Notices. DEPARTMENT OF JUSTICE

13,885 words·~63 min read·/register/2006/08/24/06-7177·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4410-11-M DEPARTMENT OF JUSTICE Drug Enforcement Administration Peter A. Ahles, M.D.; Revocation of Registration On August 15, 2005, I, the Deputy Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and further ordered the immediate suspension of DEA Certificate of Registration, AA0092558, issued to Peter A. Ahles, M.D. (Respondent), of Anaheim, California. The Show Cause Order proposed to revoke Respondent's registration as a practitioner and to deny any pending applications for renewal or modification of the registration, on the ground that Respondent's continued registration would be inconsistent with the public interest. *See* 21 U.S.C. 823(f) and 824(a)(4).

The Show Cause Order also immediately suspended Respondent's registration based on my preliminary finding that his continued registration “would constitute an immediate danger to the public health and safety because of the substantial likelihood that [he would] continue to acquire large amounts of narcotic controlled substances and * * * illegally distribute these narcotic controlled substances to potential abusers and other unauthorized persons in exchange for cash.” Show Cause Order at 3.

The Show Cause Order specifically alleged that based on a review of transaction reports filed by DEA registrants, Respondent, during the period March 2004 to March 2005, had received “nearly 570,000 tablets of Schedule III hydrocodone and codeine tablets, most of which were packaged in 500 and 1000 count bottles.” *Id.* at 1-2. The Show Cause Order alleged that “[t]hese are excessive amounts of narcotics to be legitimately dispensed or administered from a single practitioner's office in a one-year period.” *Id.* The Show Cause Order further alleged that in the thirteen month period ending in April 2005, Respondent “had purchased over one million dosage units of Schedule II through V controlled substances, [which were] predominately narcotic tablets.” *Id.* at 2.

The Show Cause Order also alleged that on three occasions during May 2005, a DEA Special Agent and a cooperating source

(CS)had visited Respondent's office and made undercover buys of hydrocodone, a Schedule III controlled substance. *Id.* The Show Cause Order alleged that on two occasions, the Special Agent observed the CS pay Respondent $500 in cash and receive a plastic bag containing approximately 500 tablets of hydrocodone. *Id.* The Show Cause Order alleged that on the other occasion, the Special Agent observed the CS pay Respondent $600 and receive a plastic bag containing 500 tablets of Norco, another hydrocodone product. *Id.* The Show Cause Order further alleged that Respondent made each of the dispensings without asking the CS for his medical complaint, taking a medical history, or conducting a physical examination. The Show Cause Order thus alleged that the distributions were made “without any legitimate medical purpose and [were] not in the course of legitimate medical practice” and violated 21 U.S.C. 841(a)(1). *Id.* Finally, the Show Cause Order alleged that Respondent had, in submitting his DEA renewal application, answered “No” the question whether his state license had ever been revoked, suspended, or placed on probation. *Id.* The Show Cause Order alleged that the Medical Board of California had, in fact, placed Respondent's state license on probation three different times and that Respondent had thus “materially falsified [his] application for registration in violation of 21 U.S.C. 843(a)(4)(A).” *Id.* at 2-3. Based on evidence in the investigative file supporting the above allegations, I further made the preliminary finding that Respondent had “grossly avoided [his] responsibilities as a registrant and [had] been responsible for the actual diversion of controlled substances into other than legitimate channels in violation of 21 U.S.C. 841(a)(1).” 1 1 The Show Cause Order also notified Respondent of his right to a hearing and the procedure for requesting one. On August 16, 2005, a DEA Diversion Investigator

(DI)personally served the Show Cause Order on Respondent. Since that time, neither Respondent, nor anyone purporting to represent him, has responded. Because

(1)more than thirty days have passed since Respondent's receipt of the Show Cause Order, and

(2)no request for a hearing has been received, I conclude that Respondent has waived his right to a hearing. *See* 21 CFR 1309.53(c). I therefore enter this final order without a hearing based on information contained in the investigative file. Findings Respondent is the holder of DEA Certificate of Registration No. AA0092588, which expired on June 30, 2005. On May 5, 2005, Respondent applied for a renewal of his registration and sought authority to prescribe Schedule II through V controlled substances including Schedule II and III narcotics. On his renewal application, Respondent answered “No” the question: “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?” According to the Medical Board of California's records, at the time Respondent filed his renewal application, he had been the subject of three separate disciplinary proceedings. In each of these cases, the California Board placed Respondent on probation. 2 I also take official notice of the records of the California Board which indicate that on February 24, 2006, Respondent surrendered his state license. 2 The proceedings were commenced in June 1975, September 1992, and October 1996. The investigative file further establishes that between March 2004 and April 2005, Respondent purchased over one million dosage units of Schedule III through Schedule V controlled substances from ANDA Pharmaceuticals. Respondent obtained hydrocodone 7.5 and 10 mg. tablets, codeine #4, Stadol (butorphanol tartrate), and Phenergan with codeine. The investigative file also establishes that in April 2005, a DEA Special Agent and a DEA Diversion Investigator debriefed a cooperating source (CS). The CS stated that he/she had purchased various controlled substances including hydrocodone, Norco, and Xanax from Respondent. During the interviews, the CS related that Respondent performed little to no medical examination and did not require that the CS give a medical reason before selling the drugs to the CS. The CS further asserted that Respondent charged $500 cash for 500 pills/tablets of controlled substances, but charged $600 for 500 pills/tablets of Norco. The CS also stated that Respondent would prescribe any drug including Schedule II controlled substances such as Oxycontin to persons he knows well. Finally, the CS related that Respondent had few legitimate patients and that most of the people he saw visited him to obtain prescription drugs either for personal use or to resell the drugs on the street. The investigative file further establishes that following the interviews, a DEA special agent accompanied the CS to Respondent's office on three separate dates. On May 12, 2005, the Special Agent observed as the CS paid Respondent $500 and received a black plastic bag containing approximately 500 hydrocodone tablets. Respondent did not perform a physical examination on the CS and did not discuss with the CS a medical reason for the dispensing. Moreover, Respondent did not give the CS any directions for use of the drugs. The Special Agent further observed that Respondent appeared to be under the influence of some substance. On May 18, 2005, the same Special Agent and the CS returned to Respondent's office. On this occasion, the CS paid $600 and received from Respondent a black plastic bag containing 500 tablets of Norco. While on this occasion Respondent weighed the CS, the CS offered no medical complaint and Respondent did not perform a physical exam. Respondent also failed to give the CS any directions for use of the drugs. Finally, on May 19, 2005, the Special Agent and the CS returned to Respondent's office. On this occasion, the Special Agent paid Respondent $500 and requested 500 hydrocodone tablets. Respondent handed the Special Agent a black plastic bag containing approximately 500 Norco tablets. The Special Agent did not complain of any medical symptoms and Respondent did not perform a physical examination. Discussion As pertinent here, Section 304 of the Controlled Substances Act

(CSA)provides that a registration to: Dispense a controlled substance * * * may be suspended or revoked * * * upon a finding that the registrant—

(1)Has materially falsified any application filed pursuant to or required by this subchapter or subchapter II of this chapter;

(3)Has had his State license or registration suspended, revoked, or denied by competent State authority and is no longer authorized by State law to engage in the * * * distribution, or dispensing of controlled substances * * *;

(4)Has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined under such section[.] 21 U.S.C. 824(a). In this case, I conclude that each of the above provisions provide independent grounds for revoking Respondent's registration. First, it is clear that Respondent materially falsified his May 5, 2005 application for renewal of his registration. On that application, Respondent was asked whether he had “ever surrendered (for cause) or had a state professional license or controlled substance registration revoked, suspended, denied, restricted, *or placed on probation* ?” (emphasis added). Respondent answered “No,” notwithstanding that the Medical Board of California had placed him on probation on three separate occasions. Given that the question specifically asked Respondent whether his medical license had ever been “placed on probation,” it is indisputable that Respondent's answer was a material falsification. The CSA requires DEA to determine whether the issuance of a registration would be consistent with the public interest. *See* 21 U.S.C. 823(f). The provision of truthful information on applications is absolutely essential to effectuating this statutory purpose. *See* 21 U.S.C. 824(a)(1); *see also VI Pharmacy, Rushdi Z. Salem* , 69 FR 5584, 5585 (2004); *Terrance E. Murphy, M.D.* , 61 FR 2841, 2845 (1996). As the Sixth Circuit recently observed: “Candor during DEA investigations * * * is considered by the DEA to be an important factor when assessing whether a physician's registration is consistent with the public interest.” *Hoxie* v. *DEA* , 419 F.3d 477, 483 (2005). Our cases accordingly hold that “'falsification cannot be tolerated.”' *VI Pharmacy* , 69 FR at 5585 (quoting *Murphy* , 61 FR at 2845) (other citation omitted). Respondent's failure to truthfully answer the question regarding prior state disciplinary actions is thus reason alone to revoke his registration. Respondent's drug dealing provides an additional ground for revoking his registration. Such conduct clearly constitutes acts which “render his registration * * * inconsistent with the public interest.” *See* 21 U.S.C. 824(a)(4). Moreover, while the CSA sets forth five factors to be considered in determining the public interest, *see id* . § 823(f), I am “not required to make findings as to all of the factors, and can give each factor the weight [I] determine[] is appropriate.” *Hoxie* , 419 F.3d at 482; *see also Morall* v. *DEA* , 412 F.3d 165, 173-74 (D.C. Cir. 2005). Where, as here, a registrant has engaged in such egregious misconduct as drug dealing, a lengthy analysis of each of the factors is unnecessary. It is indisputable that Respondent did not comply with applicable State and Federal laws “relating to controlled substances” and that his conduct “threaten[s] public health and safety.” 21 U.S.C. 823(f)(4) and (5). Furthermore, while the investigative file does not contain evidence establishing what action the Medical Board of California took in response to this investigation, *see id* . § 823(f)(1), I have taken official notice of the fact that on February 24, 2006, Respondent surrendered his California medical license in response to the State Board's accusation that Respondent committed unprofessional conduct for, *inter alia* , violating state and federal drug laws. 3 *See also id* . § 824(a)(3). Thus, it is clear that Respondent “has committed such acts as would render his registration * * * inconsistent with the public interest as determined under” section 823(f). Id. § 824(a)(4). The revocation of Respondent's registration is therefore necessary to protect the public interest. 3 Although the Show Cause Order did not allege Respondent's loss of state authority as a ground for this proceeding, the CSA does not authorize DEA “to maintain a registration if the registrant is without state authority to handle controlled substances in the state in which he practices.” *Sheran Arden Yeates, M.D.* , 71 FR 39130, 39131 (2006). DEA has consistently applied this rule. *Id.; see also Dominick A. Ricci, M.D.* , 58 FR 51104 (1993); *Bobby Watts, M.D.* , 53 FR 11919 (1988). Because Respondent no longer has authority under California law to handle controlled substances, he is not entitled to maintain his DEA registration and revocation of his registration is warranted for this reason as well. Furthermore, an allegation that a practitioner has committed acts that render his continued registration inconsistent with the public interest incorporates the statutory factors of 21 U.S.C. 823(f). *See* 21 U.S.C. 824(a)(4). The first factor requires consideration of “[t]he recommendation of the appropriate State licensing board or professional disciplinary authority.” *See id.* § 823(f)(1). An allegation brought under section 824(a)(4) thus provides adequate notice that a loss of a State license may be considered during the proceeding. Order Accordingly, pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 28 CFR 0.100(b) and 0.104, I hereby order that DEA Certificate of Registration, AA0092558, issued to Peter A. Ahles, M.D., be, and it hereby is, revoked. I further order that any pending applications for renewal or modification of such registration be, and they hereby are, denied. This order is effective September 25, 2006. Dated: August 15, 2006. Michele M. Leonhart, Deputy Administrator. [FR Doc. E6-14050 Filed 8-23-06; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 05-27] Michael's Discount Pharmacy; Revocation of Registration On April 8, 2005, I, the Deputy Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and further ordered the immediate suspension of DEA Certification of Registration, BM8291572, issued to Michael's Discount Pharmacy (Respondent) of Kenner, Louisiana. The Show Cause Order proposed to revoke Respondent's registration and to deny any pending applications for renewal or modification of its registration on the ground that Respondent's continued registration as a retail pharmacy would be inconsistent with the public interest. *See* 21 U.S.C. 823(f) and 824(a). The Show Cause Order also immediately suspended Respondent's registration based on my preliminary finding that Respondent's continued registration constitutes an imminent danger to public health and safety “because of the substantial likelihood that [Respondent would] continue to divert controlled substances to drug abusers.” *See* Show Cause Order at 17; *see also* 21 U.S.C. 824(d). The Order further notified Respondent of its right to a hearing. *See* Show Cause Order at 17-18. The Show Cause Order specifically alleged that Respondent was purchasing enormous amounts of hydrocodone products, a Schedule III controlled substance, and that its purchases dwarfed the quantities of the same drugs that were bought by other retail pharmacies in the same area. For example, the Show Cause Order alleged that from January 2, 2004, through February 3, 2005, Respondent purchased 2,486,600 dosage units of Hydrocodone 10/650. *Id.* at 3. The Order further alleged that the next largest pharmacy purchaser had bought only 13,500 dosage units in the same time period. *Id.* The Order also alleged that during the year 2004, Respondent was the second largest purchaser of hydrocodone products in the State of Louisiana. *Id* . The Show Cause Order alleged that Respondent was filling large amounts of combination prescriptions consisting of hydrocodone, either alprazolam or diazepam (both Schedule IV depressants), and carisoprodol, a non-controlled analgesic that metabolizes into meprobamate, a Schedule IV depressant, and which is often used by drug abusers in conjunction with narcotics. *See id.* at 4. The Show Cause Order alleged that these “combination prescriptions are issued to persons of all types, regardless of their age, weight, height, gender and complaint.” *Id* . The Order also alleged that an accountability audit had found multiple discrepancies which included large underages of hydrocodone, diazepam, and alprazolam products. *See id.* at 5. Most significantly, the Show Cause Order alleged that the Kenner Police Department

(KPD)had received numerous complaints of persons illegally selling prescription drugs in Respondent's parking lot. *Id.* at 8. The Show Cause Order described the arrests of more than twenty individuals (who were first observed either leaving Respondent's store or in its parking lot) for either the illegal possession of controlled substances or the illegal distribution of controlled substances which had been obtained from Respondent. *See id.* at 9-17. The Show Cause Order further alleged that many of the arrestees had continued to obtain large quantities of combination prescriptions from Respondent even after their arrests. *See id.* The Order also alleged that a number of the arrestees possessed other controlled substances such as marijuana and methamphetamine. *See id.* at 9, 11-13. The Order also alleged that Respondent's employees knew that the KPD was arresting Respondent's customers, that customers would often complain about the police, and that the police would sometimes enter the pharmacy to look for a suspect. *See id.* at 16. In addition, many of Respondent's customers were from out of town. *See id.* The Show Cause Order also recounted the facts surrounding a complaint that had been filed with the Louisiana Board of Pharmacy against Respondent. The complainant alleged that on both January 17 and February 3, 2004, her 19 year old son had obtained from Respondent a combination prescription of 90 hydrocodone 10 mg., 90 carisoprodol 350 mg., and 30 alprazolam 2mg. *See id.* at 16. On February 5, 2004, the complainant's son died of respiratory failure due to acute and chronic drug use. *Id.* The autopsy's toxicology tests found elevated levels of hydrocodone and alprazolam. *See id.* Finally, the Show Cause Order alleged that the majority of prescriptions filled by Respondent were for the aforementioned drug combination and were issued by a small group of doctors. *See id.* at 17. The Order alleged that “[b]ased upon the sheer volume of duplicate prescriptions from the large volume of customers written by the same group of doctors, and the knowledge that [Respondent's] customers were routinely being arrested * * * after leaving” the pharmacy, Respondent “knows or should know that the combination prescriptions it fills are not valid prescriptions.” *Id.* The Order thus alleged that Respondent and its pharmacists were diverting “massive amounts of controlled substances” in violation of 21 U.S.C. 841(a)(1), and 21 CFR 1306.04. *Id.* at 17. On May 5, 2005, Respondent requested a hearing; the case was assigned to Administrative Law Judge

(ALJ)Mary Ellen Bittner. On May 25, 2005, the Government sought to stay the proceeding and moved for summary disposition. The basis for the motion was that on April 28, 2005, Respondent had entered into a consent agreement with the Louisiana Board of Pharmacy. Pursuant to the agreement, Respondent surrendered its Louisiana Controlled Dangerous Substances License. The Government thus contended that because Respondent no longer had authority under state law to engage in the distribution of controlled substances, *see* 21 U.S.C. 824(a)(3), it was no longer entitled to hold a Federal registration. The Government further contended that Respondent's request for a hearing should be dismissed. On June 9, 2005, Respondent filed a response. Respondent advised that it did not oppose the Government's motion. Respondent further acknowledged that it had voluntarily surrendered its state license and was thus not eligible to hold a DEA registration. On July 1, 2005, the ALJ granted the Government's motion for summary disposition. The ALJ observed that, under longstanding agency precedent, “a registrant may not hold a DEA registration if it is without appropriate authority under the laws of the state in which it does business.” ALJ Dec. at 2 (citing, *inter alia, Rx Network of South Florida, LLC,* 69 FR 62,093-01 (2004); *Wingfield Drugs, Inc.* , 52 FR 27,070 (1987)). The ALJ further noted that Respondent had admitted that it was no longer licensed in Louisiana and thus was not entitled to hold a DEA registration. *Id.* Because there were no material facts in dispute, the ALJ granted the Government's motion and recommended that I revoke Respondent's registration and deny any pending applications for renewal or modification of its registration. *See id.* at 2-3. Having considered the record as a whole, I hereby issue this decision and final order. I adopt in its entirety the ALJ's opinion and recommended decision. Because the facts are straightforward and not in dispute, I conclude that there is no need to elaborate on them. As the ALJ found, Respondent is no longer authorized to distribute controlled substances under State law. Therefore, under our precedents, Respondent is not entitled to maintain its DEA registration. *See, e.g., Rx Network of South Florida,* 69 FR at 62095. Order Accordingly, pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 28 CFR 0.100(b) and 0.104, I hereby order that DEA Certificate of Registration, No. BM8291572, issued to Michael's Discount Pharmacy, be, and it hereby is, revoked. I further order that any pending applications for renewal or modification of such registration be, and they hereby are, denied. This order is effective September 25, 2006. Dated: August 15, 2006. Michele M. Leonhart, Deputy Administrator. [FR Doc. E6-14049 Filed 8-23-06; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 05-15] Oakland Medical Pharmacy; Revocation of Registration On October 27, 2004, I, the Deputy Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and further ordered the immediate suspension of DEA Certificate of Registration, AO6837477, issued to Oakland Medical Pharmacy (Respondent) of Madison Heights, Michigan. The Show Cause Order proposed to revoke Respondent's pharmacy registration and to deny any pending applications for renewal or modification of its registration on the ground that Respondent's continued registration would be inconsistent with the public interest. *See* 21 U.S.C. 823(f) and 824(a). The Order of Immediate Suspension was based on my preliminary finding that Respondent's continued registration “would constitute an imminent danger to the public health and safety because of the substantial likelihood” that Howard Applebaum, Respondent's owner and chief pharmacist would “continue to divert controlled substances to persons who will abuse them.” Show Cause Order at 3. The Show Cause Order also notified Respondent of its right to a hearing. *Id.* The Show Cause Order specifically alleged that between February 2002 and October 2004, Mr. Applebaum had “[o]n many occasions * * * provided [two undercover] agents with refills of controlled substance prescriptions when refills had not been authorized by a physician.” *Id.* at 2. The Show Cause Order further alleged that Mr. Applebaum had “also provided the agents with excessive amounts of controlled substances that had not been authorized by a physician” by providing the agents with refills when he dispensed the initial prescriptions. *Id.* The Order also alleged that Mr. Applebaum had provided refills to the agents long before their original prescriptions would have been used up. *Id.* The Show Cause Order alleged that on July 26, 2004, Mr. Applebaum filled a controlled substance prescription for an agent “with no authorization from her physician.” *Id.* The Order also alleged that on the same day, the agent observed Mr. Applebaum provide another customer with two refills for a controlled substance. *Id.* The Show Cause Order further alleged that a review Respondent's records for the period January 2003 through May 2004 indicated that “Mr. Applebaum routinely dispenses unauthorized controlled substances by providing early refills * * * and multiple refills of prescriptions for the same controlled substances on the same date.” *Id.* The Order also alleged that Respondent's records show that “Mr. Applebaum dispenses narcotic to drug addicts and to individuals obtaining treatment for narcotic addiction.” *Id.* The Show Cause Order alleged that “Mr. Applebaum was “routinely dispens[ing] contraindicated controlled substances at the same time to the same patient,” and that he was also “routinely dispens[ing] controlled substances” to doctor shoppers. *Id.* Finally, the Show Cause Order alleged that from October 2003 through April 2004, Respondent had purchased 350,000 units of hydrocodone products and that 46 percent of the hydrocodone prescriptions it dispensed were issued by the same physician. *Id.* at 3. The Order thus alleged that there was a “substantial likelihood that Mr. Applebaum will continue to divert controlled substances to” drug abusers and that Respondent's continued registration “would constitute an imminent danger to public health and safety.” *Id.* On December 13, 2004, the Office of the Administrative Law Judges received Respondent's request for a hearing. The case was assigned to Administrative Law Judge

(ALJ)Gail A. Randall. On December 22, 2004, the Government moved for summary disposition. The basis for the motion was that on November 16, 2004, the Michigan Board of Pharmacy had filed an Administrative Complaint against Respondent and had also summarily suspended Respondent's state pharmacy license. The State's Order of Summary Suspension was effective immediately. The Government thus contended that because Respondent no longer had authority under state law to distribute or dispense controlled substances, see 21 U.S.C. 824(a)(3), it was not entitled to hold its Federal registration. The Government further contended that there was no factual matter in dispute. 1 1 Upon receipt of the Government's motion, the ALJ ordered that the proceedings be stayed pending a decision on the motion and further order Respondent to file a reply. On January 21, 2005, Respondent filed an opposition to the Government's motion. While Respondent acknowledged that the State had summarily suspended its registration, it contended that the State's action “was predicated in large part on the immediate ex-parte suspension of respondent's DEA registration * * * and the facts developed by the DEA.” Resp. Answer to Motion for Summary Disp. at 1. Respondent further contended that the hearing before the State ALJ was ongoing and that the state order was not final. See id. Respondent argued that for DEA to rely on the State's summary suspension when the State's action was based on the original DEA proceeding “is a case of boot-strapping extraordinaire.” *Id.* at 2. Respondent thus contended that it would be “fundamentally unfair” to grant the Government's motion. *Id.* Respondent further contended that revocation was not required by the statutory language of 21 U.S.C. 824(a)(3). *See id.* (quoting 21 U.S.C. 824(a)(3) (“a registration * * * may be suspended or revoked by the Attorney General upon a finding that the registrant has had his State license or registration suspended, revoked or denied by competent State authority”). According to Respondent, “[t]he action is not mandatory nor is it warranted in this situation where the respondent has specifically requested a hearing on the merits and is currently in the midst of” a State hearing “on the issue of whether * * * Respondent's conduct merits [an] order of summary suspension of the licenses by the State.” *Id.* at 2-3. Respondent thus requested that the ALJ deny the Government's motion for summary disposition and that the Federal proceeding be stayed until the State issued a decision on the merits. On February 4, 2005, the ALJ issued an Order for Status Report. In the order, the ALJ notified the parties that she had taken the matter under advisement and that the proceedings would remain stayed. The ALJ also ordered Respondent to file a status report with respect to its State license on or before April 18, 2005. The ALJ further notified Respondent that if it failed to file the report, the ALJ would rule on the government's motion based on the information then before her. *See* Order for Status Report at 1. As of May 27, 2005, Respondent had not filed a status report. The ALJ therefore issued her order, opinion and recommended decision. In her order, the ALJ granted the Government's motion for summary disposition, denied the Respondent's request for a continued stay of the proceedings and recommended the revocation of Respondent's registration on the ground that Respondent lacked State authority to handle controlled substances. *See* ALJ Dec. at 5-7. The ALJ specifically found that “Respondent did not deny that it is currently without state authorization to handle controlled substances.” ALJ Dec. at 5. The ALJ further noted that Respondent had failed to file a report advising her of the status of the state proceeding. *See id* . Because state authorization is an essential prerequisite to a DEA registration, *see id* . at 4, and it was undisputed that “that the Respondent does not have authority to handle controlled substances in the jurisdiction where it seeks to maintain its DEA registration,” the ALJ granted the Government's motion for summary disposition. *Id* . at 5. The ALJ acknowledged Respondent's argument that it was “unfair” for DEA to revoke its registration based on the Michigan suspension, because it had been based on the DEA Order to Show Cause and Immediate Suspension of Registration. *Id* . at 5-6. The ALJ further noted that “such an action is circular and may result in the Respondent being denied an opportunity to adjudicate the facts.” *Id* . at 6. The ALJ also denied Respondent's request for a stay until the conclusion of the state proceeding. According to the ALJ, “[t]he fact remains that the Respondent currently lacks state authorization to handle controlled substances, and therefore *cannot* remain registered with the DEA.” *Id* . The ALJ thus concluded that she had “no choice but to grant summary disposition at the present time, and to deny” Respondent's motion for a stay. *Id* . Thereafter, Respondent sought reconsideration of the ALJ's recommended decision. The basis for Respondent's motion was that he had not intentionally failed to file a Status Report but had erroneously believed, based on a phone conversation with Government counsel that occurred on April 11, 2005, that Government counsel “was going to investigate the matter and confirm with Respondent's counsel whether it was still necessary for him to file anything additional in writing given the status of the” state hearing. Resp. Req. for Recon. at 2. Respondent's counsel stated that when he did not hear back from Government counsel, he “wrongly assumed that the issue had been resolved.” *Id* . Respondent further informed the ALJ that the state proceedings were continuing and that the proceeding had been “an elongated and vigorously contested hearing,” which had been held on five different dates with one additional date to follow, at which the State's “expert pharmacy witness” was to testify. *Id* . at 3. The Government responded that while it did not object to the late filing of the status report, it did object to reconsideration of the ALJ's decision. *See* Govt. Resp. at 2. While the Government counsel did not remember the aforementioned telephone conversation, he did not dispute that Respondent's counsel may have asked him whether he had to file anything. *Id* . The Government further pointed out that Respondent's counsel did not contend that he had not received the ALJ's Order for Status Report, and that the Order, which the Government had not received, presumably clearly stated the deadline for filing the Status Report. *See id* . at 2-3. The Government contended that whether Respondent should be permitted to file a status report was irrelevant because Respondent's state license had been suspended in November 2004 and had remained so since then. The Government further argued that “Respondent still does not know when the state proceedings will end, and there is no assurance that Respondent will regain its state authority.” *Id* . at 3. According to the Government, “[t]he ALJ based her Decision on the fact that Respondent had no state authority to handle controlled substances at the time of the Decision. That fact was true at the time of the deadline for the status report, at the time of the Decision and is true at the present.” *Id* . Therefore, the Government argued that there was no basis for the ALJ to reconsider her decision. The ALJ denied Respondent's motion for reconsideration. Again, the ALJ noted that “under the Controlled Substances Act it is clear that the DEA does not have statutory authority to maintain a registration if the registrant is without state authority to handle controlled substances in the state in which the registrant conducts business.” Order Denying Resp. Req. for Recon. at 2. The ALJ then transmitted the record to me. 2 2 I emphasize that there is no provision in DEA's regulations for either party to request reconsideration of an ALJ's recommended decision. See generally 21 CFR Subpart D. The appropriate means of challenging the ALJ's decision is to file exceptions. See 21 CFR 1316.66. Having considered the record as a whole, I hereby issue this decision and final order. I adopt the ALJ's findings of fact and conclusions of law. I further adopt the ALJ's recommended decision to revoke Respondent's registration. I do not, however, adopt the opinion to the extent it suggests that it was “unfair” for this agency to revoke Respondent's Federal registration based on the State proceeding and that “such an action is circular and may result in the Respondent being denied an opportunity to adjudicate the facts.” ALJ Dec. at 6. I acknowledge that the State's Administrative Complaint relied in part on my Order to Show Cause and Immediate Suspension of Registration. *See* Admin. Complaint at 3. But the state complaint did not rely solely on my action. The state complaint cited a variety of grounds under Michigan law for imposing sanctions including “failing to comply with applicable Federal laws,” *id* . at 2 (citing Mich. Comp. Laws § 333.7311(1)(f)); dispensing of “controlled substances for other than legitimate medical purposes,” *id* . (citing Mich. Comp. Laws § 333.7311(1)(g)); and “if an officer or stockholder of the pharmacy lacks good moral character.” *Id* . at 2-3 (citing Mich. Comp. Laws § 333.17768(2)(a)). The complaint further alleged that Respondent had violated these provisions of state law. *Id* . at 3-4. Furthermore, the State's Order of Summary Suspension was based on the “careful consideration of the documentation filed” in the State's administrative proceeding including the complaint. Order of Summary Suspension 1. The State's Order also provided a procedure for Respondent to petition for dissolution of the state suspension. *See id* . I take the State on its word and conclude that its decision to summarily suspend Respondent's state license was not based solely on my order but was also based on its own evaluation of the evidence. Furthermore, as Respondent itself pointed out, the State proceeding has been “an elongated and vigorously contested hearing,” which included at least six days of hearings with the State putting on an expert witness. It is hard to imagine why a proceeding would take so long to litigate and require expert testimony if it did not involve an adjudication of the underlying facts. Thus, I do not accept the ALJ's conclusion that it is “circular” for this agency to revoke Respondent's registration based on the State's summary suspension order and that doing so “may result in * * * Respondent being denied an opportunity to adjudicate the facts.” ALJ Dec. at 6. Quite the opposite, it appears that the State entered its suspension order based on its own examination of the evidence; it further appears that Respondent has had a full and fair opportunity to litigate the facts in the State proceeding. DEA's regulations make clear that the ALJ's decision is only a recommendation; it is not the final agency action. The revocation of Respondent's Federal registration becomes final only with this order. Yet in the interval between the ALJ's decision and the publication of this order, Respondent has submitted no evidence to show that the State has lifted its suspension. As the ALJ correctly recognized, DEA has consistently held that a registrant may not hold a DEA registration if it is without appropriate authority under the laws of the state in which it does business. *See, e.g., Rx Network of South Florida, LLC* , 69 FR 62,093 (2004); *Wingfield Drugs, Inc.* , 52 FR 27,070 (1987). Respondent does not have authority under Michigan law to handle controlled substances. Therefore, it is not entitled to maintain its DEA registration. *See Rx Network of South Florida* , 69 FR at 62095. Order Accordingly, pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 28 CFR 0.100(b) and 0.104, I hereby order that DEA Certificate of Registration, No. AO6837477, issued to Oakland Medical Pharmacy be, and it hereby is, revoked. I further order that any pending applications for renewal or modification of its registration be, and they hereby are, denied. This order is effective September 25, 2006. Dated: August 15, 2006. Michele M. Leonhart, Deputy Administrator. [FR Doc. E6-14045 Filed 8-23-06; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Sujak Distributors; Denial of Application On May 18, 2005, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Sujak Distributors (Respondent). The Show Cause Order proposed to deny Respondent's application for a DEA Certificate of Registration as a distributor of List I chemicals on the ground that Respondent's registration would be inconsistent with the public interest. *See* U.S.C. 823(h). The Show Cause Order specifically alleged that Respondent was proposing to sell ephedrine and pseudoephedrine products, which are precursors used in the manufacture of methamphetamine, to convenience stores, gas stations and liquor stores in the Davenport, Iowa area. *See* Show Cause Order at 2. The Show Cause Order alleged that only a small percentage of sales of non-prescription ephedrine and pseudoephedrine products occur in these retail outlets and that these establishments are a primary supply source of these products for the illegal manufacture of methamphetamine. *See id.* at 1-2. The Show Cause Order further alleged that Respondent's proposed registered location was at a storage unit rental facility and that Respondent's unit was not “sufficiently secure from entry from adjacent units.” *Id.* at 2. The Show Cause Order also alleged that Respondent's co-owner, Mr. Dennis Carney, had told DEA Diversion Investigators that “25 to 35 percent of his business would consist of listed chemical product sales to convenience stores, liquor stores and gas stations.” *Id.* The Show Cause Order alleged that “the average small store could expect to sell monthly only about $15.00 to $40.00 worth of pseudoephedrine products.” *Id.* at 3. Finally, the Show Cause Order alleged that methamphetamine is “one of the most popular and widely abused drugs throughout the Midwest.” *Id.* The Show Cause order also notified Respondent of its right to a hearing. *Id.* at 4. The Show Cause Order was served on Respondent by certified mail, return receipt requested, and on June 3, 2005, Respondent acknowledged receipt. Since that time, neither Respondent, nor anyone purporting to represent it, has responded. Because

(1)more than thirty days have passed since Respondent's receipt of the Show Cause Order, and

(2)no request for a hearing has been received, I conclude that Respondent has waived its right to a hearing. *See* 21 CFR 1309.53(c). I therefore enter this final order without a hearing based on relevant material in the investigative file and make the following findings. Findings Ephedrine and pseudoephedrine are List I chemicals that, while having therapeutic uses, are easily extracted from lawful products and used in the illicit manufacture of methamphetamine, a schedule II controlled substance. *See* 21 U.S.C. 802(34); 21 CFR 1308.12(d). As noted in numerous prior DEA orders, “methamphetamine is an extremely potent central nervous system stimulant.” *David M. Starr* , 71 FR 39367 (2006); *A-1 Distribution Wholesale* , 70 FR 28573 (2005). Methamphetamine abuse has destroyed lives and families, ravaged communities, and created serious environmental harms. *Starr* , 71 FR at 39637. Respondent is organized as a partnership which is co-owned by Mr. and Mrs. Dennis Carney. The investigate file contains additional information suggesting that Mr. Greg Glowacki, an employee of Respondent, may also have a financial interest in Respondent. Respondent is located at 2501 N. Lincoln Ave, M-3, Davenport, Iowa. The location is a unit in a storage rental facility. On July 16, 2004, Respondent, through its co-owner, submitted an application for a registration to distribute the List I chemicals ephedrine and pseudoephedrine. On November 18, 2004, two DEA Diversion Investigators

(DIs)visited Respondent at its proposed registered location to conduct a pre-registration investigation. The DIs met with Mr. Carney and discussed the nature of Respondent's business. Respondent supplies general merchandise and seasonal items to convenience stores, gas stations, and liquor stores in the Davenport, Iowa area. Respondent's business includes customers in both Iowa and Illinois. Mr. Carney advised the DIs that he was seeking registration in order to sell the following List I chemical products which contain ephedrine: Mini Two Way 12.5/200 mg. in 6 count packets, 12 count blister cards, and 48 count bottles; Twin Tabs 12.5/200 mg. in 48 count bottles; and Rapid Action 12.5/200 mg. in 48 count bottles. Mr. Carney further advised the DIs that neither he or his wife, nor his employee, had any experience in handling List I chemicals. Background checks on Mr. Carney, his wife, and Mr. Glowacki, did not find any adverse information. Respondent's proposed registered location was a 10 foot by 20 foot unit in a rental storage facility with approximately 100 units. The facility's office hours were 9 a.m. to 5 p.m., Monday through Friday. All occupants have access to the main corridor where Respondent's unit is located and can apparently obtain access to the facility at any time through use of a key-pad entry system. Moreover, the main corridor is wide enough so that a motor vehicle can be driven into the facility. The facility has at least two video cameras in place; one covers the main entrance, another covers the corridor adjacent to Respondent's unit and the loading dock. The entry system records the identification number of any person who has entered or exited the facility. In the event of a break-in, the security company notifies the local police department. Respondent's unit is protected by a padlock. Mr. Carney also told the DIs that he intended to purchase a steel storage cabinet for the List I chemical products. However, Mr. Carney has not provided documentation that the cabinet was in fact purchased. Upon entering Respondent's storage unit, the DIs observed that the unit did not have a solid ceiling. Instead, the top of the unit was comprised of wire, which was run both length and width wise at perhaps one foot intervals. 1 The DIs found that the wire could easily be tampered with and that a person could gain access to Respondent's unit from other storage units. 1 The estimates of the interval is based on the photographs. No actual measurement was taken. The DIs also discussed with Mr. Carney his firm's business practices. Mr. Carney told the DIs that he did not have any procedures to determine whether new customers are legitimate purchasers other than visiting their businesses and “checking them out.” The DIs found that Mr. Carney understood the record-keeping requirements. Mr. Carney also appears to have adequate procedures for receiving and delivering List I chemicals. Mr. Carney further told the DIs that he would not engage in any transactions triggering the reporting threshold, *see* 21 CFR 1310.04 and 1310.05, and that he would contact DEA in the event a customer placed a suspicious order. Subsequent to the pre-registration investigation, the DIs conducted customer verifications. The verifications did not uncover any adverse information. Discussion Under 21 U.S.C. 823(h), an applicant to distribute List I chemicals is entitled to be registered unless I determine that the registration would be inconsistent with the public interest. In making this determination, Congress directed that I consider the following factors:

(1)Maintenance by the applicant of effective controls against diversion of listed chemicals into other than legitimate channels;

(2)Compliance by the applicant with applicable Federal, State, and local law;

(3)Any prior conviction record of the applicant under Federal or State laws relating to controlled substances or to chemicals controlled under Federal or State law;

(4)Any past experience of the applicant in the manufacture and distribution of chemicals; and

(5)Such other factors as are relevant to and consistent with the public health and safety. *Id.* “These factors are considered in the disjunctive.” *Joy's Ideas* , 70 FR 33195, 33197 (2005). I “may rely on any one or combination of factors, and may give each factor the weight I deem appropriate in determining whether a registration should be revoked or an application for a registration be denied.” *Starr* , 71 FR 39368. *See also Energy Outlet* , 64 FR 14269 (1999). In this case, I conclude that factors one, four and five establish that Respondent's application should be denied. Factor One—Maintenance of Effective Controls Against Diversion The investigative file does not establish that Respondent would fail to properly comply with DEA's regulations pertaining to recordkeeping and reports. But “the adequacy [of an] applicant's systems for monitoring the receipt, distribution, and disposition of List I chemicals,” 21 CFR 1309.71(b)(8), is only one part of the inquiry under factor one. Determining whether an applicant will provide proper physical security of listed chemicals is also critical in evaluating the effectiveness of an applicant's controls against diversion. *See* 21 CFR 1309.71(b). Here, the investigative file establishes that Respondent's proposed location does not provide adequate security for listed chemicals for several reasons. First, Respondent's storage unit lacks an adequate ceiling. Thus, even individuals who have lawful access to the facility could easily break in to the unit. Second, DEA's regulations specifically mandate that I consider “the extent of unsupervised public access to the facility.” *Id.* 1309.71(b)(5). Here, there are 100 rental units in the facility and it is apparent that a large number of people have access to the building. Beyond that, it appears that the facility has employees on-site only from Monday through Friday, and only between the hours of 9 a.m. to 5 p.m. The facility is however, accessible 24 hours a day, every day of the year. Thus, access to the facility is largely unsupervised. Moreover, Respondent does not know whether any of the other tenants have criminal records. Nor does it control who the landlord rents to. While Respondent's owner claimed to the DIs that no other occupant of the facility would be aware that he was handling List I chemicals, it is certainly possible, if not likely, that other occupants would eventually find out either through word of mouth or by observing Respondent's employees. Perhaps none of the other tenants (and the acquaintances they may bring to the facility) is a criminal, but this is a risk I decline to assume. I thus conclude that Respondent's proposed registered location does not provide adequate security for storing listed chemicals. This factor thus weighs heavily in support of denying Respondent's application. 2 2 Having concluded that Respondent's proposed location does not provide adequate security, I do not decide whether Respondent has adequate procedures for verifying the legitimacy of customers. Factors Two and Three—Compliance With Applicable Law and the Applicant's Prior Record of Relevant Criminal Convictions While there is evidence that Respondent failed to comply with Federal regulations when it was run by its previous owner, I have already concluded that those violations are not relevant. The more important question is whether there is any evidence that either the co-owners of Respondent or its employee have failed to comply with applicable Federal, state or local laws. The investigative file does not establish that any of these persons has failed to comply with applicable laws. Relatedly, none of these persons has been convicted of a criminal offense relating to controlled substances or chemicals. I thus conclude that both of these factors support granting Respondent's application. Factor Four—Past Experience in the Manufacture or Distribution of Controlled Substances Neither of Respondent's co-owners, nor its sole employee, have any prior experience in the manufacture or distribution of List I chemicals. Because of the potential for diversion, DEA has repeatedly held that an applicant's lack of experience in distributing List I chemicals is a factor which weighs heavily against granting an application for registration. *See, e.g., Starr* , 71 FR at 39368; *Jay Enterprises* , 70 FR 24620, 24621 (2005); *ANM Wholesale* , 69 FR 11652, 11653 (2004). The fact that neither of Respondent's co-owners, nor its employee, has any experience thus provides a substantial reason to deny the application. Factor Five—Other Factors That Are Relevant to and Consistent With Public Health and Safety Numerous DEA cases recognize that the sale of certain List I chemical products by non-traditional retailers is an area of particular concern in preventing diversion of these products into the illicit manufacture of methamphetamine. *See, e.g., Joey Enterprises* , 70 FR 76866, 76867 (2005). As *Joey Enterprises* explains, “[w]hile there are no specific prohibitions under the Controlled Substances Act regarding the sale of listed chemical products to [gas stations and convenience stores], DEA has nevertheless found that [these entities] constitute sources for the diversion of listed chemical products.” *Id. See also TNT Distributors* , 70 FR 12729, 12730

(2005)(special agent testified that “80 to 90 percent of ephedrine and pseudoephedrine being used [in Tennessee] to manufacture methamphetamine was being obtained from convenience stores”); *OTC Distribution Co.* , 68 FR 70538, 70541

(2003)(noting “over 20 different seizures of [gray market distributor's] pseudoephedrine product at clandestine sites,” and that in an 8-month period distributor's product “was seized at clandestine laboratories in eight states, with over 2 million dosage units seized in Oklahoma alone.”); *MDI Pharmaceuticals* , 68 FR 4233, 4236

(2003)(finding that “pseudoephedrine products distributed by [gray market distributor] have been uncovered at numerous clandestine methamphetamine settings throughout the United States and/or discovered in the possession of individuals apparently involved in the illicit manufacture of methamphetamine”). Moreover, during clandestine lab seizures, DEA has frequently found high count List I chemical products, thus indicating that these are the preferred products for illicit methamphetamine manufacturers. *See OTC Distribution* , 68 FR at 70541, *MDI Pharmaceuticals* , 68 FR at 4236. Respondent proposed to sell similar high count products. Significantly, all of Respondent's proposed customers participate in the non-traditional market for ephedrine and pseudoephedrine products. DEA final orders recognize that there is a substantial risk of diversion of List I chemicals into the illicit manufacture of methamphetamine when these products are sold by non-traditional retailers. *See, e.g., Joy's Ideas* , 70 FR at 33199 (finding that the risk of diversion was “real, substantial and compelling”); *Jay Enterprises* , 70 FR at 24621 (noting “heightened risk of diversion” should application be granted); *Xtreme Enterprises* , 67 FR at 76197. Under DEA precedents, an applicant's proposal to sell into the non-traditional market weighs heavily against the granting of a registration under factor five. So too here. Furthermore, DEA has repeatedly denied an application when an applicant proposed to sell into the non-traditional market and analysis of one of the other statutory factors supports the conclusion that granting the application would create an unacceptable risk of diversion. Thus, in *Xtreme Enterprises* , my predecessor denied an application observing that the respondent's “lack of criminal record, compliance with the law and willingness to upgrade her security system are far outweighed by her lack of experience with selling List I chemicals and the fact that she intends to sell ephedrine almost exclusively in the gray market.” 67 FR at 76197. More recently, I denied an application observing that the respondent's “lack of a criminal record and any intent to comply with the law and regulations are far outweighed by his lack of experience and the company's intent to sell ephedrine and pseudoephedrine exclusively to the gray market.” *Jay Enterprises* , 70 FR at 24621. *Accord Prachi Enterprises,* 69 FR 69407, 69409 (2004). I also note that the State of Iowa recently enacted legislation making all ephedrine products Schedule V controlled substances. *See* 2005 Iowa Acts Ch.15, S.F. 169 (codified at Iowa Code Ann. 124.212 (West 2006)). Under Iowa law, all ephedrine products must be sold in licensed pharmacies. Therefore, it appears that none of Respondent's customers can now lawfully sell the products that Respondent proposed to distribute. 3 *See* Iowa Code Ann. 124.302. Relatedly, Respondent can not distribute ephedrine products without obtaining an Iowa controlled substances registration. *See id.* As I have previously explained, where, as here, state efforts to combat the illicit manufacture of methamphetamine are consistent with Federal policy, it is appropriate to give them due weight in determining whether the granting of a registration would be consistent with public health and safety. *See McBride Marketing* , 71 FR 35710, 35711 (2006); *Joy's Ideas* , 70 FR 33195, 33199 (2005). I thus conclude that granting Respondent's application would be inconsistent with public health and safety. 3 The Iowa Act also placed limits on the sale of pseudoephedrine products, generally limiting their sale to pharmacies except for packages of liquid, liquid capsule, and liquid-filled gel caps that contain 360 milligrams or less. Respondent also has customers in Illinois. Respondent did not, however, include any customers from Illinois in its list of potential List I chemical customers. I therefore do not consider the effect of Illinois' recently enacted Methamphetamine Precursor Control Act. In summary, there are several factors which support the conclusion that granting the application would be inconsistent with the public interest. Respondent's proposed security measures are plainly inadequate and are thus grounds alone to deny the application. Moreover, Respondent lacks experience in the distribution of List I chemicals and proposes to sell into the non-traditional market. Furthermore, none of Respondent's customers can lawfully sell ephedrine products under Iowa law. I therefore conclude that granting Respondent's application would be “inconsistent with the public interest.” 21 U.S.C. 823(h). Order Accordingly, pursuant to the authority vested in me by 21 U.S.C. 823(h) and 28 CFR 0.100(b) and 0.104, I hereby order that the application of Sujak Distributors for a DEA Certificate of Registration as a distributor of List I chemicals be, and it hereby is, *denied* . This order is effective August 24, 2006. Dated: August 16, 2006. Michele M. Leonhart, Deputy Administrator. [FR Doc. E6-14048 Filed 8-23-06; 8:45 am] BILLING CODE 4410-09-P NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-369 and 50-370] Duke Power Company LLC; Notice of Consideration of Issuance of Amendment to Facility Operating License and Opportunity for a Hearing The U.S. Nuclear Regulatory Commission (the Commission) is considering issuance of an amendment to Facility Operating Licenses NPF-9 and NPF-17, issued to Duke Power Company (the licensee), for operation of the McGuire Nuclear Station, Units 1 and 2, located in Mecklenburg County, North Carolina. The proposed amendment would revise the McGuire Nuclear Station's licensing basis to adopt the alternative source term radiological analysis methodology in accordance with Title 10 of the Code of Federal Regulations (10 CFR) section 50.67. Before issuance of the proposed license amendment, the Commission will have made findings required by the Atomic Energy Act of 1954, as amended (the Act), and the Commission's regulations. Within 60 days after the date of publication of this notice, the licensee may file a request for a hearing with respect to issuance of the amendment to the subject facility operating license and any person whose interest may be affected by this proceeding and who wishes to participate as a party in the proceeding must file a written request for a hearing and a petition for leave to intervene. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Rules of Practice for Domestic Licensing Proceedings” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309, which is available at the Commission's public document room (PDR), located at One White Flint North, Public File Area O1 F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the Agencywide Documents Access and Management System's (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site, *http://www.nrc.gov/reading-rm/doc-collections/cfr/.* If a request for a hearing or petition for leave to intervene is filed by the above date, the Commission or a presiding officer designated by the Commission or by the Chief Administrative Judge of the Atomic Safety and Licensing Board Panel, will rule on the request and/or petition; and the Secretary or the Chief Administrative Judge of the Atomic Safety and Licensing Board will issue a notice of a hearing or an appropriate order. As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner/requestor in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements:

(1)The name, address and telephone number of the requestor or petitioner;

(2)the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding;

(3)the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and

(4)the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also identify the specific contentions which the petitioner/requestor seeks to have litigated at the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner/requestor shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner must also provide references to those specific sources and documents of which the petitioner is aware and on which the petitioner intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the petitioner/requestor to relief. A petitioner/requestor who fails to satisfy these requirements with respect to at least one contention will not be permitted to participate as a party. Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing. Nontimely requests and/or petitions and contentions will not be entertained absent a determination by the Commission or the presiding officer of the Atomic Safety and Licensing Board that the petition, request and/or the contentions should be granted based on a balancing of the factors specified in 10 CFR 2.309(a)(1)(i)-(viii). A request for a hearing or a petition for leave to intervene must be filed by:

(1)First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff;

(2)courier, express mail, and expedited delivery services: Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff;

(3)E-mail addressed to the Office of the Secretary, U.S. Nuclear Regulatory Commission, *HEARINGDOCKET@NRC.GOV* ; or

(4)facsimile transmission addressed to the Office of the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC, Attention: Rulemakings and Adjudications Staff at

(301)415-1101, verification number is

(301)415-1966. A copy of the request for hearing and petition for leave to intervene should also be sent to the Office of the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and it is requested that copies be transmitted either by means of facsimile transmission to 301-415-3725 or by e-mail to *OGCMailCenter@nrc.gov.* A copy of the request for hearing and petition for leave to intervene should also be sent to Ms. Lisa F. Vaughn, Duke Power Company LLC, 422 South Church Street, Charlotte, North Carolina 28201-1006, attorney for the licensee. If a request for a hearing is received, the Commission's staff may issue the amendment after it completes its technical review and prior to the completion of any required hearing if it publishes a further notice for public comment of its proposed finding of no significant hazards consideration in accordance with 10 CFR 50.91 and 50.92. For further details with respect to this action, see the application for amendment dated December 20, 2005, as supplemented by letter dated May 4, 2006, which are available for public inspection at the Commission's PDR, located at One White Flint North, Public File Area O1 F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible electronically from the ADAMS Public Electronic Reading Room on the Internet at the NRC Web site, *http://www.nrc.gov/reading-rm/adams.html.* Persons who do not have access to ADAMS or who encounter problems in accessing the documents located in ADAMS should contact the NRC PDR Reference staff by telephone at 1-800-397-4209, or 301-415-4737, or by e-mail to *pdr@nrc.gov.* Dated at Rockville, Maryland, this 21st day of August 2006. For the Nuclear Regulatory Commission. John F. Stang, Senior Project Manager, Plant Licensing Branch II-1, Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation. [FR Doc. E6-14039 Filed 8-23-06; 8:45 am] BILLING CODE 7590-01-P SECURITIES AND EXCHANGE COMMISSION Proposed Collection; Comment Request Upon Written Request, Copies Available From: Securities and Exchange Commission, Office of Filings and Information Services, Washington, DC 20549. Extension: Rule 17i-3; SEC File No. 270-529; OMB Control No. 3235-0593. Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 1 the Securities and Exchange Commission (“Commission”) intends to submit to the Office of Management and Budget a request for extension of the previously approved collection of information discussed below. The Code of Federal Regulation citation to this collection of information is the following rule: 17 CFR 240.17i-3. 1 44 U.S.C. 3501 *et seq.* Section 231 of the Gramm-Leach-Bliley Act of 1999 2 (the “GLBA”) amended Section 17 of the Securities Exchange Act of 1934 to create a regulatory framework under which a holding company of a broker-dealer (“investment bank holding company” or “IBHC”) may voluntarily be supervised by the Commission as a supervised investment bank holding company (or “SIBHC”). 3 In 2004, the Commission promulgated rules, including Rule 17i-3, to create a framework for the Commission to supervise SIBHCs. 4 This framework includes qualification criteria for SIBHCs, as well as recordkeeping and reporting requirements. Among other things, this regulatory framework for SIBHCs is intended to provide a basis for non-U.S. financial regulators to treat the Commission as the principal U.S. consolidated, home-country supervisor for SIBHCs and their affiliated broker-dealers. 5 2 Pub. L. 106-102, 113 Stat. 1338 (1999). 3 See 15 U.S.C. 78q(i). 4 See Exchange Act Release No. 49831 (Jun. 8, 2004), 69 FR 34472 (Jun. 21, 2004). 5 See H.R. Conf. Rep. No. 106-434, 165 (1999). See also Exchange Act Release No. 49831, at 6 (Jun. 8, 2004), 69 FR 34472, at 34473 (Jun. 21, 2004). Rule 17i-3 permits an SIBHC to withdraw from Commission supervision by filing a notice of withdrawal with the Commission. The Rule requires that an SIBHC include in its notice of withdrawal a statement that it is in compliance with Rule 17i-2(c) regarding amendments to its Notice of Intention to help to assure that the Commission has updated information when considering the SIBHC's withdrawal request. The collection of information required by Rule 17i-3 is necessary to enable the Commission to evaluate whether it is necessary and appropriate in the furtherance of Section 17 of the Exchange Act for the Commission to allow an SIBHC to withdraw from supervision. Without this information, the Commission would be unable to make this evaluation. We estimate, for Paperwork Reduction Act purposes only, that one SIBHC may wish to withdraw from Commission supervision as an SIBHC over a ten-year period. Each SIBHC that withdraws from Commission supervision as an SIBHC will require approximately 24 hours to draft a withdrawal notice and submit it to the Commission. An SIBHC likely would have an attorney perform this task. Further, an SIBHC likely will have a senior attorney or executive officer review the notice of withdrawal before submitting it to the Commission, which will take approximately eight hours. Thus, we estimate that the annual, aggregate burden of withdrawing from Commission supervision as an SIBHC will be approximately 3.2 hours each year. 6 6 (1 SIBHC/every 10 years) × (24 hours to draft + 8 hours to review) = 3.2 hours. Written comments are invited on:

(a)Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b)the accuracy of the agency's estimate of the burden of the collection of information;

(c)ways to enhance the quality, utility, and clarity of the information collected; and

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments should be directed to R. Corey Booth, Director/Chief Information Officer, Securities and Exchange Commission, C/O Shirley Martinson, 6432 General Green Way, Alexandria, Virginia 22312 or send an e-mail to: *PRA_Mailbox@sec.gov.* Comments must be submitted within 60 days of this notice. Dated: August 14, 2006. J. Lynn Taylor, Assistant Secretary. [FR Doc. E6-14020 Filed 8-23-06; 8:45 am] BILLING CODE 8010-01-P SECURITIES AND EXCHANGE COMMISSION Proposed Collection; Comment Request Upon Written Request, Copies Available From: Securities and Exchange Commission, Office of Filings and Information Services; Washington, DC 20549. Extension: Rule 17i-4; SEC File No. 270-530; OMB Control No. 3235-0594. Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 1 the Securities and Exchange Commission (“Commission”) intends to submit to the Office of Management and Budget a request for extension of the previously approved collection of information discussed below. The Code of Federal Regulation citation to this collection of information is the following rule: 17 CFR 240.17i-4. 1 44 U.S.C. 3501 *et seq.* Section 231 of the Gramm-Leach-Bliley Act of 1999 2 (the “GLBA”) amended Section 17 of the Securities Exchange Act of 1934 to create a regulatory framework under which a holding company of a broker-dealer (“investment bank holding company” or “IBHC”) may voluntarily be supervised by the Commission as a supervised investment bank holding company (or “SIBHC”). 3 In 2004, the Commission promulgated rules, including Rule 17i-4, to create a framework for the Commission to supervise SIBHCs. 4 This framework includes qualification criteria for SIBHCs, as well as recordkeeping and reporting requirements. Among other things, this regulatory framework for SIBHCs is intended to provide a basis for non-U.S. financial regulators to treat the Commission as the principal U.S. consolidated, home-country supervisor for SIBHCs and their affiliated broker-dealers. 5 2 Pub. L. 106-102, 113 Stat. 1338 (1999). 3 See 15 U.S.C. 78q(i). 4 See Exchange Act Release No. 49831 (Jun. 8, 2004), 69 FR 34472 (Jun. 21, 2004). 5 See—H.R. Conf. Rep. No. 106-434, 165 (1999). See also—Exchange Act Release No. 49831, at 6 (Jun. 8, 2004), 69 FR 34472, at 34473 (Jun. 21, 2004). Rule 17i-4 requires an SIBHC to comply with present Exchange Act Rule 15c3-4 6 as though it were a broker-dealer, which requires that the firm establish, document and maintain a system of internal risk management controls to assist it in managing the risks associated with its business activities (including market, credit, operational, funding, and legal risks). In addition, Rule 17i-4 requires that an SIBHC establish, document, and maintain procedures for the detection and prevention of money laundering and terrorist financing as part of its internal risk management control system. Finally, Rule 17i-4 requires that an SIBHC periodically review its internal risk management control system for integrity of the risk measurement, monitoring, and management process, and accountability, at the appropriate organizational level, for defining the permitted scope of activity and level of risk. The records required to be created pursuant to Rule 17i-4 must be preserved for a period of not less than three years. 7 6 17 CFR 240.15c3-4. 7 17 CFR 240.17i-5(b)(5). The collection of information required pursuant to Rule 17i-4 is needed so that the Commission can adequately supervise the activities of these SIBHCs, and to allow the Commission to effectively determine whether supervision of an IBHC as an SIBHC is necessary or appropriate in furtherance of the purposes of § 17 of the Act. Without this information, the Commission would be unable to adequately supervise the SIBHC as provided for under the Exchange Act. We estimate that three IBHCs will file Notices of Intention with the Commission to be supervised by the Commission as SIBHCs. An SIBHC will require, on average, about 3,600 hours to assess its present structure, businesses, and controls, and establish and document its risk management control system. In addition, an SIBHC will require, on average, approximately 250 hours each year to maintain its risk management control system. Consequently, the total initial burden for all SIBHCs is approximately 10,800 hours 8 and the continuing annual burden is about 750 hours. 9 Thus, the total burden relating to Rule 17i-4 for all SIBHCs is approximately 11,550 hours 10 in the first year, and approximately 750 hours each year thereafter. 11 8 (3,600 hours × 3 SIBHCs) = 10,800 hours. 9 (250 hours per year × 3 SIBHCs) = 750 hours per year. 10 (3,600 hours × 3 SIBHCs) + (250 hours per year × 3 SIBHCs). 11 (250 hours per year × 3 SIBHCs). We believe that an IBHC likely would upgrade its information technology (“IT”) systems in order to more efficiently comply with certain of the SIBHC framework rules (including Rules 17i-4, 17i-5, 17i-6 and 17i-7), and that this would be a one-time cost. Depending on the state of development of the IBHC's IT systems, it would cost an IBHC between $1 million and $10 million to upgrade its IT systems to comply with the SIBHC framework of rules. Thus, on average, it would cost each of the three SIBHCs about $5.5 million to upgrade their IT systems, or approximately $16.5 million in total. It is impossible to determine what percentage of the IT systems costs would be attributable to each Rule, so we allocated the total estimated upgrade costs equally (at 25% for each of the above-mentioned Rules), with $4,125,000 attributable to Rule 17i-5. Written comments are invited on:

(a)Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b)the accuracy of the agency's estimate of the burden of the collection of information;

(c)ways to enhance the quality, utility, and clarity of the information collected; and

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication. Comments should be directed to: R. Corey Booth, Director/Chief Information Officer, Securities and Exchange Commission, C/O Shirley Martinson, 6432 General Green Way, Alexandria, Virginia 22312 or send an e-mail to: *PRA_Mailbox@sec.gov.* Comments must be submitted to OMB within 60 days of this notice. Dated: August 16, 2006. J. Lynn Taylor, Assistant Secretary. [FR Doc. E6-14022 Filed 8-23-06; 8:45 am] BILLING CODE 8010-01-P SECURITIES AND EXCHANGE COMMISSION Proposed Collection; Comment Request Upon Written Request, Copies Available From: Securities and Exchange Commission, Office of Filings and Information Services, Washington, DC 20549. Extension: Rule 17Ad-15; SEC File No. 270-360; OMB Control No. 3235-0409. Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ), the Securities and Exchange Commission (“Commission”) is soliciting comments on the collection of information summarized below. The Commission plans to submit this existing collection of information to the Office of Management and Budget for extension and approval. Rule 17Ad-15—Signature Guarantees Rule 17Ad-15 (17 CFR 240.17Ad-15) under the Securities Exchange Act of 1934 (15 U.S.C. 78a *et seq.* ) (the “Act”) requires approximately 760 transfer agents to establish written standards for the acceptance or rejection of guarantees of securities transfers from eligible guarantor institutions. Transfer agents are required to establish procedures to ensure that those standards are used by the transfer agent to determine whether to accept or reject guarantees from eligible guarantor institutions. Transfer agents must maintain, for a period of three years following the date of a rejection of transfer, a record of all transfers rejected, along with the reason for the rejection, identification of the guarantor, and whether the guarantor failed to meet the transfer agent's guarantee standard. These recordkeeping requirements assist the Commission and other regulatory agencies with monitoring transfer agents and ensuring compliance with the rule. There are approximately 760 registered transfer agents. The staff estimates that every transfer agent will spend about 40 hours annually to comply with Rule 17Ad-15. The total annual burden for all transfer agents is 30,400 hours. The average cost per hour is approximately $50. Therefore, the total cost of compliance for all transfer agents is $1,520,000. Written comments are invited on:

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimates of the burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication. Comments should be direct to: R. Corey Booth, Director/Chief Information Officer, Securities and Exchange Commission, C/O Shirley Martinson, 6432 General Green Way, Alexandria, Virginia 22312 or by sending an e-mail to: *PRA_Mailbox@sec.gov.* Comments must be submitted to OMB within 60 days of this notice. Dated: August 16, 2006. J. Lynn Taylor, Assistant Secretary. [FR Doc. E6-14023 Filed 8-23-06; 8:45 am] BILLING CODE 8010-01-P SECURITIES AND EXCHANGE COMMISSION Proposed Collection; Comment Request Upon Written Request, Copies Available From: Securities and Exchange Commission, Office of Filings and Information Services, Washington, DC 20549. Extension: Rule 17i-2, SEC File No. 270-528, OMB Control No. 3235-0592. Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 1 the Securities and Exchange Commission (“Commission”) intends to submit to the Office of Management and Budget a request for extension of the previously approved collection of information discussed below. The Code of Federal Regulation citation to this collection of information is the following rule: 17 CFR 240.17i-2. 1 44 U.S.C. 3501 *et seq.* Section 231 of the Gramm-Leach-Bliley Act of 1999 2 (the “GLBA”) amended Section 17 of the Securities Exchange Act of 1934 to create a regulatory framework under which a holding company of a broker-dealer (“investment bank holding company” or “IBHC”) may voluntarily be supervised by the Commission as a supervised investment bank holding company (or “SIBHC”). 3 In 2004, the Commission promulgated rules, including Rule 17i-2, to create a framework for the Commission to supervise SIBHCs. 4 This framework includes qualification criteria for SIBHCs, as well as recordkeeping and reporting requirements. Among other things, this regulatory framework for SIBHCs is intended to provide a basis for non-US financial regulators to treat the Commission as the principal U.S. consolidated, home-country supervisor 5 for SIBHCs and their affiliated broker-dealers. 2 Pub. L. 106-102, 113 Stat. 1338 (1999). 3 See 15 U.S.C. 78q(i). 4 See Exchange Act Release No. 49831 (Jun. 8, 2004), 69 FR 34472 (Jun. 21, 2004). 5 *See* H.R. Conf. Rep. No. 106-434, 165 (1999). See also Exchange Act Release No. 49831, at 6 (Jun. 8, 2004), 69 FR 34472, at 34473 (Jun. 21, 2004). Rule 17i-2 provides the method by which an IBHC can elect to become an SIBHC. In addition, Rule 17i-2 indicates that the IBHC will automatically become an SIBHC 45 days after the Commission receives its completed Notice of Intention unless the Commission issues an order indicating either that it will begin its supervision sooner or that it does not believe it to be necessary or appropriate in furtherance of Section 17 of the Act for the IBHC to be so supervised. Finally, Rule 17i-2 sets forth the criteria the Commission would use to make this determination. The records required to be created pursuant to Rule 17i-2 must be preserved for a period of not less than three years. 6 6 17 CFR 240.17i-5(b)(2). The collections of information required by Rule 17i-2 are necessary to allow the Commission to effectively determine whether supervision of an IBHC as an SIBHC is necessary or appropriate in furtherance of the purposes of § 17 of the Act. In addition, these collections are needed so that the Commission can adequately supervise the activities of these SIBHCs. Finally, these rules enhance the Commission's supervision of the SIBHCs' subsidiary broker-dealers through collection of additional information and inspections of affiliates of those broker-dealers. We estimate that three IBHCs will file Notices of Intention with the Commission to be supervised by the Commission as SIBHCs. Each IBHC that files a Notice of Intention to become supervised by the Commission as an SIBHC will require approximately 900 hours to draft the Notice of Intention, compile the various documents to be included with the Notice of Intention, and work with the Commission staff. Further, each IBHC likely will have an attorney review its Notice of Intention, and it will take the attorney approximately 100 hours to complete such a review. Consequently, we estimate the total one-time burden for all three firms to file their Notices of Intention would be approximately 3,000 hours. 7 Rule 17i-2 also requires that an IBHC/SIBHC update its Notice of Intention on an ongoing basis. 8 Each IBHC/SIBHC will require approximately two hours each month to update its Notice of Intention, as necessary. Thus, we estimate that it will take the three IBHC/SIBHCs, in the aggregate, about 72 hours each year to update their Notices of Intention. 9 Thus, the total burden relating to Rule 17i-2 for all SIBHCs would be approximately 3,072 hours in the first year, 10 and approximately 72 hours each year thereafter. 7 (900 hours + 100 hours) × 3 IBHCs/SIBHCs = 3,000 hours. 8 An IBHC would be required to review and update its Notice of Intention to the extent it becomes inaccurate prior to a Commission determination, and an SIBHC would be required to update its Notice of Intention if it changes a mathematical model used to calculate its risk allowances pursuant to Rule 17i-7 after a Commission determination was made. 9 (2 hours × 12 months each year) × 3 SIBHCs = 72. 10 (3,000 hours to file the Notices of Intention + 72 hours to update them). Written comments are invited on:

(a)Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b)the accuracy of the agency's estimate of the burden of the collection of information;

(c)ways to enhance the quality, utility, and clarity of the information collected; and

(10)and 17 CFR 200.402(a) (3), (5), (7), (9)(ii), and

(10)permit consideration of the scheduled matters at the Closed Meeting. Commissioner Casey, as duty officer, voted to consider the items listed for the closed meeting in closed session. The subject matters of the Closed Meeting scheduled for Tuesday, August 29, 2006 will be: Formal orders of investigation; Institution and settlement of injunctive actions; Institution and settlement of administrative proceedings of an enforcement nature; An adjudicatory matter; Requests for information in an investigative file; Litigation matter; and Other matters related to enforcement proceedings. At times, changes in Commission priorities require alterations in the scheduling of meeting items. For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact: The Office of the Secretary at

(202)551-5400. Dated: August 22, 2006. Nancy M. Morris, Secretary. [FR Doc. 06-7177 Filed 8-22-06; 3:54 pm]

Connectionstraces to 19

Traces to 19 documents

U.S. Code