Importer of Controlled Substances Application: Groff NA Hemplex LLC, 76855-76856 [2023-24575]

Download as PDF Federal Register / Vol. 88, No. 214 / Tuesday, November 7, 2023 / Notices Notice of request for public comments. ACTION: In accordance with the provisions of the Paperwork Reduction Act of 1995, the U.S. International Trade Commission (Commission or USITC) hereby gives notice that it plans to submit a request for approval of a questionnaire to the Office of Management and Budget (OMB) for review and requests public comment on its draft proposed collection. DATES: To ensure that the Commission will consider your comments, it must receive them no later than 60 days after publication of this notice in the Federal Register. ADDRESSES: All Commission offices are in the U.S. International Trade Commission Building, 500 E Street SW, Washington, DC. FOR FURTHER INFORMATION CONTACT: Please direct all questions to the project team via email at sa.emissions@ usitc.gov or via phone to Shova KC at 202–205–2234. The public record for this investigation may be viewed on the Commission’s electronic docket (EDIS) at https://edis.usitc.gov. General information concerning the Commission may be obtained by accessing its internet address (https://www.usitc.gov). Hearing-impaired individuals are advised that information on this matter can be obtained by contacting the TDD terminal on 202–205–1810. SUPPLEMENTARY INFORMATION: The information requested by the questionnaire is for use by the Commission in connection with Investigation No. 332–598, Greenhouse Gas Emissions Intensities of the U.S. Steel and Aluminum Industries at the Product Level, instituted under the authority of section 332(g) of the Tariff Act of 1930 (19 U.S.C. 1332(g)). This investigation and report were requested by the United States Trade Representative (USTR) on June 5, 2023. This investigation was initiated on July 5, 2023, and the notice of investigation was published in the Federal Register on July 10, 2023 (88 FR 43633). The Commission will deliver its report to USTR by January 28, 2025. As stated in the notice of investigation, the USTR requested that the Commission’s report include greenhouse gas (GHG) emissions intensities of covered steel and aluminum products produced in the United States. Such information is not available in the requested specificity from governmental or other public sources. The Commission indicated in its notice of investigation that it will khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:30 Nov 06, 2023 Jkt 262001 need to obtain much of such data and information through a survey. The survey will assist the Commission in developing, as requested, GHG emissions intensities which reflect scope 1 and scope 2 GHG emissions associated with production of covered steel and aluminum products produced at facilities in the United States, as well as certain scope 3 GHG emissions associated with the upstream intermediate inputs into these products. Summary of Proposal: The Commission intends to submit the following draft information collection plan to OMB and invites public comment. (1) Number of forms submitted: 2. (2) Title of forms: Greenhouse Gas (GHG) Emissions Intensity Questionnaire, Company-level and Facility-level. (3) Type of request: New. (4) Frequency of use: Industry questionnaire, single data gathering in two-step collection, scheduled for 2024. (5) Description of respondents: U.S. companies and facilities that produce covered steel and aluminum products. (6) Estimated number of respondents: 1,000 companies and 2,500 facilities. (7) Estimated total number of hours to complete the questionnaire per respondent: 1 hour per company, 25 hours per facility. (8) Information obtained from the questionnaire will be treated as confidential business information by the Commission and not disclosed in a manner that would reveal the individual operations of a business. Method of Collection: The proposed collection is a two-step data collection. First, identified steel and aluminum companies will be sent a letter and/or email with a link and individual questionnaire token for accessing the online questionnaire’s section 1.1. This step involves the company providing information (including contact information) on the facilities it owns that produce covered steel and/or aluminum products. Once submitted by the company, each facility identified will receive a questionnaire token and link to complete the remainder of the questionnaire applicable to that facility. Respondents will be able to download a PDF version of the questionnaire to see all questions in their entirety, but this PDF will not be accepted as a submission. Request for Comments: Comments are invited on (1) the elements of the draft questionnaire; (2) whether the proposed collection of information is necessary; (3) the accuracy of the agency’s estimate of the burden of the proposed information collection (4) ways to PO 00000 Frm 00137 Fmt 4703 Sfmt 4703 76855 enhance the quality, utility, and clarity of the information to be collected; and (5) 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. The draft questionnaire and other supplementary documents may be downloaded from the USITC website at https://www.usitc.gov/saemissions. Any comments on the draft questionnaire should be sent via email at sa.emissions@usitc.gov. Comments submitted in response to this notice will be summarized and included in the request for OMB approval of this information collection; they will also become a matter of public record. As such, proprietary or confidential business information should not be submitted as part of comments on the draft questionnaire. By order of the Commission. Issued: November 2, 2023. Lisa Barton, Secretary to the Commission. [FR Doc. 2023–24572 Filed 11–6–23; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1289] Importer of Controlled Substances Application: Groff NA Hemplex LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Groff NA Hemplex LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before December 7, 2023. Such persons may also file a written request for a hearing on the application on or before December 7, 2023. ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for SUMMARY: E:\FR\FM\07NON1.SGM 07NON1 76856 Federal Register / Vol. 88, No. 214 / Tuesday, November 7, 2023 / Notices submitting comments. Upon submission of your comment, you will receive a Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. All requests for a hearing must 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. All requests for a hearing should also be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on September 19, 2023, Groff NA Hemplex LLC, 100 Redco Avenue, Suite A, Red Lion, Pennsylvania 17356–1436, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Controlled substance Drug code Marihuana Extract .................................................................................................................................................... Marihuana ................................................................................................................................................................ Tetrahydrocannabinols ............................................................................................................................................ The company plans to import the listed controlled substances in bulk form to manufacture research grade material for clinical trial studies. Several types of Marihuana Extract compounds are listed under drug code 7350. No other activities for these drug codes are 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. Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2023–24575 Filed 11–6–23; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration khammond on DSKJM1Z7X2PROD with NOTICES Jagjit Kaleka, D.V.M.; Decision and Order On February 25, 2022, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to Jagjit Kaleka, D.V.M. (Respondent), of Mauston, Wisconsin. Request for Final Agency Action (RFAA), Government Exhibit (RFAAX) 13, at 1, 5. The OSC proposed the revocation of Respondent’s DEA Certificate of Registration (registration), Control No. AK7830640, alleging that Respondent has ‘‘committed such acts as would render [his] registration inconsistent with the public interest.’’ Id. at 1, 2 (citing 21 U.S.C. 824(a)(4), 823(g)(1) 1). 1 Effective December 2, 2022, the Medical Marijuana and Cannabidiol Research Expansion VerDate Sep<11>2014 16:30 Nov 06, 2023 Jkt 262001 The Agency makes the following findings of fact based on the uncontroverted evidence submitted by the Government in its RFAA dated April 6, 2023.2 I. Findings of Fact According to the Declaration of a DEA Diversion Investigator (the DI), Respondent was the owner of and a veterinarian at Mauston Pet Hospital (the Pet Hospital). RFAA, Declaration of Diversion Investigator (Declaration), at 2. From June 21, 2019, through February 22, 2021, the Pet Hospital purchased 500 tablets of 10 mg oxycodone (Schedule II), 1000 tablets of 2 mg alprazolam (Schedule IV), and 100 tablets of 5 mg zolpidem (Schedule IV). Id.; see also RFAAX 2; RFAAX 9. On June 8, 2021, the DI served a Notice of Inspection at the Pet Hospital, and Respondent consented to an inspection of the premises. Declaration, at 2; see also RFAAX 7. Prior to the inspection, the DI asked Respondent to take an inventory of all controlled substances at the Pet Hospital,3 and on the day of the inspection, the DI asked Respondent to produce a biennial inventory, which Respondent was unable to produce. Declaration, at 2, 4. During the inspection, Respondent denied personally ordering the controlled substances in question, Act, Pub. L. 117–215, 136 Stat. 2257 (2022) (Marijuana Research Amendments or MRA), amended the Controlled Substances Act (CSA) and other statutes. Relevant to this matter, the MRA redesignated 21 U.S.C. 823(f), cited in the OSC, as 21 U.S.C. 823(g)(1). Accordingly, this Decision cites to the current designation, 21 U.S.C. 823(g)(1), and to the MRA-amended CSA throughout. 2 By letter dated March 14, 2022, Respondent requested a hearing. RFAAX 15, at 1. On May 16, 2022, Respondent withdrew his hearing request and Chief Administrative Law Judge John J. Mulrooney, II, issued an Order Terminating Proceedings. RFAAX 16; RFAAX 17. 3 On June 6, 2021, Respondent emailed the DI a document titled ‘‘Controlled Drug Inventory 5–25– 2021.’’ Declaration, at 4; see also RFAAX 6. PO 00000 Frm 00138 Fmt 4703 Sfmt 4703 7350 7360 7370 Schedule I I I namely, oxycodone, alprazolam, and zolpidem. Declaration, at 2.4 The DI explained that despite the Pet Hospital’s purchases, ‘‘[n]one of these drugs could be located on the premises and there were no records showing that the drugs had been dispensed, lost, stolen, or otherwise disposed of.’’ Id. at 2, 3.5 Further, ‘‘[t]hough Respondent denied knowledge that [G.K., another practitioner at the Pet Hospital,] had been using the Pet Hospital’s account to purchase and obtain controlled substances for other than a legitimate medical purpose in the usual course of veterinary practice, Respondent [admitted that he] was aware of at least one incident during which [G.K.] purchased and received alprazolam.’’ Id.6 Notably, Respondent admitted that 4 As noted by the DI, the most recent invoice indicated that Respondent himself purchased 100 tablets of 2 mg alprazolam under his own DEA registration; all of the other invoices for the controlled substance purchases in question showed that the controlled substances were shipped to another practitioner at the Pet Hospital, G.K. Id. at 2–3; see also RFAAX 2, at 66; RFAAX 8, at 1; RFAAX 9, at 3. Respondent also admitted that his wife paid for all of the controlled substances ordered for the Pet Hospital. Declaration, at 3. 5 Though unable to produce dispensing records for the controlled substances in question, Respondent was able to produce dispensing records for other controlled substances. Id. at 3; see also RFAAX 4. According to the DI, these other dispensing records were commingled with records of other practitioners, including G.K., and because the records lacked detail, the DI was unable to determine which controlled substances had been dispensed by Respondent. Id. Because there were no records showing the disposition of the oxycodone, alprazolam, or zolpidem in question, the DI was unable to confirm whether the drugs had been purchased for a legitimate medical purpose; moreover, there was no evidence that Respondent had contacted any law enforcement agency to report the diversion of any oxycodone, alprazolam, or zolpidem. Declaration, at 3. 6 Respondent admitted to DI that he observed G.K. receiving a shipment of alprazolam in 2019; specifically, Respondent observed G.K. meet a delivery driver outside the Pet Hospital who gave G.K. several boxes that G.K. then placed in his personal vehicle. Id. Respondent stated that he then E:\FR\FM\07NON1.SGM 07NON1

Agencies

[Federal Register Volume 88, Number 214 (Tuesday, November 7, 2023)]
[Notices]
[Pages 76855-76856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24575]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1289]


Importer of Controlled Substances Application: Groff NA Hemplex 
LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

-----------------------------------------------------------------------

SUMMARY: Groff NA Hemplex LLC has applied to be registered as an 
importer of basic class(es) of controlled substance(s). Refer to 
SUPPLEMENTARY INFORMATION listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may submit electronic comments on or 
objections to the issuance of the proposed registration on or before 
December 7, 2023. Such persons may also file a written request for a 
hearing on the application on or before December 7, 2023.

ADDRESSES: The Drug Enforcement Administration requires that all 
comments be submitted electronically through the Federal eRulemaking 
Portal, which provides the ability to type short comments directly into 
the comment field on the web page or attach a file for lengthier 
comments. Please go to https://www.regulations.gov and follow the 
online instructions at that site for

[[Page 76856]]

submitting comments. Upon submission of your comment, you will receive 
a Comment Tracking Number. Please be aware that submitted comments are 
not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number, 
your comment has been successfully submitted and there is no need to 
resubmit the same comment. All requests for a hearing must 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. All requests 
for a hearing should also be sent to: Drug Enforcement Administration, 
Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 
22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on September 19, 2023, Groff NA Hemplex LLC, 100 Redco 
Avenue, Suite A, Red Lion, Pennsylvania 17356-1436, applied to be 
registered as an importer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
          Controlled substance               Drug code       Schedule
------------------------------------------------------------------------
Marihuana Extract.......................            7350               I
Marihuana...............................            7360               I
Tetrahydrocannabinols...................            7370               I
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
bulk form to manufacture research grade material for clinical trial 
studies. Several types of Marihuana Extract compounds are listed under 
drug code 7350. No other activities for these drug codes are 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.

Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-24575 Filed 11-6-23; 8:45 am]
BILLING CODE 4410-09-P
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