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