Importer of Controlled Substances Application: Scottsdale Research Institute, 20738-20739 [2021-08162]

Download as PDF 20738 Federal Register / Vol. 86, No. 75 / Wednesday, April 21, 2021 / Notices Drug code Controlled substance Etorphine HCl .......................................................................................................................................................................... Dihydrocodeine ........................................................................................................................................................................ Diphenoxylate .......................................................................................................................................................................... Ecgonine .................................................................................................................................................................................. Ethylmorphine .......................................................................................................................................................................... Levomethorphan ...................................................................................................................................................................... Levorphanol ............................................................................................................................................................................. Isomethadone .......................................................................................................................................................................... Meperidine ............................................................................................................................................................................... Meperidine intermediate–A ...................................................................................................................................................... Meperidine intermediate–B ...................................................................................................................................................... Meperidine intermediate–C ..................................................................................................................................................... Metazocine .............................................................................................................................................................................. Oliceridine (N-[(3-methoxythiophen-2yl)methyl] ({2-[9r)-9-(pyridin-2-yl)-6-oxaspiro [4.5]decan-9-yl]ethyl{time})amine fumarate). Metopon ................................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) ...................................................................................................................... Dihydroetorphine ..................................................................................................................................................................... Opium tincture ......................................................................................................................................................................... Opium, powdered .................................................................................................................................................................... Opium, granulated ................................................................................................................................................................... Noroxymorphone ..................................................................................................................................................................... Phenazocine ............................................................................................................................................................................ Thiafentanil .............................................................................................................................................................................. Piminodine ............................................................................................................................................................................... Racemethorphan ..................................................................................................................................................................... Racemorphan .......................................................................................................................................................................... Alfentanil .................................................................................................................................................................................. Remifentanil ............................................................................................................................................................................. Sufentanil ................................................................................................................................................................................. Carfentanil ............................................................................................................................................................................... Tapentadol ............................................................................................................................................................................... Bezitramide .............................................................................................................................................................................. Moramide-intermediate ............................................................................................................................................................ The company plans to import small quantities of the listed controlled substances for the National Institute on Drug Abuse for research activities. The company plans to import analytical reference standards for distribution to its customers for research and analytical purposes. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. William T. McDermott, Assistant Administrator. [FR Doc. 2021–08166 Filed 4–20–21; 8:45 am] khammond on DSKJM1Z7X2PROD with NOTICES BILLING CODE P VerDate Sep<11>2014 18:12 Apr 20, 2021 Jkt 253001 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–822] Importer of Controlled Substances Application: Scottsdale Research Institute Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Scottsdale Research Institute has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTAL INFORMATION listed below for further drug information. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before May 21, 2021. Such persons may also file a written request for a hearing on the application on or before May 21, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia SUMMARY: PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 Schedule 9059 9120 9170 9180 9190 9210 9220 9226 9230 9232 9233 9234 9240 9245 II II II II II II II II II II II II II II 9260 9273 9334 9630 9639 9640 9668 9715 9729 9730 9732 9733 9737 9739 9740 9743 9780 9800 9802 II II II II II II II II II II II II II II II II II II II 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on January 28, 2021, Scottsdale Research Institute, 5436 East Tapekim Road, Cave Creek, Arizona 85331, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Controlled substance Marihuana ........................ Tetrahydrocannabinols .... Psilocybin ........................ Psilocyn ........................... Drug code Schedule 7360 7370 7437 7438 I I I I The company plans to import Marijuana (7360) and Tetrahydrocannabinols (7370) as E:\FR\FM\21APN1.SGM 21APN1 Federal Register / Vol. 86, No. 75 / Wednesday, April 21, 2021 / Notices flowering plants to support analytical purposes, research, and the manufacturing of dosage forms for clinical trials. This notice does not constitute an evaluation or determination of the merits of the company’s application. The company plans to import fungi material from which Psilocybin (7437) and Psilocyn (7438) will be produced for further manufacturing prior to use in research and clinical trials. No other activity for these drug codes is authorized for this registration. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. William T. McDermott, Assistant Administrator. [FR Doc. 2021–08162 Filed 4–20–21; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE [CPCLO Order No. 001–2021] Privacy Act of 1974; Systems of Records Justice Management Division, United States Department of Justice. ACTION: Notice of a new system of records. AGENCY: Pursuant to the Privacy Act of 1974 and Office of Management and Budget (OMB) Circular No. A–108, notice is hereby given that the Justice Management Division, (JMD), a component within the United States Department of Justice (DOJ or ‘‘the Department’’), proposes to develop a new system of records notice titled, ‘‘DOJ Personnel Public Health Emergency Records System,’’ JUSTICE/ JMD–025. JMD proposes to establish this system of records to protect the Department’s workforce and respond to Coronavirus Disease 2019 (COVID–19), a declared public health emergency, and other high-consequence public health threats. DATES: In accordance with 5 U.S.C. 552a(e)(4) and (11), this notice is effective upon publication, subject to a 30-day period in which to comment on the routine uses, described below. Please submit any comments by May 21, 2021. ADDRESSES: The public, OMB, and Congress are invited to submit any comments by mail to the United States khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:12 Apr 20, 2021 Jkt 253001 Department of Justice, Office of Privacy and Civil Liberties, ATTN: Privacy Analyst, Two Constitution Square (2CON), 145 N Street, NE, Suite 8W.300, Washington, DC 20530; by facsimile at 202–307–0693; or by email at privacy.compliance@usdoj.gov. To ensure proper handling, please reference the above CPCLO Order No. on your correspondence. FOR FURTHER INFORMATION CONTACT: Michael H. Allen, Deputy Assistant Attorney General, Policy, Management, and Procurement, 950 Pennsylvania Avenue NW, Washington, DC 20530– 0001, (202) 514–3101. SUPPLEMENTARY INFORMATION: This system of records covers information necessary and relevant to Department activities responding to and mitigating COVID–19 and other high-consequence public health threats, and diseases or illnesses relating to a public health emergency. Such information may include information on Department personnel, including employees, interns, and contractors, who have contracted or may have been exposed to a suspected or confirmed disease or illness that is the subject of a declared public health emergency or who undergo preventative testing for, or receive a vaccination to prevent, a disease or illness that is the subject of a declared public health emergency, in accordance with federal, state, or local public health orders. The information collected may include identifying and contact information of individuals who have been suspected or confirmed to have contracted a disease or illness, or who have been exposed to an individual who had been suspected or confirmed to have contracted a disease or illness, related to a declared public health emergency; individual circumstances and dates of suspected exposure; testing results, symptoms, and treatments; vaccination records; health status information; and other information necessary and relevant to Department activities responding to and mitigating COVID–19 and other high-consequence public health threats and diseases or illnesses relating to a public health emergency. The Department maintains this information to understand the impact of an illness or disease on the Department workforce, and to assist in reducing the spread of the disease or illness among Department personnel. In certain instances, depending on the type of record collected and maintained, records maintained in this system of records may also be covered by Office of Personnel Management/Government10 Employee Medical File System Records, 75 FR 35,099 (June 21, 2010). PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 20739 However, JUSTICE/JMD–025 covers additional records—specifically records collected in response to COVID–19, a high-consequence public health threat, as well as other declared public health emergencies. When collecting information on Department employees, there are several employment laws that govern the collection, dissemination, and retention of employee medical information. These employment laws include the Americans with Disability Act (ADA), the Rehabilitation Act of 1973 (Rehab Act), and the Occupational Safety and Health Act of 1970 (OSH Act). Generally, under federal employment laws, medical information pertaining to employees is confidential and may be obtained by an employer only for certain reasons and only at certain points in the employment relationship. In response to a high-consequence public health threat such as COVID–19, or relating to other public health emergencies, an employer may be permitted to collect certain employee medical information that it would not otherwise be permitted to collect, depending upon the circumstances. This system of records will apply if it is determined that the circumstances permit the Department to legally collect the employee medical information at issue. Further, this system of records notice (SORN) includes a reference to the Genetic Information Nondiscrimination Act of 2008 (GINA), 42 U.S.C. 2000ff to ff-11. Title II of GINA prohibits employment discrimination based on genetic information, including family medical history; restricts the circumstances under which employers may lawfully acquire applicants’ and employees’ genetic information; and prohibits the disclosure of applicants’ and employees’ genetic information, with limited exceptions, including those stated in 42 U.S.C. 2000ff–5(b) and 29 CFR 1635.9(b). The Department may request the circumstances of an individual’s suspected or actual exposure to a disease or illness, including the source of exposure. Although it is not the intent for the Department to collect family medical information, an individual may indicate that they were exposed to specific family members who have been diagnosed with, or are suspected to have, the disease or illness in question. To the extent this information may be acquired inadvertently, such information will be kept as a ‘‘confidential medical record’’ and maintained separately from an employee’s general medical files, E:\FR\FM\21APN1.SGM 21APN1

Agencies

[Federal Register Volume 86, Number 75 (Wednesday, April 21, 2021)]
[Notices]
[Pages 20738-20739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08162]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-822]


Importer of Controlled Substances Application: Scottsdale 
Research Institute

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Scottsdale Research Institute has applied to be registered as 
an importer of basic class(es) of controlled substance(s). Refer to 
Supplemental Information listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before May 21, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before May 21, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for a hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on January 28, 2021, Scottsdale Research Institute, 5436 
East Tapekim Road, Cave Creek, Arizona 85331, applied to be registered 
as an importer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Marihuana...............................    7360  I
Tetrahydrocannabinols...................    7370  I
Psilocybin..............................    7437  I
Psilocyn................................    7438  I
------------------------------------------------------------------------

    The company plans to import Marijuana (7360) and 
Tetrahydrocannabinols (7370) as

[[Page 20739]]

flowering plants to support analytical purposes, research, and the 
manufacturing of dosage forms for clinical trials. This notice does not 
constitute an evaluation or determination of the merits of the 
company's application.
    The company plans to import fungi material from which Psilocybin 
(7437) and Psilocyn (7438) will be produced for further manufacturing 
prior to use in research and clinical trials. No other activity for 
these drug codes is authorized for this registration.
    Approval of permit applications will occur only when the 
registrant's business activity is consistent with what is authorized 
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import 
of Food and Drug Administration-approved or non-approved finished 
dosage forms for commercial sale.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-08162 Filed 4-20-21; 8:45 am]
BILLING CODE P
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