Bulk Manufacturer of Controlled Substances Application: Scottsdale Research Institute, 10462 [2020-03611]

Download as PDF lotter on DSKBCFDHB2PROD with NOTICES 10462 Federal Register / Vol. 85, No. 36 / Monday, February 24, 2020 / Notices agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public’s reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format. We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the OSMRE; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the OSMRE enhance the quality, utility, and clarity of the information to be collected; and (5) how might the OSMRE minimize the burden of this collection on the respondents, including through the use of information technology. Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Abstract: Part 732 establishes the procedures and criteria for approval and disapproval of State program submissions. The information is used to evaluate whether State regulatory authorities are meeting the provisions of their approved programs. Title of Collection: Procedures and Criteria for Approval or Disapproval of State Program Submissions. OMB Control Number: 1029–0024. Form Number: None. Type of Review: Extension of a currently approved collection. Respondents/Affected Public: State and tribal regulatory authorities. Total Estimated Number of Annual Respondents: 33. Total Estimated Number of Annual Responses: 33. Estimated Completion Time per Response: Varies from 5 hours to 350 hours, depending on activity. Total Estimated Number of Annual Burden Hours: 4,765. VerDate Sep<11>2014 18:30 Feb 21, 2020 Jkt 250001 Respondent’s Obligation: Retain a Benefit. Frequency of Collection: Annually. Total Estimated Annual Nonhour Burden Cost: None. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Mark J. Gehlhar, Information Collection Clearance Officer, Division of Regulatory Support. [FR Doc. 2020–03591 Filed 2–21–20; 8:45 am] BILLING CODE 4310–05–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–593] Bulk Manufacturer of Controlled Substances Application: Scottsdale Research Institute ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before April 24, 2020. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: In accordance with 21 CFR 1301.33(a), this is notice that on October 31, 2019, Scottsdale Research Institute, 5436 E Tapekim Road, Cave Creek, Arizona 85331 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Psilocybin ..................... Psilocyn ........................ Drug code I 7437 7438 Schedule I II The company plans to bulk manufacture the above controlled substances to provide consistent medical grade active pharmaceutical ingredient (API) and reference standards for distribution to their research customers. PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 Dated: January 31, 2020. William T. McDermott, Assistant Administrator. [FR Doc. 2020–03611 Filed 2–21–20; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Jaime C. David, M.D.; Decision and Order On September 26, 2017, the Acting Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, Government), issued an Order to Show Cause (hereinafter, OSC) to Jaime C. David, M.D. (hereinafter, Registrant) of Apple Valley, California. OSC, at 1. The OSC proposed the revocation of Registrant’s Certificate of Registration No. BD9798818. Id. It alleged that Registrant is without ‘‘authority to handle controlled substances in the State of California, the state in which [Registrant is] registered with the DEA.’’ Id. (citing 21 U.S.C. 823(f) and 824(a)(3)). Specifically, the OSC alleged that the Medical Board of California (hereinafter, Board) issued an Order on August 24, 2016 revoking Registrant’s medical license effective September 23, 2016, and that such Order remains in effect. Id. The OSC further alleged that because the Board revoked Registrant’s medical license, Registrant lacks the authority to handle controlled substances in the State of California. Id. The OSC notified Registrant of the right to request a hearing on the allegations or to submit a written statement, while waiving the right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option. Id. at 2 (citing 21 CFR 1301.43). The OSC also notified Registrant of the opportunity to submit a corrective action plan. Id. at 3 (citing 21 U.S.C. 824(c)(2)(C)). Adequacy of Service In a Declaration dated April 13, 2018, a Diversion Investigator (hereinafter, DI) assigned to the Riverside Resident Office of the Los Angeles Field Division in Riverside, California, detailed her attempts to serve the OSC to Registrant. Request for Final Agency Action (hereinafter, RFAA) Ex. 3. The DI stated that she attempted to serve Registrant in person at his last known residence, 41145 Ridgegate Lane, Palmdale, California 93551 (hereinafter, the residence). Id. at 2. The DI obtained this address from a report written by the E:\FR\FM\24FEN1.SGM 24FEN1

Agencies

[Federal Register Volume 85, Number 36 (Monday, February 24, 2020)]
[Notices]
[Page 10462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03611]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-593]


Bulk Manufacturer of Controlled Substances Application: 
Scottsdale Research Institute

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before April 24, 2020.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on October 31, 2019, Scottsdale Research Institute, 5436 
E Tapekim Road, Cave Creek, Arizona 85331 applied to be registered as a 
bulk manufacturer of the following basic classes of controlled 
substances:

------------------------------------------------------------------------
                                           Drug
         Controlled  substance             code          Schedule
------------------------------------------------------------------------
Psilocybin.............................     7437  I
Psilocyn...............................     7438  I
------------------------------------------------------------------------

    The company plans to bulk manufacture the above controlled 
substances to provide consistent medical grade active pharmaceutical 
ingredient (API) and reference standards for distribution to their 
research customers.

    Dated: January 31, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-03611 Filed 2-21-20; 8:45 am]
BILLING CODE 4410-09-P