to dispense any controlled substance within Indiana must have 
a registration issued by the [Indiana Board of Pharmacy] in accordance 
with the board's rules.'' Ind. Code Sec.  35-48-3-3(b) (2021). 
``Dispense'' means ``to deliver a controlled substance to an ultimate 
user or research subject by or pursuant to the lawful order of a 
practitioner and includes the prescribing, administering, packaging, 
labeling, or compounding necessary to prepare the substance for that 
delivery.'' Ind. Code Sec.  35-28-1-12 (2021).
    Additionally, as discussed herein, there is direct evidence on the 
record that the terms of Respondent's probation explicitly prohibit him 
from access to controlled substances in Indiana. See Status Update, 
Exhibit 1, at 1; see also MSD, Exhibit 4.
    Here, the undisputed evidence in the record is that Respondent 
currently lacks authority to dispense controlled substances in Indiana. 
As already discussed, a physician must hold a controlled substances 
registration to dispense a controlled substance in Indiana. Thus, 
because Respondent lacks authority to handle controlled substances in 
Indiana, Respondent is not eligible to maintain a DEA registration. 
Accordingly, I will order

[[Page 17406]]

that Respondent's DEA registration be revoked.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. 
FG7707409 issued to Brenton D. Goodman. Further, pursuant to 28 CFR 
0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby 
deny any pending application of Brenton D. Goodman to renew or modify 
this registration, as well as any other application of Brenton D. 
Goodman, for additional registration in Indiana. This Order is 
effective May 3, 2021.

D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-06801 Filed 4-1-21; 8:45 am]
BILLING CODE 4410-09-P

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