Bulk Manufacturer of Controlled Substances Application: Cambridge Isotope Lab, 61074-61075 [2019-24544]

Download as PDF 61074 Federal Register / Vol. 84, No. 218 / Tuesday, November 12, 2019 / Notices projects and programs in the following technology areas: Multi-function Materials, Cyber, Big Data Analytics/ Artificial Intelligence/Machine Learning, Directed Energy Science & Engineering, Advanced Computing and Software Engineering, Autonomous and Unmanned Systems, Sensor Systems, Gun and Projectile Systems, Digital Engineering, Human Systems Integration, Quantum Technologies, Threat Engineering, Mission Engineering and Analysis, Integrated Warfare Systems, Virtualization, Asymmetric Warfare, Manufacturing, Lethality, Surface Offensive & Defensive Engagements, and Launcher Technology. Suzanne Morris, Chief, Premerger and Division Statistics Unit, Antitrust Division. [FR Doc. 2019–24483 Filed 11–8–19; 8:45 am] BILLING CODE 4410–11–P Controlled substance Drug code Levorphanol ................... Morphine ........................ Oripavine ....................... Thebaine ........................ Oxymorphone ................ Noroxymorphone ........... Tapentadol ..................... Fentanyl ......................... 9220 9300 9330 9333 9652 9668 9780 9801 Schedule II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for conversion and sale to finished dosage form manufacturers. In reference to drug codes 7360 (marihuana), and 7370 (tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic cannabidiol (CBD) and tetrahydrocannabinol (THC). No other activities for drug codes 7360 and 7370 are authorized for this registration. Dated: October 30, 2019. William T. McDermott, Assistant Administrator. DEPARTMENT OF JUSTICE [FR Doc. 2019–24545 Filed 11–8–19; 8:45 am] Drug Enforcement Administration BILLING CODE 4410–09–P [Docket No. DEA–541] DEPARTMENT OF JUSTICE Bulk Manufacturer of Controlled Substances Application: Rhodes Technologies ACTION: Drug Enforcement Administration 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 January 13, 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 August 16, 2019, Rhodes Technologies, 498 Washington Street, Coventry, Rhode Island 02816 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: DATES: Controlled substance Marihuana ...................... Tetrahydrocannabinols .. Dihydromorphine ........... Methylphenidate ............ Codeine ......................... Dihydrocodeine .............. Oxycodone .................... Hydromorphone ............. Hydrocodone ................. VerDate Sep<11>2014 Drug code 7360 7370 9145 1724 9050 9120 9143 9150 9193 17:47 Nov 08, 2019 Schedule I I I II II II II II II Jkt 250001 Lisdexamfetamine .. Methylphenidate ..... ANPP (4-Anilino-Nphenethyl-4-piperidine). Phenylacetone ........ Cocaine .................. Codeine .................. Oxycodone ............. Hydromorphone ...... Hydrocodone .......... Morphine ................. Oripavine ................ Thebaine ................. Opium extracts ....... Opium fluid extract Opium tincture ........ Opium, powdered ... Oxymorphone ......... Noroxymorphone .... Fentanyl .................. Schedule 1205 1724 8333 II II II 8501 9041 9050 9143 9150 9193 9300 9330 9333 9610 9620 9630 9639 9652 9668 9801 II II II II II II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for conversion to other controlled substances and sale to its customers, for dosage form development, for clinical trials, and for use in stability qualification studies. Dated: October 30, 2019. William T. McDermott, Assistant Administrator. BILLING CODE 4410–09–P Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City ACTION: Drug code [FR Doc. 2019–24543 Filed 11–8–19; 8:45 am] [Docket No. DEA–539] Notice of application. Controlled substance DEPARTMENT OF JUSTICE Drug Enforcement Administration Notice of application. [Docket No. DEA–534] 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 January 13, 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 May 15, 2019, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616–3466 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Drug code Gamma Hydroxybutyric Acid. Amphetamine ......... PO 00000 Frm 00070 Fmt 4703 Schedule 2010 I 1100 II Sfmt 4703 Bulk Manufacturer of Controlled Substances Application: Cambridge Isotope Lab 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 January 13, 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 July 24, 2019 Cambridge Isotope Lab, 50 Frontage Road, Andover, Massachusetts 01810–5413 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: DATES: E:\FR\FM\12NON1.SGM 12NON1 61075 Federal Register / Vol. 84, No. 218 / Tuesday, November 12, 2019 / Notices Controlled substance Drug code Schedule Tetrahydrocannabinols ................................................................................................................................ 7370 I The company plans to synthetically bulk manufacture the controlled substance to produce analytical standards for distribution to its customers. No other activity for this drug code is authorized for this registration. Dated: October 29, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–24544 Filed 11–8–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [OMB Number: 1103–0117] Agency Information Collection Activities; Proposed eCollection; eComments Requested; Extension of a Currently Approved Collection; Departmental Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery All components, Department of Justice. ACTION: 30-Day notice. AGENCY: As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, Department of Justice will be submitting a Generic Information Collection Request (Generic ICR): ‘‘Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery’’ to OMB for approval under the Paperwork Reduction Act (PRA). DATES: The purpose of this notice is to allow 30 days for public comment until December 12, 2019. FOR FURTHER INFORMATION CONTACT: If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Melody Braswell, Department Clearance Officer, melody.braswell2@usdoj.gov; or the DOJ Clearance Officer at 202–307– 0890. SUPPLEMENTARY INFORMATION: Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: SUMMARY: VerDate Sep<11>2014 17:47 Nov 08, 2019 Jkt 250001 —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; —Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Evaluate the quality, utility, and clarity of the information to be collected; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Collection: Title: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery. Abstract: The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration’s commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential nonresponse bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results. Below we provide the Department of Justice’s projected average estimates for the next three years: Current Action: Extension. Type of Review: Extension of a currently approved collection. Affected Public: Individuals and Households, Businesses and Organizations, State, Local or Tribal Government. Average Expected Annual Number of Activities: 42. Average Number of Respondents per Activity: 51,500. Annual Responses: 309,000. Frequency of Response: Once per request. Average Minutes per Response: 30 min. Burden Hours: 99,847. Federal Government Cost: $176,925. 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 Office of Management and Budget control number. If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405B, Washington, DC 20530. Dated: November 5, 2019. Melody D. Braswell, Department Clearance Officer for PRA, U.S. Department of Justice. Written comments and suggestions from the public and affected agencies concerning the proposed collection of E:\FR\FM\12NON1.SGM 12NON1

Agencies

[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Notices]
[Pages 61074-61075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24544]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-534]


Bulk Manufacturer of Controlled Substances Application: Cambridge 
Isotope Lab

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 January 13, 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 July 
24, 2019 Cambridge Isotope Lab, 50 Frontage Road, Andover, 
Massachusetts 01810-5413 applied to be registered as a bulk 
manufacturer of the following basic classes of controlled substances:

[[Page 61075]]



------------------------------------------------------------------------
      Controlled substance             Drug code           Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols...........               7370                   I
------------------------------------------------------------------------

    The company plans to synthetically bulk manufacture the controlled 
substance to produce analytical standards for distribution to its 
customers. No other activity for this drug code is authorized for this 
registration.

    Dated: October 29, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-24544 Filed 11-8-19; 8:45 am]
 BILLING CODE 4410-09-P
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