Decision and Order: Zelideh I. Cordova-Velazco, M.D., 62902-62907 [2018-26485]

Download as PDF 62902 Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices AL; Rockwell Collins, Inc., Cedar Rapids, IA; Toyon Research Corporation, Goleta, CA; ELCOMM, LLC, Acworth, GA; Business Integra Technology Solutions, Inc., Bethesda, MD; Astra Space, Inc., Alameda, CA; Disruptive Technology Associates, Ltd., Phoenix, AZ; SpaceNav, LLC, Boulder, CO; Oceaneering International, Inc., Houston, TX; Torch Technologies, Inc., Huntsville, AL; KinetX, Inc., Tempe, AZ; IAI, LLC, Chantilly, VA; CACI NSS, Inc., Colorado Springs, CO; Teledyne Brown Engineering, Inc., Huntsville, AL; Airbus OneWeb Satellites LLC, Cocoa, FL; Knight Sky, LLC, Frederick, MD; Interstate Electronics Corporation, Anaheim, CA; Crean & Associates, Lakeway, TX; AS and D, Inc., Beltsville, MD; ISYS Incorporated, Littleton, CO; Peraton Incorporated, Herndon, VA; Slingshot Aerospace, Inc., El Segundo, CA; Millennium Engineering and Integration Company, Arlington, VA; Vulcan Wireless, Inc., Carlsbad, CA; Delta Solutions & Strategies, LLC, Colorado Springs, CO; Oewaves, Inc., Pasadena, CA; T2S, LLC, Belcamp, MD; Lucid Circuit, Inc., Santa Monica, CA; Arete Associates, Northridge, CA; Bluestaq, Colorado Springs, CO; DRS Suzanne Morris, Chief, Premerger and Division Statistics Unit, Antitrust Division. Absolute Standards, Inc ..................................... 83 FR 48868 .................................................... [FR Doc. 2018–26509 Filed 12–4–18; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 20:35 Dec 04, 2018 Jkt 247001 Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Registration ACTION: Notice of registration. The registrant listed below has applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of a schedule I controlled substance. SUMMARY: The company listed below applied to be registered as a bulk manufacturer of a controlled substance. Information on the previously published notice is listed in the table below. No comments or objections were submitted for this notice. SUPPLEMENTARY INFORMATION: BILLING CODE 4410–11–P FR Docket Dated: November 30, 2018. John J. Martin, Assistant Administrator. DEPARTMENT OF JUSTICE [FR Doc. 2018–26398 Filed 12–4–18; 8:45 am] Company The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of this registrant to manufacture the applicable basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed company. khammond on DSK30JT082PROD with NOTICES Networking & Imaging Systems, LLC, Dallas, TX; LeoLabs, Inc., Menlo Park, CA; Microwave Photonics Systems, Inc., West Chester, PA; Astrapi Corporation, Dallas, TX; and SA Photonics, Los Gatos, CA, have been added as parties to this venture. Also, Blacknight Cybersecurity International, Inc., Redmond, VA; CMA Technologies, Orlando, FL; and ATS– MER, LLC, Tuscon, AZ have withdrawn as parties to this venture. No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and SpEC intends to file additional written notifications disclosing all changes in membership. On August 23, 2018, SpEC filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the Federal Register pursuant to Section 6(b) of the Act on October 2, 2018 (83 FR 49576). Published DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 18–21] Decision and Order: Zelideh I. Cordova-Velazco, M.D. On February 27, 2018, the Acting Assistant Administrator, Diversion Control Division, issued an Order to Show Cause to Zelideh I. CordovaVelazco, M.D. (Respondent), of Puerto Rico. The Show Cause Order proposed the denial of the Respondent’s application for a DEA Certificate of Registration in Puerto Rico as a practitioner, Control No. W16052461C, on the grounds that Respondent materially falsified that application. Order to Show Cause, at 1 (citing 21 U.S.C. 824(a)(1)). With respect to the Agency’s jurisdiction, the Show Cause Order alleged that on June 16, 2016, Respondent applied for a DEA Registration as a practitioner in schedules II through V at the proposed business address of Hacienda Del Dorado, K1 Calle Delonix, Toa Alta, Puerto Rico. Id. The Order also alleged PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 September 27, 2018. that DEA assigned Control No. W16052461C to the application. Id. As to the substantive grounds for the proceeding, the Show Cause Order alleged that Respondent previously held DEA Certificate of Registration No. BC4141139 in Michigan. Id. at 2. In addition, the Order alleged that Respondent ‘‘voluntarily surrendered for cause’’ that Registration ‘‘on or about January 17, 2014.’’ Id. The Order further alleged that Respondent materially falsified her application for a new DEA Registration in Puerto Rico on June 16, 2016 with respect to two liability questions on the application. Id. The Order alleged that the first material falsification was that the Respondent answered ‘‘N’’ when asked: ‘‘Has the applicant ever surrendered (for cause) or had a federal controlled substance registration, revoked, suspended, restricted or denied, or is any such action pending?’’ Id. The Order alleged that the second material falsification was that Respondent answered ‘‘N’’ when asked: ‘‘Has the applicant ever surrendered (for cause) or had a state professional license or controlled substance registration revoked, suspended, denied, restricted, or placed E:\FR\FM\06DEN1.SGM 06DEN1 khammond on DSK30JT082PROD with NOTICES Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices on probation, or is any such action pending?’’ Id. The Order asserted that these alleged material falsifications ‘‘warrant the denial of your application for registration.’’ Id. (citing 21 U.S.C § 824(a)(1)). The Show Cause Order notified Respondent of her right to request a hearing on the allegations or to submit a written statement while waiving her right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option. Id. at 2–3 (citing 21 CFR 1301.43). The Order also notified Respondent of the opportunity to submit a corrective action plan. Id. at 3 (citing 21 U.S.C. § 824(c)(2)(C)). After being served with the Order, Respondent filed a timely ‘‘Request for Hearing’’ on March 26, 2018 requesting a hearing on the allegations. Request for Hearing (dated March 22, 2018) (hereinafter Hearing Request). In her Hearing Request, Respondent states that she ‘‘d[id] not recall that I indicate [sic] ‘no’ to the questions’’ in the application and that she ‘‘was helped by a friend in filling out the application and probably by mistake and/or ignorance in understanding the questions I answered ‘no.’’’ Id. at 2. Respondent also states that she surrendered her Michigan medical license and ‘‘accept[ed] a six months and one day suspension, for being negligent, in not securing my prescription pad’’ and then ‘‘voluntarily surrender[ed her] DEA license to prescribe[] control[led] substance[s].’’ Id. She also asserts that ‘‘[i]f I would have known the consequences of accepting the suspension, I would have litigated the case in Michigan, because I did nothing wrong. There is no practical reason not to inform the suspension of Michigan. The suspension appears online in the medical board data bank.’’ Id. She also ‘‘request[ed] discovery in the present matter, including [a] copy of the record and/or file with DEA.’’ Id. The matter was placed on the docket of the Office of Administrative Law Judges and assigned to Administrative Law Judge Charles Wm. Dorman (ALJ). Thereafter, on March 26, 2018, the ALJ entered an Order for Prehearing Statements, directing the Government to file its Prehearing Statement on April 10, 2018, and the Respondent to file hers on April 24, 2018. Order for Prehearing Statements, at 1. The Order also directed the parties to participate in a telephonic prehearing conference on April 25, 2018. Id. at 2. The Government filed its Prehearing Statement on April 10, 2018, and Respondent filed, through counsel, her Prehearing Statement on April 20, 2018. VerDate Sep<11>2014 20:35 Dec 04, 2018 Jkt 247001 In Respondent’s Prehearing Statement, Respondent stipulated that she voluntarily surrendered her Michigan medical license after being informed of an investigation for improperly prescribing medication. Respondent’s Prehearing Statement, at 2. In addition, Respondent stipulated that she was previously registered with DEA pursuant to DEA Certificate of Registration No. BC4141139, and that she voluntarily surrendered for cause that registration. Id. at 3. On April 20, 2018, the Government filed a Motion for Summary Disposition based upon the Respondent’s material falsification of her application for a DEA Registration in Puerto Rico on June 16, 2016. Specifically, the Government alleged that there was no dispute of material fact that Respondent materially falsified her application for a DEA Registration when she answered ‘‘N’’ to the following liability questions on the application: (1) ‘‘Has the applicant ever surrendered (for cause) or had a federal controlled substance registration, revoked, suspended, restricted or denied, or is any such action pending?’’; and (2) ‘‘Has the applicant ever surrendered (for cause) or had a state professional license or controlled substance registration revoked, suspended, denied, restricted, or placed on probation, or is any such action pending?’’ Government’s Motion for Summary Disposition (hereinafter ‘‘Government’s Motion’’ or ‘‘Govt. Mot.’’), at 2. On April 25, 2018, the ALJ held a telephonic prehearing conference pursuant to 21 CFR 1316.55. The ALJ entered a Prehearing Ruling (PHR) on April 26, 2018, reflecting that the parties had agreed to a series of factual stipulations, including the fact that (1) on April 19, 2013, the Michigan Board of Medicine suspended Respondent’s Michigan medical license for a minimum period of six months and one day; (2) in January 2014, Respondent ‘‘voluntarily surrendered for cause’’ a DEA Registration that Respondent had previously held in Michigan; (3) Respondent answered ‘‘N’’ when asked: ‘‘Has the applicant ever surrendered (for cause) or had a federal controlled substance registration revoked, suspended, restricted or denied, or is any such action pending?’’ and (4) Respondent answered ‘‘N’’ when asked: ‘‘Has the applicant ever surrendered (for cause) or had a state professional license or controlled substance registration revoked, suspended, denied, restricted, or placed on probation, or is any such action pending?’’ PHR, at 1–2. In his Prehearing Ruling, the ALJ also ordered Respondent to file a response to PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 62903 the Government’s Motion by May 4, 2018, and directed the parties to attempt to draft additional ‘‘mutually agreeable joint stipulations’’ by May 30, 2018. Id. at 2. On May 3, 2018, Respondent filed her response to the Government’s Motion and asserted that the Government had failed to ‘‘establish bad faith, negligence or intentionally trying to mislead,’’ and failed to prove that she ‘‘is unfit to practice medicine, and therefore, unfit to prescribe medication.’’ ‘‘Respondent’s Response to Government’s Motion for Summary Disposition and Respondant’s [sic] ‘Motion for Summary Disposition’’’ (Resp. Reply), at 4. In addition, Respondent attached a certificate of good standing for her Puerto Rico medical license and a copy of her license. Id., Attachment (Att.) 1–2. Additionally, she attached her own sworn statement, in which she asserts that she ‘‘misunderstood the questions.’’ Id., Att. 3, at 2. She also argued that approving her application was warranted because she holds an active medical license in good standing and has never been sued for malpractice. Id. at 3–4. On May 8, 2018, after considering these pleadings, the ALJ entered an Order recommending that I find that Respondent had failed to raise a triable issue of material fact as to whether she had materially falsified her application. Order Granting Government’s Motion for Summary Disposition and Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision (Recommended Decision or R.D.), at 8– 9. As a result, the ALJ granted the Government’s Motion and recommended that I deny Respondent’s DEA application Control No. W1602461C. Id. at 12. On May 17, 2018, Respondent filed her ‘‘Request for Reconsideration’’ of the ALJ’s Recommended Decision,1 and on the same day the ALJ entered an Order Directing Government to Respond to Respondent’s Request for Reconsideration. In that Order, the ALJ noted that there is no provision in DEA’s regulations for either party to request reconsideration of an ALJ’s recommended decision, and thus the ALJ would treat the request as Exceptions to the Recommended Decision. Order Directing Government 1 On May 11, 2018, Respondent also filed a ‘‘Supplemental Motion Submitting Document’’ enclosing ‘‘a certified translation of Resolution Num. 2017–118, issued by the Health Department Board of Licensing and Medical Discipline of Puerto Rico, in the case of In Re: Sr. Zelideh Cordova Velazco (Lic. #4865), Case No. Q–JDLM– 2013–41.’’ Supplemental Motion Submitting Document, at 1. E:\FR\FM\06DEN1.SGM 06DEN1 62904 Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices khammond on DSK30JT082PROD with NOTICES to Respond to Respondent’s Request for Reconsideration, at 1. The Order directed the Government to file any response to Respondent’s Exceptions by May 22, 2018. According to the record, the Government filed no Exceptions of its own nor any response to Respondent’s Exceptions. On June 4, 2018, the record was forwarded to my Office for Final Agency Action.2 2 Respondent submitted two post-certification filings. On June 12, 2018, Respondent filed her Request to Grant Motion for Reconsideration As Unopposed, and on August 17, 2018, Respondent filed her Second Request to Grant Motion for Reconsideration As Unopposed. On June 12, 2018 and on August 20, 2018, respectively, the ALJ issued Orders forwarding Respondent’s postcertification filings to my Office and noted that his ‘‘jurisdiction over the case terminated upon transmittal of the record to the Acting Administrator.’’ Order Forwarding Respondent’s Motion to Acting Administrator, at 1; Second Order Forwarding Respondent’s Motion to Acting Administrator, at 1. I find that the ALJ properly forwarded Respondent’s post-certification filings for my consideration because, as the ALJ correctly notes, his jurisdiction over this matter terminated when he certified and transmitted the record to my Office. Regarding the timing of Respondent’s filings, neither the Controlled Substances Act nor DEA’s implementing regulations provide for a supplemental filing by a party after the ALJ has certified the record. However, the Agency has, on occasion, exercised its discretion to consider such filings (however styled) after the ALJ has certified and transmitted the administrative record to my Office. E.g., Joe W. Morgan, D.O., 78 FR 61961, 61961 (2013) (allowing Respondent’s postcertification filing and ‘‘treat[ing it] as a motion for reconsideration’’); Wesley G. Harline, M.D., 64 FR 72678, 72684–85 (1999) (allowing Respondent’s post-certification filing and treating it as a motion to reopen the record); Robert M. Golden, M.D., 61 FR 24808, 24808 (1996) (same). Indeed, the Agency has even exercised its discretion to consider motions for reconsideration after the Agency has issued its final decision and order. E.g., Lyle E. Craker, Ph.D., 76 FR 51403, 51405 (2011). To justify consideration of her filings at this stage of the case, Respondent must show that there has been an intervening change of controlling law, the availability of new evidence, or the need to correct a clear error or prevent manifest injustice. E.g., Foster v. Sedgwick Claims Mgmt. Services, 842 F.3d 721, 735 (D.C. Cir. 2016) (‘‘A motion for reconsideration is discretionary and need not be granted unless the district court finds that there is an intervening change of controlling law, the availability of new evidence, or the need to correct a clear error or prevent manifest injustice.’’) (citations and internal quotation marks omitted); Virgin Atl. Airways v. Nat’l Mediation Bd., 956 F.2d 1245, 1255 (2d Cir.) (same), cert. denied, 506 U.S. 820 (1992). Here, Respondent claims in both filings that her Exceptions should be deemed ‘‘unopposed’’ because the Government chose not to respond to her Exceptions. Respondent failed to offer any other basis in fact that her Exceptions were ‘‘unopposed’’ by the Government. I am aware of no DEA regulation or Agency precedent compelling a finding that a party who does not respond to an opposing party’s Exceptions to an ALJ’s Recommended Decision is deemed to have taken a position of ‘‘unopposed’’ to the opposing party’s Exceptions. Moreover, Respondent’s claim is not the type of intervening change in controlling law, newly available evidence, or clear error that would justify consideration of her post-certification filings VerDate Sep<11>2014 20:35 Dec 04, 2018 Jkt 247001 Having considered the entire record, including the ALJ’s Recommended Decision, I find that Respondent materially falsified her application for DEA registration with respect to Liability Questions 2 and 3 on her 2016 application. I therefore adopt the ALJ’s recommendation that I deny Respondent’s DEA Registration application. I make the following factual findings. Findings of Fact Respondent is a physician who previously held an active medical license, No. 43–01063034, in the State of Michigan. Ex. 4 to Govt. Mot. On April 19, 2013, Respondent entered into a Consent Order with the Michigan Board of Medicine in which she agreed to the suspension of her medical license for a minimum period of six months and one day based on her improper prescribing of controlled substances to home health patients. See id.; see also R.D., at 10. Specifically, the Michigan administrative complaint against Respondent alleged, among other things, that she prescribed controlled substances, primarily oxycodone, Xanax, and Phenergan with codeine, to 26 patients despite: ‘‘failing to document medical indication or necessity for these controlled substances’’; failing to document ‘‘any physical examination or clinical findings to justify the combination of’’ controlled drugs prescribed; failing to document an appropriate medical history; failing to make ‘‘any findings pertaining to pain assessment, level of dysfunction from pain, treatment plan or diagnostic testing’’; failing to obtain ‘‘a report from the Michigan Automated Prescription System’’; failing to conduct a toxicology screen; failing to monitor the ‘‘patients’ use of the controlled substances for drug dependency or diversion’’; failing to counsel the patients regarding the risks associated with controlled substances; and consistently prescribing the maximum dose of Xanax ‘‘without documenting prior medication use or use of Xanax.’’ Ex. 4 to Govt. Mot., at 9–11.3 Respondent also previously held DEA Certificate of Registration No. BC4141139. Ex. 3 to Govt. Mot. In January 2014, Respondent voluntarily surrendered this registration for cause. Exs. 3, 5 to Govt. Mot. under Agency precedent at this stage of the case. For all these reasons, I do not consider Respondent’s post-certification filings. 3 The Consent Order recited that Respondent ‘‘does not contest the allegations of fact and law’’ in the state administrative complaint against her. Id. at 3. PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 On June 15, 2016, Respondent applied for a practitioner’s registration seeking authority to dispense controlled substances in schedules II through V with a proposed business address of Hacienda Del Dorado, K1 Calle Delonix, Toa Alta, Puerto Rico. Exhibits (Exs.) 1, 2 to Govt. Mot. DEA assigned Respondent’s DEA registration application Control No. W16052461C.4 DEA’s Application for Registration includes liability questions which an applicant must answer either affirmatively (‘‘Y’’) or negatively (‘‘N’’). Exs. 1–3 to Govt. Mot. Liability Question 2 on the DEA Application for Registration filed by Respondent asks: ‘‘Has the applicant ever surrendered (for cause) or had a federal controlled substance registration revoked, suspended, restricted or denied, or is any such action pending?’’ Exs. 1–2 to Govt. Mot. Respondent answered this question: ‘‘N’’ for no. Id. I find that this answer was false. Liability Question 3 on the DEA Application for Registration filed by Respondent asks: ‘‘Has the applicant ever surrendered (for cause) or had a state professional license or controlled substance registration revoked, suspended, denied, restricted, or placed on probation, or is any such action pending?’’ Id. Respondent answered this question: ‘‘N’’ for no. I find that this answer was also false. Discussion A. Standard for Denial of an Application for Registration Section 303(f) of the Controlled Substances Act provides that an application for a practitioner’s registration may be denied upon a determination ‘‘that the issuance of such registration would be inconsistent with the public interest.’’ 21 U.S.C. 823(f). In making the public interest determination, the CSA requires the consideration of the following factors: (1) The recommendation of the appropriate State licensing board or professional disciplinary authority. (2) The applicant’s experience in dispensing . . . controlled substances. (3) The applicant’s conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances. 4 The ALJ recommended that I make this fact finding based on the parties’ stipulation that DEA assigned Control No. W16052461C to Respondent’s DEA application. R.D., at 3 (citing PHR, 1–2). In addition, the record includes a notarized sworn statement by Respondent that DEA assigned Control No. W16052461C to her. Att. 3 to Resp. Reply, at 1. E:\FR\FM\06DEN1.SGM 06DEN1 Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices khammond on DSK30JT082PROD with NOTICES (4) Compliance with applicable State, Federal, or local laws relating to controlled substances. (5) Such other conduct which may threaten the public health and safety. Id. ‘‘These factors are . . . considered in the disjunctive.’’ Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). DEA precedent provides that I ‘‘may rely on any one or a combination of factors, and may give each factor the weight I deem appropriate in determining whether . . . an application for registration should be denied.’’ Richard D. Vitalis, 79 FR 68701, 68708 (2014) (citing Robert A. Leslie, M.D., supra). Moreover, it is well established that I am ‘‘not required to make findings as to all of the factors.’’ Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Kevin Dennis, M.D., 78 FR 52787, 52974 (2013); MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011). ‘‘The provision of truthful information on applications is absolutely essential’’ to a determination of whether granting an application is in the public interest. Peter H. Ahles, M.D., 71 FR 50097, 50098 (2006). ‘‘Since DEA must rely on the truthfulness of information supplied by applicants in registering them to handle controlled substances, falsification cannot be tolerated.’’ Bobby Watts, M.D., 58 FR 46995, 46995 (1993). Accordingly, ‘‘materially falsifying an application . . . provides an independent and adequate ground for denying an application.’’ The Lawsons, Inc., 72 FR 74334, 74338 (2007); see also Richard A. Herbert, M.D., 76 FR 53942, 53945 (2011) (‘‘Under the CSA, material falsification provides a separate and independent ground for denying an application.’’).5 One materially false statement is enough to justify revocation or denial. Harold Edward Smith, M.D., 76 FR 53961, 53964 (2011). The Government bears the burden of proof in showing that the issuance of a registration is inconsistent with the public interest. 21 CFR 1301.44(d). 5 Under Section 304(a)(1) of the Controlled Substances Act (CSA), a registration may be revoked or suspended ‘‘upon a finding that the registrant * * * has materially falsified any application filed pursuant to or required by this subchapter.’’ 21 U.S.C. 824(a)(1). ‘‘DEA has long held that the various grounds for revocation or suspension of an existing registration that Congress enumerated in section 304(a), 21 U.S.C. 824(a), are also properly considered in deciding whether to grant or deny an application under section 303.’’ Richard D. Vitalis, D.O., 79 FR 68701, 68708 (2014) (citing Anthony D. Funches, 64 FR 14267, 14268 (1999); Alan R. Schankman, 63 FR 45260 (1998); Kuen H. Chen, 58 FR 65401, 65402 (1993)). Thus, the allegation that Respondent materially falsified his application is properly considered in this proceeding. Vitalis, 79 FR at 68708 (citing Samuel S. Jackson, 72 FR 23848, 23852 (2007)). VerDate Sep<11>2014 20:35 Dec 04, 2018 Jkt 247001 Having considered the record, including the ALJ’s Recommended Decision and Respondent’s Exceptions, I conclude that the Government was entitled to summary disposition on the grounds that Respondent materially falsified her application for a DEA Certificate of Registration. B. Material Falsification Here, as I have already noted, Respondent made two false statements when she submitted her DEA Application for Registration in 2016 in Puerto Rico. First, Respondent falsely stated in her response to Liability Question 2 on her DEA Application for Registration that she had never surrendered a DEA registration for cause when, in fact, she had surrendered DEA Certificate of Registration No. BC4141139 in Michigan for cause in January 2014. Second, Respondent falsely stated in her response to Liability Question 3 on her DEA Application that she has not had her state professional license revoked, even though in 2013 she had entered into a Consent Order with the Michigan Board of Medicine agreeing to the suspension of her Michigan medical license. Turning to whether these false statements were material, Agency precedent establishes that ‘‘[a] false statement is material if it ‘has a natural tendency to influence, or was capable of influencing the decision of the decision[-]making body to which it was addressed.’ ’’ Gilbert Eugene Johnson, M.D., 75 FR 65663, 65665 (2010) (quoting Kungys v. United States, 485 U.S. 759, 770 (1998)). The false statement need only have the capacity to influence the decision-making body; it does not need to have exerted any actual influence. Alvin Darby, M.D., 75 FR 26993, 26998 (2010) (citing United States v. Alemany Rivera, 781 F.2d 229, 234 (1st Cir. 1985)). The Government must prove that the false information is material by ‘‘clear, unequivocal, and convincing’’ evidence. Hoi Y. Kam, M.D., 78 FR 62694, 62696 (2013) (quoting Kungys, 485 U.S. at 772). Whether a falsification is material is a question of law. Harold Edward Smith, M.D., 76 FR 53961, 53964 (2011) (citing Kungys, 485 U.S. at 772). As stated below, I find that the Respondent’s answers to both Liability Question 2 and Liability Question 3 were material. As far as Liability Question 3 is concerned, DEA precedent holds that the failure to disclose a prior suspension relating to the prescribing of controlled substances is material, even where the suspension was no longer effective at the time of the application: ‘‘[E]ven where an applicant currently PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 62905 holds unrestricted state authority to dispense controlled substances, the failure to disclose state action against his medical license may be material if the action was based on conduct (or on the status arising from such conduct, i.e., a conviction for a controlled substance offense or mandatory exclusion from federal health care programs) which is actionable under either the public interest factors or the grounds for denial, suspension, and revocation set forth in section 824.’’ Richard D. Vitalis, 79 FR at 681708 (2014). Here, the Government has provided evidence demonstrating that the underlying state investigation which prompted the suspension of Respondent’s Michigan medical license and the surrender of her DEA registration concerned unlawful prescribing of controlled substances. See Ex. 4 to Govt. Mot. Given that the allegations concern the unlawful prescribing of controlled substances, I find that they are material because they are ‘‘capable of influencing’’ the DEA’s decision.6 Kungys, 485 U.S. at 770; Jose G. Zavaleta, M.D., 78 FR 27431, 27435 (2013); Smith, 76 FR at 53964. Likewise, Respondent’s failure to disclose her surrender for cause of her prior DEA registration in Michigan in response to Liability Question 2 was also material according to DEA precedent. Zavaleta, 78 FR at 27435 (failure to disclose voluntary surrender of DEA registration following an investigation into unlawful prescribing was ‘‘clearly capable of influencing’’ the DEA’s decision and was thus material); Smith, 76 FR at 53964 (failure to disclose fact that the applicant had ‘‘been accused of writing unlawful prescriptions . . . [was] material to the [DEA’s] investigation and assessment of [the applicant’s] experience in dispensing controlled substances and his compliance with applicable laws related to’’ controlled substances). In addition, the Government must show that Respondent ‘‘knew or should have known that [her] response[s] given to the liability question[s] [were] false.’’ Samuel S. Jackson, D.D.S., 72 FR 23848, 23852 (2007) (quoting Samuel Arnold, D.D.S., 63 FR 8687, 8688 (1998)); Merlin E. Shuck, D.V.M., 69 FR 22566, 22568 (2004). ‘‘Under DEA precedent, the Government is not required to show that the falsification was intentional but only that the applicant ‘knew or should have known that the response given to the 6 The Consent Order recited that Respondent ‘‘does not contest the allegations of fact and law’’ in the state administrative complaint against her. Id. at 3. E:\FR\FM\06DEN1.SGM 06DEN1 62906 Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices khammond on DSK30JT082PROD with NOTICES liability question was false.’’’ Alvin Darby, M.D., 75 FR 26993, 26999 (2010) (quoting The Lawsons, Inc., 72 FR 74334, 74339 (2007)). In Richard Jay Blackburn, D.O., the Acting Administrator determined that a copy of the state administrative complaint, the respondent’s letter to the state board ‘‘surrendering his state license,’’ the state board’s acceptance of the surrender, and a printout displaying the status of respondent’s state license were sufficient to demonstrate that respondent ‘‘knowingly falsified his application.’’ 82 FR 18669, 18673 (2017). The DEA has found that material falsifications are committed knowingly even where, as here, a respondent claims that he or she misunderstood the questions. Darby, 75 FR at 26999. Here, the Government attached a copy of the Respondent’s 2016 application, a copy of the administrative complaint and Consent Order issued by the Michigan Department of Licensing and Regulatory Affairs against Respondent, and a copy of the form which Respondent signed surrendering her Michigan DEA registration. See Exs. 1, 4–5 to Govt. Mot. Additionally, the Government attached two notarized documents signed by the Chief of DEA’s Registration and Program Support Section verifying the Respondent’s DEA registration history and her responses on her 2016 application. Exs. 2–3 to Govt. Mot. The Government’s evidence is the same type of evidence as that submitted in Blackburn and therefore is sufficient to show that Respondent either knew or should have known that her application was materially false. 82 FR at 18673. As a result, even if Respondent’s statements that she misunderstood the questions were true, I find that she should have known under the facts in this case that her responses to the liability questions in this case were false. See Darby, 75 FR at 26999. Thus, I find that the Government has offered sufficient evidence to show that the Respondent materially falsified her 2016 application for a DEA registration in Puerto Rico. C. Sanction Once the Government makes a prima facie case for material falsification, the next question ‘‘becomes whether revocation [or denial] is the appropriate sanction in light of the facts.’’ Arnold, 63 FR at 8688. Although the Respondent acknowledges that the answers she provided in response to Liability Questions 2 and 3 on her 2016 application were false, she explains that she did not intend to provide false statements, but instead misunderstood VerDate Sep<11>2014 20:35 Dec 04, 2018 Jkt 247001 the questions. Resp. Reply, at 4–5; App. 3, at 2, para. 7. Respondent’s insistence that her undisputed false statements should be excused because she ‘‘misunderstood’’ the liability questions is misplaced. In her Request for Hearing, the Respondent merely stated the following concerning her alleged misunderstanding of the questions: ‘‘I was helped by a friend in filling out the application and probably by mistake and/or ignorance in understanding the questions I answered ‘no.’’ Resp. Request for Hearing, at 2. Later, in her Response to Government’s Motion for Summary Disposition, she further specified that she ‘‘misunderstood’’ Liability Questions 2 and 3, but her purported explanation disregards the actual wording of the questions. Att. 3 to Resp. Reply, at 2. For example, as to Liability Question 2, Respondent claims she misunderstood that question because her registration was surrendered voluntarily, and was not revoked, suspended or denied. Id. However, Liability Question 2 not only asked whether the applicant ever had a registration ‘‘revoked, suspended, restricted or denied,’’ but also expressly asked whether any registration had ever been surrendered for cause. Ex. 1 to Govt. Mot. Moreover, Respondent stipulated that her prior registration was surrendered for cause, so her negative answer was clearly false, and her claimed ‘‘misunderstanding’’ of Liability Question 2 rings hollow. See Shannon L. Gallentine, D.P.M., 76 FR 45864, 45866 (2011). Similarly, Respondent’s claim that she misunderstood Liability Question 3 also ignores the question itself. Respondent explained her ‘‘misunderstanding’’ as to Liability Question 3 as follows: ‘‘As to question #3, again Ms. Cordova[’s] Registration was not revoked, suspended, denied, restricted, or placed on probation, nor is [sic] any such action was pending when she voluntarily surrender [sic] her Registration.’’ Att. 3 to Resp. Reply, at 2. However, Liability Question 3 actually inquires: ‘‘Has the applicant ever surrendered (for cause) or had a state professional license or controlled substance registration revoked, suspended, denied, restricted, or placed on probation, or is any such action pending?’’ Ex. 1 to Govt. Mot. (emphasis added). It is undisputed that Respondent’s state professional license for Michigan was suspended, and she clearly knew it was suspended, because she is the one who agreed to that suspension in writing when she entered into a Consent Order with the State of Michigan Board of Medicine. Thus, Respondent’s claimed PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 misunderstanding of Liability Question 3 is untenable on its face. Moreover, applicants for DEA registrations bear ‘‘‘the responsibility to carefully read the question and to honestly answer all parts of the question.’’’ Arnold, 63 FR at 8688 (quoting Martha Hernandez, M.D., 62 FR 61145, 61147 (1997)). Allegedly misunderstanding or misinterpreting liability questions does not relieve the applicant of this responsibility. Hernandez, 62 FR at 61147–48 (concluding applicant committed material falsification despite misinterpreting one question); see also Gallentine, 76 FR at 45866. Additionally, inadvertence is legally irrelevant in resolving a material falsification case because the Government only needs to prove that Respondent ‘‘‘knew or should have known’’’ that the answers were false. Richard A. Herbert, M.D., 76 FR 53942, 53956 (2011) (quoting The Lawsons, Inc., 72 FR 74334, 74338 (2007)) (emphasis added). See, e.g., Zavaleta, 78 FR at 27436, 27438–39 (ruling respondent materially falsified his application even where respondent testified that he made mistakes in filling out the application and ‘‘should have give[n] [his applications] more careful review’’). Thus, Respondent’s defense of inadvertence, even if it were true, is legally inconsequential in deciding whether she materially falsified her 2016 application. Furthermore, the evidence that Respondent now holds a valid medical license in good standing in Puerto Rico is simply not relevant in terms of resolving the allegation that she materially falsified her application. Resp. Reply, at 3; Att. 1–2 to Resp. Reply; Hernandez, 62 FR at 61147. The same holds true of the evidence that Respondent has never been sued for malpractice or been the subject of a professional complaint, except for the Michigan action, in her 19–20 year career. Resp. Reply at Att. 3, para. 8, 10. With respect to Liability Questions 2 and 3 of Respondent’s DEA Application, a material false statement is a material false statement regardless of her professional credentials. Although lack of intent to deceive and history of licensure are relevant in assessing the appropriate sanction, what is most dispositive is the fact that Respondent has not accepted responsibility for her materially false statements. See Lon F. Alexander, M.D., 82 FR 49704, 49728 (2017); Arthur H. Bell, 80 FR 50035, 50041 (2015) (finding that applicant’s failure to accept responsibility for materially falsifying application was ‘‘reason alone to E:\FR\FM\06DEN1.SGM 06DEN1 Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices conclude that he cannot be entrusted with a new registration’’). I have considered the fact that Respondent currently holds a medical license in good standing in Puerto Rico, and her sworn statement that she has never been sued for malpractice and received only one professional complaint in her 19–20 year career. Att. 1–2 to Resp. Reply; Att. 3 to Resp. Reply, at 2–4. None of these facts outweighs Respondent’s materially false application, especially given her failure to disclose extensive and serious allegations against her involving the unlawful prescribing of controlled substances. See William M. Knarr, D.O., 51 FR 2772, 2773 (1986). Thus, I find that this mitigating evidence fails to diminish the gravity of her failure to reveal the alleged misconduct in her state of prior registration. Accordingly, based upon the foregoing, I conclude that the Government was entitled to summary disposition on the allegation that Respondent materially falsified her application for a new DEA registration. Order Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 CFR 0.100(b), I order that the application of Zelidah H. Cordova-Velazco, M.D., for a DEA Certificate of Registration as a practitioner, be, and it hereby is, denied. This Order is effective immediately. Dated: November 20, 2018. Uttam Dhillon, Acting Administrator. DEPARTMENT OF JUSTICE Foreign Claims Settlement Commission [F.C.S.C. Meeting and Hearing Notice No. 11–18] Sunshine Act Meeting The Foreign Claims Settlement Commission, pursuant to its regulations (45 CFR part 503.25) and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice in regard to the scheduling of open meetings as follows: Thursday, December 13, 2018: 11:00 a.m.—Issuance of Proposed Decisions in claims against Iraq. 11:30 a.m.—Issuance of Proposed Decisions under the Guam World War II Loyalty Recognition Act, Title XVII, Public Law 114–328. Status: Open. All meetings are held at the Foreign Claims Settlement Commission, 601 D Street NW, Suite 10300, Washington, DC. Requests for information, or advance notices of intention to observe an open meeting, may be directed to: Patricia M. Hall, Foreign Claims Settlement Commission, 601 D Street NW, Suite 10300, Washington, DC 20579. Telephone: (202) 616–6975. Brian Simkin, Chief Counsel. [FR Doc. 2018–26576 Filed 12–3–18; 4:15 pm] BILLING CODE 4410–BA–P DEPARTMENT OF JUSTICE Notice of Filing of Proposed Settlement Agreement Under the Comprehensive Environmental Response, Compensation, and Liability Act [FR Doc. 2018–26485 Filed 12–4–18; 8:45 am] BILLING CODE 4410–09–P On November 21, 2018, a Notice of Settlement Agreement was filed in the Superior Court for the State of New Amount Site $16,000,000 ........................ Sharon Steel Corporation (Farrell Works Disposal Area) Superfund Site. Lower Duwamish Waterway Superfund Site ................ Lower Duwamish Waterway Superfund Site ................ San Gabriel Valley Area 2 Site ..................................... U.S. Oil Recovery Site .................................................. Lee’s Lane Landfill Superfund Site ............................... Petroleum Products Superfund Site .............................. khammond on DSK30JT082PROD with NOTICES 6,298,630 ............................ 2,200,000 ............................ 2,224,999 ............................ 300,000 ............................... 19,609 ................................. 908 ...................................... For each Class II priority distribution that Home makes, Home shall use the above amounts to determine the appropriate distribution for each of the six Superfund Sites. In consideration of payments made on the allowed Class II VerDate Sep<11>2014 20:35 Dec 04, 2018 Jkt 247001 Frm 00075 Hampshire, Merrimack County in the proceeding entitled In the Matter of the Liquidation of The Home Insurance Company, Docket No. 217–2003–EQ– 00106. The Notice informs the Court that at the conclusion of a public comment period, John R. Elias, Insurance Commissioner of the State of New Hampshire, in his capacity as Liquidator (the ‘‘Liquidator’’) of the Home Insurance Company (‘‘Home’’) may seek court approval of a Settlement Agreement between the Liquidator, and the United States of America on behalf of the U.S. Environmental Protection Agency (‘‘EPA’’), the U.S. Department of the Navy, U.S. Department of the Interior (‘‘DOI’’), and the National Oceanic and Atmospheric Administration of the U.S. Department of Commerce (‘‘NOAA’’) (collectively referred to as ‘‘the Federal Claimants’’), acting by and through the United States Department of Justice (‘‘DOJ’’). The Settlement Agreement would resolve seven proofs of claim the Federal Claimants’ have filed. The seven proofs of claim assert claims under Section 107 of the Comprehensive Environmental Response, Compensation, and Liability Act (‘‘CERCLA’’), 42 U.S.C. 9607, against insured parties in connection with six Superfund Sites: The Sharon Steel Corporation (Farrell Works Disposal Area) Superfund Site in Hermitage, PA; the Lower Duwamish Waterway Superfund Site in Seattle, WA; the San Gabriel Valley Area 2 Site in Los Angeles, CA; the U.S. Oil Recovery Site in Pasadena, TX; the Lee’s Lane Landfill Superfund Site in Louisville, KY; and the Petroleum Products Superfund Site in Pembroke Park, FL. Under the Settlement Agreement, the United States will have an allowed Class II priority claim in the amount of $27,044,146 allocated to the six Superfund Sites as follows: Home insured Sharon Steel Corporation. Manson Construction and Engineering Company. Duwamish Shipyard, Inc. Azusa Pipe & Tube Bending, Corp. Explorer Pipeline Company. Louisville Varnish Company, Inc. Shaw Trucking. Priority Claim, upon approval of the Settlement Agreement the Federal Claimants provide a covenant not to sue to Home and the Liquidator as described in the Agreement under CERCLA under the policies that are identified in the PO 00000 62907 Fmt 4703 Sfmt 4703 Settlement Agreement and in the proofs of claim. The publication of this notice opens a period for public comment on the Settlement Agreement. Comments should be addressed to the Assistant E:\FR\FM\06DEN1.SGM 06DEN1

Agencies

[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Notices]
[Pages 62902-62907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26485]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 18-21]


Decision and Order: Zelideh I. Cordova-Velazco, M.D.

    On February 27, 2018, the Acting Assistant Administrator, Diversion 
Control Division, issued an Order to Show Cause to Zelideh I. Cordova-
Velazco, M.D. (Respondent), of Puerto Rico. The Show Cause Order 
proposed the denial of the Respondent's application for a DEA 
Certificate of Registration in Puerto Rico as a practitioner, Control 
No. W16052461C, on the grounds that Respondent materially falsified 
that application. Order to Show Cause, at 1 (citing 21 U.S.C. 
824(a)(1)).
    With respect to the Agency's jurisdiction, the Show Cause Order 
alleged that on June 16, 2016, Respondent applied for a DEA 
Registration as a practitioner in schedules II through V at the 
proposed business address of Hacienda Del Dorado, K1 Calle Delonix, Toa 
Alta, Puerto Rico. Id. The Order also alleged that DEA assigned Control 
No. W16052461C to the application. Id.
    As to the substantive grounds for the proceeding, the Show Cause 
Order alleged that Respondent previously held DEA Certificate of 
Registration No. BC4141139 in Michigan. Id. at 2. In addition, the 
Order alleged that Respondent ``voluntarily surrendered for cause'' 
that Registration ``on or about January 17, 2014.'' Id. The Order 
further alleged that Respondent materially falsified her application 
for a new DEA Registration in Puerto Rico on June 16, 2016 with respect 
to two liability questions on the application. Id. The Order alleged 
that the first material falsification was that the Respondent answered 
``N'' when asked: ``Has the applicant ever surrendered (for cause) or 
had a federal controlled substance registration, revoked, suspended, 
restricted or denied, or is any such action pending?'' Id. The Order 
alleged that the second material falsification was that Respondent 
answered ``N'' when asked: ``Has the applicant ever surrendered (for 
cause) or had a state professional license or controlled substance 
registration revoked, suspended, denied, restricted, or placed

[[Page 62903]]

on probation, or is any such action pending?'' Id. The Order asserted 
that these alleged material falsifications ``warrant the denial of your 
application for registration.'' Id. (citing 21 U.S.C Sec.  824(a)(1)).
    The Show Cause Order notified Respondent of her right to request a 
hearing on the allegations or to submit a written statement while 
waiving her right to a hearing, the procedures for electing each 
option, and the consequences for failing to elect either option. Id. at 
2-3 (citing 21 CFR 1301.43). The Order also notified Respondent of the 
opportunity to submit a corrective action plan. Id. at 3 (citing 21 
U.S.C. Sec.  824(c)(2)(C)).
    After being served with the Order, Respondent filed a timely 
``Request for Hearing'' on March 26, 2018 requesting a hearing on the 
allegations. Request for Hearing (dated March 22, 2018) (hereinafter 
Hearing Request). In her Hearing Request, Respondent states that she 
``d[id] not recall that I indicate [sic] `no' to the questions'' in the 
application and that she ``was helped by a friend in filling out the 
application and probably by mistake and/or ignorance in understanding 
the questions I answered `no.''' Id. at 2. Respondent also states that 
she surrendered her Michigan medical license and ``accept[ed] a six 
months and one day suspension, for being negligent, in not securing my 
prescription pad'' and then ``voluntarily surrender[ed her] DEA license 
to prescribe[] control[led] substance[s].'' Id. She also asserts that 
``[i]f I would have known the consequences of accepting the suspension, 
I would have litigated the case in Michigan, because I did nothing 
wrong. There is no practical reason not to inform the suspension of 
Michigan. The suspension appears online in the medical board data 
bank.'' Id. She also ``request[ed] discovery in the present matter, 
including [a] copy of the record and/or file with DEA.'' Id.
    The matter was placed on the docket of the Office of Administrative 
Law Judges and assigned to Administrative Law Judge Charles Wm. Dorman 
(ALJ). Thereafter, on March 26, 2018, the ALJ entered an Order for 
Prehearing Statements, directing the Government to file its Prehearing 
Statement on April 10, 2018, and the Respondent to file hers on April 
24, 2018. Order for Prehearing Statements, at 1. The Order also 
directed the parties to participate in a telephonic prehearing 
conference on April 25, 2018. Id. at 2. The Government filed its 
Prehearing Statement on April 10, 2018, and Respondent filed, through 
counsel, her Prehearing Statement on April 20, 2018.
    In Respondent's Prehearing Statement, Respondent stipulated that 
she voluntarily surrendered her Michigan medical license after being 
informed of an investigation for improperly prescribing medication. 
Respondent's Prehearing Statement, at 2. In addition, Respondent 
stipulated that she was previously registered with DEA pursuant to DEA 
Certificate of Registration No. BC4141139, and that she voluntarily 
surrendered for cause that registration. Id. at 3.
    On April 20, 2018, the Government filed a Motion for Summary 
Disposition based upon the Respondent's material falsification of her 
application for a DEA Registration in Puerto Rico on June 16, 2016. 
Specifically, the Government alleged that there was no dispute of 
material fact that Respondent materially falsified her application for 
a DEA Registration when she answered ``N'' to the following liability 
questions on the application: (1) ``Has the applicant ever surrendered 
(for cause) or had a federal controlled substance registration, 
revoked, suspended, restricted or denied, or is any such action 
pending?''; and (2) ``Has the applicant ever surrendered (for cause) or 
had a state professional license or controlled substance registration 
revoked, suspended, denied, restricted, or placed on probation, or is 
any such action pending?'' Government's Motion for Summary Disposition 
(hereinafter ``Government's Motion'' or ``Govt. Mot.''), at 2.
    On April 25, 2018, the ALJ held a telephonic prehearing conference 
pursuant to 21 CFR 1316.55. The ALJ entered a Prehearing Ruling (PHR) 
on April 26, 2018, reflecting that the parties had agreed to a series 
of factual stipulations, including the fact that (1) on April 19, 2013, 
the Michigan Board of Medicine suspended Respondent's Michigan medical 
license for a minimum period of six months and one day; (2) in January 
2014, Respondent ``voluntarily surrendered for cause'' a DEA 
Registration that Respondent had previously held in Michigan; (3) 
Respondent answered ``N'' when asked: ``Has the applicant ever 
surrendered (for cause) or had a federal controlled substance 
registration revoked, suspended, restricted or denied, or is any such 
action pending?'' and (4) Respondent answered ``N'' when asked: ``Has 
the applicant ever surrendered (for cause) or had a state professional 
license or controlled substance registration revoked, suspended, 
denied, restricted, or placed on probation, or is any such action 
pending?'' PHR, at 1-2.
    In his Prehearing Ruling, the ALJ also ordered Respondent to file a 
response to the Government's Motion by May 4, 2018, and directed the 
parties to attempt to draft additional ``mutually agreeable joint 
stipulations'' by May 30, 2018. Id. at 2. On May 3, 2018, Respondent 
filed her response to the Government's Motion and asserted that the 
Government had failed to ``establish bad faith, negligence or 
intentionally trying to mislead,'' and failed to prove that she ``is 
unfit to practice medicine, and therefore, unfit to prescribe 
medication.'' ``Respondent's Response to Government's Motion for 
Summary Disposition and Respondant's [sic] `Motion for Summary 
Disposition''' (Resp. Reply), at 4. In addition, Respondent attached a 
certificate of good standing for her Puerto Rico medical license and a 
copy of her license. Id., Attachment (Att.) 1-2. Additionally, she 
attached her own sworn statement, in which she asserts that she 
``misunderstood the questions.'' Id., Att. 3, at 2. She also argued 
that approving her application was warranted because she holds an 
active medical license in good standing and has never been sued for 
malpractice. Id. at 3-4.
    On May 8, 2018, after considering these pleadings, the ALJ entered 
an Order recommending that I find that Respondent had failed to raise a 
triable issue of material fact as to whether she had materially 
falsified her application. Order Granting Government's Motion for 
Summary Disposition and Recommended Rulings, Findings of Fact, 
Conclusions of Law, and Decision (Recommended Decision or R.D.), at 8-
9. As a result, the ALJ granted the Government's Motion and recommended 
that I deny Respondent's DEA application Control No. W1602461C. Id. at 
12.
    On May 17, 2018, Respondent filed her ``Request for 
Reconsideration'' of the ALJ's Recommended Decision,\1\ and on the same 
day the ALJ entered an Order Directing Government to Respond to 
Respondent's Request for Reconsideration. In that Order, the ALJ noted 
that there is no provision in DEA's regulations for either party to 
request reconsideration of an ALJ's recommended decision, and thus the 
ALJ would treat the request as Exceptions to the Recommended Decision. 
Order Directing Government

[[Page 62904]]

to Respond to Respondent's Request for Reconsideration, at 1. The Order 
directed the Government to file any response to Respondent's Exceptions 
by May 22, 2018. According to the record, the Government filed no 
Exceptions of its own nor any response to Respondent's Exceptions. On 
June 4, 2018, the record was forwarded to my Office for Final Agency 
Action.\2\
---------------------------------------------------------------------------

    \1\ On May 11, 2018, Respondent also filed a ``Supplemental 
Motion Submitting Document'' enclosing ``a certified translation of 
Resolution Num. 2017-118, issued by the Health Department Board of 
Licensing and Medical Discipline of Puerto Rico, in the case of In 
Re: Sr. Zelideh Cordova Velazco (Lic. #4865), Case No. Q-JDLM-2013-
41.'' Supplemental Motion Submitting Document, at 1.
    \2\ Respondent submitted two post-certification filings. On June 
12, 2018, Respondent filed her Request to Grant Motion for 
Reconsideration As Unopposed, and on August 17, 2018, Respondent 
filed her Second Request to Grant Motion for Reconsideration As 
Unopposed. On June 12, 2018 and on August 20, 2018, respectively, 
the ALJ issued Orders forwarding Respondent's post-certification 
filings to my Office and noted that his ``jurisdiction over the case 
terminated upon transmittal of the record to the Acting 
Administrator.'' Order Forwarding Respondent's Motion to Acting 
Administrator, at 1; Second Order Forwarding Respondent's Motion to 
Acting Administrator, at 1. I find that the ALJ properly forwarded 
Respondent's post-certification filings for my consideration 
because, as the ALJ correctly notes, his jurisdiction over this 
matter terminated when he certified and transmitted the record to my 
Office.
    Regarding the timing of Respondent's filings, neither the 
Controlled Substances Act nor DEA's implementing regulations provide 
for a supplemental filing by a party after the ALJ has certified the 
record. However, the Agency has, on occasion, exercised its 
discretion to consider such filings (however styled) after the ALJ 
has certified and transmitted the administrative record to my 
Office. E.g., Joe W. Morgan, D.O., 78 FR 61961, 61961 (2013) 
(allowing Respondent's post-certification filing and ``treat[ing it] 
as a motion for reconsideration''); Wesley G. Harline, M.D., 64 FR 
72678, 72684-85 (1999) (allowing Respondent's post-certification 
filing and treating it as a motion to reopen the record); Robert M. 
Golden, M.D., 61 FR 24808, 24808 (1996) (same). Indeed, the Agency 
has even exercised its discretion to consider motions for 
reconsideration after the Agency has issued its final decision and 
order. E.g., Lyle E. Craker, Ph.D., 76 FR 51403, 51405 (2011).
    To justify consideration of her filings at this stage of the 
case, Respondent must show that there has been an intervening change 
of controlling law, the availability of new evidence, or the need to 
correct a clear error or prevent manifest injustice. E.g., Foster v. 
Sedgwick Claims Mgmt. Services, 842 F.3d 721, 735 (D.C. Cir. 2016) 
(``A motion for reconsideration is discretionary and need not be 
granted unless the district court finds that there is an intervening 
change of controlling law, the availability of new evidence, or the 
need to correct a clear error or prevent manifest injustice.'') 
(citations and internal quotation marks omitted); Virgin Atl. 
Airways v. Nat'l Mediation Bd., 956 F.2d 1245, 1255 (2d Cir.) 
(same), cert. denied, 506 U.S. 820 (1992).
    Here, Respondent claims in both filings that her Exceptions 
should be deemed ``unopposed'' because the Government chose not to 
respond to her Exceptions. Respondent failed to offer any other 
basis in fact that her Exceptions were ``unopposed'' by the 
Government. I am aware of no DEA regulation or Agency precedent 
compelling a finding that a party who does not respond to an 
opposing party's Exceptions to an ALJ's Recommended Decision is 
deemed to have taken a position of ``unopposed'' to the opposing 
party's Exceptions. Moreover, Respondent's claim is not the type of 
intervening change in controlling law, newly available evidence, or 
clear error that would justify consideration of her post-
certification filings under Agency precedent at this stage of the 
case. For all these reasons, I do not consider Respondent's post-
certification filings.
---------------------------------------------------------------------------

    Having considered the entire record, including the ALJ's 
Recommended Decision, I find that Respondent materially falsified her 
application for DEA registration with respect to Liability Questions 2 
and 3 on her 2016 application. I therefore adopt the ALJ's 
recommendation that I deny Respondent's DEA Registration application. I 
make the following factual findings.

Findings of Fact

    Respondent is a physician who previously held an active medical 
license, No. 43-01063034, in the State of Michigan. Ex. 4 to Govt. Mot. 
On April 19, 2013, Respondent entered into a Consent Order with the 
Michigan Board of Medicine in which she agreed to the suspension of her 
medical license for a minimum period of six months and one day based on 
her improper prescribing of controlled substances to home health 
patients. See id.; see also R.D., at 10. Specifically, the Michigan 
administrative complaint against Respondent alleged, among other 
things, that she prescribed controlled substances, primarily oxycodone, 
Xanax, and Phenergan with codeine, to 26 patients despite: ``failing to 
document medical indication or necessity for these controlled 
substances''; failing to document ``any physical examination or 
clinical findings to justify the combination of'' controlled drugs 
prescribed; failing to document an appropriate medical history; failing 
to make ``any findings pertaining to pain assessment, level of 
dysfunction from pain, treatment plan or diagnostic testing''; failing 
to obtain ``a report from the Michigan Automated Prescription System''; 
failing to conduct a toxicology screen; failing to monitor the 
``patients' use of the controlled substances for drug dependency or 
diversion''; failing to counsel the patients regarding the risks 
associated with controlled substances; and consistently prescribing the 
maximum dose of Xanax ``without documenting prior medication use or use 
of Xanax.'' Ex. 4 to Govt. Mot., at 9-11.\3\
---------------------------------------------------------------------------

    \3\ The Consent Order recited that Respondent ``does not contest 
the allegations of fact and law'' in the state administrative 
complaint against her. Id. at 3.
---------------------------------------------------------------------------

    Respondent also previously held DEA Certificate of Registration No. 
BC4141139. Ex. 3 to Govt. Mot. In January 2014, Respondent voluntarily 
surrendered this registration for cause. Exs. 3, 5 to Govt. Mot.
    On June 15, 2016, Respondent applied for a practitioner's 
registration seeking authority to dispense controlled substances in 
schedules II through V with a proposed business address of Hacienda Del 
Dorado, K1 Calle Delonix, Toa Alta, Puerto Rico. Exhibits (Exs.) 1, 2 
to Govt. Mot. DEA assigned Respondent's DEA registration application 
Control No. W16052461C.\4\ DEA's Application for Registration includes 
liability questions which an applicant must answer either affirmatively 
(``Y'') or negatively (``N''). Exs. 1-3 to Govt. Mot. Liability 
Question 2 on the DEA Application for Registration filed by Respondent 
asks: ``Has the applicant ever surrendered (for cause) or had a federal 
controlled substance registration revoked, suspended, restricted or 
denied, or is any such action pending?'' Exs. 1-2 to Govt. Mot. 
Respondent answered this question: ``N'' for no. Id. I find that this 
answer was false.
---------------------------------------------------------------------------

    \4\ The ALJ recommended that I make this fact finding based on 
the parties' stipulation that DEA assigned Control No. W16052461C to 
Respondent's DEA application. R.D., at 3 (citing PHR, 1-2). In 
addition, the record includes a notarized sworn statement by 
Respondent that DEA assigned Control No. W16052461C to her. Att. 3 
to Resp. Reply, at 1.
---------------------------------------------------------------------------

    Liability Question 3 on the DEA Application for Registration filed 
by Respondent asks: ``Has the applicant ever surrendered (for cause) or 
had a state professional license or controlled substance registration 
revoked, suspended, denied, restricted, or placed on probation, or is 
any such action pending?'' Id. Respondent answered this question: ``N'' 
for no. I find that this answer was also false.

Discussion

A. Standard for Denial of an Application for Registration

    Section 303(f) of the Controlled Substances Act provides that an 
application for a practitioner's registration may be denied upon a 
determination ``that the issuance of such registration would be 
inconsistent with the public interest.'' 21 U.S.C. 823(f). In making 
the public interest determination, the CSA requires the consideration 
of the following factors:
    (1) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (2) The applicant's experience in dispensing . . . controlled 
substances.
    (3) The applicant's conviction record under Federal or State laws 
relating to the manufacture, distribution, or dispensing of controlled 
substances.

[[Page 62905]]

    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

Id. ``These factors are . . . considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). DEA precedent provides that 
I ``may rely on any one or a combination of factors, and may give each 
factor the weight I deem appropriate in determining whether . . . an 
application for registration should be denied.'' Richard D. Vitalis, 79 
FR 68701, 68708 (2014) (citing Robert A. Leslie, M.D., supra). 
Moreover, it is well established that I am ``not required to make 
findings as to all of the factors.'' Hoxie v. DEA, 419 F.3d 477, 482 
(6th Cir. 2005); see also Kevin Dennis, M.D., 78 FR 52787, 52974 
(2013); MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011).

    ``The provision of truthful information on applications is 
absolutely essential'' to a determination of whether granting an 
application is in the public interest. Peter H. Ahles, M.D., 71 FR 
50097, 50098 (2006). ``Since DEA must rely on the truthfulness of 
information supplied by applicants in registering them to handle 
controlled substances, falsification cannot be tolerated.'' Bobby 
Watts, M.D., 58 FR 46995, 46995 (1993). Accordingly, ``materially 
falsifying an application . . . provides an independent and adequate 
ground for denying an application.'' The Lawsons, Inc., 72 FR 74334, 
74338 (2007); see also Richard A. Herbert, M.D., 76 FR 53942, 53945 
(2011) (``Under the CSA, material falsification provides a separate and 
independent ground for denying an application.'').\5\ One materially 
false statement is enough to justify revocation or denial. Harold 
Edward Smith, M.D., 76 FR 53961, 53964 (2011). The Government bears the 
burden of proof in showing that the issuance of a registration is 
inconsistent with the public interest. 21 CFR 1301.44(d). Having 
considered the record, including the ALJ's Recommended Decision and 
Respondent's Exceptions, I conclude that the Government was entitled to 
summary disposition on the grounds that Respondent materially falsified 
her application for a DEA Certificate of Registration.
---------------------------------------------------------------------------

    \5\ Under Section 304(a)(1) of the Controlled Substances Act 
(CSA), a registration may be revoked or suspended ``upon a finding 
that the registrant * * * has materially falsified any application 
filed pursuant to or required by this subchapter.'' 21 U.S.C. 
824(a)(1). ``DEA has long held that the various grounds for 
revocation or suspension of an existing registration that Congress 
enumerated in section 304(a), 21 U.S.C. 824(a), are also properly 
considered in deciding whether to grant or deny an application under 
section 303.'' Richard D. Vitalis, D.O., 79 FR 68701, 68708 (2014) 
(citing Anthony D. Funches, 64 FR 14267, 14268 (1999); Alan R. 
Schankman, 63 FR 45260 (1998); Kuen H. Chen, 58 FR 65401, 65402 
(1993)). Thus, the allegation that Respondent materially falsified 
his application is properly considered in this proceeding. Vitalis, 
79 FR at 68708 (citing Samuel S. Jackson, 72 FR 23848, 23852 
(2007)).
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B. Material Falsification

    Here, as I have already noted, Respondent made two false statements 
when she submitted her DEA Application for Registration in 2016 in 
Puerto Rico. First, Respondent falsely stated in her response to 
Liability Question 2 on her DEA Application for Registration that she 
had never surrendered a DEA registration for cause when, in fact, she 
had surrendered DEA Certificate of Registration No. BC4141139 in 
Michigan for cause in January 2014. Second, Respondent falsely stated 
in her response to Liability Question 3 on her DEA Application that she 
has not had her state professional license revoked, even though in 2013 
she had entered into a Consent Order with the Michigan Board of 
Medicine agreeing to the suspension of her Michigan medical license.
    Turning to whether these false statements were material, Agency 
precedent establishes that ``[a] false statement is material if it `has 
a natural tendency to influence, or was capable of influencing the 
decision of the decision[-]making body to which it was addressed.' '' 
Gilbert Eugene Johnson, M.D., 75 FR 65663, 65665 (2010) (quoting Kungys 
v. United States, 485 U.S. 759, 770 (1998)). The false statement need 
only have the capacity to influence the decision-making body; it does 
not need to have exerted any actual influence. Alvin Darby, M.D., 75 FR 
26993, 26998 (2010) (citing United States v. Alemany Rivera, 781 F.2d 
229, 234 (1st Cir. 1985)). The Government must prove that the false 
information is material by ``clear, unequivocal, and convincing'' 
evidence. Hoi Y. Kam, M.D., 78 FR 62694, 62696 (2013) (quoting Kungys, 
485 U.S. at 772). Whether a falsification is material is a question of 
law. Harold Edward Smith, M.D., 76 FR 53961, 53964 (2011) (citing 
Kungys, 485 U.S. at 772).
    As stated below, I find that the Respondent's answers to both 
Liability Question 2 and Liability Question 3 were material. As far as 
Liability Question 3 is concerned, DEA precedent holds that the failure 
to disclose a prior suspension relating to the prescribing of 
controlled substances is material, even where the suspension was no 
longer effective at the time of the application: ``[E]ven where an 
applicant currently holds unrestricted state authority to dispense 
controlled substances, the failure to disclose state action against his 
medical license may be material if the action was based on conduct (or 
on the status arising from such conduct, i.e., a conviction for a 
controlled substance offense or mandatory exclusion from federal health 
care programs) which is actionable under either the public interest 
factors or the grounds for denial, suspension, and revocation set forth 
in section 824.'' Richard D. Vitalis, 79 FR at 681708 (2014).
    Here, the Government has provided evidence demonstrating that the 
underlying state investigation which prompted the suspension of 
Respondent's Michigan medical license and the surrender of her DEA 
registration concerned unlawful prescribing of controlled substances. 
See Ex. 4 to Govt. Mot. Given that the allegations concern the unlawful 
prescribing of controlled substances, I find that they are material 
because they are ``capable of influencing'' the DEA's decision.\6\ 
Kungys, 485 U.S. at 770; Jose G. Zavaleta, M.D., 78 FR 27431, 27435 
(2013); Smith, 76 FR at 53964. Likewise, Respondent's failure to 
disclose her surrender for cause of her prior DEA registration in 
Michigan in response to Liability Question 2 was also material 
according to DEA precedent. Zavaleta, 78 FR at 27435 (failure to 
disclose voluntary surrender of DEA registration following an 
investigation into unlawful prescribing was ``clearly capable of 
influencing'' the DEA's decision and was thus material); Smith, 76 FR 
at 53964 (failure to disclose fact that the applicant had ``been 
accused of writing unlawful prescriptions . . . [was] material to the 
[DEA's] investigation and assessment of [the applicant's] experience in 
dispensing controlled substances and his compliance with applicable 
laws related to'' controlled substances).
---------------------------------------------------------------------------

    \6\ The Consent Order recited that Respondent ``does not contest 
the allegations of fact and law'' in the state administrative 
complaint against her. Id. at 3.
---------------------------------------------------------------------------

    In addition, the Government must show that Respondent ``knew or 
should have known that [her] response[s] given to the liability 
question[s] [were] false.'' Samuel S. Jackson, D.D.S., 72 FR 23848, 
23852 (2007) (quoting Samuel Arnold, D.D.S., 63 FR 8687, 8688 (1998)); 
Merlin E. Shuck, D.V.M., 69 FR 22566, 22568 (2004). ``Under DEA 
precedent, the Government is not required to show that the 
falsification was intentional but only that the applicant `knew or 
should have known that the response given to the

[[Page 62906]]

liability question was false.''' Alvin Darby, M.D., 75 FR 26993, 26999 
(2010) (quoting The Lawsons, Inc., 72 FR 74334, 74339 (2007)).
    In Richard Jay Blackburn, D.O., the Acting Administrator determined 
that a copy of the state administrative complaint, the respondent's 
letter to the state board ``surrendering his state license,'' the state 
board's acceptance of the surrender, and a printout displaying the 
status of respondent's state license were sufficient to demonstrate 
that respondent ``knowingly falsified his application.'' 82 FR 18669, 
18673 (2017). The DEA has found that material falsifications are 
committed knowingly even where, as here, a respondent claims that he or 
she misunderstood the questions. Darby, 75 FR at 26999.
    Here, the Government attached a copy of the Respondent's 2016 
application, a copy of the administrative complaint and Consent Order 
issued by the Michigan Department of Licensing and Regulatory Affairs 
against Respondent, and a copy of the form which Respondent signed 
surrendering her Michigan DEA registration. See Exs. 1, 4-5 to Govt. 
Mot. Additionally, the Government attached two notarized documents 
signed by the Chief of DEA's Registration and Program Support Section 
verifying the Respondent's DEA registration history and her responses 
on her 2016 application. Exs. 2-3 to Govt. Mot. The Government's 
evidence is the same type of evidence as that submitted in Blackburn 
and therefore is sufficient to show that Respondent either knew or 
should have known that her application was materially false. 82 FR at 
18673. As a result, even if Respondent's statements that she 
misunderstood the questions were true, I find that she should have 
known under the facts in this case that her responses to the liability 
questions in this case were false. See Darby, 75 FR at 26999.
    Thus, I find that the Government has offered sufficient evidence to 
show that the Respondent materially falsified her 2016 application for 
a DEA registration in Puerto Rico.

C. Sanction

    Once the Government makes a prima facie case for material 
falsification, the next question ``becomes whether revocation [or 
denial] is the appropriate sanction in light of the facts.'' Arnold, 63 
FR at 8688. Although the Respondent acknowledges that the answers she 
provided in response to Liability Questions 2 and 3 on her 2016 
application were false, she explains that she did not intend to provide 
false statements, but instead misunderstood the questions. Resp. Reply, 
at 4-5; App. 3, at 2, para. 7.
    Respondent's insistence that her undisputed false statements should 
be excused because she ``misunderstood'' the liability questions is 
misplaced. In her Request for Hearing, the Respondent merely stated the 
following concerning her alleged misunderstanding of the questions: ``I 
was helped by a friend in filling out the application and probably by 
mistake and/or ignorance in understanding the questions I answered 
`no.'' Resp. Request for Hearing, at 2. Later, in her Response to 
Government's Motion for Summary Disposition, she further specified that 
she ``misunderstood'' Liability Questions 2 and 3, but her purported 
explanation disregards the actual wording of the questions. Att. 3 to 
Resp. Reply, at 2. For example, as to Liability Question 2, Respondent 
claims she misunderstood that question because her registration was 
surrendered voluntarily, and was not revoked, suspended or denied. Id. 
However, Liability Question 2 not only asked whether the applicant ever 
had a registration ``revoked, suspended, restricted or denied,'' but 
also expressly asked whether any registration had ever been surrendered 
for cause. Ex. 1 to Govt. Mot. Moreover, Respondent stipulated that her 
prior registration was surrendered for cause, so her negative answer 
was clearly false, and her claimed ``misunderstanding'' of Liability 
Question 2 rings hollow. See Shannon L. Gallentine, D.P.M., 76 FR 
45864, 45866 (2011).
    Similarly, Respondent's claim that she misunderstood Liability 
Question 3 also ignores the question itself. Respondent explained her 
``misunderstanding'' as to Liability Question 3 as follows: ``As to 
question #3, again Ms. Cordova['s] Registration was not revoked, 
suspended, denied, restricted, or placed on probation, nor is [sic] any 
such action was pending when she voluntarily surrender [sic] her 
Registration.'' Att. 3 to Resp. Reply, at 2. However, Liability 
Question 3 actually inquires: ``Has the applicant ever surrendered (for 
cause) or had a state professional license or controlled substance 
registration revoked, suspended, denied, restricted, or placed on 
probation, or is any such action pending?'' Ex. 1 to Govt. Mot. 
(emphasis added). It is undisputed that Respondent's state professional 
license for Michigan was suspended, and she clearly knew it was 
suspended, because she is the one who agreed to that suspension in 
writing when she entered into a Consent Order with the State of 
Michigan Board of Medicine. Thus, Respondent's claimed misunderstanding 
of Liability Question 3 is untenable on its face.
    Moreover, applicants for DEA registrations bear ```the 
responsibility to carefully read the question and to honestly answer 
all parts of the question.''' Arnold, 63 FR at 8688 (quoting Martha 
Hernandez, M.D., 62 FR 61145, 61147 (1997)). Allegedly misunderstanding 
or misinterpreting liability questions does not relieve the applicant 
of this responsibility. Hernandez, 62 FR at 61147-48 (concluding 
applicant committed material falsification despite misinterpreting one 
question); see also Gallentine, 76 FR at 45866. Additionally, 
inadvertence is legally irrelevant in resolving a material 
falsification case because the Government only needs to prove that 
Respondent ```knew or should have known''' that the answers were false. 
Richard A. Herbert, M.D., 76 FR 53942, 53956 (2011) (quoting The 
Lawsons, Inc., 72 FR 74334, 74338 (2007)) (emphasis added). See, e.g., 
Zavaleta, 78 FR at 27436, 27438-39 (ruling respondent materially 
falsified his application even where respondent testified that he made 
mistakes in filling out the application and ``should have give[n] [his 
applications] more careful review''). Thus, Respondent's defense of 
inadvertence, even if it were true, is legally inconsequential in 
deciding whether she materially falsified her 2016 application.
    Furthermore, the evidence that Respondent now holds a valid medical 
license in good standing in Puerto Rico is simply not relevant in terms 
of resolving the allegation that she materially falsified her 
application. Resp. Reply, at 3; Att. 1-2 to Resp. Reply; Hernandez, 62 
FR at 61147. The same holds true of the evidence that Respondent has 
never been sued for malpractice or been the subject of a professional 
complaint, except for the Michigan action, in her 19-20 year career. 
Resp. Reply at Att. 3, para. 8, 10. With respect to Liability Questions 
2 and 3 of Respondent's DEA Application, a material false statement is 
a material false statement regardless of her professional credentials.
    Although lack of intent to deceive and history of licensure are 
relevant in assessing the appropriate sanction, what is most 
dispositive is the fact that Respondent has not accepted responsibility 
for her materially false statements. See Lon F. Alexander, M.D., 82 FR 
49704, 49728 (2017); Arthur H. Bell, 80 FR 50035, 50041 (2015) (finding 
that applicant's failure to accept responsibility for materially 
falsifying application was ``reason alone to

[[Page 62907]]

conclude that he cannot be entrusted with a new registration''). I have 
considered the fact that Respondent currently holds a medical license 
in good standing in Puerto Rico, and her sworn statement that she has 
never been sued for malpractice and received only one professional 
complaint in her 19-20 year career. Att. 1-2 to Resp. Reply; Att. 3 to 
Resp. Reply, at 2-4. None of these facts outweighs Respondent's 
materially false application, especially given her failure to disclose 
extensive and serious allegations against her involving the unlawful 
prescribing of controlled substances. See William M. Knarr, D.O., 51 FR 
2772, 2773 (1986). Thus, I find that this mitigating evidence fails to 
diminish the gravity of her failure to reveal the alleged misconduct in 
her state of prior registration.
    Accordingly, based upon the foregoing, I conclude that the 
Government was entitled to summary disposition on the allegation that 
Respondent materially falsified her application for a new DEA 
registration.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 
CFR 0.100(b), I order that the application of Zelidah H. Cordova-
Velazco, M.D., for a DEA Certificate of Registration as a practitioner, 
be, and it hereby is, denied. This Order is effective immediately.

    Dated: November 20, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-26485 Filed 12-4-18; 8:45 am]
 BILLING CODE 4410-09-P